5-aminolevulinic acid (Ameluz)
5-aminolevulinic acid [1], breast-feeding ---> SmPC of [1] of EMA
A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued for 12 hours after treatment with Ameluz.
5-aminolevulinic acid [1], fertility ---> SmPC of [1] of EMA
There are no data available on the effect of 5-aminolaevulinic acid on fertility.
5-aminolevulinic acid [1], griseofulvin ---> SmPC of [1] of EMA
Concomitant use of medicinal products with known phototoxic or photoallergic potential may enhance the phototoxic reaction to photodynamic therapy.
5-aminolevulinic acid [1], phenothiazines ---> SmPC of [1] of EMA
Concomitant use of medicinal products with known phototoxic or photoallergic potential may enhance the phototoxic reaction to photodynamic therapy.
5-aminolevulinic acid [1], photosensitizing agents ---> SmPC of [1] of EMA
Concomitant use of medicinal products with known phototoxic or photoallergic potential may enhance the phototoxic reaction to photodynamic therapy.
5-aminolevulinic acid [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure, it is preferable to avoid the use of Ameluz during pregnancy.
5-aminolevulinic acid [1], quinolones ---> SmPC of [1] of EMA
Concomitant use of medicinal products with known phototoxic or photoallergic potential may enhance the phototoxic reaction to photodynamic therapy.
5-aminolevulinic acid [1], St. John's wort ---> SmPC of [1] of EMA
Concomitant use of medicinal products with known phototoxic or photoallergic potential may enhance the phototoxic reaction to photodynamic therapy.
5-aminolevulinic acid [1], sulfonylureas ---> SmPC of [1] of EMA
Concomitant use of medicinal products with known phototoxic or photoallergic potential may enhance the phototoxic reaction to photodynamic therapy.
5-aminolevulinic acid [1], sulphonamides ---> SmPC of [1] of EMA
Concomitant use of medicinal products with known phototoxic or photoallergic potential may enhance the phototoxic reaction to photodynamic therapy.
5-aminolevulinic acid [1], sun ---> SmPC of [1] of EMA
As a general precaution, sun exposure on the treated lesion sites and surrounding skin should be avoided for approximately 48 hours following treatment.
5-aminolevulinic acid [1], tetracyclines ---> SmPC of [1] of EMA
Concomitant use of medicinal products with known phototoxic or photoallergic potential may enhance the phototoxic reaction to photodynamic therapy.
5-aminolevulinic acid [1], thiazides ---> SmPC of [1] of EMA
Concomitant use of medicinal products with known phototoxic or photoallergic potential may enhance the phototoxic reaction to photodynamic therapy.
5-aminolevulinic acid [1], topical application ---> SmPC of [1] of EMA
Ameluz does not significantly increase the natural plasma levels of 5-aminolaevulinic acid or protoporphyrin IX following topical application (see section 5.2).
5-aminolevulinic acid, hypericin extract
Increased phototoxic reaction
CONTRAINDICATIONS of 5-aminolevulinic acid (Ameluz)
- Hypersensitivity to the active substance, to porphyrins or to any of the excipients listed in section 6.1.
- Porphyria.
- Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematoides or phemphigus erythemtoides.
https://www.ema.europa.eu/en/documents/product-information/ameluz-epar-product-information_en.pdf 05/03/2024
Other trade names: Gliolan,
Abacavir (Ziagen)
Abacavir [1], ability to drive ---> SmPC of [1] of EMA
No studies on the effects on ability to drive and use machines have been performed.
Abacavir [1], alcohol ---> SmPC of [1] of EMA
The metabolism of abacavir is altered by concomitant ethanol resulting in an increase in AUC of abacavir of about 41%. These findings are not considered clinically significant.
Abacavir [1], breast-feeding ---> SmPC of [1] of EMA
There are no data available on the safety of abacavir when administered to babies less than three months old. It is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV.
Abacavir [1], CYP450 ---> SmPC of [1] of EMA
P450 does not play a major role in the metabolism of abacavir, and abacavir shows limited potential to inhibit metabolism mediated by CYP 3A4.
Abacavir [1], didanosine ---> SmPC of [1] of EMA
Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Abacavir [1], ethanol ---> SmPC of [1] of EMA
Riociguat dose may need to be reduced. Consult the riociguat prescribing information for dosing recommendations.
Abacavir [1], fertility ---> SmPC of [1] of EMA
Studies in animals showed that abacavir had no effect on fertility (see section 5.3).
Abacavir [1], glucuronidation inductors ---> SmPC of [1] of EMA
Potent enzymatic inducers such as rifampicin, phenobarbital and phenytoin may via their action on UDP-glucuronyltransferases slightly decrease the plasma concentrations of abacavir.
Abacavir [1], methadone ---> SmPC of [1] of EMA
In a pharmacokinetic study abacavir increased the mean methadone systemic clearance by 22%. The induction of drug metabolising enzymes cannot therefore be excluded.
Abacavir [1], mitochondrial dysfunction ---> SmPC of [1] of EMA
There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).
Abacavir [1], mitochondrial function ---> SmPC of [1] of EMA
Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Abacavir [1], phenobarbital ---> SmPC of [1] of EMA
Potent enzymatic inducers such as rifampicin, phenobarbital and phenytoin may via their action on UDP-glucuronyltransferases slightly decrease the plasma concentrations of abacavir.
Abacavir [1], phenytoin ---> SmPC of [1] of EMA
Potent enzymatic inducers such as rifampicin, phenobarbital and phenytoin may via their action on UDP-glucuronyltransferases slightly decrease the plasma concentrations of abacavir.
Abacavir [1], pregnancy ---> SmPC of [1] of EMA
Placental transfer of abacavir and/or its related metabolites has been shown to occur in human.
Abacavir [1], retinoids ---> SmPC of [1] of EMA
Retinoid compounds are eliminated via alcohol dehydrogenase. Interaction with abacavir is possible but has not been studied.
Abacavir [1], ribavirin ---> SmPC of [1] of EMA
As abacavir and ribavirin share the same phosphorylation pathways, a possible intracellular interaction between these drugs has been postulated, which could lead to a reduction in intracellular phosphorylated metabolites of ribavirin
Abacavir [1], rifampicin ---> SmPC of [1] of EMA
Potent enzymatic inducers such as rifampicin, phenobarbital and phenytoin may via their action on UDP-glucuronyltransferases slightly decrease the plasma concentrations of abacavir.
Abacavir [1], stavudine ---> SmPC of [1] of EMA
Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Abacavir [1], zidovudine ---> SmPC of [1] of EMA
Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Abacavir, alcohol dehydrogenase inductors
The induction of alcohol dehydrogenase may decrease the abacavir exposition
Abacavir, alcohol dehydrogenase inhibitors
The inhibition of alcohol dehydrogenase may increase the abacavir exposition
Abacavir, amprenavir [2] ---> SmPC of [2] of EMA
No dose adjustment is necessary for either medicinal product when abacavir is administered in combination with amprenavir.
Abacavir, atazanavir [2] ---> SmPC of [2] of EMA
The co-administration of atazanavir with abacavir is not expected to significantly alter the exposure of abacavir.
Abacavir, clarithromycin
Separate administration by at least 2 hours
Abacavir, daclatasvir [2] ---> SmPC of [2] of EMA
No dose adjustment of Daklinza or the NRTI is required.
Abacavir, darunavir/cobicistat [2] ---> SmPC of [2] of EMA
Based on the different elimination pathways, no interactions are expected with darunavir/cobicistat. The can be used without dose adjustment.
Abacavir, darunavir/ritonavir ---> SmPC of [darunavir] of EMA
Darunavir co-administered with low dose ritonavir can be used with abacavir without dose adjustment.
Abacavir, dolutegravir/abacavir/lamivudine [2] ---> SmPC of [2] of EMA
Triumeq should not be taken with any other medicinal products containing dolutegravir, abacavir, lamivudine or emtricitabine.
Abacavir, doravirine [2] ---> SmPC of [2] of EMA
No dose adjustment is required.
Abacavir, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA
No dose adjustment is required.
Abacavir, elvitegravir [2] ---> SmPC of [2] of EMA
No dose adjustment is required when elvitegravir is co-administered with abacavir.
Abacavir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
No clinically significant interaction is observed. No dosage adjustment necessary.
Abacavir, glucuronidation inhibitors
The glucuronidation inhibition may increase the plasma concentrations of abacavir
Abacavir, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA
The induction of the glucuronidation by lopinavir/ritonavir may decrease the plasma concentrations of abacavir
Abacavir, maribavir [2] ---> SmPC of [2] of EMA
No dose adjustment is required.
Abacavir, nevirapine [2] ---> SmPC of [2] of EMA
Abacavir and Viramune can be coadministered without dose adjustments.
Abacavir, protease inhibitors
Possible decrease of abacavir plasma concentrations.
Abacavir, rilpivirine [2] ---> SmPC of [2] of EMA
No clinically relevant drug-drug interactions are expected. No dose adjustment is required.
Abacavir, simeprevir [2] ---> SmPC of [2] of EMA
No clinically relevant drug-drug interaction is expected. No dose adjustment is required.
Abacavir, telaprevir [2] ---> SmPC of [2] of EMA
An effect of telaprevir on UDP-glucuronyltransferases cannot be ruled out and may affect the plasma concentrations of abacavir.
Abacavir, tipranavir/ritonavir ---> SmPC of [tipranavir] of EMA
The concomitant use of tipranavir, co-administered with low dose ritonavir, with zidovudine or abacavir, results in a significant decrease in plasma concentration of these nucleoside reverse transcriptase inhibitors
CONTRAINDICATIONS of Abacavir (Ziagen)
- Hypersensitivity to abacavir or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/ziagen-epar-product-information_en.pdf 09/01/2024
Abacavir/lamivudine (Kivexa)
Abacavir/lamivudine [1], ability to drive ---> SmPC of [1] of EMA
The clinical status of the patient and the adverse reaction profile of Kivexa should be borne in mind when considering the patient's ability to drive or operate machinery.
Abacavir/lamivudine [1], alcohol ---> SmPC of [1] of EMA
Increase of the AUC of abacavir by inhibition of alcohol dehydrogenase. No dosage adjustment necessary.
Abacavir/lamivudine [1], alcohol ---> SmPC of [1] of EMA
When possible, avoid chronic coadministration of Kivexa with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Abacavir/lamivudine [1], alcohol dehydrogenase inductors ---> SmPC of [1] of EMA
The induction of alcohol dehydrogenase may decrease the abacavir exposition
Abacavir/lamivudine [1], alcohol dehydrogenase inhibitors ---> SmPC of [1] of EMA
The inhibition of alcohol dehydrogenase may increase the abacavir exposition
Abacavir/lamivudine [1], breast-feeding ---> SmPC of [1] of EMA
As a general rule, it is recommended that mothers infected with HIV do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Abacavir/lamivudine [1], cimetidine ---> SmPC of [1] of EMA
No dosage adjustment necessary.
Abacavir/lamivudine [1], cladribine ---> SmPC of [1] of EMA
In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical. Therefore, the concomitant use of lamivudine with cladribine is not recommended
Abacavir/lamivudine [1], cotrimoxazole ---> SmPC of [1] of EMA
No Kivexa dosage adjustment necessary. When concomitant administration with co-trimoxazole is warranted, patients should be monitored clinically.
Abacavir/lamivudine [1], CYP450 substrates ---> SmPC of [1] of EMA
Abacavir and lamivudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system.
Abacavir/lamivudine [1], cytidine analogues ---> SmPC of [1] of EMA
Due to similarities, abacavir/lamivudine should not be administered concomitantly with other cytidine analogues
Abacavir/lamivudine [1], cytochrome P450 ---> SmPC of [1] of EMA
Abacavir and lamivudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system.
Abacavir/lamivudine [1], didanosine ---> SmPC of [1] of EMA
No dosage adjustment necessary.
Abacavir/lamivudine [1], emtricitabine ---> SmPC of [1] of EMA
Due to similarities, abacavir/lamivudine should not be administered concomitantly with other cytidine analogues, such as emtricitabine.
Abacavir/lamivudine [1], fertility ---> SmPC of [1] of EMA
Studies in animals showed that neither abacavir nor lamivudine had any effect on fertility (see section 5.3).
Abacavir/lamivudine [1], glucuronidation inductors ---> SmPC of [1] of EMA
The glucuronidation induction may decrease the exposition of abacavir
Abacavir/lamivudine [1], glucuronidation inhibitors ---> SmPC of [1] of EMA
The glucuronidation inhibition may increase the exposition of abacavir
Abacavir/lamivudine [1], isotretinoin ---> SmPC of [1] of EMA
Possible interaction given common pathway (retinoids and abacavir) of elimination via alcohol dehydrogenase.
Abacavir/lamivudine [1], lactitol ---> SmPC of [1] of EMA
When possible, avoid chronic coadministration of Kivexa with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Abacavir/lamivudine [1], lamivudine ---> SmPC of [1] of EMA
Kivexa should not be taken with any other medicinal products containing lamivudine
Abacavir/lamivudine [1], mannitol ---> SmPC of [1] of EMA
When possible, avoid chronic coadministration of Kivexa with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Abacavir/lamivudine [1], methadone ---> SmPC of [1] of EMA
Methadone dosage adjustment unlikely in majority of patients; occasionally methadone retitration may be required.
Abacavir/lamivudine [1], OCT inhibitors ---> SmPC of [1] of EMA
Co-administration of lamivudine with OCT inhibitors may increase lamivudine exposure.
Abacavir/lamivudine [1], phenobarbital ---> SmPC of [1] of EMA
Potential to slightly decrease abacavir plasma concentrations through UGT induction. Insufficient data to recommend dosage adjustment.
Abacavir/lamivudine [1], phenytoin ---> SmPC of [1] of EMA
Potential to slightly decrease abacavir plasma concentrations through UGT induction. Insufficient data to recommend dosage adjustment.
Abacavir/lamivudine [1], pregnancy ---> SmPC of [1] of EMA
There are no data on the use of Kivexa in pregnancy, however the malformative risk is unlikely in humans based on those data.
Abacavir/lamivudine [1], ranitidine ---> SmPC of [1] of EMA
No dosage adjustment necessary.
Abacavir/lamivudine [1], retinoids ---> SmPC of [1] of EMA
Possible interaction due to common metabolic pathway through alcohol dehydrogenase
Abacavir/lamivudine [1], ribavirin ---> SmPC of [1] of EMA
As abacavir and ribavirin share the same phosphorylation pathways, a possible intracellular interaction between these medicinal products has been postulated, which could lead to a reduction in intracellular phosphorylated metabolites of ribavirin
Abacavir/lamivudine [1], rifampicin ---> SmPC of [1] of EMA
Potential to slightly decrease abacavir plasma concentrations through UGT induction. Insufficient data to recommend dosage adjustment.
Abacavir/lamivudine [1], riociguat ---> SmPC of [1] of EMA
Concomitant administration of a single dose of riociguat (0.5 mg) to HIV patients receiving the combination of abacavir/dolutegravir/lamivudine (600mg/50mg/300mg once daily) led to an approximately three-fold higher riociguat
Abacavir/lamivudine [1], trimethoprim/sulfamethoxazol ---> SmPC of [1] of EMA
No Kivexa dosage adjustment necessary. When concomitant administration with co-trimoxazole is warranted, patients should be monitored clinically.
Abacavir/lamivudine [1], xylitol ---> SmPC of [1] of EMA
When possible, avoid chronic coadministration of Kivexa with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Abacavir/lamivudine [1], zidovudine ---> SmPC of [1] of EMA
No dosage adjustment necessary.
Abacavir/lamivudine, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SmPC of [dasabuvir] of EMA
No dose adjustment needed for abacavir or lamivudine when administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Abacavir/lamivudine, ledipasvir/sofosbuvir [2] ---> SmPC of [2] of EMA
No dose adjustment is required
Abacavir/lamivudine, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC of [2] of EMA
No dose adjustment needed for abacavir/lamivudine when administered with Viekirax with or without dasabuvir.
Mitochondrial dysfunction following exposure in utero, nucleoside analogues ---> SmPC of [abacavir/lamivudine] of
Nucleoside and nucleotide analogues have been demonstrated to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues
Mitochondrial dysfunction following exposure in utero, nucleotide analogues ---> SmPC of [abacavir/lamivudine] of
Nucleoside and nucleotide analogues have been demonstrated to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues
CONTRAINDICATIONS of Abacavir/lamivudine (Kivexa)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. See sections 4.4 and 4.8.
https://www.ema.europa.eu/en/documents/product-information/kivexa-epar-product-information_en.pdf. 27/11/2023
Abacavir/lamivudine/zidovudine (Trizivir)
Abacavir/lamivudine/zidovudine [1], ability to drive ---> SmPC of [1] of EMA
The clinical status of the patient and the adverse event profile of Trizivir should be borne in mind when considering the patient's ability to drive or operate machinery.
Abacavir/lamivudine/zidovudine [1], alcohol ---> SmPC of [1] of EMA
Increase of the AUC of abacavir by inhibition of alcohol dehydrogenase. No dosage adjustment necessary.
Abacavir/lamivudine/zidovudine [1], amphotericin ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], atovaquone ---> SmPC of [1] of EMA
Increased zidovudine AUC. As only limited data available the clinical significance is unknown.
Abacavir/lamivudine/zidovudine [1], breast-feeding ---> SmPC of [1] of EMA
It is recommended that mothers infected by HIV do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Abacavir/lamivudine/zidovudine [1], cimetidine ---> SmPC of [1] of EMA
No dosage adjustment necessary.
Abacavir/lamivudine/zidovudine [1], cladribine ---> SmPC of [1] of EMA
In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical. Therefore, the concomitant use of lamivudine with cladribine is not recommended
Abacavir/lamivudine/zidovudine [1], clarithromycin ---> SmPC of [1] of EMA
Decreased zidovudine AUC. Separate administration of abacavir/lamivudine/zidovudine and clarithromycin by at least 2 hours
Abacavir/lamivudine/zidovudine [1], cotrimoxazole ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], dapsone ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], didanosine ---> SmPC of [1] of EMA
No dosage adjustment necessary.
Abacavir/lamivudine/zidovudine [1], doxorubicine ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], emtricitabine ---> SmPC of [1] of EMA
Abacavir/lamivudine/zidovudine should not be taken with medicinal products containing emtricitabine.
Abacavir/lamivudine/zidovudine [1], fertility ---> SmPC of [1] of EMA
Studies in animals showed that neither abacavir nor lamivudine nor zidovudine had any effect on fertility (see section 5.3). Zidovudine has been shown not to affect the number of sperm, sperm morphology and motility in man.
Abacavir/lamivudine/zidovudine [1], fluconazole ---> SmPC of [1] of EMA
Increased zidovudine AUC (by UGT inhibition). As only limited data are available the clinical significance is not known.
Abacavir/lamivudine/zidovudine [1], flucytosine ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], ganciclovir ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], interferon ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], isotretinoin ---> SmPC of [1] of EMA
Possible interaction given common pathway (retinoids and abacavir) of elimination via alcohol dehydrogenase.
Abacavir/lamivudine/zidovudine [1], lactitol ---> SmPC of [1] of EMA
When possible, avoid chronic coadministration of Trizivir with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Abacavir/lamivudine/zidovudine [1], lamivudine ---> SmPC of [1] of EMA
Abacavir/lamivudine/zidovudine should not be taken with any other medicinal products containing lamivudine
Abacavir/lamivudine/zidovudine [1], mannitol ---> SmPC of [1] of EMA
When possible, avoid chronic coadministration of Trizivir with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Abacavir/lamivudine/zidovudine [1], methadone ---> SmPC of [1] of EMA
Increased AUC of zidovudine. Monitor for signs of zidovudine toxicity
Abacavir/lamivudine/zidovudine [1], mitochondrial dysfunction ---> SmPC of [1] of EMA
Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Abacavir/lamivudine/zidovudine [1], monosaccharide alcohol ---> SmPC of [1] of EMA
When possible, avoid chronic coadministration of Trizivir with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Abacavir/lamivudine/zidovudine [1], myelosuppressive agents ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], nephrotoxic substances ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], pentamidine ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], phenobarbital ---> SmPC of [1] of EMA
Potential to slightly decrease abacavir und zidovudine plasma concentrations (both by UGT induction)
Abacavir/lamivudine/zidovudine [1], phenytoin ---> SmPC of [1] of EMA
Potential to decrease abacavir plasma concentrations (by UGT induction) and to increase/decrease the AUC of phenytoin
Abacavir/lamivudine/zidovudine [1], pregnancy ---> SmPC of [1] of EMA
There are no data on the use of the medicinal product with Trizivir in pregnancy.
Abacavir/lamivudine/zidovudine [1], probenecide ---> SmPC of [1] of EMA
The UGT inhibition may increase the AUC of zidovudine. Monitor for signs of zidovudine toxicity
Abacavir/lamivudine/zidovudine [1], pyrimethamine ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], ranitidine ---> SmPC of [1] of EMA
No dosage adjustment necessary.
Abacavir/lamivudine/zidovudine [1], retinoids ---> SmPC of [1] of EMA
Possible interaction given common pathway (retinoids and abacavir) of elimination via alcohol dehydrogenase.
Abacavir/lamivudine/zidovudine [1], ribavirin ---> SmPC of [1] of EMA
Ribavirin inhibits phosphorylation of zidovudine, which may increase the HIV plasma viraemia. Concomitant use is not recommended due to an increased risk of anaemia
Abacavir/lamivudine/zidovudine [1], rifampicin ---> SmPC of [1] of EMA
Potential to slightly decrease abacavir plasma concentrations through and decreased AUC of zidovudine (both by UGT induction)
Abacavir/lamivudine/zidovudine [1], riociguat ---> SmPC of [1] of EMA
Riociguat dose may need to be reduced. Consult the riociguat prescribing information for dosing recommendations.
Abacavir/lamivudine/zidovudine [1], sorbitol ---> SmPC of [1] of EMA
When possible, avoid chronic coadministration of Trizivir with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Abacavir/lamivudine/zidovudine [1], stavudine ---> SmPC of [1] of EMA
In vitro antagonism of anti-HIV activity between stavudine and zidovudine could result in decreased efficacy of both drugs. Combination not recommended.
Abacavir/lamivudine/zidovudine [1], trimethoprim/sulfamethoxazol ---> SmPC of [1] of EMA
Increased lamivudine AUC. No abacavir/lamivudine/zidovudine dosage adjustment necessary, unless patient has renal impairment
Abacavir/lamivudine/zidovudine [1], valproic acid ---> SmPC of [1] of EMA
Potential to increase the AUC of zidovudine (by UGT inhibition)
Abacavir/lamivudine/zidovudine [1], vinblastine ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], vincristine ---> SmPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Abacavir/lamivudine/zidovudine [1], xylitol ---> SmPC of [1] of EMA
When possible, avoid chronic coadministration of Trizivir with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Didanosine, mitochondrial function ---> SmPC of [abacavir/lamivudine/zidovudine] of EMA
Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Hepatitis, zidovudine ---> SmPC of [abacavir/lamivudine/zidovudine] of EMA
Caution should be exercised when administering zidovudine to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Mitochondrial function, stavudine ---> SmPC of [abacavir/lamivudine/zidovudine] of EMA
Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Mitochondrial function, zidovudine ---> SmPC of [abacavir/lamivudine/zidovudine] of EMA
Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
CONTRAINDICATIONS of Abacavir/lamivudine/zidovudine (Trizivir)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Patients with end-stage renal disease.
- Due to the active substance zidovudine, Trizivir is contraindicated in patients with abnormally low neutrophil counts (< 0.75 x 10^9/l), or abnormally low haemoglobin levels (< 7.5 g/dl or 4.65 mmol/l)
https://www.ema.europa.eu/en/documents/product-information/trizivir-epar-product-information_en.pdf. 29/11/2023
Abaloparatide (Eladynos)
Abaloparatide [1], ability to drive ---> SmPC of [1] of EMA
Transient orthostatic hypotension or dizziness may occur following administration of abaloparatide (see section 4.8). These patients should refrain from driving or the use of machines until symptoms have subsided.
Abaloparatide [1], biphosphonates ---> SmPC of [1] of EMA
There is no data on efficacy of abaloparatide in patients with prior or concomitant bisphosphonate or glucocorticoid treatment.
Abaloparatide [1], breast-feeding ---> SmPC of [1] of EMA
Eladynos is contraindicated during breast-feeding
Abaloparatide [1], digoxin ---> SmPC of [1] of EMA
Sporadic case reports have suggested that hypercalcaemia may predispose patients to digitalis toxicity. Because abaloparatide has been shown to increase serum calcium, it should be used with caution in patients taking digitalis.
Abaloparatide [1], fertility ---> SmPC of [1] of EMA
No data are available on the effect of abaloparatide on human fertility. Studies in rats with abaloparatide have shown no effects on male fertility
Abaloparatide [1], glucocorticoids ---> SmPC of [1] of EMA
There is no data on efficacy of abaloparatide in patients with prior or concomitant bisphosphonate or glucocorticoid treatment.
Abaloparatide [1], pregnancy ---> SmPC of [1] of EMA
Eladynos is contraindicated during pregnancy
Abaloparatide [1], vasoactive medicinal product ---> SmPC of [1] of EMA
Concomitant use of vasoactive medicinal products may predispose to orthostatic hypotension since the blood pressure lowering effect of abaloparatide may be increased
Abaloparatide [1], women of childbearing potential ---> SmPC of [1] of EMA
This medicine is not indicated in women of childbearing potential. It is not to be used in women who are, or may be, pregnant or breast-feeding
CONTRAINDICATIONS of Abaloparatide (Eladynos)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Pregnancy and breast-feeding (see section 4.6)
- Women of childbearing potential (see sections 4.6 and 5.3)
- Pre-existing hypercalcaemia
- Severe renal impairment (see sections 4.2 and 5.2)
- Unexplained elevations of serum alkaline phosphatase
- Patients with known risks for osteosarcoma such as those who have received prior external beam or implant radiation therapy involving the skeleton (see section 5.3)
- Patients with skeletal malignancies or bone metastases
https://www.ema.europa.eu/en/documents/product-information/eladynos-epar-product-information_en.pdf 12/04/2024
Abatacept (Orencia)
Abatacept [1], ability to drive ---> SmPC of [1] of EMA
However, dizziness and reduced visual acuity have been reported as common and uncommon adverse reactions respectively from patients treated with ORENCIA, therefore if a patient experiences such symptoms, driving and use of machinery should be avoided.
Abatacept [1], anakinra ---> SmPC of [1] of EMA
There is insufficient evidence to assess the safety and efficacy of abatacept in combination with anakinra or rituximab (see section 4.4).
Abatacept [1], breast-feeding ---> SmPC of [1] of EMA
Breast-feeding should be discontinued during treatment with ORENCIA and for up to 14 weeks after the last dose of abatacept treatment.
Abatacept [1], corticosteroids ---> SmPC of [1] of EMA
Population pharmacokinetic analyses did not detect any effect of methotrexate, NSAIDs, and corticosteroids on abatacept clearance (see section 5.2).
Abatacept [1], fertility ---> SmPC of [1] of EMA
Formal studies of the potential effect of abatacept on human fertility have not been conducted. In rats, abatacept had no undesirable effects on male or female fertility (see section 5.3).
Abatacept [1], hydroxychloroquine ---> SmPC of [1] of EMA
No major safety issues were identified with use of abatacept in combination with sulfasalazine, hydroxychloroquine, or leflunomide.
Abatacept [1], immune response ---> SmPC of [1] of EMA
Abatacept may blunt the effectiveness of the immune response, but did not significantly inhibit the ability to develop a clinically significant or positive immune response.
Abatacept [1], immune system ---> SmPC of [1] of EMA
Medicinal products that affect the immune system, including abatacept, may blunt the effectiveness of some immunisations (see sections 4.4 and 4.6).
Abatacept [1], immunomodulatory agents ---> SmPC of [1] of EMA
Co-administration of abatacept with biologic immunosuppressive or immunomodulatory agents could potentiate the effects of abatacept on the immune system.
Abatacept [1], leflunomide ---> SmPC of [1] of EMA
No major safety issues were identified with use of abatacept in combination with sulfasalazine, hydroxychloroquine, or leflunomide.
Abatacept [1], methotrexate ---> SmPC of [1] of EMA
Population pharmacokinetic analyses did not detect any effect of methotrexate, NSAIDs, and corticosteroids on abatacept clearance
Abatacept [1], NSAID ---> SmPC of [1] of EMA
Population pharmacokinetic analyses did not detect any effect of methotrexate, NSAIDs, and corticosteroids on abatacept clearance (see section 5.2).
Abatacept [1], pregnancy ---> SmPC of [1] of EMA
ORENCIA should not be used in pregnant women unless clearly necessary. Women of child-bearing potential should use effective contraception during treatment with ORENCIA and up to 14 weeks after the last dose of abatacept treatment.
Abatacept [1], rituximab ---> SmPC of [1] of EMA
There is insufficient evidence to assess the safety and efficacy of abatacept in combination with anakinra or rituximab (see section 4.4).
Abatacept [1], sulfasalazine ---> SmPC of [1] of EMA
No major safety issues were identified with use of abatacept in combination with sulfasalazine, hydroxychloroquine, or leflunomide.
Abatacept [1], TNF inhibitors ---> SmPC of [1] of EMA
While TNF-inhibitors did not influence abatacept clearance, in placebo-controlled clinical trials, patients receiving concomitant treatment with abatacept and TNF-inhibitors experienced more infections and serious infections
Abatacept [1], vaccinations ---> SmPC of [1] of EMA
Administration of live vaccines to infants exposed to abatacept in utero is not recommended for 14 weeks following the mother's last exposure to abatacept during pregnancy.
Abatacept [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA
Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation.
Abatacept [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential have to use effective contraception during treatment and up to 14 weeks after the last dose of abatacept.
Abatacept, adalimumab [2] ---> SmPC of [2] of EMA
Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, and other potential pharmacological interactions.
Abatacept, certolizumab pegol [2] ---> SmPC of [2] of EMA
Severe infections and neutropaenia may result with concurrent use. The combination of certolizumab pegol and abatacept is not recommended
Abatacept, etanercept [2] ---> SmPC of [2] of EMA
In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events. This combination has not demonstrated increased clinical benefit; such use is not recommended
Abatacept, golimumab [2] ---> SmPC of [2] of EMA
The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4).
Abatacept, infliximab [2] ---> SmPC of [2] of EMA
The combination of Inflectra with other biological therapeutics used to treat the same conditions as Inflectra, including anakinra and abatacept, is not recommended
CONTRAINDICATIONS of Abatacept (Orencia)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Severe and uncontrolled infections such as sepsis and opportunistic infections
https://www.ema.europa.eu/en/documents/product-information/orencia-epar-product-information_en.pdf 26/06/2025
Abciximab
Abciximab, breast-feeding
Lactation should be discontinued
Abciximab, cangrelor [2] ---> SPC of [2] of EMA
In clinical studies, cangrelor has been co-administered with bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors with no apparent effect upon the pharmacokinetics or pharmacodynamics of cangrelor.
Abciximab, dalteparin [2] ---> SPC of [2] of eMC
Enhancement of the anticoagulant effect of dalteparin by anticoagulant/antiplatelet agents
Abciximab, desirudin [2] ---> SPC of [2] of EMA
Desirudin should be used with caution in conjunction with medicinal products which affect platelet function
Abciximab, drotrecogin alfa [2] ---> SPC of [2] of EMA
Caution should be employed when using drotrecogin alfa with other drugs that affect haemostasis
Abciximab, enoxaparin [2] ---> SPC of [2] of eMC
The co-administration may enhance the pharmacologic effect and increase the bleeding risk. A close clinical and laboratory monitoring is recommended
Abciximab, heparin
The combination may increase the risk of bleeding
Abciximab, iloprost [2] ---> SPC of [2] of EMA
Since iloprost inhibits platelet function its use with anticoagulants or other inhibitors of platelet aggregation may increase the risk of bleeding. A careful monitoring of the patients is recommended.
Abciximab, phenindione
The co-administration is not recommended since it may increase the intensity of bleedings
Abciximab, pregnancy
Should not be used during pregnancy unless clearly needed
Abciximab, reteplase [2] ---> SPC of [2] of EMA
The abciximab may increase the risk of bleeding if administered prior to, during or after reteplase therapy
Abciximab, retinol
Concomitant use of parenteral anticoagulants with vitamin A may increase the anticoagulant effect and the risk of bleeding
Abciximab, thrombolytics
The combination may increase the risk of bleeding
Abciximab, vitamin A
Concomitant use of parenteral anticoagulants with vitamin A may increase the anticoagulant effect and the risk of bleeding
Abemaciclib (Verzenios)
Abemaciclib [1], ability to drive ---> SmPC of [1] of EMA
Patients should be advised to be cautious when driving or using machines in case they experience fatigue or dizziness during treatment with Verzenios
Abemaciclib [1], anastrozole ---> SmPC of [1] of EMA
In a clinical study in patients with breast cancer, there was no clinically-relevant pharmacokinetic drug interaction between abemaciclib and anastrozole, fulvestrant, exemestane, letrozole or tamoxifen.
Abemaciclib [1], BCRP substrates with narrow therapeutic range ---> SmPC of [1] of EMA
Based on the in vitro inhibition of P-gp and BCRP observed with abemaciclib, in vivo interactions of abemaciclib with narrow therapeutic index substrates of these transporters, such as digoxin or dabigatran etexilate, may occur.
Abemaciclib [1], breast-feeding ---> SmPC of [1] of EMA
It is unknown whether abemaciclib is excreted in human milk. A risk to breast-feeding children cannot be excluded. Patients receiving abemaciclib should not breast-feed.
Abemaciclib [1], carbamazepine ---> SmPC of [1] of EMA
Concomitant use of strong CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib.
Abemaciclib [1], clarithromycin ---> SmPC of [1] of EMA
Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided. If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced, followed by careful monitoring of toxicity.
Abemaciclib [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA
No dose adjustment is necessary for patients treated with moderate or weak CYP3A4 inhibitors. There should, however, be close monitoring for signs of toxicity.
Abemaciclib [1], dabigatran etexilate ---> SmPC of [1] of EMA
Based on the in vitro inhibition of P-gp and BCRP observed with abemaciclib, in vivo interactions of abemaciclib with narrow therapeutic index substrates of these transporters, such as digoxin or dabigatran etexilate, may occur.
Abemaciclib [1], digoxin ---> SmPC of [1] of EMA
Based on the in vitro inhibition of P-gp and BCRP observed with abemaciclib, in vivo interactions of abemaciclib with narrow therapeutic index substrates of these transporters, such as digoxin or dabigatran etexilate, may occur.
Abemaciclib [1], dofetilide ---> SmPC of [1] of EMA
Abemaciclib and its major active metabolites inhibit the renal transporters OCT2, MATE1, and MATE2-K. In vivo interactions of abemaciclib with clinically relevant substrates of these transporters, such as dofetilide or creatinine, may occur
Abemaciclib [1], exemestane ---> SmPC of [1] of EMA
In a clinical study in patients with breast cancer, there was no clinically-relevant pharmacokinetic drug interaction between abemaciclib and anastrozole, fulvestrant, exemestane, letrozole or tamoxifen.
Abemaciclib [1], fertility ---> SmPC of [1] of EMA
No adverse effects on female reproductive organs in mice, rats, or dogs, nor effects on female fertility and early embryonic development in rats were observed (see section 5.3).
Abemaciclib [1], fulvestrant ---> SmPC of [1] of EMA
In a clinical study in patients with breast cancer, there was no clinically-relevant pharmacokinetic drug interaction between abemaciclib and anastrozole, fulvestrant, exemestane, letrozole or tamoxifen.
Abemaciclib [1], grapefruit juice ---> SmPC of [1] of EMA
Avoid grapefruit or grapefruit juice.
Abemaciclib [1], hormonal contraceptives ---> SmPC of [1] of EMA
It is currently unknown whether abemaciclib may reduce the effectiveness of systemically acting hormonal contraceptives.
Abemaciclib [1], itraconazol ---> SmPC of [1] of EMA
Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided. If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced, followed by careful monitoring of toxicity.
Abemaciclib [1], ketoconazole ---> SmPC of [1] of EMA
Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided. If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced, followed by careful monitoring of toxicity.
Abemaciclib [1], letrozol ---> SmPC of [1] of EMA
In a clinical study in patients with breast cancer, there was no clinically-relevant pharmacokinetic drug interaction between abemaciclib and anastrozole, fulvestrant, exemestane, letrozole or tamoxifen.
Abemaciclib [1], loperamide ---> SmPC of [1] of EMA
In healthy subjects, co-administration of abemaciclib and the P-glycoprotein (P-gp) substrate loperamide resulted in an increase in loperamide plasma exposure of 9 % based on AUC0-? and 35% based on Cmax.
Abemaciclib [1], lopinavir/ritonavir ---> SmPC of [1] of EMA
Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided. If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced, followed by careful monitoring of toxicity.
Abemaciclib [1], MATE1 substrates ---> SmPC of [1] of EMA
Abemaciclib and its major active metabolites inhibit the renal transporters OCT2, MATE1, and MATE2-K. In vivo interactions of abemaciclib with clinically relevant substrates of these transporters, such as dofetilide or creatinine, may occur
Abemaciclib [1], MATE2-K substrates ---> SmPC of [1] of EMA
Abemaciclib and its major active metabolites inhibit the renal transporters OCT2, MATE1, and MATE2-K. In vivo interactions of abemaciclib with clinically relevant substrates of these transporters, such as dofetilide or creatinine, may occur
Abemaciclib [1], metformin ---> SmPC of [1] of EMA
In a clinical drug interaction study with metformin (substrate of OCT2, MATE1 and 2) co-administered with 400 mg abemaciclib, a small but not clinically relevant increase (37 %) in metformin plasma exposure was observed.
Abemaciclib [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
No dose adjustment is necessary for patients treated with moderate or weak CYP3A4 inhibitors. There should, however, be close monitoring for signs of toxicity.
Abemaciclib [1], OCT2 substrates ---> SmPC of [1] of EMA
Abemaciclib and its major active metabolites inhibit the renal transporters OCT2, MATE1, and MATE2-K. In vivo interactions of abemaciclib with clinically relevant substrates of these transporters, such as dofetilide or creatinine, may occur
Abemaciclib [1], P-glycoprotein substrates with small therapeutic index ---> SmPC of [1] of EMA
Based on the in vitro inhibition of P-gp and BCRP observed with abemaciclib, in vivo interactions of abemaciclib with narrow therapeutic index substrates of these transporters, such as digoxin or dabigatran etexilate, may occur.
Abemaciclib [1], phenytoin ---> SmPC of [1] of EMA
Concomitant use of strong CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib.
Abemaciclib [1], posaconazole ---> SmPC of [1] of EMA
Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided. If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced, followed by careful monitoring of toxicity.
Abemaciclib [1], pregnancy ---> SmPC of [1] of EMA
Verzenios is not recommended during pregnancy and in women of child-bearing potential not using contraception.
Abemaciclib [1], rifampicin ---> SmPC of [1] of EMA
Concomitant use of strong CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib.
Abemaciclib [1], St. John's wort ---> SmPC of [1] of EMA
Concomitant use of strong CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib.
Abemaciclib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Concomitant use of strong CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib.
Abemaciclib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided. If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced, followed by careful monitoring of toxicity.
Abemaciclib [1], tamoxifen ---> SmPC of [1] of EMA
In a clinical study in patients with breast cancer, there was no clinically-relevant pharmacokinetic drug interaction between abemaciclib and anastrozole, fulvestrant, exemestane, letrozole or tamoxifen.
Abemaciclib [1], voriconazole ---> SmPC of [1] of EMA
Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided. If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced, followed by careful monitoring of toxicity.
Abemaciclib [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential should use highly effective contraception methods (e.g. double-barrier contraception) during treatment and for at least 3 weeks after completing therapy (see section 4.5).
Abemaciclib, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA
Serum concentrations may be increased due to CYP3A4 inhibition by ritonavir. Coadministration of abemaciclib and Paxlovid should be avoided.
Abemaciclib, ritonavir [2] ---> SmPC of [2] of EMA
Co-administration of abemaciclib and Norvir should be avoided. If this co-administration is judged unavoidable, refer to the abemaciclib SmPC for dosage adjustment recommendations.
CONTRAINDICATIONS of Abemaciclib (Verzenios)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/verzenios-epar-product-information_en.pdf 12/03/2024
Abiraterone (Zytiga)
Abiraterone [1], amiodarone ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], breast-feeding ---> SmPC of [1] of EMA
ZYTIGA is not for use in women.
Abiraterone [1], carbamazepine ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Abiraterone [1], class IA antiarrhythmic agents ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], class III antiarrhythmic agents ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], codeine ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], CYP2C8 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
Patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly. Examples of medicinal products metabolised by CYP2C8 include pioglitazone and repaglinide
Abiraterone [1], cytotoxic agents ---> SmPC of [1] of EMA
The safety and efficacy of concomitant use of ZYTIGA with cytotoxic chemotherapy has not been established
Abiraterone [1], desipramine ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], dextromethorphan ---> SmPC of [1] of EMA
Abiraterone, CYP2D6 inhibitor, may increase the systemic exposure (AUC) of dextromethorphan. Caution is advised
Abiraterone [1], disopyramide ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], dofetilide ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], drugs primarily metabolised by CYP2C8 ---> SmPC of [1] of EMA
Patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly. Examples of medicinal products metabolised by CYP2C8 include pioglitazone and repaglinide
Abiraterone [1], drugs primarily metabolised by CYP2D6 ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], drugs primarily metabolised by CYP2D6 with narrow therapeutic index ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], fertility ---> SmPC of [1] of EMA
Abiraterone acetate affected fertility in male and female rats, but these effects were fully reversible (see section 5.3).
Abiraterone [1], flecainide ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], foods ---> SmPC of [1] of EMA
ZYTIGA tablets must be taken as a single dose once daily on an empty stomach. ZYTIGA must be taken at least two hours after eating and food must not be eaten for at least one hour after taking ZYTIGA. The tablets must be swallowed whole with water
Abiraterone [1], haloperidol ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], hypertensive drugs ---> SmPC of [1] of EMA
Caution is required in treating patients whose underlying medical conditions might be compromised by increases in blood pressure
Abiraterone [1], hypokalemia ---> SmPC of [1] of EMA
Caution is required in treating patients whose underlying medical conditions might be compromised by hypokalaemia
Abiraterone [1], ibutilide ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], ketoconazole ---> SmPC of [1] of EMA
In a separate clinical pharmacokinetic interaction study of healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.
Abiraterone [1], men ---> SmPC of [1] of EMA
A condom is required if the patient is engaged in sexual activity with a pregnant woman.
Abiraterone [1], men ---> SmPC of [1] of EMA
If the patient is engaged in sex with a woman of childbearing potential, a condom is required along with another effective contraceptive method. Studies in animals have shown reproductive toxicity (see section 5.3).
Abiraterone [1], methadone ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], metoprolol ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], moxifloxacin ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], myopathy ---> SmPC of [1] of EMA
Caution is recommended in patients concomitantly treated with drugs known to be associated with myopathy/rhabdomyolysis.
Abiraterone [1], neuroleptics ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], OATP1B1 substrates ---> SmPC of [1] of EMA
In vitro, the major metabolites abiraterone sulphate and N-oxide abiraterone sulphate were shown to inhibit the hepatic uptake transporter OATP1B1 and as a consequence it may increase the concentrations of medicinal products eliminated by OATP1B1.
Abiraterone [1], oxycodone ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], phenobarbital ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Abiraterone [1], phenytoin ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Abiraterone [1], pioglitazone ---> SmPC of [1] of EMA
Patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly. Examples of medicinal products metabolised by CYP2C8 include pioglitazone and repaglinide
Abiraterone [1], pregnancy ---> SmPC of [1] of EMA
ZYTIGA is not for use in women and is contraindicated in women who are or may potentially be pregnant
Abiraterone [1], propafenone ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], propranolol ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], quinidine ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], repaglinide ---> SmPC of [1] of EMA
Patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly. Examples of medicinal products metabolised by CYP2C8 include pioglitazone and repaglinide
Abiraterone [1], rhabdomyolysis ---> SmPC of [1] of EMA
Caution is recommended in patients concomitantly treated with drugs known to be associated with myopathy/rhabdomyolysis.
Abiraterone [1], rifabutin ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Abiraterone [1], rifampicin ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Abiraterone [1], rifapentine ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Abiraterone [1], risperidone ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], sotalol ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], spironolactone ---> SmPC of [1] of EMA
Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels. Use with ZYTIGA is not recommended
Abiraterone [1], St. John's wort ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Abiraterone [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Abiraterone [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
In a separate clinical pharmacokinetic interaction study of healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.
Abiraterone [1], torsades de pointes inducing drugs ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Abiraterone [1], tramadol ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], venlafaxine ---> SmPC of [1] of EMA
Caution is advised when administering abiraterone with medicinal products activated by or metabolised by CYP2D6, particularly with medicinal products that have a narrow therapeutic index.
Abiraterone [1], women of childbearing potential ---> SmPC of [1] of EMA
There are no human data on the use of ZYTIGA in pregnancy and this medicinal product is not for use in women of childbearing potential.
Abiraterone, relugolix [2] ---> SmPC of [2] of EMA
No clinically meaningful interaction is expected and no dose adjustment of Orgovyx is required.
CONTRAINDICATIONS of Abiraterone (Zytiga)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Women who are or may potentially be pregnant
- Severe hepatic impairment [Child-Pugh Class C]
- ZYTIGA with prednisone or prednisolone is contraindicated in combination with Ra-223.
https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf 18/10/2024
Other trade names: Abiraterone Accord, Abiraterone Mylan,
Abiraterone/niraparib (Akeega)
Ability to drive, abiraterone/niraparib [2] ---> SmPC of [2] of EMA
Akeega has moderate influence on the ability to drive or use machines. Patients who take Akeega may experience asthenia, fatigue, dizziness or difficulties concentrating. Patients should use caution when driving or using machines.
Abiraterone/niraparib [1], amiodarone ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], breast-feeding ---> SmPC of [1] of EMA
Akeega is not for use in women.
Abiraterone/niraparib [1], carbamazepine ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St. John's wort [Hypericum perforatum]) during treatment with Akeega should be avoided unless there is no therapeutic alternative
Abiraterone/niraparib [1], class IA antiarrhythmic agents ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], class III antiarrhythmic agents ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], codeine ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], CYP2C8 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
Patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with Akeega because of the abiraterone acetate component.
Abiraterone/niraparib [1], cytotoxic agents ---> SmPC of [1] of EMA
Caution should be taken if Akeega is used in combination with live or live-attenuated vaccines, immunosuppressant agents or with other cytotoxic medicinal products.
Abiraterone/niraparib [1], desipramine ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], dextromethorphan ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], disopyramide ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], dofetilide ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], drugs primarily metabolised by CYP2C8 ---> SmPC of [1] of EMA
Patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with Akeega because of the abiraterone acetate component.
Abiraterone/niraparib [1], drugs primarily metabolised by CYP2D6 ---> SmPC of [1] of EMA
Examples of medicinal products metabolised by CYP2D6 include metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone and tramadol.
Abiraterone/niraparib [1], drugs primarily metabolised by CYP2D6 with narrow therapeutic index ---> SmPC of [1] of
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], fertility ---> SmPC of [1] of EMA
In animal studies, male fertility was reduced with niraparib or abiraterone acetate but these effects were reversible following treatment cessation
Abiraterone/niraparib [1], flecainide ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], haloperidol ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], ibutilide ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], immunosuppressives ---> SmPC of [1] of EMA
Caution should be taken if Akeega is used in combination with live or live-attenuated vaccines, immunosuppressant agents or with other cytotoxic medicinal products.
Abiraterone/niraparib [1], ketoconazole ---> SmPC of [1] of EMA
In a separate clinical study in healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.
Abiraterone/niraparib [1], methadone ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], metoprolol ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], moxifloxacin ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], neuroleptics ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], oxycodone ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], phenobarbital ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St. John's wort [Hypericum perforatum]) during treatment with Akeega should be avoided unless there is no therapeutic alternative
Abiraterone/niraparib [1], phenytoin ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St. John's wort [Hypericum perforatum]) during treatment with Akeega should be avoided unless there is no therapeutic alternative
Abiraterone/niraparib [1], pioglitazone ---> SmPC of [1] of EMA
Patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with Akeega because of the abiraterone acetate component.
Abiraterone/niraparib [1], precaution ---> SmPC of [1] of EMA
Women who are or may become pregnant should wear gloves when handling the tablets
Abiraterone/niraparib [1], pregnancy ---> SmPC of [1] of EMA
Akeega is not for use in women
Abiraterone/niraparib [1], pregnant woman ---> SmPC of [1] of EMA
During treatment and for four months after the last dose of Akeega: A condom is required if the patient is engaged in sexual activity with a pregnant woman.
Abiraterone/niraparib [1], propafenone ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], propranolol ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], quinidine ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], radium dichloride ---> SmPC of [1] of EMA
Treatment with Akeega plus prednisone or prednisolone in combination with Ra-223 treatment is contraindicated due to an increased risk of fractures and a trend for increased mortality among asymptomatic or mildly symptomatic prostate cancer patients
Abiraterone/niraparib [1], repaglinide ---> SmPC of [1] of EMA
Patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with Akeega because of the abiraterone acetate component.
Abiraterone/niraparib [1], rifabutin ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St. John's wort [Hypericum perforatum]) during treatment with Akeega should be avoided unless there is no therapeutic alternative
Abiraterone/niraparib [1], rifampicin ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St. John's wort [Hypericum perforatum]) during treatment with Akeega should be avoided unless there is no therapeutic alternative
Abiraterone/niraparib [1], rifapentine ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St. John's wort [Hypericum perforatum]) during treatment with Akeega should be avoided unless there is no therapeutic alternative
Abiraterone/niraparib [1], risperidone ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], sotalol ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering Akeega with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes
Abiraterone/niraparib [1], spironolactone ---> SmPC of [1] of EMA
Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels. Use with Akeega is not recommended
Abiraterone/niraparib [1], St. John's wort ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St. John's wort [Hypericum perforatum]) during treatment with Akeega should be avoided unless there is no therapeutic alternative
Abiraterone/niraparib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Strong inducers of CYP3A4 during treatment are to be avoided unless there is no therapeutic alternative, due to risk of decreased exposure of abiraterone
Abiraterone/niraparib [1], thrombocytopenia ---> SmPC of [1] of EMA
Due to the risk of thrombocytopenia, other medicinal products known to reduce platelet counts should be used with caution in patients taking Akeega (see section 4.8).
Abiraterone/niraparib [1], tramadol ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], vaccinations ---> SmPC of [1] of EMA
Caution should be taken if Akeega is used in combination with live or live-attenuated vaccines, immunosuppressant agents or with other cytotoxic medicinal products.
Abiraterone/niraparib [1], venlafaxine ---> SmPC of [1] of EMA
Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Abiraterone/niraparib [1], women of childbearing potential ---> SmPC of [1] of EMA
During treatment and for four months after the last dose of Akeega: If the patient is engaged in sex with a woman of childbearing potential, a condom is required along with another effective contraceptive method.
CONTRAINDICATIONS of Abiraterone/niraparib (Akeega)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Women who are or may become pregnant (see section 4.6).
- Severe hepatic impairment [Child-Pugh Class C (see sections 4.2, 4.4 and 5.2)].
- Akeega plus prednisone or prednisolone is contraindicated in combination with Ra-223 treatment.
https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf 17/03/2026
Abrocitinib (Cibinqo)
Abrocitinib [1], antacids ---> SmPC of [1] of EMA
The effect of elevating gastric pH with antacids, or proton pump inhibitors (omeprazole) on the pharmacokinetics of abrocitinib has not been studied and may be similar to that seen with famotidine.
Abrocitinib [1], apalutamide ---> SmPC of [1] of EMA
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)
Abrocitinib [1], breast-feeding ---> SmPC of [1] of EMA
A risk to newborns/infants cannot be excluded and Cibinqo is contraindicated during breast-feeding
Abrocitinib [1], caffeine ---> SmPC of [1] of EMA
Co-administration of abrocitinib 200 mg once daily with caffeine 100 mg single dose increased the AUCinf of caffeine by 40% with lack of effect on Cmax, suggesting that abrocitinib is a mild inhibitor of CYP1A2 enzyme.
Abrocitinib [1], clopidogrel ---> SmPC of [1] of EMA
Caution should be exercised when using abrocitinib concomitantly with narrow therapeutic index medicines that are primarily metabolised by CYP2C19 enzyme (e.g. S-mephenytoin and clopidogrel).
Abrocitinib [1], dabigatran ---> SmPC of [1] of EMA
In vitro, abrocitinib is an inhibitor of P glycoprotein (P-gp). Caution should be exercised for concomitant use of abrocitinib with dabigatran.
Abrocitinib [1], digoxin ---> SmPC of [1] of EMA
Caution should be exercised as the levels of P-gp substrates with a narrow therapeutic index, such as digoxin, may increase.
Abrocitinib [1], duloxetine ---> SmPC of [1] of EMA
The exposures of medicinal products metabolised by CYP2B6 (e.g. bupropion, efavirenz) and CYP1A2 (e.g. alosetron, duloxetine, ramelteon, tizanidine) may be decreased
Abrocitinib [1], efavirenz ---> SmPC of [1] of EMA
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)
Abrocitinib [1], enzalutamide ---> SmPC of [1] of EMA
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)
Abrocitinib [1], famotidine ---> SmPC of [1] of EMA
When abrocitinib 200 mg was administered concomitantly with famotidine 40 mg, an H2-receptor antagonist, abrocitinib active moiety exposures decreased by approximately 35%.
Abrocitinib [1], fertility ---> SmPC of [1] of EMA
Based on the findings in rats, oral administration of Cibinqo may result in temporary reduced fertility in females of reproductive potential.
Abrocitinib [1], fluconazole ---> SmPC of [1] of EMA
When 100 mg abrocitinib was administered concomitantly with fluconazole (a strong CYP2C19, moderate CYP2C9 and CYP3A inhibitor), the extent of exposure of abrocitinib active moiety increased by 155%, compared with administration alone
Abrocitinib [1], fluvoxamine ---> SmPC of [1] of EMA
When 100 mg abrocitinib was administered concomitantly with fluvoxamine (a strong CYP2C19 and moderate CYP3A inhibitor), the extent of exposure of abrocitinib active moiety increased by 91%, compared with administration alone
Abrocitinib [1], foods ---> SmPC of [1] of EMA
Method of administration This medicinal product is to be taken orally once daily with or without food at approximately the same time each day. In patients who experience nausea, taking tablets with food may improve nausea.
Abrocitinib [1], gastric pH increasing medication ---> SmPC of [1] of EMA
The effect of elevating gastric pH with antacids, or proton pump inhibitors (omeprazole) on the pharmacokinetics of abrocitinib has not been studied and may be similar to that seen with famotidine.
Abrocitinib [1], mephenytoin ---> SmPC of [1] of EMA
The exposures of medicinal products metabolised by CYP2C19 (e.g. S-mephenytoin) may be increased initially and then decreased, when used concomitantly with abrocitinib.
Abrocitinib [1], mephenytoin ---> SmPC of [1] of EMA
Caution should be exercised when using abrocitinib concomitantly with narrow therapeutic index medicines that are primarily metabolised by CYP2C19 enzyme (e.g. S-mephenytoin and clopidogrel).
Abrocitinib [1], metabolized by CYP2C9 with narrow therapeutic index ---> SmPC of [1] of EMA
Caution should be exercised when using abrocitinib concomitantly with narrow therapeutic index medicines that are primarily metabolised by CYP2C19 enzyme (e.g. S-mephenytoin and clopidogrel).
Abrocitinib [1], moderate CYP2C9 inductors ---> SmPC of [1] of EMA
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)
Abrocitinib [1], moderate CYP2C9 inductors ---> SmPC of [1] of EMA
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)
Abrocitinib [1], omeprazole ---> SmPC of [1] of EMA
The effect of elevating gastric pH with antacids, or proton pump inhibitors (omeprazole) on the pharmacokinetics of abrocitinib has not been studied and may be similar to that seen with famotidine.
Abrocitinib [1], oral contraceptives ---> SmPC of [1] of EMA
No clinically significant effects of abrocitinib were observed in interaction studies with oral contraceptives (e.g. ethinyl oestradiol/levonorgestrel).
Abrocitinib [1], P-glycoprotein substrates with small therapeutic index ---> SmPC of [1] of EMA
Caution should be exercised as the levels of P-gp substrates with a narrow therapeutic index, such as digoxin, may increase.
Abrocitinib [1], pregnancy ---> SmPC of [1] of EMA
Cibinqo is contraindicated during pregnancy
Abrocitinib [1], probenecide ---> SmPC of [1] of EMA
When abrocitinib 200 mg was administered concomitantly with probenecid, an OAT3 inhibitor, abrocitinib active moiety exposures increased by approximately 66%. This is not clinically significant, and a dose adjustment is not needed.
Abrocitinib [1], proton pump inhibitors ---> SmPC of [1] of EMA
The effect of elevating gastric pH with antacids, or proton pump inhibitors (omeprazole) on the pharmacokinetics of abrocitinib has not been studied and may be similar to that seen with famotidine.
Abrocitinib [1], ramelteon ---> SmPC of [1] of EMA
The exposures of medicinal products metabolised by CYP2B6 (e.g. bupropion, efavirenz) and CYP1A2 (e.g. alosetron, duloxetine, ramelteon, tizanidine) may be decreased
Abrocitinib [1], rifampicin ---> SmPC of [1] of EMA
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)
Abrocitinib [1], rosuvastatin ---> SmPC of [1] of EMA
No clinically significant effects of abrocitinib were observed in interaction studies with substrates of BCRP and OAT3 (e.g. rosuvastatin), MATE1/2K (e.g. metformin), CYP3A4 (e.g. midazolam), and CYP2B6 (e.g. efavirenz).
Abrocitinib [1], strong CYP2C19 inductors ---> SmPC of [1] of EMA
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)
Abrocitinib [1], strong CYP2C19 inhibitors and moderate CYP2C9 inhibitors ---> SmPC of [1] of EMA
In patients receiving dual strong inhibitors of CYP2C19 and moderate inhibitors of CYP2C9, or strong inhibitors of CYP2C19 alone, the recommended dose should be reduced by half to 100 mg or 50 mg once daily
Abrocitinib [1], strong CYP2C9 inductors ---> SmPC of [1] of EMA
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)
Abrocitinib [1], strong CYP2C9 inhibitors ---> SmPC of [1] of EMA
In patients receiving dual strong inhibitors of CYP2C19 and moderate inhibitors of CYP2C9, or strong inhibitors of CYP2C19 alone, the recommended dose should be reduced by half to 100 mg or 50 mg once daily
Abrocitinib [1], vaccinations ---> SmPC of [1] of EMA
Use of live, attenuated vaccines should be avoided during or immediately prior to treatment.
Abrocitinib [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of reproductive potential should be advised to use effective contraception during treatment and for 1 month following the final dose of Cibinqo. Pregnancy planning and prevention for females of reproductive potential should be encouraged.
CONTRAINDICATIONS of Abrocitinib (Cibinqo)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Active serious systemic infections, including tuberculosis (TB) (see section 4.4).
- Severe hepatic impairment (see section 4.2).
- Pregnancy and breast-feeding (see section 4.6).
https://www.ema.europa.eu/en/documents/product-information/cibinqo-epar-product-information_en.pdf 08/07/2025
Acalabrutinib (Calquence)
Ability to drive, acalabrutinib [2] ---> SmPC of [2] of EMA
However, during treatment with acalabrutinib, fatigue and dizziness have been reported and patients who experience these symptoms should be advised not to drive or use machines until symptoms abate.
Acalabrutinib [1], antacids ---> SmPC of [1] of EMA
Acalabrutinib solubility decreases with increasing pH. For use with antacids, the interval between taking the medicinal product should be at least 2 hours
Acalabrutinib [1], BCRP substrates ---> SmPC of [1] of EMA
Acalabrutinib may increase exposure to co-administered BCRP substrates (e.g., methotrexate) by inhibition of intestinal BCRP
Acalabrutinib [1], BCRP substrates with narrow therapeutic range ---> SmPC of [1] of EMA
To minimise the potential for an interaction in the Gastrointestinal (GI) tract, oral narrow therapeutic range BCRP substrates such as methotrexate should be taken at least 6 hours before or after acalabrutinib.
Acalabrutinib [1], breast-feeding ---> SmPC of [1] of EMA
Breast-feeding mothers are advised not to breast-feed during treatment with Calquence and for 2 days after receiving the last dose
Acalabrutinib [1], caffeine ---> SmPC of [1] of EMA
In vitro studies indicate that acalabrutinib induces CYP1A2. Co-administration of acalabrutinib with CYP1A2 substrates (e.g. theophylline, caffeine) may decrease their exposure.
Acalabrutinib [1], calcium carbonate ---> SmPC of [1] of EMA
Acalabrutinib solubility decreases with increasing pH. For use with antacids, the interval between taking the medicinal product should be at least 2 hours
Acalabrutinib [1], carbamazepine ---> SmPC of [1] of EMA
Concomitant use with strong inducers of CYP3A activity (e.g., phenytoin, rifampicin, carbamazepine) should be avoided.
Acalabrutinib [1], clarithromycin ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], conivaptan ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], cyclosporine ---> SmPC of [1] of EMA
Caution should be exercised if co-administering acalabrutinib with CYP3A4 substrates with narrow therapeutic range administered orally (e.g. cyclosporine, ergotamine, pimozide).
Acalabrutinib [1], CYP3A4 and P-glycoprotein-inhibitors ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], CYP3A4 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
Caution should be exercised if co-administering acalabrutinib with CYP3A4 substrates with narrow therapeutic range administered orally (e.g. cyclosporine, ergotamine, pimozide).
Acalabrutinib [1], drugs primarily metabolised by CYP1A2 ---> SmPC of [1] of EMA
In vitro studies indicate that acalabrutinib induces CYP1A2. Co-administration of acalabrutinib with CYP1A2 substrates (e.g. theophylline, caffeine) may decrease their exposure.
Acalabrutinib [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA
Based on in vitro data, it cannot be excluded that acalabrutinib is an inhibitor of CYP3A4 at the intestinal level and may increase the exposure of CYP3A4 substrates sensitive to gut CYP3A metabolism.
Acalabrutinib [1], ergotamine ---> SmPC of [1] of EMA
Caution should be exercised if co-administering acalabrutinib with CYP3A4 substrates with narrow therapeutic range administered orally (e.g. cyclosporine, ergotamine, pimozide).
Acalabrutinib [1], famotidine ---> SmPC of [1] of EMA
For H2-receptor antagonists, take Calquence should be taken 2 hours before (or 10 hours after) taking the H2-receptor antagonist.
Acalabrutinib [1], fertility ---> SmPC of [1] of EMA
There are no data on the effect of Calquence on human fertility. In a non-clinical study of acalabrutinib in male and female rats, no adverse effects on fertility parameters were observed (see section 5.3).
Acalabrutinib [1], fluconazole ---> SmPC of [1] of EMA
No dose adjustment is required in combination with moderate CYP3A inhibitors. Monitor patients closely for adverse reactions (see Section 4.2).
Acalabrutinib [1], H2 antagonists ---> SmPC of [1] of EMA
For H2-receptor antagonists, take Calquence should be taken 2 hours before (or 10 hours after) taking the H2-receptor antagonist.
Acalabrutinib [1], indinavir ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], itraconazol ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], ketoconazole ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], MATE1 substrates ---> SmPC of [1] of EMA
ACP-5862 may increase exposure to co-administered MATE1 substrates (e.g., metformin) by inhibition of MATE1
Acalabrutinib [1], methotrexate ---> SmPC of [1] of EMA
To minimise the potential for an interaction in the Gastrointestinal (GI) tract, oral narrow therapeutic range BCRP substrates such as methotrexate should be taken at least 6 hours before or after acalabrutinib.
Acalabrutinib [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
No dose adjustment is required in combination with moderate CYP3A inhibitors. Monitor patients closely for adverse reactions (see Section 4.2).
Acalabrutinib [1], omeprazole ---> SmPC of [1] of EMA
Due to the long-lasting effect of proton pump inhibitors, separation of doses with proton pump inhibitors may not eliminate the interaction with Calquence and therefore concomitant use should be avoided
Acalabrutinib [1], phenytoin ---> SmPC of [1] of EMA
Concomitant use with strong inducers of CYP3A activity (e.g., phenytoin, rifampicin, carbamazepine) should be avoided.
Acalabrutinib [1], pimozide ---> SmPC of [1] of EMA
Caution should be exercised if co-administering acalabrutinib with CYP3A4 substrates with narrow therapeutic range administered orally (e.g. cyclosporine, ergotamine, pimozide).
Acalabrutinib [1], posaconazole ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], pregnancy ---> SmPC of [1] of EMA
Calquence should not be used during pregnancy unless the clinical condition of the woman requires treatment with acalabrutinib.
Acalabrutinib [1], proton pump inhibitors ---> SmPC of [1] of EMA
Due to the long-lasting effect of proton pump inhibitors, separation of doses with proton pump inhibitors may not eliminate the interaction with Calquence and therefore concomitant use should be avoided
Acalabrutinib [1], ranitidine ---> SmPC of [1] of EMA
For H2-receptor antagonists, take Calquence should be taken 2 hours before (or 10 hours after) taking the H2-receptor antagonist.
Acalabrutinib [1], rifampicin ---> SmPC of [1] of EMA
Concomitant use with strong inducers of CYP3A activity (e.g., phenytoin, rifampicin, carbamazepine) should be avoided.
Acalabrutinib [1], ritonavir ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], St. John's wort ---> SmPC of [1] of EMA
Concomitant treatment with St. John's wort, which may unpredictably decrease acalabrutinib plasma concentrations, should be avoided.
Acalabrutinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Concomitant use with strong inducers of CYP3A activity (e.g., phenytoin, rifampicin, carbamazepine) should be avoided.
Acalabrutinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Co-administration of strong CYP3A inhibitors with Calquence may lead to increased acalabrutinib exposure and consequently a higher risk for toxicity. Concomitant use with strong CYP3A inhibitors should be avoided.
Acalabrutinib [1], strong P-gp inhibitors ---> SmPC of [1] of EMA
Co-administration of strong P-gp inhibitors with Calquence may lead to increased acalabrutinib exposure. Concomitant use with strong P-gp inhibitors should be avoided.
Acalabrutinib [1], telaprevir ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], theophylline ---> SmPC of [1] of EMA
In vitro studies indicate that acalabrutinib induces CYP1A2. Co-administration of acalabrutinib with CYP1A2 substrates (e.g. theophylline, caffeine) may decrease their exposure.
Acalabrutinib [1], vitamin K antagonists ---> SmPC of [1] of EMA
Warfarin or other vitamin K antagonists should not be administered concomitantly with Calquence.
Acalabrutinib [1], voriconazole ---> SmPC of [1] of EMA
If the strong CYP3A/P-gp inhibitors (e.g., ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole) will be used short-term, treatment with Calquence should be interrupted
Acalabrutinib [1], warfarin ---> SmPC of [1] of EMA
Warfarin or other vitamin K antagonists should not be administered concomitantly with Calquence.
Acalabrutinib [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential should be advised to avoid becoming pregnant while receiving Calquence.
CONTRAINDICATIONS of Acalabrutinib (Calquence)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf 19/02/2024
Acamprosate
Acamprosate, breast-feeding
Not recommended during the lactation
Acamprosate, diltiazem
The co-administration may deteriorate an angina pectoris
Acamprosate, foods
The co-administration with foods decreases the bioavailibility
Acamprosate, naltrexone [2] ---> SPC of [2] of eMC
Co-administration of naltrexone with acamprosate in non-treatment seeking, alcohol dependent individuals showed that naltrexone administration significantly increased acamprosate plasma level.
Acamprosate, pregnancy
Not recommended during the pregnancy
CONTRAINDICATIONS of Acamprosate
Acamprosate is contraindicated:
- in patients with a known hypersensitivity to acamprosate or to any of the excipients
- lactating women
- in cases of renal insufficiency (serum creatinine >120 micromol/L)
http://www.medicines.org.uk/emc/
Acarbose
Acarbose, albiglutide [2] ---> SPC of [2] of EMA
Acarbose is contraindicated in patients with intestinal obstruction. Caution is advised if used concomitantly with albiglutide
Acarbose, aluminium
The co-administration may reduce the effect of acarbose and should not therefore be taken concomitantly
Acarbose, antacids
The co-administration may reduce the effect of acarbose and should not therefore be taken concomitantly
Acarbose [1], breast-feeding ---> SPC of [1] of eMC
The use of acarbose is contra-indicated in nursing mothers.
Acarbose, calcium
The co-administration may reduce the effect of acarbose and should not therefore be taken concomitantly
Acarbose, calcium antagonists
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose [1], carbon hydrates ---> SPC of [1] of eMC
Overdosage can lead to meteorism, flatulence, and diarrhoea.
Acarbose, cholestyramine
The co-administration may reduce the effect of acarbose and should not therefore be taken concomitantly
Acarbose, corticosteroids
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose, digestive enzymes
The co-administration may reduce the effect of acarbose and should not therefore be taken concomitantly
Acarbose [1], digoxin ---> SPC of [1] of eMC
In individual cases acarbose may affect digoxin bioavailability, which may require dose adjustment of digoxin
Acarbose, diuretics
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose, estrogens
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose [1], foods ---> SPC of [1] of eMC
Acarbose tablets are administered orally and should be chewed with the first mouthful of food, or swallowed whole with a little liquid directly before the meal.
Acarbose, gliclazide [2] ---> SPC of [2] of eMC
Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when other antidiabetic agents are taken
Acarbose, hyperglycemic agents
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose, insulin
A further lowering of blood glucose may increase the potential for hypoglycemia and it may be necessary to decrease the insulin dose.
Acarbose, intestinal adsorbents
The co-administration may reduce the effect of acarbose and should not therefore be taken concomitantly
Acarbose, isoniazid
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose, magnesium
The co-administration may reduce the effect of acarbose and should not therefore be taken concomitantly
Acarbose, metformin
A further lowering of blood glucose may increase the potential for hypoglycemia and it may be necessary to decrease the metformin dose.
Acarbose [1], neomycin ---> SPC of [1] of eMC
Oral neomycin may lead to enhanced reductions of postprandial blood glucose and to an increase in the frequency and severity of gastro-intestinal side-effects.
Acarbose, nicotinic acid
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose, orlistat [2] ---> SPC of [2] of EMA
In the absence of pharmacokinetic interaction studies, the concomitant administration of orlistat with acarbose should be avoided.
Acarbose, phenothiazines
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose, phenytoin
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose [1], pregnancy ---> SPC of [1] of eMC
The use of acarbose is contra-indicated in pregnancy
Acarbose [1], saccharose ---> SPC of [1] of eMC
Sucrose often causes abdominal discomfort or even diarrhoea during treatment with acarbose as a result of increased carbohydrate fermentation in the colon.
Acarbose, sulfonylureas
A further lowering of blood glucose may increase the potential for hypoglycemia and it may be necessary to decrease the sulphonylurea dose
Acarbose, thiazides
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
Acarbose, thyroid hormones
The combined active ingredient with acarbose may cause hyperglycaemia, what may attenuate the acarbose effects. Monitorization of the blood-sugar concentration is recommended
CONTRAINDICATIONS of Acarbose
- Hypersensitivity to acarbose or any of the excipients
- Use during pregnancy and in nursing mothers
- Acarbose Tablets are also contra-indicated in patients with colonic ulceration, inflammatory bowel disease, partial intestinal obstruction or in patients predisposed to intestinal obstruction.
- In addition, Acarbose Tablets should not be used in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who suffer from states which may deteriorate as a result of increased gas formation in the intestine, e.g. larger hernias.
- Acarbose Tablets are contra-indicated in patients with hepatic impairment.
- As acarbose has not been studied in patients with severe renal impairment, it should not be used in patients with a creatinine clearance of less than 25 ml/min/1.73 m².
http://www.medicines.org.uk/emc/
Aceclofenac
ACE inhibitors, aceclofenac [2] ---> SPC of [2] of eMC
NSAID's may reduce the effect of antihypertensives. The risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function when ACE-inhibitors are combined with NSAIDs.
AIIRA, aceclofenac [2] ---> SPC of [2] of eMC
NSAID's may reduce the effect of antihypertensives. The risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function angiotensin II receptor antagonists are combined with NSAIDs.
NSAID, aceclofenac [2] ---> SPC of [2] of eMC
Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, including GI bleeding
SSRI, aceclofenac [2] ---> SPC of [2] of eMC
Selective serotonin reuptake inhibitors (SSRIs) increase risk of gastrointestinal bleeding
Ability to drive, aceclofenac [2] ---> SPC of [2] of eMC
Undesirable effects such as dizziness, drowsiness, vertigo, fatigue, visual disturbances or other central nervous system disorders are possible after taking NSAIDs. If affected, patients should not drive or operate machinery
Aceclofenac [1], antihypertensives ---> SPC of [1] of eMC
NSAID's may reduce the effect of antihypertensives.
Aceclofenac, betablockers
Aceclofenac can reduce the anti-hypertensive effect of beta-blocker
Aceclofenac [1], breast-feeding ---> SPC of [1] of eMC
The use of aceclofenac should therefore be avoided in lactation unless the potential benefits to the other outweigh the possible risks to the foetus.
Aceclofenac, cardiac glycosides
NSAIDs may exacerbate cardiac failure, reduce GFR (glomerular filtration rate) and inhibit the renal clearance of glycosides, resulting in increased plasma glycoside levels.
Aceclofenac [1], corticosteroids ---> SPC of [1] of eMC
Increased risk of gastrointestinal ulceration or bleeding
Aceclofenac [1], coumarin anticoagulants ---> SPC of [1] of eMC
NSAIDs may enhance the effects of anti-coagulants, such as warfarin
Aceclofenac [1], coxibs ---> SPC of [1] of eMC
Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, including GI bleeding
Aceclofenac [1], cyclosporine ---> SPC of [1] of eMC
Administration of NSAID drugs together with cyclosporin is thought to increase the risk of nephrotoxicity due to decreased synthesis of prostacyclin in the kidney. During combination therapy it is therefore important to carefully monitor renal function.
Aceclofenac [1], digoxin ---> SPC of [1] of eMC
NSAIDs may exacerbate cardiac failure, reduce GFR (glomerular filtration rate) and inhibit the renal clearance of glycosides, resulting in increased plasma glycoside levels.
Aceclofenac [1], diuretics ---> SPC of [1] of eMC
Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. Diuretics can increase the risk of nephrotoxicity of NSAIDs
Aceclofenac, drugs with high protein binding
Aceclofenac may displace other principle actives from its plasma protein binding
Aceclofenac [1], lithium ---> SPC of [1] of eMC
Several NSAID drugs inhibit the renal clearance of lithium, resulting in increased serum concentrations of lithium. The combination should be avoided unless frequent monitoring of lithium can be performed
Aceclofenac [1], methotrexate ---> SPC of [1] of eMC
Caution should be exercised if both an NSAID and methotrexate are administered within 24 hours of each other, since NSAIDs may increase plasma levels of methotrexate, resulting in increased toxicity
Aceclofenac [1], oral antidiabetics ---> SPC of [1] of eMC
Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents with influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects
Aceclofenac, phenytoin
Aceclofenac may increase the plasma levels of phenytoin
Aceclofenac [1], platelet aggregation inhibitors ---> SPC of [1] of eMC
Anti-platelet agents increase risk of gastrointestinal bleeding
Aceclofenac [1], potassium-sparing diuretics ---> SPC of [1] of eMC
When concomitant administration of diclofenac with potassium-sparing diuretics is employed, serum potassium should be monitored.
Aceclofenac [1], pregnancy ---> SPC of [1] of eMC
During the first and second trimester of pregnancy, aceclofenac should not be given unless clearly necessary. Aceclofenac is contraindicated during the third trimester of pregnancy
Aceclofenac, quinolones
Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions
Aceclofenac, strong CYP2C9 inhibitors
The CYP2C9 inhibition may increase the plasma concentrations of aceclofenac
Aceclofenac [1], tacrolimus ---> SPC of [1] of eMC
Administration of NSAID drugs together with tacrolimus is thought to increase the risk of nephrotoxicity due to decreased synthesis of prostacyclin in the kidney. During combination therapy it is therefore important to carefully monitor renal function.
Aceclofenac, thiazides
Reduced diuretic effect. Diuretic can increase the risk of nephrotoxicity of the NSAID
Aceclofenac [1], warfarin ---> SPC of [1] of eMC
NSAIDs may enhance the effects of anti-coagulants, such as warfarin
Aceclofenac [1], zidovudine ---> SPC of [1] of eMC
Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There are indications of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen
CONTRAINDICATIONS of Aceclofenac
- Hypersensitivity to aceclofenac or to any of the excipients listed in section 6.1.
- Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
- NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
- Severe heart failure, hepatic failure and renal failure (see section 4.4).
- History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
- Active bleedings or bleeding disorders.
- Preservex should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used (see section 4.6).
http://www.medicines.org.uk/emc/
Acenocoumarol
NSAID, acenocoumarol [2] ---> SPC of [2] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
SSRI, acenocoumarol [2] ---> SPC of [2] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
St. John's wort, acenocoumarol
St. John's wort may decrease the anticoagulant effect of acenocoumarol
Acenocoumarol [1], acetylsalicylic acid ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol [1], alcohol ---> SPC of [1] of eMC
Since it is not possible to predict the severity of any drug interactions, patients should limit their alcohol intake
Acenocoumarol, allopurinol
Allopurinol may enhance the anticoagulant effect of acenocoumarol
Acenocoumarol, alteplase
The co-administration may enhance the anticoagulant effect and increase the bleeding risk.
Acenocoumarol [1], aminoglutethimide ---> SPC of [1] of eMC
Aminoglutethimide may decrease the anticoagulant effect of acenocoumarol
Acenocoumarol [1], amiodarone ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, amoxicillin ---> SPC of [amoxicillin/clavulanic acid] of eMC
In the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol and prescribed a course of amoxicillin.
Acenocoumarol, amoxicillin/clavulanic acid [2] ---> SPC of [2] of eMC
In the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol and prescribed a course of amoxicillin.
Acenocoumarol [1], anabolic steroids ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], androgens ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, antacids
Antacids may enhance the anticoagulant effect of acenocoumarol
Acenocoumarol [1], antiarrhythmics ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], antineoplastics ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol, aprepitant [2] ---> SPC of [2] of EMA
As a mild inducer of CYP2C9, CYP3A4 and glucuronidation, aprepitant can decrease plasma concentrations of substrates eliminated by these routes within 2 weeks following initiation and treatment.
Acenocoumarol, argatroban
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol [1], atorvastatin ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, azathioprine [2] ---> SPC of [2] of eMC
Inhibition of the anticoagulant effect of warfarin and acenocoumarol has been reported when co-administered with azathioprine. Coagulation tests should be closely monitored when anticoagulants are coadministered with azathioprine.
Acenocoumarol, azole antifungals
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], barbiturates ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol [1], bendroflumethiazide ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol [1], breast-feeding ---> SPC of [1] of eMC
Acenocoumarol is excreted in small quantity in human breast milk
Acenocoumarol [1], carbamazepine ---> SPC of [1] of eMC
Carbamazepine may lower the plasma level of oral anticoagulant
Acenocoumarol, celecoxib
The co-administration may enhance the anticoagulant effect and increase the bleeding risk.
Acenocoumarol [1], cephalosporins of the second generation ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], cephalosporins of the third generation ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, chloramphenicol
Cloramfenicol may enhance the anticoagulant effect of acenocoumarol
Acenocoumarol [1], chlorpropamide ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], cholestyramine ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect of acenocoumarol
Acenocoumarol [1], cimetidine ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, cisapride
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], citalopram ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, clarithromycin
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, clindamycin
Clindamycin may enhance the anticoagulant effect of acenocoumarol
Acenocoumarol, clofibric acid
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], clopidogrel ---> SPC of [1] of eMC
The co-administration, on strict indication, may enhance the anticoagulant effect and increase the bleeding risk.
Acenocoumarol, corticosteroids
Corticosteroids may enhance the anticoagulant effect of acenocoumarol
Acenocoumarol [1], cotrimoxazole ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], coxibs ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol, currant juice
Currant juice should be avoided due to a theoretical risk of enhanced anticoagulation
Acenocoumarol, dabrafenib [2] ---> SPC of [2] of EMA
Interactions with many medicinal products eliminated through metabolism or active transport is expected. These medicinal products are to be avoided or used with caution.
Acenocoumarol [1], dextrothyroxine ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], diflunisal ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol, dipyridamole
It is possible that dipyridamole may enhance the effects of oral anti-coagulants.
Acenocoumarol [1], disulfiram ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, econazole
Patients taking oral anticoagulants, such as warfarin or acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored more frequently.
Acenocoumarol, efavirenz [2] ---> SPC of [2] of EMA
Increased/decreased plasma concentrations of acenocoumarol
Acenocoumarol, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Interaction not studied. Plasma concentrations and effects of warfarin or acenocoumarol are potentially increased or decreased by efavirenz. Dose adjustment of warfarin or acenocoumarol may be required when co-administered with Atripla.
Acenocoumarol, enzalutamide [2] ---> SPC of [2] of EMA
Enzalutamide, enzymatic inductor, may increase the metabolism of acenocoumarol and decrease its plasma levels and effect
Acenocoumarol [1], erythromycin ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], ethacrynic acid ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, ethinyl estradiol
Ethinylestradiol may reduce the effects of anticoagulants
Acenocoumarol [1], fibrates ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], fluoxetine ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], fluvastatin ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, fosaprepitant [2] ---> SPC of [2] of EMA
Fosaprepitant, CYP2C9 inductor, may decrease the plasma concentrations of anticoagulant. Caution is advised
Acenocoumarol [1], gemfibrozil ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, glibenclamide
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], glucagon ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, glucosamine
The co-administration may enhance the effect of coumarin anticoagulant
Acenocoumarol [1], griseofulvin ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect of acenocoumarol
Acenocoumarol [1], heparin ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol [1], hydantoins ---> SPC of [1] of eMC
The co-administration may increase the plasma concentrations of hydantoin
Acenocoumarol, imatinib [2] ---> SPC of [2] of EMA
Imatinib may increase the anticoagulant effect of acenocoumarol (because of known increased risk of bleeding in conjunction with the use of imatinib)
Acenocoumarol, ketoconazole
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, macrolide antibiotics
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, magaldrate
Decreased absorption of acenocoumarol. It is recommended to administer the two substances at least 2-3 hours apart.
Acenocoumarol, magnesium hydroxide
Antacids may enhance the anticoagulant effect of acenocoumarol
Acenocoumarol, mercaptopurine
The co-administration may decrease the anticoagulant effect
Acenocoumarol, methylprednisolone
Corticosteroids may enhance the anticoagulant effect of acenocoumarol
Acenocoumarol [1], metronidazole ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, miconazole
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, naproxen [2] ---> SPC of [2] of eMC
NSAIDs may enhance the effects of anti-coagulants
Acenocoumarol [1], nelfinavir ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol [1], neomycin ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, nevirapine
Nevirapine may decrease the anticoagulant effect of acenocoumarol
Acenocoumarol [1], noscapine ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, omeprazole
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, oral antidiabetics
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], oral contraceptives ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol [1], para-aminosalicylic acid ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol [1], paracetamol ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], paroxetine ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], phenobarbital ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol [1], phenylbutazone ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol [1], phenytoin ---> SPC of [1] of eMC
The co-administration may increase the plasma concentrations of phenytoin
Acenocoumarol, piracetam [2] ---> SPC of [2] of eMC
The addition of piracetam 9.6 g/d significantly decreased platelet aggregation, beta-thromboglobulin release, levels of fibrinogen and von Willebrand's factors and whole blood and plasma viscosity.
Acenocoumarol, plasminogen activators
The co-administration may enhance the anticoagulant effect and increase the bleeding risk.
Acenocoumarol [1], platelet aggregation inhibitors ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol [1], pravastatine ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect and increase the bleeding risk.
Acenocoumarol, prednisone
Corticosteroids may enhance the anticoagulant effect of acenocoumarol
Acenocoumarol [1], pregnancy ---> SPC of [1] of eMC
Should not be used during pregnancy (contra-indicated)
Acenocoumarol, prokinetics
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, propafenone [2] ---> SPC of [2] of eMC
Propafenone has been shown to increase the plasma levels of oral anticoagulants (e.g. warfarin), with an accompanying increase in prothrombin time, which may require a reduction in the dose of oral anticoagulants.
Acenocoumarol [1], protease inhibitors ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol, proton pump inhibitors
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], pyrazolones ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol [1], quinidine ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], quinolones ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, retinol
Possibly increased anticoagulant effect and risk of bleeding
Acenocoumarol [1], rifampicin ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol [1], ritonavir ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol [1], salicylates ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol [1], salicylic acid ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol, sertraline
The co-administration may enhance the anticoagulant effect and increase the bleeding risk.
Acenocoumarol [1], simvastatine ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, sitaxentan [2] ---> SPC of [2] of EMA
It is expected that an increase in anticoagulant effect will be seen with warfarin analogues
Acenocoumarol, sonidegib [2] ---> SPC of [2] of EMA
Sonidegib is a competitive inhibitor of CYP2B6 and CYP2C9 in vitro. Substances that are substrates of CYP2B6 and CYP2C9 enzymes with narrow therapeutic range (e.g. warfarin, acenocoumarol, efavirenz, methadone) should be avoided.
Acenocoumarol, spinach
The spinach may decrease the anticoagulant effect of acenocoumarol due to the vitamin K1 content
Acenocoumarol [1], statins ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], strong CYP2C19 inductors ---> SPC of [1] of eMC
Inducers of CYP2C19 may diminish the anticoagulant effect of acenocoumarol.
Acenocoumarol [1], strong CYP2C9 inductors ---> SPC of [1] of eMC
Inducers of CYP2C9 may diminish the anticoagulant effect of acenocoumarol.
Acenocoumarol [1], strong CYP2C9 inhibitors ---> SPC of [1] of eMC
The potent CYP2C9 inhibition may increase the plasma concentrations of acenocoumarol
Acenocoumarol [1], strong CYP3A4 inductors ---> SPC of [1] of eMC
Inducers of CYP3A4 may diminish the anticoagulant effect of acenocoumarol.
Acenocoumarol [1], sulfinpyrazone ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol [1], sulfonylureas ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], sulphonamides ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, sunitinib [2] ---> SPC of [2] of EMA
Periodic monitoring by complete blood counts (platelets), coagulation factors (PT/INR), and physical examination
Acenocoumarol [1], tamoxifen ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, tegafur
Patients receiving coumarin anticoagulants (e.g. warfarin or acenocoumarol) should be closely monitored for their prothrombin time INR
Acenocoumarol [1], tetracyclines ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], thiazides ---> SPC of [1] of eMC
The co-administration may decrease the anticoagulant effect
Acenocoumarol, thiouracil
The co-administration may decrease the anticoagulant effect
Acenocoumarol, thrombin inhibitors
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acenocoumarol, thrombolytics
The co-administration may enhance the anticoagulant effect and increase the bleeding risk.
Acenocoumarol [1], thyroid hormones ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, ticlopidine
Increased bleeding risk (combination of the anticoagulant and platelet aggregation inhibitor effect)
Acenocoumarol [1], tolbutamide ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], tramadol ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol [1], trimethoprim/sulfamethoxazol ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acenocoumarol, viloxazine
Viloxazine may enhance the anticoagulant effect of acenocoumarol
Acenocoumarol, vitamin A
Possibly increased anticoagulant effect and risk of bleeding
Acenocoumarol, voriconazole [2] ---> SPC of [2] of EMA
Voriconazole may increase the plasma concentrations of coumarins that may cause an increase in prothrombin time.
Acenocoumarol, warfarin
Patients taking oral anticoagulants, such as warfarin or acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored more frequently.
Corticosteroids, coumarin anticoagulants ---> SPC of [acenocoumarol] of eMC
The co-administration may potentiate the anticoagulant effect of coumarin derivative
CONTRAINDICATIONS of Acenocoumarol
- Known hypersensitivity to acenocoumarol and related coumarin derivatives or to the excipients
- Pregnancy.
- In patients unable to co-operate (e.g. unsupervised and senile patients, alcoholics and patients with psychiatric disorders).
- All conditions where the risk of haemorrhage exceeds possible clinical benefit e.g.
- haemorrhagic diathesis and/or blood dyscrasia;
- immediately prior to, or after surgery on the central nervous system or eyes and traumatising surgery involving extensive exposure of the tissues;
- peptic ulceration or haemorrhage in the gastro-intestinal tract, urogenital tract or respiratory system; cerebrovascular haemorrhages; acute pericarditis; pericardial effusion; infective endocarditis;
- severe hypertension (due to occult risks);
- severe hepatic or renal disease;
- and in cases of increased fibrinolytic activity following operations on the lung, prostate or uterus.
http://www.medicines.org.uk/emc/
Acetylcysteine
Ability to drive, acetylcysteine
Somnolence may occur
Acetylcysteine, activated charcoal
Decreased effect of acetylcysteine
Acetylcysteine, antibiotics
To avoid incompatibilities or inactivations, they should be administered separately and at an interval of at least 2 hours
Acetylcysteine, anticholinergics
Dangerous secretory congestion due to the reduced cough reflex and the inhibitor of the bronchial secretions. Co-administration is not recommended
Acetylcysteine, antitussives
Dangerous secretory congestion due to cough reflex inhibition. Co-administration is not recommended
Acetylcysteine, atropine
Dangerous secretory congestion due to cough reflex inhibition. Co-administration is not recommended
Acetylcysteine, breast-feeding
Medical supervision is recommended
Acetylcysteine, erythromycin
To avoid incompatibilities or inactivations, they should be administered separately and at an interval of at least 2 hours
Acetylcysteine, nitroglycerine [2] ---> SPC of [2] of eMC
N-acetylcysteine may potentiate the vasodilator effects of glyceryl trinitrate.
Acetylcysteine, penicillins
To avoid incompatibilities or inactivations, they should be administered separately and at an interval of at least 2 hours
Acetylcysteine [1], pregnancy ---> SPC of [1] of eMC
Prior to use in pregnancy, the potential risks should be balanced against the potential benefits.
Acetylcysteine, tetracyclines
To avoid incompatibilities or inactivations, they should be administered separately and at an interval of at least 2 hours
CONTRAINDICATIONS of Acetylcysteine
There are no contraindications to the treatment of paracetamol overdose with acetylcysteine.
http://www.medicines.org.uk/emc/
Acetylsalicylic acid
ACE inhibitors, acetylsalicylic acid [2] ---> SPC of [2] of eMC
As for other NSAIDs concomitant administration with ACE-inhibitors increases the risk of acute renal insufficiency.
AIIRA, acetylsalicylic acid ---> SPC of [irbesartan] of EMA
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may decrease the antihypertensive effect, increase the renal failure risk and cause hypercaliemia
NSAID, acetylsalicylic acid [2] ---> SPC of [2] of eMC
Increased risk of ulcerations and gastrointestinal bleeding due to synergistic effects.
SSRI, acetylsalicylic acid ---> SPC of [sertraline] of EMA
The risk of bleeding may be increased when medicines acting on platelet function or other medicines that might increase bleeding risk are concomitantly administered with SSRIs
Acenocoumarol [1], acetylsalicylic acid ---> SPC of [1] of eMC
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Acetazolamide, salicylates ---> SPC of [acetylsalicylic acid] of eMC
May result in severe acidosis and increased central nervous system toxicity
Acetylsalicylic acid, afamelanotide [2] ---> SPC of [2] of EMA
Patients taking substances which reduce coagulation, acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation.
Acetylsalicylic acid [1], alcohol ---> SPC of [1] of eMC
The co-administration of alcohol with acetylsalicylic acid increases the risk of gastrointestinal bleeding
Acetylsalicylic acid, aldosterone antagonists
Decreased effects of aldosterone antagonist
Acetylsalicylic acid, algeldrate/magnesium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Acetylsalicylic acid, aliskiren/hydrochlorothiazide [2] ---> SPC of [2] of EMA
NSAIDs may reduce the anti-hypertensive effect of aliskiren. NSAIDs may weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
Acetylsalicylic acid, almasilate
There are studies that prove a reduction of salicylate plasma levels by a higher elimination due to urinary alkalinisation
Acetylsalicylic acid, aluminium
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Acetylsalicylic acid, aluminium oxide/magnesium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Acetylsalicylic acid, aminosalicyclic acid
Salicylate increases the plasma levels of aminosalicyclic acid
Acetylsalicylic acid, amlodipine/valsartan [2] ---> SPC of [2] of EMA
Concomitant use of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may decrease the antihypertensive effect, increase the renal failure risk and cause hypercaliemia
Acetylsalicylic acid, anagrelide [2] ---> SPC of [2] of EMA
At the doses recommended for use in the treatment of essential thrombocythaemia, anagrelide may potentiate the effects of other medicinal products that inhibit or modify platelet function
Acetylsalicylic acid [1], antacids ---> SPC of [1] of eMC
Alkalizers of urine (eg antacids, citrates) - increased excretion of aspirin.
Acetylsalicylic acid, antihypertensives ---> SPC of [parecoxib] of EMA
NSAIDs may reduce the effect of antihypertensive medicinal products.
Acetylsalicylic acid, apixaban [2] ---> SPC of [2] of EMA
Apixaban should be used with caution when co-administered with NSAIDs (including acetylsalicylic acid) because these medicinal products typically increase the bleeding risk.
Acetylsalicylic acid, articaine/epinephrine
There is an increase in the tendency to bleed during the treatment with anticoagulant medicinal products
Acetylsalicylic acid, ascorbic acid
Concomitant administration of acetylsalicylic acid and ascorbic acid may interfere with absorption of ascorbic acid.
Acetylsalicylic acid, asparaginase [2] ---> SPC of [2] of EMA
Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4). This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Acetylsalicylic acid, azilsartan ---> SPC of [azilsartan medoxomil] of EMA
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may attenuate the antihypertensive effect, lead to an increased risk of worsening of renal function and an increase in serum potassium.
Acetylsalicylic acid, azilsartan medoxomil [2] ---> SPC of [2] of EMA
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may attenuate the antihypertensive effect, lead to an increased risk of worsening of renal function and an increase in serum potassium.
Acetylsalicylic acid, barbiturates
The acetylsalicylic acid increases the barbiturate plasma levels
Acetylsalicylic acid, bemiparin
The concomitant administration of bemiparin and acetyl salicylic acid is not advisable. Increased risk of bleeding.
Acetylsalicylic acid, benzbromarone ---> SPC of [clopidogrel/acetylsalicylic acid] of EMA
Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Acetylsalicylic acid, betablockers
The NSAID can reduce the anti-hypertensive effect of beta-blocker
Acetylsalicylic acid, biphosphonates ---> SPC of [ibandronic acid] of EMA
Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration
Acetylsalicylic acid, breast-feeding
Acetylsalicylic acid is excreted into breast milk. It is not recommended during breast-feeding
Acetylsalicylic acid, candesartan ---> SPC of [candesartan cilexetil] of eMC
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may decrease the antihypertensive effect, increase the renal failure risk and cause hypercaliemia
Acetylsalicylic acid, candesartan cilexetil [2] ---> SPC of [2] of eMC
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may decrease the antihypertensive effect, increase the renal failure risk and cause hypercaliemia
Acetylsalicylic acid, cangrelor [2] ---> SPC of [2] of EMA
No pharmacokinetic or pharmacodynamic interaction with cangrelor was observed in an interaction study with acetylsalicylic acid, heparin, or nitroglycerin.
Acetylsalicylic acid, canreonate
The co-administration of NSAIDs with potassium canreonate may cause hyperpotassemia and decrease the diuretic effect of potassium canreonate
Acetylsalicylic acid, captopril [2] ---> SPC of [2] of eMC
It has been described NSAIDs and ACE inhibitors exert an additive effect on the increase in serum potassium whereas renal function may decrease. Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor.
Acetylsalicylic acid, carvedilol
Decreased hypotensive effect of carvedilol due to water and sodium retention
Acetylsalicylic acid, celecoxib [2] ---> SPC of [2] of EMA
Increased risk of gastrointestinal ulcus/complications
Acetylsalicylic acid, certoparin
The co-administration may enhance the pharmacological effects of certoparin
Acetylsalicylic acid, cilazapril [2] ---> SPC of [2] of eMC
When ACE inhibitors are administered simultaneously with NSAIDs attenuation of the antihypertensive effect may occur. Concomitant use may also lead to an increased risk of worsening of renal function, and an increase in serum potassium
Acetylsalicylic acid, citalopram [2] ---> SPC of [2] of eMC
Caution is warranted for patients who are being treated simultaneously with anticoagulants, medicinal products that affect platelet function, or other medicines that can increase the risk of haemorrhage
Acetylsalicylic acid, clopidogrel [2] ---> SPC of [2] of EMA
ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
Acetylsalicylic acid [1], corticosteroids ---> SPC of [1] of eMC
The co-administration may increase the risk of gastrointestinal bleeding and ulceration
Acetylsalicylic acid [1], cyclosporine ---> SPC of [1] of eMC
Concomitant use of NSAIDs and ciclosporin may increase the nephrotoxic effect of ciclosporin. The renal function should be monitored in case of concomitant use
Acetylsalicylic acid, dabigatran [2] ---> SPC of [2] of EMA
The combination may increase the risk for any bleeding
Acetylsalicylic acid, dabigatran etexilate [2] ---> SPC of [2] of EMA
The combination may increase the risk for any bleeding
Acetylsalicylic acid, dalteparin [2] ---> SPC of [2] of eMC
NSAIDs reduce production of vasodilatatory prostaglandins, and thereby renal blood flow and the renal excretion. Caution is recommended
Acetylsalicylic acid, dapoxetine [2] ---> SPC of [2] of eMC
There have been reports of bleeding abnormalities with SSRIs. Caution is advised in patients taking dapoxetine, particularly in concomitant use with medicinal products known to affect platelet function
Acetylsalicylic acid, daunorubicin
In association with the concurrent intake of daunorubicin and thrombocyte aggregation inhibiting substances (e.g. acetylsalicylic acid), an additionally increased bleeding tendency must be anticipated in thrombocytopenic patients.
Acetylsalicylic acid, deferasirox [2] ---> SPC of [2] of EMA
The concomitant administration of deferasirox with substances that have known ulcerogenic potential, such as NSAIDs (including acetylsalicylic acid at high dosage), may increase the risk of gastrointestinal toxicity
Acetylsalicylic acid, desirudin [2] ---> SPC of [2] of EMA
Desirudin should be used with caution in conjunction with medicinal products which affect platelet function
Acetylsalicylic acid, dexibuprofen [2] ---> SPC of [2] of eMC
The combination may inhibit the effect of low dose acetylsalicylic acid on platelet aggregation. Caution should be exercised
Acetylsalicylic acid [1], digoxin ---> SPC of [1] of eMC
NSAIDs increase the digoxin plasma levels which may reach toxic values. The combination of digoxin and NSAIDs is not recommended
Acetylsalicylic acid, dimethyl fumarate [2] ---> SPC of [2] of EMA
Long term use of acetylsalicylic acid is not recommended for the management of flushing. Potential risks associated with acetylsalicylic acid therapy should be considered prior to co-administration with Tecfidera.
Acetylsalicylic acid, dipyridamole [2] ---> SPC of [2] of eMC
Addition of dipyridamole to acetylsalicylic acid does not increase the incidence of bleeding events.
Acetylsalicylic acid [1], diuretics ---> SPC of [1] of eMC
NSAIDs may decrease the antihypertensive effects of diuretics and other antihypertensive agents.
Acetylsalicylic acid, domperidone
Domperidone increased rate of absorption of aspirin
Acetylsalicylic acid, edoxaban [2] ---> SPC of [2] of EMA
The concomitant chronic use of high dose ASA (325 mg) with edoxaban is not recommended. Concomitant administration of higher doses than 100 mg ASA should only be performed under medical supervision.
Acetylsalicylic acid, enalapril [2] ---> SPC of [2] of eMC
Enalapril can be safely administered concomitantly with acetyl salicylic acid (at cardiologic doses), thrombolytics and betablockers.
Acetylsalicylic acid, enoxaparin [2] ---> SPC of [2] of eMC
The co-administration may enhance the pharmacologic effect and increase the bleeding risk. A close clinical and laboratory monitoring is recommended
Acetylsalicylic acid, enoxaparin sodium [2] ---> SPC of [2] of EMA
It is recommended that agents which affect haemostasis should be discontinued prior to enoxaparin therapy unless their use is essential.
Acetylsalicylic acid, epinephrine
There is an increase in the tendency to bleed during the treatment with anticoagulant medicinal products
Acetylsalicylic acid, etoricoxib [2] ---> SPC of [2] of eMC
Concomitant administration of etoricoxib with doses of acetylsalicylic acid above those for cardiovascular prophylaxis or with other NSAIDs is not recommended
Acetylsalicylic acid, flucloxacillin
Displacement of flucloxacillin from its plasma protein binding
Acetylsalicylic acid, fluoxetine [2] ---> SPC of [2] of eMC
Caution is advised in patients taking SSRIs, particularly in concomitant use with oral anticoagulants, drugs known to affect platelet function or other drugs that may increase risk of bleeding as well as in patients with a history of bleeding disorders.
Acetylsalicylic acid, flurbiprofen [2] ---> SPC of [2] of eMC
As with other products containing NSAIDs, concomitant administration of flurbiprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.
Acetylsalicylic acid, fluvoxamine [2] ---> SPC of [2] of eMC
Caution is advised in patients taking SSRIs particularly in elderly patients and in patients who concomitantly use drugs known to affect platelet function or drugs that increase risk of bleeding
Acetylsalicylic acid, fondaparinux [2] ---> SPC of [2] of EMA
Other antiplatelet medicinal products and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.
Acetylsalicylic acid, fossil tree
Possible increase in risk of bleeding
Acetylsalicylic acid, furosemide [2] ---> SPC of [2] of eMC
NSAID may reduce the diuretic effects of furosemide.
Acetylsalicylic acid, gallopamil
Increased bleeding tendency
Acetylsalicylic acid [1], heparin ---> SPC of [1] of eMC
Increased risk of bleeding due to inhibited thrombocyte function, injury of the duodenal mucosa and displacement of oral anticoagulants from their plasma protein binding sites. The bleeding time should be monitored
Acetylsalicylic acid, hypoglycemic drugs
Acetylsalicylic acid may increase the effect of hypoglycaemic agents
Acetylsalicylic acid, ibandronic acid [2] ---> SPC of [2] of EMA
Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration
Acetylsalicylic acid [1], ibuprofen ---> SPC of [1] of eMC
Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Caution should be exercised
Acetylsalicylic acid, iloprost [2] ---> SPC of [2] of EMA
Since iloprost inhibits platelet function its use with anticoagulants or other inhibitors of platelet aggregation may increase the risk of bleeding. A careful monitoring of the patients is recommended.
Acetylsalicylic acid, imidapril [2] ---> SPC of [2] of eMC
Imidapril may be used concomitantly with acetylsalicylic acid (when used as a thrombolytic), thrombolytics, and beta-blockers.
Acetylsalicylic acid, insulin
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity
Acetylsalicylic acid, insulin lispro [2] ---> SPC of [2] of EMA
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity
Acetylsalicylic acid, interferon alfa
The acetylsalicylic acid decreases the activity of interferon alfa.
Acetylsalicylic acid, irbesartan [2] ---> SPC of [2] of EMA
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may decrease the antihypertensive effect, increase the renal failure risk and cause hypercaliemia
Acetylsalicylic acid, ivabradine [2] ---> SPC of [2] of EMA
In pivotal phase III clinical trials aspirin and other anti-platelet medicinal products were routinely combined with ivabradine with no evidence of safety concerns
Acetylsalicylic acid, ketorolac [2] ---> SPC of [2] of eMC
There is an increased risk of gastrointestinal bleeding when anti-platelet agents are combined with NSAIDs.
Acetylsalicylic acid, laropiprant/nicotinic acid [2] ---> SPC of [2] of EMA
In a clinical study, concomitant administration of laropiprant with acetylsalicylic acid did not have an effect on collagen-induced platelet aggregation or on bleeding time compared to treatment with acetylsalicylic acid alone
Acetylsalicylic acid, lesinurad [2] ---> SPC of [2] of EMA
Consistent serum uric acid lowering was observed in patients who were receiving low dose acetylsalicylic acid in the placebo-controlled clinical studies in combination with allopurinol or febuxostat.
Acetylsalicylic acid, lisinopril [2] ---> SPC of [2] of eMC
Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor. NSAIDs and ACE inhibitors exert an additive effect on the increase in serum potassium and may result in a deterioration of renal function.
Acetylsalicylic acid [1], lithium ---> SPC of [1] of eMC
Acetylsalicylic acid impairs the renal excretion of lithium, resulting in increased plasma concentrations.
Acetylsalicylic acid, loop diuretics
Decreased effects of loop diuretic
Acetylsalicylic acid, losartan [2] ---> SPC of [2] of eMC
When AIIRAs are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Concomitant use of AIIRA and NSAIDs may lead to an increased risk of worsening of renal function, and an increase in serum potassium
Acetylsalicylic acid, losartan/hydrochlorothiazide [2] ---> SPC of [2] of eMC
When AIIRAs are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect, increased risk of worsening of renal function, and an increase in serum potassium may occur
Acetylsalicylic acid, lumiracoxib
Lumiracoxib may be used with low dose of acetylsalicylic acid. Concomitant use of lumiracoxib with high doses of acetylsalicylic acid, other NSAIDs or COX-2 inhibitors should be avoided
Acetylsalicylic acid, melagatran
The co-administration may significantly increase the bleeding risk
Acetylsalicylic acid, meloxicam
Concomitant use of several NSAIDs should be avoided due to an increased risk of adverse effects, particularly upper gastrointestinal disorders.
Acetylsalicylic acid, metamizole ---> SPC of [clopidogrel/acetylsalicylic acid] of EMA
Metamizole may reduce the effect of ASA on platelet aggregation when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose ASA for cardioprotection
Acetylsalicylic acid, methotrexate [2] ---> SPC of [2] of EMA
In animal experiments non-steroidal anti-inflammatory drugs (NSAIDs) including salicylic acid caused reduction of tubular methotrexate secretion and consequently increased its toxic effects.
Acetylsalicylic acid, methylprednisolone
Increased risk of gastrointestinal haemorrhage and ulceration.
Acetylsalicylic acid, metildigoxin
Increased plasma levels of metildigoxin
Acetylsalicylic acid, metoclopramide
Metoclopramide increased rate of absorption of aspirin.
Acetylsalicylic acid, nabumetone [2] ---> SPC of [2] of eMC
ASA doesn't affect nabumetone metabolism and bioavailability
Acetylsalicylic acid, nadroparin
The co-administration may increase the nadroparin effect
Acetylsalicylic acid, nicergoline
Nicergoline may enhance the prolongation of bleeding time caused by acetylsalicylic acid
Acetylsalicylic acid, nimesulide
Concomitant use of several NSAIDs should be avoided due to an increased risk of adverse effects, particularly upper gastrointestinal disorders.
Acetylsalicylic acid, nitroglycerine
The col-administration of glycerol trinitrate with acetylsalicylic acid may decrease the clearance of glycerol trinitrate
Acetylsalicylic acid, olmesartan ---> SPC of [olmesartan medoxomil] of eMC
NSAIDs (including ASA at doses >3 g/day and also COX-2 inhibitors) and AIIRAs may act synergistically by decreasing glomerular filtration (risk of acute renal failure). Additionally, concomitant treatment can reduce the antihypertensive effect of AIIRAs
Acetylsalicylic acid, olmesartan medoxomil [2] ---> SPC of [2] of eMC
NSAIDs (including ASA at doses >3 g/day and also COX-2 inhibitors) and AIIRAs may act synergistically by decreasing glomerular filtration (risk of acute renal failure). Additionally, concomitant treatment can reduce the antihypertensive effect of AIIRAs
Acetylsalicylic acid [1], oral anticoagulants ---> SPC of [1] of eMC
Increased risk of bleeding due to inhibited thrombocyte function, injury of the duodenal mucosa and displacement of oral anticoagulants from their plasma protein binding sites. The bleeding time should be monitored
Acetylsalicylic acid, oral antidiabetics
Decreased blood sugar level
Acetylsalicylic acid, ototoxic agents
Ototoxic medicine (eg vancomycin) - potential for ototoxicity increased. Hearing loss may occur and may progress to deafness even after discontinuation of the medication.
Acetylsalicylic acid, padeliporfin [2] ---> SPC of [2] of EMA
Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD.
Acetylsalicylic acid, parecoxib [2] ---> SPC of [2] of EMA
In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of parecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid
Acetylsalicylic acid, paroxetine [2] ---> SPC of [2] of eMC
Concomitant use of paroxetine and NSAIDs/acetylsalicylic acid can lead to an increased haemorrhagic risk.
Acetylsalicylic acid, pegaspargase [2] ---> SPC of [2] of EMA
The use of Oncaspar can lead to fluctuating coagulation factors. This can promote the tendency to bleeding and/or thrombosis. Caution is therefore needed when anticoagulants are given concomitantly.
Acetylsalicylic acid, pemetrexed [2] ---> SPC of [2] of EMA
Caution should be made when administering higher doses of NSAIDs or aspirin, concurrently with pemetrexed to patients with normal function (creatinine clearance ≥ 80 ml/min).
Acetylsalicylic acid, penicillins
The co-administration may delay the elimination of the penicillin and increase its plasma levels
Acetylsalicylic acid, pentosan polysulfate sodium [2] ---> SPC of [2] of EMA
Patients who are concomitantly treated should be evaluated for any haemorrhagic event in order to adapt the dose if needed
Acetylsalicylic acid, perindopril [2] ---> SPC of [2] of eMC
When ACE-inhibitors are administered simultaneously with NSAIDS attenuation of the antihypertensive effect, an increased risk of worsening of renal function, including possible acute renal failure and an increase in serum potassium may occur
Acetylsalicylic acid, phenprocoumon
Enhancement of phenprocoumon effect and increased bleeding risk with the concomitant administration of acetylsalicylic acid
Acetylsalicylic acid, phenylalkylamines
The co-administration may increase the bleeding risk
Acetylsalicylic acid, phenylbutazone
Increased risk of gastrointestinal bleedings
Acetylsalicylic acid [1], phenytoin ---> SPC of [1] of eMC
Acetylsalicylic acid increases the phenytoin plasma levels
Acetylsalicylic acid, phytomenadione
The co-administration may decrease or inhibit the effect of vitamin K
Acetylsalicylic acid, piretanide
NSAIDs may weaken the antihypertensive and diuretic effect of piretanide
Acetylsalicylic acid, piroxicam [2] ---> SPC of [2] of eMC
The use of piroxicam together with acetyl-salicylic acid must be avoided. Studies in man have shown that the concomitant administration resulted in a reduction of plasma levels of piroxicam to about 80% of the normal values.
Acetylsalicylic acid [1], platelet aggregation inhibitors ---> SPC of [1] of eMC
The co-administration increases the risk of bleeding and is not recommended
Acetylsalicylic acid, potassium canrenoate
The co-administration of NSAIDs with potassium canreonate may cause hyperpotassemia and decrease the diuretic effect of potassium canreonate
Acetylsalicylic acid, prasugrel [2] ---> SPC of [2] of EMA
Prasugrel is to be administered concomitantly with acetylsalicylic acid (ASA). Although a pharmacodynamic interaction with ASA leading to an increased risk of bleeding is possible
Acetylsalicylic acid, pravastatine [2] ---> SPC of [2] of eMC
In interaction studies, no statistically significant differences in bioavailability were observed when pravastatin was administered with acetylsalicylic acid
Acetylsalicylic acid, prednisolone
The ulcerogenic effect of NSAID may increase
Acetylsalicylic acid, pregnancy
The acetylsalicylic acid crosses the placental barrier. Contraindicated in the third trimester of pregnancy
Acetylsalicylic acid, probenecide ---> SPC of [clopidogrel/acetylsalicylic acid] of EMA
Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Acetylsalicylic acid, propantheline
Retardation of gastric emptying by propantheline
Acetylsalicylic acid, protirelin
Reduction of TSH-increase
Acetylsalicylic acid, pyrazinamide
Decrease of acetylsalicylic acid uricosuric effect
Acetylsalicylic acid, ramipril [2] ---> SPC of [2] of eMC
Reduction of the antihypertensive effect of ramipril is to be anticipated. Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.
Acetylsalicylic acid, reteplase [2] ---> SPC of [2] of EMA
Caution should be employed when used reteplase with other medicinal products affecting haemostasis
Acetylsalicylic acid, riociguat [2] ---> SPC of [2] of EMA
Riociguat did not potentiate the bleeding time caused by acetyl-salicylic acid or affect the platelet aggregation in humans.
Acetylsalicylic acid, rivaroxaban [2] ---> SPC of [2] of EMA
Care is to be taken if patients are treated concomitantly with medicinal products affecting haemostasis such as non-steroidal anti-inflammatory medicinal products
Acetylsalicylic acid, saralasin
Attenuation of the antihypertensive effect. Increased risk of worsening of renal function and increase in serum potassium. The concomitant use should be done with caution
Acetylsalicylic acid, sertraline [2] ---> SPC of [2] of EMA
The risk of bleeding may be increased when medicines acting on platelet function or other medicines that might increase bleeding risk are concomitantly administered with SSRIs
Acetylsalicylic acid, sildenafil [2] ---> SPC of [2] of EMA
Sildenafil did not potentiate the increase in bleeding time caused by acetyl salicylic acid
Acetylsalicylic acid, sodium valproate [2] ---> SPC of [2] of eMC
Acetylsalicylic acid may displace valproic acid from its protein binding sites and increase the free valproic acid plasma levels.
Acetylsalicylic acid, spironolactone [2] ---> SPC of [2] of eMC
The acetylsalicylic may reduce the diuretic effect of spironolactone.
Acetylsalicylic acid, streptokinase [2] ---> SPC of [2] of eMC
There is an increased risk of haemorrhage in patients who are receiving or who have recently been treated with anticoagulants or drugs which inhibit platelet formation or function
Acetylsalicylic acid, streptokinase/streptodornase
There is an increased risk of haemorrhage in patients who are receiving or who have recently been treated with anticoagulants or drugs which inhibit platelet formation or function
Acetylsalicylic acid, sucroferric oxyhydroxide [2] ---> SPC of [2] of EMA
In vitro studies did not show any relevant interaction
Acetylsalicylic acid, sulfinpyrazone ---> SPC of [clopidogrel/acetylsalicylic acid] of EMA
Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Acetylsalicylic acid [1], sulfonylureas ---> SPC of [1] of eMC
The co-administration of acetylsalicylic acid with sulfonylureas increases the hypoglycemic effect of the sulfonylurea
Acetylsalicylic acid, tacrolimus [2] ---> SPC of [2] of EMA
Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects
Acetylsalicylic acid, tadalafil [2] ---> SPC of [2] of EMA
Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid.
Acetylsalicylic acid, tapentadol
The co-administration may increase the systemic exposition of tapentadol
Acetylsalicylic acid, telmisartan [2] ---> SPC of [2] of EMA
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Acetylsalicylic acid, telmisartan/amlodipine [2] ---> SPC of [2] of EMA
NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Acetylsalicylic acid, thiopental
Pretreatment with acetylsalicylic acid has been shown to potentiate thiopental sodium anaesthesia.
Acetylsalicylic acid, thrombolytics
The co-administration increases the risk of bleeding and is not recommended
Acetylsalicylic acid, tiaprofenic acid
It is considered unsafe to take NSAIDs in combination with platelet aggregation inhibitors due to increased risk of bleeding. If coadministration is unavoidable, patient should be closely monitored.
Acetylsalicylic acid, ticagrelor [2] ---> SPC of [2] of EMA
Co-administration of ticagrelor with AAS did not have any effect on ADP-induced platelet aggregation. If clinically indicated, medicinal products that alter haemostasis should be used with caution in combination with ticagrelor
Acetylsalicylic acid, ticlopidine [2]
It is considered unsafe to take NSAIDs in combination with platelet aggregation inhibitors due to increased risk of bleeding. If coadministration is unavoidable, patient should be closely monitored.
Acetylsalicylic acid, tirofiban [2] ---> SPC of [2] of eMC
The concomitant administration of tirofiban and ASA increases the inhibition of platelet aggregation
Acetylsalicylic acid, trandolapril/verapamil [2] ---> SPC of [2] of eMC
The concomitant use of acetylsalicylic acid can increase the side effect profile of acetylsalicylic acid (may increase the risk of bleeding).
Acetylsalicylic acid, tricyclic antidepressants
Respiratory weakness may occur
Acetylsalicylic acid, uricosuric agents ---> SPC of [clopidogrel/acetylsalicylic acid] of EMA
Caution is required because ASA may inhibit the effect of uricosuric agents through competitive elimination of uric acid.
Acetylsalicylic acid, urinary alkalinizing agents
The urinary alkalinizing agent increases the pH of renal tubular urine and the urinary excretion of acetylsalicylic acid
Acetylsalicylic acid, urokinase [2] ---> SPC of [2] of eMC
Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided
Acetylsalicylic acid [1], valproic acid ---> SPC of [1] of eMC
Acetylsalicylic acid may displace valproic acid from its protein binding sites and increase the free valproic acid plasma levels.
Acetylsalicylic acid, valsartan [2] ---> SPC of [2] of eMC
When AIIRAs are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur. Furthermore, the concomitant use may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Acetylsalicylic acid [1], vancomycin ---> SPC of [1] of eMC
The acetylsalicylic acid increases the ototoxicity risk of vancomycin.
Acetylsalicylic acid, vardenafil [2] ---> SPC of [2] of EMA
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
Acetylsalicylic acid [1], varicella vaccine ---> SPC of [1] of eMC
It is recommended not to give salicylates for 6 weeks after the varicella vaccine to avoid a possible increased risk of developing Reye's syndrome.
Acetylsalicylic acid, venlafaxine
Possible prolongation of bleeding time. Caution is recommended
Acetylsalicylic acid, verapamil [2] ---> SPC of [2] of eMC
Concomitant use of verapamil and acetylsalicylic acid may increase the risk of bleeding.
Acetylsalicylic acid, vitamin K
The co-administration may decrease or inhibit the effect of vitamin K
Acetylsalicylic acid, vortioxetine [2] ---> SPC of [2] of EMA
Caution should be exercised when vortioxetine is combined with oral anticoagulants or antiplatelet medicinal products due to a potential increased risk of bleeding
Acetylsalicylic acid, warfarin
Salicylates may enhance the anticoagulant effect with risk of bleeding
Acetylsalicylic acid, ximelagatran
The co-administration may significantly increase the bleeding risk
Acetylsalicylic acid, xipamide
Possible decrease of the antihypertensive and diuretic effect of xipamide
Acetylsalicylic acid, zafirlukast [2] ---> SPC of [2] of eMC
Co-administration with acetylsalicylic acid may result in increased plasma levels of zafirlukast, by approximately 45%.
Acetylsalicylic acid, zidovudine
The acetylsalicylic acid may increase the zidovudine plasma levels by inhibition of glucuronidation or microsomal hepatic metabolism
Antacids, salicylates
Antacids may increase the salicylate excretion by alkalinization of urine
Oral anticoagulants, salicylates ---> SPC of [acetylsalicylic acid] of eMC
Displacement of oral anticoagulants from their plasma protein binding sites
CONTRAINDICATIONS of Acetylsalicylic acid
Acetylsalicylic acid should not be taken by patients with the following conditions:
- Known hypersensitivity to aspirin, other ingredients in the product, other salicylates or non-steroidal anti-inflammatory drugs (a patient may have developed anaphylaxis, angioedema, asthma, rhinitis or urticaria induced by aspirin or other NSAIDs).
- Nasal polyps associated with asthma (high risk of severe sensitivity reactions).
- Active peptic ulceration or a past history of ulceration or dyspepsia.
- Haemophilia or other haemorrhagic disorder (including thrombocytopenia) as there is an increased risk of bleeding.
- Concurrent anticoagulant therapy should be avoided.
- Severe hepatic impairment
- Severe renal impairment
- Severe cardiac failure
- third trimester of pregnancy
- Methotrexate used at doses > 15 mg/week
- children under 16 years old, unless specifically indicated (e.g. Kawasaki's disease).
http://www.medicines.org.uk/emc/
Aciclovir
Ability to drive, aciclovir
Headache and dizziness may occur
Aciclovir, aminophylline
Aciclovir reduces clearance of theophylline and a reduced dosage may therefore be necessary to avoid side-effects
Aciclovir, ataluren [2] ---> SPC of [2] of EMA
Caution should be exercised when ataluren is co-administered with medicinal products that are substrates of UGT1A9, OAT1, OAT3, or OATP1B3 because of the risk of increase concentration of these medicinal products
Aciclovir, bendamustine [2] ---> SPC of [2] of eMC
Bendamustine metabolism involves cytochrome P450 (CYP) 1A2 isoenzyme. Therefore, the potential for interaction with CYP1A2 inhibitors
Aciclovir [1], breast-feeding ---> SPC of [1] of eMC
Aciclovir has been detected in breast milk
Aciclovir [1], cimetidine ---> SPC of [1] of eMC
The medicinal products eliminated by active tubular secretion can increase the plasma concentrations of aciclovir
Aciclovir, clofarabine [2] ---> SPC of [2] of EMA
The concomitant use of medicinal products eliminated by tubular secretion should be avoided
Aciclovir, cyclosporine
Increased risk of nephrotoxicity. Caution should be exercised
Aciclovir, emtricitabine/rilpivirine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Co-administration of medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Aciclovir, emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Use of Truvada should be avoided with concurrent or recent use of a nephrotoxic medicinal product
Aciclovir, foscarnet
Since foscarnet can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs
Aciclovir, gentamicin
Increased risk of nephrotoxicity. Caution should be exercised.
Aciclovir, ifosfamide
The previous or concomitant treatment of nephrotoxic drugs may enhance the nephrotoxicity of ifosfamide and thus also the hematotoxicity and CNS toxicity
Aciclovir, interferon
The combination may mutually potentiate the efficacy
Aciclovir, letermovir [2] ---> SPC of [2] of EMA
No dose adjustment required.
Aciclovir, meglumine and sodium ioxitalamate
The co-administration with other medicinal products with nephrotoxic potential may decrease the renal function and cause a permanent damage
Aciclovir, mycophenolate [2]
Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
Aciclovir, mycophenolate mofetil [2] ---> SPC of [2] of EMA
Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
Aciclovir, mycophenolic acid [2] ---> SPC of [2] of eMC
Increased levels of mycophenolic acid glucuronide (MPAG) and aciclovir may be expected when aciclovir and mycophenolic acid are coadministered, possibly as a result of competition for the tubular secretion pathway.
Aciclovir, nephrotoxic substances
The co-administration of aciclovir with nephrotoxic drugs should only done with caution, particularly in patients with renal failure
Aciclovir, netilmicin
The administration concurrent or sequential of netilmicin with other potentially nephrotoxic or neurotoxic drugs may increase the nephrotoxicity and/or neurotoxicity
Aciclovir, ospemifene [2] ---> SPC of [2] of EMA
Ospemifene and its major metabolite, 4-hydroxyospemifene, inhibited organic cation transporter (OCT)1 in vitro at clinically relevant concentrations. Therefore, ospemifene may increase concentrations of medicinal products which are substrates of OCT1
Aciclovir, pethidine
Concomitant use of aciclovir may increase the plasma concentrations of pethidine and its metabolite norpethidine
Aciclovir [1], pregnancy ---> SPC of [1] of eMC
The use of aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks.
Aciclovir, probenecide
The medicinal products eliminated by active tubular secretion can increase the plasma concentrations of aciclovir
Aciclovir, safinamide [2] ---> SPC of [2] of EMA
Safinamide inhibits OCT1 in vitro at clinically relevant portal vein concentrations. Therefore, caution is necessary when safinamide is taken concomitantly with medicinal products that are OCT1 substrates and have a tmax similar to safinamide (2 hours)
Aciclovir, tacrolimus [2] ---> SPC of [2] of EMA
Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects
Aciclovir, talimogene laherparepvec [2] ---> SPC of [2] of EMA
Acyclovir and other anti-viral agents may interfere with the effectiveness of Imlygic if administered systemically or topically directly to the injection site.
Aciclovir, tenofovir
The medicinal products eliminated by active tubular secretion can increase the plasma concentrations of aciclovir
Aciclovir, theophylline
Aciclovir reduces clearance of theophylline and a reduced dosage may therefore be necessary to avoid side-effects
Aciclovir, tiopronin
Enhancement of adverse effects of systemic aciclovir, particularly renal damage
Aciclovir, tubular secretion
The medicinal products eliminated by active tubular secretion can increase the plasma concentrations of aciclovir
Aciclovir, zidovudine
The combination may cause neuropathies, convulsions and lethargy.
CONTRAINDICATIONS of Aciclovir
Hypersensitivity to aciclovir or valaciclovir or to any of the excipients
http://www.medicines.org.uk/emc/
Acitretin
Ability to drive, acitretin [2] ---> SPC of [2] of eMC
Decreased night vision has been reported with Acitretin therapy.
Acitretin [1], alcohol ---> SPC of [1] of eMC
The co-administration produces etretinate, which is very teratogen
Acitretin [1], breast-feeding ---> SPC of [1] of eMC
Acitretin must not be given to nursing mothers
Acitretin [1], demeclocycline ---> SPC of [1] of eMC
The co-administration may increase the intracranial pressure. The combination is contraindicated
Acitretin, isotretinoin [2] ---> SPC of [2] of eMC
Risk of A hypervitaminosis. The co-administration should be avoided.
Acitretin [1], methotrexate ---> SPC of [1] of eMC
Increased hepatitis risk. Co-administration contraindicated
Acitretin [1], oral contraceptives ---> SPC of [1] of eMC
Low dose progesterone-only products (minipills) may be an inadequate method of contraception during acitretin therapy
Acitretin [1], phenytoin ---> SPC of [1] of eMC
Acitretin displaces partially phenytoin from its plasma protein binding
Acitretin [1], pregnancy ---> SPC of [1] of eMC
Acitretin is contraindicated in pregnant women
Acitretin, progesterone
Possible decreased plasma concentrations of progesterone
Acitretin [1], retinoids ---> SPC of [1] of eMC
Risk of hypervitaminosis A. The combination is contraindicated
Acitretin, retinol [1] ---> SPC of [1] of eMC
Risk of hypervitaminosis A. The combination is contraindicated
Acitretin, sun
Patients should be advised to avoid extensive exposure to either UV irradiation or sunlight.
Acitretin [1], tetracyclines ---> SPC of [1] of eMC
The co-administration may increase the intracranial pressure. The combination is contraindicated
Acitretin [1], tretinoin ---> SPC of [1] of eMC
Risk of hypervitaminosis A. The combination is contraindicated
Acitretin [1], vitamin A ---> SPC of [1] of eMC
Risk of hypervitaminosis A. The combination is contraindicated
Retinoids, sun
Patients should be advised to avoid extensive exposure to either UV irradiation or sunlight.
CONTRAINDICATIONS of Acitretin
- Acitretin is highly teratogenic and must not be used by women who are pregnant. The same applies to women of childbearing potential unless strict contraception is practiced 4 weeks before, during and for 2 years after treatment
- The use of Acitretin is contra-indicated in women who are breast feeding.
- Acitretin is contra-indicated in patients with severe hepatic or renal impairment and in patients with chronic abnormally elevated blood lipid values.
- Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated. Supplementary treatment with antibiotics such as tetracyclines is therefore contra-indicated
- An increased risk of hepatitis has been reported following the concomitant use of methotrexate and etretinate. Consequently, the concomitant use of methotrexate and acitretin should be avoided
- Concomitant administration of Acitretin with other retinoids or Vitamin A is contra-indicated due to the risk of hypervitaminosis A.
- Acitretin is contra-indicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids.
http://www.medicines.org.uk/emc/
Aclidinium (Bretaris Genuair)
Ability to drive, aclidinium [2] ---> SmPC of [2] of EMA
Aclidinium bromide may have minor influence on the ability to drive and use machines. The occurrence of headache, dizziness or blurred vision following administration of aclidinium bromide may influence the ability to drive or to use machinery.
Aclidinium [1], anticholinergics ---> SmPC of [1] of EMA
Co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has not been studied and is not recommended.
Aclidinium [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bretaris Genuair therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Aclidinium [1], bronchodilatators ---> SmPC of [1] of EMA
Inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Aclidinium [1], COPD medicinal products ---> SmPC of [1] of EMA
Inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Aclidinium [1], corticosteroids ---> SmPC of [1] of EMA
Inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Aclidinium [1], esterase ---> SmPC of [1] of EMA
Inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Aclidinium [1], fertility ---> SmPC of [1] of EMA
Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3).
Aclidinium [1], methylxanthine ---> SmPC of [1] of EMA
Inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Aclidinium [1], pregnancy ---> SmPC of [1] of EMA
Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks.
Aclidinium [1], sympathomimetics ---> SmPC of [1] of EMA
Inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Aclidinium, metabolized by cytochrome P450 ---> SmPC of [aclidinium/formoterol] of EMA
Aclidinium bromide or the metabolites at the therapeutic dose are not expected to cause interactions with active substances that are substrates of P-glycoprotein or active substances metabolised by cytochrome P450 enzymes and esterases
Aclidinium, P-glycoprotein substrates ---> SmPC of [aclidinium/formoterol] of EMA
Aclidinium bromide or the metabolites at the therapeutic dose are not expected to cause interactions with active substances that are substrates of P-glycoprotein or active substances metabolised by cytochrome P450 enzymes and esterases
CONTRAINDICATIONS of Aclidinium (Bretaris Genuair)
- Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.
Other trade names: Eklira Genuair,
Aclidinium/formoterol (Duaklir Genuair)
Ability to drive, aclidinium/formoterol [2] ---> SmPC of [2] of EMA
The occurrence of blurred vision or dizziness may influence the ability to drive or to use machines.
Aclidinium/formoterol [1], anticholinergics ---> SmPC of [1] of EMA
Co-administration of aclidinium/formoterol with other anticholinergic and/or long beta2-adrenergic agonist containing medicinal products has not been studied and is not recommended.
Aclidinium/formoterol [1], antihistamines ---> SmPC of [1] of EMA
The action of formoterol on the cardiovascular system may be potentiated by these medicinal products. Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Aclidinium/formoterol [1], beta2-adrenergic agonists ---> SmPC of [1] of EMA
Co-administration of aclidinium/formoterol with other anticholinergic and/or long beta2-adrenergic agonist containing medicinal products has not been studied and is not recommended.
Aclidinium/formoterol [1], betablockers ---> SmPC of [1] of EMA
Beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists.
Aclidinium/formoterol [1], breast-feeding ---> SmPC of [1] of EMA
The use of Duaklir Genuair by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
Aclidinium/formoterol [1], fertility ---> SmPC of [1] of EMA
Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium and formoterol (see section 5.3).
Aclidinium/formoterol [1], IMAOs ---> SmPC of [1] of EMA
The action of formoterol on the cardiovascular system may be potentiated by these medicinal products. Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Aclidinium/formoterol [1], loop diuretics ---> SmPC of [1] of EMA
Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of ?2-adrenergic agonists, therefore caution is advised in their concomitant use (see section 4.4).
Aclidinium/formoterol [1], macrolide antibiotics ---> SmPC of [1] of EMA
The action of formoterol on the cardiovascular system may be potentiated by these medicinal products. Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Aclidinium/formoterol [1], metabolized by cytochrome P450 ---> SmPC of [1] of EMA
In vitro studies have shown that aclidinium or its metabolites at the therapeutic dose are not expected to cause interactions with P-glycoprotein (P-gp) substrate drugs or drugs metabolised by cytochrome P450 (CYP450) enzymes and esterases.
Aclidinium/formoterol [1], non-potassium-sparing diuretics ---> SmPC of [1] of EMA
Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of ?2-adrenergic agonists, therefore caution is advised in their concomitant use (see section 4.4).
Aclidinium/formoterol [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
In vitro studies have shown that aclidinium or its metabolites at the therapeutic dose are not expected to cause interactions with P-glycoprotein (P-gp) substrate drugs or drugs metabolised by cytochrome P450 (CYP450) enzymes and esterases.
Aclidinium/formoterol [1], pregnancy ---> SmPC of [1] of EMA
Duaklir Genuair should only be used during pregnancy if the expected benefits outweigh the potential risks.
Aclidinium/formoterol [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
The action of formoterol on the cardiovascular system may be potentiated by these medicinal products. Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Aclidinium/formoterol [1], steroids ---> SmPC of [1] of EMA
Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of ?2-adrenergic agonists, therefore caution is advised in their concomitant use (see section 4.4).
Aclidinium/formoterol [1], thiazides ---> SmPC of [1] of EMA
Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of ?2-adrenergic agonists, therefore caution is advised in their concomitant use (see section 4.4).
Aclidinium/formoterol [1], tricyclic antidepressant ---> SmPC of [1] of EMA
The action of formoterol on the cardiovascular system may be potentiated by these medicinal products. Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Aclidinium/formoterol [1], xanthines ---> SmPC of [1] of EMA
Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of ?2-adrenergic agonists, therefore caution is advised in their concomitant use (see section 4.4).
Aclidinium/formoterol, COPD [2] ---> SmPC of [2] of EMA
Duaklir Genuair has been used concomitantly with other COPD medicinal products including short-acting beta2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
CONTRAINDICATIONS of Aclidinium/formoterol (Duaklir Genuair)
- Hypersensitivity to the active substances or to the excipient listed in section 6.1.
Other trade names: Brimica Genuair,
Acoramidis (Beyonttra)
Acid-reducing agent, acoramidis [2] ---> SmPC of [2] of EMA
No dedicated in vivo drug-drug interaction study with gastric acid reducing agents was performed. Thus, the effect of gastric acid reducing agents on the pharmacokinetics of acoramidis is unknown.
Acoramidis [1], BCRP inhibitors ---> SmPC of [1] of EMA
Acoramidis is a substrate for BCRP. Based on an in vitro study, a clinically relevant interaction with BCRP inhibitors is not expected.
Acoramidis [1], BCRP substrates ---> SmPC of [1] of EMA
Based on an in vitro study, no drug-drug interaction with co-administered breast cancer resistance protein (BCRP) substrates is anticipated at clinically relevant concentrations.
Acoramidis [1], breast-feeding ---> SmPC of [1] of EMA
It is unknown whether acoramidis or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded (see section 5.3). Acoramidis should not be used during breast-feeding.
Acoramidis [1], CYP2C8 substrates ---> SmPC of [1] of EMA
However, acoramidis was shown to be an inhibitor of CYP2C8 and CYP2C9 in vitro. No in vivo study has been performed. Therefore, concomitant CYP2C8 and CYP2C9 substrates with narrow therapeutic index should be used with caution.
Acoramidis [1], CYP2C9 substrates ---> SmPC of [1] of EMA
However, acoramidis was shown to be an inhibitor of CYP2C8 and CYP2C9 in vitro. No in vivo study has been performed. Therefore, concomitant CYP2C8 and CYP2C9 substrates with narrow therapeutic index should be used with caution.
Acoramidis [1], cytochrome P450 ---> SmPC of [1] of EMA
Based on in vitro studies, acoramidis is unlikely to cause any clinically relevant uridine 5'-diphospho (UDP)-glucuronosyl transferase-dependent or Cytochrome P450-dependent interactions.
Acoramidis [1], diuretics ---> SmPC of [1] of EMA
Based on population pharmacokinetic (PK) analysis, concomitant diuretic use in patients does not affect steady-state plasma acoramidis concentrations.
Acoramidis [1], fertility ---> SmPC of [1] of EMA
No human data on fertility is available. Impairment of fertility has not been observed in non-clinical studies in supratherapeutic exposures.
Acoramidis [1], pregnancy ---> SmPC of [1] of EMA
Acoramidis is not recommended during pregnancy and in women of childbearing potential not using contraception.
Acoramidis [1], thyroxine ---> SmPC of [1] of EMA
Acoramidis may decrease serum concentrations of free thyroxine without an accompanying change in thyroid stimulating hormone (TSH). No corresponding clinical findings consistent with thyroid dysfunction have been observed.
Adefovir, OAT inhibitors ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
Bumetanide, OAT inhibitors ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
Cidofovir, OAT inhibitors ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
Furosemide, OAT inhibitors ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
Ganciclovir, OAT inhibitors ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
Lamivudine, OAT inhibitors ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
Methotrexate, OAT inhibitors ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
NSAID, OAT inhibitors ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
OAT inhibitors, OAT1 substrates ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
OAT inhibitors, OAT3 substrates ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
OAT inhibitors, oseltamivir ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
OAT inhibitors, tenofovir ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
OAT inhibitors, zalcitabine ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
OAT inhibitors, zidovudine ---> SmPC of [acoramidis] of EMA
Based on a clinical study in healthy adult volunteers, inhibition of organic anion transporter (OAT)-1 and -3 is not expected to result in clinically relevant drug-drug interactions with OAT-1 and OAT-3 substrates
CONTRAINDICATIONS of Acoramidis (Beyonttra)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/beyonttra-epar-product-information_en.pdf 05/11/2025
Adagrasib (Krazati)
Ability to drive, adagrasib [2] ---> SmPC of [2] of EMA
Patients should be advised that dizziness may occur and that, if affected, they should not drive, use machines, or take part in other activities where this would put themselves or others at risk.
Adagrasib [1], alfuzosin ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], amiodarone ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], BCRP substrates ---> SmPC of [1] of EMA
No clinically significant differences in the pharmacokinetics of rosuvastatin (a BCRP/OATP1B1 substrate) were observed when coadministered with adagrasib.
Adagrasib [1], breast-feeding ---> SmPC of [1] of EMA
A risk to breast-fed newborns/infants cannot be excluded. Adagrasib should not be used during breast-feeding.
Adagrasib [1], cisapride ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], CYP2C9 substrates ---> SmPC of [1] of EMA
In vitro, adagrasib inhibits CYP2C9. Avoid concomitant use of adagrasib with sensitive CYP2C9 substrates where minimal concentration changes may lead to serious adverse reactions unless otherwise recommended in the SmPC for these substrates.
Adagrasib [1], CYP2D6 substrates ---> SmPC of [1] of EMA
Avoid concomitant use of adagrasib with sensitive CYP2D6 substrates where minimal concentration changes may lead to serious adverse reactions unless otherwise recommended in the SmPC for these substrates.
Adagrasib [1], CYP3A4 substrates ---> SmPC of [1] of EMA
Avoid concomitant use of adagrasib with sensitive CYP3A substrates unless otherwise recommended in the SmPC for these substrates.
Adagrasib [1], dextromethorphan ---> SmPC of [1] of EMA
Avoid concomitant use of adagrasib with sensitive CYP2D6 substrates where minimal concentration changes may lead to serious adverse reactions unless otherwise recommended in the SmPC for these substrates.
Adagrasib [1], digoxin ---> SmPC of [1] of EMA
Avoid concomitant use of adagrasib with P-gp substrates where minimal concentration changes may lead to serious adverse reactions unless otherwise recommended in the SmPC for these substrates.
Adagrasib [1], dihydroergotamine ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], drugs metabolised by CYP3A4 ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], ergotamine ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], fertility ---> SmPC of [1] of EMA
No clinical data are available on the possible effects of adagrasib on fertility.
Adagrasib [1], itraconazol ---> SmPC of [1] of EMA
Adagrasib Cmax increased by 2.4-fold and AUC increased by 4-fold following concomitant use of a single dose of 200 mg (0.33 times the approved recommended dose) with itraconazole (a strong CYP3A inhibitor).
Adagrasib [1], lovastatine ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], midazolam ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], OATP1B1 substrates ---> SmPC of [1] of EMA
No clinically significant differences in the pharmacokinetics of rosuvastatin (a BCRP/OATP1B1 substrate) were observed when coadministered with adagrasib.
Adagrasib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
Avoid concomitant use of adagrasib with P-gp substrates where minimal concentration changes may lead to serious adverse reactions unless otherwise recommended in the SmPC for these substrates.
Adagrasib [1], pimozide ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], pregnancy ---> SmPC of [1] of EMA
There are no data from the use of adagrasib in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Adagrasib is not recommended during pregnancy.
Adagrasib [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
QTc interval prolongation can occur in patients treated with adagrasib (see section 4.8). It is recommended that a baseline electrocardiogram (ECG) prior to treatment initiation be performed in all patients and repeated during treatment.
Adagrasib [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
In patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia, KRAZATI should be permanently discontinued (see sections 4.2, 4.5 and 4.8).
Adagrasib [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
The use of medicinal products known to prolong the QTc interval should be avoided (see section 4.5).
Adagrasib [1], quetiapine ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], quinidine ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], rifampicin ---> SmPC of [1] of EMA
Co-administration of multiple doses of rifampicin 600 mg QD (strong CYP3A4 inducer) with a single 600 mg dose of adagrasib decreased adagrasib Cmax by 88% and AUC by 95% in healthy subjects.
Adagrasib [1], rosuvastatin ---> SmPC of [1] of EMA
No clinically significant differences in the pharmacokinetics of rosuvastatin (a BCRP/OATP1B1 substrate) were observed when coadministered with adagrasib.
Adagrasib [1], sildenafil ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], simvastatine ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], sirolimus ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Concomitant use of strong CYP3A inducers should be avoided.
Adagrasib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant use of strong CYP3A inhibitors should be avoided.
Adagrasib [1], tacrolimus ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], ticagrelor ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], transaminases ---> SmPC of [1] of EMA
Increased transaminases occurred in patients treated with adagrasib (see section 4.8).
Adagrasib [1], triazolam ---> SmPC of [1] of EMA
Adagrasib is a strong CYP3A4 inhibitor. Co-administration of medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Adagrasib [1], women of childbearing potential ---> SmPC of [1] of EMA
Female patients of childbearing potential receiving adagrasib must use an effective contraceptive method during treatment and for at least 5 days following the last dose of adagrasib.
CONTRAINDICATIONS of Adagrasib (Krazati)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Concomitant use of CYP3A substrates with a narrow therapeutic index (see sections 4.4 and 4.5).
https://www.ema.europa.eu/en/documents/product-information/krazati-epar-product-information_en.pdf 13/03/2024
Adalimumab (Humira)
Abatacept, adalimumab [2] ---> SmPC of [2] of EMA
Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, and other potential pharmacological interactions.
Ability to drive, adalimumab [2] ---> SmPC of [2] of EMA
Humira may have a minor influence on the ability to drive and use machines. Vertigo and visual impairment may occur following administration of Humira (see section 4.8).
Adalimumab [1], anakinra ---> SmPC of [1] of EMA
Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, and other potential pharmacological interactions.
Adalimumab [1], breast-feeding ---> SmPC of [1] of EMA
No effects on the breastfed newborns/infants are anticipated. Consequently, Humira can be used during breastfeeding.
Adalimumab [1], disease modifying anti-rheumatic drug ---> SmPC of [1] of EMA
Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, and other potential pharmacological interactions.
Adalimumab [1], fertility ---> SmPC of [1] of EMA
Preclinical data on fertility effects of adalimumab are not available.
Adalimumab [1], methotrexate ---> SmPC of [1] of EMA
Administration of Humira without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab
Adalimumab [1], pregnancy ---> SmPC of [1] of EMA
Due to its inhibition of TNF-alfa, adalimumab administered during pregnancy could affect normal immune responses in the newborn. Administration of adalimumab is not recommended during pregnancy.
Adalimumab [1], TNF inhibitors ---> SmPC of [1] of EMA
Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, and other potential pharmacological interactions.
Adalimumab [1], vaccinations ---> SmPC of [1] of EMA
Patients on Humira may receive concurrent vaccinations, except for live vaccines. Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Adalimumab [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Humira treatment.
Adalimumab, imlifidase [2] ---> SmPC of [2] of EMA
Recommended time interval after administration of 0.25 mg/kg imlifidase: 4 days
CONTRAINDICATIONS of Adalimumab (Humira)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Active tuberculosis or other severe infections such as sepsis, and opportunistic infections
- Moderate to severe heart failure (NYHA class III/IV)
https://www.ema.europa.eu/en/documents/product-information/humira-epar-product-information_en.pdf 13/08/2025
Other trade names: Amgevita, Amsparity, Cyltezo, Halimatoz, Hefiya, Hukyndra, Hulio, Hyrimoz, Idacio, Imraldi, Kromeya, Libmyris, Solymbic, Trudexa, Yuflyma,
Adapalene
Adapalene [1], breast-feeding ---> SPC of [1] of eMC
Adapalene can be used during breastfeeding. To avoid contact exposure of the infant, application to the chest should be avoided when used during breast-feeding.
Adapalene, methotrexate
The additional administration of methotrexate with hepatotoxic and hematotoxic products increases the probability of hepatotoxic and hematotoxic effects of methotrexate
Adapalene [1], pregnancy ---> SPC of [1] of eMC
Should not be used during pregnancy.
Adapalene [1], retinoids ---> SPC of [1] of eMC
Medicinal products with a similar mode of action should not be used concurrently.
Adapalene, sun
Patients should be advised to avoid extensive exposure to either UV irradiation or sunlight.
CONTRAINDICATIONS of Adapalene
Hypersensitivity to the active substance or to any of the excipients
http://www.medicines.org.uk/emc/
Adefovir dipivoxil (Hepsera)
Ability to drive, adefovir dipivoxil [2] ---> SmPC of [2] of EMA
Hepsera is expected to have no or negligible influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed.
Adefovir dipivoxil [1], aminoglycoside antibiotics ---> SmPC of [1] of EMA
Co-administration of adefovir dipivoxil with intravenous aminoglycosides may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil [1], amphotericin ---> SmPC of [1] of EMA
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil [1], breast-feeding ---> SmPC of [1] of EMA
It is unknown whether adefovir dipivoxil is excreted in human milk. A risk to the newborns/infants cannot be excluded. It is recommended that mothers being treated with adefovir dipivoxil do not breast-feed their infants.
Adefovir dipivoxil [1], cidofovir ---> SmPC of [1] of EMA
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil [1], contraceptives ---> SmPC of [1] of EMA
The use of adefovir dipivoxil must be accompanied by the use of effective contraception.
Adefovir dipivoxil [1], cyclosporine ---> SmPC of [1] of EMA
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil [1], cytochrome P450 ---> SmPC of [1] of EMA
The potential for CYP450 mediated interactions involving adefovir with other medicinal products is low, based on the results of in vitro experiments in which adefovir did not influence any of the common CYP isoforms known to be involved in drug metabolism
Adefovir dipivoxil [1], fertility ---> SmPC of [1] of EMA
No human data on the effect of adefovir dipivoxil on fertility are available. Animal studies do not indicate harmful effects of adefovir dipivoxil on male and female fertility.
Adefovir dipivoxil [1], foscarnet ---> SmPC of [1] of EMA
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil [1], gentamicin ---> SmPC of [1] of EMA
Co-administration of adefovir dipivoxil with intravenous aminoglycosides may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil [1], lamivudine ---> SmPC of [1] of EMA
Concomitant administration of 10 mg adefovir dipivoxil and 100 mg lamivudine did not alter the pharmacokinetic profile of either medicinal product.
Adefovir dipivoxil [1], pegylated interferon ---> SmPC of [1] of EMA
Even though a pharmacokinetic interaction is unlikely given the two products are eliminated via different pathways, caution is recommended if both products are co-administered.
Adefovir dipivoxil [1], pentamidine ---> SmPC of [1] of EMA
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil [1], pregnancy ---> SmPC of [1] of EMA
Adefovir dipivoxil is not recommended during pregnancy and in women of childbearing potential not using contraception.
Adefovir dipivoxil [1], pregnancy ---> SmPC of [1] of EMA
Adefovir dipivoxil should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Adefovir dipivoxil [1], tacrolimus ---> SmPC of [1] of EMA
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil [1], tubular secretion ---> SmPC of [1] of EMA
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil [1], vancomycin ---> SmPC of [1] of EMA
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product
Adefovir dipivoxil, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Symtuza should not be administered concomitantly with medicinal products containing tenofovir disoproxil (as fumarate, phosphate or succinate), lamivudine, or adefovir dipivoxil used for the treatment of HBV infection.
Adefovir dipivoxil, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Genvoya should not be administered concomitantly with medicinal products containing tenofovir disoproxil (as fumarate), lamivudine or adefovir dipivoxil used for the treatment of HBV infection.
Adefovir dipivoxil, emtricitabine/rilpivirine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Odefsey should not be co-administered with other medicinal products containing tenofovir alafenamide, lamivudine, tenofovir disoproxil (as fumarate) or adefovir dipivoxil
Adefovir dipivoxil, emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Descovy should not be administered concomitantly with medicinal products containing tenofovir disoproxil (as fumarate), lamivudine or adefovir dipivoxil used for the treatment of HBV infection.
Adefovir dipivoxil, emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA
Adefovir dipivoxil and Truvada should not be administered concomitantly
Adefovir dipivoxil, meglumine and sodium ioxitalamate
The co-administration with other medicinal products with nephrotoxic potential may decrease the renal function and cause a permanent damage
Adefovir dipivoxil, netilmicin
The administration concurrent or sequential of netilmicin with other potentially nephrotoxic or neurotoxic drugs may increase the nephrotoxicity and/or neurotoxicity
Adefovir dipivoxil, nevirapine [2] ---> SmPC of [2] of EMA
Adefovir and nevirapine can be co-administered without dose adjustments
Adefovir dipivoxil, tenofovir disoproxil [2] ---> SmPC of [2] of EMA
Viread should not be administered concomitantly with adefovir dipivoxil.
CONTRAINDICATIONS of Adefovir dipivoxil (Hepsera)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/hepsera-epar-product-information_en.pdf 01/03/2023 (Withdrawn)
Adenosine
ACE inhibitors, adenosine [2] ---> SPC of [2] of eMC
Adenosine may interact with drugs tending to impair cardiac conduction.
Adenosine [1], adenosine antagonists ---> SPC of [1] of eMC
The adenosine antagonist decreases the adenosine effect. The co-administration should be avoided for 24 hours prior to use of adenosine.
Adenosine [1], aminophylline ---> SPC of [1] of eMC
The anti-arrhythmic effect of adenosine is antagonised by theophylline
Adenosine [1], antiadrenergics ---> SPC of [1] of eMC
Adenosine may interact with drugs tending to impair cardiac conduction.
Adenosine [1], antiarrhythmics ---> SPC of [1] of eMC
Adenosine may interact with drugs tending to impair cardiac conduction.
Adenosine [1], betablockers ---> SPC of [1] of eMC
Adenosine may interact with drugs tending to impair cardiac conduction.
Adenosine [1], breast-feeding ---> SPC of [1] of eMC
Adenosine should not be used during breast-feeding.
Adenosine [1], caffeine ---> SPC of [1] of eMC
The caffeine, adenosine antagonist, decreases the adenosine effect. The co-administration should be avoided for 24 hours prior to use of adenosine.
Adenosine [1], calcium antagonists ---> SPC of [1] of eMC
Adenosine may interact with drugs tending to impair cardiac conduction.
Adenosine [1], cardioactive drugs ---> SPC of [1] of eMC
Adenosine may interact with drugs tending to impair cardiac conduction.
Adenosine [1], digital glycosides ---> SPC of [1] of eMC
Adenosine may interact with drugs tending to impair cardiac conduction.
Adenosine [1], dipyridamole ---> SPC of [1] of eMC
Dipyridamole inhibits adenosine cellular uptake and metabolism, and potentiates the action of adenosine. The co-administration is contraindicated
Adenosine [1], foods ---> SPC of [1] of eMC
Avoid caffeine, chocolate, cola and tea containing foods and drinks for at least 12 hours prior to use of adenosine
Adenosine, nicotine
Nicotine may increase the hemodynamic effects of adenosine
Adenosine [1], nitrates ---> SPC of [1] of eMC
Adenosine may interact with drugs tending to impair cardiac conduction.
Adenosine, prajmalium
The co-administration may prolong the QT interval
Adenosine [1], pregnancy ---> SPC of [1] of eMC
Adenosine is not recommended during pregnancy unless the physician considers the benefits to outweigh the potential risks.
Adenosine [1], theophylline ---> SPC of [1] of eMC
The theophylline, adenosine antagonist, decreases the adenosine effect. The co-administration should be avoided for 24 hours prior to use of adenosine.
Adenosine [1], xanthines ---> SPC of [1] of eMC
The xanthine, adenosine antagonist, decreases the adenosine effect. The co-administration should be avoided for 24 hours prior to use of adenosine.
CONTRAINDICATIONS of Adenosine
Adenoscan® is contra-indicated in patients suffering from:
- Hypersensitivity to the active substance or to any of the excipients.
- Second or third degree atrioventricular (AV) block, sick sinus syndrome except in patients with a functioning artificial pacemaker
- Long QT syndrome
- Severe hypotension
- Unstable angina not successfully stabilised with medical therapy
- Decompensated states of heart failure
- Chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma bronchiale)
- Concomitant use of dipyridamole
http://www.medicines.org.uk/emc/
Adrenaline (EURneffy)
Ability to drive, adrenaline [2] ---> SmPC of [2] of EMA
EURneffy has no or negligible influence on the ability to drive and use machines. It is not recommended that patients who are suffering an anaphylactic reaction drive or use machines because of the anaphylactic reaction.
Adrenaline [1], alcohol ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], alfa-adrenergic receptor blockers ---> SmPC of [1] of EMA
Pressor effects of adrenaline may be counteracted by rapidly acting vasodilators or alpha-adrenergic blocking medicinal products such as phentolamine.
Adrenaline [1], antiadrenergics ---> SmPC of [1] of eMC
Adrenaline specifically reverses the antihypertensive effects of adrenergic neurone blockers such as guanethidine with the risk of severe hypertension.
Adrenaline [1], atropine ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], betablockers ---> SmPC of [1] of EMA
The beta-stimulating effect of adrenaline may be inhibited by simultaneous treatment with betablocking medicinal products, e.g. propanolol.
Adrenaline [1], breast-feeding ---> SmPC of [1] of EMA
A risk to the newborns/ infants cannot be excluded. However, due to its poor oral bioavailability and short half-life, exposure is expected to be very low in the breastfed infants.
Adrenaline [1], catecholamine-O-methyltransferase inhibitors ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], chlormerodrin ---> SmPC of [1] of EMA
Caution is indicated in patients receiving medicinal products that may sensitise the heart to arrhythmias,
Adrenaline [1], chlorpheniramine ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], corticosteroids ---> SmPC of [1] of eMC
Drugs which cause potassium loss (corticosteroids, potassium-depleting diuretic, aminophylline, theophylline) increase the risk of hypokalemia.
Adrenaline [1], cyclopentolate ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], diabetic patient ---> SmPC of [1] of EMA
But for diabetic patients receiving adrenaline it may be necessary to increase their dose of insulin or oral hypoglycaemic medicinal products.
Adrenaline [1], digital glycosides ---> SmPC of [1] of eMC
The risk of cardiac arrhythmias is higher when adrenaline is given to patients receiving digoxin or quinidine.
Adrenaline [1], digoxin ---> SmPC of [1] of EMA
Caution is indicated in patients receiving medicinal products that may sensitise the heart to arrhythmias,
Adrenaline [1], diphenhydramine ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], diuretics ---> SmPC of [1] of eMC
Drugs which cause potassium loss (corticosteroids, potassium-depleting diuretic, aminophylline, theophylline) increase the risk of hypokalemia.
Adrenaline [1], entacapone ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], ergot derivatives ---> SmPC of [1] of eMC
The vasoconstrictor and pressor effects of adrenaline, mediated by its alpha-adrenergic action, may be enhanced by concomitant administration of drugs with similar effects, such as ergot alkaloids or oxytocin.
Adrenaline [1], fertility ---> SmPC of [1] of EMA
Adrenaline is an endogenous substance and blood levels after administration of EURneffy are within normal physiological ranges and as such it is unlikely that there would be any detrimental effects on fertility.
Adrenaline [1], guanethidine ---> SmPC of [1] of eMC
Adrenaline specifically reverses the antihypertensive effects of adrenergic neurone blockers such as guanethidine with the risk of severe hypertension.
Adrenaline [1], halogenated anaesthetics ---> SmPC of [1] of eMC
Volatile liquid anaesthetics such as halothane increase the risk of adrenaline-induced ventricular arrhythmias and acute pulmonary oedema if hypoxia is present.
Adrenaline [1], homatropine ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], hyoscine ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], hypercalcemia ---> SmPC of [1] of eMC
If the calcium level is increased, use of adrenaline may lead to severe cardiac arrhythmia.
Adrenaline [1], imipramine ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], insulin ---> SmPC of [1] of EMA
Adrenaline inhibits the secretion of insulin, thus increasing the blood glucose level.
Adrenaline [1], levodopa ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], merbaphen ---> SmPC of [1] of EMA
Caution is indicated in patients receiving medicinal products that may sensitise the heart to arrhythmias,
Adrenaline [1], mercaptomerin ---> SmPC of [1] of EMA
Caution is indicated in patients receiving medicinal products that may sensitise the heart to arrhythmias,
Adrenaline [1], mercurial ---> SmPC of [1] of EMA
Caution is indicated in patients receiving medicinal products that may sensitise the heart to arrhythmias,
Adrenaline [1], mercurophylline ---> SmPC of [1] of EMA
Caution is indicated in patients receiving medicinal products that may sensitise the heart to arrhythmias,
Adrenaline [1], non-selective betablockers ---> SmPC of [1] of eMC
Severe hypertension and bradycardia may occur when adrenaline (epinephrine) is administered with nonselective beta-blocking medicinal products.
Adrenaline [1], opicapone ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], oral antidiabetics ---> SmPC of [1] of eMC
Adrenaline-induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with hypoglycaemic agents.
Adrenaline [1], oxytocin ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], parasympatholytics ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], phenelzine ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], phentolamine ---> SmPC of [1] of EMA
Pressor effects of adrenaline may be counteracted by rapidly acting vasodilators or alpha-adrenergic blocking medicinal products such as phentolamine.
Adrenaline [1], pregnancy ---> SmPC of [1] of EMA
The use of this medicinal product may be considered during pregnancy, if necessary.
Adrenaline [1], propranolol ---> SmPC of [1] of EMA
The beta-stimulating effect of adrenaline may be inhibited by simultaneous treatment with betablocking medicinal products, e.g. propanolol.
Adrenaline [1], quinidine ---> SmPC of [1] of EMA
Caution is indicated in patients receiving medicinal products that may sensitise the heart to arrhythmias,
Adrenaline [1], selegiline ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], sulfonylureas ---> SmPC of [1] of eMC
Adrenaline-induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with hypoglycaemic agents.
Adrenaline [1], theophylline ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], thiazides ---> SmPC of [1] of eMC
Drugs which cause potassium loss (corticosteroids, potassium-depleting diuretic, aminophylline, theophylline) increase the risk of hypokalemia.
Adrenaline [1], thyroid hormones ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], tolcapone ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], tranylcypromine ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], tricyclic antidepressant ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], tropicamide ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline [1], vasodilators ---> SmPC of [1] of EMA
Pressor effects of adrenaline may be counteracted by rapidly acting vasodilators or alpha-adrenergic blocking medicinal products such as phentolamine.
Adrenaline, aliskiren/amlodipine/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Hydrochlorothiazide may reduce the response to pressor amines
Adrenaline, amiloride/hydrochlorothiazide
The effect of adrenaline can be weaken with the concomitant administration of amiloride/hydrochlorothiazide
Adrenaline, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Hydrochlorothiazide may reduce the response to pressor amines. The clinical significance of this effect is uncertain and not sufficient to preclude their use.
Adrenaline, anticholinergics
The effects of adrenaline may be potentiated by parasympatholytics
Adrenaline, anticoagulants
The tendency to bleed is increased during the treatment with anticoagulants and adrenaline
Adrenaline, atenolol [2] ---> SmPC of [2] of eMC
Alfa- and beta-adrenergic agonists in combination with atenolol may unmask the alpha-adrenoceptor-mediated vasoconstrictor effects of these agents leading to blood pressure increase and exacerbated intermittent claudication.
Adrenaline, atenolol/chlortalidone [2] ---> SmPC of [2] of eMC
Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the effect of beta-blockers.
Adrenaline, benperidol
Benperidol may antagonise the action of adrenaline (epinephrine) and other sympathomimetic agents.
Adrenaline, betablockers ---> SmPC of [atenolol] of eMC
Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the effect of beta-blockers.
Adrenaline, betablockers ---> SmPC of [bimatoprost/timolol] of EMA
Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.
Adrenaline, betaxolol
The combination of adrenaline and betaxolol may cause strong hypertension
Adrenaline, bisoprolol [2] ---> SmPC of [2] of eMC
Combination with bisoprolol may unmask the alfa-adrenoceptor-mediated vasoconstrictor effects leading to blood pressure increase and exacerbated intermittent claudication.
Adrenaline, brinzolamide/timolol [2] ---> SmPC of [2] of EMA
Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.
Adrenaline, bromperidol
Paradoxal hypotension, tachycardia
Adrenaline, calcium
Hypercalcemia may cause severe heart rhythm disorders
Adrenaline, calcium acetate [2] ---> SmPC of [2] of eMC
If the calcium level is increased, use of adrenaline may lead to severe cardiac arrhythmia.
Adrenaline, calcium aminoethyl phosphate
Hypercalcemia may cause severe heart rhythm disorders
Adrenaline, calcium gluconate
The co-administration of calcium and epinephrine may cause heart rhythm disorders
Adrenaline, calcium saccharate
Hypercalcemia may cause severe heart rhythm disorders
Adrenaline, carteolol [2] ---> SmPC of [2] of eMC
Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.
Adrenaline, celiprolol [2] ---> SmPC of [2] of eMC
Sympathomimetic agents, such as adrenaline, may counteract the effects of beta blockers.
Adrenaline, chlorprothixene
Paradoxal hypotension, tachycardia
Adrenaline, chlortalidone
Decreased sympathomimetic effect
Adrenaline, clomipramine [2] ---> SmPC of [2] of eMC
Clomipramine may potentiate the cardiovascular effects of adrenaline
Adrenaline, clozapine [2] ---> SmPC of [2] of eMC
Owing to its anti-alpha-adrenergic properties, clozapine may reverse the pressor effect of epinephrine.
Adrenaline, dorzolamide/timolol [2] ---> SmPC of [2] of eMC
Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. of adrenaline. The anaesthesiologist should be informed when the patient is receiving timolol.
Adrenaline, doxazosin
Doxazosin may reduce blood pressure and vascular reactions to adrenaline
Adrenaline, doxylamine
Hypotension (adrenaline reversal)
Adrenaline, entacapone [2] ---> SmPC of [2] of EMA
However, the experience of the clinical use of entacapone with several medicinal products is still limited. Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and 4.4).
Adrenaline, flupentixol
The co-administration may cause hypotension (paradoxical effect)
Adrenaline, fluphenazine [2] ---> SmPC of [2] of eMC
Fluphenazine antagonizes the action of adrenaline and other sympathomimetic agents
Adrenaline, fluspirilene
The co-administration may cause hypotension (paradoxical effect)
Adrenaline, furosemide
The co-administration may weaken the effect of pressor amine
Adrenaline, glibenclamide [2] ---> SmPC of [2] of EMA
Weakening of the blood-glucose- lowering effect
Adrenaline, glimepiride [2] ---> SmPC of [2] of eMC
Weakening of the blood-glucose-lowering effect and possible hyperglycaemia
Adrenaline, haloperidol [2] ---> SmPC of [2] of eMC
Haloperidol may antagonise the action of adrenaline
Adrenaline, heparin
The tendency to bleed is increased during the treatment with anticoagulants and adrenaline
Adrenaline, hydrochlorothiazide ---> SmPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
Hydrochlorothiazide may reduce the response to pressor amines. The clinical significance of this effect is uncertain and not sufficient to preclude their use.
Adrenaline, hydroxyzine [2] ---> SmPC of [2] of eMC
Hydroxyzine has been shown to inhibit and reverse the vasopressor effect of adrenaline
Adrenaline, IMAOs [2] ---> SmPC of [2] of EMA
The effects of adrenaline may be potentiated
Adrenaline, insulin glargin [2] ---> SmPC of [2] of EMA
Reduced blood-glucose-lowering effect
Adrenaline, insulin glargine/lixisenatide [2] ---> SmPC of [2] of EMA
This substance may reduce the blood-glucose-lowering effect.
Adrenaline, insulin glulisin [2] ---> SmPC of [2] of EMA
Possible decrease in blood-glucose-lowering activity
Adrenaline, isoflurane [2] ---> SmPC of [2] of eMC
Alpha- and beta-sympathomimetic agents like adrenaline and noradrenaline should be used with caution during isoflurane narcosis, due to a potential risk of ventricular arrhythmia.
Adrenaline, isoniazid
Increased adverse effects of sympathomimetic agent
Adrenaline, isoprenaline
Isoprenaline should not be coadministered with sympathomimetic agents like adrenalin, due to the combined effect can induce arrythmias
Adrenaline, labetalol
The co-administration may cause bradycardia and hypertension
Adrenaline, levobunolol [2] ---> SmPC of [2] of eMC
Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.
Adrenaline, levomepromazine
Adrenaline (epinephrine) must not be used in patients overdosed with neuroleptics.
Adrenaline, lofepramine [2] ---> SmPC of [2] of eMC
Lofepramine should not be given with sympathomimetic agents since their cardiovascular effects may be potentiated.
Adrenaline, loop diuretics
Decreased effect of pressor amine
Adrenaline, losartan/hydrochlorothiazide [2] ---> SmPC of [2] of eMC
Possible decreased response to pressor amines but not sufficient to preclude their use.
Adrenaline, loxapine [2] ---> SmPC of [2] of EMA
Co-administration of loxapine and adrenaline may cause worsening of hypotension
Adrenaline, maprotiline
The adrenergic effect on autonomic nervous system of sympathomimetic amines may be significantly enhanced with the co-administration of maprotiline
Adrenaline, mefruside
Decreased sympathomimetic effect
Adrenaline, melitracen
The antidepressant may enhance the cardiovascular effects of sympathomimetic agent resulting in severe arrhytmias, tachycardia, hypertension and hyperpyrexia
Adrenaline, methyldopa
The co-administration may potentiate the effects of adrenaline.
Adrenaline, metoprolol [2] ---> SmPC of [2] of eMC
The administration of adrenaline (epinephrine) or noradrenaline (norepinephrine) to patients undergoing beta-blockade can result in an increase in blood pressure and bradycardia, although this is less likely to occur with beta1-selective drugs.
Adrenaline, milnacipran
The effects of adrenaline may be potentiated by noradrenergic-serotoninergic antidepressants.
Adrenaline, nadolol [2] ---> SmPC of [2] of eMC
Beta-adrenoceptor stimulants such as isoprenaline and verapamil, or alpha-adrenoceptor stimulants such as noradrenaline and adrenaline, will reverse the hypotensive effects and increase vasoconstrictor activity.
Adrenaline, neuroleptics
Antipsychotics may antagonise the effects of sympathomimetic agents
Adrenaline, opipramol
The antidepressant may enhance the cardiovascular effects of sympathomimetic agent resulting in severe arrhytmias, tachycardia, hypertension and hyperpyrexia
Adrenaline, oxprenolol [2] ---> SmPC of [2] of eMC
Non-cardioselective beta-blockers enhance the pressor response to sympathomimetic drugs, resulting in hypertension and bradycardia.
Adrenaline, pancuronium
Possible enhancement/decrease of pancuronium effect and the intensity of neuromuscular block
Adrenaline, peanut protein [2] ---> SmPC of [2] of EMA
Severe allergic reactions may be treated with adrenaline (see section 4.4). Please refer to the SmPC for adrenaline for further information on medicines that may potentiate or inhibit the effects of adrenaline.
Adrenaline, perphenazine
Hypotension (adrenaline reversal)
Adrenaline, phenothiazines ---> SmPC of [articaine/epinephrine] of eMC
Phenothiazines may decrease or reverse the pressor effect of epinephrine.
Adrenaline, phenoxybenzamine
Adrenaline enhances the hypotensive effect of phenoxybenzamine (effect inversion!)
Adrenaline, pindolol
Simultaneous administration of pindolol and adrenaline may lead to an increase of blood pressure
Adrenaline, pioglitazone/glimepiride [2] ---> SmPC of [2] of EMA
Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur
Adrenaline, piretanide
The effect of hypertensor sympathomimetic agent may be diminished by the co-administration of piretanide
Adrenaline, potassium canrenoate
The effect of adrenalin on blood vessels may be decreased
Adrenaline, promethazine
Promethazine should not be combined with adrenaline due to a possible paradoxal hypotension (adrenaline reversal)
Adrenaline, propranolol [2] ---> SmPC of [2] of eMC
Care should be taken in the parenteral administration of preparations containing adrenaline (epinephrine) to patients taking beta-adrenoceptor blocking drugs as, in rare cases, vasoconstriction, hypertension and bradycardia may result.
Adrenaline, prothipendyl
Prothipendyl (antiadrenergic properties) may antagonize the vasoconstrictor effects of adrenaline
Adrenaline, sevoflurane [2] ---> SmPC of [2] of eMC
Sevoflurane is similar to isoflurane in the sensitisation of the myocardium to the arrhythmogenic effect of exogenously administered adrenaline.
Adrenaline, sibutramine
The effects of adrenaline may be potentiated by noradrenergic-serotoninergic antidepressants.
Adrenaline, SSNRI
The effects of adrenaline may be potentiated by noradrenergic-serotoninergic antidepressants.
Adrenaline, sympathomimetics
Concurrent therapy with sympathomimetics may potentiate the effects of adrenaline (epinephrine).
Adrenaline, talinolol [2] ---> SmPC of [2] of eMC
Sympathomimetic agents, such as adrenaline, may counteract the effects of beta blockers.
Adrenaline, tetracyclic antidepressant
The antidepressant may enhance the cardiovascular effects of sympathomimetic agent resulting in severe arrhytmias, tachycardia, hypertension and hyperpyrexia
Adrenaline, tolbutamide
Decreased hypoglycaemic effect may occur
Adrenaline, tolcapone [2] ---> SmPC of [2] of EMA
Tolcapone, COMT inhibitor, may increase the plasma concentrations of drugs metabolised by COMT
Adrenaline, torasemid [2] ---> SmPC of [2] of eMC
Torasemide may decrease arterial responsiveness to pressor agents
Adrenaline, travoprost/timolol [2] ---> SmPC of [2] of EMA
Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline has been reported occasionally.
Adrenaline, triamterene/hydrochlorothiazide
The co-administration of triamterene/hydrochlorothiazide may weaken the effect of adrenaline
Adrenaline, venlafaxine
The effects of adrenaline may be potentiated by noradrenergic-serotoninergic antidepressants.
Adrenaline, xipamide
The co-administration may weaken the adrenaline effect
Adrenaline, zotepine
The co-administration may cause hypotension
Articaine/epinephrine, non-selective betablockers ---> SmPC of [adrenaline] of eMC
Severe hypertension and bradycardia may occur when adrenaline (epinephrine) is administered with nonselective beta-blocking medicinal products.
CONTRAINDICATIONS of Adrenaline (EURneffy)
- None.
https://www.ema.europa.eu/en/documents/product-information/eurneffy-epar-product-information_en.pdf 27/03/2025
Other trade names: Anapen,
Afamelanotide (Scenesse)
Ability to drive, afamelanotide [2] ---> SmPC of [2] of EMA
Following administration of this medicinal product, somnolence, fatigue, dizziness, and nausea have been reported. Patients should not drive or use machines in case they are affected by these symptoms.
Acetylsalicylic acid, afamelanotide [2] ---> SmPC of [2] of EMA
Patients taking substances which reduce coagulation, acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation.
Afamelanotide [1], anticoagulants ---> SmPC of [1] of EMA
Patients taking substances which reduce coagulation, acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation.
Afamelanotide [1], breast-feeding ---> SmPC of [1] of EMA
A risk to newborns/infants cannot be excluded. SCENESSE should not be used during breastfeeding.
Afamelanotide [1], fertility ---> SmPC of [1] of EMA
There are no clinical data on the effects of afamelanotide on fertility. Animal studies have not shown any harmful effect on fertility and reproduction.
Afamelanotide [1], NSAID ---> SmPC of [1] of EMA
Patients taking substances which reduce coagulation, acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation.
Afamelanotide [1], pregnancy ---> SmPC of [1] of EMA
SCENESSE should not be used during pregnancy and in women of childbearing potential not using effective contraception.
Afamelanotide [1], warfarin ---> SmPC of [1] of EMA
Patients taking substances which reduce coagulation, acetylsalicylic acid and non-steroidal anti-inflammatory drug (NSAIDs) may experience increased bruising or bleeding at the site of implantation.
Afamelanotide [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential have to use effective contraception during treatment with SCENESSE and for a period of three months thereafter.
CONTRAINDICATIONS of Afamelanotide (Scenesse)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Presence of severe hepatic disease
- Hepatic impairment
- Renal impairment
https://www.ema.europa.eu/en/documents/product-information/scenesse-epar-product-information_en.pdf 21/10/2025
Afatinib (Giotrif)
Ability to drive, afatinib [2] ---> SmPC of [2] of EMA
During treatment, ocular adverse reactions (conjunctivitis, dry eye, keratitis) have been reported in some patients (see section 4.8) which may affect patients ability to drive or use machines.
Afatinib [1], amiodarone ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], BCRP substrates ---> SmPC of [1] of EMA
In vitro studies indicated that afatinib is a substrate and an inhibitor of the transporter BCRP. Afatinib may increase the bioavailability of orally administered BCRP substrates (including but not limited to rosuvastatin and sulfasalazine).
Afatinib [1], breast-feeding ---> SmPC of [1] of EMA
Based on this, it is likely that afatinib is excreted in human milk. A risk to the breast-feeding child cannot be excluded. Mothers should be advised against breast-feeding while receiving this medicinal product.
Afatinib [1], carbamazepine ---> SmPC of [1] of EMA
Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Afatinib [1], cyclosporine ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], erythromycin ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], fertility ---> SmPC of [1] of EMA
Available non-clinical toxicology data have shown effects on reproductive organs at higher doses. Therefore, an adverse effect of this medicinal product on human fertility cannot be excluded.
Afatinib [1], foods ---> SmPC of [1] of EMA
This medicinal product should be taken without food. Food should not be consumed for at least 3 hours before and at least 1 hour after taking this medicinal product
Afatinib [1], itraconazol ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], ketoconazole ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], nelfinavir ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
Based on in vitro data, afatinib is a moderate inhibitor of P-gp. However, based on clinical data it is considered unlikely that GIOTRIF treatment will result in changes of the plasma concentrations of other P-gp substrates.
Afatinib [1], P-gp inductors ---> SmPC of [1] of EMA
The induction of P-glycoprotein may decrease the plasma concentrations of afatinib
Afatinib [1], phenobarbital ---> SmPC of [1] of EMA
Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Afatinib [1], phenytoin ---> SmPC of [1] of EMA
Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Afatinib [1], pregnancy ---> SmPC of [1] of EMA
If used during pregnancy or if the patient becomes pregnant while or after receiving GIOTRIF, she should be informed of the potential hazard to the foetus.
Afatinib [1], quinidine ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], rifampicin ---> SmPC of [1] of EMA
Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Afatinib [1], rosuvastatin ---> SmPC of [1] of EMA
In vitro studies indicated that afatinib is a substrate and an inhibitor of the transporter BCRP. Afatinib may increase the bioavailability of orally administered BCRP substrates (including but not limited to rosuvastatin and sulfasalazine).
Afatinib [1], saquinavir ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], St. John's wort ---> SmPC of [1] of EMA
Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Afatinib [1], strong P-gp inductors ---> SmPC of [1] of EMA
Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Afatinib [1], strong P-gp inhibitors ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], sulfasalazine ---> SmPC of [1] of EMA
In vitro studies indicated that afatinib is a substrate and an inhibitor of the transporter BCRP. Afatinib may increase the bioavailability of orally administered BCRP substrates (including but not limited to rosuvastatin and sulfasalazine).
Afatinib [1], sun ---> SmPC of [1] of EMA
For patients who are exposed to sun, protective clothing, and use of sun screen is advisable.
Afatinib [1], tacrolimus ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], verapamil ---> SmPC of [1] of EMA
Therefore, it is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Afatinib [1], women of childbearing potential ---> SmPC of [1] of EMA
As a precautionary measure, women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with GIOTRIF. Adequate contraceptive methods should be used during therapy and for at least 1 month after the last dose.
Afatinib, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA
The extent of increase (AUC and Cmax of afatinib) depends on the timing of ritonavir administration. Due to BCRP (breast cancer resistance protein/ABCG2) and acute P-gp inhibition by Kaletra.
Afatinib, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA
Serum concentrations may be increased due to Breast Cancer Resistance Protein (BCRP) and acute P-gp inhibition by ritonavir.
Afatinib, ritonavir [2] ---> SmPC of [2] of EMA
Serum concentrations may be increased due to Breast Cancer Resistance Protein (BCRP) and acute P-gp inhibition by ritonavir. The extent of increase in AUC and Cmax depends on the timing of ritonavir administration.
CONTRAINDICATIONS of Afatinib (Giotrif)
- Hypersensitivity to afatinib or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/giotrif-epar-product-information_en.pdf 21/06/2023
Aflibercept (Eylea)
Ability to drive, aflibercept [2] ---> SmPC of [2] of EMA
Patients should not drive or use machines until their visual function has recovered sufficiently.
Aflibercept [1], breast-feeding ---> SmPC of [1] of EMA
As a precautionary measure, breast-feeding is not recommended during the use of Eylea.
Aflibercept [1], fertility ---> SmPC of [1] of EMA
Results from animal studies with high systemic exposure indicate that aflibercept can impair male and female fertility (see section 5.3). Such effects are not expected after ocular administration with very low systemic exposure.
Aflibercept [1], pregnancy ---> SmPC of [1] of EMA
Eylea should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Aflibercept [1], VEGF inhibitors ---> SmPC of [1] of EMA
Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may relate to VEGF inhibition.
Aflibercept [1], verteporfin ---> SmPC of [1] of EMA
Adjunctive use of verteporfin photodynamic therapy (PDT) and aflibercept has not been studied, therefore, a safety profile is not established.
Aflibercept [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential have to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept (see section 4.4).
CONTRAINDICATIONS of Aflibercept (Eylea)
- Hypersensitivity to the active substance aflibercept or to any of the excipients listed in section 6.1.
- Active or suspected ocular or periocular infection
- Active severe intraocular inflammation
https://www.ema.europa.eu/en/documents/product-information/eylea-epar-product-information_en.pdf 05/03/2025
Other trade names: Afqlir, Ahzantive, Baiama, Eydenzelt, afili, Opuviz, Pavblu, Skojoy (withdrawn), Yesafili, Zaltrap,
Agalsidase alfa (Replagal)
Agalsidase alfa [1], amiodarone ---> SmPC of [1] of EMA
Agalsidase alfa should not be co-administered with amiodarone since this substance has the potential to inhibit intra-cellular alfa-galactosidase activity.
Agalsidase alfa [1], benoquin ---> SmPC of [1] of EMA
Agalsidase alfa should not be co-administered with benoquin since this substance has the potential to inhibit intra-cellular alfa-galactosidase activity.
Agalsidase alfa [1], breast-feeding ---> SmPC of [1] of EMA
It is not known whether Replagal is excreted in human milk. Caution should be exercised when prescribing to breast-feeding women.
Agalsidase alfa [1], carbamazepine ---> SmPC of [1] of EMA
In clinical studies, neuropathic pain medicinal products (such as carbamazepine, phenytoin, and gabapentin) were administered concurrently to most patients without any evidence of interaction.
Agalsidase alfa [1], chloroquine ---> SmPC of [1] of EMA
Agalsidase alfa should not be co-administered with chloroquine since this substance has the potential to inhibit intra-cellular alfa-galactosidase activity.
Agalsidase alfa [1], cytochrome P450 ---> SmPC of [1] of EMA
As alfa-galactosidase A is itself an enzyme, it would be an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Agalsidase alfa [1], fertility ---> SmPC of [1] of EMA
No effects on male fertility were seen in reproductive studies in male rats.
Agalsidase alfa [1], gentamicin ---> SmPC of [1] of EMA
Agalsidase alfa should not be co-administered with gentamicin since this substance has the potential to inhibit intra-cellular alfa-galactosidase activity.
Agalsidase alfa [1], pregnancy ---> SmPC of [1] of EMA
Caution should be exercised when prescribing to pregnant women
CONTRAINDICATIONS of Agalsidase alfa (Replagal)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/replagal-epar-product-information_en.pdf 18/09/2025
Agalsidase beta (Fabrazyme)
Ability to drive, agalsidase beta [2] ---> SmPC of [2] of EMA
Agalsidase beta may have a minor influence on the ability to drive or use machines on the day of agalsidase beta administration because dizziness, somnolence, vertigo and syncope may occur
Agalsidase beta [1], amiodarone ---> SmPC of [1] of EMA
Agalsidase beta should not be administered with amiodarone due to a theoretical risk of inhibition of intra-cellular alfa-galactosidase activity.
Agalsidase beta [1], benoquin ---> SmPC of [1] of EMA
Agalsidase beta should not be administered with benoquin due to a theoretical risk of inhibition of intra-cellular alfa-galactosidase activity.
Agalsidase beta [1], breast-feeding ---> SmPC of [1] of EMA
Agalsidase beta may be excreted in milk. Because there are no data available on effects in neonates exposed to agalsidase beta via breast milk, it is recommended to stop breast-feeding when Fabrazyme is used.
Agalsidase beta [1], chloroquine ---> SmPC of [1] of EMA
Agalsidase beta should not be administered with chloroquine due to a theoretical risk of inhibition of intra-cellular alfa-galactosidase activity.
Agalsidase beta [1], cytochrome P450 ---> SmPC of [1] of EMA
Based on its metabolism, agalsidase beta is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Agalsidase beta [1], fertility ---> SmPC of [1] of EMA
Studies have not been conducted to assess the potential effects of Fabrazyme on impairment of fertility.
Agalsidase beta [1], gentamicin ---> SmPC of [1] of EMA
Agalsidase beta should not be administered with gentamicin due to a theoretical risk of inhibition of intra-cellular alfa-galactosidase activity.
Agalsidase beta [1], pregnancy ---> SmPC of [1] of EMA
Fabrazyme should not be used during pregnancy unless clearly necessary.
CONTRAINDICATIONS of Agalsidase beta (Fabrazyme)
- Life threatening hypersensitivity (anaphylactic reaction)to the active substance or any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/fabrazyme-epar-product-information_en.pdf 04/09/2024
Agomelatine (Valdoxan)
Ability to drive, agomelatine [2] ---> SmPC of [2] of EMA
Considering that dizziness and somnolence are common adverse reactions patients should be cautioned about their ability to drive a car or operate machinery.
Agomelatine [1], alcohol ---> SmPC of [1] of EMA
The combination of Valdoxan and alcohol is not advisable
Agomelatine [1], benzodiazepines ---> SmPC of [1] of EMA
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials
Agomelatine [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Valdoxan therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Agomelatine [1], ciprofloxacin ---> SmPC of [1] of EMA
Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Agomelatine [1], CYP1A2 inhibitors ---> SmPC of [1] of EMA
The CYP1A2 inhibition may increase plasma concentrations of agomelatine. Caution should be exercised
Agomelatine [1], CYP450 ---> SmPC of [1] of EMA
In vivo, agomelatine does not induce CYP450 isoenzymes. Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro. Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450.
Agomelatine [1], drugs with high protein binding ---> SmPC of [1] of EMA
Plasma protein binding is 95% irrespective of the concentration and is not modified with age and in patients with renal impairment but the free fraction is doubled in patients with hepatic impairment.
Agomelatine [1], electroconvulsive therapy ---> SmPC of [1] of EMA
Animal studies have not shown proconvulsant properties (see section 5.3). Therefore, clinical consequences of ECT concomitant treatment with Valdoxan are considered to be unlikely.
Agomelatine [1], enoxacin ---> SmPC of [1] of EMA
Caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) until more experience has been gained (see section 4.4).
Agomelatine [1], estrogens ---> SmPC of [1] of EMA
Caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) until more experience has been gained (see section 4.4).
Agomelatine [1], fertility ---> SmPC of [1] of EMA
Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility (see section 5.3).
Agomelatine [1], fluconazole ---> SmPC of [1] of EMA
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials
Agomelatine [1], fluvoxamine ---> SmPC of [1] of EMA
Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure. Coadministration contraindicated.
Agomelatine [1], lithium ---> SmPC of [1] of EMA
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials
Agomelatine [1], moderate CYP1A2 inhibitors ---> SmPC of [1] of EMA
Caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) until more experience has been gained (see section 4.4).
Agomelatine [1], nicotine ---> SmPC of [1] of EMA
Smoking induces CYP1A2 and has been shown to decrease the bioavailability of agomelatine, especially in heavy smokers (>= 15 cigarettes/day)
Agomelatine [1], paroxetine ---> SmPC of [1] of EMA
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials
Agomelatine [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure, it is preferable to avoid the use of Valdoxan during pregnancy.
Agomelatine [1], propranolol ---> SmPC of [1] of EMA
Caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) until more experience has been gained (see section 4.4).
Agomelatine [1], rifampicin ---> SmPC of [1] of EMA
Rifampicin an inducer of all three cytochromes involved in the metabolism of agomelatine may decrease the bioavailability of agomelatine.
Agomelatine [1], strong CYP1A2 inhibitors ---> SmPC of [1] of EMA
Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Agomelatine [1], theophylline ---> SmPC of [1] of EMA
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials
Agomelatine, strong CYP1A2 inductors
The strong CYP1A2 induction may decrease plasma concentrations of agomelatine.
Agomelatine, vemurafenib [2] ---> SmPC of [2] of EMA
Vemurafenib may increase the plasma exposure of substances predominantly metabolised by CYP1A2 and dose adjustments may be considered, if clinically indicated.
CONTRAINDICATIONS of Agomelatine (Valdoxan)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 X upper limit of normal
- Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin)
https://www.ema.europa.eu/en/documents/product-information/valdoxan-epar-product-information_en.pdf 15/04/2025
Other trade names: Thymanax,
Alanyl glutamine
Alanyl glutamine, breast-feeding
Strict indication
Alanyl glutamine, pregnancy
Strict indication
Albendazole
Albendazole, breast-feeding
Albendazole should not be used during breast-feeding
Albendazole, carbamazepine
The co-administration may decrease the plasma concentrations of active albendazole metabolite
Albendazole, cimetidine
The co-administration may increase the plasma concentrations of active albendazole metabolite
Albendazole, dexamethasone
The co-administration may increase the plasma concentrations of active albendazole metabolite
Albendazole, phenobarbital
The co-administration may decrease the plasma concentrations of active albendazole metabolite
Albendazole, phenytoin
The co-administration may decrease the plasma concentrations of active albendazole metabolite
Albendazole, praziquantel
The co-administration may increase the plasma concentrations of active albendazole metabolite
Albendazole, pregnancy
Albendazole is contraindicated during pregnancy
Albendazole, ritonavir
The co-administration may decrease the plasma concentrations of active albendazole metabolite
Albiglutide (Eperzan)
Ability to drive, albiglutide [2] ---> SmPC of [2] of EMA
When Eperzan is used in combination with insulin secretagogues (such as sulphonylureas) or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines
Acarbose, albiglutide [2] ---> SmPC of [2] of EMA
Acarbose is contraindicated in patients with intestinal obstruction. Caution is advised if used concomitantly with albiglutide
Albiglutide [1], breast-feeding ---> SmPC of [1] of EMA
A decision should be made whether to discontinue breast-feeding or to discontinue therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Albiglutide [1], digoxin ---> SmPC of [1] of EMA
Albiglutide did not meaningfully alter the pharmacokinetics of a single-dose of digoxin (0.5 mg) when coadministered with steady-state albiglutide (50 mg weekly).
Albiglutide [1], drugs with a narrow therapeutic window ---> SmPC of [1] of EMA
Albiglutide delays gastric emptying. Caution should be exercised in patients receiving medicinal products with a narrow therapeutic index or medicinal products that require careful clinical monitoring.
Albiglutide [1], fertility ---> SmPC of [1] of EMA
Studies in mice showed reduced oestrous cycling at maternally toxic doses, but did not indicate harmful effects with respect to fertility (see section 5.3). The potential risk for humans is unknown.
Albiglutide [1], insulin ---> SmPC of [1] of EMA
The risk of hypoglycaemia is increased when albiglutide is used in combination with insulin. Therefore, patients may require a lower dose of insulin to reduce the risk of hypoglycaemia
Albiglutide [1], oral contraceptives ---> SmPC of [1] of EMA
Albiglutide (50 mg weekly at steady-state) had no clinically relevant effects on the steady-state pharmacokinetics of a combination oral contraceptive containing norethindrone 0.5 mg and ethinyl estradiol 0.035 mg.
Albiglutide [1], pancreatitis ---> SmPC of [1] of EMA
Caution should be exercised in patients with a history of pancreatitis.
Albiglutide [1], pregnancy ---> SmPC of [1] of EMA
Eperzan should not be used during pregnancy, and is not recommended in women of childbearing potential not using effective contraception.
Albiglutide [1], simvastatine ---> SmPC of [1] of EMA
Albiglutide showed no impact on the safety of simvastatin in clinical studies.
Albiglutide [1], sulfonylureas ---> SmPC of [1] of EMA
The risk of hypoglycaemia is increased when albiglutide is used in combination with insulin secretagogues (such as sulphonylurea). Therefore, patients may require a lower dose of sulphonylurea to reduce the risk of hypoglycaemia
Albiglutide [1], warfarin ---> SmPC of [1] of EMA
Albiglutide did not significantly alter the pharmacodynamic effects of warfarin as measured by the international normalized ratio (INR). In addition, albiglutide did not significantly alter the pharmacodynamic effects of warfarin as measured by the INR.
Albiglutide [1], washout period ---> SmPC of [1] of EMA
Eperzan should be discontinued at least 1 month before a planned pregnancy due to the long washout period for albiglutide.
CONTRAINDICATIONS of Albiglutide (Eperzan)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/eperzan-epar-product-information_en.pdf 20/02/2019 (withdrawn)
Albutrepenonacog alfa (Idelvion)
Albutrepenonacog alfa [1], breast-feeding ---> SPC of [1] of EMA
Factor IX should be used during pregnancy and lactation only if clearly indicated.
Albutrepenonacog alfa [1], pregnancy ---> SPC of [1] of EMA
Factor IX should be used during pregnancy and lactation only if clearly indicated.
CONTRAINDICATIONS of Albutrepenonacog alfa (Idelvion)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Known allergic reaction to hamster protein.
https://www.ema.europa.eu/en/documents/product-information/idelvion-epar-product-information_en.pdf 19/12/2024
Aldesleukin
ACE inhibitors, aldesleukin [2] ---> SPC of [2] of eMC
The co-administration may enhance the hypotension caused by aldesleukin.
Ability to drive, aldesleukin [2] ---> SPC of [2] of eMC
Hallucination, somnolence, syncope, convulsions may occur during treatment with Proleukin and may affect the patient's ability to drive and operate machines.
Aldesleukin [1], antihypertensives ---> SPC of [1] of eMC
The co-administration may enhance the hypotension caused by aldesleukin.
Aldesleukin [1], antineoplastics ---> SPC of [1] of eMC
Hypersensitivity reactions have been reported in patients receiving combination regimens containing sequential high dose aldesleukin and antineoplastic agents, specifically, dacarbazine, cisplatin, tamoxifen and interferon-alpha.
Aldesleukin [1], betablockers ---> SPC of [1] of eMC
The co-administration may enhance the hypotension caused by aldesleukin.
Aldesleukin [1], breast-feeding ---> SPC of [1] of eMC
Because the potential for serious adverse reactions in nursing infants is unknown, mothers should not breast feed their infants during treatment.
Aldesleukin [1], calcium antagonists ---> SPC of [1] of eMC
The co-administration may enhance the hypotension caused by aldesleukin.
Aldesleukin [1], cisplatin ---> SPC of [1] of eMC
Fatal tumour lysis syndrome has been reported in combination of aldesleukin with treatment with cis-platinum, vinblastine and dacarbazine. Concomitant use of the mentioned active substances is therefore not recommended.
Aldesleukin [1], dacarbazine ---> SPC of [1] of eMC
Fatal tumour lysis syndrome has been reported in combination of aldesleukin with treatment with cis-platinum, vinblastine and dacarbazine. Concomitant use of the mentioned active substances is therefore not recommended.
Aldesleukin, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Aldesleukin, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Use of efavirenz/emtricitabine/tenofovir disoproxil fumarate should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Aldesleukin, emtricitabine/rilpivirine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Use of emtricitabine/rilpivirine/tenofovir should be avoided with concurrent or recent use of a nephrotoxic medicinal product
Aldesleukin, emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Use of Truvada should be avoided with concurrent or recent use of a nephrotoxic medicinal product
Aldesleukin [1], glucocorticoids ---> SPC of [1] of eMC
The co-administration can decrease the efficacy of aldesleukin and should be avoided
Aldesleukin [1], hepatotoxic drugs ---> SPC of [1] of eMC
Concurrent administration of medicinal products with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic effects may increase the toxicity of Proleukin in these systems.
Aldesleukin [1], interferon alfa ---> SPC of [1] of eMC
The co-administration appear to increase severe rhabdomyolysis and myocardial injury, including myocardial infarction, myocarditis and ventricular hypokinesia
Aldesleukin, iodixanol
There was a greater frequency of late reactions to contrast media in patients who were treated 2 weeks before examination with iodinated contrast agents with interleukin-2 (flulike symptoms or skin reactions)
Aldesleukin, iohexol
Patients treated with interleukin-2 less than two weeks previously have been associated with an increased risk for delayed reactions (flu-like symptoms or skin reactions).
Aldesleukin, iopamidol
There was a greater frequency of late reactions to contrast media in patients who were treated 2 weeks before examination with iodinated contrast agents with interleukin-2 (flulike symptoms or skin reactions)
Aldesleukin, iopromide
Previous treatment (up to several weeks) with Interleukin-2 is associated with an increased risk of delayed reactions
Aldesleukin [1], medicines with cardiotoxic effects ---> SPC of [1] of eMC
Concurrent administration of medicinal products with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic effects may increase the toxicity of Proleukin in these systems.
Aldesleukin [1], medicines with myelotoxic effects ---> SPC of [1] of eMC
Concurrent administration of medicinal products with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic effects may increase the toxicity of Proleukin in these systems.
Aldesleukin [1], nephrotoxic substances ---> SPC of [1] of eMC
Concurrent administration of medicinal products with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic effects may increase the toxicity of Proleukin in these systems.
Aldesleukin [1], pregnancy ---> SPC of [1] of eMC
It should not be used during pregnancy unless the potential benefit to the patient justifies the potential risk to the foetus.
Aldesleukin [1], psycholeptics ---> SPC of [1] of eMC
Aldesleukin may influence the CNS and modify the reaction to psychotropic medicinal products
Aldesleukin [1], radiologic contrasts ---> SPC of [1] of eMC
The combination may result in a recall of the aldesleukin toxicity. The contrast medium should be avoided within 2 weeks after treatment with aldesleukin
Aldesleukin, tenofovir disoproxil [2] ---> SPC of [2] of EMA
Use of tenofovir should be avoided with recent or concurrent use of a nephrotoxic medicinal product
Aldesleukin [1], vinblastine ---> SPC of [1] of eMC
Fatal tumour lysis syndrome has been reported in combination of aldesleukin with treatment with cis-platinum, vinblastine and dacarbazine. Concomitant use of the mentioned active substances is therefore not recommended.
CONTRAINDICATIONS of Aldesleukin
Proleukin therapy is contra-indicated in the following patients:
1. Hypersensitivity to the active substance or to any of the excipients
2. Patients with a performance status of ECOG ≥ 2.
3. Patients with a simultaneous presence of a performance status of ECOG 1 or greater) and more than one organ with metastatic disease sites and a period of < 24 months between initial diagnosis of primary tumour and the date the patient is evaluated for Proleukin treatment.
4. Patients with a significant history or current evidence of severe cardiac disease. In questionable cases a stress test should be performed.
5. Patients with evidence of active infection requiring antibiotic therapy.
6. Patients with a PaO2 < 60 mm Hg during rest.
7. Patients with pre-existing severe major organ dysfunction.
8. Patients with Central Nervous System (CNS) metastases or seizure disorders, with the exception of patients with successfully treated brain metastases (negative computerized tomography (CT); neurologically stable).
In addition, it is recommended to exclude the following patients:
1. Patients with White Blood Count (WBC) < 4.000/mm³; platelets < 100.000/mm³; hematocrit (HCT) < 30%.
2. Patients with serum bilirubin and creatinine outside normal range.
3. Patients with organ allografts.
4. Patients who are likely to require corticosteroids.
5. Patients with pre-existing auto-immune disease.
http://www.medicines.org.uk/emc/
Alectinib (Alecensa)
Ability to drive, alectinib [2] ---> SmPC of [2] of EMA
Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, dizziness, hypotension) or vision disorders while taking Alecensa
Alectinib [1], antacids ---> SmPC of [1] of EMA
Therefore, no dose adjustments are required when Alecensa is co-administered with proton pump inhibitors or other medicinal products which raise gastric pH (e.g. H2 receptor antagonists or antacids).
Alectinib [1], BCRP substrates ---> SmPC of [1] of EMA
In vitro, alectinib and M4 are inhibitors of the efflux transporter BCRP. When Alecensa is co-administered with BCRP substrates (e.g., methotrexate, mitoxantrone, topotecan and lapatinib), appropriate monitoring is recommended.
Alectinib [1], breast-feeding ---> SmPC of [1] of EMA
It is unknown whether alectinib and its metabolites are excreted in human milk. A risk to the newborn/infant cannot be excluded. Mothers should be advised against breast-feeding while receiving Alecensa.
Alectinib [1], carbamazepine ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Alectinib [1], CYP3A4 inductors ---> SmPC of [1] of EMA
Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inducers.
Alectinib [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA
Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inhibitors.
Alectinib [1], CYP3A4 substrates ---> SmPC of [1] of EMA
Multiple doses of 600 mg alectinib had no influence on the exposure of midazolam (2 mg), a sensitive CYP3A substrate. Therefore, no dose adjustment is required for co-administered CYP3A substrates.
Alectinib [1], dabigatran etexilate ---> SmPC of [1] of EMA
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Alectinib [1], digoxin ---> SmPC of [1] of EMA
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Alectinib [1], drugs inducing bradycardia ---> SmPC of [1] of EMA
If patients experience symptomatic bradycardia or life-threatening events, concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products should be evaluated
Alectinib [1], everolimus ---> SmPC of [1] of EMA
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Alectinib [1], fertility ---> SmPC of [1] of EMA
No fertility studies in animals have been performed to evaluate the effect of alectinib. No adverse effects on male and female reproductive organs were observed in general toxicology studies (see section 5.3).
Alectinib [1], foods ---> SmPC of [1] of EMA
The hard capsules should be swallowed whole, and must not be opened or dissolved. They must be taken with food
Alectinib [1], grapefruit ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], grapefruit juice ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], H2 antagonists ---> SmPC of [1] of EMA
Therefore, no dose adjustments are required when Alecensa is co-administered with proton pump inhibitors or other medicinal products which raise gastric pH (e.g. H2 receptor antagonists or antacids).
Alectinib [1], itraconazol ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], ketoconazole ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], lapatinib ---> SmPC of [1] of EMA
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Alectinib [1], methotrexate ---> SmPC of [1] of EMA
In vitro, alectinib and M4 are inhibitors of the efflux transporter BCRP. When Alecensa is co-administered with BCRP substrates (e.g., methotrexate, mitoxantrone, topotecan and lapatinib), appropriate monitoring is recommended.
Alectinib [1], midazolam ---> SmPC of [1] of EMA
Multiple doses of 600 mg alectinib had no influence on the exposure of midazolam (2 mg), a sensitive CYP3A substrate. Therefore, no dose adjustment is required for co-administered CYP3A substrates.
Alectinib [1], mitoxantrone ---> SmPC of [1] of EMA
In vitro, alectinib and M4 are inhibitors of the efflux transporter BCRP. When Alecensa is co-administered with BCRP substrates (e.g., methotrexate, mitoxantrone, topotecan and lapatinib), appropriate monitoring is recommended.
Alectinib [1], nefazodone ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], nilotinib ---> SmPC of [1] of EMA
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Alectinib [1], oral contraceptives ---> SmPC of [1] of EMA
The effectiveness of concomitant administration of oral contraceptives may be reduced.
Alectinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Alectinib [1], P-gp inhibitors ---> SmPC of [1] of EMA
M4 is a substrate of P-glycoprotein (P-gp). As alectinib inhibits P-gp, it is not expected that co-medication with P-gp inhibitors has a relevant effect on M4 exposure.
Alectinib [1], phenobarbital ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Alectinib [1], phenytoin ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Alectinib [1], posaconazole ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], pregnancy ---> SmPC of [1] of EMA
Based on its mechanism of action, Alecensa may cause foetal harm when administered to a pregnant woman. Studies in animals have shown reproductive toxicity
Alectinib [1], pregnancy ---> SmPC of [1] of EMA
Female patients, who become pregnant while taking Alecensa or during the 3 months following the last dose of Alecensa must contact their doctor and should be advised of the potential harm to the foetus.
Alectinib [1], proton pump inhibitors ---> SmPC of [1] of EMA
Therefore, no dose adjustments are required when Alecensa is co-administered with proton pump inhibitors or other medicinal products which raise gastric pH (e.g. H2 receptor antagonists or antacids).
Alectinib [1], rifabutin ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Alectinib [1], rifampicin ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Alectinib [1], ritonavir ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], saquinavir ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], Seville orange ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], sirolimus ---> SmPC of [1] of EMA
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Alectinib [1], St. John's wort ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Alectinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Alectinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], telithromycin ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], topotecan ---> SmPC of [1] of EMA
When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Alectinib [1], voriconazole ---> SmPC of [1] of EMA
Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors
Alectinib [1], women of childbearing potential ---> SmPC of [1] of EMA
Female patients of child-bearing potential receiving Alecensa must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alecensa (see sections 4.4 and 4.5).
CONTRAINDICATIONS of Alectinib (Alecensa)
- Hypersensitivity to alectinib or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf 19/06/2024
Alemtuzumab (Lemtrada)
Ability to drive, alemtuzumab [2] ---> SmPC of [2] of EMA
Some of the IARs (e.g. dizziness) could temporarily impact the patient's ability to drive or use machines and caution should be exercised until these are resolved.
Alemtuzumab [1], breast-feeding ---> SmPC of [1] of EMA
A risk to the suckling newborn/infant cannot be excluded. Therefore, breast-feeding should be discontinued during each course of treatment with LEMTRADA and for 4 months following the last infusion of each treatment course.
Alemtuzumab [1], fertility ---> SmPC of [1] of EMA
Animal data have shown effects on fertility in humanised mice (see section 5.3), however a potential impact on human fertility during the period of exposure is unknown based on the available data.
Alemtuzumab [1], Graves' disease ---> SmPC of [1] of EMA
In mothers with Graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing foetus and can cause transient neonatal Graves' disease.
Alemtuzumab [1], MS patients ---> SmPC of [1] of EMA
In a controlled clinical trial in MS patients recently treated with beta interferon and glatiramer acetate were required to discontinue treatment 28 days before initiating treatment with LEMTRADA.
Alemtuzumab [1], pregnancy ---> SmPC of [1] of EMA
LEMTRADA should be administered during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Alemtuzumab [1], vaccinations ---> SmPC of [1] of EMA
It is recommended that patients have completed local immunisation requirements at least 6 weeks prior to treatment with LEMTRADA. The ability to generate an immune response to any vaccine following LEMTRADA treatment has not been studied.
Alemtuzumab [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA
The safety of immunisation with live viral vaccines following a course of LEMTRADA treatment has not been formally studied in controlled clinical trials in MS and should not be administered to MS patients who have recently received a course of LEMTRADA.
Alemtuzumab [1], varicella ---> SmPC of [1] of EMA
VZV vaccination of antibody-negative patients should be considered prior to treatment initiation with LEMTRADA. To allow for the full effect of the VZV vaccination to occur, treatment with LEMTRADA should be postponed for 6 weeks following vaccination.
Alemtuzumab [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential have to use effective contraception when receiving a course of treatment with LEMTRADA and up to 4 months after each course of treatment.
Alemtuzumab, imlifidase [2] ---> SmPC of [2] of EMA
Recommended time interval after administration of 0.25 mg/kg imlifidase: 4 days
Alemtuzumab, siponimod [2] ---> SmPC of [2] of EMA
Due to the characteristics and duration of alemtuzumab immune suppressive effects described in its product information, initiating treatment with siponimod after alemtuzumab is not recommended.
Alemtuzumab, tiopronin
Blood count alterations
CONTRAINDICATIONS of Alemtuzumab (Lemtrada)
- Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
- Human Immunodeficiency Virus (HIV) infection.
- Patients with severe active infection until complete resolution.
- Patients with uncontrolled hypertension.
- Patients with a history of arterial dissection of the cervicocephalic arteries.
- Patients with a history of stroke.
- Patients with a history of angina pectoris or myocardial infarction.
- Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy.
- Patients with other concomitant autoimmune diseases (besides MS).
https://www.ema.europa.eu/en/documents/product-information/lemtrada-epar-product-information_en.pdf 27/10/2025
Alendronate/colecalciferol (Adrovance)
Ability to drive, alendronate/colecalciferol [2] ---> SmPC of [2] of EMA
Patients may experience certain adverse reactions (for example blurred vision, dizziness and severe bone muscle or joint pain (see section 4.8)) that may influence the ability to drive and use machines.
Alendronate/colecalciferol [1], antiepileptics ---> SmPC of [1] of EMA
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Alendronate/colecalciferol [1], bile-acid sequestrants ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronate/colecalciferol [1], breast-feeding ---> SmPC of [1] of EMA
A risk to the newborns/infants cannot be excluded. Alendronate should not be used during breast-feeding. Colecalciferol and some of its active metabolites pass into breast milk.
Alendronate/colecalciferol [1], cholestyramine ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronate/colecalciferol [1], cimetidine ---> SmPC of [1] of EMA
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Alendronate/colecalciferol [1], colestipol ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronate/colecalciferol [1], fertility ---> SmPC of [1] of EMA
However, there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.
Alendronate/colecalciferol [1], foods ---> SmPC of [1] of EMA
Patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product
Alendronate/colecalciferol [1], mineral oil ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronate/colecalciferol [1], NSAID ---> SmPC of [1] of EMA
Since non Steroidal Anti-Inflammatory Drug (NSAID) use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Alendronate/colecalciferol [1], olestra ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronate/colecalciferol [1], orlistat ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronate/colecalciferol [1], pregnancy ---> SmPC of [1] of EMA
Studies in animals have shown hypercalcaemia and reproductive toxicity with high doses of vitamin D (see section 5.3). ADROVANCE should not be used during pregnancy.
Alendronate/colecalciferol [1], thiazides ---> SmPC of [1] of EMA
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Alendronate/colecalciferol [1], women ---> SmPC of [1] of EMA
ADROVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
Biphosphonates, chemotherapy ---> SmPC of [alendronate/colecalciferol] of EMA
Osteonecrosis of the external auditory canal has been reported with bisphosphonates. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Biphosphonates, steroids ---> SmPC of [alendronate/colecalciferol] of EMA
Osteonecrosis of the external auditory canal has been reported with bisphosphonates. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
CONTRAINDICATIONS of Alendronate/colecalciferol (Adrovance)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
- Inability to stand or sit upright for at least 30 minutes.
- Hypocalcaemia.
https://www.ema.europa.eu/en/documents/product-information/adrovance-epar-product-information_en.pdf 20/02/2024
Other trade names: Fosavance, Vantavo (previously Alendronate sodium and colecalciferol, MSD),
Alendronic acid
NSAID, alendronic acid ---> SPC of [alendronic acid/colecalciferol] of EMA
Since Non-Steroidal Anti-Inflammatory Drug (NSAID) use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Alendronic acid, antacids ---> SPC of [alendronic acid/colecalciferol] of EMA
If taken at the same time, it is likely that calcium supplements and antacids will interfere with absorption of alendronate. Patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product
Alendronic acid [1], breast-feeding ---> SPC of [1] of eMC
It is not known whether alendronate is excreted into human breast milk. Alendronate should not be used by breast-feeding women
Alendronic acid, calcium ---> SPC of [alendronic acid/colecalciferol] of EMA
If taken at the same time, it is likely that calcium supplements and antacids will interfere with absorption of alendronate. Patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product
Alendronic acid, chemotherapy
Osteonecrosis of the external auditory canal has been reported with bisphosphonates. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Alendronic acid [1], estrogens ---> SPC of [1] of eMC
A number of patients in the clinical trials received oestrogen (intravaginal, transdermal, or oral) while taking alendronate. No adverse experiences attributable to their concomitant use were identified.
Alendronic acid, foods ---> SPC of [alendronic acid/colecalciferol] of EMA
Alendronate must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day.
Alendronic acid, iron
Formation of non-absorbable complexes. Patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product
Alendronic acid, magnesium ---> SPC of [alendronic acid/colecalciferol] of EMA
If taken at the same time, it is likely that calcium supplements and antacids will interfere with absorption of alendronate. Patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product
Alendronic acid, magnesium hydroxide
The magnesium hydroxide may decrease the absorption of alendronic acid. Separate administration by 2-3 hours
Alendronic acid, parathyroid hormone [2] ---> SPC of [2] of EMA
Co-administration of alendronic acid and Natpar may lead to a reduction in the calcium sparing effect, which can interfere with the normalisation of serum calcium.
Alendronic acid [1], pregnancy
Alendronate should not be used during pregnancy.
Alendronic acid, steroids
Osteonecrosis of the external auditory canal has been reported with bisphosphonates. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
CONTRAINDICATIONS of Alendronic acid
- Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
- Inability to stand or sit upright for at least 30 minutes.
- Hypersensitivity to alendronate or to any of the excipients.
- Hypocalcaemia.
http://www.medicines.org.uk/emc/
Alendronic acid/colecalciferol (Vantavo)
Ability to drive, alendronic acid/colecalciferol [2] ---> SmPC of [2] of EMA
Certain adverse reactions (for example blurred vision, dizziness and severe bone muscle or joint pain) have been reported
Alendronic acid, magnesium ---> SmPC of [alendronic acid/colecalciferol] of EMA
If taken at the same time, it is likely that calcium supplements and antacids will interfere with absorption of alendronate. Patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product
Alendronic acid/colecalciferol [1], antacids ---> SmPC of [1] of EMA
If taken at the same time, it is likely that calcium supplements and antacids will interfere with absorption of alendronate. Patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product
Alendronic acid/colecalciferol [1], antiepileptics ---> SmPC of [1] of EMA
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D.
Alendronic acid/colecalciferol [1], bile-acid sequestrants ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronic acid/colecalciferol [1], breast-feeding ---> SmPC of [1] of EMA
Alendronic acid/colecalciferol is only intended for use in postmenopausal women and therefore it should not be used in breast-feeding women.
Alendronic acid/colecalciferol [1], calcium ---> SmPC of [1] of EMA
If taken at the same time, it is likely that calcium supplements and antacids will interfere with absorption of alendronate. Patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product
Alendronic acid/colecalciferol [1], cholestyramine ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronic acid/colecalciferol [1], cimetidine ---> SmPC of [1] of EMA
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D.
Alendronic acid/colecalciferol [1], colestipol ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronic acid/colecalciferol [1], fertility ---> SmPC of [1] of EMA
However, there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.
Alendronic acid/colecalciferol [1], foods ---> SmPC of [1] of EMA
Alendronate must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day.
Alendronic acid/colecalciferol [1], mineral oil ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronic acid/colecalciferol [1], NSAID ---> SmPC of [1] of EMA
Since Non-Steroidal Anti-Inflammatory Drug (NSAID) use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Alendronic acid/colecalciferol [1], olestra ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronic acid/colecalciferol [1], orlistat ---> SmPC of [1] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Alendronic acid/colecalciferol [1], pregnancy ---> SmPC of [1] of EMA
Alendronic acid/colecalciferol is only intended for use in postmenopausal women and therefore it should not be used during pregnancy
Alendronic acid/colecalciferol [1], thiazides ---> SmPC of [1] of EMA
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D.
Antiepileptics, cholecalciferol ---> SmPC of [alendronic acid/colecalciferol] of EMA
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D.
Cholecalciferol, cimetidine ---> SmPC of [alendronic acid/colecalciferol] of EMA
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D.
Cholecalciferol, colestipol ---> SmPC of [alendronic acid/colecalciferol] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Cholecalciferol, olestra ---> SmPC of [alendronic acid/colecalciferol] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Cholecalciferol, orlistat ---> SmPC of [alendronic acid/colecalciferol] of EMA
Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
CONTRAINDICATIONS of Alendronic acid/colecalciferol (Vantavo)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
- Inability to stand or sit upright for at least 30 minutes.
- Hypocalcaemia.
https://www.ema.europa.eu/en/documents/product-information/vantavo-epar-product-information_en.pdf 20/02/2024
Other trade names: previously Alendronate sodium and colecalciferol, MSD
Alfacalcidol
Alfacalcidol, aluminium
Decreased absorption of alfacalcidol. At least 2 hours should elapse between the administration of both.
Alfacalcidol, antacids
The concomitant use of alfacalcidol and antacids with magnesium may increase the risk of hypermagnesemia
Alfacalcidol, barbiturates
The coadministration may require an increased dose of alfacalcidol to produce the desired effect.
Alfacalcidol, bile-acid sequestrants
Decreased absorption of alfacalcidol
Alfacalcidol, breast-feeding
Alfacalcidol is excreted in small quantity in human breast milk
Alfacalcidol, calcium
The co-administration may increase the risk of hypercalcemia
Alfacalcidol, cardiac glycosides
Hypercalcaemia in patients taking digitalis preparations may precipitate cardiac arrhythmias. Close monitorization.
Alfacalcidol [1], cholestyramine ---> SPC of [1] of eMC
Concomitant administration of colestyramine may interfere with the intestinal absorption of alfacalcidol.
Alfacalcidol, colestipol
Decreased absorption of alfacalcidol
Alfacalcidol, corticosteroids
There is a functional antagonism between vitamin D analogues (promotion of absorption) and the corticosteroids (inhibition of absorption).
Alfacalcidol, danazol [2] ---> SPC of [2] of eMC
Danazol may increase the calcaemic response in primary hypoparathyroidism necessitating a reduction in dosage of this agent.
Alfacalcidol, estrogens
The co-administration may enhance the alfacalcidol effect in the peri and postmenopause
Alfacalcidol, laxatives
Laxatives should not be used during the treatment with alfacalcidol due to increased risk of hypermagnesemia
Alfacalcidol, phenytoin
The coadministration may require an increased dose of alfacalcidol to produce the desired effect.
Alfacalcidol [1], pregnancy ---> SPC of [1] of eMC
Caution should be taken when prescribing to pregnant women as hypercalcaemia during pregnancy may produce congenital disorders in the offspring.
Alfacalcidol, primidone
Primidone, enzymatic inductor, may accelerate the vitamin D/vitamin D preparations metabolism, influence the calcium metabolism and cause symptome of osteomalacia
Alfacalcidol, sucralfate
Decreased absorption of alfacalcidol
Alfacalcidol, thiazides
The co-administration may increase the risk of hypercalcemia
Alfacalcidol, vitamin D
The co-administration may increase the risk of hypercalcemia
CONTRAINDICATIONS of Alfacalcidol
- Hypercalcaemia, metastatic calcification.
- Hypersensitivity to alfacalcidol or any of the other ingredients.
http://www.medicines.org.uk/emc/
Alfentanyl
CNS depressants, alfentanyl [2] ---> SPC of [2] of eMC
CNS depressants may enhance or prolong the respiratory depressant effects of alfentanil.
IMAOs, alfentanyl
Possible severe side effects on the CNS and side effects on the respiratory and circulatory function. IMAO should be avoided within 2 weeks before a surgical operation
IMAOs, opioid analgesics ---> SPC of [alfentanyl] of eMC
The co-administration of opioids with MAO inhibitors may stimulate/inhibit the CNS or induce hypertension or hypotension. The combination is contraindicated or within 2 weeks of discontinuation of MAOI
Ability to drive, alfentanyl [2] ---> SPC of [2] of eMC
Not to drive or operate machinery for at least 3-6 or 12-24 hours following administration.
Alcohol, alfentanyl [2] ---> SPC of [2] of eMC
CNS depressants may enhance or prolong the respiratory depressant effects of alfentanil.
Alcohol, opiates ---> SPC of [alfentanyl] of eMC
The co-administration may enhance or prolong the respiratory depressant effect of opioid.
Alfentanyl, anaesthetics
Treatment with drugs which may depress the heart or increase vagal tone, such as beta-blockers and anaesthetic agents, may predispose to bradycardia or hypotension.
Alfentanyl, aprepitant [2] ---> SPC of [2] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Alfentanyl [1], barbiturates ---> SPC of [1] of eMC
CNS depressants may enhance or prolong the respiratory depressant effects of alfentanil.
Alfentanyl [1], benzodiazepines ---> SPC of [1] of eMC
CNS depressants may enhance or prolong the respiratory depressant effects of alfentanil.
Alfentanyl, betablockers
Treatment with drugs which may depress the heart or increase vagal tone, such as beta-blockers and anaesthetic agents, may predispose to bradycardia or hypotension.
Alfentanyl [1], breast-feeding ---> SPC of [1] of eMC
Alfentanil may appear in breast milk. It is therefore recommended that breast feeding is not initiated within 24 hours of treatment.
Alfentanyl, ceritinib [2] ---> SPC of [2] of EMA
Co-administration of ceritinib with CYP3A substrates known to have narrow therapeutic indices should be avoided.
Alfentanyl [1], cimetidine ---> SPC of [1] of eMC
Available human pharmacokinetic data indicate that the metabolism of alfentanil is inhibited by known cytochrome P450 3A4 enzyme inhibitors. This could increase the risk of prolonged or delayed respiratory depression.
Alfentanyl, clarithromycin
Clarithromycin, CYP3A4 inhibitor, may increase the plasma concentrations of alfentanyl (small therapeutic range). Clarithromycin should be used with caution
Alfentanyl, crizotinib [2] ---> SPC of [2] of EMA
Coadministration of crizotinib (moderate inhibitor of CYP3A) with CYP3A substrates with narrow therapeutic indices should be avoided. If the combination is needed, then close clinical monitoring should be exercised.
Alfentanyl, darunavir/cobicistat [2] ---> SPC of [2] of EMA
REZOLSTA is expected to increase alfentanil plasma concentrations. The concomitant use with REZOLSTA may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Alfentanyl, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
It is expected to increase alfentanil plasma concentrations. The concomitant use with Symtuza may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Alfentanyl, darunavir/ritonavir ---> SPC of [darunavir] of EMA
The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by boosted darunavir.
Alfentanyl, dexmedetomidine [2] ---> SPC of [2] of EMA
Specific studies have confirmed that the co-administration of dexmedetomidine with isoflurane, propofol, alfentanil, and midazolam enhances the effects
Alfentanyl [1], diltiazem ---> SPC of [1] of eMC
Available human pharmacokinetic data indicate that the metabolism of alfentanil is inhibited by known cytochrome P450 3A4 enzyme inhibitors. This could increase the risk of prolonged or delayed respiratory depression.
Alfentanyl, eluxadoline [2] ---> SPC of [2] of EMA
Eluxadoline may increase the exposure of co-administered medicinal products metabolised by Cytochrome CYP3A4. Caution should be exercised when administering such products, especially for those with a narrow therapeutic index.
Alfentanyl, eribulin [2] ---> SPC of [2] of EMA
Caution and monitoring for adverse effects is recommended with concomitant use of substances that have a narrow therapeutic window and that are eliminated mainly via CYP3A4-mediated metabolism
Alfentanyl [1], erythromycin ---> SPC of [1] of eMC
Available human pharmacokinetic data indicate that the metabolism of alfentanil is inhibited by known cytochrome P450 3A4 enzyme inhibitors. This could increase the risk of prolonged or delayed respiratory depression.
Alfentanyl, etomidate [2] ---> SPC of [2] of eMC
Co-administration of etomidate with alfentanil has been reported to decrease the terminal half-life of etomidate to approximately 29 minutes.
Alfentanyl, fluconazole [2] ---> SPC of [2] of eMC
During concomitant treatment with fluconazole (400 mg) and intravenous alfentanil (20 µg/kg) in healthy volunteers the alfentanil AUC10 increased 2-fold, probably through inhibition of CYP3A4. Alfentanil dose adjustment of may be necessary
Alfentanyl, fosaprepitant [2] ---> SPC of [2] of EMA
Caution is advised during co-administration of fosaprepitant and orally administered active principles metabolised primarily through CYP3A4 and with a narrow therapeutic range
Alfentanyl [1], halogenated anaesthetics ---> SPC of [1] of eMC
CNS depressants may enhance or prolong the respiratory depressant effects of alfentanil.
Alfentanyl, idebenone [2] ---> SPC of [2] of EMA
CYP3A4 substrates known to have a narrow therapeutic index should be administered with caution in patients receiving idebenone.
Alfentanyl, idelalisib [2] ---> SPC of [2] of EMA
The co-administration of idelalisib with alfentanyl may increase the serum concentrations of alfentanyl. Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.
Alfentanyl, imatinib [2] ---> SPC of [2] of EMA
Imatinib inhibits CYP3A4 and may increase plasma concentration of other CYP3A4 metabolised drugs. Caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window
Alfentanyl, indinavir [2] ---> SPC of [2] of EMA
Indinavir with or without ritonavir should not be administered with medicinal products with narrow therapeutic ranges and which are CYP3A4 substrates. The elevated plasma concentrations of these medicines may cause serious or life-threatening reactions.
Alfentanyl, indinavir/ritonavir ---> SPC of [indinavir] of EMA
Indinavir with or without ritonavir should not be administered with medicinal products with narrow therapeutic ranges and which are CYP3A4 substrates. The elevated plasma concentrations of these medicines may cause serious or life-threatening reactions.
Alfentanyl, interferon
Caution should be used when administering interferon with medicines mainly metabolised by hepatic cytochrome P450 and have a narrow therapeutic window
Alfentanyl, isavuconazole [2] ---> SPC of [2] of EMA
No CRESEMBA dose adjustment necessary. Short-acting opiates (alfentanyl, fentanyl): careful monitoring for any occurrence of drug toxicity, and dose reduction if required.
Alfentanyl [1], itraconazol ---> SPC of [1] of eMC
Alfentanil is metabolised mainly via the human cytochrome P450 3A4 enzyme. In vitro data suggest that cytochrome P450 3A4 enzyme inhibitors may inhibit the metabolism of alfentanil
Alfentanyl [1], ketoconazole ---> SPC of [1] of eMC
Alfentanil is metabolised mainly via the human cytochrome P450 3A4 enzyme. In vitro data suggest that cytochrome P450 3A4 enzyme inhibitors may inhibit the metabolism of alfentanil
Alfentanyl, letermovir [2] ---> SPC of [2] of EMA
PREVYMIS should be used with caution with medicinal products that are CYP3A substrates with narrow therapeutic ranges as co-administration may result in increases in the plasma concentrations of CYP3A substrates.
Alfentanyl [1], moderate CYP3A4 inhibitors ---> SPC of [1] of eMC
Available human pharmacokinetic data indicate that the metabolism of alfentanil is inhibited by known cytochrome P450 3A4 enzyme inhibitors. This could increase the risk of prolonged or delayed respiratory depression.
Alfentanyl, netupitant/palonosetron [2] ---> SPC of [2] of EMA
Netupitant/palonosetron should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Alfentanyl [1], neuroleptics ---> SPC of [1] of eMC
CNS depressants may enhance or prolong the respiratory depressant effects of alfentanil.
Alfentanyl, nilotinib [2] ---> SPC of [2] of EMA
Nilotinib is a moderate CYP3A4 inhibitor. Appropriate monitoring and dose adjustment may be necessary for drugs that are CYP3A4 substrates and have a narrow therapeutic index when co-administered with nilotinib.
Alfentanyl, niraparib [2] ---> SPC of [2] of EMA
Caution is recommended when niraparib is combined with principles the metabolism of which is CYP3A4-dependent and, notably, those having a narrow therapeutic range (e.g. ciclosporin, tacrolimus, alfentanil, ergotamine, pimozide, quetiapine, and halofantrine
Alfentanyl, palbociclib [2] ---> SPC of [2] of EMA
The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.
Alfentanyl [1], pregnancy ---> SPC of [1] of eMC
It is necessary to consider possible risks and potential advantages before administering this drug to pregnant patients.
Alfentanyl [1], propofol ---> SPC of [1] of eMC
In combination with alfentanil, the blood concentrations of propofol are 17% higher than in the absence of alfentanil.
Alfentanyl, ribociclib [2] ---> SPC of [2] of EMA
Caution is recommended in case of concomitant use with sensitive CYP3A4 substrates with a narrow therapeutic index (see section 4.4). The dose of a sensitive CYP3A4 substrate with a narrow therapeutic index
Alfentanyl [1], ritonavir ---> SPC of [1] of eMC
Alfentanil is metabolised mainly via the human cytochrome P450 3A4 enzyme. In vitro data suggest that cytochrome P450 3A4 enzyme inhibitors may inhibit the metabolism of alfentanil
Alfentanyl, rucaparib [2] ---> SPC of [2] of EMA
Caution is advised when co-administering medicinal products that CYP3A substrates with a narrow therapeutic index. Dose adjustments may be considered, if clinically indicated based on observed adverse reactions.
Alfentanyl, saquinavir [2] ---> SPC of [2] of EMA
Saquinavir, CYP3A4 inhibitor, may increase the plasma concentrations of alfentanyl.
Alfentanyl, saquinavir/ritonavir ---> SPC of [saquinavir] of EMA
Saquinavir, CYP3A4 inhibitor, may increase the plasma concentrations of alfentanyl. Contraindicated due to the potential for life threatening cardiac arrhythmia
Alfentanyl, sevoflurane [2] ---> SPC of [2] of eMC
Opioids are expected to decrease the MAC of sevoflurane. Opioids, when combined with sevoflurane, may lead to a synergistic fall in heart rate, blood pressure and respiratory rate.
Alfentanyl [1], strong CYP3A4 inhibitors ---> SPC of [1] of eMC
Alfentanil is metabolised mainly via the human cytochrome P450 3A4 enzyme. In vitro data suggest that cytochrome P450 3A4 enzyme inhibitors may inhibit the metabolism of alfentanil
Alfentanyl, telaprevir [2] ---> SPC of [2] of EMA
The co-administration increases the alfentanil plasma levels. Careful monitoring of therapeutic and adverse effects is recommended
Alfentanyl, voriconazole [2] ---> SPC of [2] of EMA
Dose reduction of alfentanil, fentanyl and other short-acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered.
Barbiturates, opiates ---> SPC of [alfentanyl] of eMC
The co-administration may enhance or prolong the respiratory depressant effect of opioid.
Neuroleptics, opiates ---> SPC of [alfentanyl] of eMC
The co-administration may enhance or prolong the respiratory depressant effect of opioid.
CONTRAINDICATIONS of Alfentanyl
- Known intolerance of alfentanil or other morphinomimetics. Pregnancy, and concurrent administration with monoamine oxidase inhibitors.
http://www.medicines.org.uk/emc/
Alfuzosin
QT interval prolonging drugs, alfuzosin [2] ---> SPC of [2] of eMC
Patients who are taking drugs known to increase the QTc interval should be evaluated before and during the administration of alfuzosin.
Ability to drive, alfuzosin [2] ---> SPC of [2] of eMC
Vertigo, dizziness and asthenia may occur.
Alfa1-adrenergic receptor blockers, alfuzosin [2] ---> SPC of [2] of eMC
The combination of alfuzosin with other alpha-1-receptor blockers is contraindicated
Alfuzosin, amprenavir [2] ---> SPC of [2] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Alfuzosin [1], antihypertensives ---> SPC of [1] of eMC
The concomitant use can cause profound hypotension.
Alfuzosin, atazanavir [2] ---> SPC of [2] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Alfuzosin, atazanavir/cobicistat [2] ---> SPC of [2] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Alfuzosin, boceprevir/peginterferon alfa/ribavirin [2] ---> SPC of [2] of EMA
Victrelis, with peginterferon alfa and ribavirin, is contraindicated in coadministration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma levels are associated with serious and/or life-threatening events
Alfuzosin [1], breast-feeding ---> SPC of [1] of eMC
Due to the type of indication this section is not applicable.
Alfuzosin, carteolol
Increased antihypertensive effect, increased risk of orthostatic hypotension
Alfuzosin, clarithromycin
Clarithromycin, CYP3A4 inhibitor, may increase the plasma concentrations of alfuzosin (small therapeutic range). Clarithromycin should be used with caution
Alfuzosin, cobicistat [2] ---> SPC of [2] of EMA
Co-administration of cobicistat with medicinal products which are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Alfuzosin, darunavir/cobicistat [2] ---> SPC of [2] of EMA
Co-administration of darunavir/cobicistat with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Alfuzosin, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Based on theoretical consideration DRV/COBI is expected to increase alfuzosin concentrations (CYP3A4 inhibition). The concomitant use of Symtuza with alfuzosin is contra-indicated
Alfuzosin, darunavir/ritonavir ---> SPC of [darunavir] of EMA
Co-administration of darunavir boosted with ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events is contraindicated
Alfuzosin, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SPC of [ombitasvir/paritaprevir/ritonavir] of EMA
Ritonavir is a strong inhibitor of CYP3A. Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events are contraindicated
Alfuzosin, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated
Alfuzosin, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Co-administration of Stribild and other medicinal products primarily metabolised by CYP3A such as amiodarone, quinidine, cisapride, pimozide, alfuzosin and sildenafil for pulmonary arterial hypertension is contraindicated
Alfuzosin, eplerenone [2] ---> SPC of [2] of eMC
When alpha-1-blockers are combined with eplerenone, there is the potential for increased hypotensive effect and/or postural hypotension.
Alfuzosin, fosamprenavir/ritonavir ---> SPC of [fosamprenavir] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4). Co-administration of amprenavir/ritonavir with alfuzosin is contraindicated
Alfuzosin [1], general anesthetics ---> SPC of [1] of eMC
It could cause profound hypotension. It is recommended that alfuzosin be withdrawn 24 hours before surgery
Alfuzosin, idelalisib [2] ---> SPC of [2] of EMA
The co-administration of idelalisib with alfuzosin may increase the serum concentrations of alfuzosin. Idelalisib should not be co-administered with alfuzosin.
Alfuzosin, indinavir [2] ---> SPC of [2] of EMA
Indinavir with or without ritonavir should not be administered with medicinal products with narrow therapeutic ranges and which are CYP3A4 substrates. The elevated plasma concentrations of these medicines may cause serious or life-threatening reactions.
Alfuzosin, indinavir/ritonavir ---> SPC of [indinavir] of EMA
Indinavir/ritonavir should not be administered with alfuzosin
Alfuzosin, interferon
Caution should be used when administering interferon with medicines mainly metabolised by hepatic cytochrome P450 and have a narrow therapeutic window
Alfuzosin [1], itraconazol ---> SPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of alfuzosin
Alfuzosin [1], ketoconazole ---> SPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of alfuzosin
Alfuzosin, lopinavir/ritonavir [2] ---> SPC of [2] of EMA
Lopinavir/ritonavir should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events.
Alfuzosin, nelfinavir [2] ---> SPC of [2] of EMA
Co-administration of nelfinavir with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4 is contraindicated.
Alfuzosin, ombitasvir/paritaprevir/ritonavir [2] ---> SPC of [2] of EMA
Ritonavir is a strong inhibitor of CYP3A. Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events are contraindicated
Alfuzosin [1], organic nitrates ---> SPC of [1] of eMC
The concomitant use can cause profound hypotension.
Alfuzosin [1], pregnancy ---> SPC of [1] of eMC
Due to the type of indication this section is not applicable.
Alfuzosin, ramipril [2] ---> SPC of [2] of eMC
Potentiation of the risk of hypotension is to be anticipated. Caution is recommended
Alfuzosin, ribociclib [2] ---> SPC of [2] of EMA
Concomitant administration of ribociclib at the 600 mg dose this CYP3A4 substrates should be avoided
Alfuzosin, ritonavir [2] ---> SPC of [2] of EMA
Ritonavir co-administration is likely to result in increased plasma concentrations of alfuzosin and is therefore contraindicated
Alfuzosin, saquinavir/ritonavir ---> SPC of [saquinavir] of EMA
Increased plasma levels of alfuzosin (contraindicated combination, possible hypotension)
Alfuzosin [1], strong CYP3A4 inhibitors ---> SPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of alfuzosin
Alfuzosin, telaprevir [2] ---> SPC of [2] of EMA
Concomitant administration of telaprevir is contraindicated with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Alfuzosin, tipranavir/ritonavir ---> SPC of [tipranavir] of EMA
Tipranavir and ritonavir, CYP3A4 inhibitors, may increase the plasma concentrations of alfuzosin. Concomitant therapy is contraindicated.
Alfuzosin, vardenafil [2] ---> SPC of [2] of EMA
The concomitant use may lead to symptomatic hypotension in some patients. Vardenafil may be administered at any time with tamsulosin or with alfuzosin.
Alfuzosin, xipamide
Increased hypotensive effect. Risk of orthostatic hypotension
CONTRAINDICATIONS of Alfuzosin
- Hypersensitivity to the active substance or any of the excipients
- history of orthostatic hypotension;
- combination with other alpha-1 receptor blockers;
- severe hepatic insufficiency.
http://www.medicines.org.uk/emc/
Algeldrate/magnesium hydroxide
H2 antagonists, algeldrate/magnesium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
NSAID, algeldrate/magnesium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Acetylsalicylic acid, algeldrate/magnesium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, allopurinol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, atenolol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, biphosphonates
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide [1], breast-feeding ---> SPC of [1] of eMC
Caution should be exercised when prescribing to lactating women.
Algeldrate/magnesium hydroxide, captopril
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, cefpodoxime
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs by chelate formation
Algeldrate/magnesium hydroxide, cephalosporins
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs by chelate formation
Algeldrate/magnesium hydroxide, chloroquine
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, chlorpromazine
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, ciprofloxacin
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs by chelate formation
Algeldrate/magnesium hydroxide, citrate
The intake of acid beverages (e. g. fruit juices, wine) together with aluminium-containing antacids increases the intestinal absorption of aluminium
Algeldrate/magnesium hydroxide, diclofenac
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, dicoumarol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, diflunisal
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, digoxin
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, ethambutol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, fruit juice
The intake of acid beverages (e. g. fruit juices, wine) together with aluminium-containing antacids increases the intestinal absorption of aluminium
Algeldrate/magnesium hydroxide, glucocorticoids
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, indometacin
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, iron
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, isoniazid
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, juices
The intake of acid beverages (e. g. fruit juices, wine) together with aluminium-containing antacids increases the intestinal absorption of aluminium
Algeldrate/magnesium hydroxide, ketoconazole
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, levothyroxine
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, lincosamides
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, metoprolol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, norfloxacin
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs by chelate formation
Algeldrate/magnesium hydroxide, pefloxacine
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs by chelate formation
Algeldrate/magnesium hydroxide, penicillamine
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, phenothiazines
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide [1], pregnancy ---> SPC of [1] of eMC
Use of antacids should be avoided in the first trimester of pregnancy. Caution should be exercised when prescribing to pregnant women.
Algeldrate/magnesium hydroxide, propranolol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, quinidine
The co-administration of quinidine with algeldrate/magnesium hydroxide may increase plasma levels of quinidine and cause a quinidine overdose
Algeldrate/magnesium hydroxide, quinolones
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs by chelate formation
Algeldrate/magnesium hydroxide, rosuvastatin ---> SPC of [aluminium oxide/magnesium hydroxide] of eMC
The simultaneous dosing of rosuvastatin with an antacid suspension containing magnesium hydroxide resulted in a decrease in rosuvastatin plasma concentration of approximately 50%.
Algeldrate/magnesium hydroxide, salicylates
Antacids may increase the salicylate excretion by alkalinization of urine
Algeldrate/magnesium hydroxide, sodium fluoride
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Algeldrate/magnesium hydroxide, sucralfate
The co-administration may decrease the effect of sucralfate. It is recommended to administer the two substances at least 2-4 hours apart.
Algeldrate/magnesium hydroxide, tetracyclines
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs by chelate formation
Algeldrate/magnesium hydroxide, wine
The intake of acid beverages (e. g. fruit juices, wine) together with aluminium-containing antacids increases the intestinal absorption of aluminium
Antacids, sucralfate
The co-administration may decrease the effect of sucralfate. It is recommended to administer the two substances at least 2-4 hours apart.
CONTRAINDICATIONS of Algeldrate/magnesium hydroxide
- It should not be used in patients who are severely debilitated or suffering from renal insufficiency, or if there is severe abdominal pain and/or the possibility of bowel
obstruction.
http://www.medicines.org.uk/emc/
Alglucosidase alfa (Myozyme)
Ability to drive, alglucosidase alfa [2] ---> SmPC of [2] of EMA
Because dizziness, somnolence, tremor and hypotension have been reported as an infusion associated reaction, this may affect the ability to drive and use machines on the day of the infusion.
Alglucosidase alfa [1], breast-feeding ---> SmPC of [1] of EMA
Breastfeeding during treatment with Myozyme may therefore be considered. As a precautionary measure, breastfeeding interruption for the first 24 hours after treatment may be considered.
Alglucosidase alfa [1], cytochrome P450 ---> SmPC of [1] of EMA
Because it is a recombinant human protein, alglucosidase alfa is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Alglucosidase alfa [1], fertility ---> SmPC of [1] of EMA
There is too limited clinical data on the effects of alglucosidase alfa on fertility to evaluate its impact. Preclinical data did not reveal any significant adverse findings (see section 5.3).
Alglucosidase alfa [1], pregnancy ---> SmPC of [1] of EMA
Studies in animals have shown reproductive toxicity (see section 5.3). Myozyme should not be used during pregnancy unless the clinical condition of the woman requires treatment with alglucosidase alfa.
CONTRAINDICATIONS of Alglucosidase alfa (Myozyme)
- Life threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1, when rechallenge was unsuccessful
https://www.ema.europa.eu/en/documents/product-information/myozyme-epar-product-information_en.pdf 16/08/2024
Alimemazine
CNS depressants, alimemazine [2] ---> SPC of [2] of eMC
The sedative effects of phenothiazines may be intensified (additively) by other sedatives
IMAOs, alimemazine
There may be increased antimuscarinic and sedative effects of phenothiazines
Ability to drive, alimemazine [2] ---> SPC of [2] of eMC
Drowsiness may occur
Alcohol, alimemazine [2] ---> SPC of [2] of eMC
The sedative effects of phenothiazines may be intensified (additively) by alcohol
Alimemazine [1], aluminium ---> SPC of [1] of eMC
The co-administration may decrease the absorption of phenothiazine. Separate administration by at least 2 hours
Alimemazine [1], antacids ---> SPC of [1] of eMC
The antacid can decrease the gastrointestinal absorption of phenothiazine
Alimemazine [1], antidiarrheals ---> SPC of [1] of eMC
The antidiarrhoic agent can decrease the gastrointestinal absorption of oral administered phenothiazine
Alimemazine [1], antihypertensives ---> SPC of [1] of eMC
The co-administration may increase the hypotensive effect
Alimemazine [1], anxiolytics ---> SPC of [1] of eMC
The sedative effects of phenothiazines may be intensified (additively) by anxiolytics
Alimemazine [1], barbiturates ---> SPC of [1] of eMC
The sedative effects of phenothiazines may be intensified (additively) by barbiturates
Alimemazine [1], breast-feeding ---> SPC of [1] of eMC
Phenothiazines may be excreted in milk: breast feeding should be suspended during treatment.
Alimemazine [1], hypnotics ---> SPC of [1] of eMC
The sedative effects of phenothiazines may be intensified (additively) by hypnotics
Alimemazine [1], pregnancy ---> SPC of [1] of eMC
Alimemazine should be avoided in pregnancy unless the physician considers it essential.
Alimemazine [1], sedatives ---> SPC of [1] of eMC
The sedative effects of phenothiazines may be intensified (additively) by other sedatives
Alimemazine [1], sun ---> SPC of [1] of eMC
Exposure to sunlight should be avoided during treatment
Antacids, phenothiazines ---> SPC of [alimemazine] of eMC
The antacid can decrease the gastrointestinal absorption of phenothiazine
Antacids, promethazine ---> SPC of [alimemazine] of eMC
The antacid can decrease the gastrointestinal absorption of phenothiazine
Antacids, trifluoperazine ---> SPC of [alimemazine] of eMC
Antacids can reduce the absorption of phenothiazines.
Antidiarrheals, phenothiazines ---> SPC of [alimemazine] of eMC
The antidiarrhoic agent can decrease the gastrointestinal absorption of oral administered phenothiazine
CONTRAINDICATIONS of Alimemazine
- Alimemazine should be avoided in patients with hepatic or renal dysfunction, epilepsy, Parkinson's disease, hypothyroidism, phaeochromocytoma, myasthenia gravis, prostatic
hypertrophy.
- It should be avoided in patients known to be hypersensitive to phenothiazines or to any of the excipients or with history of narrow angle glaucoma.
- Alimemazine is contraindicated for use in children less than 2 years of age
http://www.medicines.org.uk/emc/
Alipogene tiparvovec (Glybera)
Ability to drive, alipogene tiparvovec [2] ---> SmPC of [2] of EMA
Glybera has minor influence on the ability to drive and use machines¸ dizziness was commonly observed after Glybera administration (see section 4.8). Patients experiencing dizziness are advised to not drive or use machines.
Alipogene tiparvovec [1], anticoagulants ---> SmPC of [1] of EMA
Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with alipogen at the time of injection.
Alipogene tiparvovec [1], breast-feeding ---> SmPC of [1] of EMA
Glybera should not be administered to women who are breast-feeding as long as breastfeeding is ongoing.
Alipogene tiparvovec [1], fertility ---> SmPC of [1] of EMA
No clinical data on the effect of Glybera on fertility are available. Effects on male and female fertility have not been evaluated in animal studies.
Alipogene tiparvovec [1], men ---> SmPC of [1] of EMA
Male patients, including vasectomised males, are advised to practise barrier contraception methods for at least 12 months following Glybera administration.
Alipogene tiparvovec [1], oral contraceptives ---> SmPC of [1] of EMA
Oral contraceptive use is contraindicated in LPLD patients as this may exacerbate the underlying disease.
Alipogene tiparvovec [1], oral contraceptives ---> SmPC of [1] of EMA
Oral contraceptive use is contraindicated in LPLD patients (see section 4.3) as this may exacerbate the underlying disease.
Alipogene tiparvovec [1], platelet aggregation inhibitors ---> SmPC of [1] of EMA
Anti-platelet or other anti-coagulant medicinal products must not be taken for at least one week before the leg injections or one day after the injection (see section 4.3).
Alipogene tiparvovec [1], pregnancy ---> SmPC of [1] of EMA
Glybera should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Alipogene tiparvovec [1], women of childbearing potential ---> SmPC of [1] of EMA
Therefore, use of barrier contraception methods for at least 12 months following Glybera administration is recommended.
CONTRAINDICATIONS of Alipogene tiparvovec (Glybera)
- Hypersensitivity to the active substance or any of the excipients of Glybera listed in section 6.1.
- Immunodeficiency
- Patients with increased bleeding risk (such as thrombocytopenia) and muscle disease (such as myositis), must not be treated in view of the large number of intramuscular injections required.
- Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with Glybera at the time of injection and for at least one week before or one day after the injection.
- Oral contraceptive use (see section 4.6).
https://www.ema.europa.eu/en/documents/product-information/glybera-epar-product-information_en.pdf 10/07/2017 (withdrawn)
Alirocumab (Praluent)
Alirocumab [1], breast-feeding ---> SmPC of [1] of EMA
Since the effects of alirocumab on the breast-fed infant are unknown, a decision should be made whether to discontinue nursing or to discontinue Praluent during this period.
Alirocumab [1], cytochrome P450 ---> SmPC of [1] of EMA
Since alirocumab is a biological medicinal product, no pharmacokinetic effects of alirocumab on other medicinal products and no effect on cytochrome P450 enzymes are anticipated.
Alirocumab [1], ezetimibe ---> SmPC of [1] of EMA
Statins and other lipid-modifying therapy are known to increase production of PCSK9, the protein targeted by alirocumab. This leads to the increased target-mediated clearance and reduced systemic exposure of alirocumab.
Alirocumab [1], fenofibrate ---> SmPC of [1] of EMA
Statins and other lipid-modifying therapy are known to increase production of PCSK9, the protein targeted by alirocumab. This leads to the increased target-mediated clearance and reduced systemic exposure of alirocumab.
Alirocumab [1], fertility ---> SmPC of [1] of EMA
In animal studies, there were no adverse effects on surrogate markers of fertility (see section 5.3). There are no data on adverse effects on fertility in humans.
Alirocumab [1], lipid-lowering agents ---> SmPC of [1] of EMA
Statins and other lipid-modifying therapy are known to increase production of PCSK9, the protein targeted by alirocumab. This leads to the increased target-mediated clearance and reduced systemic exposure of alirocumab.
Alirocumab [1], pregnancy ---> SmPC of [1] of EMA
The use of Praluent is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.
Alirocumab [1], statins ---> SmPC of [1] of EMA
Statins and other lipid-modifying therapy are known to increase production of PCSK9, the protein targeted by alirocumab. This leads to the increased target-mediated clearance and reduced systemic exposure of alirocumab.
Alirocumab, LDL-C reduction---> SmPC of [1] of EMA
However, reduction of LDL-C is maintained during the dosing interval when alirocumab is administered every two weeks.
CONTRAINDICATIONS of Alirocumab (Praluent)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/praluent-epar-product-information_en.pdf 21/10/2025
liskiren (Rasilez)
Ability to drive, aliskiren [2] ---> SmPC of [2] of EMA
When driving vehicles or using machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilez.
ACE inhibitors, aliskiren [2] ---> SmPC of [2] of EMA
The combination of ACE inhibitors with aliskiren is contraindicated in diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) and is not recommended in other patients
ACE inhibitors, aliskiren [2] ---> SmPC of [2] of EMA
Dual blockade of the RAAS through the combined use of ACEIs, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure)
AIIRA, aliskiren [2] ---> SmPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren [1], amiodarone ---> SmPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren [1], amlodipine ---> SmPC of [1] of EMA
Co-administration of Rasilez had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics. As a result no dose adjustment for Rasilez or these co-administered medicinal products is necessary.
Aliskiren [1], breast-feeding ---> SmPC of [1] of EMA
It is unknown whether aliskiren/metabolites are excreted in human milk. Aliskiren was secreted in the milk of lactating rats. A risk to the newborns/infants cannot be excluded. Aliskiren should not be used during breast-feeding.
Aliskiren [1], cimetidine ---> SmPC of [1] of EMA
Co-administration of aliskiren with either metformin (< 28%), amlodipine (> 29%) or cimetidine (> 19%) resulted in between 20% and 30% change in Cmax or AUC of Rasilez.
Aliskiren [1], clarithromycin ---> SmPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren [1], coxibs ---> SmPC of [1] of EMA
NSAIDs may reduce the anti-hypertensive effect of aliskiren
Aliskiren [1], cyclosporine ---> SmPC of [1] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren [1], cytochrome P450 ---> SmPC of [1] of EMA
Aliskiren is metabolised minimally by the cytochrome P450 enzymes. Hence, interactions due to inhibition or induction of CYP450 isoenzymes are not expected.
Aliskiren [1], digoxin ---> SmPC of [1] of EMA
Digoxin and verapamil bioavailability may be slightly decreased by Rasilez.
Aliskiren [1], erythromycin ---> SmPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren [1], fertility ---> SmPC of [1] of EMA
There are no clinical data on fertility.
Aliskiren [1], foods ---> SmPC of [1] of EMA
Although meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially, the efficacy of aliskiren was shown to be similar when taken either with a light meal or without a meal (see section 4.2).
Aliskiren [1], fruit juice ---> SmPC of [1] of EMA
Therefore, because of the risk of therapeutic failure, fruit juice should not be taken together with aliskiren.
Aliskiren [1], furosemide ---> SmPC of [1] of EMA
Oral co-administration of aliskiren and furosemide had no effect on the pharmacokinetics of aliskiren but reduced exposure to furosemide by 20-30%
Aliskiren [1], grapefruit juice ---> SmPC of [1] of EMA
Administration of grapefruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren. Grapefruit juice should not be taken together with aliskiren
Aliskiren [1], heparin ---> SmPC of [1] of EMA
Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels may lead to increases in serum potassium.
Aliskiren [1], hyperkalemia ---> SmPC of [1] of EMA
Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels may lead to increases in serum potassium.
Aliskiren [1], itraconazol ---> SmPC of [1] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren [1], ketoconazole ---> SmPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren [1], metformin ---> SmPC of [1] of EMA
Co-administration of Rasilez had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics. As a result no dose adjustment for Rasilez or these co-administered medicinal products is necessary.
Aliskiren [1], moderate P-gp inhibitors ---> SmPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren [1], NSAID ---> SmPC of [1] of EMA
NSAIDs may reduce the anti-hypertensive effect of aliskiren. In some patients with compromised renal function aliskiren given concomitantly with NSAIDs may result in further deterioration of renal function, including possible acute renal failure
Aliskiren [1], OATP inhibitors ---> SmPC of [1] of EMA
Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides. Therefore, the potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly
Aliskiren [1], P-glycoprotein and CYP3A4 inhibitors ---> SmPC of [1] of EMA
Increased aliskiren exposure during co-administration of CYP3A4 inhibitors that also inhibit P-gp can therefore be expected
Aliskiren [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
In experimental animals, it has been shown that P-gp is a major determinant of Rasilez bioavailability. Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Rasilez.
Aliskiren [1], P-gp inductors ---> SmPC of [1] of EMA
In experimental animals, it has been shown that P-gp is a major determinant of Rasilez bioavailability. Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Rasilez.
Aliskiren [1], P-gp inhibitors ---> SmPC of [1] of EMA
Therefore, P-gp inhibitors may increase tissue levels more than plasma levels. The potential for drug interactions at the P-gp site will likely depend on the degree of inhibition of this transporter.
Aliskiren [1], pharmacokinetics ---> SmPC of [1] of EMA
Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide. No interactions have been identified.
Aliskiren [1], pharmacokinetics ---> SmPC of [1] of EMA
Co-administration of Rasilez had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics. As a result no dose adjustment for Rasilez or these co-administered medicinal products is necessary
Aliskiren [1], plant extracts ---> SmPC of [1] of EMA
Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with aliskiren (see section 4.2)
Aliskiren [1], potassium ---> SmPC of [1] of EMA
Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels may lead to increases in serum potassium.
Aliskiren [1], potassium-sparing diuretics ---> SmPC of [1] of EMA
Concomitant use of other agents affecting the RAAS, of NSAIDs or of agents that increase serum potassium levels may lead to increases in serum potassium.
Aliskiren [1], pregnancy ---> SmPC of [1] of EMA
Rasilez should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters
Aliskiren [1], quinidine ---> SmPC of [1] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren [1], rifampicin ---> SmPC of [1] of EMA
Rifampicin, which is an inducer of P-gp, reduced aliskiren bioavailability by approximately 50% in a clinical study.
Aliskiren [1], St. John's wort ---> SmPC of [1] of EMA
Other inducers of P-gp (St. John's wort) might decrease the bioavailability of aliskiren.
Aliskiren [1], strong P-gp inhibitors ---> SmPC of [1] of EMA
Therefore, concomitant use of aliskiren and P-gp potent inhibitors is contraindicated (see section 4.3).
Aliskiren [1], telithromycin ---> SmPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren [1], torasemid ---> SmPC of [1] of EMA
Since aliskiren has been shown to be a substrate for the OATP1A2, there is a potential for aliskiren to reduce plasma torasemide exposure by an interference with the absorption process.
Aliskiren [1], verapamil ---> SmPC of [1] of EMA
Digoxin and verapamil bioavailability may be slightly decreased by Rasilez.
Aliskiren, amlodipine/valsartan [2] ---> SmPC of [2] of EMA
Dual blockade of the RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, atorvastatin ---> SmPC of [aliskiren/amlodipine] of EMA
Coadministration of aliskiren had no significant impact on atorvastatin pharmacokinetics. As a result no dose adjustment is necessary.
Aliskiren, azilsartan medoxomil [2] ---> SmPC of [2] of EMA
Concomitant use of azilsartan medoxomil with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) is contraindicated and is not recommended in other patients
Aliskiren, cabozantinib [2] ---> SmPC of [2] of EMA
Cabozantinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp. Subjects should be cautioned regarding taking a P-gp substrate while receiving cabozantinib.
Aliskiren, felodipine/ramipril [2] ---> SmPC of [2] of eMC
The combination is contraindicated in patients with diabetes mellitus or moderate to severe renal impairment and is not recommended in other patients
Aliskiren, fosinopril
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, idebenone [2] ---> SmPC of [2] of EMA
Idebenone may inhibit P-glycoprotein (P-gp) with possible exposure increases of, e.g., dabigatran etexilate, digoxin or aliskiren. These medicines should be administered with caution in patients receiving idebenone.
Aliskiren, imidapril
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, irbesartan [2] ---> SmPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, irbesartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function
Aliskiren, lisinopril
Dual blockade of the RAA system through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function
Aliskiren, lomitapide [2] ---> SmPC of [2] of EMA
Coadministration of Lojuxta with P gp may increase the absorption of P gp substrates. Dose reduction of the P gp substrate should be considered when used concomitantly with Lojuxta.
Aliskiren, losartan
Dual blockade of the RAA system (e.g. by adding an ACE inhibitor or aliskiren to an AIIRA) should be limited to individually defined cases with close monitoring of arterial pressure, renal function, and electrolytes
Aliskiren, losartan/hydrochlorothiazide [2] ---> SmPC of [2] of eMC
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, metformin ---> SmPC of [aliskiren/amlodipine] of EMA
Coadministration of aliskiren had no significant impact on metformin pharmacokinetics. As a result no dose adjustment is necessary.
Aliskiren, olmesartan medoxomil
The concomitant use of ARBs with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) and is not recommended in other patients
Aliskiren, olmesartan medoxomil/amlodipine
The concomitant use of ARBs with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) and is not recommended in other patients
Aliskiren, quinapril
The concomitant use of ARBs with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) and is not recommended in other patients
Aliskiren, ramipril [2] ---> SmPC of [2] of eMC
Dual blockade of the RAA system through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function
Aliskiren, sacubitril/valsartan [2] ---> SmPC of [2] of EMA
The concomitant use of Entresto with aliskiren-containing products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2)
Aliskiren, sacubitril/valsartan [2] ---> SmPC of [2] of EMA
Combination of Entresto with aliskiren is potentially associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, sacubitril/valsartan [2] ---> SmPC of [2] of EMA
The concomitant use of sacubitril/valsartan with aliskiren-containing medicinal products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see section 4.3).
Aliskiren, telmisartan [2] ---> SmPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, telmisartan/amlodipine [2] ---> SmPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, telmisartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Aliskiren, tepotinib [2] ---> SmPC of [2] of EMA
Caution and monitoring for adverse reactions of other P-gp-dependent substances with a narrow therapeutic index (e.g. digoxin, aliskiren, everolimus, sirolimus) is recommended during co-administration with TEPMETKO.
Aliskiren, valsartan ---> SmPC of [amlodipine/valsartan] of EMA
The concomitant use of ARBs with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²)
Aliskiren, vemurafenib [2] ---> SmPC of [2] of EMA
Caution should be exercised, dose reduction and/or additional drug level monitoring for P-gp substrate medicinal products with narrow therapeutic index (NTI) may be considered if these medicinal products are used concomitantly with vemurafenib
Aliskiren, warfarin ---> SmPC of [aliskiren/amlodipine] of EMA
The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Aliskiren, zofenopril
Dual blockade of the RAAS through the combined use of ACE-inhibitors, AIIRAs or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
CONTRAINDICATIONS of Aliskiren (Rasilez)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- History of angioedema with aliskiren.
- Hereditary or idiopathic angioedema.
- Second and third trimesters of pregnancy
- The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
- The concomitant use of Rasilez with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²)
- Children from birth to less than 2 years (see sections 4.2 and 5.3).
https://www.ema.europa.eu/en/documents/product-information/rasilez-epar-product-information_en.pdf 23/02/2023
Other trade names: Enviage, Riprazo, Sprimeo, Tekturna,
Aliskiren/amlodipine (Rasilamlo)
ACE inhibitors, aliskiren/amlodipine [2] ---> SPC of [2] of EMA
The combination of ACE inhibitors with aliskiren is contraindicated in diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) and is not recommended in other patients
AIIRA, aliskiren/amlodipine [2] ---> SPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
NSAID, aliskiren/amlodipine [2] ---> SPC of [2] of EMA
As with other medicinal products acting on the renin-angiotensin-aldosterone system, NSAIDs may reduce the anti-hypertensive effect of aliskiren. The combination of aliskiren with an NSAID requires caution
OATP inhibitors, aliskiren/amlodipine [2] ---> SPC of [2] of EMA
Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides. Therefore, the potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly
St. John's wort, aliskiren/amlodipine [2] ---> SPC of [2] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Ability to drive, aliskiren/amlodipine [2] ---> SPC of [2] of EMA
When driving vehicles or using machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilamlo.
Aliskiren, atorvastatin ---> SPC of [aliskiren/amlodipine] of EMA
Coadministration of aliskiren had no significant impact on atorvastatin pharmacokinetics. As a result no dose adjustment is necessary.
Aliskiren, metformin ---> SPC of [aliskiren/amlodipine] of EMA
Coadministration of aliskiren had no significant impact on metformin pharmacokinetics. As a result no dose adjustment is necessary.
Aliskiren, warfarin ---> SPC of [aliskiren/amlodipine] of EMA
The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Aliskiren/amlodipine [1], amiodarone ---> SPC of [1] of EMA
Aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion. Caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors
Aliskiren/amlodipine [1], antihypertensives ---> SPC of [1] of EMA
The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other antihypertensive medicinal products.
Aliskiren/amlodipine [1], atorvastatin ---> SPC of [1] of EMA
Coadministration of aliskiren had no significant impact on atorvastatin pharmacokinetics. As a result no dose adjustment is necessary.
Aliskiren/amlodipine [1], azole antifungals ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine [1], breast-feeding ---> SPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Rasilamlo therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Aliskiren/amlodipine [1], clarithromycin ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine, cyclosporine ---> SPC of [aliskiren] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/amlodipine [1], dantrolene ---> SPC of [1] of EMA
Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Aliskiren/amlodipine [1], digoxin ---> SPC of [1] of EMA
Digoxin bioavailability may be slightly decreased by aliskiren.
Aliskiren/amlodipine [1], diltiazem ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine [1], erythromycin ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine [1], foods ---> SPC of [1] of EMA
Meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially. Concomitant administration of aliskiren with fruit juice or drinks containing plant extracts, including herbal teas, should be avoided.
Aliskiren/amlodipine [1], fruit juice ---> SPC of [1] of EMA
Administration of fruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren. Therefore, because of the risk of therapeutic failure, fruit juice should not be taken together with aliskiren/amlodipine.
Aliskiren/amlodipine [1], furosemide ---> SPC of [1] of EMA
Oral co-administration of aliskiren and furosemide had no effect on the pharmacokinetics of aliskiren but reduced exposure to furosemide by 20-30%
Aliskiren/amlodipine [1], grapefruit juice ---> SPC of [1] of EMA
Administration of fruit juice resulted in a decrease in AUC and Cmax of aliskiren. The bioavailability of amlodipine may be increased in some patients. Administration with grapefruit or grapefruit juice is not recommended
Aliskiren/amlodipine [1], heparin ---> SPC of [1] of EMA
Concomitant use of aliskiren/amlodipine and other agents that increase serum potassium levels may lead to increases in serum potassium. Caution is advisable.
Aliskiren/amlodipine [1], itraconazol ---> SPC of [1] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/amlodipine [1], ketoconazole ---> SPC of [1] of EMA
Aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion. Caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors
Aliskiren/amlodipine [1], metformin ---> SPC of [1] of EMA
Coadministration of aliskiren had no significant impact on metformin pharmacokinetics. As a result no dose adjustment is necessary.
Aliskiren/amlodipine [1], moderate CYP3A4 inhibitors ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine [1], moderate P-gp inhibitors ---> SPC of [1] of EMA
Aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion. Caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors
Aliskiren/amlodipine [1], plant extracts ---> SPC of [1] of EMA
Compounds potentially inhibiting organic anion transporting polypeptide-mediated uptake of aliskiren are widely present in many plant products. Drinks containing plant extracts, including herbal teas, should not be taken with aliskiren/amlodipine.
Aliskiren/amlodipine [1], potassium ---> SPC of [1] of EMA
Concomitant use of aliskiren/amlodipine and other agents that increase serum potassium levels may lead to increases in serum potassium. Caution is advisable.
Aliskiren/amlodipine [1], potassium-sparing diuretics ---> SPC of [1] of EMA
Concomitant use of aliskiren/amlodipine and other agents that increase serum potassium levels may lead to increases in serum potassium. Caution is advisable.
Aliskiren/amlodipine [1], pregnancy ---> SPC of [1] of EMA
Rasilamlo should not be used during the first trimester of pregnancy. Rasilamlo is contraindicated during the second and third trimesters
Aliskiren/amlodipine [1], protease inhibitors ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine [1], quinidine ---> SPC of [1] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/amlodipine [1], rifampicin ---> SPC of [1] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Aliskiren/amlodipine [1], simvastatine ---> SPC of [1] of EMA
Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Aliskiren/amlodipine [1], strong CYP3A4 inductors ---> SPC of [1] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Aliskiren/amlodipine [1], strong CYP3A4 inhibitors ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine, strong P-gp inductors ---> SPC of [aliskiren] of EMA
Inducers of P-gp might decrease the bioavailability of aliskiren. Caution required with concomitant use
Aliskiren/amlodipine [1], strong P-gp inhibitors ---> SPC of [1] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/amlodipine [1], telithromycin ---> SPC of [1] of EMA
Aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion. Caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors
Aliskiren/amlodipine [1], torasemid ---> SPC of [1] of EMA
Since aliskiren has been shown to be a substrate for the OATP1A2, there is a potential for aliskiren to reduce plasma torasemide exposure by an interference with the absorption process.
Aliskiren/amlodipine [1], verapamil ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine [1], warfarin ---> SPC of [1] of EMA
The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Amlodipine, antihypertensives ---> SPC of [aliskiren/amlodipine] of EMA
The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other antihypertensive medicinal products.
Amlodipine, dantrolene ---> SPC of [aliskiren/amlodipine] of EMA
Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Amlodipine, diltiazem ---> SPC of [aliskiren/amlodipine] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, simvastatine ---> SPC of [aliskiren/amlodipine] of EMA
Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Calcium antagonists, dantrolene ---> SPC of [aliskiren/amlodipine] of EMA
Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
CONTRAINDICATIONS of Aliskiren/amlodipine (Rasilamlo)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or other dihydropyridine derivatives.
- History of angioedema with aliskiren.
- Hereditary or idiopathic angioedema
- Second and third trimesters of pregnancy
- The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
- The concomitant use of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m²)
- Severe hypotension.
- Shock (including cardiogenic shock).
- Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis).
- Haemodynamically unstable heart failure after acute myocardial infarction.
- Children from birth to less than 2 years (see sections 4.2 and 5.3).
https://www.ema.europa.eu/en/documents/product-information/rasilamlo-epar-product-information_en.pdf 21/03/2017 (withdrawn)
Aliskiren/amlodipine/hydrochlorothiazide (Rasitrio)
ACE inhibitors, aliskiren/amlodipine/hydrochlorothiazide [2] ---> SPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
AIIRA, aliskiren/amlodipine/hydrochlorothiazide [2] ---> SPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
NSAID, aliskiren/amlodipine/hydrochlorothiazide [2] ---> SPC of [2] of EMA
As with other agents acting on the renin-angiotensin system, NSAIDs may reduce the anti-hypertensive effect of aliskiren. NSAIDs may also weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
OATP inhibitors, aliskiren/amlodipine/hydrochlorothiazide [2] ---> SPC of [2] of EMA
The potential exists for interactions between OATP inhibitors and aliskiren when administered concomitantly
St. John's wort, aliskiren/amlodipine/hydrochlorothiazide ---> SPC of [aliskiren] of EMA
Inducers of P-gp might decrease the bioavailability of aliskiren. Caution required with concomitant use
Ability to drive, aliskiren/amlodipine/hydrochlorothiazide [2] ---> SPC of [2] of EMA
When driving vehicles or using machines it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasitrio.
Adrenaline, aliskiren/amlodipine/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Hydrochlorothiazide may reduce the response to pressor amines
Alcohol, aliskiren/amlodipine/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Concomitant administration of thiazide diuretics with subtances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Aliskiren/amlodipine/hydrochlorothiazide [1], allopurinol ---> SPC of [1] of EMA
Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Aliskiren/amlodipine/hydrochlorothiazide [1], amantadine ---> SPC of [1] of EMA
Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Aliskiren/amlodipine/hydrochlorothiazide [1], amiodarone ---> SPC of [1] of EMA
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Aliskiren/amlodipine/hydrochlorothiazide [1], amisulpride ---> SPC of [1] of EMA
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Aliskiren/amlodipine/hydrochlorothiazide [1], anticholinergics ---> SPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Aliskiren/amlodipine/hydrochlorothiazide [1], antigout preparations ---> SPC of [1] of EMA
Possible increase of the level of serum uric acid. Dosage adjustment of the antigout medicinal product may be necessary
Aliskiren/amlodipine/hydrochlorothiazide [1], antihypertensives ---> SPC of [1] of EMA
The blood pressure lowering effects of amlodipine add to the blood pressure lowering effects of other antihypertensive medicinal products.
Aliskiren/amlodipine/hydrochlorothiazide [1], atropine ---> SPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Aliskiren/amlodipine/hydrochlorothiazide [1], azole antifungals ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine/hydrochlorothiazide [1], barbiturates ---> SPC of [1] of EMA
Concomitant administration of thiazide diuretics with subtances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Aliskiren/amlodipine/hydrochlorothiazide [1], bepridil ---> SPC of [1] of EMA
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Aliskiren/amlodipine/hydrochlorothiazide [1], betablockers ---> SPC of [1] of EMA
Concomitant use of thiazide diuretics with beta blockers may increase the risk of hyperglycaemia.
Aliskiren/amlodipine/hydrochlorothiazide [1], bile-acid sequestrants ---> SPC of [1] of EMA
Absorption of thiazide is impaired in the presence of anionic exchange resins. The thiazide should be taken at least 4 hours before or 4-6 hours after of the other drug
Aliskiren/amlodipine/hydrochlorothiazide [1], biperiden ---> SPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Aliskiren/amlodipine/hydrochlorothiazide [1], breast-feeding ---> SPC of [1] of EMA
The use of Rasitrio during breast-feeding is not recommended. If Rasitrio is used during breast-feeding, doses should be kept as low as possible.
Aliskiren/amlodipine/hydrochlorothiazide [1], calcium ---> SPC of [1] of EMA
Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium.
Aliskiren/amlodipine/hydrochlorothiazide [1], cholestyramine ---> SPC of [1] of EMA
Absorption of thiazide is impaired in the presence of anionic exchange resins. The thiazide should be taken at least 4 hours before or 4-6 hours after of the other drug
Aliskiren/amlodipine/hydrochlorothiazide [1], cisapride ---> SPC of [1] of EMA
It is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazide-type diuretics.
Aliskiren/amlodipine/hydrochlorothiazide [1], clarithromycin ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/amlodipine/hydrochlorothiazide [1], class IA antiarrhythmic agents ---> SPC of [1] of EMA
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Aliskiren/amlodipine/hydrochlorothiazide [1], class III antiarrhythmic agents ---> SPC of [1] of EMA
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Aliskiren/amlodipine/hydrochlorothiazide [1], colestipol ---> SPC of [1] of EMA
Absorption of thiazide is impaired in the presence of anionic exchange resins. The thiazide should be taken at least 4 hours before or 4-6 hours after of the other drug
Aliskiren/amlodipine/hydrochlorothiazide [1], curare-type muscle relaxants ---> SPC of [1] of EMA
Thiazides, including hydrochlorothiazide, potentiate the action of skeletal muscle relaxants such as curare derivatives.
Aliskiren/amlodipine/hydrochlorothiazide [1], cyclophosphamide ---> SPC of [1] of EMA
Thiazides may reduce the renal excretion of cytotoxic medicinal and potentiate their myelosuppressive effects.
Aliskiren/amlodipine/hydrochlorothiazide [1], cyclophosphamide ---> SPC of [1] of EMA
Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Aliskiren/amlodipine/hydrochlorothiazide, cyclosporine ---> SPC of [aliskiren] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/amlodipine/hydrochlorothiazide [1], cytotoxic agents ---> SPC of [1] of EMA
Thiazides may reduce the renal excretion of cytotoxic medicinal and potentiate their myelosuppressive effects.
Aliskiren/amlodipine/hydrochlorothiazide [1], dantrolene ---> SPC of [1] of EMA
Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Aliskiren/amlodipine/hydrochlorothiazide [1], diazoxide ---> SPC of [1] of EMA
Thiazide diuretics, including hydrochlorothiazide, may enhance the hyperglycaemic effect of diazoxide.
Aliskiren/amlodipine/hydrochlorothiazide [1], digital glycosides ---> SPC of [1] of EMA
Thiazide induced hypokalaemia/hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias. Periodic monitoring of serum potassium and ECG is recommended
Aliskiren/amlodipine/hydrochlorothiazide [1], digoxin ---> SPC of [1] of EMA
Thiazide induced hypokalaemia/hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias. Periodic monitoring of serum potassium and ECG is recommended
Aliskiren/amlodipine/hydrochlorothiazide [1], diltiazem ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine/hydrochlorothiazide [1], erythromycin ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/amlodipine/hydrochlorothiazide [1], foods ---> SPC of [1] of EMA
Meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially
Aliskiren/amlodipine/hydrochlorothiazide [1], grapefruit juice ---> SPC of [1] of EMA
Administration of grapefruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren. Grapefruit juice should not be taken together with aliskiren
Aliskiren/amlodipine/hydrochlorothiazide [1], heparin ---> SPC of [1] of EMA
Concomitant use of aliskiren with other agents that increase serum potassium levels may lead to increases in serum potassium. If co-medication is considered necessary, caution is advisable.
Aliskiren/amlodipine/hydrochlorothiazide [1], hyperkalemia ---> SPC of [1] of EMA
Concomitant use of aliskiren with other agents that increase serum potassium levels may lead to increases in serum potassium. If co-medication is considered necessary, caution is advisable.
Aliskiren/amlodipine/hydrochlorothiazide [1], insulin ---> SPC of [1] of EMA
Thiazides may alter glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary
Aliskiren/amlodipine/hydrochlorothiazide [1], interactions ---> SPC of [1] of EMA
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.
Aliskiren/amlodipine/hydrochlorothiazide [1], iodinated contrast media ---> SPC of [1] of EMA
In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products. Patients should be rehydrated before administration.
Aliskiren/amlodipine/hydrochlorothiazide [1], itraconazol ---> SPC of [1] of EMA
The strong inhibition of P-glycoprotein increases the plasma levels of aliskiren. The concomitant use is contra-indicated
Aliskiren/amlodipine/hydrochlorothiazide [1], ketoconazole ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/amlodipine/hydrochlorothiazide [1], lithium ---> SPC of [1] of EMA
Renal clearance of lithium is reduced by thiazides, therefore the risk of lithium toxicity may be increased with hydrochlorothiazide. Co-administration of lithium and hydrochlorothiazide is not recommended.
Aliskiren/amlodipine/hydrochlorothiazide [1], macrolide antibiotics ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine/hydrochlorothiazide [1], metformin ---> SPC of [1] of EMA
Risk of lactic acidosis induced by a possible functional renal failure linked to hydrochlorothiazide.
Aliskiren/amlodipine/hydrochlorothiazide [1], methotrexate ---> SPC of [1] of EMA
Thiazides may reduce the renal excretion of cytotoxic medicinal and potentiate their myelosuppressive effects.
Aliskiren/amlodipine/hydrochlorothiazide [1], methotrexate ---> SPC of [1] of EMA
Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Aliskiren/amlodipine/hydrochlorothiazide [1], methyldopa ---> SPC of [1] of EMA
There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Aliskiren/amlodipine/hydrochlorothiazide, moderate CYP3A4 inhibitors ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine/hydrochlorothiazide [1], moderate P-gp inhibitors ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/amlodipine/hydrochlorothiazide [1], muscle relaxants (non-depolarizing) ---> SPC of [1] of EMA
Thiazides potentiate the action of skeletal muscle relaxants such as curare derivatives.
Aliskiren/amlodipine/hydrochlorothiazide [1], narcotics ---> SPC of [1] of EMA
Concomitant administration of thiazide diuretics with subtances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Aliskiren/amlodipine/hydrochlorothiazide [1], noradrenaline ---> SPC of [1] of EMA
Hydrochlorothiazide may reduce the response to pressor amines
Aliskiren/amlodipine/hydrochlorothiazide [1], oral antidiabetics ---> SPC of [1] of EMA
Thiazides may alter glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary
Aliskiren/amlodipine/hydrochlorothiazide [1], potassium ---> SPC of [1] of EMA
Concomitant use of aliskiren with other agents that increase serum potassium levels may lead to increases in serum potassium. If co-medication is considered necessary, caution is advisable.
Aliskiren/amlodipine/hydrochlorothiazide [1], potassium-sparing diuretics ---> SPC of [1] of EMA
Concomitant use of aliskiren with other agents that increase serum potassium levels may lead to increases in serum potassium. If co-medication is considered necessary, caution is advisable.
Aliskiren/amlodipine/hydrochlorothiazide [1], pregnancy ---> SPC of [1] of EMA
Rasitrio should not be used during the first trimester of pregnancy. Rasitrio is contraindicated during the second and third trimesters
Aliskiren/amlodipine/hydrochlorothiazide [1], pressor amines ---> SPC of [1] of EMA
Hydrochlorothiazide may reduce the response to pressor amines
Aliskiren/amlodipine/hydrochlorothiazide [1], probenecide ---> SPC of [1] of EMA
Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid. Increase of dose of probenecid or sulfinpyrazone may be necessary.
Aliskiren/amlodipine/hydrochlorothiazide [1], prokinetics ---> SPC of [1] of EMA
It is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazide-type diuretics.
Aliskiren/amlodipine/hydrochlorothiazide [1], protease inhibitors ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine/hydrochlorothiazide, quinidine ---> SPC of [aliskiren] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/amlodipine/hydrochlorothiazide [1], rifampicin ---> SPC of [1] of EMA
The concomitant use of CYP3A4 inducers (e.g. rifampicin, Hypericum perforatum) may give a lower plasma concentration of amlodipine.
Aliskiren/amlodipine/hydrochlorothiazide [1], simvastatine ---> SPC of [1] of EMA
Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Aliskiren/amlodipine/hydrochlorothiazide [1], strong CYP3A4 inductors ---> SPC of [1] of EMA
The concomitant use of CYP3A4 inducers (e.g. rifampicin, Hypericum perforatum) may give a lower plasma concentration of amlodipine.
Aliskiren/amlodipine/hydrochlorothiazide [1], strong CYP3A4 inhibitors ---> SPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Aliskiren/amlodipine/hydrochlorothiazide, strong P-gp inductors ---> SPC of [aliskiren] of EMA
Inducers of P-gp might decrease the bioavailability of aliskiren. Caution required with concomitant use
Aliskiren/amlodipine/hydrochlorothiazide, strong P-gp inhibitors ---> SPC of [aliskiren] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/amlodipine/hydrochlorothiazide [1], sulfinpyrazone ---> SPC of [1] of EMA
Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid. Increase of dose of probenecid or sulfinpyrazone may be necessary.
Aliskiren/amlodipine/hydrochlorothiazide [1], telithromycin ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/amlodipine/hydrochlorothiazide [1], torsades de pointes inducing drugs ---> SPC of [1] of EMA
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Aliskiren/amlodipine/hydrochlorothiazide [1], uricosuric agents ---> SPC of [1] of EMA
Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid. Increase of dose of probenecid or sulfinpyrazone may be necessary.
Aliskiren/amlodipine/hydrochlorothiazide [1], verapamil ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/amlodipine/hydrochlorothiazide [1], vitamin D ---> SPC of [1] of EMA
Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium.
Aliskiren/amlodipine/hydrochlorothiazide [1], warfarin ---> SPC of [1] of EMA
The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Allopurinol, thiazides ---> SPC of [aliskiren/amlodipine/hydrochlorothiazide] of EMA
Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
CONTRAINDICATIONS of Aliskiren/amlodipine/hydrochlorothiazide (Rasitrio)
- Hypersensitivity to the active substances or to any of the excipients, to other dihydropyridine derivatives, or to other sulphonamide-derived substances.
- History of angioedema with aliskiren.
- Hereditary or idiopathic angioedema.
- Second and third trimesters of pregnancy
- Anuria.
- Severe renal impairment (GFR <30 ml/min/1.73 m²).
- Hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia and refractory hypokalaemia.
- Severe hepatic impairment.
- The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
- The concomitant use of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m²)
- Severe hypotension.
- Shock (including cardiogenic shock).
- Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis).
- Haemodynamically unstable heart failure after acute myocardial infarction.
https://www.ema.europa.eu/en/documents/product-information/rasitrio-epar-product-information_en.pdf 20/09/2012 (withdrawn)
Aliskiren/hydrochlorothiazide (Rasilez HCT)
ACE inhibitors, aliskiren/hydrochlorothiazide [2] ---> SPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
AIIRA, aliskiren/hydrochlorothiazide [2] ---> SPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
NSAID, aliskiren/hydrochlorothiazide [2] ---> SPC of [2] of EMA
NSAIDs may reduce the anti-hypertensive effect of aliskiren. NSAIDs may weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
OATP inhibitors, aliskiren/hydrochlorothiazide [2] ---> SPC of [2] of EMA
The inhibition of OATP may increase the plasma levels of aliskiren.
St. John's wort, aliskiren/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Inducers of P-gp might decrease the bioavailability of aliskiren. Caution required with concomitant use
Ability to drive, aliskiren/hydrochlorothiazide [2] ---> SPC of [2] of EMA
When driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally occur when taking Rasilez HCT.
Acetylsalicylic acid, aliskiren/hydrochlorothiazide [2] ---> SPC of [2] of EMA
NSAIDs may reduce the anti-hypertensive effect of aliskiren. NSAIDs may weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
Alcohol, aliskiren/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Concomitant administration of thiazide diuretics with subtances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Aliskiren/hydrochlorothiazide [1], amantadine ---> SPC of [1] of EMA
Thiazides may increase the risk of adverse reactions caused by amantadine.
Aliskiren/hydrochlorothiazide [1], amiodarone ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/hydrochlorothiazide [1], amphotericin ---> SPC of [1] of EMA
The potassium-depleting effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia
Aliskiren/hydrochlorothiazide [1], anticholinergics ---> SPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Aliskiren/hydrochlorothiazide [1], antihypertensives ---> SPC of [1] of EMA
The antihypertensive effect of aliskiren/hydrochlorothiazide may be increased with the concomitant use of other antihypertensive agents.
Aliskiren/hydrochlorothiazide [1], atropine ---> SPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Aliskiren/hydrochlorothiazide [1], barbiturates ---> SPC of [1] of EMA
Concomitant administration of thiazide diuretics with subtances that also have a blood pressure lowering effect may potentiate orthostatic hypotension.
Aliskiren/hydrochlorothiazide [1], betablockers ---> SPC of [1] of EMA
Concomitant use of thiazide diuretics with beta blockers may increase the risk of hyperglycaemia.
Aliskiren/hydrochlorothiazide, bile-acid sequestrants ---> SPC of [amlodipine/valsartan/hydrochlorothiazide] of EM
Absorption of thiazide diuretics is decreased by cholestyramine and other anionic exchange resins. The thiazide should be taken at least 4 hours before or 4-6 hours after of the other medicinal product
Aliskiren/hydrochlorothiazide [1], biperiden ---> SPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Aliskiren/hydrochlorothiazide [1], breast-feeding ---> SPC of [1] of EMA
The use of Rasilez HCT during breast-feeding is not recommended. If Rasilez HCT is used during breast-feeding, doses should be kept as low as possible.
Aliskiren/hydrochlorothiazide [1], calcium ---> SPC of [1] of EMA
Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium.
Aliskiren/hydrochlorothiazide [1], carbenoxolone ---> SPC of [1] of EMA
The potassium-depleting effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia
Aliskiren/hydrochlorothiazide [1], catecholamines ---> SPC of [1] of EMA
Hydrochlorothiazide may reduce the response to pressor amines
Aliskiren/hydrochlorothiazide [1], cholestyramine ---> SPC of [1] of EMA
Absorption of thiazide diuretics is decreased by cholestyramine. This could result in sub-therapeutic effects of thiazide diuretics. The thiazide should be administered at least 4 hours before or 4-6 hours after the administration of resin
Aliskiren/hydrochlorothiazide [1], cisapride ---> SPC of [1] of EMA
Prokinetic substances may decrease the bioavailability of thiazide-type diuretics.
Aliskiren/hydrochlorothiazide [1], clarithromycin ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/hydrochlorothiazide [1], class IA antiarrhythmic agents ---> SPC of [1] of EMA
Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes
Aliskiren/hydrochlorothiazide [1], class III antiarrhythmic agents ---> SPC of [1] of EMA
Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes
Aliskiren/hydrochlorothiazide [1], colestipol ---> SPC of [1] of EMA
Absorption of thiazide diuretics is decreased by colestipol. The thiazide should be taken at least 1 hour before or 4 hours after the administration of the resin
Aliskiren/hydrochlorothiazide [1], corticosteroids ---> SPC of [1] of EMA
The potassium-depleting effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia
Aliskiren/hydrochlorothiazide [1], coxibs ---> SPC of [1] of EMA
NSAIDs may reduce the anti-hypertensive effect of aliskiren. NSAIDs may weaken the diuretic and antihypertensive activity of hydrochlorothiazide.
Aliskiren/hydrochlorothiazide [1], curare-type muscle relaxants ---> SPC of [1] of EMA
Thiazides, including hydrochlorothiazide, potentiate the action of skeletal muscle relaxants such as curare derivatives.
Aliskiren/hydrochlorothiazide [1], cyclosporine ---> SPC of [1] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/hydrochlorothiazide [1], cytotoxic agents ---> SPC of [1] of EMA
Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Aliskiren/hydrochlorothiazide [1], diazoxide ---> SPC of [1] of EMA
Thiazide diuretics, including hydrochlorothiazide, may enhance the hyperglycaemic effect of diazoxide.
Aliskiren/hydrochlorothiazide [1], digital glycosides ---> SPC of [1] of EMA
Thiazide-induced hypokalaemia or hypomagnesaemia may occur as undesirable effects, favouring the onset of digitalis-induced cardiac arrhythmias. Periodic monitoring of serum potassium and ECG is recommended
Aliskiren/hydrochlorothiazide [1], digoxin ---> SPC of [1] of EMA
Digoxin bioavailability may be slightly decreased by aliskiren.
Aliskiren/hydrochlorothiazide [1], electrolyte imbalance ---> SPC of [1] of EMA
Treatment with Rasilez HCT should only start after correction of hypokalaemia and any coexisting hypomagnesaemia.
Aliskiren/hydrochlorothiazide [1], erythromycin ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/hydrochlorothiazide [1], foods ---> SPC of [1] of EMA
Although meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially, the efficacy of aliskiren was shown to be similar when taken either with a light meal or without a meal
Aliskiren/hydrochlorothiazide [1], fruit juice ---> SPC of [1] of EMA
Administration of fruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren. This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren
Aliskiren/hydrochlorothiazide, furosemide ---> SPC of [aliskiren] of EMA
Oral co-administration of aliskiren and furosemide had no effect on the pharmacokinetics of aliskiren but reduced exposure to furosemide by 20-30%
Aliskiren/hydrochlorothiazide [1], grapefruit juice ---> SPC of [1] of EMA
Administration of grapefruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren. Grapefruit juice should not be taken together with aliskiren
Aliskiren/hydrochlorothiazide [1], heparin ---> SPC of [1] of EMA
Concomitant use of aliskiren with other agents that increase serum potassium levels may lead to increases in serum potassium. If co-medication is considered necessary, caution is advisable.
Aliskiren/hydrochlorothiazide, hydroquinidine ---> SPC of [losartan/hydrochlorothiazide] of eMC
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Aliskiren/hydrochlorothiazide [1], hypokalemia ---> SPC of [1] of EMA
The co-administration may increase the risk of hypokalaemia. Monitoring of potassium plasma levels is advised.
Aliskiren/hydrochlorothiazide [1], insulin ---> SPC of [1] of EMA
The co-administration may decrease the effect of insulin
Aliskiren/hydrochlorothiazide [1], iodinated contrast media ---> SPC of [1] of EMA
In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products. Patients should be rehydrated before administration.
Aliskiren/hydrochlorothiazide [1], itraconazol ---> SPC of [1] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/hydrochlorothiazide [1], kaliuretic medicines ---> SPC of [1] of EMA
The potassium-depleting effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia
Aliskiren/hydrochlorothiazide [1], ketoconazole ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/hydrochlorothiazide [1], laxatives ---> SPC of [1] of EMA
The potassium-depleting effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia
Aliskiren/hydrochlorothiazide [1], lithium ---> SPC of [1] of EMA
Renal clearance of lithium is reduced by thiazides, therefore the risk of lithium toxicity may be increased with hydrochlorothiazide. Co-administration of lithium and hydrochlorothiazide is not recommended.
Aliskiren/hydrochlorothiazide [1], loop diuretics ---> SPC of [1] of EMA
The potassium-depleting effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia
Aliskiren/hydrochlorothiazide [1], metformin ---> SPC of [1] of EMA
Co-administration of aliskiren had no significant impact on atorvastatin, metformin or amlodipine pharmacokinetics. As a result no dose adjustment for aliskiren or these co-administered medicinal products is necessary.
Aliskiren/hydrochlorothiazide [1], methyldopa ---> SPC of [1] of EMA
There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Aliskiren/hydrochlorothiazide [1], moderate P-gp inhibitors ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/hydrochlorothiazide [1], muscle relaxants (non-depolarizing) ---> SPC of [1] of EMA
Thiazides, including hydrochlorothiazide, potentiate the action of skeletal muscle relaxants such as curare derivatives.
Aliskiren/hydrochlorothiazide [1], oral antidiabetics ---> SPC of [1] of EMA
Thiazides may alter glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary
Aliskiren/hydrochlorothiazide [1], penicillin G ---> SPC of [1] of EMA
The potassium-depleting effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia
Aliskiren/hydrochlorothiazide [1], photosensitizing agents ---> SPC of [1] of EMA
Cases of photosensitivity reactions have been reported with thiazide diuretics. If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Aliskiren/hydrochlorothiazide [1], potassium ---> SPC of [1] of EMA
Concomitant use of aliskiren with other agents that increase serum potassium levels may lead to increases in serum potassium. If co-medication is considered necessary, caution is advisable.
Aliskiren/hydrochlorothiazide [1], potassium-sparing diuretics ---> SPC of [1] of EMA
Concomitant use of aliskiren with other agents that increase serum potassium levels may lead to increases in serum potassium. If co-medication is considered necessary, caution is advisable.
Aliskiren/hydrochlorothiazide [1], pregnancy ---> SPC of [1] of EMA
Rasilez HCT should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters
Aliskiren/hydrochlorothiazide [1], probenecide ---> SPC of [1] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Aliskiren/hydrochlorothiazide, prokinetics ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Prokinetic substances may decrease the bioavailability of thiazide-type diuretics.
Aliskiren/hydrochlorothiazide [1], quinidine ---> SPC of [1] of EMA
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
Aliskiren/hydrochlorothiazide [1], rifampicin ---> SPC of [1] of EMA
Inducers of P-gp might decrease the bioavailability of aliskiren. Caution required with concomitant use
Aliskiren/hydrochlorothiazide [1], sitagliptin ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/hydrochlorothiazide [1], strong P-gp inductors ---> SPC of [1] of EMA
Inducers of P-gp might decrease the bioavailability of aliskiren. Caution required with concomitant use
Aliskiren/hydrochlorothiazide [1], strong P-gp inhibitors ---> SPC of [1] of EMA
Concomitant use of aliskiren and P-gp potent inhibitors is contraindicated
Aliskiren/hydrochlorothiazide [1], sulfinpyrazone ---> SPC of [1] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Aliskiren/hydrochlorothiazide [1], telithromycin ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/hydrochlorothiazide [1], thiazides ---> SPC of [1] of EMA
The potassium-depleting effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia
Aliskiren/hydrochlorothiazide, torasemid ---> SPC of [aliskiren] of EMA
Since aliskiren has been shown to be a substrate for the OATP1A2, there is a potential for aliskiren to reduce plasma torasemide exposure by an interference with the absorption process.
Aliskiren/hydrochlorothiazide [1], torsades de pointes inducing drugs ---> SPC of [1] of EMA
Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes
Aliskiren/hydrochlorothiazide [1], uricosuric agents ---> SPC of [1] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Aliskiren/hydrochlorothiazide [1], verapamil ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/hydrochlorothiazide [1], vitamin D ---> SPC of [1] of EMA
Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium.
Aliskiren/hydrochlorothiazide [1], warfarin ---> SPC of [1] of EMA
The effects of aliskiren on warfarin pharmacokinetics have not been evaluated.
Amantadine, chlortalidone ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides may increase the risk of adverse reactions caused by amantadine.
Anticholinergics, hydrochlorothiazide ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Atropine, hydrochlorothiazide ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Atropine, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Bendroflumethiazide, betablockers ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Concomitant use of thiazide diuretics with beta blockers may increase the risk of hyperglycaemia.
Betablockers, chlortalidone ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Concomitant use of thiazide diuretics with beta blockers may increase the risk of hyperglycaemia.
Biperiden, hydrochlorothiazide ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Biperiden, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Cholestyramine, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Absorption of thiazide diuretics is decreased by cholestyramine. This could result in sub-therapeutic effects of thiazide diuretics. The thiazide should be administered at least 4 hours before or 4-6 hours after the administration of resin
Cisapride, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Prokinetic substances may decrease the bioavailability of thiazide-type diuretics.
Colestipol, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Absorption of thiazide diuretics is decreased by colestipol. The thiazide should be taken at least 1 hour before or 4 hours after the administration of the resin
Curare-type muscle relaxants, hydrochlorothiazide ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides potentiate the action of curare derivatives.
Curare-type muscle relaxants, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides potentiate the action of curare derivatives.
Cyclophosphamide, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides may reduce the renal excretion of cytotoxic medicinal and potentiate their myelosuppressive effects.
Cytotoxic agents, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides may reduce the renal excretion of cytotoxic medicinal and potentiate their myelosuppressive effects.
Diazoxide, hydrochlorothiazide ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazide diuretics, including hydrochlorothiazide, may enhance the hyperglycaemic effect of diazoxide.
Digital glycosides, hydrochlorothiazide ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazide induced hypokalaemia/hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias. Periodic monitoring of serum potassium and ECG is recommended
Digital glycosides, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazide-induced hypokalaemia or hypomagnesaemia may occur as undesirable effects, favouring the onset of digitalis-induced cardiac arrhythmias. Periodic monitoring of serum potassium and ECG is recommended
Digoxin, hydrochlorothiazide ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazide induced hypokalaemia/hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias. Periodic monitoring of serum potassium and ECG is recommended
Diuretics, iodinated contrast media ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products. Patients should be rehydrated before administration.
Diuretics, iopamidol ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products. Patients should be rehydrated before administration.
Hydrochlorothiazide, insulin ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides may alter glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary
Hydrochlorothiazide, iodinated contrast media ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products. Patients should be rehydrated before administration.
Hydrochlorothiazide, muscle relaxants (non-depolarizing) ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides potentiate the action of curare derivatives.
Hydrochlorothiazide, oral antidiabetics ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides may alter glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary
Hydrochlorothiazide, probenecide ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Hydrochlorothiazide, sulfinpyrazone ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Hydrochlorothiazide, tubocuranine ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides potentiate the action of curare derivatives.
Insulin, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides may alter glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary
Iodinated contrast media, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products. Patients should be rehydrated before administration.
Lisinopril/hydrochlorothiazide, torsades de pointes inducing drugs ---> SPC of [aliskiren/hydrochlorothiazide] of
Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes
Methotrexate, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides may reduce the renal excretion of cytotoxic medicinal and potentiate their myelosuppressive effects.
Muscle relaxants (non-depolarizing), thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides potentiate the action of curare derivatives.
Oral antidiabetics, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides may alter glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary
Prokinetics, thiazides ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Prokinetic substances may decrease the bioavailability of thiazide-type diuretics.
CONTRAINDICATIONS of Aliskiren/hydrochlorothiazide (Rasilez HCT)
- Hypersensitivity to the active substances or to any of the excipients, or to other sulphonamide-derived substances.
- History of angioedema with aliskiren.
- Hereditary or idiopathic angioedema.
- Second and third trimesters of pregnancy
- Anuria.
- Severe renal impairment (GFR < 30 ml/min/1.73 m²).
- Hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia and refractory hypokalaemia.
- Severe hepatic impairment.
- The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated
- The concomitant use of Rasilez HCT with an ACEI or an ARB is contraindicated in patients with diabetes mellitus or renal impairment
- Children from birth to less than 2 years (see sections 4.2 and 5.3).
https://www.ema.europa.eu/en/documents/product-information/rasilez-hct-epar-product-information_en.pdf 20/05/2022 (withdrawn)
Alitretinoin
St. John's wort, alitretinoin [2] ---> SPC of [2] of eMC
Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John's Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives
Ability to drive, alitretinoin [2] ---> SPC of [2] of eMC
Decreased night vision has been reported in patients treated with alitretinoin and other retinoids.
Ability to drive, retinoids ---> SPC of [alitretinoin] of eMC
Decreased night vision has been reported in patients treated with retinoids.
Alitretinoin [1], breast-feeding
Because of the potential for undesirable effects from Panretin gel in infants being breast-fed, mothers must discontinue breast-feeding prior to using the medicinal product and not initiate breast-feeding while using the medicinal product.
Alitretinoin [1], cyclosporine ---> SPC of [1] of eMC
No pharmacokinetic interactions were observed when alitretinoin was co-administered with cyclosporine
Alitretinoin [1], enzyme inductors
It is possible that co-administration of medicinal products which induce CYP isozymes may reduce circulating levels of alitretinoin, with a possible negative effect on the efficacy of Panretin gel.
Alitretinoin [1], ethinyl estradiol ---> SPC of [1] of eMC
No pharmacokinetic interactions were observed when alitretinoin was co-administered with the oral contraceptive ethinylestradiol.
Alitretinoin [1], insect repellent
It is not recommended for patients to apply Panretin gel concurrently with products that contain N,Ndiethyl-m-toluamide (DEET ), a common component of insect repellent products.
Alitretinoin, isotretinoin
Risk of A hypervitaminosis. The co-administration should be avoided.
Alitretinoin [1], ketoconazole ---> SPC of [1] of eMC
Co-administration of alitretinoin with CYP3A4 inhibitors such as ketoconazole increases the plasma level of alitretinoin and dose reduction may be required. The effects of other inhibitors of CYP3A4 have not been studied.
Alitretinoin [1], mineral oil
The use of other topical products on Panretin treated KS lesions should be avoided. Mineral oil may be used between Panretin applications in order to help prevent excessive dryness or itching.
Alitretinoin [1], norgestimate ---> SPC of [1] of eMC
No pharmacokinetic interactions were observed when alitretinoin was co-administered with the oral contraceptive norgestimate.
Alitretinoin [1], oral contraceptives ---> SPC of [1] of eMC
Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John's Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives
Alitretinoin [1], pregnancy
Panretin is contraindicated (see section 4.3) in pregnancy, as alitretinoin may cause foetal harm when administered systemically to a pregnant woman.
Alitretinoin [1], retinoids ---> SPC of [1] of eMC
Patients should not take vitamin A or other retinoids as concurrent medication due to the risk of hypervitaminosis A.
Alitretinoin [1], simvastatine ---> SPC of [1] of eMC
A 16% reduction of simvastatin plasma levels was observed when co-administered with alitretinoin.
Alitretinoin, strong CYP3A4 inductors
The strong CYP3A4 induction may decrease the plasma concentrations of alitretinoin
Alitretinoin [1], strong CYP3A4 inhibitors ---> SPC of [1] of eMC
Co-administration of alitretinoin with CYP3A4 inhibitors such as ketoconazole increases the plasma level of alitretinoin and dose reduction may be required. The effects of other inhibitors of CYP3A4 have not been studied.
Alitretinoin [1], sun ---> SPC of [1] of eMC
The effects of UV light are enhanced by retinoid therapy. Therefore patients should avoid excessive exposure to sunlight and the unsupervised use of sun lamps.
Alitretinoin [1], vitamin A ---> SPC of [1] of eMC
Patients should not take vitamin A or other retinoids as concurrent medication due to the risk of hypervitaminosis A.
Retinoids, tetracyclines ---> SPC of [alitretinoin] of eMC
Cases of benign intracranial hypertension (pseudotumor cerebri) have been reported with concomitant use of retinoids and tetracyclines. Therefore, concomitant treatment with tetracyclines must be avoided
Retinol, tetracyclines ---> SPC of [alitretinoin] of eMC
Cases of benign intracranial hypertension (pseudotumor cerebri) have been reported with concomitant use of retinoids and tetracyclines. Therefore, concomitant treatment with tetracyclines must be avoided
Tetracyclines, vitamin A ---> SPC of [alitretinoin] of eMC
Cases of benign intracranial hypertension (pseudotumor cerebri) have been reported with concomitant use of retinoids and tetracyclines. Therefore, concomitant treatment with tetracyclines must be avoided
CONTRAINDICATIONS of Alitretinoin
Gel:
- Hypersensitivity to retinoids in general, to alitretinoin or to any of the excipients.
- Pregnancy and breast-feeding
- Treatment of KS lesions in close proximity to other skin disorders.
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Oral:
Pregnancy is an absolute contraindication to treatment with Toctino
Toctino is contraindicated in woman of childbearing potential unless all of the conditions of the Pregnancy Prevention Program are met
Toctino contains soya oil and sorbitol. Patients who are allergic to peanut, soya or with rare hereditary fructose intolerance should not take this medicine.
Toctino is contraindicated in nursing mothers.
Toctino is also contraindicated in patients
- With hepatic insufficiency
- With severe renal insufficiency
- With uncontrolled hypercholesterolemia
- With uncontrolled hypertriglyceridemia
- With uncontrolled hypothyroidism
- With hypervitaminosis A
- With hypersensitivity either to alitretinoin, to other retinoids or to any of the excipients listed in section 6.1, in particular in case of allergies to peanut or soya
- Receiving concomitant treatment with tetracyclines
http://www.medicines.org.uk/emc/
Allopurinol
ACE inhibitors, allopurinol ---> SPC of [captopril] of eMC
Concomitant administration of allopurinol with ACE inhibitors may lead to an increased risk for leucopenia especially when the latter are used at higher than currently recommended doses.
Ability to drive, allopurinol [2] ---> SPC of [2] of eMC
Adverse reactions such as somnolence, vertigo and ataxia have been reported in patients receiving allopurinol
Acenocoumarol, allopurinol
Allopurinol may enhance the anticoagulant effect of acenocoumarol
Algeldrate/magnesium hydroxide, allopurinol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aliskiren/amlodipine/hydrochlorothiazide [1], allopurinol ---> SPC of [1] of EMA
Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Allopurinol, aluminium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Allopurinol, aluminium oxide/magnesium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Allopurinol, aminophylline
Allopurinol (high doses e.g. 600 mg daily) may decrease aminophylline clearance resulting in increased plasma theophylline concentrations and the potential for increased toxicity
Allopurinol, amlodipine/valsartan/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Allopurinol, amoxicillin [2] ---> SPC of [2] of eMC
Concomitant administration of amoxicillin and allopurinol may promote the occurrence of allergic cutaneous reactions and is therefore not advised.
Allopurinol [1], ampicillin ---> SPC of [1] of eMC
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared with patients who are not receiving both drugs.
Allopurinol, ampicillin/sulbactam
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared with patients who are not receiving both drugs.
Allopurinol, antacids
The co-administration may decrease the gastrointestinal absorption of allopurinol. Separate administration by at least 3 hours
Allopurinol, azathioprine [2] ---> SPC of [2] of eMC
Oxipurinol, xanthine oxidase inhibitor, reduces conversion of active 6-thioinosinic acid to inactive 6-thiouric acid. If oxipurinol is coadministered with azathioprine, the azathioprine dose should be reduced to 25 % of the original dose
Allopurinol, benazepril
Increased blood count alterations
Allopurinol, benzbromarone
Decreased allopurinol effect
Allopurinol [1], bleomycin ---> SPC of [1] of eMC
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease (other than leukaemia), in the presence of allopurinol.
Allopurinol [1], breast-feeding ---> SPC of [1] of eMC
There are no data concerning the effects of allopurinol or its metabolites on the breast-fed baby.
Allopurinol, capecitabine [2] ---> SPC of [2] of EMA
Interactions with allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU. Concomitant use of allopurinol with capecitabine should be avoided.
Allopurinol, captopril [2] ---> SPC of [2] of eMC
Concomitant administration of allopurinol with ACE inhibitors may lead to an increased risk for leucopenia especially when the latter are used at higher than currently recommended doses.
Allopurinol, carbaldrate
The aluminium salt decreases the absorption of the co-administered active principle. Separate administration by at least 2 hours
Allopurinol [1], chlorpropamide ---> SPC of [1] of eMC
If allopurinol is given concomitantly with chlorpropamide when renal function is poor, there may be an increased risk of prolonged hypoglycaemic activity, because allopurinol and chlorpropamide may compete for excretion in the renal tubule
Allopurinol [1], chlortalidone ---> SPC of [1] of eMC
Coadministration of a thiazide and allopurinol may increase the incidence of hypersensitivity reactions to allopurinol.
Allopurinol, cilazapril
Increased blood count alterations
Allopurinol, cisplatin
Cisplatin causes an increase in serum uric acid concentration
Allopurinol [1], coumarin anticoagulants ---> SPC of [1] of eMC
There have been rare reports of increased effect of warfarin and other coumarin anticoagulants when co-administered with allopurinol, therefore, all patients receiving anticoagulants must be carefully monitored.
Allopurinol [1], cyclophosphamide ---> SPC of [1] of eMC
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease (other than leukaemia), in the presence of allopurinol.
Allopurinol [1], cyclosporine ---> SPC of [1] of eMC
Reports suggest that the plasma concentration of ciclosporin may be increased during concomitant treatment with allopurinol. The possibility of enhanced ciclosporin toxicity should be considered if the drugs are co-administered.
Allopurinol [1], cytotoxic agents ---> SPC of [1] of eMC
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease (other than leukaemia), in the presence of allopurinol.
Allopurinol, daunorubicin
Incompatibility
Allopurinol, delapril [2]
Concomitant administration of allopurinol with ACE inhibitors may lead to an increased risk for leucopenia especially when the latter are used at higher than currently recommended doses.
Allopurinol, didanosine [2] ---> SPC of [2] of eMC
Inhibitors of xanthine oxidase may increase exposure to didanosine when administered concomitantly and thus increase the potential for didanosine associated undesirable effects.
Allopurinol [1], diuretics ---> SPC of [1] of eMC
Patients under treatment for hypertension or cardiac insufficiency, for example with diuretics, may have some concomitant impairment of renal function and allopurinol should be used with care in this group.
Allopurinol, doxofylline
The co-administration may decrease the hepatic elimination of the xanthine and increase its plasma levels
Allopurinol [1], doxorubicine ---> SPC of [1] of eMC
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease (other than leukaemia), in the presence of allopurinol.
Allopurinol, felodipine/ramipril [2] ---> SPC of [2] of eMC
Increased likelihood of haematological reactions.
Allopurinol, fluorouracil
Allopurinol may decrease the efficacy and toxicity of fluorouracil
Allopurinol, foods
Take with a full glass of water.
Allopurinol, glibenclamide
The co-administration may enhance the hypoglycemic effect
Allopurinol, glimepiride [2] ---> SPC of [2] of eMC
Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia
Allopurinol, gliquidone
The co-administration may enhance the hypoglycemic effect of gliquidone
Allopurinol, hydrochlorothiazide ---> SPC of [losartan/hydrochlorothiazide] of eMC
Dosage adjustment of uricosuric medicinal products may be necessary since hydrochlorothiazide may raise the level of serum uric acid. Hydrochlorothiazid may increase the incidence of hypersensitivity reactions to allopurinol.
Allopurinol, ifosfamide
The co-administration of ifosfamide and allopurinol may enhance the myelosuppression
Allopurinol, lesinurad [2] ---> SPC of [2] of EMA
Based on interaction studies in healthy subjects or gout patients, Zurampic does not have clinically significant interactions with NSAIDs (naproxen and indomethacin), colchicine, repaglinide, tolbutamide, febuxostat or allopurinol.
Allopurinol, lisinopril
The concomitant use of allopurinol and ACE inhibitors increases the risk of renal impairment and may cause an increased risk of leucopenia
Allopurinol, losartan/hydrochlorothiazide [2] ---> SPC of [2] of eMC
Dosage adjustment of uricosuric medicinal products may be necessary since hydrochlorothiazide may raise the level of serum uric acid. Hydrochlorothiazid may increase the incidence of hypersensitivity reactions to allopurinol.
Allopurinol [1], mechloroethamine ---> SPC of [1] of eMC
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease (other than leukaemia), in the presence of allopurinol.
Allopurinol, mercaptopurine [2] ---> SPC of [2] of EMA
When allopurinol and Xaluprine are administered concomitantly it is essential that only a quarter of the usual dose of Xaluprine is given since allopurinol decreases the rate of metabolism of 6-mercaptopurine via xanthine oxidase.
Allopurinol, moexipril
Concomitant administration of allopurinol with moexipril may lead to an increased risk of leucopenia.
Allopurinol, pentostatine [2] ---> SPC of [2] of eMC
Allopurinol and pentostatin are both associated with skin rashes.
Allopurinol, perindopril
Increased blood count alterations
Allopurinol, phenindione
Allopurinol potentiates the effect of phenindione
Allopurinol, phenprocoumon
Enhancement of phenprocoumon effect and increased bleeding risk with the concomitant administration of allopurinol
Allopurinol [1], phenytoin ---> SPC of [1] of eMC
Allopurinol may inhibit hepatic oxidation of phenytoin but the clinical significance has not been demonstrated.
Allopurinol, pioglitazone/glimepiride [2] ---> SPC of [2] of EMA
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur
Allopurinol, porfimer [2] ---> SPC of [2] of EMA
Possible interaction with the photodynamic therapy
Allopurinol [1], pregnancy ---> SPC of [1] of eMC
Use in pregnancy only when there is no safer alternative and when the disease itself carries risk for the mother or unborn child.
Allopurinol [1], probenecide ---> SPC of [1] of eMC
Hence drugs with uricosuric activity such as probenecid may accelerate the excretion of oxipurinol. This may decrease the therapeutic activity of allopurinol (but the significance needs to be assessed in each case.)
Allopurinol [1], procarbazine ---> SPC of [1] of eMC
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease (other than leukaemia), in the presence of allopurinol.
Allopurinol, quinapril [2] ---> SPC of [2] of eMC
Concomitant administration of allopurinol with ACE inhibitors may lead to an increased risk for leucopenia.
Allopurinol, ramipril [2] ---> SPC of [2] of eMC
Increased likelihood of haematological reactions
Allopurinol [1], salicylates ---> SPC of [1] of eMC
Large doses of salicylates may accelerate the excretion of oxipurinol. This may decrease the therapeutic activity of allopurinol (but the significance needs to be assessed in each case.).
Allopurinol, spirapril
Increased blood count alterations
Allopurinol, sulfinpyrazone
Decreased allopurinol effect
Allopurinol, sulfonylureas
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia
Allopurinol, tegafur/gimeracil/oteracil [2] ---> SPC of [2] of EMA
Allopurinol may decrease anti-tumour activity due to suppression of phosphorylation of 5-FU. Concomitant use should be avoided
Allopurinol, telmisartan/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid. Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Allopurinol, teniposide
The co-administration may enhance the changes in the blood picture
Allopurinol, theophylline [2] ---> SPC of [2] of eMC
Allopurinol reduces clearance of theophylline and a reduced dosage may therefore be necessary to avoid side-effects
Allopurinol, thiazides ---> SPC of [aliskiren/amlodipine/hydrochlorothiazide] of EMA
Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Allopurinol, tolbutamide
Increased hypoglycaemic effects have occurred or might be expected
Allopurinol, trandolapril [2] ---> SPC of [2] of eMC
Concomitant administration of allopurinol with ACE inhibitors may lead to an increased risk for leucopenia especially when the latter are used at higher than currently recommended doses.
Allopurinol, trandolapril/verapamil [2] ---> SPC of [2] of eMC
Concomitant administration of allopurinol with ACE inhibitors may lead to an increased risk for leukopenia
Allopurinol, trofosfamide
The co-administration of trofosfamide with allopurinol may increase the concentration of toxic metabolites, what may cause increased bone marrow depression
Allopurinol [1], uricosuric agents ---> SPC of [1] of eMC
Hence drugs with uricosuric activity such as probenecid may accelerate the excretion of oxipurinol. This may decrease the therapeutic activity of allopurinol (but the significance needs to be assessed in each case.)
Allopurinol, urokinase
Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided
Allopurinol [1], vidarabine ---> SPC of [1] of eMC
The plasma half-life of adenine arabinoside is increased in the presence of allopurinol with the risk of enhanced toxicity. When the two products are used concomitantly extra vigilance is necessary, to recognise enhanced toxic effects.
Allopurinol, warfarin [2] ---> SPC of [2] of eMC
Allopurinol potentiates the effect of warfarin
Allopurinol, xanthines
The co-administration may decrease the hepatic elimination of the xanthine and increase its plasma levels
Allopurinol, zofenopril
Increased risk of hypersensitivity reactions when ACE inhibitors are used concurrently. Data from other ACE inhibitors indicate an increased risk of leucopenia when used concurrently.
CONTRAINDICATIONS of Allopurinol
- Allopurinol should not be administered to individuals known to be hypersensitive to allopurinol or to any of the components of the formulation.
http://www.medicines.org.uk/emc/
Allopurinol/lesinurad (Duzallo)
Ability to drive, allopurinol/lesinurad [2] ---> SmPC of [2] of EMA
Somnolence, vertigo and ataxia have been reported in patients receiving allopurinol
ACE inhibitors, allopurinol/lesinurad [2] ---> SmPC of [2] of EMA
Concurrent use of allopurinol and ACE inhibitors may lead to an increased risk of hypersensitivity, especially if there is pre-existing renal impairment.
Adenine arabinoside, allopurinol/lesinurad [2] ---> SmPC of [2] of EMA
Evidence suggests that the plasma half-life of adenine arabinoside is increased in the presence of allopurinol and hence when these two active substances are administered concomitantly, extra vigilance is required to recognize enhanced toxic effects.
Alkylator, allopurinol/lesinurad [2] ---> SmPC of [2] of EMA
With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are administered alone.
Allopurinol/lesinurad [1], aluminium hydroxide ---> SmPC of [1] of EMA
If aluminium hydroxide is taken concomitantly, allopurinol-containing medicinal products may have an attenuated effect. There should be an interval of at least 3 hours between the concomitant use of those medicinal products.
Allopurinol/lesinurad [1], amiodarone ---> SmPC of [1] of EMA
Lesinurad exposure is increased when it is co-administered with inhibitors of CYP2C9. Therefore, it is recommended that Duzallo should be used with caution in patients taking moderate inhibitors of CYP2C9.
Allopurinol/lesinurad [1], amlodipine ---> SmPC of [1] of EMA
Patients using lipid lowering or anti-hypertensive medicinal products that were CYP3A substrates required concomitant medicinal product change when treated with lesinurad 200 mg in combination with a xanthine oxidase inhibitor
Allopurinol/lesinurad [1], amoxicillin ---> SmPC of [1] of EMA
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both medicinal products.
Allopurinol/lesinurad [1], azathioprine ---> SmPC of [1] of EMA
Serum concentrations of 6-mercaptopurine and azathioprine can reach toxic levels unless dose reduction is undertaken.
Allopurinol/lesinurad [1], bleomycin ---> SmPC of [1] of EMA
With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are administered alone.
Allopurinol/lesinurad [1], breast-feeding ---> SmPC of [1] of EMA
Allopurinol and its metabolite oxypurinol are excreted in human breast milk. Duzallo is not recommended during breastfeeding.
Allopurinol/lesinurad [1], bupropion ---> SmPC of [1] of EMA
Lesinurad may be a mild inducer of CYP2B6. Therefore, it is recommended that patients are monitored for reduced efficacy of CYP2B6 substrates (e.g. bupropion, efavirenz) when co-administered with lesinurad.
Allopurinol/lesinurad [1], calcium antagonists metabolised by CYP3A4 ---> SmPC of [1] of EMA
Patients using lipid lowering or anti-hypertensive medicinal products that were CYP3A substrates required concomitant medicinal product change when treated with lesinurad 200 mg in combination with a xanthine oxidase inhibitor
Allopurinol/lesinurad [1], carbamazepine ---> SmPC of [1] of EMA
Lesinurad exposure is expected to decrease when it is co-administered with inducers of CYP2C9 (e.g. carbamazepine, a moderate CYP2C9 inducer).
Allopurinol/lesinurad [1], chlorpropamide ---> SmPC of [1] of EMA
If Duzallo which contains the active substance allopurinol is given concomitantly with chlorpropamide when renal function is poor, there may be an increased risk of prolonged hypoglycaemic activity.
Allopurinol/lesinurad [1], coumarin anticoagulants ---> SmPC of [1] of EMA
An interaction between allopurinol and coumarins has been seen under experimental conditions. All patients receiving coumarin anticoagulants must be carefully monitored.
Allopurinol/lesinurad [1], cyclophosphamide ---> SmPC of [1] of EMA
With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are administered alone.
Allopurinol/lesinurad [1], cyclosporine ---> SmPC of [1] of EMA
Allopurinol can increase the plasma concentration of ciclosporin when concomitantly administered. The possibility of an increased occurrence of ciclosporin-specific adverse reactions is to be considered.
Allopurinol/lesinurad [1], CYP2B6 substrates ---> SmPC of [1] of EMA
Lesinurad may be a mild inducer of CYP2B6. Therefore, it is recommended that patients are monitored for reduced efficacy of CYP2B6 substrates (e.g. bupropion, efavirenz) when co-administered with lesinurad.
Allopurinol/lesinurad [1], CYP2C9 inductors ---> SmPC of [1] of EMA
Lesinurad exposure is expected to decrease when it is co-administered with inducers of CYP2C9 (e.g. carbamazepine, a moderate CYP2C9 inducer).
Allopurinol/lesinurad [1], cytostatics ---> SmPC of [1] of EMA
With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are administered alone.
Allopurinol/lesinurad [1], didanosine ---> SmPC of [1] of EMA
Plasma didanosine Cmax and AUC values were approximately doubled with concomitant allopurinol treatment (300 mg daily) without affecting terminal half-life. Co- administration of these 2 active substances is generally not recommended.
Allopurinol/lesinurad [1], diuretics ---> SmPC of [1] of EMA
An increased risk of hypersensitivity has been reported when allopurinol is given with diuretics, in particular thiazides, especially in renal impairment
Allopurinol/lesinurad [1], doxorubicine ---> SmPC of [1] of EMA
With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are administered alone.
Allopurinol/lesinurad [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA
Mild to moderate induction of CYP3A by lesinurad may reduce plasma exposures of co-administered medicinal products that are sensitive substrates of CYP3A.
Allopurinol/lesinurad [1], efavirenz ---> SmPC of [1] of EMA
Lesinurad may be a mild inducer of CYP2B6. Therefore, it is recommended that patients are monitored for reduced efficacy of CYP2B6 substrates (e.g. bupropion, efavirenz) when co-administered with lesinurad.
Allopurinol/lesinurad [1], felodipine ---> SmPC of [1] of EMA
Patients using lipid lowering or anti-hypertensive medicinal products that were CYP3A substrates required concomitant medicinal product change when treated with lesinurad 200 mg in combination with a xanthine oxidase inhibitor
Allopurinol/lesinurad [1], fertility ---> SmPC of [1] of EMA
In male and female rats, there was no effect on mating or fertility with lesinurad. Reproductive studies with allopurinol have been performed in rats and rabbits and it was concluded that there was no impaired fertility.
Allopurinol/lesinurad [1], fluconazole ---> SmPC of [1] of EMA
Lesinurad exposure is increased when it is co-administered with inhibitors of CYP2C9. Therefore, it is recommended that Duzallo should be used with caution in patients taking moderate inhibitors of CYP2C9.
Allopurinol/lesinurad [1], foods ---> SmPC of [1] of EMA
Duzallo should be taken in the morning with food and water.
Allopurinol/lesinurad [1], hormonal contraceptives ---> SmPC of [1] of EMA
Lesinurad is a mild to moderate inducer of CYP3A and therefore may lower plasma concentrations of some hormonal contraceptives, thereby decreasing contraceptive effectiveness
Allopurinol/lesinurad [1], inhibitors of epoxide hydrolase ---> SmPC of [1] of EMA
Inhibitors of microsomal Epoxide Hydrolase (mEH) (e.g. valproic acid, valpromide) may interfere with the metabolism of lesinurad. Duzallo should not be administered with inhibitors of mEH.
Allopurinol/lesinurad [1], lovastatine ---> SmPC of [1] of EMA
Additional monitoring of lipids is recommended in patients using sensitive CYP3A substrate lipid lowering medicinal products, since their efficacy may be reduced
Allopurinol/lesinurad [1], mercaptopurine ---> SmPC of [1] of EMA
Serum concentrations of 6-mercaptopurine and azathioprine can reach toxic levels unless dose reduction is undertaken.
Allopurinol/lesinurad [1], nisoldipine ---> SmPC of [1] of EMA
Patients using lipid lowering or anti-hypertensive medicinal products that were CYP3A substrates required concomitant medicinal product change when treated with lesinurad 200 mg in combination with a xanthine oxidase inhibitor
Allopurinol/lesinurad [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure, it is preferable to avoid the use of Duzallo during pregnancy.
Allopurinol/lesinurad [1], probenecide ---> SmPC of [1] of EMA
Medicinal products with known non-selective uricosuric activity such as probenecid may accelerate the excretion of oxypurinol. This may decrease the therapeutic activity of Duzallo which contains the active substance allopurinol
Allopurinol/lesinurad [1], procarbazine ---> SmPC of [1] of EMA
With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkylating agents), blood dyscrasias occur more frequently than when these active substances are administered alone.
Allopurinol/lesinurad [1], salicylates ---> SmPC of [1] of EMA
Salicylates at doses higher than 325 mg per day may decrease the serum uric acid lowering activity of lesinurad and should not be co-administered with Duzallo.
Allopurinol/lesinurad [1], sildenafil ---> SmPC of [1] of EMA
Patients using lipid lowering or anti-hypertensive medicinal products that were CYP3A substrates required concomitant medicinal product change when treated with lesinurad 200 mg in combination with a xanthine oxidase inhibitor
Allopurinol/lesinurad [1], simvastatine ---> SmPC of [1] of EMA
Additional monitoring of lipids is recommended in patients using sensitive CYP3A substrate lipid lowering medicinal products, since their efficacy may be reduced
Allopurinol/lesinurad [1], statins metabolised by CYP3A4 ---> SmPC of [1] of EMA
Additional monitoring of lipids is recommended in patients using sensitive CYP3A substrate lipid lowering medicinal products, since their efficacy may be reduced
Allopurinol/lesinurad [1], strong CYP2C9 inhibitors ---> SmPC of [1] of EMA
Lesinurad exposure is increased when it is co-administered with inhibitors of CYP2C9. Therefore, it is recommended that Duzallo should be used with caution in patients taking moderate inhibitors of CYP2C9.
Allopurinol/lesinurad [1], theophylline ---> SmPC of [1] of EMA
Inhibition of the metabolism of theophylline by allopurinol has been reported. Theophylline levels should be monitored in patients undergoing Duzallo therapy.
Allopurinol/lesinurad [1], uricosuric agents ---> SmPC of [1] of EMA
Medicinal products with known non-selective uricosuric activity such as probenecid may accelerate the excretion of oxypurinol. This may decrease the therapeutic activity of Duzallo which contains the active substance allopurinol
Allopurinol/lesinurad [1], valproic acid ---> SmPC of [1] of EMA
Inhibitors of microsomal Epoxide Hydrolase (mEH) (e.g. valproic acid, valpromide) may interfere with the metabolism of lesinurad. Duzallo should not be administered with inhibitors of mEH.
Allopurinol/lesinurad [1], valpromide ---> SmPC of [1] of EMA
Inhibitors of microsomal Epoxide Hydrolase (mEH) (e.g. valproic acid, valpromide) may interfere with the metabolism of lesinurad. Duzallo should not be administered with inhibitors of mEH.
Drugs primarily metabolised by CYP3A4, lesinurad ---> SmPC of [allopurinol/lesinurad] of EMA
Mild to moderate induction of CYP3A by lesinurad may reduce plasma exposures of co-administered medicinal products that are sensitive substrates of CYP3A.
CONTRAINDICATIONS of Allopurinol/lesinurad (Duzallo)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Tumour lysis syndrome or Lesch-Nyhan syndrome.
- Severe renal impairment (CrCL less than 30 mL/min), end-stage renal disease, kidney transplant recipients or patients on dialysis
https://www.ema.europa.eu/en/documents/product-information/duzallo-epar-product-information_en.pdf 06/08/2020 (withdrawn)
Almasilate
Acetylsalicylic acid, almasilate
There are studies that prove a reduction of salicylate plasma levels by a higher elimination due to urinary alkalinisation
Acid beverages, almasilate
Concomitant use of aluminium-containing antacids with acid beverages increases the intestinal absorption of aluminium
Almasilate, anionic drugs
Almasilate, urinary alkalinizing agent, increases the urinary excretion of anionic drug
Almasilate, antacids
Antacids may modify the absorption of coadministered drugs. It is recommended to separate administration of both drugs by at least 2 hours
Almasilate, betablockers
Decreased absorption of beta-blocker
Almasilate, breast-feeding
It is excreted into breast milk but its concentration is not high enough in order to cause side effects
Almasilate, cationic drugs
Almasilate, urinary alkalinizing agent, decreases the urinary excretion of cationic drug
Almasilate, chlorpromazine
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, chlortetracycline
Absorption reduction of the active principle co-administered with almasilate due to formation of non-soluble complexes. It is recommended to administer the two substances at least 2 to 3 hours apart.
Almasilate, cimetidine
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, ciprofloxacin
Absorption reduction of the active principle co-administered with almasilate due to formation of non-soluble complexes. It is recommended to administer the two substances at least 2 to 3 hours apart.
Almasilate, demeclocycline
Absorption reduction of the active principle co-administered with almasilate due to formation of non-soluble complexes. It is recommended to administer the two substances at least 2 to 3 hours apart.
Almasilate, digital glycosides
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, digitoxin
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, digoxin
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, doxycycline
Absorption reduction of the active principle co-administered with almasilate due to formation of non-soluble complexes. It is recommended to administer the two substances at least 2 to 3 hours apart.
Almasilate, famotidine
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, flufenamic acid
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, fluoride
Antacids may decrease the gastrointestinal absorption of fluorides
Almasilate, fluoroquinolones
Absorption reduction of the active principle co-administered with almasilate due to formation of non-soluble complexes. It is recommended to administer the two substances at least 2 to 3 hours apart.
Almasilate, folic acid
The antacid can decrease the gastrointestinal absorption of folic acid
Almasilate, fruit juice
Concomitant use of aluminium-containing antacids with acid beverages increases the intestinal absorption of aluminium
Almasilate, gabapentin
Possible decrease in gabapentin absorption due to pH gastrointestinal changes
Almasilate, halofantrine
Decreased absorption of halofantrine
Almasilate, indometacin
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, iron
Absorption reduction of the active principle co-administered with almasilate due to formation of non-soluble complexes. It is recommended to administer the two substances at least 2 to 3 hours apart.
Almasilate, isoniazid
The antacid can decrease the gastrointestinal absorption of isoniazide
Almasilate, ketoconazole
Possible decrease in ketoconazole absorption due to pH gastrointestinal changes
Almasilate, lansoprazole
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, levodopa
Increased absorption of levodopa
Almasilate, mecamylamine
Concomitant use of almasilate and mecamylamine may decrease the efficacy of mecamylamine. Concomitant use is not recommended
Almasilate, mefenamic acid
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, methenamine
Concomitant use of almasilate and methenamine may decrease the efficacy of methenamine. Concomitant use is not recommended
Almasilate, nonsteroidal antiinflammatory drugs
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, penicillamine
Absorption reduction of the active principle co-administered with almasilate due to formation of non-soluble complexes. It is recommended to administer the two substances at least 2 to 3 hours apart.
Almasilate, phenothiazines
The antacid can decrease the gastrointestinal absorption of phenothiazine
Almasilate, phenytoin
Decreased absorption of phenytoin
Almasilate, phosphates
Antacids may decrease the gastrointestinal absorption of phosphates
Almasilate, prednisone
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almasilate, pregnancy
Long-lasting or at high-dose treatment with antacids is contraindicated during pregnancy due to possible systemic effect
Almasilate, quinidine
Almasilate, urinary alkalinizing agent, decreases the urinary excretion of quinidine
Almasilate, ranitidine
Decreased absorption of ranitidine
Almasilate, salicylates
There are studies that prove a reduction of salicylate plasma levels by a higher elimination due to urinary alkalinisation
Almasilate, tetracyclines
Absorption reduction of the active principle co-administered with almasilate due to formation of non-soluble complexes. It is recommended to administer the two substances at least 2 to 3 hours apart.
Almasilate, wine
Concomitant use of aluminium-containing antacids with acid beverages increases the intestinal absorption of aluminium
H2 antagonists, almasilate
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Almotriptan
IMAOs, almotriptan [2] ---> SPC of [2] of eMC
As with other 5-HT1 agonists, the potential risk of a serotoninergic syndrome due to a pharmacodynamic interaction in case of concomitant treatment of almotriptan with MAOIs cannot be ruled out.
IMAOs, triptans ---> SPC of [almotriptan] of eMC
As with other 5-HT1 agonists, the potential risk of a serotoninergic syndrome due to a pharmacodynamic interaction in case of concomitant treatment of almotriptan with MAOIs cannot be ruled out.
SNRIs, triptans ---> SPC of [almotriptan] of eMC
There have been reports describing patients with symptoms compatible with serotonin syndrome following the use of serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans
SSNRI, almotriptan [2] ---> SPC of [2] of eMC
There have been reports describing patients with symptoms compatible with serotonin syndrome following the use of serotonin noradrenaline reuptake inhibitors (SNRIs) and triptans
SSRI, almotriptan [2] ---> SPC of [2] of eMC
There have been reports describing patients with symptoms compatible with serotonin syndrome following the use of selective serotonin reuptake inhibitors (SSRIs) and triptans
SSRI, triptans ---> SPC of [almotriptan] of eMC
There have been reports describing patients with symptoms compatible with serotonin syndrome following the use of selective serotonin reuptake inhibitors (SSRIs) and triptans
St. John's wort, almotriptan [2] ---> SPC of [2] of eMC
Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John's Wort (Hypericum perforatum ).
Ability to drive, almotriptan [2] ---> SPC of [2] of eMC
Since somnolence may occur during a migraine attack and has been reported as a side effect of treatment with almotriptan, caution is recommended in patients performing skilled tasks.
Almotriptan [1], breast-feeding ---> SPC of [1] of eMC
Caution should therefore be exercised when prescribing during lactation. Infant exposure may be minimized by avoiding breast feeding for 24 hours after treatment.
Almotriptan [1], ergot derivatives ---> SPC of [1] of eMC
Concomitant administration of almotriptan with ergotamine, ergotamine derivatives (including methysergide) and other 5-HT1B/1D agonists is contraindicated.
Almotriptan [1], ergotamine ---> SPC of [1] of eMC
Concomitant administration of almotriptan with ergotamine, ergotamine derivatives (including methysergide) and other 5-HT1B/1D agonists is contraindicated.
Almotriptan [1], methysergide ---> SPC of [1] of eMC
Concomitant administration of almotriptan with ergotamine, ergotamine derivatives (including methysergide) and other 5-HT1B/1D agonists is contraindicated.
Almotriptan [1], pregnancy ---> SPC of [1] of eMC
Caution should be exercised when prescribing almotriptan to pregnant women.
Almotriptan [1], propranolol ---> SPC of [1] of eMC
Multiple dosing with propranolol did not alter the pharmacokinetics of almotriptan.
Almotriptan, trandolapril/verapamil [2] ---> SPC of [2] of eMC
Verapamil may increase the plasma concentrations of almotriptan thus increasing risk of toxicity
Almotriptan [1], triptans ---> SPC of [1] of eMC
Concomitant administration of almotriptan with ergotamine, ergotamine derivatives (including methysergide) and other 5-HT1B/1D agonists is contraindicated.
Almotriptan [1], verapamil ---> SPC of [1] of eMC
Multiple dosing with the calcium channel blocker verapamil, a substrate of CYP3A4, resulted in a 20% increase in Cmax and AUC of almotriptan. The increase is not considered clinically relevant.
CONTRAINDICATIONS of Almotriptan
- Hypersensitivity to the active substance or to any of the excipients
- As with other 5-HT1B/1D receptor agonists, almotriptan should not be used in patients with a history, symptoms or signs of ischaemic heart disease (myocardial infarction, angina pectoris, documented silent ischaemia, Prinzmetal's angina) or severe hypertension and uncontrolled mild or moderate hypertension.
- Patients with a previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA). Peripheral vascular disease.
- Concomitant administration with ergotamine, ergotamine derivatives (including methysergide) and other 5-HT1B/1D agonists is contraindicated.
- Patients with severe hepatic impairment
http://www.medicines.org.uk/emc/
Alogliptin (Vipidia)
Ability to drive, alogliptin [2] ---> SmPC of [2] of EMA
However patients should be alerted to the risk of hypoglycaemia especially when combined with a sulphonylurea, insulin or combination therapy with thiazolidinedione plus metformin.
Alogliptin [1], breast-feeding ---> SmPC of [1] of EMA
A decision on whether to discontinue breast-feeding or to discontinue alogliptin therapy should be made taking into account the benefit of breast-feeding for the child and the benefit of alogliptin therapy for the woman.
Alogliptin [1], cytochrome P450 ---> SmPC of [1] of EMA
Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2). Interactions with CYP inhibitors are thus not expected and have not been shown.
Alogliptin [1], fertility ---> SmPC of [1] of EMA
The effect of alogliptin on fertility in humans has not been studied. No adverse effects on fertility were observed in animal studies (see section 5.3).
Alogliptin [1], pharmacokinetics ---> SmPC of [1] of EMA
Evidence of a low propensity to cause interaction with substrates of CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein, and OCT2.
Alogliptin [1], pharmacokinetics ---> SmPC of [1] of EMA
There are no clinically relevant effects of gemfibrozil, fluconazole, ketoconazole, cyclosporine, voglibose, digoxin, metformin, cimetidine, pioglitazone or atorvastatin on the pharmacokinetics of alogliptin.
Alogliptin [1], pharmacokinetics ---> SmPC of [1] of EMA
Results from studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha-glucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Alogliptin [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure, it is preferable to avoid the use of alogliptin during pregnancy.
Alogliptin [1], warfarin ---> SmPC of [1] of EMA
In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
CONTRAINDICATIONS of Alogliptin (Vipidia)
- Hypersensitivity to the active substance or to any of the excipients or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor
https://www.ema.europa.eu/en/documents/product-information/vipidia-epar-product-information_en.pdf 21/07/2023
Alogliptin/metformin (Vipdomet)
Ability to drive, alogliptin/metformin [2] ---> SmPC of [2] of EMA
Vipdomet has no or negligible influence on the ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia especially when used in combination with insulin or pioglitazone.
ACE inhibitors, alogliptin/metformin [2] ---> SmPC of [2] of EMA
ACE inhibitors may decrease blood glucose levels. If necessary, the dose of Vipdomet should be adjusted during therapy with the other medicinal product and upon its discontinuation.
ACE inhibitors, alogliptin/metformin [2] ---> SmPC of [2] of EMA
Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including COX II inhibitors, ACE inhibitors, ARA II and diuretics. Close monitoring of renal function is necessary.
AIIRA, alogliptin/metformin [2] ---> SmPC of [2] of EMA
Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including COX II inhibitors, ACE inhibitors, ARA II and diuretics. Close monitoring of renal function is necessary.
Alcohol, alogliptin/metformin [2] ---> SmPC of [2] of EMA
Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic impairment. Concomitant use not recommended
Alogliptin/metformin [1], beta2-adrenergic agonists ---> SmPC of [1] of EMA
Beta-2 agonists have intrinsic hyperglycaemic activity. Should be more frequent blood glucose monitoring performed
Alogliptin/metformin [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy
Alogliptin/metformin [1], cationic substances eliminated by renal tubular secretion ---> SmPC of [1] of EMA
Close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered.
Alogliptin/metformin [1], cimetidine ---> SmPC of [1] of EMA
Close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered.
Alogliptin/metformin [1], coxibs ---> SmPC of [1] of EMA
Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including COX II inhibitors, ACE inhibitors, ARA II and diuretics. Close monitoring of renal function is necessary.
Alogliptin/metformin [1], CYP450 ---> SmPC of [1] of EMA
Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2). Interactions with CYP inhibitors are thus not expected and have not been shown.
Alogliptin/metformin [1], diuretics ---> SmPC of [1] of EMA
Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including COX II inhibitors, ACE inhibitors, ARA II and diuretics. Close monitoring of renal function is necessary.
Alogliptin/metformin [1], fertility ---> SmPC of [1] of EMA
Vipdomet has no or negligible influence on the ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia especially when used in combination with insulin or pioglitazone.
Alogliptin/metformin [1], foods ---> SmPC of [1] of EMA
Vipdomet should be taken twice daily because of the pharmacokinetics of its metformin component. It should also be taken with meals to reduce the GI adverse reactions associated with metformin. The tablets should be swallowed whole with water.
Alogliptin/metformin [1], glucocorticoids ---> SmPC of [1] of EMA
Glucocorticoids have intrinsic hyperglycaemic activity. Should be more frequent blood glucose monitoring performed
Alogliptin/metformin [1], iodinated contrast media ---> SmPC of [1] of EMA
Vipdomet must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.
Alogliptin/metformin [1], NSAID ---> SmPC of [1] of EMA
Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including COX II inhibitors, ACE inhibitors, ARA II and diuretics. Close monitoring of renal function is necessary.
Alogliptin/metformin [1], pharmacokinetics ---> SmPC of [1] of EMA
Results from clinical interaction studies also demonstrate that there are no clinically relevant effects of gemfibrozil (a CYP2C8/9 inhibitor), fluconazole (a CYP2C9 inhibitor), ketoconazole (a CYP3A4 inhibitor), cyclosporine (a p-glycoprotein inhibitor), voglibose (an alpha-glucosidase inhibitor), digoxin, metformin, cimetidine, pioglitazone or atorvastatin on the pharmacokinetics of alogliptin.
Alogliptin/metformin [1], pharmacokinetics of other drugs ---> SmPC of [1] of EMA
In clinical studies, alogliptin had no clinically relevant effect on the pharmacokinetics of caffeine, (R)-warfarin, pioglitazone, glyburide, tolbutamide, (S)-warfarin, dextromethorphan, atorvastatin, midazolam, an oral contraceptive (norethindrone and ethinyl oestradiol), digoxin, fexofenadine, metformin, or cimetidine, thus providing in vivo evidence of a low propensity to cause interaction with substrates of CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein, and OCT2.
Alogliptin/metformin [1], pharmacokinetics of other drugs ---> SmPC of [1] of EMA
Results from studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha-glucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Alogliptin/metformin [1], pregnancy ---> SmPC of [1] of EMA
Vipdomet should not be used during pregnancy.
Alogliptin/metformin [1], prothrombin time ---> SmPC of [1] of EMA
In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
Alogliptin/metformin [1], sulfonylureas ---> SmPC of [1] of EMA
Alogliptin/metformin should not be used in combination with a sulphonylurea, as the safety and efficacy of this combination have not been fully established.
CONTRAINDICATIONS of Alogliptin/metformin (Vipdomet)
- Hypersensitivity to the active substances or to any of the excipients or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor
- Diabetic ketoacidosis, diabetic pre-coma
- Moderate and severe renal impairment and end-stage renal disease (creatinine clearance < 60 mL/min)
- Acute conditions with the potential to alter renal function such as:
- dehydration
- severe infection
- shock
- Acute or chronic disease which may cause tissue hypoxia (see section 4.4) such as:
- cardiac or respiratory failure
- recent myocardial infarction
- shock
- Hepatic impairment
- Acute alcohol intoxication, alcoholism
https://www.ema.europa.eu/en/documents/product-information/vipdomet-epar-product-information_en.pdf 31/01/2024
Alogliptin/pioglitazone (Incresync)
Ability to drive, alogliptin/pioglitazone [2] ---> SmPC of [2] of EMA
Patients who experience visual disturbance should be cautious when driving or using machines.
Alogliptin/pioglitazone [1], atorvastatin ---> SmPC of [1] of EMA
There are no clinically relevant effects of gemfibrozil, fluconazole, ketoconazole, cyclosporine, voglibose, digoxin, metformin, cimetidine, pioglitazone or atorvastatin on the pharmacokinetics of alogliptin
Alogliptin/pioglitazone [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Incresync therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Alogliptin/pioglitazone [1], cytochrome P450 ---> SmPC of [1] of EMA
Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2). Interactions with CYP inhibitors are thus not expected and have not been shown.
Alogliptin/pioglitazone [1], digoxin ---> SmPC of [1] of EMA
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon or metformin.
Alogliptin/pioglitazone [1], fertility ---> SmPC of [1] of EMA
No adverse effects on fertility were observed in animal studies conducted with alogliptin (see section 5.3). In animal fertility studies conducted with pioglitazone there was no effect on copulation, impregnation or fertility index.
Alogliptin/pioglitazone [1], gemfibrozil ---> SmPC of [1] of EMA
Gemfibrozil, CYP2C8 inhibitor, may increase the AUC of pioglitazone. Close monitoring of glycaemic control should be considered
Alogliptin/pioglitazone [1], metformin ---> SmPC of [1] of EMA
Results from alogliptin studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha-glucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Alogliptin/pioglitazone [1], oral contraceptives ---> SmPC of [1] of EMA
Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers and HMGCoA reductase inhibitors, are not to be expected.
Alogliptin/pioglitazone [1], pregnancy ---> SmPC of [1] of EMA
Incresync should not be used during pregnancy.
Alogliptin/pioglitazone [1], rifampicin ---> SmPC of [1] of EMA
The CYP2C8 induction may decrease the plasma concentrations of pioglitazone. Close monitoring of glycaemic control should be considered
Alogliptin/pioglitazone [1], sulfonylureas ---> SmPC of [1] of EMA
Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Alogliptin/pioglitazone [1], warfarin ---> SmPC of [1] of EMA
In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
CONTRAINDICATIONS of Alogliptin/pioglitazone (Incresync)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor
- Cardiac failure or history of cardiac failure (NYHA stages I to IV;
- Hepatic impairment
- Diabetic ketoacidosis
- Current bladder cancer or a history of bladder cancer
- Uninvestigated macroscopic haematuria
https://www.ema.europa.eu/en/documents/product-information/incresync-epar-product-information_en.pdf 09/09/2022
Alpelisib (Piqray)
Ability to drive, alpelisib [2] ---> SmPC of [2] of EMA
Patients should be advised to be cautious when driving or using machines in case they experience fatigue or blurred vision during treatment
Alpelisib [1], antacids ---> SmPC of [1] of EMA
Alpelisib can be co-administered with acid-reducing agents, provided alpelisib is taken immediately after food
Alpelisib [1], apalutamide ---> SmPC of [1] of EMA
Co-administration with a strong CYP3A4 inducer decreases alpelisib AUC, which may reduce alpelisib efficacy. Co-administration of alpelisib with strong CYP3A4 inducers should be avoided
Alpelisib [1], BCRP inhibitors ---> SmPC of [1] of EMA
BCRP is involved in the hepatobiliary export and intestinal secretion of alpelisib, therefore inhibition of BCRP in the liver and in the intestine during elimination may lead to an increase in systemic exposure of alpelisib.
Alpelisib [1], BCRP substrates with narrow therapeutic range ---> SmPC of [1] of EMA
Piqray should be used with caution in combination with sensitive substrates of OAT3 drug transporters and intestinal BCRP and P-gp which exhibit a narrow therapeutic index because Piqray may increase the systemic exposure of these substrates.
Alpelisib [1], breast-feeding ---> SmPC of [1] of EMA
Because of the potential for serious adverse reactions in the breast-fed infant, it is recommended that women should not breast-feed during treatment and for at least 1 week after the last dose of Piqray.
Alpelisib [1], bupropion ---> SmPC of [1] of EMA
Sensitive CYP2B6 substrates (e.g. bupropion) or CYP2B6 substrates with a narrow therapeutic window should be used with caution in combination with Piqray, as alpelisib may reduce the clinical activity of such medicinal products.
Alpelisib [1], carbamazepine ---> SmPC of [1] of EMA
Co-administration with a strong CYP3A4 inducer decreases alpelisib AUC, which may reduce alpelisib efficacy. Co-administration of alpelisib with strong CYP3A4 inducers should be avoided
Alpelisib [1], drugs primarily metabolised by CYP2B6 ---> SmPC of [1] of EMA
Sensitive CYP2B6 substrates (e.g. bupropion) or CYP2B6 substrates with a narrow therapeutic window should be used with caution in combination with Piqray, as alpelisib may reduce the clinical activity of such medicinal products.
Alpelisib [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA
No dose adjustment is required when co-administering Piqray with CYP3A4 substrates (e.g. everolimus, midazolam).
Alpelisib [1], eltrombopag ---> SmPC of [1] of EMA
BCRP is involved in the hepatobiliary export and intestinal secretion of alpelisib, therefore inhibition of BCRP in the liver and in the intestine during elimination may lead to an increase in systemic exposure of alpelisib.
Alpelisib [1], encorafenib ---> SmPC of [1] of EMA
Caution is recommended when Piqray is used in combination with CYP3A4 substrates that also possess an additional time-dependent inhibition and induction potential on CYP3A4 that affects their own metabolism (e.g. rifampicin, ribociclib, encorafenib).
Alpelisib [1], enzalutamide ---> SmPC of [1] of EMA
Co-administration with a strong CYP3A4 inducer decreases alpelisib AUC, which may reduce alpelisib efficacy. Co-administration of alpelisib with strong CYP3A4 inducers should be avoided
Alpelisib [1], everolimus ---> SmPC of [1] of EMA
No dose adjustment is required when co-administering Piqray with CYP3A4 substrates (e.g. everolimus, midazolam).
Alpelisib [1], fertility ---> SmPC of [1] of EMA
There are no clinical data available on the effects of alpelisib on fertility. Based on repeated dose toxicity and fertility studies in animals, alpelisib may impair fertility in males and females of reproductive potential (see section 5.3).
Alpelisib [1], foods ---> SmPC of [1] of EMA
Piqray should be taken immediately after food, at approximately the same time each day (see section 5.2).
Alpelisib [1], H2 antagonists ---> SmPC of [1] of EMA
Alpelisib can be co-administered with acid-reducing agents, provided alpelisib is taken immediately after food
Alpelisib [1], hormonal contraceptives ---> SmPC of [1] of EMA
No clinical studies were conducted assessing the drug-drug-interaction potential between alpelisib and hormonal contraceptives.
Alpelisib [1], hyperglycaemia ---> SmPC of [1] of EMA
Severe hyperglycaemia, in some cases associated with hyperglycaemic hyperosmolar nonketotic syndrome (HHNKS) or ketoacidosis, has been observed in patients treated with Piqray.
Alpelisib [1], lapatinib ---> SmPC of [1] of EMA
BCRP is involved in the hepatobiliary export and intestinal secretion of alpelisib, therefore inhibition of BCRP in the liver and in the intestine during elimination may lead to an increase in systemic exposure of alpelisib.
Alpelisib [1], men ---> SmPC of [1] of EMA
Male patients with sexual partners who are pregnant, possibly pregnant or who could become pregnant should use condoms during sexual intercourse while taking Piqray and for at least 1 week after stopping treatment with Piqray.
Alpelisib [1], midazolam ---> SmPC of [1] of EMA
No dose adjustment is required when co-administering Piqray with CYP3A4 substrates (e.g. everolimus, midazolam).
Alpelisib [1], mitotane ---> SmPC of [1] of EMA
Co-administration with a strong CYP3A4 inducer decreases alpelisib AUC, which may reduce alpelisib efficacy. Co-administration of alpelisib with strong CYP3A4 inducers should be avoided
Alpelisib [1], OAT3 substrates with narrow therapeutic window ---> SmPC of [1] of EMA
Piqray should be used with caution in combination with sensitive substrates of OAT3 drug transporters and intestinal BCRP and P-gp which exhibit a narrow therapeutic index because Piqray may increase the systemic exposure of these substrates.
Alpelisib [1], omeprazole ---> SmPC of [1] of EMA
No dose adjustment is required when co-administering Piqray with CYP3A4 substrates (e.g. everolimus, midazolam), CYP2C8 substrates (e.g. repaglinide), CYP2C9 substrates (e.g. warfarin), CYP2C19 substrates (e.g. omeprazole).
Alpelisib [1], P-glycoprotein substrates with small therapeutic index ---> SmPC of [1] of EMA
Piqray should be used with caution in combination with sensitive substrates of OAT3 drug transporters and intestinal BCRP and P-gp which exhibit a narrow therapeutic index because Piqray may increase the systemic exposure of these substrates.
Alpelisib [1], pantoprazole ---> SmPC of [1] of EMA
BCRP is involved in the hepatobiliary export and intestinal secretion of alpelisib, therefore inhibition of BCRP in the liver and in the intestine during elimination may lead to an increase in systemic exposure of alpelisib.
Alpelisib [1], phenytoin ---> SmPC of [1] of EMA
Co-administration with a strong CYP3A4 inducer decreases alpelisib AUC, which may reduce alpelisib efficacy. Co-administration of alpelisib with strong CYP3A4 inducers should be avoided
Alpelisib [1], postmenopausal women ---> SmPC of [1] of EMA
Piqray is indicated in men and postmenopausal women. It is not to be used in women who are, or may be, pregnant or breast-feeding (see section 4.1).
Alpelisib [1], pregnancy ---> SmPC of [1] of EMA
Piqray is not recommended during pregnancy and in women of childbearing potential not using contraception.
Alpelisib [1], proton pump inhibitors ---> SmPC of [1] of EMA
Alpelisib can be co-administered with acid-reducing agents, provided alpelisib is taken immediately after food
Alpelisib [1], ranitidine ---> SmPC of [1] of EMA
Alpelisib can be co-administered with acid-reducing agents, provided alpelisib is taken immediately after food
Alpelisib [1], repaglinide ---> SmPC of [1] of EMA
No dose adjustment is required when co-administering Piqray with CYP3A4 substrates (e.g. everolimus, midazolam), CYP2C8 substrates (e.g. repaglinide), CYP2C9 substrates (e.g. warfarin), CYP2C19 substrates (e.g. omeprazole).
Alpelisib [1], ribociclib ---> SmPC of [1] of EMA
Caution is recommended when Piqray is used in combination with CYP3A4 substrates that also possess an additional time-dependent inhibition and induction potential on CYP3A4 that affects their own metabolism (e.g. rifampicin, ribociclib, encorafenib).
Alpelisib [1], rifampicin ---> SmPC of [1] of EMA
Co-administration with a strong CYP3A4 inducer decreases alpelisib AUC, which may reduce alpelisib efficacy. Co-administration of alpelisib with strong CYP3A4 inducers should be avoided
Alpelisib [1], St. John's wort ---> SmPC of [1] of EMA
Co-administration with a strong CYP3A4 inducer decreases alpelisib AUC, which may reduce alpelisib efficacy. Co-administration of alpelisib with strong CYP3A4 inducers should be avoided
Alpelisib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration with a strong CYP3A4 inducer decreases alpelisib AUC, which may reduce alpelisib efficacy. Co-administration of alpelisib with strong CYP3A4 inducers should be avoided
Alpelisib [1], warfarin ---> SmPC of [1] of EMA
In healthy subjects, co-administration of a CYP2C9 substrate (S-warfarin) with alpelisib increased S-warfarin exposure on average by 34% and 19% for AUCinf and Cmax respectively, compared to administration with S-warfarin alone
Alpelisib [1], women of childbearing potential ---> SmPC of [1] of EMA
Females of reproductive potential should be advised that animal studies and the mechanism of action have shown that alpelisib can be harmful to the developing foetus.
Alpelisib [1], women of childbearing potential ---> SmPC of [1] of EMA
In case females of reproductive potential take Piqray, they should use effective contraception (e.g. double-barrier method) when taking Piqray and for at least 1 week after stopping treatment with Piqray.
CONTRAINDICATIONS of Alpelisib (Piqray)
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/piqray-epar-product-information_en.pdf 21/08/2024
Other trade names: Vijoice (Withdrawn),
Alpha1-antytripsin
Alpha1-antytripsin, breast-feeding
A decision must be made to either discontinue breast-feeding or to discontinue/abstain from therapy
Alpha1-antytripsin, nicotine
Decreased effect of alpha1-antitrypsin
Alpha1-antytripsin, pregnancy
Caution is recommended in pregnant women
Human alpha1-proteinase inhibitor
Ability to drive, human alpha1-proteinase inhibitor [2] ---> SPC of [2] of EMA
Dizziness may occur following the administration of Respreeza. Therefore, Respreeza may have a minor influence on the ability to drive and use machines.
Breast-feeding, human alpha1-proteinase inhibitor [2] ---> SPC of [2] of EMA
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Respreeza should be made
Human alpha1-proteinase inhibitor [1], pregnancy ---> SPC of [1] of EMA
Respreeza should be given with caution to pregnant women.
CONTRAINDICATIONS of Human alpha1-proteinase inhibitor
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4).
- IgA deficient patients with known antibodies against IgA, due to the risk of severe hypersensitivity and anaphylactic reactions.
Alprazolam
CNS depressants, alprazolam [2] ---> SPC of [2] of eMC
Enhancement of the central depressive effect may occur in case of concomitant use of alprazolam with other CNS depressants
CYP3A4 inhibitors, alprazolam
Compounds that inhibit certain hepatic enzymes (particularly cytochrome P450 3A4) may increase the concentration of alprazolam and enhance its activity.
St. John's wort, alprazolam
The co-administration may decrease the effect of alprazolam
Ability to drive, alprazolam [2] ---> SPC of [2] of eMC
Sedation, amnesia, impaired concentration and impaired muscle function may adversely affect the ability to drive or use machines.
Alcohol, alprazolam [2] ---> SPC of [2] of eMC
Benzodiazepines produce an additive effect when co-administered with alcohol
Alprazolam [1], anaesthetics ---> SPC of [1] of eMC
Enhancement of the central depressive effect may occur in case of concomitant use of alprazolam with other CNS depressants
Alprazolam [1], antidepressants ---> SPC of [1] of eMC
Enhancement of the central depressive effect may occur in case of concomitant use of alprazolam with other CNS depressants
Alprazolam [1], antiepileptics ---> SPC of [1] of eMC
Enhancement of the central depressive effect may occur in case of concomitant use of alprazolam with other CNS depressants
Alprazolam [1], anxiolytics ---> SPC of [1] of eMC
Enhancement of the central depressive effect may occur in case of concomitant use of alprazolam with other CNS depressants
Alprazolam, aprepitant [2] ---> SPC of [2] of EMA
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these medicinal products with EMEND (125 mg/80 mg).
Alprazolam [1], azole antifungals ---> SPC of [1] of eMC
Compounds that inhibit certain hepatic enzymes (particularly cytochrome P450 3A4) may increase the concentration of alprazolam and enhance its activity. Co-administration is not recommended
Alprazolam, boceprevir [2] ---> SPC of [2] of EMA
Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during co-administration of Victrelis with intravenous benzodiazepines. Dose adjustment of the benzodiazepine should be considered.
Alprazolam [1], breast-feeding ---> SPC of [1] of eMC
Alprazolam is excreted in breast milk at low level. However, alprazolam is not recommended during breast-feeding.
Alprazolam, carbamazepine [2] ---> SPC of [2] of eMC
Carbamazepine may decrease the plasma levels of alprazolam
Alprazolam [1], cimetidine ---> SPC of [1] of eMC
Caution and consideration of dose reduction is recommended when alprazolam is co-administered with cimetidine
Alprazolam [1], clarithromycin ---> SPC of [1] of eMC
Concomitant use of alprazolam and clarithromycin may increase the plasma levels of alprazolam. The co-administration should be avoided
Alprazolam, clomipramine
The co-administration may increase the plasma levels of antidepressant
Alprazolam, clozapine
The co-administration of alprazolam with clozapine increases the risk of respiratory and/or cardiac arrest
Alprazolam, daclatasvir [2] ---> SPC of [2] of EMA
No dose adjustment is required
Alprazolam, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SPC of [dasabuvir] of EMA
CYP3A4 inhibition by ritonavir. Clinical monitoring of patients is recommended. A decrease in alprazolam dose can be considered based on clinical response.
Alprazolam, dextropropoxyphene
Increased plasma levels of alprazolam
Alprazolam [1], digoxin ---> SPC of [1] of eMC
Serum levels of digoxin may be increased by concomitant administration of alprazolam
Alprazolam, diltiazem
Concomitant use of alprazolam and strong CYP3A4 inhibitors should be done with caution a significant dose reduction should be considered
Alprazolam, efavirenz
May increase the effect and toxicity of alprazolam
Alprazolam, erythromycin
The co-administration of drugs metabolised by the cytochrome P450 system may be associated with elevated serum levels if administered concomitantly with erythromycin.
Alprazolam, fluoxetine
Concomitant use of alprazolam and strong CYP3A4 inhibitors should be done with caution a significant dose reduction should be considered
Alprazolam, fluvoxamine [2] ---> SPC of [2] of eMC
The plasma levels of oxidatively metabolised benzodiazepines are likely to be increased when co-administered with fluvoxamine. The dosage of these benzodiazepines should be reduced during co-administration with fluvoxamine.
Alprazolam, foods
Take with food
Alprazolam, fosaprepitant [2] ---> SPC of [2] of EMA
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 should be considered when co-administering these medicinal products with fosaprepitant.
Alprazolam, haloperidol [2] ---> SPC of [2] of eMC
Inhibition of the CYP3A4 by another drug may result in increased haloperidol concentrations and an increased risk of adverse events, including QT-prolongation.
Alprazolam [1], hypnotics ---> SPC of [1] of eMC
Enhancement of the central depressive effect may occur in case of concomitant use of alprazolam with other CNS depressants
Alprazolam, imatinib [2] ---> SPC of [2] of EMA
The CYP3A4 inhibition may increase plasma concentrations of the triazolobenzodiazepine
Alprazolam, indinavir [2] ---> SPC of [2] of EMA
Indinavir with or without ritonavir should not be administered with medicinal products with narrow therapeutic ranges and which are CYP3A4 substrates. The elevated plasma concentrations of these medicines may cause serious or life-threatening reactions.
Alprazolam, indinavir/ritonavir ---> SPC of [indinavir] of EMA
Indinavir with or without ritonavir should not be administered with medicinal products with narrow therapeutic ranges and which are CYP3A4 substrates. The elevated plasma concentrations of these medicines may cause serious or life-threatening reactions.
Alprazolam [1], itraconazol ---> SPC of [1] of eMC
The CYP3A4 inhibition may increase the plasma concentrations of alprazolam. Co-administration is not recommended
Alprazolam, ivacaftor [2] ---> SPC of [2] of EMA
Administration of ivacaftor may increase systemic exposure of medicinal products which are substrates of CYP3A, which may increase or prolong their therapeutic effect and adverse reactions.
Alprazolam, ketoconazole [2] ---> SPC of [2] of EMA
Contraindicated due to the risk of potentially prolonged or increased sedation and respiratory depression
Alprazolam, lomitapide [2] ---> SPC of [2] of EMA
Weak CYP3A4 inhibitors are expected to increase the exposure of lomitapide when taken simultaneously. Separate the dose of the medications by 12 hours OR decrease the dose of Lojuxta by half.
Alprazolam, macrolide antibiotics
Concomitant use of alprazolam and strong CYP3A4 inhibitors should be done with caution a significant dose reduction should be considered
Alprazolam, medroxyprogesterone
The co-administration increases the alprazolam plasma levels and therefore the toxicity risk (central nervous system depression and hypotension)
Alprazolam, metildigoxin
Increased plasma levels of metildigoxin
Alprazolam, muscle relaxants
Enhanced muscle relaxant effect
Alprazolam, naloxegol [2] ---> SPC of [2] of EMA
No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin)
Alprazolam [1], narcotics ---> SPC of [1] of eMC
Enhancement of the central depressive effect may occur in case of concomitant use of alprazolam with other CNS depressants
Alprazolam [1], nefazodone ---> SPC of [1] of eMC
The co-administration of nefazodone increases the AUC of alprazolam by approximately 2-fold.
Alprazolam, netupitant/palonosetron [2] ---> SPC of [2] of EMA
The potential effects of increased plasma concentrations of benzodiazepines metabolized via CYP3A4 should be considered when coadministering these active substances with netupitant/palonosetron.
Alprazolam [1], neuroleptics ---> SPC of [1] of eMC
Enhancement of the central depressive effect may occur in case of concomitant use of alprazolam with other CNS depressants
Alprazolam, ombitasvir/paritaprevir/ritonavir [2] ---> SPC of [2] of EMA
CYP3A4 substrates may require dose adjustment and/or clinical monitoring
Alprazolam [1], opioid analgesics ---> SPC of [1] of eMC
The co-administration may enhance the depressive effect on the CNS and an enhancement of the euphoria, leading to an increase in psychic dependence
Alprazolam, oral contraceptives
Concomitant use of alprazolam and strong CYP3A4 inhibitors should be done with caution a significant dose reduction should be considered
Alprazolam, phenytoin
The strong CYP3A4 induction may decrease the plasma levels of alprazolam
Alprazolam, posaconazole [2] ---> SPC of [2] of EMA
Concomitant use of posaconazole with any benzodiazepine that is metabolised by CYP3A4 increases plasma concentrations of the benzodiazepine. Due to the risk of prolonged sedation it is recommended that dose adjustments should be considered
Alprazolam [1], pregnancy ---> SPC of [1] of eMC
Alprazolam should not be used during pregnancy unless the clinical condition of the woman requires treatment with alprazolam.
Alprazolam, propoxyphene
It is caution recommended when coadministering alprazolam and propoxyphene
Alprazolam, protease inhibitors
Interactions involving HIV protease inhibitors (e.g. ritonavir) and alprazolam are complex and time dependent.
Alprazolam, rifampicin
The strong CYP3A4 induction may decrease the plasma levels of alprazolam
Alprazolam, ritonavir [2] ---> SPC of [2] of EMA
Alprazolam metabolism was inhibited following the introduction of ritonavir. After ritonavir use for 10 days, no inhibitory effect of ritonavir was observed.
Alprazolam, saquinavir/ritonavir ---> SPC of [saquinavir] of EMA
Increased benzodiazepine plasma concentrations. Careful monitoring of patients with regard to sedative effects is warranted.
Alprazolam [1], sedating antihistamines ---> SPC of [1] of eMC
Se puede producir una potenciación del efecto depresor sobre el SNC al administrar concomitantemente alprazolam con otros depresores del SNC
Alprazolam [1], sedatives ---> SPC of [1] of eMC
Enhancement of the central depressive effect may occur in case of concomitant use of alprazolam with other CNS depressants
Alprazolam, sertraline
Concomitant use of alprazolam and strong CYP3A4 inhibitors should be done with caution a significant dose reduction should be considered
Alprazolam, stiripentol [2] ---> SPC of [2] of EMA
Increased plasma benzodiazepine levels may occur via decreased hepatic metabolism leading to excessive sedation. Caution should be exercised
Alprazolam [1], strong CYP3A4 inductors ---> SPC of [1] of eMC
Since alprazolam is metabolized by CYP3A4, inducers of this enzyme may enhance the metabolism of alprazolam.
Alprazolam, strong CYP3A4 inhibitors
Compounds that inhibit certain hepatic enzymes (particularly cytochrome P450 3A4) may increase the concentration of alprazolam and enhance its activity.
Alprazolam, telaprevir [2] ---> SPC of [2] of EMA
The CYP3A4 inhibition may increase the plasma levels of alprazolam.
Alprazolam, telithromycin [2] ---> SPC of [2] of EMA
The CYP3A4 inhibition by telithromycin may increase the plasma levels of alprazolam.
Alprazolam, tetracyclic antidepressants
The co-administration may increase the plasma levels of antidepressant
Alprazolam, tricyclic antidepressants
The co-administration may increase the plasma levels of antidepressant
Alprazolam, troleandomycin
Concomitant use of alprazolam and strong CYP3A4 inhibitors should be done with caution a significant dose reduction should be considered
Alprazolam, voriconazole [2] ---> SPC of [2] of EMA
Voriconazole is likely to increase the plasma concentrations of benzodiazepines that are metabolised by CYP3A4 and lead to a prolonged sedative effect.
Alprazolam, warfarin
It could not be determined if there was any effect on the prothrombin time and the warfarin plasma concentrations
Alprazolam, yohimbine
Decreased effect of alprazolam
CONTRAINDICATIONS of Alprazolam
- Alprazolam is contraindicated in patients with known hypersensitivity to benzodiazepines, alprazolam, or to any of the excipients
- Benzodiazepines are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency.
http://www.medicines.org.uk/emc/
Alprostadil
NSAID, alprostadil
NSAID decreases the endogen prostaglandin synthesis and decreases its effect
PDE5 inhibitors, alprostadil [2] ---> SPC of [2] of eMC
Treatments for erectile dysfunction (e.g. sildenafil) or other drugs inducing erection (e.g. papaverine) should not be used in combination with alprostadil due to the potential for inducing prolonged erections.
Ability to drive, alprostadil
Hypotension or syncope may occur.
Alfa-adrenergic agonists, alprostadil
The co-administration may decrease the vasodilatator effect of alprostadil
Alprostadil [1], anticoagulants ---> SPC of [1] of eMC
Alprostadil may enhance the effects of anticoagulants
Alprostadil [1], antihypertensives ---> SPC of [1] of eMC
Alprostadil may enhance the effects of antihypertensives
Alprostadil, breast-feeding
It is not for use in women.
Alprostadil, labetalol
Possible enhancement of hypotensive effect of labetalol
Alprostadil, metaraminol
The co-administration may decrease the vasodilatator effect of alprostadil
Alprostadil, methyldopa
Concomitant use of methyldopa and alprostadil may enhance the hypotensive effect.
Alprostadil, metoprolol
Concurrent use of alprostadil and metoprolol may result in an enhanced hypotensive effect.
Alprostadil, oxytocin
Prostaglandin potentiates the uterotonic effect of oxytocic drugs. Co-administration is not recommended
Alprostadil [1], papaverine ---> SPC of [1] of eMC
Treatments for erectile dysfunction (e.g. sildenafil) or other drugs inducing erection (e.g. papaverine) should not be used in combination with alprostadil due to the potential for inducing prolonged erections.
Alprostadil [1], platelet aggregation inhibitors ---> SPC of [1] of eMC
Alprostadil may enhance the effects of platelet aggregation inhibitors.
Alprostadil, pregnancy
It is not for use in women.
Alprostadil [1], sympathomimetics ---> SPC of [1] of eMC
Sympathomimetics may reduce the effect of alprostadil.
Alprostadil, triamterene
The co-administration of triamterene and alprostadil may enhance the hypotensive effect
Alprostadil [1], vasodilators ---> SPC of [1] of eMC
Alprostadil may enhance the effects of vasodilative agents
CONTRAINDICATIONS of Alprostadil
- Hypersensitivity to the active substances or to any other ingredients.
- Patients with diseases causing priapism e.g. sickle-cell anaemia or trait, multiple myeloma or leukaemia or patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie's disease. Patients with penis implants should not use alprostadil
- Alprostadil should not be used in men for whom sexual activity is contraindicated (e.g. patients suffering from severe heart disease).
http://www.medicines.org.uk/emc/
Alteplase
ACE inhibitors, alteplase [2] ---> SPC of [2] of eMC
Concomitant treatment with ACE inhibitors may enhance the risk of suffering an anaphylactoid reaction
GP IIb/IIIa inhibitors, alteplase [2] ---> SPC of [2] of eMC
Concomitant use of alteplase with GPIIb/IIIa antagonists increases the risk of bleeding.
Acenocoumarol, alteplase
The co-administration may enhance the anticoagulant effect and increase the bleeding risk.
Alteplase, aprotinin
Aprotinin has a dose-dependent inhibitor effect on the effect of thrombolytic agents
Alteplase [1], breast-feeding ---> SPC of [1] of eMC
It is not known if alteplase is excreted into breast milk.
Alteplase [1], coumarin anticoagulants ---> SPC of [1] of eMC
Increased risk of haemorrhage
Alteplase [1], low molecular weight heparins ---> SPC of [1] of eMC
Increased risk of haemorrhage
Alteplase, nitroglycerine
It has been shown that IV nitroglycerin decreases the thrombolytic effect of alteplase.
Alteplase [1], oral anticoagulants ---> SPC of [1] of eMC
Increased risk of haemorrhage
Alteplase [1], platelet aggregation inhibitors ---> SPC of [1] of eMC
Increased risk of haemorrhage
Alteplase [1], pregnancy ---> SPC of [1] of eMC
In cases of an acute life-threatening disease the benefit has to be evaluated against the potential risk.
Alteplase [1], unfractionated heparins ---> SPC of [1] of eMC
Increased risk of haemorrhage
Alteplase, warfarin
Fibrinolytic drugs such as streptokinase and alteplase are contraindicated in patients receiving warfarin.
CONTRAINDICATIONS of Alteplase
Generally in all indications Actilyse should not be administered to patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients listed in section 6.1.
Additional contraindications in acute myocardial infarction, acute pulmonary embolism and acute ischaemic stroke:
Actilyse is contraindicated in cases where there is a high risk of haemorrhage such as:
- significant bleeding disorder at present or within the past 6 months
- known haemorrhagic diathesis
- patients receiving effective oral anticoagulant treatment, e.g. warfarin sodium (see section 4.4)
- manifest or recent severe or dangerous bleeding
- known history of or suspected intracranial haemorrhage
- suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm
- any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
- recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian/jugular vein puncture)
- severe uncontrolled arterial hypertension
- bacterial endocarditis, pericarditis
- acute pancreatitis
- documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformations
- neoplasm with increased bleeding risk
- severe liver disease, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- major surgery or significant trauma in past 3 months.
Additional contraindications in acute myocardial infarction:
- any known history of haemorrhagic stroke or stroke of unknown origin
- known history of ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months, except current acute ischaemic stroke within 3 hours.
Additional contraindications in acute pulmonary embolism:
- any known history of haemorrhagic stroke or stroke of unknown origin
- known history of ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months, except current acute ischaemic stroke within 3 hours.
Additional contraindications in acute ischaemic stroke:
- symptoms of ischaemic attack beginning more than 4.5 hours prior to infusion start or symptoms for which the onset time is unknown and could potentially be more than 4.5 hours ago (see section 5.1)
- minor neurological deficit or symptoms rapidly improving before start of infusion
- severe stroke as assessed clinically (e.g. NIHSS>25) and/or by appropriate imaging techniques
- seizure at onset of stroke
- evidence of intracranial haemorrhage (ICH)on the CT-scan
- administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
- patients with any history of prior stroke and concomitant diabetes
- prior stroke within the last 3 months
- platelet count of below 100,,000/mm³
- systolic blood pressure >>185 or diastolic BP >110 mm Hg, or aggressive management (intravenous pharmacotherapy) necessary to reduce BP to these limits
- blood glucose < 50 or >400 mg/dl.
Use in children, adolescents, and in elderly patients
Actilyse is not indicated for the treatment of acute stroke in paediatric patients under 18 years, and in adults over 80 years of age.
http://www.medicines.org.uk/emc/
Aluminium hydroxide
H2 antagonists, aluminium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
NSAID, aluminium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Acidifying agents, aluminium hydroxide
The co-administration may increase the intestinal absorption of aluminium. Separate administration by at least 2 hours
Allopurinol, aluminium hydroxide
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Allopurinol/lesinurad [1], aluminium hydroxide ---> SPC of [1] of EMA
If aluminium hydroxide is taken concomitantly, allopurinol-containing medicinal products may have an attenuated effect. There should be an interval of at least 3 hours between the concomitant use of those medicinal products.
Aluminium hydroxide, ascorbic acid
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Aluminium hydroxide, atenolol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, atorvastatin
Concomitant use of aluminium hydroxide may decrease the absorption and effect of atorvastatin. Separate administration by at least 2-3 hours
Aluminium hydroxide, betablockers
Concomitant use of aluminium hydroxide may decrease the absorption and effect of betablockers. Separate administration by at least 2-3 hours
Aluminium hydroxide, biphosphonates
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, breast-feeding
The aluminium hydroxide passes into the mother milk. It is not recommended during the breast-feeding
Aluminium hydroxide, calcipotriol
The absorption of aluminum may be increased
Aluminium hydroxide, capecitabine [2] ---> SPC of [2] of EMA
Small increase in plasma concentrations of capecitabine
Aluminium hydroxide, captopril
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, carbenoxolone
The aluminium hydroxide may decrease the absorption of carbenoxolone. Separate administration by at least 2 hours
Aluminium hydroxide, cefaclor
Decreased cefaclor absorption rate. Separate administration by at least 2 hours
Aluminium hydroxide, chenodeoxycholic acid [2] ---> SPC of [2] of EMA
If it is necessary to take a medicinal product containing one of these active substances it should be taken either 2 hours before or after taking chenodeoxycholic acid.
Aluminium hydroxide, chloroquine
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, chlorpromazine [2] ---> SPC of [2] of eMC
The aluminium hydroxide may decrease the absorption of chlorpromazine. Separate administration by at least 2-3 hours
Aluminium hydroxide, cholic acid [2] ---> SPC of [2] of EMA
The co-administration may decrease or prevent the absorption of cholic acid. Separate administration by at least 5 hours
Aluminium hydroxide, cimetidine
The aluminium hydroxide decreases the absorption of the co-administered active principle. Separate administration by at least 2 hours
Aluminium hydroxide, ciprofloxacin
Decreased absorption of quinolone. The quinolone should be administered 2 hours before or 4 hours after the administration of the aluminium hydroxide
Aluminium hydroxide, citrate
The citrate may cause systemic alkalosis with increased aluminium absorption and possible toxicity, particularly with renal failure
Aluminium hydroxide, clindamycin
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, cloprednol
Decreased bioavailability of cloprednol in chronic liver desease
Aluminium hydroxide, darunavir/cobicistat [2] ---> SPC of [2] of EMA
No mechanistic interaction expected based on theoretical consideration. Darunavir/cobicistat and antacids can be used concomitantly without dose adjustment.
Aluminium hydroxide, dasatinib [2] ---> SPC of [2] of EMA
Non-clinical data demonstrate that the solubility of dasatinib is pH-dependent. Antacids may be administered up to 2 hours prior to or 2 hours following dasatinib
Aluminium hydroxide, deflazacort
Decreased bioavailability of glucocorticoid in chronic liver desease
Aluminium hydroxide, diclofenac
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, dicoumarol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, diflunisal
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, digital glycosides
The aluminium hydroxide may decrease the absorption of digitalis glycoside. Separate administration by at least 2 hours
Aluminium hydroxide, digitoxin
The aluminium hydroxide may decrease the absorption of digitoxin. Separate administration by at least 2 hours
Aluminium hydroxide, digoxin
The aluminium hydroxide may decrease the absorption of digoxin. Separate administration by at least 2 hours
Aluminium hydroxide, dolutegravir [2] ---> SPC of [2] of EMA
Magnesium/ aluminium-containing antacid should be taken well separated in time from the administration of dolutegravir (minimum 2 hours after or 6 hours before).
Aluminium hydroxide, dolutegravir/abacavir/lamivudine [2] ---> SPC of [2] of EMA
Magnesium/ aluminium-containing antacid should be taken well separated in time from the administration of dolutegravir (minimum 2 hours after or 6 hours before).
Aluminium hydroxide, dolutegravir/rilpivirine [2] ---> SPC of [2] of EMA
The combination of Juluca and antacids should be used with particular caution. Antacids should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Aluminium hydroxide, efavirenz [2] ---> SPC of [2] of EMA
Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.
Aluminium hydroxide, elbasvir/grazoprevir [2] ---> SPC of [2] of EMA
No dose adjustment is required.
Aluminium hydroxide, elvitegravir [2] ---> SPC of [2] of EMA
Elvitegravir plasma levels are lower with antacids due to local complexation in the gastrointestinal tract. It is recommended to separate administration by at least 4 hours.
Aluminium hydroxide, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Elvitegravir plasma concentrations are lower with antacids due to local complexation in the gastrointestinal tract. Separate administration by at least 4 hours
Aluminium hydroxide, emtricitabine/rilpivirine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH). Antacids should only be administered either at least 2 hours before or at least 4 hours after Odefsey.
Aluminium hydroxide, epoetin
Concomitant use of aluminium hydroxide may decrease the absorption and effect of epoetin. Separate administration by at least 2-3 hours
Aluminium hydroxide, ethambutol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, fexofenadine [2] ---> SPC of [2] of eMC
Decreased bioavailability of fexofenadine. Separate administration by at least 2 hours
Aluminium hydroxide, flufenamic acid
Concomitant use of aluminium hydroxide may decrease the absorption and effect of flufenamic acid. Separate administration by at least 2-3 hours
Aluminium hydroxide, fosinopril [2] ---> SPC of [2] of eMC
Antacids may impair absorption of fosinopril. Administration of fosinopril sodium and antacids should be separated by at least 2 hours.
Aluminium hydroxide, fruit juice
The intake of acid beverages (e. g. fruit juices, wine) together with aluminium-containing antacids increases the intestinal absorption of aluminium
Aluminium hydroxide, gabapentin
Concomitant use of aluminium hydroxide may decrease the absorption and effect of gabapentin. Separate administration by at least 2-3 hours
Aluminium hydroxide, glucocorticoids
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, indometacin
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, iron
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, isoniazid
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, itraconazol [2] ---> SPC of [2] of eMC
The antacid may decrease the absorption and effect of itraconazole, it should be administered at least 2 hours after the intake of itraconazole
Aluminium hydroxide, juices
The intake of acid beverages (e. g. fruit juices, wine) together with aluminium-containing antacids increases the intestinal absorption of aluminium
Aluminium hydroxide, ketoconazole [2] ---> SPC of [2] of EMA
Acid-neutralising medicines should not be administered for at least 2 hours after the intake of ketoconazole.
Aluminium hydroxide, laxatives
Weakening of the laxative effect
Aluminium hydroxide, ledipasvir/sofosbuvir [2] ---> SPC of [2] of EMA
Ledipasvir solubility decreases as pH increases. Medicinal products that increase gastric pH are expected to decrease concentration of ledipasvir. It is recommended to separate the administration by 4 hours.
Aluminium hydroxide, levomepromazine
The co-administration may decrease the absorption of phenothiazine. Separate administration by at least 2 hours
Aluminium hydroxide, levothyroxine
The aluminium hydroxide may decrease the absorption of levothyroxine. Separate administration by at least 2 hours
Aluminium hydroxide, lincosamides
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, metoprolol
Concomitant use of aluminium hydroxide may decrease the absorption and effect of betablockers. Separate administration by at least 2-3 hours
Aluminium hydroxide, metronidazole
The aluminium hydroxide may decrease the absorption of metronidazole. Separate administration by at least 2 hours
Aluminium hydroxide, mycophenolate [2]
Decreased mycophenolic acid (MPA) exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil.
Aluminium hydroxide, mycophenolate mofetil [2] ---> SPC of [2] of EMA
Decreased mycophenolic acid (MPA) exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil.
Aluminium hydroxide, mycophenolic acid [2] ---> SPC of [2] of eMC
The chronic, daily use of magnesium-aluminium containing antacids with mycophenolic acid is not recommended due to the potential for decreased mycophenolic acid exposure and reduced efficacy.
Aluminium hydroxide, nabumetone [2] ---> SPC of [2] of eMC
Aluminium hydroxide antacids don't affect nabumetone metabolism and bioavailability
Aluminium hydroxide, naproxen
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, neuroleptics
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, nilotinib [2] ---> SPC of [2] of EMA
If necessary, an antacid may be administered approximately 2 hours before or approximately 2 hours after the dose of Tasigna.
Aluminium hydroxide, norfloxacin
Concomitant use of aluminium hydroxide may decrease the absorption and effect of quinolones. Separate administration by at least 4 hours
Aluminium hydroxide, ofloxacin [2] ---> SPC of [2] of eMC
The co-administration may decrease the absorption of ofloxacin. Separate administration by at least 2 hours
Aluminium hydroxide, oxyphenbutazone
The aluminium hydroxide may decrease the absorption of NSAID. Separate administration by at least 2 hours
Aluminium hydroxide, penicillamine
Concomitant use of aluminium hydroxide may decrease the absorption and effect of penicillamine. Separate administration by at least 2-3 hours
Aluminium hydroxide, phenothiazines
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, potassium sodium hydrogen citrate
The co-administration of citrates and aluminium-containing substances may increase the absorption of aluminium. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, prednisone
Concomitant use of aluminium hydroxide may decrease the absorption and effect of prednisone. Separate administration by at least 2-3 hours
Aluminium hydroxide [1], pregnancy ---> SPC of [1] of eMC
It should not be used during pregnancy unless clearly necessary.
Aluminium hydroxide, propranolol
Concomitant use of aluminium hydroxide may decrease the absorption and effect of betablockers. Separate administration by at least 2-3 hours
Aluminium hydroxide, quinidine
The co-administration may increase the plasma levels of quinidine
Aluminium hydroxide, quinolones
Concomitant use of aluminium hydroxide may decrease the absorption and effect of quinolones. Separate administration by at least 4 hours
Aluminium hydroxide, raltegravir [2] ---> SPC of [2] of EMA
Co-administration of raltegravir with aluminium containing antacids is not recommended.
Aluminium hydroxide, ranitidine
The aluminium hydroxide may decrease the absorption of ranitidine. Separate administration by at least 2 hours
Aluminium hydroxide, rilpivirine [2] ---> SPC of [2] of EMA
The increase of gastric pH decreases absorption, plasma level and effect of rilpivirine. The antacid should be administered at least 2 h before or 4 h after rilpivirine
Aluminium hydroxide, riociguat [2] ---> SPC of [2] of EMA
Riociguat exhibits a reduced solubility at neutral pH vs. acidic medium. Co-medication of drugs increasing the upper GI pH may decrease oral riociguat bioavailability. Antacids should be taken at least 2 hours before, or 1 hour after riociguat.
Aluminium hydroxide, rosuvastatin [2] ---> SPC of [2] of eMC
The simultaneous dosing of rosuvastatin with an antacid suspension containing aluminium hydroxide resulted in a decrease in rosuvastatin plasma concentration of approximately 50%.
Aluminium hydroxide, simeprevir [2] ---> SPC of [2] of EMA
No clinically relevant drug-drug interaction is expected. No dose adjustment is required
Aluminium hydroxide, sodium fluoride
The co-administration of antacids containing aluminium with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium hydroxide, sofosbuvir/velpatasvir [2] ---> SPC of [2] of EMA
Increase in gastric pH. It is recommended to separate antacid and Epclusa administration by 4 hours.
Aluminium hydroxide, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SPC of [2] of EMA
Increase in gastric pH decreases velpatasvir solubility. It is recommended to separate antacid and Vosevi administration by 4 hours.
Aluminium hydroxide, sotalol
Concomitant use of aluminium hydroxide may decrease the absorption and effect of betablockers. Separate administration by at least 2-3 hours
Aluminium hydroxide, tacrolimus [2] ---> SPC of [2] of EMA
The combination may increase systemic exposure of tacrolimus
Aluminium hydroxide, tetracyclines
The aluminium hydroxide may decrease the absorption of tetracycline. Separate administration by at least 3 hours
Aluminium hydroxide, tiludronic acid
Concomitant use of aluminium hydroxide may decrease the absorption and effect of tiludronic acid. Separate administration by at least 2-3 hours
Aluminium hydroxide, ursodeoxycholic acid [2] ---> SPC of [2] of eMC
Ursodeoxycholic acid should not be coadministered with antacids containing aluminium, because they bind the acid in the gut and inhibit its absorption and efficacy. It must be taken at least 2 hours before or after ursodeoxycholic acid
Aluminium hydroxide, vitamin C
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Aluminium hydroxide, vorapaxar [2] ---> SPC of [2] of EMA
No clinically relevant differences in vorapaxar pharmacokinetics were observed following daily co-administration of an aluminium hydroxide/magnesium carbonate antacid or pantoprazole (a proton pump inhibitor)
Aluminium hydroxide, wine
The intake of acid beverages (e. g. fruit juices, wine) together with aluminium-containing antacids increases the intestinal absorption of aluminium
CONTRAINDICATIONS of Aluminium hydroxide
Alu-Cap is contra-indicated in patients with
- hypophosphataemia and
- acute porphyria.
http://www.medicines.org.uk/emc/
Amantadine
CNS depressants, amantadine
Additive CNS toxicity
QT interval prolonging drugs, amantadine
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Ability to drive, amantadine [2] ---> SPC of [2] of eMC
Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness or blurred vision.
Alcohol, amantadine
Decreased alcohol tolerance. The co-administration should be avoided
Aliskiren/amlodipine/hydrochlorothiazide [1], amantadine ---> SPC of [1] of EMA
Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Aliskiren/hydrochlorothiazide [1], amantadine ---> SPC of [1] of EMA
Thiazides may increase the risk of adverse reactions caused by amantadine.
Amantadine, amfepramone
The indirect sympathomimetic effect of amfepramone may be dangerously enhanced by amantadine
Amantadine, amiodarone
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, amitriptyline
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, amlodipine/valsartan/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Amantadine [1], anticholinergics ---> SPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine, astemizole
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine [1], atropine ---> SPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine, azole antifungals
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine [1], benzatropine ---> SPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine, benzodiazepines
The co-administration is only possible by simultaneous stabilization of the blood pressure
Amantadine, bepridil
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine [1], biperiden ---> SPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine [1], bornaprine ---> SPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine [1], breast-feeding ---> SPC of [1] of eMC
Amantadine passes into breast milk. Undesirable effects have been reported in breast-fed infants. Nursing mothers should not take amantadine
Amantadine, bromperidol
The co-administration may decrease the effect of amantadine
Amantadine, budipine
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, bupropion [2] ---> SPC of [2] of eMC
Limited clinical data suggest a higher incidence of undesirable effects (e.g. nausea, vomiting, and neuropsychiatric events) in patients receiving bupropion concurrently with amantadine.
Amantadine [1], butylscopolamine ---> SPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine, butyrophenones
The dopamine antagonist should be avoided with amantadine
Amantadine, cathine
The indirect sympathomimetic effect of cathine may be dangerously enhanced by amantadine
Amantadine, chlorpromazine
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, chlortalidone ---> SPC of [aliskiren/hydrochlorothiazide] of EMA
Thiazides may increase the risk of adverse reactions caused by amantadine.
Amantadine, cisapride
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, clarithromycin
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, class IA antiarrhythmic agents
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, class III antiarrhythmic agents
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, cotrimoxazole
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, cyclopentolate
The effects of antimuscarinic agents may be enhanced by the concomitant administration of other drugs with antimuscarinic properties
Amantadine, disopyramide
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, dopamine
Amantadine enhances the effect of dopamine
Amantadine, dopamine agonists
The effects of dopaminergic agonist may be enhanced
Amantadine, dopamine antagonists
The dopamine antagonist should be avoided with amantadine
Amantadine, droperidol
The dopamine antagonist should be avoided with amantadine
Amantadine, erythromycin
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, fesoterodine [2] ---> SPC of [2] of EMA
Caution should be exercised in coadministration of fesoterodine with other antimuscarinics and medicinal products with anticholinergic properties as this may lead to more pronounced therapeutic-and side-effects
Amantadine, grepafloxacin
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, halofantrine
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, haloperidol
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, hydrochlorothiazide
The co-administration may reduce the clearance of amantadine, leading to higher plasma concentrations and toxic effects
Amantadine, indirect sympathomimetics
Enhanced central effect of amantadine
Amantadine, ioflupane [2] ---> SPC of [2] of EMA
Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline.
Amantadine, levodopa
Amantadine has a synergistic effect with levodopa
Amantadine, levodopa/benserazide [2] ---> SPC of [2] of eMC
Combination of levodopa/benserazide with other anti-Parkinsonian agents is permissible, though both the desired and undesired effects of treatment may be intensified.
Amantadine, levodopa/carbidopa
Amantadine has a synergistic effect with levodopa
Amantadine, memantin [2] ---> SPC of [2] of EMA
Concomitant use should be avoided, owing to the risk of pharmacotoxic psychosis
Amantadine [1], methantheline ---> SPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine, metoclopramide
The dopamine antagonist should be avoided with amantadine
Amantadine, naltrexone/bupropion [2] ---> SPC of [2] of EMA
Administration of naltrexone / bupropion to patients receiving either levodopa or amantadine concurrently should be undertaken with caution. Limited clinical data suggest a higher incidence of adverse reactions
Amantadine, neuroleptics
In isolated cases, worsening of psychotic symptoms has been reported in patients receiving amantadine and concomitant neuroleptic medication.
Amantadine, norpseudoephedrine
The indirect sympathomimetic effect of cathine may be dangerously enhanced by amantadine
Amantadine [1], orphenadrine ---> SPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine, oxybutynine [2] ---> SPC of [2] of EMA
The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or medicinal products with anticholinergic activity
Amantadine, pentamidine
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, perazine
The co-administration may weaken the effect of dopamine agonist
Amantadine, periciazine
The co-administration may weaken the effect of dopamine agonist
Amantadine, perphenazine
The co-administration may weaken the effect of dopamine agonist
Amantadine, phenothiazines
The dopamine antagonist should be avoided with amantadine
Amantadine, pimozide
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, piperidolate
The co-administration may increase the risk of adverse effects, e.g. paralytic ileus, retention of urine and blurred vision
Amantadine, pramipexole [2] ---> SPC of [2] of EMA
Medicines that are inhibitors of the cationic secretory transport system of renal tubules/are eliminated by this pathway may interact with pramipexole resulting in reduced clearance of pramipexole. Reduction of the pramipexole dose should be considered
Amantadine [1], pregnancy ---> SPC of [1] of eMC
Amantadine is contraindicated during pregnancy and in women wishing to become pregnant.
Amantadine, procainamide
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, procyclidine
Drugs with anticholinergic properties may increase the anticholinergic action
Amantadine, propiverine
Increased effects of propiverine due to concomitant medication with amantadine
Amantadine, quinidine
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, quinine
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, quinolones
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine [1], scopolamine ---> SPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine, selegiline [2] ---> SPC of [2] of eMC
Concomitant administration of selegiline and amantadine can lead to an increased occurrence of side-effects.
Amantadine, sotalol
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, sparfloxacin
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, terfenadine
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, thiazides ---> SPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
Thiazides may increase the risk of adverse reactions caused by amantadine.
Amantadine, thiazides ---> SPC of [telmisartan/hydrochlorothiazide] of EMA
Thiazides may increase the risk of adverse effects caused by amantadine.
Amantadine, thioridazine
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine, thioxanthenes
The dopamine antagonist should be avoided with amantadine
Amantadine, tiapride
Concomitant use of tiapride and dopaminergic agonists, except levodopa, is not recommended in patients with Parkinson disease due to mutual antagonism between dopaminergic agonists and neuroleptics
Amantadine, triamterene
The co-administration may reduce the clearance of amantadine, leading to higher plasma concentrations and toxic effects
Amantadine, tricyclic antidepressants
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amantadine [1], trihexyphenidyl ---> SPC of [1] of eMC
Extra care should be taken when trihexyphenidyl is given concomitantly with amantadine because of the possibility of increased antimuscarinic side-effects.
Amantadine, trimethoprim
Amantadine interferes with the tubular secretion of trimethoprim and vice versa
Amantadine, trospium [2] ---> SPC of [2] of eMC
Potentiation of the effect of drugs with anticholinergic action
CONTRAINDICATIONS of Amantadine
- Known hypersensitivity to amantadine or any of the excipients.
- Individuals subject to convulsions.
- A history of gastric ulceration.
- Severe renal disease.
- Pregnancy.
http://www.medicines.org.uk/emc/
Ambrisentan (Volibris)
Ability to drive, ambrisentan [2] ---> SmPC of [2] of EMA
Patients should be aware of how they might be affected by ambrisentan before driving or using machines.
Ambrisentan [1], breast-feeding ---> SmPC of [1] of EMA
It is not known whether ambrisentan is excreted in human breast milk. The excretion of ambrisentan in milk has not been studied in animals. Therefore, breast-feeding is contraindicated in patients taking ambrisentan (see section 4.3).
Ambrisentan [1], cyclosporine ---> SmPC of [1] of EMA
Steady-state co-administration of ambrisentan and cyclosporine A resulted in a 2-fold increase in ambrisentan exposure in healthy volunteers. No dose adjustment of cyclosporine A is warranted.
Ambrisentan [1], CYP3A4 inductors ---> SmPC of [1] of EMA
The potential for ambrisentan to induce CYP3A4 activity was explored in healthy volunteers with results suggesting a lack of inductive effect of ambrisentan on the CYP3A4 isoenzyme.
Ambrisentan [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA
Steady-state administration of ketoconazole (a strong inhibitor of CYP3A4) did not result in a clinically significant increase in exposure to ambrisentan
Ambrisentan [1], digoxin ---> SmPC of [1] of EMA
Steady-state administration of ambrisentan in healthy volunteers had no clinically relevant effects on the single-dose pharmacokinetics of digoxin, a substrate for Pgp
Ambrisentan [1], estrogens ---> SmPC of [1] of EMA
Based on this pharmacokinetic study, ambrisentan would not be expected to significantly affect exposure to oestrogen- or progestogen-based contraceptives.
Ambrisentan [1], foods ---> SmPC of [1] of EMA
It is recommended that the tablet is swallowed whole and it can be taken with or without food. It is recommended that the tablet should not be split, crushed or chewed.
Ambrisentan [1], gestagens ---> SmPC of [1] of EMA
Based on this pharmacokinetic study, ambrisentan would not be expected to significantly affect exposure to oestrogen- or progestogen-based contraceptives.
Ambrisentan [1], guanylate cyclase stimulators ---> SmPC of [1] of EMA
The efficacy and safety of ambrisentan when co-administered with other treatments for PAH (e.g. prostanoids and soluble guanylate cyclase stimulators) has not been specifically studied in controlled clinical trials in PAH patients.
Ambrisentan [1], ketoconazole ---> SmPC of [1] of EMA
Steady-state administration of ketoconazole (a strong inhibitor of CYP3A4) did not result in a clinically significant increase in exposure to ambrisentan
Ambrisentan [1], male fertility ---> SmPC of [1] of EMA
The development of testicular tubular atrophy in male animals has been linked to the chronic administration of ERAs, including ambrisentan (see section 5.3).
Ambrisentan [1], medicinal product-metabolising enzymes ---> SmPC of [1] of EMA
Ambrisentan does not inhibit or induce phase I or II drug metabolising enzymes at clinically relevant concentrations in in vitro and in vivo non-clinical studies, suggesting a low potential for ambrisentan to alter these profile of medicinal products
Ambrisentan [1], oral contraceptives ---> SmPC of [1] of EMA
Ambrisentan would not be expected to significantly affect exposure to oestrogen- or progestogen- based contraceptives.
Ambrisentan [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
In vitro studies in rat hepatocytes also showed that ambrisentan did not induce Pgp, BSEP or MRP2 protein expression.
Ambrisentan [1], PDE5 inhibitors ---> SmPC of [1] of EMA
Co-administration of ambrisentan with a phosphodiesterase inhibitor, either sildenafil or tadalafil (both substrates of CYP3A4) in healthy volunteers did not significantly affect the pharmacokinetics of the phosphodiesterase inhibitor or ambrisentan
Ambrisentan [1], pregnancy ---> SmPC of [1] of EMA
Ambrisentan is contraindicated in pregnancy. Animal studies have shown that ambrisentan is teratogenic. Women receiving ambrisentan must be advised of the risk of foetal harm and alternative therapy initiated if pregnancy occurs
Ambrisentan [1], prostanoids ---> SmPC of [1] of EMA
The efficacy and safety of ambrisentan when co-administered with other treatments for PAH (e.g. prostanoids and soluble guanylate cyclase stimulators) has not been specifically studied in controlled clinical trials in PAH patients.
Ambrisentan [1], rifampicin ---> SmPC of [1] of EMA
Transient increase in exposition to ambrisentan. Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin
Ambrisentan [1], sildenafil ---> SmPC of [1] of EMA
Co-administration of ambrisentan with a phosphodiesterase inhibitor, either sildenafil or tadalafil (both substrates of CYP3A4) in healthy volunteers did not significantly affect the pharmacokinetics of the phosphodiesterase inhibitor or ambrisentan
Ambrisentan [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Steady-state administration of ketoconazole (a strong inhibitor of CYP3A4) did not result in a clinically significant increase in exposure to ambrisentan
Ambrisentan [1], tadalafil ---> SmPC of [1] of EMA
Co-administration of ambrisentan with a phosphodiesterase inhibitor, either sildenafil or tadalafil (both substrates of CYP3A4) in healthy volunteers did not significantly affect the pharmacokinetics of the phosphodiesterase inhibitor or ambrisentan
Ambrisentan [1], warfarin ---> SmPC of [1] of EMA
Ambrisentan had no effects on the steady-state pharmacokinetics and anti-coagulant activity of warfarin in a healthy volunteer study. Warfarin also had no clinically significant effects on the pharmacokinetics of ambrisentan.
Ambrisentan [1], warfarin ---> SmPC of [1] of EMA
In addition, in patients, ambrisentan had no overall effect on the weekly warfarin-type anticoagulant dose, prothrombin time (PT) and international normalised ratio (INR).
Ambrisentan [1], women of childbearing potential ---> SmPC of [1] of EMA
Ambrisentan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced. Monthly pregnancy tests are recommended.
Ambrisentan [1], xenobiotic transporters ---> SmPC of [1] of EMA
In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations
Ambrisentan, cabozantinib [2] ---> SmPC of [2] of EMA
Cabozantinib may have the potential to increase plasma concentrations of co-administered substrates of P-gp. Subjects should be cautioned regarding taking a P-gp substrate while receiving cabozantinib.
Ambrisentan, lomitapide [2] ---> SmPC of [2] of EMA
Coadministration of Lojuxta with P gp may increase the absorption of P gp substrates. Dose reduction of the P gp substrate should be considered when used concomitantly with Lojuxta.
Ambrisentan, vemurafenib [2] ---> SmPC of [2] of EMA
Caution should be exercised when dosing vemurafenib concurrently with P-gp substrates and dose reduction of the concomitant medicinal product may be considered, if clinically indicated.
CONTRAINDICATIONS of Ambrisentan (Volibris)
- Hypersensitivity to the active substance, to soya, or to any of the excipients listed in section 6.1.
- Pregnancy
- Women of child-bearing potential who are not using reliable contraception
- Breast-feeding
- Severe hepatic impairment (with or without cirrhosis)
- Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT))>3xULN
- Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension
https://www.ema.europa.eu/en/documents/product-information/volibris-epar-product-information_en.pdf 02/05/2024
Other trade names: Ambrisentan Mylan,
Ambroxol
Ambroxol, antibiotics
Increased concentration of antibiotic in pulmonary tissue.
Ambroxol, antitussives
Dangerous secretory congestion due to cough reflex inhibition. Co-administration is not recommended
Ambroxol, breast-feeding
Ambroxol is excreted in human breast milk. Strict indication
Ambroxol, foods
Ambroxol syrup and drops should be taken with food.
Ambroxol, pregnancy
Do not administer during the first trimester of pregnancy.
Amifampridine (Firdapse)
Ability to drive, amifampridine [2] ---> SmPC of [2] of EMA
Due to adverse reactions such as drowsiness, dizziness, seizures and blurred vision, amifampridine may have minor or moderate influence on the ability to drive or use machines
Amifampridine [1], anticholinergics ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration.
Amifampridine [1], antiparkinsonian agents ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration.
Amifampridine [1], atropinic antispasmodic ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration.
Amifampridine [1], atropinic effect ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration.
Amifampridine [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from FIRDAPSE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Amifampridine [1], bupropion ---> SmPC of [1] of EMA
The concomitant use of amifampridine and substances known to lower the epileptic threshold leads to an increased risk of seizures
Amifampridine [1], butyrophenones ---> SmPC of [1] of EMA
The concomitant use of amifampridine and substances known to lower the epileptic threshold leads to an increased risk of seizures
Amifampridine [1], cholinergic agents ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with cholinergic effects may lead to an increased effect of both products and should be taken into consideration.
Amifampridine [1], cimetidine ---> SmPC of [1] of EMA
Potent cytochrome P450 (CYP450) enzyme inhibitors e.g. cimetidine, ketoconazole are not likely to inhibit the metabolism of amifampridine by human N-acetyl-transferase enzymes (NATs) giving rise to increased amifampridine exposure.
Amifampridine [1], cisapride ---> SmPC of [1] of EMA
The concomitant use with sultopride or other medicinal products known to cause QT prolongation is contraindicated as this combination may lead to an enhanced risk of ventricular tachycardia, notably torsade de pointes
Amifampridine [1], clozapine ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration.
Amifampridine [1], depolarizing muscle relaxants ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with depolarising muscle relaxant effects may lead to a decreased effect of both products and should be taken into consideration.
Amifampridine [1], direct cholinesterase inhibitors ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with cholinergic effects may lead to an increased effect of both products and should be taken into consideration.
Amifampridine [1], disopyramide ---> SmPC of [1] of EMA
The concomitant use with sultopride or other medicinal products known to cause QT prolongation is contraindicated as this combination may lead to an enhanced risk of ventricular tachycardia, notably torsade de pointes
Amifampridine [1], domperidone ---> SmPC of [1] of EMA
The concomitant use with sultopride or other medicinal products known to cause QT prolongation is contraindicated as this combination may lead to an enhanced risk of ventricular tachycardia, notably torsade de pointes
Amifampridine [1], drugs with a narrow therapeutic window ---> SmPC of [1] of EMA
Concomitant use of medicinal products with a narrow therapeutic window is contraindicated (see section 4.3).
Amifampridine [1], enzyme inductors ---> SmPC of [1] of EMA
The results from in vitro studies suggest there is low potential for drug-drug interactions due to enzyme induction of CYP1A2, CYP2B6, and CYP3A4 enzymes by amifampridine.
Amifampridine [1], enzyme inhibitors ---> SmPC of [1] of EMA
Regardless, patients should be closely monitored for adverse reactions when initiating treatment with a potent enzyme or renal transporter inhibitor.
Amifampridine [1], fertility ---> SmPC of [1] of EMA
Non-clinical safety data are available regarding the effects of amifampridine on reproductive function. No impairment of fertility has been observed in non-clinical studies with amifampridine (see section 5.3).
Amifampridine [1], foods ---> SmPC of [1] of EMA
Tablets are to be taken with food. Overall, food slowed and decreased the absorption of amifampridine
Amifampridine [1], ketoconazole ---> SmPC of [1] of EMA
The concomitant use with sultopride or other medicinal products known to cause QT prolongation is contraindicated as this combination may lead to an enhanced risk of ventricular tachycardia, notably torsade de pointes
Amifampridine [1], mefloquine ---> SmPC of [1] of EMA
The concomitant use of amifampridine and substances known to lower the epileptic threshold leads to an increased risk of seizures
Amifampridine [1], metabolism ---> SmPC of [1] of EMA
Thus, special care should be taken in patients undergoing concomitant treatment with medicinal products eliminated through metabolism or active secretion. Monitoring is advised when possible.
Amifampridine [1], mivacurium ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with non-depolarising muscle relaxant effects may lead to a decreased effect of both products and should be taken into consideration.
Amifampridine [1], muscle relaxants (non-depolarizing) ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with non-depolarising muscle relaxant effects may lead to a decreased effect of both products and should be taken into consideration.
Amifampridine [1], parasympathomimetics ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with cholinergic effects may lead to an increased effect of both products and should be taken into consideration.
Amifampridine [1], phenothiazines ---> SmPC of [1] of EMA
The concomitant use of amifampridine and substances known to lower the epileptic threshold leads to an increased risk of seizures
Amifampridine [1], pipercurium ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with non-depolarising muscle relaxant effects may lead to a decreased effect of both products and should be taken into consideration.
Amifampridine [1], pregnancy ---> SmPC of [1] of EMA
FIRDAPSE should not be used during pregnancy.
Amifampridine [1], pregnancy ---> SmPC of [1] of EMA
Amifampridine has shown no effect on embryo-foetal viability and development in rabbits; however, in rats, an increase in the number of mothers delivering still-born offspring was observed (see section 5.3).
Amifampridine [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
The concomitant use with sultopride or other medicinal products known to cause QT prolongation is contraindicated as this combination may lead to an enhanced risk of ventricular tachycardia, notably torsade de pointes
Amifampridine [1], rifampicin ---> SmPC of [1] of EMA
The concomitant use with sultopride or other medicinal products known to cause QT prolongation is contraindicated as this combination may lead to an enhanced risk of ventricular tachycardia, notably torsade de pointes
Amifampridine [1], seizure-threshold lowering drugs ---> SmPC of [1] of EMA
The concomitant use of amifampridine and substances known to lower the epileptic threshold leads to an increased risk of seizures
Amifampridine [1], SSRI ---> SmPC of [1] of EMA
The concomitant use of amifampridine and substances known to lower the epileptic threshold leads to an increased risk of seizures
Amifampridine [1], sultopride ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with atropinic effects may reduce the effect of both active substances and should be taken into consideration.
Amifampridine [1], suxamethonium ---> SmPC of [1] of EMA
The concomitant use of amifampridine and medicinal products with depolarising muscle relaxant effects may lead to a decreased effect of both products and should be taken into consideration.
Amifampridine [1], tramadol ---> SmPC of [1] of EMA
The concomitant use of amifampridine and substances known to lower the epileptic threshold leads to an increased risk of seizures
Amifampridine [1], tricyclic antidepressant ---> SmPC of [1] of EMA
The concomitant use of amifampridine and substances known to lower the epileptic threshold leads to an increased risk of seizures
Amifampridine [1], tubular secretion ---> SmPC of [1] of EMA
Thus, special care should be taken in patients undergoing concomitant treatment with medicinal products eliminated through metabolism or active secretion. Monitoring is advised when possible.
Amifampridine [1], women of childbearing age ---> SmPC of [1] of EMA
Women of childbearing potential must use effective contraception during FIRDAPSE treatment.
Amifampridine, barbiturates
Potent inducers of enzymes that metabolize medicinal products may increase amifampridine elimination and give rise to subtherapeutic exposure of amifampridine.
Amifampridine, carbamazepine
Potent inducers of enzymes that metabolize medicinal products may increase amifampridine elimination and give rise to subtherapeutic exposure of amifampridine.
CONTRAINDICATIONS of Amifampridine (Firdapse)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Epilepsy
- Uncontrolled asthma
- Concomitant use with sultopride
- Concomitant use with medicinal products with a narrow therapeutic window
- Concomitant use with medicinal products with a known potential to cause QTc prolongation
- In patients with congenital QT syndromes
https://www.ema.europa.eu/en/documents/product-information/firdapse-epar-product-information_en.pdf 25/05/2022
Other trade names: Amifampridine SERB, Firdapse (previously Zenas),
Amifostine
Amifostine, antihypertensives ---> SPC of [telmisartan] of EMA
Based on its pharmacological properties it can be expected that amifostine may potentiate the hypotensive effects of all antihypertensives
Amifostine, betablockers ---> SPC of [propranolol] of EMA
Drugs that induce postural hypotension may add their effects to that of beta-blockers.
Amifostine, breast-feeding
Breast-feeding must be stopped before beginning treatment
Amifostine, carteolol
Increased antihypertensive effect
Amifostine, eplerenone [2] ---> SPC of [2] of eMC
Co-administration of eplerenone with amifostine may potentially increase antihypertensive effects and risk of postural hypotension.
Amifostine, hydralazine
Concomitant use of hydralazine and amifostine can enhance the hypotensive effect. Concomitant use should be done 24 hours after interrupting the treatment with hydralazine
Amifostine, losartan [2] ---> SPC of [2] of eMC
Concomitant use of losartan with other substances inducing hypotension may increase the risk of hypotension.
Amifostine, losartan/hydrochlorothiazide [2] ---> SPC of [2] of eMC
Concomitant use of losartan with drugs that lower blood pressure, as main or side-effect, may increase the risk of hypotension.
Amifostine, nebivolol [2] ---> SPC of [2] of eMC
Concomitant use of amifostine with antihypertensives is likely to increase the fall in blood pressure, therefore the dosage of the antihypertensive medication should be adjusted accordingly.
Amifostine, pregnancy
Contraindicated
Amifostine, telmisartan [2] ---> SPC of [2] of EMA
Based on its pharmacological properties it can be expected that amifostine may potentiate the hypotensive effects of all antihypertensives including telmisartan
Amifostine, telmisartan/amlodipine [2] ---> SPC of [2] of EMA
Medicinal products with blood pressure lowering potential may potentiate the hypotensive effects of all antihypertensives
Amikacine
Ability to drive, amikacine [2] ---> SPC of [2] of eMC
Due to the occurrence of some adverse reactions the ability to drive and use machinery may be impaired.
Amikacine [1], aminoglycoside antibiotics ---> SPC of [1] of eMC
Concurrent or serial use of amikacin with other neurotoxic, ototoxic or nephrotoxic agents should be avoided either systemically or topically because of the potential for additive effects.
Amikacine [1], amphotericin ---> SPC of [1] of eMC
Concurrent or serial use of amikacin with other neurotoxic, ototoxic or nephrotoxic agents should be avoided either systemically or topically because of the potential for additive effects.
Amikacine, anaesthetics
The use of amikacin is not recommended in patients under the influence of anaesthetics or muscle-relaxing drugs as neuromuscular blockade and consequent respiratory depression may occur.
Amikacine, bacitracin
Concurrent or serial use of amikacin with other neurotoxic, ototoxic or nephrotoxic agents should be avoided either systemically or topically because of the potential for additive effects.
Amikacine [1], beta-lactam antibiotics ---> SPC of [1] of eMC
In vitro admixture of aminoglycosides with beta-lactam antibiotics (penicillins or cephalosporins) may result in significant mutual inactivation.
Amikacine, botulinus toxin
The co-administration may enhance the neuromuscular blockade
Amikacine [1], breast-feeding ---> SPC of [1] of eMC
It is not known whether amikacin is excreted in human milk. A decision should be made whether to discontinue breastfeeding or to discontinue therapy.
Amikacine, buclizine
Buclizine may mask the ototoxicity symptoms of aminoglycoside antibiotics
Amikacine, capreomycin
Concurrent or serial use of amikacin with other neurotoxic, ototoxic or nephrotoxic agents should be avoided either systemically or topically because of the potential for additive effects.
Amikacine [1], cephalosporins ---> SPC of [1] of eMC
Increased nephrotoxicity has been reported following concomitant parenteral administration of aminoglycoside antibiotics and cephalosporins.
Amikacine [1], cisplatin ---> SPC of [1] of eMC
Concurrent or serial use of amikacin with other neurotoxic, ototoxic or nephrotoxic agents should be avoided either systemically or topically because of the potential for additive effects.
Amikacine, clindamycin
Concurrent administration of aminoglycoside antibiotics with clindamycin may increase the risk of nephrotoxicity
Amikacine, curare-type muscle relaxants
The co-administration may enhance the neuromuscular blockade
Amikacine, cyclizine
Cyclizine may mask the ototoxicity symptoms of aminoglycoside antibiotics
Amikacine [1], cyclosporine ---> SPC of [1] of eMC
Concurrent or serial use of amikacin with other neurotoxic, ototoxic or nephrotoxic agents should be avoided either systemically or topically because of the potential for additive effects.
Amikacine, cytotoxic agents
Concurrent administration of aminoglycoside antibiotics with cytotoxic agents may increase the risk of nephrotoxicity
Amikacine, daunorubicin
Concurrent administration of amikacine and other potentially ototoxic or nephrotoxic drugs should be avoided.
Amikacine [1], ethacrynic acid ---> SPC of [1] of eMC
The risk of ototoxicity is increased when amikacin is used in conjunction with rapidly acting diuretic drugs, particularly when the diuretic is administered intravenously.
Amikacine [1], furosemide ---> SPC of [1] of eMC
The risk of ototoxicity is increased when amikacin is used in conjunction with rapidly acting diuretic drugs, particularly when the diuretic is administered intravenously.
Amikacine [1], halogenated anaesthetics ---> SPC of [1] of eMC
The use of amikacin is not recommended in patients under the influence of anaesthetics or muscle-relaxing drugs as neuromuscular blockade and consequent respiratory depression may occur.
Amikacine, immunosuppressives
Concurrent administration of aminoglycoside antibiotics with immunosuppresive agents may increase the risk of nephrotoxicity
Amikacine [1], indometacin ---> SPC of [1] of eMC
Indomethacin may increase the plasma concentration of amikacin in neonates.
Amikacine, loxapine
Loxapine may mask the ototoxicity symptoms of aminoglycoside antibiotics
Amikacine, magnesium
The neuromuscular blocking effect of magnesium salts can be increased by amikacin
Amikacine, meclozine
Meclozine may mask the ototoxicity symptoms of aminoglycoside antibiotics
Amikacine [1], muscle relaxants ---> SPC of [1] of eMC
The use of amikacin is not recommended in patients under the influence of anaesthetics or muscle-relaxing drugs as neuromuscular blockade and consequent respiratory depression may occur.
Amikacine, nephrotoxic substances
Concurrent use with other potentially nephrotoxic drug substances should be avoided.
Amikacine, opioid analgesics
Concurrent administration of amikacin with opioid analgesics may be additive with the respiratory depressant effects
Amikacine, ototoxic agents
Concurrent and/or sequential use of the aminoglycoside antibiotic with other medicinal products with ototoxic potential should be avoided
Amikacine, oxaliplatin
There is an increased risk of nephrotoxicity and possibly of ototoxicity when aminoglycosides are administered with platinum compounds.
Amikacine [1], pancuronium ---> SPC of [1] of eMC
The use of amikacin is not recommended in patients under the influence of anaesthetics or muscle-relaxing drugs as neuromuscular blockade and consequent respiratory depression may occur.
Amikacine, phenothiazines
Phenothiazines may mask the ototoxicity symptoms of aminoglycoside antibiotics
Amikacine, platinum compounds
There is an increased risk of nephrotoxicity and possibly of ototoxicity when aminoglycosides are administered with platinum compounds.
Amikacine, polypeptide antibiotics
The administration concurrent or sequential of polypeptide antibiotics with aminoglycoside antibiotics may increase the risk of nephrotoxicity and/or of neuromuscular blockade that can cause respiratory depression or paralysis (apnea)
Amikacine [1], pregnancy ---> SPC of [1] of eMC
Amikacin should be administered to pregnant women and neonatal infants only when clearly needed and under medical supervision
Amikacine, procainamide
The co-administration may enhance the neuromuscular blockade
Amikacine [1], strong diuretic agents ---> SPC of [1] of eMC
The risk of ototoxicity is increased when amikacin is used in conjunction with rapidly acting diuretic drugs, particularly when the diuretic is administered intravenously.
Amikacine, tacrolimus
The combination may increase the risk of nephrotoxicity. Renal function must be closely monitored.
Amikacine, thiamine
Concomitantly administered thiamine (vitamin B1) may be destroyed by the reactive sodium metabisulfite component of the amikacin sulfate formulation.
Amikacine, thioxanthenes
Thioxanthenes may mask the ototoxicity symptoms of aminoglycoside antibiotics
Amikacine, trimethobenzamide
Trimethobenzamide may mask the ototoxicity symptoms of aminoglycoside antibiotics
Amikacine [1], tubocuranine ---> SPC of [1] of eMC
The use of amikacin is not recommended in patients under the influence of anaesthetics or muscle-relaxing drugs as neuromuscular blockade and consequent respiratory depression may occur.
Amikacine, vancomycin [2] ---> SPC of [2] of eMC
Concurrent or sequential systemic or topical use of other potentially neurotoxic or nephrotoxic drugs may potentiate the nephrotoxicity and/or ototoxicity of vancomycin and consequently requires careful monitoring.
Aminoglycoside antibiotics, beta-lactam antibiotics ---> SPC of [amikacine] of eMC
In vitro admixture of aminoglycosides with beta-lactam antibiotics (penicillins or cephalosporins) may result in significant mutual inactivation.
Aminoglycoside antibiotics, cephalosporins ---> SPC of [amikacine] of eMC
Increased nephrotoxicity has been reported following concomitant parenteral administration of aminoglycoside antibiotics and cephalosporins.
Aminoglycoside antibiotics, colistin
The administration concurrent or sequential of polypeptide antibiotics with aminoglycoside antibiotics may increase the risk of nephrotoxicity and/or of neuromuscular blockade that can cause respiratory depression or paralysis (apnea)
Aminoglycoside antibiotics, methoxyflurane
Concurrent administration of aminoglycoside antibiotics with methoxyflurane may increase the risk of nephrotoxicity. The concurrent administration should be avoided
Aminoglycoside antibiotics, penicillins ---> SPC of [amikacine] of eMC
In vitro admixture of aminoglycosides with beta-lactam antibiotics (penicillins or cephalosporins) may result in significant mutual inactivation.
Aminoglycoside antibiotics, phenothiazines
Phenothiazines may mask the ototoxicity symptoms of aminoglycoside antibiotics
Aminoglycoside antibiotics, polymyxin
The administration concurrent or sequential of polypeptide antibiotics with aminoglycoside antibiotics may increase the risk of nephrotoxicity and/or of neuromuscular blockade that can cause respiratory depression or paralysis (apnea)
Aminoglycoside antibiotics, polypeptide antibiotics
The administration concurrent or sequential of polypeptide antibiotics with aminoglycoside antibiotics may increase the risk of nephrotoxicity and/or of neuromuscular blockade that can cause respiratory depression or paralysis (apnea)
Aminoglycoside antibiotics, pregnancy
The aminoglycoside antibiotic crosses the placenta
Aminoglycoside antibiotics, thioxanthenes
Thioxanthenes may mask the ototoxicity symptoms of aminoglycoside antibiotics
CONTRAINDICATIONS of Amikacine
- Myasthenia gravis.
- Amikacin sulfate injection is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients
- A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any aminoglycoside because of the known cross sensitivities of patients to drugs in this class.
http://www.medicines.org.uk/emc/
Amiloride
ACE inhibitors, amiloride
When amiloride hydrochloride is administered concomitantly with an ACE inhibitor the risk of hyperkalaemia may be increased.
AIIRA, amiloride
When amiloride hydrochloride is administered concomitantly with an angiotensin II receptor antagonist the risk of hyperkalaemia may be increased.
NSAID, amiloride ---> SPC of [amiloride/hydrochlorothiazide] of eMC
Concomitant administration of NSAIDs and potassium-sparing agents may cause hyperkalemia
Amiloride, antihypertensives
Increased hypotensive effect
Amiloride, barbiturates
Increased hypotensive effect
Amiloride, benazepril
Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.
Amiloride, breast-feeding
The mother should either stop breastfeeding or cease taking the drug.
Amiloride, captopril [2] ---> SPC of [2] of eMC
Potassium sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Amiloride, cilazapril [2] ---> SPC of [2] of eMC
Potassium sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Amiloride, cyclosporine
When amiloride hydrochloride is administered concomitantly with ciclosporin the risk of hyperkalaemia may be increased.
Amiloride, delapril
Concomitant administration of potassium-sparing diuretics or potassium salts may increase the risk of hypercaliemia
Amiloride, digitoxin
The co-administration may decrease the positive inotrope effect of digitoxin and promote heart rhythm disorders
Amiloride, digoxin
The co-administration may decrease the positive inotrope effect of digoxin and promote heart rhythm disorders
Amiloride, dofetilide
Caution should be taken when drugs that are actively secreted via this route are co-administered with dofetilide
Amiloride, enalapril [2] ---> SPC of [2] of eMC
Potassium sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Amiloride, enalapril/hydrochlorothiazide [2] ---> SPC of [2] of eMC
ACE inhibitors attenuate diuretic induced potassium loss. Potassium sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Amiloride, felodipine/ramipril [2] ---> SPC of [2] of eMC
The combination may increase the serum potassium concentration and requires close monitoring of serum potassium. The combination is not recommended
Amiloride, foods
Take with food to reduce irritation.
Amiloride, fosinopril [2] ---> SPC of [2] of eMC
Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.
Amiloride, imidapril [2] ---> SPC of [2] of eMC
Potassium sparing diuretics or supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium (potentially lethal), mainly in conjunction with renal impairment (additive hyperkaliemic effects)
Amiloride, indapamide [2] ---> SPC of [2] of eMC
Whilst rational combinations are useful in some patients, hypokalaemia or hyperkalaemia (particularly in patients with renal failure or diabetes) may still occur. Plasma potassium and ECG should be monitored and, if necessary, treatment re
Amiloride, lisinopril [2] ---> SPC of [2] of eMC
The use of potassium supplements, potassium-sparing diuretics or potassium-containing salt substitutes, particularly in patients with impaired renal function, may lead to a significant increase in serum potassium.
Amiloride, lithium
Lithium should not generally be given with diuretics because they reduce it renal clearance and add a high risk of lithium toxicity.
Amiloride, losartan [2] ---> SPC of [2] of eMC
Concomitant use of other drugs which retain potassium or may increase potassium levels, potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. Co-medication is not advisable.
Amiloride, losartan/hydrochlorothiazide [2] ---> SPC of [2] of eMC
The co-administration may lead to increases in serum potassium. Co-medication is not advisable.
Amiloride, metildigoxin
Effect weakening of metildigoxin
Amiloride, moexipril
Potassium-sparing diuretics potassium supplements or potassium-containing salt substitutes have been shown to increase the risk of hyperkalaemia when used concomitantly with ACE inhibitors.
Amiloride, oral antidiabetics
Decreased antidiabetic effect
Amiloride, perindopril [2] ---> SPC of [2] of eMC
Hyperkalaemia (potentially lethal), especially in conjunction with renal impairment (additive hyperkaliemic effects). The combination is not recommended
Amiloride, potassium
The combination may lead to hyperkalemia, particularly in renal failure. Co-administration is not recommended
Amiloride, potassium canrenoate
The co-administration of ACE inhibitors with potassium canreonate may result in an increase in serum potassium levels up to life threatening hyperkaliemia. It can also cause acute renal failure
Amiloride, potassium chloride [2] ---> SPC of [2] of eMC
Combined treatment of potassium chloride with potassium sparing diuretics increase the risk of hyperkalaemia
Amiloride, potassium-sparing diuretics
The combination may lead to hyperkalemia, particularly in renal failure. Co-administration is not recommended
Amiloride, pregnancy
Amiloride is not recommended for use during pregnancy due to limited clinical experience.
Amiloride, quinapril [2] ---> SPC of [2] of eMC
Concomitant treatments of quinapril with potassium sparing diuretics, potassium supplements or potassium salts should be used with caution and with appropriate monitoring of serum potassium.
Amiloride, sacubitril/valsartan [2] ---> SPC of [2] of EMA
Concomitant use of potassium-sparing diuretics, mineralocorticoid antagonists, potassium supplements, salt substitutes containing potassium or other agents (such as heparin) may lead to increases in serum potassium, and to increases in serum creatinine.
Amiloride, spirapril
Increased risk of hyperkalemia, particularly in renal failure
Amiloride, spironolactone [2] ---> SPC of [2] of eMC
Spironolactone should not be administered concurrently with other potassium-sparing diuretics as this may induce hyperkalaemia.
Amiloride, tacrolimus [2] ---> SPC of [2] of EMA
As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics should be avoided
Amiloride, telmisartan [2] ---> SPC of [2] of EMA
As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia. The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia
Amiloride, telmisartan/amlodipine ---> SPC of [telmisartan] of EMA
As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia. The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia
Amiloride, trandolapril [2] ---> SPC of [2] of eMC
Potassium-sparing diuretics or potassium supplements may increase the risk of hyperkalaemia, particularly in renal failure.
Amiloride, trandolapril/verapamil [2] ---> SPC of [2] of eMC
Potassium sparing diuretics may lead to significant increases in serum potassium, particularly in the presence of renal function impairment.
Amiloride, triamterene
Increased risk of severe hyperkalaemia when given amiloride with triamterene
Amiloride, valsartan [2] ---> SPC of [2] of eMC
Concomitant use with of valsartan with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other agents that may increase potassium levels (heparin, etc.) is not recommended.
Amiloride, vasodilators
Increased hypotensive effect
Amiloride, xipamide
The co-administration may cause hypokaliemia or hyperkaliemia
Amiloride, zofenopril
Potassium sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Combination is not recommended
CONTRAINDICATIONS of Amiloride
- Hyperkalaemia (plasma potassium over 5.5 mmol/l);
- other potassium-conserving agents or potassium supplements;
- anuria,
- acute renal failure,
- severe progressive renal disease,
- diabetic nephropathy;
- known sensitivity to amiloride;
- use in children as safety has not been established.
http://www.medicines.org.uk/emc/
Amiloride/hydrochlorothiazide
ACE inhibitors, amiloride/hydrochlorothiazide [2] ---> SPC of [2] of eMC
When amiloride hydrochloride is administered concomitantly with an ACE inhibitor the risk of hyperkalaemia may be increased.
AIIRA, amiloride/hydrochlorothiazide
When amiloride hydrochloride is administered concomitantly with an angiotensin II receptor antagonist the risk of hyperkalaemia may be increased.
NSAID, amiloride ---> SPC of [amiloride/hydrochlorothiazide] of eMC
Concomitant administration of NSAIDs and potassium-sparing agents may cause hyperkalemia
NSAID, amiloride/hydrochlorothiazide [2] ---> SPC of [2] of eMC
NSAIDs may reduce the effect of antihypertensive drugs, including the diuretic, natriuretic and antihypertensive effects of diuretics. Co-administration of NSAIDs and potassium-sparing agents may cause hyperkalemia, particularly in elderly patients.
NSAID, potassium-sparing diuretics ---> SPC of [amiloride/hydrochlorothiazide] of eMC
Concomitant administration of NSAIDs and potassium-sparing agents may cause hyperkalemia, particularly in elderly patients.
Ability to drive, amiloride/hydrochlorothiazide [2] ---> SPC of [2] of eMC
Infrequently, patients may experience weakness, fatigue, dizziness, stupor and vertigo. Should any of these occur, the patient should be cautioned not to drive or operate machinery.
Adrenaline, amiloride/hydrochlorothiazide
The effect of adrenaline can be weaken with the concomitant administration of amiloride/hydrochlorothiazide
Alcohol, amiloride/hydrochlorothiazide [2] ---> SPC of [2] of eMC
Co-administration with alcohol may potentiate orthostatic hypotension.
Amiloride/hydrochlorothiazide, antigout preparations
The effect of uric acid lowering agents can be weaken with the concomitant administration of amiloride/hydrochlorothiazide
Amiloride/hydrochlorothiazide, antihypertensives
The hypotensive effect of amiloride/hydrochlorothiazide can be enhanced by other hypotensive agents
Amiloride/hydrochlorothiazide [1], barbiturates ---> SPC of [1] of eMC
Co-administration with barbiturates may potentiate orthostatic hypotension.
Amiloride/hydrochlorothiazide, betablockers
The hypotensive effect of amiloride/hydrochlorothiazide can be enhanced by betablockers. The concomitant use also increases the risk of hyperglycemia
Amiloride/hydrochlorothiazide [1], breast-feeding ---> SPC of [1] of eMC
Although it is not known whether amiloride is excreted in human milk, it is known that hydrochlorothiazide is excreted in human milk in small amounts. Thiazides in high doses causing intense diuresis can inhibit the milk production.
Amiloride/hydrochlorothiazide, captopril
In patients receiving amiloride/hydrochlorothiazide, there is the risk of significant hypotension and worsening of renal function at beginning of an additional treatment with ACE inhibitors. Increased risk of hypercaliemia
Amiloride/hydrochlorothiazide, cardiac glycosides
The effect of the cardiac glycoside may be enhanced in case of potassium and/or magnesium loss
Amiloride/hydrochlorothiazide, curare-type muscle relaxants
The effect of curare-type muscle relaxant may be enhanced or prolonged by amiloride/hydrochlorothiazide
Amiloride/hydrochlorothiazide, cyclophosphamide
The co-administration of amiloride/hydrochlorothiazide and cytostatic agents may increase the risk of myelotoxicity (particularly granulocytopenia)
Amiloride/hydrochlorothiazide [1], cyclosporine ---> SPC of [1] of eMC
When amiloride hydrochloride is administered concomitantly with ciclosporin the risk of hyperkalaemia may be increased.
Amiloride/hydrochlorothiazide, cytostatics
The co-administration of amiloride/hydrochlorothiazide and cytostatic agents may increase the risk of myelotoxicity (particularly granulocytopenia)
Amiloride/hydrochlorothiazide, diuretics
The hypotensive effect of amiloride/hydrochlorothiazide can be enhanced by other diuretic agents
Amiloride/hydrochlorothiazide, enalapril
In patients receiving amiloride/hydrochlorothiazide, there is the risk of significant hypotension and worsening of renal function at beginning of an additional treatment with ACE inhibitors. Increased risk of hypercaliemia
Amiloride/hydrochlorothiazide, fluorouracil
The co-administration of amiloride/hydrochlorothiazide and cytostatic agents may increase the risk of myelotoxicity (particularly granulocytopenia)
Amiloride/hydrochlorothiazide, furosemide
The co-administration of amiloride/hydrochlorothiazide and kaliuretic diuretics (e. g. furosemide) may increase the potassium loss
Amiloride/hydrochlorothiazide, indometacin
Indometacin may decrease the antihypertensive and antidiuretic effect of amiloride/hydrochlorothiazide and increase the risk of hypercaliemia
Amiloride/hydrochlorothiazide, insulin
The effect of oral antidiabetics or insulin can be weaken with the concomitant administration of amiloride/hydrochlorothiazide
Amiloride/hydrochlorothiazide, kaliuretic medicines
The co-administration of amiloride/hydrochlorothiazide and kaliuretic diuretics (e. g. furosemide) may increase the potassium loss
Amiloride/hydrochlorothiazide [1], lithium ---> SPC of [1] of eMC
Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.
Amiloride/hydrochlorothiazide, methotrexate
The co-administration of amiloride/hydrochlorothiazide and cytostatic agents may increase the risk of myelotoxicity (particularly granulocytopenia)
Amiloride/hydrochlorothiazide, narcotics
Co-administration with narcotics may potentiate orthostatic hypotension.
Amiloride/hydrochlorothiazide, non-potassium-sparing diuretics
The co-administration of amiloride/hydrochlorothiazide and kaliuretic diuretics (e. g. furosemide) may increase the potassium loss
Amiloride/hydrochlorothiazide, noradrenaline
The effect of noradrenaline can be weaken with the concomitant administration of amiloride/hydrochlorothiazide
Amiloride/hydrochlorothiazide, oral antidiabetics
The effect of oral antidiabetics or insulin can be weaken with the concomitant administration of amiloride/hydrochlorothiazide
Amiloride/hydrochlorothiazide, organic nitrates
The hypotensive effect of amiloride/hydrochlorothiazide can be enhanced by nitrates
Amiloride/hydrochlorothiazide, phenothiazines
The hypotensive effect of amiloride/hydrochlorothiazide can be enhanced by phenothiazines
Amiloride/hydrochlorothiazide, potassium
Concomitant administration of potassium-sparing diuretics or potassium salts may increase the risk of hypercaliemia
Amiloride/hydrochlorothiazide, potassium-sparing diuretics
Concomitant administration of potassium-sparing diuretics or potassium salts may increase the risk of hypercaliemia
Amiloride/hydrochlorothiazide [1], pregnancy ---> SPC of [1] of eMC
There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester. Its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects
Amiloride/hydrochlorothiazide, salicylates
Salicylates and other NSAIDs (e. g. indometacin) may decrease the antihypertensive and antidiuretic effect of amiloride/hydrochlorothiazide
Amiloride/hydrochlorothiazide, spironolactone
Concomitant administration of potassium-sparing diuretics or potassium salts may increase the risk of hypercaliemia
Amiloride/hydrochlorothiazide [1], tacrolimus ---> SPC of [1] of eMC
When amiloride hydrochloride is administered concomitantly with tacrolimus the risk of hyperkalaemia may be increased.
Amiloride/hydrochlorothiazide, triamterene
Concomitant administration of potassium-sparing diuretics or potassium salts may increase the risk of hypercaliemia
Amiloride/hydrochlorothiazide, tricyclic antidepressants
The hypotensive effect of amiloride/hydrochlorothiazide can be enhanced by tricyclic antidepressants
Amiloride/hydrochlorothiazide, vasodilators
The hypotensive effect of amiloride/hydrochlorothiazide can be enhanced by vasodilatators
Ibuprofen, potassium-sparing diuretics ---> SPC of [amiloride/hydrochlorothiazide] of eMC
Concomitant administration of NSAIDs and potassium-sparing agents may cause hyperkalemia
CONTRAINDICATIONS of Amiloride/hydrochlorothiazide
- Hyperkalaemia (plasma potassium over 5.5 mmol/l); other potassium-conserving diuretics.
- Potassium supplements or potassium-rich food (except in severe and/or refractory cases of hypokalaemia under careful monitoring);
- concomitant use with spironolactone or triamterene;
- anuria;
- acute renal failure,
- severe progressive renal disease,
- severe hepatic failure,
- precoma associated with hepatic cirrhosis,
- Addison's disease,
- hypercalcaemia,
- concurrent lithium therapy,
- diabetic nephropathy;
- patients with blood urea over 10 mmol/l,
- patients with diabetes mellitus, or
- those with serum creatinine over 130 µmol/l in whom serum electrolyte and blood urea levels cannot be monitored carefully and frequently.
- Prior hypersensitivity to amiloride hydrochloride, hydrochlorothiazide or other sulphonamide derived drugs.
- In renal impairment, use of a potassium-conserving agent may result in rapid development of hyperkalaemia.
- Because the safety of amiloride hydrochloride for use in children has not been established, 'Moduret 25' is not recommended for children.
- For 'Use in pregnancy' and 'Use in breast-feeding mothers', see 'Pregnancy and Lactation'.
http://www.medicines.org.uk/emc/
Amiodarone
CYP3A4 inductors, amiodarone
The CYP3A4 induction may decrease the plasma concentrations of amiodarone
IMAOs, amiodarone
The concomitant use is contra-indicated
P-glycoprotein substrates, amiodarone
Amiodarone, P-gp inhibitor, may increase the plasma concentrations of substrates of P-glycoprotein
QT interval prolonging drugs, amiodarone [2] ---> SPC of [2] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
St. John's wort, amiodarone
The strong CYP3A4 induction may decrease the plasma concentrations of amiodarone. St. John's Wort should be avoided
Abiraterone [1], amiodarone ---> SPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes
Acecumarol, amiodarone
Amiodarone, CYP2C9 inhibitor, may increase the plasma concentrations and the risk of bleeding of acecumarol
Acenocoumarol [1], amiodarone ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Afatinib [1], amiodarone ---> SPC of [1] of EMA
Increased exposure to afatinib. It is recommended to administer strong P-gp inhibitors using staggered dosing, preferably 6 hours or 12 hours apart from afatinib
Agalsidase alfa [1], amiodarone ---> SPC of [1] of EMA
Agalsidase alfa should not be co-administered with amiodarone since this substance has the potential to inhibit intra-cellular alfa-galactosidase activity.
Agalsidase beta [1], amiodarone ---> SPC of [1] of EMA
Agalsidase beta should not be administered with amiodarone due to a theoretical risk of inhibition of intra-cellular alfa-galactosidase activity.
Aliskiren [1], amiodarone ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Aliskiren/amlodipine [1], amiodarone ---> SPC of [1] of EMA
Aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion. Caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors
Aliskiren/amlodipine/hydrochlorothiazide [1], amiodarone ---> SPC of [1] of EMA
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Aliskiren/hydrochlorothiazide [1], amiodarone ---> SPC of [1] of EMA
The moderate inhibition of P-glycoprotein may increase aliskiren gastrointestinal absorption and decrease its biliary excretion. Caution is recommended
Allopurinol/lesinurad [1], amiodarone ---> SPC of [1] of EMA
Lesinurad exposure is increased when it is co-administered with inhibitors of CYP2C9. Therefore, it is recommended that Duzallo should be used with caution in patients taking moderate inhibitors of CYP2C9.
Amantadine, amiodarone
The co-administration of amantadine with drugs that prolong the QT interval is contraindicated
Amiodarone [1], amisulpride ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone [1], amphotericin ---> SPC of [1] of eMC
Increased risk of hypokaliemia induced disorders of heart rhythm with intravenous amphotericin
Amiodarone, amprenavir [2] ---> SPC of [2] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amiodarone, amprenavir/ritonavir ---> SPC of [amprenavir] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4). Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Amiodarone, antiarrhythmics
The use of amiodarone with other antiarrhythmics or arrhytmogenic medicinal products may increase the incidence of cardiac arrhythmias and should be avoided
Amiodarone, apixaban [2] ---> SPC of [2] of EMA
Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp are expected to increase apixaban plasma concentration to a lesser extent. No dose adjustment for apixaban is required
Amiodarone, arrhytmogenic agents
The use of amiodarone with other antiarrhythmics or arrhytmogenic medicinal products may increase the incidence of cardiac arrhythmias and should be avoided
Amiodarone, arsenic trioxide [2] ---> SPC of [2] of EMA
Caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause QT/QTc interval prolongation
Amiodarone, atazanavir [2] ---> SPC of [2] of EMA
The CYP3A inhibition may increase the amiodarone plasma levels. Caution is warranted and therapeutic concentration monitoring is recommended when available.
Amiodarone, atazanavir/cobicistat [2] ---> SPC of [2] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Amiodarone, atenolol [2] ---> SPC of [2] of eMC
Amiodarone with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Amiodarone, atenolol/chlortalidone [2] ---> SPC of [2] of eMC
Amiodarone with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Amiodarone, atenolol/nifedipine ---> SPC of [atenolol] of eMC
Amiodarone with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Amiodarone [1], atorvastatin ---> SPC of [1] of eMC
The risk of muscular toxicity is increased by concomitant administration of amiodarone with statins metabolised by CYP 3A4 such as simvastatin, atorvastatin and lovastatin.
Amiodarone, azithromycin [2] ---> SPC of [2] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Amiodarone, bendroflumethiazide
The cardiac toxicity of amiodarone is increased if hypokalaemia occurs.
Amiodarone [1], benzothiazepines ---> SPC of [1] of eMC
Certain calcium channel inhibitors (diltiazem, verapamil); potentiation of negative chronotropic properties and conduction slowing effects may occur. Combined therapy is not recommended
Amiodarone [1], bepridil ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone [1], betablockers ---> SPC of [1] of eMC
Beta blockers and amiodarone: potentiation of negative chronotropic properties and conduction slowing effects may occur. Combined therapy is not recommended
Amiodarone, betaxolol
The combination may cause cardiac alterations of rhythm, contractibility and stimulus conduction by suppression of sympathetic compensatory mechanisms
Amiodarone, bimatoprost/timolol [2] ---> SPC of [2] of EMA
There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral anti-arrhythmics (including amiodarone)
Amiodarone, bisoprolol [2] ---> SPC of [2] of eMC
The combination of class-III antiarrhythmic medicinal products with bisoprolol may potentiate the effect on atrio-ventricular conduction time
Amiodarone, boceprevir [2] ---> SPC of [2] of EMA
Caution should be exercised with boceprevir and medicines known to prolong QT interval
Amiodarone, bosutinib [2] ---> SPC of [2] of EMA
Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation
Amiodarone [1], breast-feeding ---> SPC of [1] of eMC
Amiodarone is excreted into the breast milk in significant quantities and breast-feeding is contra-indicated.
Amiodarone, brinzolamide/timolol [2] ---> SPC of [2] of EMA
There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral anti-arrhythmics (including amiodarone)
Amiodarone, budipine
The co-administration of budipine with drugs known to prolong QT interval is contraindicated
Amiodarone, carteolol [2] ---> SPC of [2] of eMC
There is a potential for additive effects resulting in hypotension and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with antiarrhythmics (including amiodarone)
Amiodarone, carvedilol [2] ---> SPC of [2] of eMC
Isolated cases of conduction disturbance (rarely compromised haemodynamics) have been reported, if oral carvedilol and amiodarone are given concomitantly.
Amiodarone, celiprolol [2] ---> SPC of [2] of eMC
Care should be taken in prescribing beta-adrenoceptor blockers with Class I antiarrhythmic agents, since these agents may potentiate the negative effects on A-V conduction and myocardial contractility.
Amiodarone, ceritinib [2] ---> SPC of [2] of EMA
Ceritinib should be used with caution in patients taking other medicinal products that may lead to QT prolongation. Monitoring of the QT interval is indicated in the event of combinations of such medicinal products
Amiodarone, cerivastatin
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of the statine and the risk of rhabdomyolysis
Amiodarone, chloroquine [2] ---> SPC of [2] of eMC
If the patient is taking amiodarone then chloroquine may increase the risk of cardiac arrhythmias including ventricular arrhythmias, bradycardias and cardiac conduction defect. Concurrent use is contraindicated.
Amiodarone [1], chlorpromazine ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs that may induce torsades de pointes is contraindicated
Amiodarone, cholestyramine
Cholestyramine may decrease plasma levels of amiodarone. Patients should take other drugs at least 1 hour before or 4-6 hours after colestyramine to minimize possible interference with their absorption.
Amiodarone [1], cisapride ---> SPC of [1] of eMC
The co-administration may prolong the QT interval and/or induce torsades de pointes and is contraindicated
Amiodarone, clarithromycin
Clarithromycin, CYP3A4 inhibitor, may increase the plasma concentrations of amiodarone (small therapeutic range). Clarithromycin should be used with caution
Amiodarone [1], class IA antiarrhythmic agents ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone, clomipramine [2] ---> SPC of [2] of eMC
The risk of QTc prolongation and Torsade de Pointes is likely to be increased if clomipramine is co-administered with other drugs that can cause QTc prolongation. Therefore concomitant use is not recommended
Amiodarone, cobicistat [2] ---> SPC of [2] of EMA
Co-administration of cobicistat with medicinal products which are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Amiodarone, cobimetinib [2] ---> SPC of [2] of EMA
Caution should be exercised if cobimetinib is coadministered with moderate CYP3A inhibitors. When cobimetinib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.
Amiodarone, colesevelam
Bile acid sequestrants may decrease the bioavailability of amiodarone.
Amiodarone [1], corticosteroids ---> SPC of [1] of eMC
Caution should be exercised over combined therapy with drugs which may also cause hypokalaemia and/or hypomagnesaemia
Amiodarone, crizotinib [2] ---> SPC of [2] of EMA
Concomitant use of crizotinib (prolongs QT interval) with medicinal products known to prolong QT interval or medicinal products able to induce Torsades de pointes should be carefully considered.
Amiodarone, cyclophosphamide
The co-administration may increase the pulmonary toxicity
Amiodarone, cyclosporine [2] ---> SPC of [2] of eMC
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of cyclosporine
Amiodarone, dabigatran etexilate [2] ---> SPC of [2] of EMA
Dabigatran etexilate is a substrate for the efflux transporter P-gp. Caution should be exercised with mild to moderate P-gp inhibitors
Amiodarone, daclatasvir [2] ---> SPC of [2] of EMA
Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone with or without other drugs that lower heart rate. The mechanism is not established.
Amiodarone, darunavir/cobicistat [2] ---> SPC of [2] of EMA
Co-administration of darunavir/cobicistat with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Amiodarone, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Co-administration is contraindicated due to the potential for serious and/or life-threatening adverse reactions
Amiodarone, darunavir/ritonavir ---> SPC of [darunavir] of EMA
Co-administration of darunavir boosted with ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events is contraindicated
Amiodarone, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SPC of [ombitasvir/paritaprevir/ritonavir] of EM
Ritonavir is a strong inhibitor of CYP3A. Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events are contraindicated
Amiodarone, degarelix [2] ---> SPC of [2] of EMA
The combination of degarelix with medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes should be carefully evaluated
Amiodarone, delamanid [2] ---> SPC of [2] of EMA
Treatment with delamanid should not be initiated in patients with risk factors like taking medicinal products that are known to prolong the QTc interval, unless the possible benefit is considered to outweigh the potential risks.
Amiodarone, dextromethorphan
The CYP2D6 inhibition may increase the plasma concentrations of dextromethorphan
Amiodarone, dicoumarol
Amiodarone, CYP2C9 inhibitor, may increase the plasma concentrations and the risk of bleeding of dicoumarol
Amiodarone [1], digital glycosides ---> SPC of [1] of eMC
The co-administration may alter the cardiac automatism (severe bradycardia) and the atrioventricular conduction (synergic effect).
Amiodarone [1], digoxin ---> SPC of [1] of eMC
The co-administration will bring about an increase in the plasma digoxin concentration and thus precipitate symptoms and signs associated with high digoxin levels.
Amiodarone [1], dihydroergotamine ---> SPC of [1] of eMC
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of dihydroergotamine
Amiodarone, dihydropyridines
Concomitant administration of dihydropyridines with amiodarone may enhance the negative inotrope effect of amiodarone
Amiodarone [1], diltiazem ---> SPC of [1] of eMC
Certain calcium channel inhibitors (diltiazem, verapamil); potentiation of negative chronotropic properties and conduction slowing effects may occur. Combined therapy is not recommended
Amiodarone [1], disopyramide ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone, dorzolamide/timolol [2] ---> SPC of [2] of eMC
There is a potential for additive effects resulting in hypotension and/or marked bradycardia when ophthalmic betablockers solution is administered concomitantly with antiarrhythmics
Amiodarone, droperidol [2] ---> SPC of [2] of eMC
Medicinal products known to prolong the QTc interval should not be concomitantly administered with droperidol.
Amiodarone, drugs primarily metabolised by CYP2C9
Amiodarone raises the plasma concentrations of CYP2C9 substrates, like warfarin and phenytoin, by inhibition of CYP 2C9.
Amiodarone [1], drugs primarily metabolised by CYP3A4 ---> SPC of [1] of eMC
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of the medicinal products mainly metabolized by CYP3A4
Amiodarone, edoxaban [2] ---> SPC of [2] of EMA
Concomitant use of edoxaban with quinidine, verapamil, or amiodarone does not require dose reduction based on clinical data
Amiodarone, eliglustat [2] ---> SPC of [2] of EMA
Because eliglustat is predicted to cause mild increases in ECG intervals at substantially elevated plasma concentrations, use of eliglustat should be avoided in combination with Class IA and Class III antiarrhythmic medicinal products.
Amiodarone, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may increase plasma concentrations of these products, which are associated with the potential for serious/life-threatening adverse reactions. Contraindicated
Amiodarone, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Co-administration of Stribild and other medicinal products primarily metabolised by CYP3A such as amiodarone, quinidine, cisapride, pimozide, alfuzosin and sildenafil for pulmonary arterial hypertension is contraindicated
Amiodarone, enalapril/hydrochlorothiazide [2] ---> SPC of [2] of eMC
Increased risk of torsades de pointes.
Amiodarone, encorafenib [2] ---> SPC of [2] of EMA
Moderate CYP3A4 inhibitors should be co-administered with caution. When encorafenib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.
Amiodarone, enzalutamide [2] ---> SPC of [2] of EMA
The concomitant use of enzalutamide with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes should be carefully evaluated
Amiodarone, eplerenone [2] ---> SPC of [2] of eMC
Moderate CYP3A4 inhibitors may increase the AUC of eplerenone. Eplerenone dosing should not exceed 25 mg when moderate inhibitors of CYP3A4 are co-administered with eplerenone
Amiodarone [1], ergotamine ---> SPC of [1] of eMC
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of ergotamine
Amiodarone [1], erythromycin ---> SPC of [1] of eMC
The combined therapy of amiodarone with intravenous erythromycin is contra-indicated (prolongation of QT interval and increased risk of torsades de pointes)
Amiodarone, esmolol [2] ---> SPC of [2] of eMC
Concomitant use of esmolol and amiodarone can increase the action of both on the AV-conductance time and induce negative inotropic effect.
Amiodarone, etravirine [2] ---> SPC of [2] of EMA
Etravirine is expected to decrease plasma concentrations of this antiarrhythmic. Caution is warranted and therapeutic concentration monitoring, if available, is recommended for antiarrhythmics when co-administered with etravirine.
Amiodarone, ezetimibe/atorvastatin [2]
Moderate CYP3A4 inhibitors may increase plasma concentrations of atorvastatin. Appropriate clinical monitoring of the patient is recommended when concomitantly used with moderate CYP3A4 inhibitors.
Amiodarone, ezetimibe/simvastatine [2] ---> SPC of [2] of eMC
The risk of myopathy and rhabdomyolysis is increased by concomitant administration of amiodarone with simvastatin
Amiodarone, felodipine/metoprolol ---> SPC of [metoprolol] of eMC
Class I anti-arrhythmic drugs may have potentiating effects on atrial-conduction time and induce negative inotropic effect of metoprolol.
Amiodarone, fenofibrate/simvastatin [2] ---> SPC of [2] of EMA
The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone with simvastatin 40 mg per day.
Amiodarone, fentanyl [2] ---> SPC of [2] of EMA
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of fentanyl
Amiodarone, fidaxomicin [2] ---> SPC of [2] of EMA
Fidaxomicin is a substrate of P-gp. Co-administration of potent inhibitors of P-gp increases fidaxomicin exposure. Co-administration of potent inhibitors of P-gp is not recommended.
Amiodarone [1], flecainide ---> SPC of [1] of eMC
Amiodarone, CYP2D6 inhibitor, may increase the plasma concentrations of flecainide
Amiodarone, fosamprenavir/ritonavir ---> SPC of [fosamprenavir] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4). Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Amiodarone [1], fosphenytoin ---> SPC of [1] of eMC
Amiodarone, CYP2C9 inhibitor, may increase the plasma concentrations of phenytoin
Amiodarone, furosemide
Caution should be exercised over combined therapy with drugs which may also cause hypokalaemia and/or hypomagnesaemia
Amiodarone, galantamine [2] ---> SPC of [2] of eMC
As expected with cholinomimetics, a pharmacodynamic interaction is possible with medicinal products that significantly reduce the heart rate
Amiodarone, gatifloxacin
The co-administration of gatifloxacin with medicinal products that prolong the QT interval should be avoided
Amiodarone, gemifloxacin
The co-administration of gemifloxacin with medicinal products that prolong the QT interval should be avoided
Amiodarone, general anesthetics
Bradycardia unresponsive to atropine, hypotension, disturbances of conduction, decreased cardiac output.
Amiodarone [1], glucocorticoids ---> SPC of [1] of eMC
Caution should be exercised over combined therapy with drugs which may also cause hypokalaemia and/or hypomagnesaemia
Amiodarone, grapefruit juice
The CYP3A4 inhibitors may inhibit the amiodarone metabolism and increase its plasma concentrations. It is recommended to avoid the CYP3A4 inhibitors (e. g. grapefruit juice)
Amiodarone [1], haloperidol ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone, hydralazine
The co-administration may increase the hypotensive effect
Amiodarone, hydrochlorothiazide ---> SPC of [losartan/hydrochlorothiazide] of eMC
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Amiodarone [1], hydroquinidine ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone, hydroxychloroquine
Concomitant use of hydroxychloroquine and arrhytmogenic agents may increase the risk of cardiac arrhythmias
Amiodarone, hydroxyzine [2] ---> SPC of [2] of eMC
Co-administration of hydroxyzine with drugs known to prolong the QT interval and/or induce Torsade de Pointes increase the risk of cardiac arrhythmia. Therefore, the combination is contra-indicated
Amiodarone [1], hypokalemia ---> SPC of [1] of eMC
Caution should be exercised over combined therapy with drugs which may also cause hypokalaemia and/or hypomagnesaemia
Amiodarone, ibrutinib [2] ---> SPC of [2] of EMA
Ibrutinib is primarily metabolised by cytochrome P450 enzyme 3A4. Concomitant use of ibrutinib and medicinal products that moderately inhibit CYP3A4 can increase ibrutinib exposure and should be avoided.
Amiodarone, ibutilide
Possible prolongation of refractory period. Contraindicated: Combination, administration within 4 hours after infusion and only if the QTc has returned to its basal value
Amiodarone, idelalisib [2] ---> SPC of [2] of EMA
The co-administration of idelalisib with amiodarone may increase the serum concentrations of amiodarone. Idelalisib should not be co-administered with amiodarone.
Amiodarone, indapamide [2] ---> SPC of [2] of eMC
The co-administration may increase the risk of ventricular arrhythmias, particularly torsades de pointes (hypokalemia is a risk factor)
Amiodarone, indinavir [2] ---> SPC of [2] of EMA
Indinavir with or without ritonavir should not be administered with medicinal products with narrow therapeutic ranges and which are CYP3A4 substrates. The elevated plasma concentrations of these medicines may cause serious or life-threatening reactions.
Amiodarone, indinavir/ritonavir ---> SPC of [indinavir] of EMA
Indinavir with or without ritonavir should not be administered with medicinal products with narrow therapeutic ranges and which are CYP3A4 substrates. The elevated plasma concentrations of these medicines may cause serious or life-threatening reactions.
Amiodarone, interferon
Caution should be used when administering interferon with medicines mainly metabolised by hepatic cytochrome P450 and have a narrow therapeutic window
Amiodarone, iohexol
Increased risk of cardiotoxicity and arrhythmias
Amiodarone, ivabradine [2] ---> SPC of [2] of EMA
The concomitant use of cardiovascular and non-cardiovascular QT prolonging medicinal products with ivabradine should be avoided since QT prolongation may be exacerbated by heart rate reduction.
Amiodarone [1], kaliuretic medicines ---> SPC of [1] of eMC
Caution should be exercised over combined therapy with drugs which may also cause hypokalaemia and/or hypomagnesaemia
Amiodarone, latanoprost/timolol [2] ---> SPC of [2] of eMC
There is a potential for additive effects resulting in hypotension and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with antiarrhythmics (including amiodarone)
Amiodarone, ledipasvir/sofosbuvir [2] ---> SPC of [2] of EMA
Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone with or without other drugs that lower heart rate. The mechanism is not established.
Amiodarone, lercanidipine [2] ---> SPC of [2] of eMC
Caution should be exercised when lercanidipine is co-prescribed with other substrates of CYP3A4
Amiodarone, lesinurad [2] ---> SPC of [2] of EMA
Lesinurad exposure is increased when it is co-administered with inhibitors of CYP2C9. It is recommended that Zurampic should be used with caution in patients taking moderate inhibitors of CYP2C9.
Amiodarone, letermovir [2] ---> SPC of [2] of EMA
Co-administration of PREVYMIS may result in clinically relevant increases in the plasma concentrations of co-administered CYP3A substrates
Amiodarone, levobunolol
There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blocker solutions are administered concomitantly with anti-arrhythmics
Amiodarone [1], levomepromazine ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone, levothyroxine
Inhibition of peripheral conversion of T4 to T3. Amiodarone may give rise to either hypothyroidism or hyperthyroidism
Amiodarone [1], lidocaine ---> SPC of [1] of eMC
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of lidocaine
Amiodarone, lidocaine/prilocaine [2] ---> SPC of [2] of EMA
Patients on anti-arrhythmic medicinal products class III should be treated with caution.
Amiodarone, liothyronine
Inhibition of conversion of T4 to T3. Amiodarone may give rise to either hypothyroidism or hyperthyroidism
Amiodarone, lomitapide [2] ---> SPC of [2] of EMA
Caution should be exercised when lomitapide is used with other medicinal products known to have potential for hepatotoxicity
Amiodarone, lopinavir
The strong CYP3A4 inhibition increases the plasma concentrations of amiodarone. The coadministration is contraindicated.
Amiodarone, lopinavir/ritonavir [2] ---> SPC of [2] of EMA
Lopinavir/ritonavir should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events.
Amiodarone, losartan/hydrochlorothiazide [2] ---> SPC of [2] of eMC
Periodic monitoring of serum potassium and ECG is recommended when losartan/hydrochlorothiazide is administered with torsades de pointes-inducing medicinal products
Amiodarone [1], lovastatine ---> SPC of [1] of eMC
The risk of muscular toxicity is increased by concomitant administration of amiodarone with statins metabolised by CYP 3A4 such as simvastatin, atorvastatin and lovastatin.
Amiodarone, lurasidone [2] ---> SPC of [2] of EMA
Caution is advised when prescribing lurasidone with medicinal products known to prolong the QT interval
Amiodarone, manidipine
Caution is recommend when manidipine is co-administrated with other CYP3A4 substrates
Amiodarone, mequitazine
Concomitant use of mequitazine with drugs that prolong the QT interval is contraindicated
Amiodarone, metildigoxin
Increased plasma levels of metildigoxin
Amiodarone, metoprolol [2] ---> SPC of [2] of eMC
Class I anti-arrhythmic drugs may have potentiating effects on atrial-conduction time and induce negative inotropic effect of metoprolol.
Amiodarone, metronidazole
The co-administration may prolong the QT interval and cause torsade de pointes arrhythmias
Amiodarone [1], midazolam ---> SPC of [1] of eMC
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of midazolam
Amiodarone [1], mineralocorticoids ---> SPC of [1] of eMC
Caution should be exercised over combined therapy with drugs which may also cause hypokalaemia and/or hypomagnesaemia
Amiodarone, moxifloxacin [2] ---> SPC of [2] of eMC
The co-administration may have an additive effect on the QT interval prolongation. This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes. The combination is contraindicated.
Amiodarone, nadolol
Alterations of contractility, automatism and conduction (suppression of sympathetic compensatory mechanisms). Concomitant use is not recommended
Amiodarone, nebivolol [2] ---> SPC of [2] of eMC
The concomitant use should be done with caution as the effect on atrioventricular conduction time may be potentiated
Amiodarone, nelfinavir [2] ---> SPC of [2] of EMA
Co-administration of nelfinavir with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4 is contraindicated.
Amiodarone, nilotinib [2] ---> SPC of [2] of EMA
Significant prolongation of the QT interval may occur when nilotinib is inappropriately taken with medicinal products with a known potential to prolong QT. Prolongation of the QT interval may expose patients to the risk of fatal outcome.
Amiodarone, nitrendipine
Calcium antagonist may potentiate the negative inotrope effect of antiarrthymics leading to sinus arrest and AV block
Amiodarone, nitrous oxide
The pulmonary toxicity of amiodarone may be exacerbated by inhalation of high oxygen concentrations
Amiodarone, non-potassium-sparing diuretics
Caution should be exercised over combined therapy with diuretics which may also cause hypokalaemia and/or hypomagnesaemia
Amiodarone, ombitasvir/paritaprevir/ritonavir [2] ---> SPC of [2] of EMA
Ritonavir is a strong inhibitor of CYP3A. Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events are contraindicated
Amiodarone, orlistat [2] ---> SPC of [2] of EMA
Possible decrease of the amiodarone plasma levels
Amiodarone, oxprenolol [2] ---> SPC of [2] of eMC
Amiodarone may increase atrial-conduction time and induce negative inotropic effect when administered concomitantly with beta-blockers.
Amiodarone, oxygen
A few cases of adult respiratory distress syndrome
Amiodarone, oxygen therapy
Post-operative respiratory complications, sometimes with fatal outcome.
Amiodarone, padeliporfin [2] ---> SPC of [2] of EMA
Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.
Amiodarone, paliperidone [2] ---> SPC of [2] of EMA
Caution is advised when prescribing paliperidone with medicines known to prolong the QT interval
Amiodarone, panobinostat [2] ---> SPC of [2] of EMA
Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.
Amiodarone, pasireotide [2] ---> SPC of [2] of EMA
Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval
Amiodarone [1], pentamidine ---> SPC of [1] of eMC
The combined therapy of amiodarone with intravenous pentamidine is contra-indicated (prolongation of QT interval and increased risk of torsades de pointes)
Amiodarone, phenazone
Concomitant use of phenazone and antiarrhythmics delays the elimination of phenazone. There is the possibility of an accumulation
Amiodarone, phenindione
Amiodarone potentiates the effect of phenindione
Amiodarone, phenothiazines
The use of amiodarone with other antiarrhythmics or arrhytmogenic medicinal products may increase the incidence of cardiac arrhythmias and should be avoided
Amiodarone, phenprocoumon
Enhancement of phenprocoumon effect and increased bleeding risk with the concomitant administration of amiodarone
Amiodarone [1], phenylalkylamines ---> SPC of [1] of eMC
Certain calcium channel inhibitors (diltiazem, verapamil); potentiation of negative chronotropic properties and conduction slowing effects may occur. Combined therapy is not recommended
Amiodarone [1], phenytoin ---> SPC of [1] of eMC
Amiodarone, CYP2C9 inhibitor, may increase the plasma concentrations of phenytoin
Amiodarone [1], pimozide ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone, pipamperone
The co-administration of drugs that can prolong the QT interval should be avoided
Amiodarone, piperaquine ---> SPC of [piperaquine/artenimol] of EMA
The combination of piperaquine with drugs that are known to prolong the QTc interval is contraindicated: additive effect on the QTc interval
Amiodarone, piperaquine/artenimol [2] ---> SPC of [2] of EMA
The combination of piperaquine/dihydroartemisinin with drugs that are known to prolong the QTc interval is contraindicated: additive effect on the QTc interval
Amiodarone, pirfenidone [2] ---> SPC of [2] of EMA
Special care should be exercised if CYP1A2 inhibitors are being used concomitantly with potent inhibitors of one or more other CYP isoenzymes involved in the metabolism of pirfenidone
Amiodarone, prazepam
The strong CYP3A4 inhibition may increase the plasma concentrations of prazepam. Caution is recommended
Amiodarone [1], pregnancy ---> SPC of [1] of eMC
In view of its effect on the foetal thyroid gland, amiodarone is contraindicated during pregnancy, except in exceptional circumstances.
Amiodarone, propafenone [2] ---> SPC of [2] of eMC
Combination of amiodarone and propafenone can affect conduction and repolarisation and lead to abnormalities that have the potential to be proarrhythmic. Dose adjustments of both compounds based on therapeutic response may be required.
Amiodarone, propranolol [2] ---> SPC of [2] of EMA
The negative chronotropic properties of amiodarone may be additive to those seen with beta-blockers. Automatism and conduction disorders are expected because of the suppression of sympathetic compensative mechanisms.
Amiodarone, proteolytic enzymes enriched in bromelain [2] ---> SPC of [2] of EMA
NexoBrid, when absorbed, is an inhibitor of CYP2C8 and CYP2C9. This should be taken into account if it is used in patients receiving CYP2C8 substrates
Amiodarone, protirelin
Enhancement of TSH-increase
Amiodarone, pyridoxine
Possibly increased of amiodarone induced photosensitivity
Amiodarone [1], quinidine ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone [1], quinolones ---> SPC of [1] of eMC
There have been rare reports of QTc interval prolongation in patients taking amiodarone with fluoroquinolones. Concomitant use should be avoided
Amiodarone, ribociclib [2] ---> SPC of [2] of EMA
Coadministration of ribociclib at the 600 mg dose this CYP3A4 substrates should be avoided. Co-administration of Kisqali with medicines with a known potential to prolong the QT interval such as anti-arrhythmic medicinal products should be avoided
Amiodarone, risperidone [2] ---> SPC of [2] of eMC
Caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval
Amiodarone, ritonavir [2] ---> SPC of [2] of EMA
Ritonavir co-administration with amiodarone is likely to result in increased plasma concentrations of amiodarone and is therefore contraindicated
Amiodarone, roxithromycin
Caution is warranted for concomitant use of roxitromycin with other QT interval prolonging medicines
Amiodarone, saquinavir/ritonavir ---> SPC of [saquinavir] of EMA
The combination is contraindicated due to the potential for life threatening cardiac arrhythmia
Amiodarone [1], sildenafil ---> SPC of [1] of eMC
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of sildenafil
Amiodarone, simeprevir [2] ---> SPC of [2] of EMA
Simeprevir, inhibitor of intestinal CYP3A4, may increase the plasma levels of amiodarone. Mild increases in simeprevir concentrations may occur due to inhibition of CYP3A4 by amiodarone.
Amiodarone, simeprevir [2] ---> SPC of [2] of EMA
Treatment regimen with sofosbuvir: Use only if no other alternative is available. Close monitoring is recommended if this medicinal product is administered with OLYSIO in combination with sofosbuvir
Amiodarone, simvastatine [2] ---> SPC of [2] of eMC
The risk of myopathy and rhabdomyolysis is increased by concomitant administration of amiodarone with simvastatin. The dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with amiodarone.
Amiodarone, sodium iodide
The withdrawal period prior to administration of sodium [131I]iodine is ca. 4 weeks
Amiodarone, sodium picosulfate
Hypokaliemia may be a risk of torsades de pointes in patients treated with antiarrhythmics
Amiodarone, sofosbuvir [2] ---> SPC of [2] of EMA
Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another direct-acting antiviral (DAAs, including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone
Amiodarone, sofosbuvir/velpatasvir [2] ---> SPC of [2] of EMA
Cases of severe bradycardia and heart block have been observed when sofosbuvir used in combination with another direct acting antiviral, is used with concomitant amiodarone with or without other medicinal products that lower heart rate.
Amiodarone, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SPC of [2] of EMA
Cases are potentially life threatening, therefore amiodarone should only be used in patients on Vosevi when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Amiodarone [1], sotalol ---> SPC of [1] of eMC
Combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone [1], statins metabolised by CYP3A4 ---> SPC of [1] of eMC
The risk of muscular toxicity is increased by concomitant administration of amiodarone with statins metabolised by CYP 3A4 such as simvastatin, atorvastatin and lovastatin.
Amiodarone [1], stimulant laxatives ---> SPC of [1] of eMC
Stimulant laxatives, which may cause hypokalaemia thus increasing the risk of torsades de pointes; other types of laxatives should be used.
Amiodarone, strong CYP2C8 inhibitors
The CYP2C8 inhibitors may inhibit the amiodarone metabolism and increase its plasma concentrations
Amiodarone, strong CYP3A4 inductors
The strong CYP3A4 induction may decrease the plasma concentrations of amiodarone
Amiodarone, strong CYP3A4 inhibitors
The CYP3A4 inhibitors may inhibit the amiodarone metabolism and increase its plasma concentrations. It is recommended to avoid the CYP3A4 inhibitors (e. g. grapefruit juice)
Amiodarone [1], sulpiride ---> SPC of [1] of eMC
Combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone [1], tacrolimus ---> SPC of [1] of eMC
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of ergotamine
Amiodarone, tamoxifen
Amiodarone may decrease the therapeutic effect of Tamoxifen by decreasing the production of active metabolites.
Amiodarone, telaprevir [2] ---> SPC of [2] of EMA
Concomitant administration of telaprevir is contraindicated with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Amiodarone, telithromycin [2] ---> SPC of [2] of EMA
Due to a potential to increase the QT interval, telithromycin should be used with care during concomitant administration with QT interval prolonging agents
Amiodarone, telmisartan/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Periodic monitoring of serum potassium and ECG is recommended when MicardisPlus is administered with drugs affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and torsades de pointes inducing medicinal products
Amiodarone, temsirolimus [2] ---> SPC of [2] of EMA
Concomitant treatment with moderate CYP3A4 inhibitors should only be administered with caution in patients receiving 25 mg and should be avoided in patients receiving temsirolimus doses higher than 25 mg.
Amiodarone, terbinafine
Co-administration of terbinafine with drugs that inhibit CYP2C9 and CYP3A4 may increase the exposure to terbinafine
Amiodarone, terfenadine
The use of amiodarone with other antiarrhythmics or arrhytmogenic medicinal products may increase the incidence of cardiac arrhythmias and should be avoided
Amiodarone, tetrabenazine [2] ---> SPC of [2] of eMC
Tetrabenazine should be used with caution with drugs known to prolong QTc
Amiodarone [1], tetracosactide ---> SPC of [1] of eMC
Caution should be exercised over combined therapy with drugs which may also cause hypokalaemia and/or hypomagnesaemia
Amiodarone [1], thioridazine ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone [1], tiapride ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone, timolol ---> SPC of [bimatoprost/timolol] of EMA
There is a potential for additive effects resulting in hypotension, and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral anti-arrhythmics (including amiodarone)
Amiodarone, tipranavir/ritonavir ---> SPC of [tipranavir] of EMA
Co-administration of tipranavir with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events, is contraindicated.
Amiodarone, tizanidine [2] ---> SPC of [2] of eMC
Concomitant administration of drugs known to inhibit the activity of CYP1A2 may increase the plasma levels of tizanidine. Co-administration of tizanidine inhibitors of CYP1A2 is not recommended
Amiodarone, tolterodine [2] ---> SPC of [2] of eMC
Tolterodine should be used with caution in patients with risk factors for QT-prolongation
Amiodarone, toremifene [2] ---> SPC of [2] of EMA
An additive effect on QT interval prolongation between toremifene and medicinal products that may prolong the QTc interval cannot be excluded. This might lead to an increased risk of ventricular arrhythmias. Co-administration is contraindicated
Amiodarone [1], torsades de pointes inducing drugs ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs that may induce torsades de pointes is contraindicated
Amiodarone, tramadol
Amiodarone may increase or decrease the effect of tramadol
Amiodarone, travoprost/timolol [2] ---> SPC of [2] of EMA
The potential exists for additive effects and production of hypotension and/or marked bradycardia.
Amiodarone, triamcinolone acetonide
Concomitant use of triamcinolone with class III antiarrhythmics is not recommended
Amiodarone [1], triazolam ---> SPC of [1] of eMC
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of triazolam
Amiodarone, tricyclic antidepressants
The use of amiodarone with other antiarrhythmics or arrhytmogenic medicinal products may increase the incidence of cardiac arrhythmias and should be avoided
Amiodarone [1], trifluoperazine ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone, triiodthyronine
Inhibition of conversion of T4 to T3. Amiodarone may give rise to either hypothyroidism or hyperthyroidism
Amiodarone, trimipramine
Additive QT-prolongation may occur, increasing the risk of serious ventricular arrhythmias. The co-administration should be used with caution
Amiodarone, vardenafil [2] ---> SPC of [2] of EMA
Medicinal products that may prolong QTc interval, including vardenafil, are best avoided in patients with relevant risk factors, for example concomitant administration of antiarrhythmic medicinal products in Class III
Amiodarone [1], verapamil ---> SPC of [1] of eMC
Certain calcium channel inhibitors (diltiazem, verapamil); potentiation of negative chronotropic properties and conduction slowing effects may occur. Combined therapy is not recommended
Amiodarone [1], vincamine ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amiodarone, vortioxetine [2] ---> SPC of [2] of EMA
The strong CYP2C9 inhibition may increase the AUC of vortioxetine. It is caution recommended with CYP2D6 poor metabolisers
Amiodarone [1], warfarin ---> SPC of [1] of eMC
Amiodarone, CYP2C9 inhibitor, may increase the plasma concentrations and the risk of bleeding of warfarin
Amiodarone, xipamide
The combination increases the risk of ventricular arrhythmias, particularly torsades de pointes (favored by hypokaliemia). It is recommended a special caution
Amiodarone, zuclopenthixol [2] ---> SPC of [2] of eMC
Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co-administration of other drugs known to significantly increase the QT interval. Co-administration of such drugs should be avoided.
CONTRAINDICATIONS of Amiodarone
- Sinus bradycardia and sino-atrial heart block. In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, Cordarone X should be used only in conjunction with a pacemaker.
- Evidence or history of thyroid dysfunction. Thyroid function tests should be performed where appropriate prior to therapy in all patients.
- Severe respiratory failure, circulatory collapse, or severe arterial hypotension; hypotension, heart failure and cardiomyopathy are also contra-indications when using Cordarone X Intravenous as a bolus injection.
- Known hypersensitivity to iodine or to amiodarone, or to any of the excipients. (One ampoule contains approximately 56 mg iodine).
- The combination of Cordarone X with drugs which may induce torsades de pointes is contra-indicated
- Due to the content of benzyl alcohol, Cordarone X Intravenous is contraindicated in newborns or premature neonates, infants and children up to 3 years old.
- Pregnancy - except in exceptional circumstances
- Lactation
All these above contra-indications do not apply to the use of amiodarone for cardiopulmonary resuscitation of shock resistant ventricular fibrillation.
http://www.medicines.org.uk/emc/
Amisulpride
CNS depressants, amisulpride [2] ---> SPC of [2] of eMC
Caution is advised when coadministering amisulpride with CNS depressants
QT interval prolonging drugs, amisulpride [2] ---> SPC of [2] of eMC
Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval
Ability to drive, amisulpride [2] ---> SPC of [2] of eMC
Even used as recommended, amisulpride may cause somnolence so that the ability to drive vehicles or operate machinery can be impaired
Alcohol, amisulpride [2] ---> SPC of [2] of eMC
Amisulpride may enhance the central effects of alcohol. Concomitant use is not recommended
Aliskiren/amlodipine/hydrochlorothiazide [1], amisulpride ---> SPC of [1] of EMA
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Amiodarone [1], amisulpride ---> SPC of [1] of eMC
The combined therapy of amiodarone with drugs which prolong the QT interval is contra-indicated due to the increased risk of torsades de pointes
Amisulpride, amphotericin B
The co-administration of amisulpride with IV amphotericin B may cause hypokaliemia und is not recommended
Amisulpride [1], anaesthetics ---> SPC of [1] of eMC
Caution is advised when coadministering amisulpride with CNS depressants
Amisulpride [1], analgesics ---> SPC of [1] of eMC
Caution is advised when coadministering amisulpride with CNS depressants
Amisulpride, antacids
Concomitant use of amisulpride with antacids which contain calcium or magnesium salts may decrease plasma concentrations of amisulpride
Amisulpride [1], antihypertensives ---> SPC of [1] of eMC
Caution is advised when coadministering amisulpride with antihypertensive drugs and other hypotensive medications
Amisulpride [1], anxiolytics ---> SPC of [1] of eMC
Caution is advised when coadministering amisulpride with CNS depressants
Amisulpride, astemizole
Concomitant use of amisulpride with astemizole is not recommended
Amisulpride [1], barbiturates ---> SPC of [1] of eMC
Caution is advised when coadministering amisulpride with CNS depressants
Amisulpride [1], benzodiazepines ---> SPC of [1] of eMC
Caution is advised when coadministering amisulpride with CNS depressants
Amisulpride, betablockers ---> SPC of [esmolol] of eMC
Special caution must be taken when using amisulpride concomitantly with beta-blockers.
Amisulpride [1], breast-feeding ---> SPC of [1] of eMC
It is not known whether amisulpride is excreted in breast milk, breast-feeding is therefore contra-indicated.
Amisulpride [1], bromocriptine ---> SPC of [1] of eMC
Amisulpride may oppose the effect of dopamine agonists. The combination is contraindicated
Amisulpride, carteolol
The co-administration increases the risk of heart rhythm disorders, particularly torsades de pointes
Amisulpride, chlorpromazine
Co-administration is not recommended
Amisulpride [1], class IA antiarrhythmic agents ---> SPC of [1] of eMC
Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval
Amisulpride [1], class III antiarrhythmic agents ---> SPC of [1] of eMC
Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval
Amisulpride [1], clonidine ---> SPC of [1] of eMC
Caution is advised when coadministering amisulpride with CNS depressants
Amisulpride, digital glycosides
Concomitant use of amisulpride with drugs inducing bradycardia is not recommended
Amisulpride, diltiazem
Concomitant use of amisulpride with drugs inducing bradycardia is not recommended
Amisulpride [1], disopyramide ---> SPC of [1] of eMC
Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval
Amisulpride, diuretics
Concomitant use of amisulpride with drugs inducing hypokaliemia is not recommended
Amisulpride [1], dopamine agonists ---> SPC of [1] of eMC
Amisulpride may oppose the effect of dopamine agonists. The combination is contraindicated
Amisulpride, droperidol
Medicinal products known to prolong the QTc interval should not be concomitantly administered with droperidol.
Amisulpride, drugs inducing bradycardia
Concomitant use of amisulpride with drugs inducing bradycardia is not recommended
Amisulpride, erythromycin
The co-administration can induce torsades de pointes and the combination with IV erythromycin is contraindicated.
Amisulpride, glucocorticoids
Concomitant use of amisulpride with drugs inducing hypokaliemia is not recommended
Amisulpride, guanfacin
Concomitant use of amisulpride with drugs inducing bradycardia is not recommended
Amisulpride, haloperidol
Concomitant use of amisulpride with haloperidol is not recommended
Amisulpride, hydrochlorothiazide ---> SPC of [losartan/hydrochlorothiazide] of eMC
Periodic monitoring of serum potassium and ECG is recommended, when hydrochlorothiazide is administered with drugs which may induce torsades de pointes
Amisulpride, hydroquinidine
Concomitant use is not recommended due to increased risk of heart rhythm disorders (torsades de pointes)
Amisulpride, hypokalemia
Concomitant use of amisulpride with drugs inducing hypokaliemia is not recommended
Amisulpride, ibutilide
Possible increase of proarrhythmic risk if ibutilide is used with drugs that prolong the QT interval. Contraindicated within 4 hours after completing infusion
Amisulpride, indapamide [2] ---> SPC of [2] of eMC
The co-administration may increase the risk of ventricular arrhythmias, particularly torsades de pointes (hypokalemia is a risk factor)
Amisulpride [1], levodopa ---> SPC of [1] of eMC
Antagonism of effects. Association contra-indicated
Amisulpride [1], lithium ---> SPC of [1] of eMC
As a precautionary measure, lithium should be avoided in patients concomitantly treated with drugs that are known to prolong the QT interval
Amisulpride, losartan/hydrochlorothiazide [2] ---> SPC of [2] of eMC
Periodic monitoring of serum potassium and ECG is recommended when losartan/hydrochlorothiazide is administered with torsades de pointes-inducing medicinal products
Amisulpride [1], mefloquine ---> SPC of [1] of eMC
Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval
Amisulpride [1], narcotics ---> SPC of [1] of eMC
Caution is advised when coadministering amisulpride with CNS depressants
Amisulpride, neuroleptics
The co-administration of amisulpride with neuroleptics can enhance the risk of torsades de pointes or can prolong the QT interval. Concomitant use should be avoided
Amisulpride, pasireotide [2] ---> SPC of [2] of EMA
Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval
Amisulpride, pimozide
Concomitant use of amisulpride with pimozide is not recommended
Amisulpride [1], pregnancy ---> SPC of [1] of eMC
Use of the drug is not recommended during pregnancy unless the benefits justify the potential risks.
Amisulpride [1], procainamide ---> SPC of [1] of eMC
Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval
Amisulpride [1], quinidine ---> SPC of [1] of eMC
Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval
Amisulpride, rivastigmine [2] ---> SPC of [2] of EMA
Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products should be observed with caution and clinical monitoring (ECG) may also be required.
Amisulpride [1], ropinirole ---> SPC of [1] of eMC
Amisulpride may oppose the effect of dopamine agonists. The combination is contraindicated
Amisulpride [1], sedating antihistamines ---> SPC of [1] of eMC
Caution is advised when coadministering amisulpride with CNS depressants
Amisulpride [1], sotalol ---> SPC of [1] of eMC
Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval
Amisulpride, stimulant laxatives
Concomitant use of amisulpride with drugs inducing hypokaliemia is not recommended
Amisulpride, sucralfate
Concomitant use of amisulpride with sucralfate may decrease plasma concentration of amisulpride
Amisulpride, telmisartan/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Periodic monitoring of serum potassium and ECG is recommended when MicardisPlus is administered with drugs affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and torsades de pointes inducing medicinal products
Amisulpride, terfenadine
Concomitant use of amisulpride with terfenadine is not recommended
Amisulpride, tetracosactide
Concomitant use of amisulpride with drugs inducing hypokaliemia is not recommended
Amisulpride, thioridazine
Concomitant use of amisulpride with medicines that may cause severe heart rhythm disorders (torsade de pointes) is contraindicated
Amisulpride, torsades de pointes inducing drugs
Concomitant use of amisulpride with medicines that may cause severe heart rhythm disorders (torsade de pointes) is contraindicated
Amisulpride, triamterene
Hypokalaemia caused by diuretics increases risk of ventricular arrhythmias with amisulpride
Amisulpride, tricyclic antidepressants
Concomitant use of amisulpride with tricyclic antidepressants is not recommended
Amisulpride, trifluoperazine
Co-administration is not recommended
Amisulpride, vandetanib [2] ---> SPC of [2] of EMA
The concomitant use of vandetanib with medicinal products known to also prolong the QTc interval and/or induce Torsades de pointes is either contraindicated or not recommended
Amisulpride, verapamil
Concomitant use of amisulpride with drugs inducing bradycardia is not recommended
Amisulpride, vincamine
The co-administration can induce torsades de pointes and the combination with IV vincamine is contraindicated.
Amisulpride, xipamide
The combination increases the risk of ventricular arrhythmias, particularly torsades de pointes (favored by hypokaliemia). It is recommended a special caution
CONTRAINDICATIONS of Amisulpride
- Hypersensitivity to the active ingredient or to other ingredients of the medicinal product
- Concomitant prolactin-dependent tumours (e.g. pituitary gland prolactinomas or breast cancer)
- Phaeochromocytoma
- Children before the onset of puberty
- Lactation
- Combination with levodopa
http://www.medicines.org.uk/emc/
Amlodipine
ACE inhibitors, amlodipine [2] ---> SPC of [2] of eMC
The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other medicinal products with antihypertensive properties.
CYP3A4 inhibitors, amlodipine ---> SPC of [amlodipine/valsartan] of EMA
The CYP3A4 inhibition may increase the plasma concentrations of amlodipine
St. John's wort, amlodipine ---> SPC of [amlodipine/valsartan] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Ability to drive, amlodipine
Dizziness, headache, fatigue or nausea may occur
Alfa1-adrenergic receptor blockers, amlodipine [2] ---> SPC of [2] of eMC
The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other medicinal products with antihypertensive properties.
Aliskiren [1], amlodipine ---> SPC of [1] of EMA
Co-administration of aliskiren with either metformin (< 28%), amlodipine (> 29%) or cimetidine (> 19%) resulted in between 20% and 30% change in Cmax or AUC of Rasilez.
Allopurinol/lesinurad [1], amlodipine ---> SPC of [1] of EMA
Patients using lipid lowering or anti-hypertensive medicinal products that were CYP3A substrates required concomitant medicinal product change when treated with lesinurad 200 mg in combination with a xanthine oxidase inhibitor
Amlodipine, antihypertensives ---> SPC of [aliskiren/amlodipine] of EMA
The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other antihypertensive medicinal products.
Amlodipine, atazanavir/cobicistat [2] ---> SPC of [2] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Amlodipine, atorvastatin [2] ---> SPC of [2] of eMC
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin
Amlodipine, avanafil [2] ---> SPC of [2] of EMA
Avanafil may potentiate the pressure-lowering effects. There was no effect of a single dose of avanafil on amlodipine plasma levels.
Amlodipine, azilsartan medoxomil [2] ---> SPC of [2] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Amlodipine, azole antifungals ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine [1], betablockers ---> SPC of [1] of eMC
The blood pressure lowering effects of amlodipine adds to the blood pressure-lowering effects of other medicinal products with antihypertensive properties.
Amlodipine, bisoprolol [2] ---> SPC of [2] of eMC
The combination may increase the risk of hypotension, and an increase in the risk of a further deterioration of the ventricular pump function in patients with heart failure cannot be excluded
Amlodipine, boceprevir [2] ---> SPC of [2] of EMA
Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.
Amlodipine, breast-feeding
Not recommended during the lactation
Amlodipine, buflomedil
The co-administration may increase the hypotensive effect
Amlodipine, carbamazepine ---> SPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Amlodipine, clarithromycin ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, cobicistat [2] ---> SPC of [2] of EMA
Concentrations of calcium channel blockers may be increased when co-administered with cobicistat. Clinical monitoring of therapeutic effect and adverse events is recommended when these medicinal products are co-administered with Tybost.
Amlodipine, daclatasvir [2] ---> SPC of [2] of EMA
Administration of daclatasvir with amlodipine (CYP3A4 inhibitor) may result in increased concentrations of daclatasvir. Caution is advised.
Amlodipine, dantrolene ---> SPC of [aliskiren/amlodipine] of EMA
Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Amlodipine, darunavir/cobicistat [2] ---> SPC of [2] of EMA
Darunavir/cobicistat is expected to increase the calcium channel blocker plasma concentrations. (CYP3A and/or CYP2D6 inhibition)
Amlodipine, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Based on theoretical considerations DRV/COBI is expected to increase this calcium channel blocker plasma concentrations. CYP3A inhibition
Amlodipine, darunavir/ritonavir ---> SPC of [darunavir] of EMA
Boosted darunavir can be expected to increase the plasma concentrations of calcium channel blocker. (CYP3A and/or CYP2D6 inhibition)
Amlodipine, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SPC of [dasabuvir] of EMA
CYP3A4 inhibition by ritonavir may increase amlodipine and decrease paritaprevir plasma concentrations. Decrease in amlodipine dose by 50% and monitor patients for clinical effects.
Amlodipine, diltiazem ---> SPC of [aliskiren/amlodipine] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine [1], diuretics ---> SPC of [1] of eMC
The blood pressure lowering effect can be increased by concomitant use
Amlodipine, eliglustat [2] ---> SPC of [2] of EMA
Caution should be used with weak CYP3A inhibitors in poor metabolisers.
Amlodipine, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Concentrations of calcium channel blocker may be increased when co-administered with cobicistat.
Amlodipine, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Concentrations of calcium channel blockers may be increased when co-administered with cobicistat.
Amlodipine, erythromycin ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, ezetimibe/simvastatine [2] ---> SPC of [2] of eMC
Patients on amlodipine treated concomitantly with simvastatin have an increased risk of myopathy.
Amlodipine, fenofibrate/simvastatin [2] ---> SPC of [2] of EMA
The risk of myopathy and rhabdomyolysis is increased by concomitant use of amlodipine with simvastatin 40 mg per day.
Amlodipine, fluconazole [2] ---> SPC of [2] of eMC
Amlodipine is metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of amlodipine. Frequent monitoring for adverse events is recommended.
Amlodipine, fluvastatin [2] ---> SPC of [2] of eMC
No clinically significant pharmacokinetic interactions occur when fluvastatin is concomitantly administered with amlodipine.
Amlodipine, fosphenytoin ---> SPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Amlodipine, grapefruit ---> SPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
Amlodipine, grapefruit juice ---> SPC of [amlodipine/valsartan] of EMA
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
Amlodipine, idelalisib [2] ---> SPC of [2] of EMA
The co-administration of idelalisib with amlodipine may increase the serum concentrations of amlodipine. Clinical monitoring of therapeutic effect and adverse reactions is recommended.
Amlodipine, indinavir ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, indinavir/ritonavir ---> SPC of [amlodipine/valsartan] of EMA
Dose modification of calcium channel blocker should be considered when coadministered with indinavir/ritonavir as it may result in an increased response.
Amlodipine, itraconazol ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, ivabradine [2] ---> SPC of [2] of EMA
Specific drug-drug interaction studies have shown no clinically significant effect of the dihydropyridine calcium channel blockers on pharmacokinetics and pharmacodynamics of ivabradine
Amlodipine, ketoconazole ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, lesinurad [2] ---> SPC of [2] of EMA
In interaction studies conducted in healthy subjects with Zurampic and CYP3A substrates, lesinurad reduced the plasma concentrations of sildenafil and amlodipine.
Amlodipine, lomitapide [2] ---> SPC of [2] of EMA
Weak CYP3A4 inhibitors are expected to increase the exposure of lomitapide when taken simultaneously. Separate the dose of the medications by 12 hours OR decrease the dose of Lojuxta by half.
Amlodipine, lopinavir ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, macrolide antibiotics ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, miconazole ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, moderate CYP3A4 inductors ---> SPC of [amlodipine/valsartan] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Amlodipine, moderate CYP3A4 inhibitors ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, nebivolol [2] ---> SPC of [2] of eMC
Concomitant use of dihydropyridines and nebivolol may increase the risk of hypotension, and cause an increase in the risk of a further deterioration of the ventricular pump function in patients with heart failure.
Amlodipine, ombitasvir/paritaprevir/ritonavir [2] ---> SPC of [2] of EMA
CYP3A4 inhibition by ritonavir. Decrease amlodipine dose by 50% and monitor patients for clinical effects.
Amlodipine, phenobarbital ---> SPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Amlodipine, phenytoin ---> SPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Amlodipine, posaconazole
Posaconazole, strong CYP3A4 inhibitor, may increase the plasma concentrations of amlodipine
Amlodipine, pregnancy ---> SPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
Use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus.
Amlodipine, primidone ---> SPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Amlodipine, protease inhibitors ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, rifampicin ---> SPC of [amlodipine/valsartan] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Amlodipine, ritonavir [2] ---> SPC of [2] of EMA
Ritonavir, strong CYP3A4 inhibitor, may increase the plasma concentrations of amlodipine. Careful monitoring of therapeutic and adverse effects is recommended.
Amlodipine, saquinavir/ritonavir ---> SPC of [saquinavir] of EMA
Possible increase in the plasma concentrations of calcium channel antagonist. Careful monitoring of therapeutic and adverse effects is recommended.
Amlodipine, simeprevir [2] ---> SPC of [2] of EMA
The intestinal CYP3A4 enzyme and P-gp transporter inhibition by simeprevir may increase the plasma concentrations of orally administered calcium channel blocker. Amlodipine, CYP3A4 inhibitor, may increase the plasma levels of simeprevir
Amlodipine, simvastatine ---> SPC of [aliskiren/amlodipine] of EMA
Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Amlodipine, sodium zirconium cyclosilicate [2] ---> SPC of [2] of EMA
In a clinical drug-drug interaction study conducted in healthy subjects co-administration did not result in clinically meaningful drug-drug interactions and no dose adjustments are required.
Amlodipine, strong CYP3A4 inductors ---> SPC of [amlodipine/valsartan] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. Amlodipine should be used with caution together with CYP3A4 inducers.
Amlodipine, strong CYP3A4 inhibitors ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, telaprevir [2] ---> SPC of [2] of EMA
Telaprevir, CYP3A4 inhibitor, may increase the plasma levels of amlodipine. Caution and clinical monitoring are recommended
Amlodipine, telithromycin [2] ---> SPC of [2] of EMA
The strong CYP3A4 inhibition may increase the plasma concentrations of amlodipine and may result in hypotension, bradycardia or loss of consciousness
Amlodipine, telotristat ethyl [2] ---> SPC of [2] of EMA
Concomitant use of Xermelo may decrease the efficacy of medicinal products that are CYP3A4 substrates (e.g. midazolam, everolimus, sunitinib, simvastatin, ethinyloestradiol, amlodipine, cyclosporine_) by decreasing their systemic exposure
Amlodipine, tioconazole ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, tipranavir ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, troleandomycin ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, valsartan [2] ---> SPC of [2] of eMC
In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan and amlodipine
Amlodipine, verapamil ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine, vildagliptin ---> SPC of [vildagliptin/metformin] of EMA
Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin. No clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin.
Amlodipine, vildagliptin/metformin [2] ---> SPC of [2] of EMA
Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin. No clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin.
Amlodipine, voriconazole ---> SPC of [amlodipine/valsartan] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Betablockers, calcium antagonists ---> SPC of [amlodipine] of eMC
Calcium channel blockers generally potentiate the pharmacologic effects of beta-blockers. Patients taking both agents should be carefully monitored for adverse cardiovascular events.
CONTRAINDICATIONS of Amlodipine
Amlodipine is contraindicated in patients with:
- hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients
- severe hypotension
- shock (including cardiogenic shock)
- obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)
- haemodynamically unstable heart failure after acute myocardial infarction
http://www.medicines.org.uk/emc/
Amlodipine/valsartan (Dafiro)
Ability to drive, amlodipine/valsartan [2] ---> SmPC of [2] of EMA
Patients taking Dafiro and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
ACE inhibitors, amlodipine/valsartan [2] ---> SmPC of [2] of EMA
Dual blockade of the RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Acetylsalicylic acid, amlodipine/valsartan [2] ---> SmPC of [2] of EMA
Concomitant use of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may decrease the antihypertensive effect, increase the renal failure risk and cause hypercaliemia
Alfa-adrenergic receptor blockers, amlodipine/valsartan [2] ---> SmPC of [2] of EMA
The combination may increase the antihypertensive effect
Alpha-blockers, amlodipine/valsartan [2] ---> SmPC of [2] of EMA
Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers) may increase the antihypertensive effect of the combination.
Amlodipine/valsartan [1], antihypertensives ---> SmPC of [1] of EMA
Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers) may increase the antihypertensive effect of the combination.
Amlodipine/valsartan [1], atorvastatin ---> SmPC of [1] of EMA
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.
Amlodipine/valsartan [1], azole antifungals ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], breast-feeding ---> SmPC of [1] of EMA
Dafiro is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Amlodipine/valsartan [1], calcium antagonists ---> SmPC of [1] of EMA
Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Amlodipine/valsartan [1], carbamazepine ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan [1], clarithromycin ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], coxibs ---> SmPC of [1] of EMA
Concomitant use of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may decrease the antihypertensive effect, increase the renal failure risk and cause hypercaliemia
Amlodipine/valsartan [1], cyclosporine ---> SmPC of [1] of EMA
The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic efflux transporter MRP2. Co-administration of inhibitors of the MRP2 may increase the systemic exposure to valsartan.
Amlodipine/valsartan [1], digoxin ---> SmPC of [1] of EMA
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.
Amlodipine/valsartan [1], diltiazem ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], diuretics ---> SmPC of [1] of EMA
Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers) may increase the antihypertensive effect of the combination.
Amlodipine/valsartan [1], erythromycin ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], fertility ---> SmPC of [1] of EMA
Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day. Clinical data are insufficient regarding the potential effect of amlodipine on fertility.
Amlodipine/valsartan [1], fosphenytoin ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan [1], grapefruit ---> SmPC of [1] of EMA
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
Amlodipine/valsartan [1], grapefruit juice ---> SmPC of [1] of EMA
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
Amlodipine/valsartan [1], hyperkalemia ---> SmPC of [1] of EMA
If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan [1], interactions ---> SmPC of [1] of EMA
In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Amlodipine/valsartan [1], itraconazol ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], ketoconazole ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], lithium ---> SmPC of [1] of EMA
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium angiotensin II receptor antagonists, including valsartan.
Amlodipine/valsartan [1], macrolide antibiotics ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], NSAID ---> SmPC of [1] of EMA
Concomitant use of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may decrease the antihypertensive effect, increase the renal failure risk and cause hypercaliemia
Amlodipine/valsartan [1], nursing ---> SmPC of [1] of EMA
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Amlodipine/valsartan [1], OATP1B1 inhibitors ---> SmPC of [1] of EMA
The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1. Co-administration of inhibitors of OATP1B1 may increase the systemic exposure to valsartan.
Amlodipine/valsartan [1], phenobarbital ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan [1], phenytoin ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan [1], potassium ---> SmPC of [1] of EMA
If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan [1], potassium-sparing diuretics ---> SmPC of [1] of EMA
If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan [1], pregnancy ---> SmPC of [1] of EMA
The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy. The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy
Amlodipine/valsartan [1], pregnancy ---> SmPC of [1] of EMA
Use in pregnancy of amlodipine is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and foetus.
Amlodipine/valsartan [1], primidone ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan [1], protease inhibitors ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], rifampicin ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers may give a lower plasma concentration of amlodipine. The OATP1B1 inhibition by rifampicin may increase the plasma concentrations of valsartan
Amlodipine/valsartan [1], ritonavir ---> SmPC of [1] of EMA
Co-administration of inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
Amlodipine/valsartan [1], simvastatine ---> SmPC of [1] of EMA
Co-administration of multiple doses of amlodipine with simvastatin resulted in an increase in exposure to simvastatin compared to simvastatin alone. It is recommended to limit the dose of simvastatin to 20 mg daily in patients on amlodipine.
Amlodipine/valsartan [1], St. John's wort ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], tacrolimus ---> SmPC of [1] of EMA
There is a risk of increased tacrolimus blood levels when co-administered with amlodipine.
Amlodipine/valsartan [1], telithromycin ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], tricyclic antidepressant ---> SmPC of [1] of EMA
The combination may increase the antihypertensive effect
Amlodipine/valsartan [1], tricyclic antidepressant ---> SmPC of [1] of EMA
Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers) may increase the antihypertensive effect of the combination.
Amlodipine/valsartan [1], verapamil ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure. Clinical monitoring and dose adjustment may thus be required.
Amlodipine/valsartan [1], warfarin ---> SmPC of [1] of EMA
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.
Amlodipine/valsartan, cyclosporine ---> SmPC of [amlodipine/valsartan/hydrochlorothiazide] of EMA
The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1. Co-administration of inhibitors of OATP1B1 may increase the systemic exposure to valsartan.
Amlodipine/valsartan, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
The risk of myopathy and rhabdomyolysis is increased by concomitant use of amlodipine with simvastatin 40 mg per day.
CONTRAINDICATIONS of Amlodipine/valsartan (Dafiro)
- Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1.
- Severe hepatic impairment, biliary cirrhosis or cholestasis.
- Concomitant use of Dafiro with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m²)
- Second and third trimesters of pregnancy
- Severe hypotension.
- Shock (including cardiogenic shock).
- Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis).
- Haemodynamically unstable heart failure after acute myocardial infarction.
https://www.ema.europa.eu/en/documents/product-information/dafiro-epar-product-information_en.pdf 27/11/2024
Other trade names: Amlodipine/Valsartan Mylan, Copalia, Exforge, Imprida,
Amlodipine/valsartan/hydrochlorothiazide (Dafiro HCT)
Ability to drive, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Patients taking Dafiro HCT and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
ACE inhibitors, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
ACTH, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of ACTH. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised.
Acute angle-closure glaucoma, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Hydrochlorothiazide, a sulphonamide, has been associated with an idiosyncratic reaction resulting in acute transient myopia and acute angle-closure glaucoma.
Adrenaline, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Hydrochlorothiazide may reduce the response to pressor amines. The clinical significance of this effect is uncertain and not sufficient to preclude their use.
Alcohol, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Concomitant administration of thiazide diuretics with substances that also have a blood pressure lowering effect (e.g. by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Aliskiren, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
Allopurinol, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Amantadine, amlodipine/valsartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Amlodipine/valsartan/hydrochlorothiazide [1], amphotericin ---> SmPC of [1] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of amphotericin. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], angioedema ---> SmPC of [1] of EMA
Dafiro HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
Amlodipine/valsartan/hydrochlorothiazide [1], antiarrhythmics ---> SmPC of [1] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of antiarrhythmics. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], anticholinergics ---> SmPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Amlodipine/valsartan/hydrochlorothiazide [1], antidepressants ---> SmPC of [1] of EMA
The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc. Caution is indicated in long-term administration of these medicinal products.
Amlodipine/valsartan/hydrochlorothiazide [1], antiepileptics ---> SmPC of [1] of EMA
The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc. Caution is indicated in long-term administration of these medicinal products.
Amlodipine/valsartan/hydrochlorothiazide [1], antihypertensives ---> SmPC of [1] of EMA
Dafiro HCT may increase the hypotensive effect of other antihypertensive agents.
Amlodipine/valsartan/hydrochlorothiazide [1], atropine ---> SmPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Amlodipine/valsartan/hydrochlorothiazide [1], azole antifungals ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], barbiturates ---> SmPC of [1] of EMA
Concomitant administration of thiazide diuretics with substances that also have a blood pressure lowering effect (e.g.by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Amlodipine/valsartan/hydrochlorothiazide [1], betablockers ---> SmPC of [1] of EMA
Concomitant use of thiazide diuretics, including hydrochlorothiazide, with beta blockers may increase the risk of hyperglycaemia. Thiazides potentiate the antihypertensive action of other antihypertensive drugs
Amlodipine/valsartan/hydrochlorothiazide [1], biperiden ---> SmPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Amlodipine/valsartan/hydrochlorothiazide [1], breast-feeding ---> SmPC of [1] of EMA
The use of Dafiro HCT during breast-feeding is not recommended. Alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Amlodipine/valsartan/hydrochlorothiazide [1], calcium ---> SmPC of [1] of EMA
Administration of thiazide diuretics with vitamin D or with calcium salts may potentiate the rise in serum calcium.
Amlodipine/valsartan/hydrochlorothiazide [1], calcium antagonists ---> SmPC of [1] of EMA
Thiazides potentiate the antihypertensive action of other antihypertensive drugs
Amlodipine/valsartan/hydrochlorothiazide [1], carbamazepine ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan/hydrochlorothiazide [1], carbenoxolone ---> SmPC of [1] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of carbenoxolone. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], catecholamines ---> SmPC of [1] of EMA
Hydrochlorothiazide may reduce the response to pressor amines. The clinical significance of this effect is uncertain and not sufficient to preclude their use.
Amlodipine/valsartan/hydrochlorothiazide [1], cholestyramine ---> SmPC of [1] of EMA
Absorption of thiazide diuretics is decreased by cholestyramine. This could result in sub-therapeutic effects of thiazide diuretics. The thiazide should be administered at least 4 hours before or 4-6 hours after the administration of resin
Amlodipine/valsartan/hydrochlorothiazide [1], cisapride ---> SmPC of [1] of EMA
It is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazide-type diuretics.
Amlodipine/valsartan/hydrochlorothiazide [1], clarithromycin ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], class IA antiarrhythmic agents ---> SmPC of [1] of EMA
Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some antipsychotics.
Amlodipine/valsartan/hydrochlorothiazide [1], class III antiarrhythmic agents ---> SmPC of [1] of EMA
Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some antipsychotics.
Amlodipine/valsartan/hydrochlorothiazide [1], colestipol ---> SmPC of [1] of EMA
Absorption of thiazide diuretics is decreased by colestipol. This could result in sub-therapeutic effects of thiazide diuretics. The thiazide should be administered at least 4 hours before or 4-6 hours after the administration of resin
Amlodipine/valsartan/hydrochlorothiazide [1], corticosteroids ---> SmPC of [1] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of corticosteroids. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], coxibs ---> SmPC of [1] of EMA
NSAIDS can attenuate the antihypertensive effect of both AIIRA and hydrochlorothiazide when administered simultaneously. Furthermore, concomitant use may lead to worsening of renal function and an increase in serum potassium.
Amlodipine/valsartan/hydrochlorothiazide [1], curare-type muscle relaxants ---> SmPC of [1] of EMA
Thiazides, including hydrochlorothiazide, potentiate the action of curare derivatives.
Amlodipine/valsartan/hydrochlorothiazide [1], cyclooxygenase inhibitors ---> SmPC of [1] of EMA
NSAIDS can attenuate the antihypertensive effect of both AIIRA and hydrochlorothiazide when administered simultaneously. Furthermore, concomitant use may lead to worsening of renal function and an increase in serum potassium.
Amlodipine/valsartan/hydrochlorothiazide [1], cyclophosphamide ---> SmPC of [1] of EMA
Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents and potentiate their myelosuppressive effects.
Amlodipine/valsartan/hydrochlorothiazide [1], cyclosporine ---> SmPC of [1] of EMA
Ciclosporin, OATP1B1 inhibitor, may increase the systemic exposure to valsartan. Concomitant treatment of hydrochlorothiazide with ciclosporin may increase the risk of hyperuricaemia and gout-type complications.
Amlodipine/valsartan/hydrochlorothiazide [1], cytotoxic agents ---> SmPC of [1] of EMA
Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents and potentiate their myelosuppressive effects.
Amlodipine/valsartan/hydrochlorothiazide [1], dantrolene ---> SmPC of [1] of EMA
Due to risk of hyperkalaemia, it is recommended that the co-administration of calcium channel blockers be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Amlodipine/valsartan/hydrochlorothiazide [1], diazoxide ---> SmPC of [1] of EMA
Thiazide diuretics, including hydrochlorothiazide, may enhance the hyperglycaemic effect of diazoxide.
Amlodipine/valsartan/hydrochlorothiazide [1], digital glycosides ---> SmPC of [1] of EMA
Thiazide-induced hypokalaemia or hypomagnesaemia may occur as undesirable effects, favouring the onset of digitalis-induced cardiac arrhythmias.
Amlodipine/valsartan/hydrochlorothiazide [1], diltiazem ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], erythromycin ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], fertility ---> SmPC of [1] of EMA
There are no clinical studies on fertility with Dafiro HCT.
Amlodipine/valsartan/hydrochlorothiazide [1], fosphenytoin ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan/hydrochlorothiazide [1], grapefruit ---> SmPC of [1] of EMA
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
Amlodipine/valsartan/hydrochlorothiazide [1], grapefruit juice ---> SmPC of [1] of EMA
Administration of amlodipine with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
Amlodipine/valsartan/hydrochlorothiazide [1], guanethidine ---> SmPC of [1] of EMA
Thiazides potentiate the antihypertensive action of other antihypertensive drugs
Amlodipine/valsartan/hydrochlorothiazide [1], hypercalcemia ---> SmPC of [1] of EMA
Dafiro HCT is contraindicated in patients with hypercalcaemia and should only be used after correction of any pre-existing hypercalcaemia. Dafiro HCT should be discontinued if hypercalcaemia develops during treatment.
Amlodipine/valsartan/hydrochlorothiazide [1], hyperkalemia ---> SmPC of [1] of EMA
If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], insulin ---> SmPC of [1] of EMA
Thiazides may alter glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary.
Amlodipine/valsartan/hydrochlorothiazide [1], iodinated contrast media ---> SmPC of [1] of EMA
In case of diuretic-induced dehydration, there is an increased risk of acute renal failure, especially with high doses of iodine products. Patients should be rehydrated before administration.
Amlodipine/valsartan/hydrochlorothiazide [1], itraconazol ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], kaliuretic medicines ---> SmPC of [1] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of kaliuretic diuretics. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised
Amlodipine/valsartan/hydrochlorothiazide [1], ketoconazole ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], laxatives ---> SmPC of [1] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of laxatives. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], lithium ---> SmPC of [1] of EMA
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors, angiotensin II receptor antagonists including valsartan or thiazides.
Amlodipine/valsartan/hydrochlorothiazide [1], macrolide antibiotics ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], metformin ---> SmPC of [1] of EMA
Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to hydrochlorothiazide.
Amlodipine/valsartan/hydrochlorothiazide [1], methotrexate ---> SmPC of [1] of EMA
Thiazides, including hydrochlorothiazide, may reduce the renal excretion of cytotoxic agents and potentiate their myelosuppressive effects.
Amlodipine/valsartan/hydrochlorothiazide [1], methyldopa ---> SmPC of [1] of EMA
There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Amlodipine/valsartan/hydrochlorothiazide [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], MRP2 inhibitors ---> SmPC of [1] of EMA
The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic efflux transporter MRP2. Co-administration of inhibitors of the MRP2 may increase the systemic exposure to valsartan.
Amlodipine/valsartan/hydrochlorothiazide [1], muscle relaxants (non-depolarizing) ---> SmPC of [1] of EMA
Thiazides, including hydrochlorothiazide, potentiate the action of curare derivatives.
Amlodipine/valsartan/hydrochlorothiazide [1], narcotics ---> SmPC of [1] of EMA
Concomitant administration of thiazide diuretics with substances that also have a blood pressure lowering effect (e.g.by reducing sympathetic central nervous system activity or direct vasodilatation) may potentiate orthostatic hypotension.
Amlodipine/valsartan/hydrochlorothiazide [1], neuroleptics ---> SmPC of [1] of EMA
The hyponatraemic effect of diuretics may be intensified by concomitant administration of medicinal products such as antidepressants, antipsychotics, antiepileptics, etc. Caution is indicated in long-term administration of these medicinal products.
Amlodipine/valsartan/hydrochlorothiazide [1], noradrenaline ---> SmPC of [1] of EMA
Hydrochlorothiazide may reduce the response to pressor amines. The clinical significance of this effect is uncertain and not sufficient to preclude their use.
Amlodipine/valsartan/hydrochlorothiazide [1], NSAID ---> SmPC of [1] of EMA
NSAIDS can attenuate the antihypertensive effect of both AIIRA and hydrochlorothiazide when administered simultaneously. Furthermore, concomitant use may lead to worsening of renal function and an increase in serum potassium.
Amlodipine/valsartan/hydrochlorothiazide [1], OATP1B1 inhibitors ---> SmPC of [1] of EMA
The results of an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1. Co-administration of inhibitors of OATP1B1 may increase the systemic exposure to valsartan.
Amlodipine/valsartan/hydrochlorothiazide [1], oral antidiabetics ---> SmPC of [1] of EMA
Thiazides may alter glucose tolerance. Dose adjustment of the antidiabetic medicinal product may be necessary.
Amlodipine/valsartan/hydrochlorothiazide [1], penicillin G ---> SmPC of [1] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of penicillin G. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], phenobarbital ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan/hydrochlorothiazide [1], phenytoin ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan/hydrochlorothiazide [1], photosensitivity ---> SmPC of [1] of EMA
Cases of photosensitivity reactions have been reported with thiazide diuretics
Amlodipine/valsartan/hydrochlorothiazide [1], potassium ---> SmPC of [1] of EMA
If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], potassium supplements ---> SmPC of [1] of EMA
If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], potassium-sparing diuretics ---> SmPC of [1] of EMA
If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], pregnancy ---> SmPC of [1] of EMA
Based on the existing data with the components, the use of Dafiro HCT is not recommended during first trimester and contraindicated during the second and third trimester of pregnancy
Amlodipine/valsartan/hydrochlorothiazide [1], primary hyperaldosteronism ---> SmPC of [1] of EMA
Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is not activated. Therefore, Dafiro HCT is not recommended in this population.
Amlodipine/valsartan/hydrochlorothiazide [1], primidone ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan/hydrochlorothiazide [1], probenecide ---> SmPC of [1] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Amlodipine/valsartan/hydrochlorothiazide [1], prokinetics ---> SmPC of [1] of EMA
It is anticipated that prokinetic substances such as cisapride may decrease the bioavailability of thiazide-type diuretics.
Amlodipine/valsartan/hydrochlorothiazide [1], protease inhibitors ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], renin inhibitors ---> SmPC of [1] of EMA
Thiazides potentiate the antihypertensive action of other antihypertensive drugs
Amlodipine/valsartan/hydrochlorothiazide [1], rifampicin ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan/hydrochlorothiazide [1], ritonavir ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], salicylates ---> SmPC of [1] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of salicylates. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], salt substitutes containing potassium ---> SmPC of [1] of EMA
If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, frequent monitoring of potassium plasma levels is advised.
Amlodipine/valsartan/hydrochlorothiazide [1], simvastatine ---> SmPC of [1] of EMA
Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone.
Amlodipine/valsartan/hydrochlorothiazide [1], St. John's wort ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant
Amlodipine/valsartan/hydrochlorothiazide [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary. Therefore, blood pressure should be monitored and dose regulation considered both during and after concomitant medication
Amlodipine/valsartan/hydrochlorothiazide [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], sulfinpyrazone ---> SmPC of [1] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Amlodipine/valsartan/hydrochlorothiazide [1], sun ---> SmPC of [1] of EMA
If photosensitivity reaction occurs during treatment with Dafiro HCT, it is recommended to stop the treatment. If a readministration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Amlodipine/valsartan/hydrochlorothiazide [1], symptomatic hyperuricaemia ---> SmPC of [1] of EMA
Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricaemia as well as precipitate gout in susceptible patients.
Amlodipine/valsartan/hydrochlorothiazide [1], systemic lupus erythematosus ---> SmPC of [1] of EMA
Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosus.
Amlodipine/valsartan/hydrochlorothiazide [1], tacrolimus ---> SmPC of [1] of EMA
There is a risk of increased tacrolimus blood levels when co-administered with amlodipine.
Amlodipine/valsartan/hydrochlorothiazide [1], thiazides ---> SmPC of [1] of EMA
Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Dafiro HCT. Therefore careful monitoring of serum lithium concentrations is recommended during concomitant use.
Amlodipine/valsartan/hydrochlorothiazide [1], torsades de pointes inducing drugs ---> SmPC of [1] of EMA
Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some antipsychotics.
Amlodipine/valsartan/hydrochlorothiazide [1], tubocuranine ---> SmPC of [1] of EMA
Thiazides, including hydrochlorothiazide, potentiate the action of curare derivatives.
Amlodipine/valsartan/hydrochlorothiazide [1], uricosuric agents ---> SmPC of [1] of EMA
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Amlodipine/valsartan/hydrochlorothiazide [1], vasodilators ---> SmPC of [1] of EMA
Thiazides potentiate the antihypertensive action of other antihypertensive drugs
Amlodipine/valsartan/hydrochlorothiazide [1], verapamil ---> SmPC of [1] of EMA
Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors may give rise to significant increase in amlodipine exposure.
Amlodipine/valsartan/hydrochlorothiazide [1], vitamin D ---> SmPC of [1] of EMA
Administration of thiazide diuretics with vitamin D or with calcium salts may potentiate the rise in serum calcium.
CONTRAINDICATIONS of Amlodipine/valsartan/hydrochlorothiazide (Dafiro HCT)
- Hypersensitivity to the active substances, to other sulphonamide derivatives, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1.
- Second and third trimesters of pregnancy
- Hepatic impairment, biliary cirrhosis or cholestasis.
- Severe renal impairment (GFR <30 ml/min/1.73 m²), anuria and patients undergoing dialysis.
- Concomitant use of Dafiro HCT with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m²)
- Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.
- Severe hypotension.
- Shock (including cardiogenic shock).
- Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis).
- Haemodynamically unstable heart failure after acute myocardial infarction.
Other trade names: Exforge HCT, Copalia HCT,
Amivantamab (Rybrevant)
Ability to drive, amivantamab [2] ---> SmPC of [2] of EMA
If patients experience treatment-related symptoms, including vision-related adverse reactions, affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Amivantamab [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from amivantamab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Amivantamab [1], CYP450 ---> SmPC of [1] of EMA
As an IgG1 monoclonal antibody, renal excretion and hepatic enzyme-mediated metabolism of intact amivantamab are unlikely to be major elimination routes.
Amivantamab [1], fertility ---> SmPC of [1] of EMA
There are no data on the effect of amivantamab on human fertility. Effects on male and female fertility have not been evaluated in animal studies.
Amivantamab [1], pregnancy ---> SmPC of [1] of EMA
Amivantamab could cause foetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking this medicinal product the patient should be informed of the potential risk to the foetus
Amivantamab [1], vaccinations ---> SmPC of [1] of EMA
No clinical data are available on the efficacy and safety of vaccinations in patients taking amivantamab. Avoid the use of live or live-attenuated vaccines while patients are taking amivantamab.
Amivantamab [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of child-bearing potential should use effective contraception during and for 3 months after cessation of amivantamab treatment.
CONTRAINDICATIONS of Amivantamab (Rybrevant)
- Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf 29/10/2025
Amorolfine
Amorolfine [1], breast-feeding ---> SPC of [1] of eMC
Amorolfine medicated nail lacquer can be used during breast-feeding.
Amorolfine [1], pregnancy ---> SPC of [1] of eMC
As a precautionary measure it is preferable to avoid the use of amorolfine medicated nail lacquer during pregnancy.
CONTRAINDICATIONS of Amorolfine
- Hypersensitivity to the active substance or to any of the excipients
http://www.medicines.org.uk/emc/
Amoxicillin
Acenocoumarol, amoxicillin ---> SPC of [amoxicillin/clavulanic acid] of eMC
In the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol and prescribed a course of amoxicillin.
Allopurinol, amoxicillin [2] ---> SPC of [2] of eMC
Concomitant administration of amoxicillin and allopurinol may promote the occurrence of allergic cutaneous reactions and is therefore not advised.
Allopurinol/lesinurad [1], amoxicillin ---> SPC of [1] of EMA
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both medicinal products.
Aminoglycoside antibiotics, amoxicillin
A synergistic effect may occur.
Amoxicillin, bacteriostatic antibiotics
The co-administration of bactericide with bacteriostatic antibiotics should be avoided due to possible antagonist effects
Amoxicillin [1], breast-feeding ---> SPC of [1] of eMC
Amoxicillin is excreted into breast milk. Breast-feeding must be stopped if gastrointestinal disorders (diarrhoea, candidosis or skin rash) occur in the new born.
Amoxicillin, chloramphenicol
The co-administration of bactericide with bacteriostatic antibiotics should be avoided due to possible antagonist effects
Amoxicillin, chlormadinone
Decreased effect of gestagen (the antibiotic agent affects the gut flora)
Amoxicillin, coumarin anticoagulants
The co-administration may prolong the bleeding time.
Amoxicillin, digoxin
An increase in the absorption of digoxin is possible on concurrent administration with amoxicillin. A dose adjustment of digoxin may be necessary.
Amoxicillin, disulfiram
Simultaneous administration is not recommended.
Amoxicillin, erythromycin
The co-administration of bactericide with bacteriostatic antibiotics should be avoided due to possible antagonist effects
Amoxicillin, estrogens
Antibiotic may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Amoxicillin, gestagens
Decreased effect of gestagen (the antibiotic agent affects the gut flora)
Amoxicillin, oral contraceptives
Antibiotic may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Amoxicillin, oseltamivir [2] ---> SPC of [2] of EMA
Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway, suggesting that oseltamivir interaction with this pathway is weak.
Amoxicillin, phenylbutazone
The combination may delay the renal elimination of amoxicillin
Amoxicillin, piperacillin
Large doses of piperacillin may prolong the half-life of other beta-lactam antibiotics by competitive inhibition of tubular secretion
Amoxicillin [1], pregnancy ---> SPC of [1] of eMC
Amoxicillin passes the placenta. Caution should be exercised when prescribing to pregnant women.
Amoxicillin [1], probenecide ---> SPC of [1] of eMC
Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin
Amoxicillin, salicylates
The combination may delay the renal elimination of amoxicillin
Amoxicillin, sulphamides
The co-administration of bactericide with bacteriostatic antibiotics should be avoided due to possible antagonist effects
Amoxicillin, sulphonamides
The co-administration of bactericide with bacteriostatic antibiotics should be avoided due to possible antagonist effects
Amoxicillin, tetracyclines
The co-administration of bactericide with bacteriostatic antibiotics should be avoided due to possible antagonist effects
Amoxicillin, tisopurine
Increased frequency of allergic reactions (skin rash)
Amoxicillin, warfarin ---> SPC of [amoxicillin/clavulanic acid] of eMC
In the literature there are cases of increased international normalised ratio in patients maintained on warfarin and prescribed a course of amoxicillin.
Penicillins, probenecide ---> SPC of [amoxicillin] of eMC
Concurrent administration of probenecid and penicillins produces a longer half-life and lower renal clearance of the penicillin
CONTRAINDICATIONS of Amoxicillin
Amoxicillin is contraindicated in patients with:
- Hypersensitivity to penicillin; a cross-allergy to other beta-lactams such as cephalosporins should be taken into account.
- Hypersensitivity to any of the excipients.
http://www.medicines.org.uk/emc/
Amoxicillin/clavulanic acid
Ability to drive, amoxicillin/clavulanic acid [2] ---> SPC of [2] of eMC
Undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines
Acenocoumarol, amoxicillin ---> SPC of [amoxicillin/clavulanic acid] of eMC
In the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol and prescribed a course of amoxicillin.
Acenocoumarol, amoxicillin/clavulanic acid [2] ---> SPC of [2] of eMC
In the literature there are cases of increased international normalised ratio in patients maintained on acenocoumarol and prescribed a course of amoxicillin.
Amoxicillin, warfarin ---> SPC of [amoxicillin/clavulanic acid] of eMC
In the literature there are cases of increased international normalised ratio in patients maintained on warfarin and prescribed a course of amoxicillin.
Amoxicillin/clavulanic acid [1], breast-feeding ---> SPC of [1] of eMC
Amoxicillin/clavulanic acid should only be used during breast-feeding after benefit/risk assessment by the physician in charge.
Amoxicillin/clavulanic acid [1], methotrexate ---> SPC of [1] of eMC
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
Amoxicillin/clavulanic acid, mycophenolate [2]
A change in the dose of mycophenolate should not normally be necessary in the absence of clinical evidence of graft dysfunction. Close clinical monitoring
Amoxicillin/clavulanic acid, mycophenolate mofetil [2] ---> SPC of [2] of EMA
A change in the dose of mycophenolate should not normally be necessary in the absence of clinical evidence of graft dysfunction. Close clinical monitoring
Amoxicillin/clavulanic acid [1], pregnancy ---> SPC of [1] of eMC
Use should be avoided during pregnancy, unless considered essential by the physician.
Amoxicillin/clavulanic acid [1], probenecide ---> SPC of [1] of eMC
Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.
Amoxicillin/clavulanic acid [1], warfarin ---> SPC of [1] of eMC
In the literature there are cases of increased international normalised ratio in patients maintained on warfarin and prescribed a course of amoxicillin.
CONTRAINDICATIONS of Amoxicillin/clavulanic acid
- Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.
- History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
- History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid
http://www.medicines.org.uk/emc/
Amphotericin
Abacavir/lamivudine/zidovudine [1], amphotericin ---> SPC of [1] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine
Adefovir dipivoxil [1], amphotericin ---> SPC of [1] of EMA
Co-administration of adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product
Aliskiren/hydrochlorothiazide [1], amphotericin ---> SPC of [1] of EMA
The potassium-depleting effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia
Amikacine [1], amphotericin ---> SPC of [1] of eMC
Concurrent or serial use of amikacin with other neurotoxic, ototoxic or nephrotoxic agents should be avoided either systemically or topically because of the potential for additive effects.
Aminoglycoside antibiotics, amphotericin
Concurrent administration of aminoglycoside antibiotics with amphotericin may increase the risk of nephrotoxicity
Amiodarone [1], amphotericin ---> SPC of [1] of eMC
Increased risk of hypokaliemia induced disorders of heart rhythm with intravenous amphotericin
Amisulpride, amphotericin B
The co-administration of amisulpride with IV amphotericin B may cause hypokaliemia und is not recommended
Amlodipine/valsartan/hydrochlorothiazide [1], amphotericin ---> SPC of [1] of EMA
The hypokalaemic effect of hydrochlorothiazide may be increased by concomitant administration of amphotericin. If these medicines are to be prescribed with amlodipine/valsartan/hydrochlorothiazide, monitoring of potassium plasma levels is advised.
Amphotericin, antineoplastics
The co-administration of antineoplastics drugs should be avoided
Amphotericin, atenolol/chlortalidone
Increased loss of potassium and/or magnesium.
Amphotericin, azole antifungals
The co-administration may induce resistance to amphotericin by antagonism of its functions
Amphotericin, breast-feeding
It is recommended to stop breast-feeding during treatment
Amphotericin, cardiac glycosides
The co-administration of cardiac glycosides and drugs that cause potassium and magnesium loss may enhance the effects and adverse reactions of cardiac glycosides
Amphotericin, cephalosporins
Cephalosporins may have an increased risk of nephrotoxicity in the presence of amphotericin
Amphotericin, chlortalidone
The hypokalaemic effect of diuretics may be potentiated by amphotericin
Amphotericin, cisplatin [2] ---> SPC of [2] of eMC
Concomitant administration of cisplatin and nephrotoxic medicinal products will potentiate the toxic effect of cisplatin on the kidneys.
Amphotericin, clofarabine [2] ---> SPC of [2] of EMA
The concomitant use of medicinal products eliminated by tubular secretion should be avoided
Amphotericin, clotrimazole
Clotrimazole decreases the efficacy of amphotericin and other polyene antibiotics
Amphotericin, corticosteroids
Increased risk of hypokalaemia with amphotericin.
Amphotericin, corticotropin
The co-administration may increase the potassium loss due to amphotericin
Amphotericin, cyclophosphamide
The co-administration may increase the nephrotoxicity
Amphotericin, digital glycosides
Electrolyte imbalance may increase the toxicity of cardiac glycosides
Amphotericin, digitoxin
Increased effect of digitoxin and risk of digitoxin intoxication due to drug-induced hypokaliemia and hypomagnesemia
Amphotericin, digoxin [2] ---> SPC of [2] of eMC
Agents causing hypokalaemia or intracellular potassium deficiency may cause increased sensitivity to digoxin
Amphotericin, doxorubicine [2] ---> SPC of [2] of eMC
Marked nephrotoxicity of Amphotericin B can occur during doxorubicin therapy.
Amphotericin, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Use of emtricitabine/rilpivirine/tenofovir should be avoided with concurrent or recent use of a nephrotoxic medicinal product
Amphotericin, flucytosine
The combination therapy of flucytosine and amphotericin B has a synergistic effect
Amphotericin, foscarnet [2] ---> SPC of [2] of eMC
Since foscarnet can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs
Amphotericin, fosphenytoin [2] ---> SPC of [2] of eMC
The phenytoin plasma concentrations can increase
Amphotericin, ganciclovir [2]
Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations
Amphotericin, gentamicin [2] ---> SPC of [2] of eMC
Amphotericin is potential enhancer of nephrotoxicity
Amphotericin, hydrochlorothiazide
Concomitant use of hydrochlorothiazide und amphotericin B (parenteral), carbenoxolone, corticosteroids, corticotropin (ACTH) or stimulant laxatives may intensify the electrolyte disorder, specially hypokaliemia
Amphotericin, hydroquinidine
Concomitant use of hydroquinidine and hypokalaemic agents increases the risk of heart rhythm disorders (torsades de pointes)
Amphotericin, hypokalemia
The co-administration may increase the hypokalaemic effect
Amphotericin, ifosfamide
The previous or concomitant treatment of nephrotoxic drugs may enhance the nephrotoxicity of ifosfamide and thus also the hematotoxicity and CNS toxicity
Amphotericin, indapamide [2] ---> SPC of [2] of eMC
Increased risk of hypokalaemia (additive effect).
Amphotericin, irbesartan/hydrochlorothiazide [2] ---> SPC of [2] of EMA
The co-administration may increase the risk of hypokalaemia. Monitoring of potassium plasma levels is advised.
Amphotericin, kaliuretic medicines
The co-administration may increase the hypokalaemic effect
Amphotericin, lactitol
The co-administration of hypokaliemia-inducer drugs may enhance the potassium loss
Amphotericin, lactulose
Lactulose may enhance other drug-induced hypokalemia
Amphotericin, lamivudine/zidovudine [2] ---> SPC of [2] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine.
Amphotericin, leukocyte transfusion
Acute pulmonary reactions may occur
Amphotericin, loop diuretics
The hypokalaemic effect of diuretics may be potentiated by amphotericin
Amphotericin, losartan/hydrochlorothiazide [2] ---> SPC of [2] of eMC
Hydrochlorothiazide may intensify electrolyte imbalance, particularly hypokalaemia.
Amphotericin, meglumine and sodium ioxitalamate
The co-administration with other medicinal products with nephrotoxic potential may decrease the renal function and cause a permanent damage
Amphotericin, methylprednisolone
The co-administration may increase the potassium loss due to amphotericin
Amphotericin, metildigoxin
Electrolyte imbalance may increase the toxicity of cardiac glycosides
Amphotericin, micafungin [2] ---> SPC of [2] of EMA
Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure.
Amphotericin, moxifloxacin [2] ---> SPC of [2] of eMC
Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels
Amphotericin, muscle relaxants
The hypokalaemia following amphotericin therapy may enhance the curariform actions of skeletal muscle relaxants.
Amphotericin, neomycin
The co-administration may enhance the nephrotoxicity and/or ototoxicity
Amphotericin, nephrotoxic substances
Concomitant administration of amphotericin and other nephrotoxic drugs requires that the renal function be closely monitored
Amphotericin, netilmicin
The administration concurrent or sequential of netilmicin with other potentially nephrotoxic or neurotoxic drugs may increase the nephrotoxicity and/or neurotoxicity
Amphotericin, pentamidine
The co-administration of nephrotoxic drugs should be avoided
Amphotericin, phenytoin
The phenytoin plasma concentrations can increase
Amphotericin, piretanide
The co-administration of piretanide with amphotericin B may cause a great loss of potassium with the risk of hypokaliemia
Amphotericin, prednisone [2] ---> SPC of [2] of eMC
The risk of hypokalaemia may be increased.
Amphotericin, pregnancy
Amphotericin should be used during pregnancy only if the possible benefits to be derived outweigh the potential risks involved.
Amphotericin, sotalol [2] ---> SPC of [2] of eMC
With potassium-depleting drugs may occur hypokalaemia, increasing the potential for torsade de pointes
Amphotericin, succinylcholine
The co-administration may enhance the neuromuscular blocking action of suxamethonium
Amphotericin, sucralfate
The co-administration may decrease the absorption of amphotericin. It is recommended to administer the two substances at least 2 hours apart.
Amphotericin, sulpiride [2] ---> SPC of [2] of eMC
The co-administration of sulpiride and amphotericin IV may induce torsades de pointes or prolong the QT interval. The combination is not recommended
Amphotericin, suxamethonium
The co-administration may enhance the neuromuscular blocking action of suxamethonium
Amphotericin, tacrolimus [2] ---> SPC of [2] of EMA
Enhanced nephrotoxicity has been observed following the administration of amphotericin B in conjunction with tacrolimus.
Amphotericin, teicoplanin [2] ---> SPC of [2] of eMC
Teicoplanin should be used with care in conjunction with or sequentially with other medicinal products with known nephrotoxic or ototoxic potential.
Amphotericin, telbivudine [2] ---> SPC of [2] of EMA
Since telbivudine is eliminated primarily by renal excretion, co-administration with substances that affect renal function may affect plasma concentrations of telbivudine and/or the co-administered substance. The combination should be used with caution.
Amphotericin, telmisartan/hydrochlorothiazide [2] ---> SPC of [2] of EMA
Medicinal products associated with potassium loss and hypokalaemia: These medicinal products may potentiate the effect of hydrochlorothiazide on serum potassium
Amphotericin, tetracosactide
Increase of tetracosactide potassium elimination
Amphotericin, thiazides
The hypokalaemic effect of diuretics may be potentiated by amphotericin
Amphotericin, tiopronin
Increased risk of nephrotoxicity. Caution should be exercised
Amphotericin, triamcinolone [2]
Patients should be observed for hypokalaemia.
Amphotericin, triamcinolone acetonide [2] ---> SPC of [2] of eMC
Patients should be observed for hypokalaemia.
Amphotericin, valganciclovir [2] ---> SPC of [2] of eMC
Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations
Amphotericin, vancomycin [2] ---> SPC of [2] of eMC
Concurrent or sequential systemic or topical use of other potentially neurotoxic or nephrotoxic drugs may potentiate the nephrotoxicity and/or ototoxicity of vancomycin and consequently requires careful monitoring.
Amphotericin, xipamide [2] ---> SPC of [2] of eMC
Concomitant use with xipamide may provoke hypokalaemia.
Amphotericin, zidovudine ---> SPC of [lamivudine/zidovudine] of EMA
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine.
Amprenavir
PDE5 inhibitors, amprenavir [2] ---> SPC of [2] of EMA
Amprenavir, CYP3A4 inhibitor, may increase PDE5 inhibitor plasma levels and cause hypotension, visual changes and priapism. The combination is not recommended
PDE5 inhibitors, amprenavir/ritonavir ---> SPC of [amprenavir] of EMA
Amprenavir/ritonavir, CYP3A4 inhibitors, may increase PDE5 inhibitor plasma concentrations. Concomitant use is not recommended
St. John's wort, amprenavir [2] ---> SPC of [2] of EMA
Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking amprenavir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir
St. John's wort, amprenavir/ritonavir ---> SPC of [amprenavir] of EMA
Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking amprenavir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir
Abacavir, amprenavir [2] ---> SPC of [2] of EMA
No dose adjustment is necessary for either medicinal product when abacavir is administered in combination with amprenavir.
Alfuzosin, amprenavir [2] ---> SPC of [2] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amiodarone, amprenavir [2] ---> SPC of [2] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amiodarone, amprenavir/ritonavir ---> SPC of [amprenavir] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4). Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Amprenavir [1], antacids ---> SPC of [1] of EMA
It is advisable not to take antacids at the same time as amprenavir, since its absorption may be impaired. It is recommended at least 1 hour apart to administer them
Amprenavir [1], astemizole ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amprenavir [1], atorvastatin ---> SPC of [1] of EMA
Amprenavir, strong CYP3A4 inhibitor, must not be administered with drugs with narrow therapeutic range that are substrates of CYP3A4. Possible serious adverse events
Amprenavir [1], avanafil ---> SPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Amprenavir [1], bepridil ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amprenavir, bosutinib [2] ---> SPC of [2] of EMA
The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.
Amprenavir [1], breast-feeding ---> SPC of [1] of EMA
It is recommended that mothers being treated with amprenavir do not breast-feed their infants.
Amprenavir [1], carbamazepine ---> SPC of [1] of EMA
Concomitant administration of anticonvulsant active substances known as enzymatic inductors with amprenavir may lead to a decrease in the plasma concentrations of amprenavir.
Amprenavir [1], cimetidine ---> SPC of [1] of EMA
Amprenavir may increase the plasma concentrations of cimetidine
Amprenavir [1], cisapride ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amprenavir [1], clarithromycin ---> SPC of [1] of EMA
The CYP3A4 inhibition may moderately increase the clarithromycin exposition. Use with caution
Amprenavir, clonazepam
Increased risk of prolonged sedation and respiratory depression
Amprenavir [1], clozapine ---> SPC of [1] of EMA
Amprenavir may increase the plasma concentrations of clozapine
Amprenavir, cobimetinib [2] ---> SPC of [2] of EMA
Caution should be exercised if cobimetinib is coadministered with moderate CYP3A inhibitors. When cobimetinib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.
Amprenavir [1], cyclosporine ---> SPC of [1] of EMA
Frequent therapeutic concentration monitoring of immunosuppressant levels is recommended until levels have stabilised as plasma concentrations of immunosuppressant may be increased when co-administered with amprenavir
Amprenavir, dabrafenib [2] ---> SPC of [2] of EMA
Interactions with many medicinal products eliminated through metabolism or active transport is expected. These medicinal products are to be avoided or used with caution.
Amprenavir, dapoxetine [2] ---> SPC of [2] of eMC
Concomitant treatment of dapoxetine with moderate CYP3A4 inhibitors may give rise to significantly increased exposure of dapoxetine and desmethyldapoxetine, especially in CYP2D6 poor metabolizers.
Amprenavir [1], dapsone ---> SPC of [1] of EMA
Amprenavir may increase the plasma concentrations of dapsone
Amprenavir [1], delavirdine ---> SPC of [1] of EMA
Decreased AUC, Cmax and Cmin of delavirdine and increased AUC, Cmax and Cmin of amprenavir
Amprenavir [1], desipramine ---> SPC of [1] of EMA
Careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they are concomitantly administered with amprenavir
Amprenavir, dextromethorphan/quinidine [2] ---> SPC of [2] of EMA
Concomitant administration of medicines that inhibit CYP3A4 can be expected to increase plasma levels of quinidine, which could increase risk relating to QTc prolongation. Strong and moderate CYP3A4 inhibitors should be avoided during treatment.
Amprenavir [1], didanosine ---> SPC of [1] of EMA
It is recommended that didanosine and amprenavir should be administered at least 1 hour apart
Amprenavir [1], dihydroergotamine ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amprenavir [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4)
Amprenavir, encorafenib [2] ---> SPC of [2] of EMA
Moderate CYP3A4 inhibitors should be co-administered with caution. When encorafenib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.
Amprenavir [1], ergot derivatives ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amprenavir [1], ergotamine ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amprenavir [1], erythromycin ---> SPC of [1] of EMA
Plasma levels of both medicinal products may be increased when co-administered.
Amprenavir [1], ethinyl estradiol ---> SPC of [1] of EMA
Amprenavir, CYP3A4 inductor, may decrease the plasma concentrations of ethinylestradiol. Decreased AUC and Cmin of amprenavir. Alternative non-hormonal methods of contraception are recommended for women of childbearing potential
Amprenavir, everolimus [2] ---> SPC of [2] of EMA
Increase in everolimus concentration is expected. Use caution when co-administration of moderate CYP3A4 inhibitors or PgP inhibitors cannot be avoided.
Amprenavir, fentanyl [2] ---> SPC of [2] of EMA
The concomitant use of fentanyl with moderate CYP3A4 inhibitors may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression.
Amprenavir [1], fluticasone ---> SPC of [1] of EMA
Amprenavir, CYP3A4 inhibitor, may increase the plasma concentrations of fluticasone.
Amprenavir [1], halofantrine ---> SPC of [1] of EMA
The combination may cause serious adverse reactions. Concomitant use is not recommended
Amprenavir, ibrutinib [2] ---> SPC of [2] of EMA
Ibrutinib is primarily metabolised by cytochrome P450 enzyme 3A4. Concomitant use of ibrutinib and medicinal products that moderately inhibit CYP3A4 can increase ibrutinib exposure and should be avoided.
Amprenavir, indinavir [2] ---> SPC of [2] of EMA
The appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Amprenavir, indinavir/ritonavir ---> SPC of [indinavir] of EMA
Ritonavir increases the serum levels of amprenavir as a result of CYP3A4 inhibition. The appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Amprenavir, isavuconazole [2] ---> SPC of [2] of EMA
No CRESEMBA dose adjustment necessary. Protease inhibitors: careful monitoring for any occurrence of drug toxicity and /or lack of antiviral efficacy, and dose adjustment if required.
Amprenavir [1], itraconazol ---> SPC of [1] of EMA
The CYP3A4 inhibition by amprenavir may increase the plasma concentrations of itraconazole
Amprenavir, ixabepilone
The strong CYP3A4 inhibition may increase the plasma concentrations of ixabepilone. The coadministration should be avoided
Amprenavir [1], ketoconazole ---> SPC of [1] of EMA
The CYP3A4 inhibition by amprenavir may increase the plasma concentrations of ketoconazole
Amprenavir [1], lamivudine ---> SPC of [1] of EMA
No dose adjustment is necessary for either medicinal product when lamivudine is administered in combination with amprenavir.
Amprenavir [1], lidocaine ---> SPC of [1] of EMA
The combination may cause serious adverse reactions. Concomitant use is not recommended
Amprenavir [1], lopinavir/ritonavir ---> SPC of [1] of EMA
Decreased plasma concentrations of lopinavir and increased plasma concentrations of amprenavir. Concomitant use is not recommended
Amprenavir [1], loratadine ---> SPC of [1] of EMA
Amprenavir may increase the plasma concentrations of loratadine
Amprenavir [1], lovastatine ---> SPC of [1] of EMA
Lovastatin is highly dependent on CYP3A4 for metabolism, thus concomitant use of amprenavir with lovastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis.
Amprenavir, lurasidone [2] ---> SPC of [2] of EMA
Coadministration of lurasidone with mild inducers of CYP3A4 would be expected to give a <2-fold reduction in lurasidone exposure during co-administration and for up to 2 weeks after discontinuation of mild or moderate CYP3A4 inducers.
Amprenavir [1], methadone ---> SPC of [1] of EMA
Amprenavir, CYP3A4 inductor, may decrease the plasma concentrations of methadone.
Amprenavir [1], midazolam ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4) (oral midazolam).
Amprenavir, nelfinavir [2] ---> SPC of [2] of EMA
No dose adjustment is necessary for either medicinal product when nelfinavir is administered in combination with amprenavir.
Amprenavir [1], nevirapine ---> SPC of [1] of EMA
The effect of nevirapine on other protease inhibitors and the limited evidence available suggest that nevirapine may decrease the serum concentrations of amprenavir.
Amprenavir [1], norethisterone ---> SPC of [1] of EMA
Amprenavir, CYP3A4 inductor, may decrease the plasma concentrations of norethisterone. Alternative non-hormonal methods of contraception are recommended for women of childbearing potential
Amprenavir [1], nortriptyline ---> SPC of [1] of EMA
Careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they are concomitantly administered with amprenavir
Amprenavir [1], oral anticoagulants ---> SPC of [1] of EMA
A reinforced monitoring of the International Normalised Ratio is recommended in case of administration of Amprenavir with warfarin or other oral anticoagulants, due to a possible decrease or increase of their antithrombotic effect
Amprenavir [1], paroxetine ---> SPC of [1] of EMA
Decreased plasma concentrations of paroxetine.
Amprenavir [1], phenobarbital ---> SPC of [1] of EMA
Concomitant administration of anticonvulsant active substances known as enzymatic inductors with amprenavir may lead to a decrease in the plasma concentrations of amprenavir.
Amprenavir [1], phenytoin ---> SPC of [1] of EMA
Concomitant administration of anticonvulsant active substances known as enzymatic inductors with amprenavir may lead to a decrease in the plasma concentrations of amprenavir.
Amprenavir [1], pimozide ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amprenavir, piperaquine/artenimol [2] ---> SPC of [2] of EMA
Concomitant treatment with medicinal products which inhibit CYP3A4 may lead to a marked increase of piperaquine plasma concentration resulting in an exacerbation of the effect on QTc
Amprenavir [1], pregnancy ---> SPC of [1] of EMA
This medicinal product should be used during pregnancy only after careful weighing of the potential benefits compared to the potential risk to the foetus.
Amprenavir, protease inhibitors
Generally, dual therapy with protease inhibitors is not recommended
Amprenavir [1], quinidine ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amprenavir [1], rapamycin ---> SPC of [1] of EMA
Frequent therapeutic concentration monitoring of immunosuppressant levels is recommended until levels have stabilised as plasma concentrations of immunosuppressant may be increased when co-administered with amprenavir
Amprenavir [1], rifabutin ---> SPC of [1] of EMA
Co-administration of amprenavir with rifabutin resulted in a 193 %increase in rifabutin AUC and an increase of rifabutin-related adverse events.
Amprenavir [1], rifampicin ---> SPC of [1] of EMA
It is expected that the CYP3A4 induction by rifampicin reduces amprenavir AUC. The decrease in amprenavir AUC can result in virological failure and resistance development.
Amprenavir [1], ritonavir ---> SPC of [1] of EMA
Ritonavir increases the serum levels of amprenavir as a result of CYP3A4 inhibition.
Amprenavir, ruxolitinib [2] ---> SPC of [2] of EMA
Mild or moderate CYP3A4 inhibitors may increase ruxolitinib exposition. No dose adjustment is recommended when ruxolitinib is co-administered with mild or moderate CYP3A4 inhibitors
Amprenavir [1], saquinavir ---> SPC of [1] of EMA
No dose adjustment is necessary for either medicinal product when saquinavir is administered in combination with amprenavir.
Amprenavir, simeprevir [2] ---> SPC of [2] of EMA
The CYP3A4 enzyme induction or inhibition may alter plasma concentrations of simeprevir. It is not recommended to co-administer simeprevir with any HIV PI, with or without ritonavir.
Amprenavir [1], simvastatine ---> SPC of [1] of EMA
Simvastatin is highly dependent on CYP3A4 for metabolism, thus concomitant use of amprenavir with simvastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis.
Amprenavir [1], strong CYP3A4 inductors ---> SPC of [1] of EMA
The strong CYP3A4 induction may decrease the plasma levels of amprenavir
Amprenavir [1], strong CYP3A4 inhibitors ---> SPC of [1] of EMA
The strong CYP3A4 inhibition may increase the plasma concentrations of amprenavir
Amprenavir [1], tacrolimus ---> SPC of [1] of EMA
Frequent therapeutic concentration monitoring of immunosuppressant levels is recommended until levels have stabilised as plasma concentrations of immunosuppressant may be increased when co-administered with amprenavir
Amprenavir [1], terfenadine ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
Amprenavir, ticagrelor [2] ---> SPC of [2] of EMA
Co-administration of diltiazem with ticagrelor increased the ticagrelor Cmax by 69% and AUC to 2.7 fold. Other moderate CYP3A4 inhibitors would be expected to have a similar effect and can as well be co-administered with ticagrelor.
Amprenavir [1], triazolam ---> SPC of [1] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4) (oral triazolam).
Amprenavir [1], tricyclic antidepressants ---> SPC of [1] of EMA
Careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they are concomitantly administered with amprenavir
Amprenavir, voriconazole [2] ---> SPC of [2] of EMA
In vitro studies show that voriconazole may inhibit the metabolism of HIV protease inhibitors and the metabolism of voriconazole may also be inhibited by HIV protease inhibitors.
Amprenavir [1], warfarin ---> SPC of [1] of EMA
A reinforced monitoring of the International Normalised Ratio is recommended in case of administration of Amprenavir with warfarin or other oral anticoagulants, due to a possible decrease or increase of their antithrombotic effect
Amprenavir [1], zidovudine ---> SPC of [1] of EMA
No dose adjustment is necessary for either medicinal product when zidovudine is administered in combination with amprenavir.
Amprenavir/ritonavir, antacids ---> SPC of [amprenavir] of EMA
It is advisable not to take antacids at the same time as amprenavir, since its absorption may be impaired. It is recommended at least 1 hour apart to administer them
Amprenavir/ritonavir, atorvastatin ---> SPC of [amprenavir] of EMA
Amprenavir/ritonavir, CYP3A4 inhibitors, increase the plasma concentrations of atorvastatin. Doses of atorvastatin no greater than 20 mg/day should be administered
Amprenavir/ritonavir, bepridil ---> SPC of [amprenavir] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4). Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Amprenavir/ritonavir, clarithromycin ---> SPC of [amprenavir] of EMA
When ritonavir is co-administered with amprenavir an increase in clarithromycin concentrations may occur.
Amprenavir/ritonavir, corticosteroids primarily metabolised by CYP3A ---> SPC of [amprenavir] of EMA
Concomitant use of Agenerase with ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects
Amprenavir/ritonavir, drugs primarily metabolised by CYP2D6 with narrow therapeutic index ---> SPC of [amprenavir]
Amprenavir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism
Amprenavir/ritonavir, drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SPC of [amprenavir]
Amprenavir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP3A4 metabolism
Amprenavir/ritonavir, ethinyl estradiol ---> SPC of [amprenavir] of EMA
Amprenavir/ritonavir, CYP3A4 inductors, may decrease the plasma concentrations of ethinylestradiol. Alternative non-hormonal methods of contraception are recommended for women of childbearing potential
Amprenavir/ritonavir, etravirine ---> SPC of [amprenavir] of EMA
Increased AUC of amprenavir. Amprenavir may require dose reduction
Amprenavir/ritonavir, flecainide ---> SPC of [amprenavir] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 2D6 (CYP2D6). Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Amprenavir/ritonavir, fluticasone ---> SPC of [amprenavir] of EMA
Concomitant use of Agenerase with ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects
Amprenavir/ritonavir, itraconazol ---> SPC of [amprenavir] of EMA
The CYP3A4 inhibition by amprenavir may increase the plasma concentrations of ketoconazole
Amprenavir/ritonavir, ketoconazole ---> SPC of [amprenavir] of EMA
The CYP3A4 inhibition by amprenavir may increase the plasma concentrations of itraconazole
Amprenavir/ritonavir, lovastatine ---> SPC of [amprenavir] of EMA
Concomitant use of amprenavir with lovastatin is contraindicated because of increased plasma concentrations of lovastatin which can increase the risk of myopathy, including rhabdomyolysis
Amprenavir/ritonavir, midazolam ---> SPC of [amprenavir] of EMA
Amprenavir/ritonavir, CYP3A4 inhibitors, increase the plasma concentrations of midazolam. They should not be co-administered with orally administered midazolam
Amprenavir/ritonavir, norethisterone ---> SPC of [amprenavir] of EMA
Amprenavir/ritonavir, CYP3A4 inductors, may decrease the plasma concentrations of norethisterone. Alternative non-hormonal methods of contraception are recommended for women of childbearing potential
Amprenavir/ritonavir, paroxetine ---> SPC of [amprenavir] of EMA
Decreased plasma concentrations of paroxetine.
Amprenavir/ritonavir, propafenone ---> SPC of [amprenavir] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 2D6 (CYP2D6). Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Amprenavir/ritonavir, quinidine ---> SPC of [amprenavir] of EMA
Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4). Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Amprenavir/ritonavir, rapamycin ---> SPC of [amprenavir] of EMA
Frequent therapeutic concentration monitoring of immunosuppressant levels is recommended until levels have stabilised as plasma concentrations of immunosuppressant may be increased when co-administered with amprenavir
Amprenavir/ritonavir, rifampicin ---> SPC of [amprenavir] of EMA
It is expected that the CYP3A4 induction by rifampicin reduces amprenavir AUC. The decrease in amprenavir AUC can result in virological failure and resistance development. Combination with concomitant low-dose ritonavir is contraindicated
Amprenavir/ritonavir, sildenafil ---> SPC of [amprenavir] of EMA
Amprenavir/ritonavir, CYP3A4 inhibitors, may increase plasma concentrations of sildenafil, which is contraindicated for the treatment of pulmonary arterial hypertension
Amprenavir/ritonavir, simvastatine ---> SPC of [amprenavir] of EMA
Simvastatin is highly dependent on CYP3A4 for metabolism, thus concomitant use of amprenavir with simvastatin is not recommended due to an increased risk of myopathy, including rhabdomyolysis.
Amprenavir/ritonavir, tacrolimus ---> SPC of [amprenavir] of EMA
Frequent therapeutic concentration monitoring of immunosuppressant levels is recommended until levels have stabilised as plasma concentrations of immunosuppressant may be increased when co-administered with amprenavir
Amprenavir/saquinavir, efavirenz ---> SPC of [amprenavir] of EMA
Significant decreased exposition of both protease inhibitors. Co-administration is not recommended
CONTRAINDICATIONS of Amprenavir
- Hypersensitivity to the active substance or to any of the excipients.
- Amprenavir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4).
- Co-administration may result in competitive inhibition of the metabolism of these medicinal products and create the potential for serious and/or life-threatening adverse events such as cardiac arrhythmia (e.g. amiodarone, bepridil, quinidine, terfenadine, astemizole, cisapride, pimozide), respiratory depression and /or prolonged sedation (e.g. oral triazolam and oral midazolam (for caution on parenterally administered midazolam) or peripheral vasospasm or ischaemia and ischaemia of other tissues, including cerebral or myocardial ischaemia (e.g. ergot derivatives).
- Amprenavir in combination with ritonavir is contraindicated in patients with severe hepatic impairment.
- Combination of rifampicin with Agenerase with concomitant low-dose ritonavir is contraindicated.
- Amprenavir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism, e.g. flecainide and propafenone
- Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking amprenavir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir
Anagrelide (Xagrid)
Ability to drive, anagrelide [2] ---> SmPC of [2] of EMA
In clinical development, dizziness was commonly reported. Patients are advised not to drive or operate machinery while taking anagrelide if dizziness is experienced.
Acetylsalicylic acid, anagrelide [2] ---> SmPC of [2] of EMA
At the doses recommended for use in the treatment of essential thrombocythaemia, anagrelide may potentiate the effects of other medicinal products that inhibit or modify platelet function
Amrinone, anagrelide [2] ---> SmPC of [2] of EMA
Anagrelide is an inhibitor of PDE III. The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide.
Anagrelide [1], breast-feeding ---> SmPC of [1] of EMA
Breast-feeding should be discontinued during treatment with anagrelide.
Anagrelide [1], cilostazol ---> SmPC of [1] of EMA
Anagrelide is an inhibitor of PDE III. The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide.
Anagrelide [1], CYP1A2 inductors ---> SmPC of [1] of EMA
Therefore, clinical and biological monitoring is recommended in patients taking concomitant CYP1A2 inducers. If needed, anagrelide dose adjustment could be made.
Anagrelide [1], digoxin ---> SmPC of [1] of EMA
In vivo interaction studies in humans have demonstrated that digoxin and warfarin do not affect the pharmacokinetic properties of anagrelide.
Anagrelide [1], digoxin ---> SmPC of [1] of EMA
In vivo interaction studies in humans have demonstrated that anagrelide does not affect the pharmacokinetic properties of digoxin or warfarin.
Anagrelide [1], drugs primarily metabolised by CYP1A2 ---> SmPC of [1] of EMA
Anagrelide demonstrates some limited inhibitory activity towards CYP1A2 which may present a theoretical potential for interaction with other co-administered medicinal products sharing that clearance mechanism
Anagrelide [1], enoxacin ---> SmPC of [1] of EMA
Anagrelide is primarily metabolised by CYP1A2. It is known that CYP1A2 is inhibited by several medicinal products, and such medicinal products could theoretically adversely influence the clearance of anagrelide.
Anagrelide [1], enoximone ---> SmPC of [1] of EMA
Anagrelide is an inhibitor of PDE III. The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide.
Anagrelide [1], fertility ---> SmPC of [1] of EMA
In male rats, there was no effect on fertility or reproductive performance with anagrelide. In female rats, using doses in excess of the therapeutic range, anagrelide disrupted implantation (see section 5.3).
Anagrelide [1], fluvoxamine ---> SmPC of [1] of EMA
Anagrelide is primarily metabolised by CYP1A2. It is known that CYP1A2 is inhibited by several medicinal products, and such medicinal products could theoretically adversely influence the clearance of anagrelide.
Anagrelide [1], foods ---> SmPC of [1] of EMA
Food delays the absorption of anagrelide, but does not significantly alter systemic exposure. The effects of food on bioavailability are not considered clinically relevant to the use of anagrelide.
Anagrelide [1], hypokalemia ---> SmPC of [1] of EMA
Caution should be taken when using anagrelide in patients with known risk factors for prolongation of the QT interval, medicinal products that can prolong QTc interval and hypokalaemia.
Anagrelide [1], milrinone ---> SmPC of [1] of EMA
Anagrelide is an inhibitor of PDE III. The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide.
Anagrelide [1], olprinone ---> SmPC of [1] of EMA
Anagrelide is an inhibitor of PDE III. The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide.
Anagrelide [1], omeprazole ---> SmPC of [1] of EMA
Therefore, clinical and biological monitoring is recommended in patients taking concomitant CYP1A2 inducers. If needed, anagrelide dose adjustment could be made.
Anagrelide [1], oral contraceptives ---> SmPC of [1] of EMA
Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Anagrelide [1], PDE3 inhibitors ---> SmPC of [1] of EMA
Anagrelide is an inhibitor of PDE III. The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide.
Anagrelide [1], platelet aggregation inhibitors ---> SmPC of [1] of EMA
At the doses recommended for use in the treatment of essential thrombocythaemia, anagrelide may potentiate the effects of other medicinal products that inhibit or modify platelet function
Anagrelide [1], pregnancy ---> SmPC of [1] of EMA
Xagrid is not recommended during pregnancy. If anagrelide is used during pregnancy, or if the patient becomes pregnant while using the medicinal product, she should be advised of the potential risk to the foetus.
Anagrelide [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Caution should be taken when using anagrelide in patients with known risk factors for prolongation of the QT interval, medicinal products that can prolong QTc interval and hypokalaemia.
Anagrelide [1], strong CYP1A2 inhibitors ---> SmPC of [1] of EMA
Anagrelide is primarily metabolised by CYP1A2. It is known that CYP1A2 is inhibited by several medicinal products, and such medicinal products could theoretically adversely influence the clearance of anagrelide.
Anagrelide [1], theophylline ---> SmPC of [1] of EMA
Anagrelide demonstrates some limited inhibitory activity towards CYP1A2 which may present a theoretical potential for interaction with other co-administered medicinal products sharing that clearance mechanism
Anagrelide [1], warfarin ---> SmPC of [1] of EMA
In vivo interaction studies in humans have demonstrated that digoxin and warfarin do not affect the pharmacokinetic properties of anagrelide.
Anagrelide [1], warfarin ---> SmPC of [1] of EMA
In vivo interaction studies in humans have demonstrated that anagrelide does not affect the pharmacokinetic properties of digoxin or warfarin.
Anagrelide [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of child-bearing potential should use adequate birth-control measures during treatment with anagrelide.
Anagrelide, iloprost [2] ---> SmPC of [2] of EMA
Since iloprost inhibits platelet function its use with anticoagulants or other inhibitors of platelet aggregation may increase the risk of bleeding. A careful monitoring of the patients is recommended.
Anagrelide, nilotinib [2] ---> SmPC of [2] of EMA
Nilotinib may be given with anagrelide if clinically indicated.
CONTRAINDICATIONS of Anagrelide (Xagrid)
- Hypersensitivity to anagrelide or to any of the excipients listed in section 6.1.
- Patients with moderate or severe hepatic impairment
- Patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min)
https://www.ema.europa.eu/en/documents/product-information/xagrid-epar-product-information_en.pdf 20/02/2023
Other trade names: Anagrelide Mylan,
Anakinra (Kineret)
Adalimumab [1], anakinra ---> SmPC of [1] of EMA
Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, and other potential pharmacological interactions.
Anakinra [1], breast-feeding ---> SmPC of [1] of EMA
It is unknown whether anakinra/metabolites are excreted in human milk. A risk to the newborns/ infants cannot be excluded. Breast-feeding should be discontinued during treatment with Kineret.
Anakinra [1], CYP450 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation.
Anakinra [1], CYP450 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
This would be clinically relevant for CYP450 substrates with a narrow therapeutic index (e.g. warfarin and phenytoin).
Anakinra [1], disease modifying anti-rheumatic drug ---> SmPC of [1] of EMA
In clinical studies, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory medicinal products, glucocorticoids, and DMARDs) have not been observed.
Anakinra [1], etanercept ---> SmPC of [1] of EMA
Concurrent administration of Kineret and etanercept has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone in RA patients.
Anakinra [1], glucocorticoids ---> SmPC of [1] of EMA
In clinical studies, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory medicinal products, glucocorticoids, and DMARDs) have not been observed.
Anakinra [1], NSAID ---> SmPC of [1] of EMA
In clinical studies, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory medicinal products, glucocorticoids, and DMARDs) have not been observed.
Anakinra [1], phenytoin ---> SmPC of [1] of EMA
Thus, it may be expected that for an IL-1 receptor antagonist, such as anakinra, the formation of CYP450 enzymes could be normalized during treatment.
Anakinra [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure, it is preferable to avoid the use of anakinra during pregnancy and in woman of childbearing potential not using contraception.
Anakinra [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA
No data are available on either the effects of live vaccination or on the secondary transmission of infection. Therefore, live vaccines should not be given concurrently
Anakinra [1], warfarin ---> SmPC of [1] of EMA
Thus, it may be expected that for an IL-1 receptor antagonist, such as anakinra, the formation of CYP450 enzymes could be normalized during treatment.
Anakinra, certolizumab pegol [2] ---> SmPC of [2] of EMA
Severe infections and neutropaenia may result with concurrent use. The combination of certolizumab pegol and anakinra is not recommended
Anakinra, etanercept [2] ---> SmPC of [2] of EMA
Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra alone (historical data).
Anakinra, golimumab [2] ---> SmPC of [2] of EMA
The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4).
Anakinra, infliximab [2] ---> SmPC of [2] of EMA
Co-administration of anakinra and etanercept has been associated with an increased risk of serious infections and neutropenia. The concurrent administration of anakinra and etanercept or other TNF antagonists is not recommended
Anakinra, TNF inhibitors ---> SmPC of [anakinra] of EMA
Concurrent Kineret and etanercept treatment has not demonstrated increased clinical benefit. The concurrent use of Kineret with etanercept or any other TNF-? antagonist is not recommended (see section 4.4).
Anakinra, TNF inhibitors ---> SmPC of [golimumab] of EMA
Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept. The combination of Simponi and anakinra is not recommended
CONTRAINDICATIONS of Anakinra (Kineret)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to E. coli derived proteins.
- Kineret treatment must not be initiated in patients with neutropenia (ANC <1.5 x 109/l)
https://www.ema.europa.eu/en/documents/product-information/kineret-epar-product-information_en.pdf 15/10/2025
Anastrozole
Ability to drive, anastrozole [2] ---> SPC of [2] of eMC
Asthenia and somnolence have been reported with the use of anastrozole
Anastrozole [1], breast-feeding ---> SPC of [1] of eMC
Anastrozole is contraindicated in lactating women.
Anastrozole [1], estrogens ---> SPC of [1] of eMC
Oestrogen-containing therapies should not be co-administered with anastrozole as they would negate its pharmacological action.
Anastrozole [1], growth hormone ---> SPC of [1] of eMC
Anastrozole should not be used in boys/girls with growth hormone deficiency in addition to growth hormone treatment.
Anastrozole [1], pregnancy ---> SPC of [1] of eMC
Anastrozole is contraindicated in pregnant women.
Anastrozole [1], tamoxifen ---> SPC of [1] of eMC
Tamoxifen should not be co-administered with anastrozole, as this may diminish its pharmacological action
Anastrozole, trastuzumab [2] ---> SPC of [2] of EMA
The administration of concomitant anastrozole did not appear to influence the pharmacokinetics of trastuzumab.
CONTRAINDICATIONS of Anastrozole
Anastrozole is contraindicated in:
- Premenopausal women.
- Pregnant or lactating women.
- Patients with severe renal impairment (creatinine clearance less than 20 ml/min).
- Patients with moderate or severe hepatic disease.
- Patients with known hypersensitivity to anastrozole or to any of the excipients
Oestrogen-containing therapies should not be co-administered with anastrozole as they would negate its pharmacological action.
Concurrent tamoxifen therapy
http://www.medicines.org.uk/emc/
Andexanet alfa (Ondexxya)
Andexanet alfa [1], breast-feeding ---> SmPC of [1] of EMA
A risk to newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with andexanet alfa.
Andexanet alfa [1], fertility ---> SmPC of [1] of EMA
There are no data on the effects of andexanet alfa on humanfertility.
Andexanet alfa [1], heparin ---> SmPC of [1] of EMA
Use of andexanet as an antidote for heparin or low-molecular weight heparin has not been evaluated and is not recommended.
Andexanet alfa [1], pregnancy ---> SmPC of [1] of EMA
Andexanet alfa is not recommended during pregnancy or in women of childbearing potential not using contraception.
CONTRAINDICATIONS of Andexanet alfa (Ondexxya)
- Hypersensitivity to the active substance or to any other ingredients listed in section 6.1.
- Known allergic reaction to hamster proteins.
https://www.ema.europa.eu/en/documents/product-information/ondexxya-epar-product-information_en.pdf 25/07/2025
Angiotensin II (Giapreza)
ACE inhibitors, angiotensin II [2] ---> SmPC of [2] of EMA
Patients who have recently received angiotensin converting enzyme (ACE) inhibitors may be more sensitive to GIAPREZA's action with an increased response.
AIIRA, angiotensin II [2] ---> SmPC of [2] of EMA
Patients who have recently received angiotensin II receptor blockers (ARBs) may be less sensitive to GIAPREZA's actions with a reduced response.
Angiotensin II [1], breast-feeding ---> SmPC of [1] of EMA
Breast-feeding should be discontinued during treatment with GIAPREZA.
Angiotensin II [1], pregnancy ---> SmPC of [1] of EMA
Use during pregnancy should be avoided if possible and the potential benefit to the patient weighed against any possible risk to the foetus.
Angiotensin II [1], vasopressor ---> SmPC of [1] of EMA
Concomitant administration of GIAPREZA and other vasopressors may have an additive effect on mean arterial pressure (MAP).
CONTRAINDICATIONS of Angiotensin II (Giapreza)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/giapreza-epar-product-information_en.pdf 25/09/2024
Anidulafungin (Ecalta)
Anidulafungin [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ECALTA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Anidulafungin [1], co-administration ---> SmPC of [1] of EMA
No dosage adjustment of either medicinal product is recommended when anidulafungin is co-administered with ciclosporin, voriconazole or tacrolimus, and no dosage adjustment is recommended when co-administered with amphotericin B or rifampicin.
Anidulafungin [1], cytochrome P450 ---> SmPC of [1] of EMA
Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A). Of note, in vitro studies do not fully exclude possible in vivo interactions.
Anidulafungin [1], fertility ---> SmPC of [1] of EMA
For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Anidulafungin [1], pregnancy ---> SmPC of [1] of EMA
ECALTA is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
CONTRAINDICATIONS of Anidulafungin (Ecalta)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Hypersensitivity to other medicinal products of the echinocandin class.
https://www.ema.europa.eu/en/documents/product-information/ecalta-epar-product-information_en.pdf 27/06/2023
Anifrolumab (Saphnelo)
Anifrolumab [1], biologic therapy ---> SmPC of [1] of EMA
Treatment with anifrolumab is not recommended in combination with biologic therapies.
Anifrolumab [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue from Saphnelo therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Anifrolumab [1], CYP450 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
In patients who are being treated with other medicines that are CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin), therapeutic monitoring is recommended.
Anifrolumab [1], enzyme ---> SmPC of [1] of EMA
Anifrolumab is not expected to undergo metabolism by hepatic enzymes or renal elimination.
Anifrolumab [1], pregnancy ---> SmPC of [1] of EMA
Saphnelo is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the possible benefit justifies the potential risk.
Anifrolumab [1], tuberculosis ---> SmPC of [1] of EMA
Anifrolumab should not be administered to patients with active TB.
Anifrolumab [1], vaccinations ---> SmPC of [1] of EMA
Concurrent use of live or attenuated vaccines should be avoided in patients treated with anifrolumab.
Anifrolumab [1], warfarin ---> SmPC of [1] of EMA
In patients who are being treated with other medicines that are CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin), therapeutic monitoring is recommended.
CONTRAINDICATIONS of Anifrolumab (Saphnelo)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/saphnelo-epar-product-information_en.pdf 18/12/2025
Antithrombin alfa (ATryn)
Anticoagulants, antithrombin alfa [2] ---> SmPC of [2] of EMA
Antithrombin replacement during administration of anticoagulants that potentiate the anticoagulant activity of antithrombin (e.g., heparin, low molecular weight heparin), may increase the risk of bleeding.
Antithrombin alfa [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ATryn therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Antithrombin alfa [1], fertility ---> SmPC of [1] of EMA
No information is available on the possible effects of antithrombin alfa on male and female fertility.
Antithrombin alfa [1], heparin ---> SmPC of [1] of EMA
Antithrombin replacement during administration of anticoagulants that potentiate the anticoagulant activity of antithrombin (e.g., heparin, low molecular weight heparin), may increase the risk of bleeding.
Antithrombin alfa [1], low molecular weight heparins ---> SmPC of [1] of EMA
Antithrombin replacement during administration of anticoagulants that potentiate the anticoagulant activity of antithrombin (e.g., heparin, low molecular weight heparin), may increase the risk of bleeding.
Antithrombin alfa [1], pregnancy ---> SmPC of [1] of EMA
Antithrombin alfa should not be used in pregnant women.
CONTRAINDICATIONS of Antithrombin alfa (ATryn)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Hypersensitivity to goat proteins or goat milk components
https://www.ema.europa.eu/en/documents/product-information/atryn-epar-product-information_en.pdf 02/07/2019 (withdrawn)
Antithrombin III
Antithrombin III, breast-feeding
Strict indication
Antithrombin III, heparin
Increased effect of antithrombin III
Antithrombin III, pregnancy
Strict indication
Antithrombin III, retinol
Concomitant use of parenteral anticoagulants with vitamin A may increase the anticoagulant effect and the risk of bleeding
Antithrombin III, vitamin A
Concomitant use of parenteral anticoagulants with vitamin A may increase the anticoagulant effect and the risk of bleeding
Mycobacterium tuberculosis derived antigens (Siiltibcy)
Breast-feeding, Mycobacterium tuberculosis derived antigens [2] ---> SmPC of [2] of EMA
No effects on the breast-fed newborns/infants are anticipated since the systemic exposure of the breast-feeding mother to SIILTIBCY is negligible. The skin test can be carried out during breast-feeding.
Corticosteroids, Mycobacterium tuberculosis derived antigens [2] ---> SmPC of [2] of EMA
Similar to other Mycobacterium tuberculosis skin tests, reactivity to SIILTIBCY may be decreased in persons who are receiving corticosteroids or immunosuppressive agents.
Fertility, Mycobacterium tuberculosis derived antigens [2] ---> SmPC of [2] of EMA
No animal studies have been conducted on the effects of SIILTIBCY on fertility. Considering the negligible human systemic exposure to SIILTIBCY, no effects on fertility in male and female subjects is anticipated.
Medicinal products, Mycobacterium tuberculosis derived antigens [2] ---> SmPC of [2] of EMA
Regardless of the concomitant use of other medicinal products a positive test result indicates infection with Mycobacterium tuberculosis.
Mycobacterium tuberculosis derived antigens [1], pregnancy ---> SmPC of [1] of EMA
No effects during pregnancy are anticipated, since systemic exposure to SIILTIBCY is negligible. SIILTIBCY can be used during pregnancy.
Mycobacterium tuberculosis derived antigens [1], reactivity ---> SmPC of [1] of EMA
Reduced reactivity may be observed when SIILTIBCY is used after vaccination with live vaccines (e.g. vaccines against measles, mumps and rubella). This decreased reactivity may result in false-negative reactions.
Mycobacterium tuberculosis derived antigens [1], vaccinations ---> SmPC of [1] of EMA
Therefore, SIILTIBCY should be administered either before or at the same time of the vaccination or should be postponed for 4 weeks after vaccination.
CONTRAINDICATIONS of Mycobacterium tuberculosis derived antigens (Siiltibcy)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Hypersensitivity to Lactococcus lactis.
- Severe local or systemic reaction to other Mycobacterium tuberculosis derived products.
https://www.ema.europa.eu/en/documents/product-information/siiltibcy-epar-product-information_en.pdf 24/10/2025
Apalutamide (Erleada)
Ability to drive, apalutamide [2] ---> SmPC of [2] of EMA
Seizures have been reported in patients taking Erleada. Patients should be advised of this risk in regards to driving or operating machines.
Abrocitinib [1], apalutamide ---> SmPC of [1] of EMA
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g. rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin)
Acenocoumarol, apalutamide [2] ---> SmPC of [2] of EMA
If Erleada is co-administered with an anticoagulant metabolised by CYP2C9 (such as warfarin or acenocoumarol), additional International Normalised Ratio (INR) monitoring should be conducted
Alpelisib [1], apalutamide ---> SmPC of [1] of EMA
Co-administration with a strong CYP3A4 inducer decreases alpelisib AUC, which may reduce alpelisib efficacy. Co-administration of alpelisib with strong CYP3A4 inducers should be avoided
Amiodarone, apalutamide [2] ---> SmPC of [2] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products able to induce Torsade de pointes should be carefully evaluated
Anticoagulant metabolised by CYP2C9 [1], apalutamide ---> SmPC of [1] of EMA
If Erleada is co-administered with an anticoagulant metabolised by CYP2C9 (such as warfarin or acenocoumarol), additional International Normalised Ratio (INR) monitoring should be conducted
Apalutamide [1], BCRP substrates ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], breast-feeding ---> SmPC of [1] of EMA
A risk to the suckling child cannot be excluded. Erleada should not be used during breast-feeding.
Apalutamide [1], cardiovascular disease ---> SmPC of [1] of EMA
If Erleada is prescribed, patients with clinically significant cardiovascular disease should be monitored for risk factors such as hypercholesterolaemia, hypertriglyceridaemia, or other cardio-metabolic disorders
Apalutamide [1], clarithromycin ---> SmPC of [1] of EMA
No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin) however, a reduction of the Erleada dose based on tolerability should be considered
Apalutamide [1], class IA antiarrhythmic agents ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products able to induce Torsade de pointes should be carefully evaluated
Apalutamide [1], class III antiarrhythmic agents ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products able to induce Torsade de pointes should be carefully evaluated
Apalutamide [1], clopidogrel ---> SmPC of [1] of EMA
No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP2C8 (e.g., gemfibrozil, clopidogrel) however, a reduction of the Erleada dose based on tolerability should be considered
Apalutamide [1], colchicine ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], coumarin anticoagulants ---> SmPC of [1] of EMA
Co-administration of apalutamide with warfarin and coumarin-like anticoagulants should be avoided.
Apalutamide [1], dabigatran ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], darunavir ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised by CYP3A4 (e.g., darunavir, felodipine, midazolam, simvastatin) can result in lower exposure to these medicinal products.
Apalutamide [1], diazepam ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised CYP2C19 (e.g., diazepam, omeprazole) can result in lower exposure to these medicinal products.
Apalutamide [1], digoxin ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], disopyramide ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products able to induce Torsade de pointes should be carefully evaluated
Apalutamide [1], dofetilide ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products able to induce Torsade de pointes should be carefully evaluated
Apalutamide [1], drugs primarily metabolised by CYP2B6 ---> SmPC of [1] of EMA
When substrates of CYP2B6 (e.g., efavirenz) are administered with Erleada, monitoring for an adverse reaction and evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required
Apalutamide [1], drugs primarily metabolised by CYP2C19 ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised CYP2C19 (e.g., diazepam, omeprazole) can result in lower exposure to these medicinal products.
Apalutamide [1], drugs primarily metabolised by CYP2C8 ---> SmPC of [1] of EMA
Apalutamide did not cause clinically meaningful changes in exposure to the CYP2C8 substrate.
Apalutamide [1], drugs primarily metabolised by CYP2C9 ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised by CYP2C9 (e.g., warfarin, phenytoin) can result in lower exposure to these medicinal products.
Apalutamide [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised by CYP3A4 (e.g., darunavir, felodipine, midazolam, simvastatin) can result in lower exposure to these medicinal products.
Apalutamide [1], drugs primarily metabolised by UGT ---> SmPC of [1] of EMA
Concomitant administration of Erleada with medicinal products that are substrates of UGT (e.g., levothyroxine, valproic acid) can result in lower exposure to these medicinal products.
Apalutamide [1], efavirenz ---> SmPC of [1] of EMA
When substrates of CYP2B6 (e.g., efavirenz) are administered with Erleada, monitoring for an adverse reaction and evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required
Apalutamide [1], felodipine ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised by CYP3A4 (e.g., darunavir, felodipine, midazolam, simvastatin) can result in lower exposure to these medicinal products.
Apalutamide [1], fertility ---> SmPC of [1] of EMA
Based on animal studies, Erleada may decrease fertility in males of reproductive potential (see section 5.3).
Apalutamide [1], gemfibrozil ---> SmPC of [1] of EMA
No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP2C8 (e.g., gemfibrozil, clopidogrel) however, a reduction of the Erleada dose based on tolerability should be considered
Apalutamide [1], haloperidol ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products known to prolong the QT interval should be carefully evaluated
Apalutamide [1], ibutilide ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products able to induce Torsade de pointes should be carefully evaluated
Apalutamide [1], itraconazol ---> SmPC of [1] of EMA
No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin) however, a reduction of the Erleada dose based on tolerability should be considered
Apalutamide [1], ketoconazole ---> SmPC of [1] of EMA
No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin) however, a reduction of the Erleada dose based on tolerability should be considered
Apalutamide [1], lapatinib ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], leuprolide ---> SmPC of [1] of EMA
In mHSPC subjects receiving leuprolide acetate (a GnRH analog), co-administration with apalutamide had no apparent effect on the steady-state exposure of leuprolide.
Apalutamide [1], levothyroxine ---> SmPC of [1] of EMA
Concomitant administration of Erleada with medicinal products that are substrates of UGT (e.g., levothyroxine, valproic acid) can result in lower exposure to these medicinal products.
Apalutamide [1], methadone ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products known to prolong the QT interval should be carefully evaluated
Apalutamide [1], methotrexate ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], midazolam ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised by CYP3A4 (e.g., darunavir, felodipine, midazolam, simvastatin) can result in lower exposure to these medicinal products.
Apalutamide [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
Mild or moderate inhibitors of CYP3A4 are not expected to affect the exposure of apalutamide.
Apalutamide [1], moderate inhibitors of CYP2C8 ---> SmPC of [1] of EMA
Mild or moderate inhibitors of CYP2C8 are not expected to affect the exposure of apalutamide.
Apalutamide [1], moxifloxacin ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products known to prolong the QT interval should be carefully evaluated
Apalutamide [1], neuroleptics ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products known to prolong the QT interval should be carefully evaluated
Apalutamide [1], OATP1B1 substrates ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], omeprazole ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised CYP2C19 (e.g., diazepam, omeprazole) can result in lower exposure to these medicinal products.
Apalutamide [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], phenytoin ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised by CYP2C9 (e.g., warfarin, phenytoin) can result in lower exposure to these medicinal products.
Apalutamide [1], pregnancy ---> SmPC of [1] of EMA
Erleada is contraindicated in women who are or may become pregnant. Based on its mechanism of action, Erleada may cause foetal harm when administered during pregnancy.
Apalutamide [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products known to prolong the QT interval should be carefully evaluated
Apalutamide [1], quinidine ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products able to induce Torsade de pointes should be carefully evaluated
Apalutamide [1], repaglinide ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], rosuvastatin ---> SmPC of [1] of EMA
When substrates of P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Apalutamide [1], seizure-threshold lowering drugs ---> SmPC of [1] of EMA
The risk of seizure may be increased in patients receiving concomitant medicinal products that lower the seizure threshold.
Apalutamide [1], simvastatine ---> SmPC of [1] of EMA
Concomitant use of Erleada with medicinal products that are primarily metabolised by CYP3A4 (e.g., darunavir, felodipine, midazolam, simvastatin) can result in lower exposure to these medicinal products.
Apalutamide [1], sotalol ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products able to induce Torsade de pointes should be carefully evaluated
Apalutamide [1], strong CYP2C8 inductors ---> SmPC of [1] of EMA
No dose adjustment is necessary when Erleada is co-administered with inducers of CYP3A4 or CYP2C8.
Apalutamide [1], strong CYP2C8 inhibitors ---> SmPC of [1] of EMA
No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP2C8 (e.g., gemfibrozil, clopidogrel) however, a reduction of the Erleada dose based on tolerability should be considered
Apalutamide [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
No dose adjustment is necessary when Erleada is co-administered with inducers of CYP3A4 or CYP2C8.
Apalutamide [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin) however, a reduction of the Erleada dose based on tolerability should be considered
Apalutamide [1], torsades de pointes inducing drugs ---> SmPC of [1] of EMA
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Erleada with medicinal products able to induce Torsade de pointes should be carefully evaluated
Apalutamide [1], valproic acid ---> SmPC of [1] of EMA
Concomitant administration of Erleada with medicinal products that are substrates of UGT (e.g., levothyroxine, valproic acid) can result in lower exposure to these medicinal products.
Apalutamide [1], warfarin ---> SmPC of [1] of EMA
If Erleada is co-administered with an anticoagulant metabolised by CYP2C9 (such as warfarin or acenocoumarol), additional International Normalised Ratio (INR) monitoring should be conducted
Apalutamide [1], women of childbearing potential ---> SmPC of [1] of EMA
For patients having sex with female partners of reproductive potential, a condom should be used along with another highly effective contraceptive method during treatment and for 3 months after the last dose of Erleada.
Apalutamide, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SmPC of [dasabuvir] of EMA
CYP3A4 induction by apalutamide may decrease the plasma concentrations of dasabuvir, ombitasvir and paritaprevir. Concomitant use is contraindicated
Apalutamide, duvelisib [2] ---> SmPC of [2] of EMA
Co-administration of duvelisib with strong CYP3A4 inducers (e.g., apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's wort) should be avoided.
Apalutamide, entrectinib [2] ---> SmPC of [2] of EMA
Co-administration of entrectinib with CYP3A/P-gp inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's Wort -Hypericum perforatum-, apalutamide, ritonavir) should be avoided.
Apalutamide, erdafitinib [2] ---> SmPC of [2] of EMA
Avoid co-administration of Balversa with strong CYP3A4 inducers (such as apalutamide, enzalutamide, lumacaftor, ivosidenib, mitotane, rifapentine, rifampicin, carbamazepine, phenytoin, and St. John's wort).
Apalutamide, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA
Apalutamide is a moderate to strong CYP3A4 inducer and this may lead to a decreased exposure of lopinavir/ritonavir. Serum concentrations of apalutamide may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Apalutamide, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA
Apalutamide is a moderate to strong CYP3A4 inducer and this may lead to a decreased exposure of Nirmatrelvir/ritonavir and potential loss of virologic response. Concomitant use is not recommended.
Apalutamide, quizartinib [2] ---> SmPC of [2] of EMA
Decreased quizartinib exposure may lead to reduced efficacy. Co-administration of VANFLYTA with strong or moderate CYP3A inducers should be avoided.
Apalutamide, relugolix [2] ---> SmPC of [2] of EMA
Co-administration of Orgovyx with rifampicin and other strong CYP3A4 and Pgp inducers is not recommended, as this may decrease the AUC and Cmax of relugolix and may therefore reduce the therapeutic effects of Orgovyx.
Apalutamide, ritonavir [2] ---> SmPC of [2] of EMA
Apalutamide is a moderate to strong CYP3A4 inducer and this may lead to a decreased exposure of ritonavir and potential loss of virologic response.
Apalutamide, tacrolimus [2] ---> SmPC of [2] of EMA
May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see section 4.4]. It is recommended that concomitant use should be avoided.
CONTRAINDICATIONS of Apalutamide (Erleada)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Women who are or may become pregnant (see section 4.6).
https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf 04/12/2024
Apixaban (Eliquis)
Acetylsalicylic acid, apixaban [2] ---> SmPC of [2] of EMA
Pharmacokinetic or pharmacodynamic interactions were not evident when apixaban was coadministered with ASA 325 mg once a day.
Activated charcoal, apixaban [2] ---> SmPC of [2] of EMA
Administration of activated charcoal reduces apixaban exposure
Amiodarone, apixaban [2] ---> SmPC of [2] of EMA
Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp are expected to increase apixaban plasma concentration to a lesser extent. No dose adjustment for apixaban is required
Apixaban [1], atenolol ---> SmPC of [1] of EMA
No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when apixaban was coadministered with atenolol or famotidine.
Apixaban [1], azole antifungals ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from apixaban therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Apixaban [1], carbamazepine ---> SmPC of [1] of EMA
The concomitant use of apixaban with strong CYP3A4 and P-gp inducers may lead to reduced apixaban plasma concentrations. No dose adjustment for apixaban (almost always) is required during concomitant therapy with such agents
Apixaban [1], surgery---> SmPC of [1] of EMA
Following surgery, other platelet aggregation inhibitors are not recommended concomitantly with apixaban (see section 4.5).
Apixaban [1], clarithromycin ---> SmPC of [1] of EMA
Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp are expected to increase apixaban plasma concentration to a lesser extent. No dose adjustment for apixaban is required
Apixaban [1], clopidogrel ---> SmPC of [1] of EMA
As such agents increase the bleeding risk, co-administration of these medicinal products with apixaban is not recommended
Apixaban [1], coumarin anticoagulants ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], dabigatran ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], dalteparin ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], desirudin ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], dextran ---> SmPC of [1] of EMA
As such agents increase the bleeding risk, co-administration of these medicinal products with apixaban is not recommended
Apixaban [1], digoxin ---> SmPC of [1] of EMA
Coadministration of apixaban (20 mg once a day) and digoxin (0.25 mg once a day), a P-gp substrate, did not affect digoxin AUC or Cmax. Therefore, apixaban does not inhibit P-gp mediated substrate transport.
Apixaban [1], diltiazem ---> SmPC of [1] of EMA
Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp are expected to increase apixaban plasma concentration to a lesser extent. No dose adjustment for apixaban is required
Apixaban [1], dipyridamole ---> SmPC of [1] of EMA
As such agents increase the bleeding risk, co-administration of these medicinal products with apixaban is not recommended
Apixaban [1], direct Factor Xa inhibitors ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], direct thrombin inhibitors ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], enoxaparin ---> SmPC of [1] of EMA
After combined administration of enoxaparin (40 mg single dose) with apixaban (5 mg single dose), an additive effect on anti-Factor Xa activity was observed.
Apixaban [1], factor Xa inhibitors ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], famotidine ---> SmPC of [1] of EMA
No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when apixaban was coadministered with atenolol or famotidine.
Apixaban [1], fertility ---> SmPC of [1] of EMA
Studies in animals dosed with apixaban have shown no effect on fertility (see section 5.3).
Apixaban [1], fluconazole ---> SmPC of [1] of EMA
Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp are expected to increase apixaban plasma concentration to a lesser extent. No dose adjustment for apixaban is required
Apixaban [1], fondaparinux ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], GP IIb/IIIa inhibitors ---> SmPC of [1] of EMA
As such agents increase the bleeding risk, co-administration of these medicinal products with apixaban is not recommended
Apixaban [1], heparin ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], indirect Factor Xa inhibitors ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], itraconazol ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], ketoconazole ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], low molecular weight heparins ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], naproxen ---> SmPC of [1] of EMA
Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp are expected to increase apixaban plasma concentration to a lesser extent. No dose adjustment for apixaban is required
Apixaban [1], NSAID ---> SmPC of [1] of EMA
Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Apixaban [1], oral anticoagulants ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], P-glycoprotein and CYP3A4 inhibitors ---> SmPC of [1] of EMA
Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp are expected to increase apixaban plasma concentration to a lesser extent. No dose adjustment for apixaban is required
Apixaban [1], P2Y12 platelet inhibitors ---> SmPC of [1] of EMA
Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Apixaban [1], phenobarbital ---> SmPC of [1] of EMA
The concomitant use of apixaban with strong CYP3A4 and P-gp inducers may lead to reduced apixaban plasma concentrations. No dose adjustment for apixaban (almost always) is required during concomitant therapy with such agents
Apixaban [1], phenytoin ---> SmPC of [1] of EMA
The concomitant use of apixaban with strong CYP3A4 and P-gp inducers may lead to reduced apixaban plasma concentrations. No dose adjustment for apixaban (almost always) is required during concomitant therapy with such agents
Apixaban [1], platelet aggregation inhibitors ---> SmPC of [1] of EMA
The concomitant use of apixaban with antiplatelet agents increases the risk of bleeding (see section 4.5).
Apixaban [1], posaconazole ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], pregnancy ---> SmPC of [1] of EMA
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of apixaban during pregnancy.
Apixaban [1], protease inhibitors ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], quinidine ---> SmPC of [1] of EMA
Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp are expected to increase apixaban plasma concentration to a lesser extent. No dose adjustment for apixaban is required
Apixaban [1], rifampicin ---> SmPC of [1] of EMA
The concomitant use of apixaban with strong CYP3A4 and P-gp inducers may lead to reduced apixaban plasma concentrations. No dose adjustment for apixaban (almost always) is required during concomitant therapy with such agents
Apixaban [1], ritonavir ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], rivaroxaban ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], SNRIs ---> SmPC of [1] of EMA
Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Apixaban [1], SSRI ---> SmPC of [1] of EMA
Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Apixaban [1], St. John's wort ---> SmPC of [1] of EMA
The concomitant use of apixaban with strong CYP3A4 and P-gp inducers may lead to reduced apixaban plasma concentrations. No dose adjustment for apixaban (almost always) is required during concomitant therapy with such agents
Apixaban [1], strong CYP3A4 and P-glycoprotein inductors ---> SmPC of [1] of EMA
The concomitant use of apixaban with strong CYP3A4 and P-gp inducers may lead to reduced apixaban plasma concentrations. No dose adjustment for apixaban (almost always) is required during concomitant therapy with such agents
Apixaban [1], strong CYP3A4 and P-glycoprotein-inhibitors ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
The concomitant use of apixaban with strong CYP3A4 and P-gp inducers may lead to reduced apixaban plasma concentrations. No dose adjustment for apixaban (almost always) is required during concomitant therapy with such agents
Apixaban [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], strong P-gp inductors ---> SmPC of [1] of EMA
The concomitant use of apixaban with strong P-gp inducers may lead to a reduction in apixaban exposure.
Apixaban [1], strong P-gp inhibitors ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], sulfinpyrazone ---> SmPC of [1] of EMA
As such agents increase the bleeding risk, co-administration of these medicinal products with apixaban is not recommended
Apixaban [1], thrombolytics ---> SmPC of [1] of EMA
As such agents increase the bleeding risk, co-administration of these medicinal products with apixaban is not recommended
Apixaban [1], unfractionated heparins ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], verapamil ---> SmPC of [1] of EMA
Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp are expected to increase apixaban plasma concentration to a lesser extent. No dose adjustment for apixaban is required
Apixaban [1], vitamin K antagonists ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban [1], voriconazole ---> SmPC of [1] of EMA
The use of apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp
Apixaban [1], warfarin ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Apixaban, dabigatran etexilate [2] ---> SmPC of [2] of EMA
Concomitant treatment of dabigatran with any other anticoagulants is contraindicated, except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter
Apixaban, darunavir/cobicistat [2] ---> SmPC of [2] of EMA
Co-administration of REZOLSTA with this anticoagulant may increase concentrations of the anticoagulant. (CYP3A and/or P-glycoprotein inhibition). Co-administration of REZOLSTA and this anticoagulant is not recommended.
Apixaban, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Based on theoretical considerations co-administration of DRV/COBI with this anticoagulant may increase concentrations of the anticoagulant. (CYP3A and/or P-glycoprotein inhibition). Co-administration of Symtuza and this anticoagulant is not recommended.
Apixaban, darunavir/ritonavir ---> SmPC of [darunavir] of EMA
Co-administration of boosted darunavir (CYP3A and/or P-gp inhibition) with this anticoagulant may increase concentrations of the anticoagulant. The use of boosted darunavir and the anticoagulant is not recommended.
Apixaban, defibrotide [2] ---> SmPC of [2] of EMA
The use of defibrotide with antithrombotic/fibrinolytic medicinal products is not recommended. However, if used, in exceptional cases, caution should be exercised by closely monitoring the coagulation parameters (see section 4.4).
Apixaban, inotersen [2] ---> SmPC of [2] of EMA
Caution should be used with antithrombotic medicinal products, antiplatelet medicinal products, and medicinal products that may lower platelet count
Apixaban, parecoxib [2] ---> SmPC of [2] of EMA
The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban)
CONTRAINDICATIONS of Apixaban (Eliquis)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Active clinically significant bleeding.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- Lesion or condition if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
- Concomitant treatment with any other anticoagulant agent e.g., unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.) except under specific circumstances of switching anticoagulant therapy (see section 4.2), when UFH is given at doses necessary to maintain an open central venous or arterial catheter or when UFH is given during catheter ablation for atrial fibrillation (see sections 4.4 and 4.5).
https://www.ema.europa.eu/en/documents/product-information/eliquis-epar-product-information_en.pdf 08/03/2024
Other trade names: Apixaban Accord,
Apomorphine
QT interval prolonging drugs, apomorphine [2] ---> SPC of [2] of eMC
It is recommended to avoid the administration of apomorphine with other drugs known to prolong the QT interval.
Ability to drive, apomorphine [2] ---> SPC of [2] of eMC
Somnolence and/or sudden sleep episodes may occur
Antihypertensives, apomorphine [2] ---> SPC of [2] of eMC
Apomorphine may potentiate the antihypertensive effects of antihypertensive products
Apomorphine, azithromycin
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Apomorphine [1], breast-feeding ---> SPC of [1] of eMC
A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy should be made
Apomorphine, clozapine
There is a potential interaction; however clozapine may also be used to reduce the symptoms of neuropsychiatric complications.
Apomorphine, entacapone [2] ---> SPC of [2] of EMA
Because of its mechanism of action, entacapone may interfere with the metabolism of medicinal products containing a catechol group and potentiate their action
Apomorphine [1], neuroleptics ---> SPC of [1] of eMC
Neuroleptic medicinal products may have an antagonistic effect if used with apomorphine.
Apomorphine, ondansetron [2] ---> SPC of [2] of eMC
Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated.
Apomorphine [1], pregnancy ---> SPC of [1] of eMC
Apomorphine should not be used in pregnancy unless clearly necessary.
Apomorphine, tiapride
Concomitant use of tiapride and dopaminergic agonists, except levodopa, is not recommended in patients with Parkinson disease due to mutual antagonism between dopaminergic agonists and neuroleptics
Apomorphine, tolcapone [2] ---> SPC of [2] of EMA
Tolcapone, COMT inhibitor, may increase the plasma concentrations of drugs metabolised by COMT
Apomorphine [1], vasoactive drugs ---> SPC of [1] of eMC
Apomorphine may potentiate the antihypertensive effects of cardiac active medicinal products
CONTRAINDICATIONS of Apomorphine
- In patients with respiratory depression, dementia, psychotic diseases or hepatic insufficiency.
- Apomorphine HCl treatment must not be administered to patients who have an 'on' response to levodopa which is marred by severe dyskinesia or dystonia.
- APO-go should not be administered to patients who have a known hypersensitivity to apomorphine or any excipients of the medicinal product.
- APO-go is contraindicated for children and adolescents under 18 years of age.
http://www.medicines.org.uk/emc/
Apraclonidine
CNS depressants, apraclonidine [2] ---> SPC of [2] of eMC
The possibility of an additive or potentiating effect with CNS depressants should be considered.
IMAOs, apraclonidine [2] ---> SPC of [2] of eMC
Apraclonidine is contraindicated in patients receiving monoamine oxidase inhibitors
Ability to drive, apraclonidine [2] ---> SPC of [2] of eMC
Since clonidine-like drugs may cause dizziness or somnolence, patients so affected are advised not to drive or operate machinery.
Alcohol, apraclonidine [2] ---> SPC of [2] of eMC
The possibility of an additive or potentiating effect with CNS depressants should be considered.
Anaesthetics, apraclonidine [2] ---> SPC of [2] of eMC
The possibility of an additive or potentiating effect with CNS depressants should be considered.
Antihypertensives, apraclonidine [2] ---> SPC of [2] of eMC
Since apraclonidine may reduce pulse and blood pressure, caution in using drugs such as antihypertensives
Apraclonidine [1], barbiturates ---> SPC of [1] of eMC
The possibility of an additive or potentiating effect with CNS depressants should be considered.
Apraclonidine [1], benzodiazepines ---> SPC of [1] of eMC
The possibility of an additive or potentiating effect with CNS depressants should be considered.
Apraclonidine [1], betablockers ---> SPC of [1] of eMC
Since apraclonidine may reduce pulse and blood pressure, caution in using drugs such as beta-blockers (ophthalmic and systemic)
Apraclonidine [1], breast-feeding ---> SPC of [1] of eMC
A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued during treatment
Apraclonidine [1], cardiac glycosides ---> SPC of [1] of eMC
Since apraclonidine may reduce pulse and blood pressure, caution in using drugs such as cardiac glycosides
Apraclonidine [1], insulin ---> SPC of [1] of eMC
Systemic clonidine may inhibit the production of catecholamine in response to insulin-induced hypoglycaemia and mask the signs and symptoms of hypoglycaemia.
Apraclonidine [1], neuroleptics ---> SPC of [1] of eMC
An additive hypotensive effect has been reported with the combination of systemic clonidine and neuroleptic therapy.
Apraclonidine [1], opiates ---> SPC of [1] of eMC
The possibility of an additive or potentiating effect with CNS depressants should be considered.
Apraclonidine [1], pregnancy ---> SPC of [1] of eMC
Apraclonidine is not recommended during pregnancy
Apraclonidine [1], sedatives ---> SPC of [1] of eMC
The possibility of an additive or potentiating effect with CNS depressants should be considered.
Apraclonidine [1], sympathomimetics ---> SPC of [1] of eMC
Apraclonidine is contraindicated in patients receiving systemic sympathomimetics
Apraclonidine [1], tricyclic antidepressants ---> SPC of [1] of eMC
Apraclonidine is contraindicated in patients receiving tricyclic antidepressants
Clonidine, insulin ---> SPC of [apraclonidine] of eMC
Systemic clonidine may inhibit the production of catecholamine in response to insulin-induced hypoglycaemia and mask the signs and symptoms of hypoglycaemia.
CONTRAINDICATIONS of Apraclonidine
- IOPIDINE is contraindicated in children, in patients with a history of severe or unstable and uncontrolled cardiovascular disease including severe uncontrolled arterial hypertension.
- IOPIDINE is contraindicated in patients with hypersensitivity to any component of the formulation or to systemic clonidine and in patients receiving monoamine oxidase inhibitors, systemic sympathomimetics or tricyclic antidepressants.
http://www.medicines.org.uk/emc/
Apremilast (Otezla)
Apremilast [1], breast-feeding ---> SmPC of [1] of EMA
It is not known whether apremilast, or its metabolites, are excreted in human milk. A risk to the breastfed infant cannot be excluded, therefore apremilast should not be used during breast-feeding.
Apremilast [1], carbamazepine ---> SmPC of [1] of EMA
Co-administration of strong CYP3A4 enzyme inducer rifampicin resulted in a reduction of systemic exposure of apremilast. Therefore, the use of strong CYP3A4 enzyme inducers with apremilast is not recommended.
Apremilast [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA
There was no clinically meaningful interaction between ketoconazole and apremilast. Apremilast can be co-administered with a potent CYP3A4 inhibitor such as ketoconazole.
Apremilast [1], fertility ---> SmPC of [1] of EMA
In animal studies in mice, no adverse effects on fertility were observed in males at exposure levels 3-fold clinical exposure and in females at exposure levels 1-fold clinical exposure. For pre-clinical fertility data, see section 5.3.
Apremilast [1], ketoconazole ---> SmPC of [1] of EMA
There was no clinically meaningful interaction between ketoconazole and apremilast. Apremilast can be co-administered with a potent CYP3A4 inhibitor such as ketoconazole.
Apremilast [1], methotrexate ---> SmPC of [1] of EMA
There was no pharmacokinetic drug-drug interaction between apremilast and methotrexate in psoriatic arthritis patients. Apremilast can be co-administered with methotrexate.
Apremilast [1], oral contraceptives ---> SmPC of [1] of EMA
There was no pharmacokinetic drug-drug interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate. Apremilast can be co-administered with oral contraceptives.
Apremilast [1], phenobarbital ---> SmPC of [1] of EMA
Co-administration of strong CYP3A4 enzyme inducer rifampicin resulted in a reduction of systemic exposure of apremilast. Therefore, the use of strong CYP3A4 enzyme inducers with apremilast is not recommended.
Apremilast [1], phenytoin ---> SmPC of [1] of EMA
Co-administration of strong CYP3A4 enzyme inducer rifampicin resulted in a reduction of systemic exposure of apremilast. Therefore, the use of strong CYP3A4 enzyme inducers with apremilast is not recommended.
Apremilast [1], pregnancy ---> SmPC of [1] of EMA
Apremilast is contraindicated during pregnancy.
Apremilast [1], rifampicin ---> SmPC of [1] of EMA
Co-administration of strong CYP3A4 enzyme inducer rifampicin resulted in a reduction of systemic exposure of apremilast. Therefore, the use of strong CYP3A4 enzyme inducers with apremilast is not recommended.
Apremilast [1], St. John's wort ---> SmPC of [1] of EMA
Co-administration of strong CYP3A4 enzyme inducer rifampicin resulted in a reduction of systemic exposure of apremilast. Therefore, the use of strong CYP3A4 enzyme inducers with apremilast is not recommended.
Apremilast [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration of strong CYP3A4 enzyme inducer rifampicin resulted in a reduction of systemic exposure of apremilast. Therefore, the use of strong CYP3A4 enzyme inducers with apremilast is not recommended.
Apremilast [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
There was no clinically meaningful interaction between ketoconazole and apremilast. Apremilast can be co-administered with a potent CYP3A4 inhibitor such as ketoconazole.
Apremilast [1], women of childbearing potential ---> SmPC of [1] of EMA
Pregnancy should be excluded before treatment can be initiated. Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment.
CONTRAINDICATIONS of Apremilast (Otezla)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy
https://www.ema.europa.eu/en/documents/product-information/otezla-epar-product-information_en.pdf 22/10/2024
Other trade names: Apremilast Accord, Apremilast Viatris,
Aprepitant (Emend)
Ability to drive, aprepitant [2] ---> SmPC of [2] of EMA
Dizziness and fatigue may occur following administration of EMEND
Acenocoumarol, aprepitant [2] ---> SmPC of [2] of EMA
As a mild inducer of CYP2C9, CYP3A4 and glucuronidation, aprepitant can decrease plasma concentrations of substrates eliminated by these routes within 2 weeks following initiation and treatment.
Alfentanyl, aprepitant [2] ---> SmPC of [2] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Alprazolam, aprepitant [2] ---> SmPC of [2] of EMA
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these medicinal products with EMEND (125 mg/80 mg).
Aprepitant [1], astemizole ---> SmPC of [1] of EMA
EMEND must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride (see section 4.3).
Aprepitant [1], breast-feeding ---> SmPC of [1] of EMA
Aprepitant is excreted in the milk of lactating rats. It is not known whether aprepitant is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND.
Aprepitant [1], carbamazepine ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination results in reductions of the plasma concentrations of aprepitant that may result in decreased efficacy of aprepitant
Aprepitant [1], chemotherapeutic agents that are substrates for CYP3A4 ---> SmPC of [1] of EMA
An interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g., etoposide, vinorelbine) cannot be excluded.
Aprepitant [1], cisapride ---> SmPC of [1] of EMA
EMEND must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride (see section 4.3).
Aprepitant [1], clarithromycin ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously, as the combination is expected to result several-fold in increased plasma concentrations of aprepitant
Aprepitant [1], cyclosporine ---> SmPC of [1] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Aprepitant [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA
The CYP3A4 inhibition may increase the plasma concentrations of aprepitant
Aprepitant [1], dexamethasone ---> SmPC of [1] of EMA
The usual oral dexamethasone dose should be reduced by approximately 50 % when co-administered with EMEND 125 mg/80 mg regimen
Aprepitant [1], dicoumarol ---> SmPC of [1] of EMA
Aprepitant, CYP2C9 inductor, may decrease the plasma concentrations of anticoagulant. Caution is advised
Aprepitant [1], digoxin ---> SmPC of [1] of EMA
Aprepitant does not seem to interact with the P-glycoprotein transporter, as suggested by the lack of interaction of aprepitant with digoxin.
Aprepitant [1], dihydroergotamine ---> SmPC of [1] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Aprepitant [1], docetaxel ---> SmPC of [1] of EMA
EMEND, when given as a regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3, did not influence the pharmacokinetics of docetaxel administered intravenously on Day 1 or vinorelbine administered intravenously on Day 1 or Day 8.
Aprepitant [1], dolasetron ---> SmPC of [1] of EMA
In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of dolasetron
Aprepitant [1], drugs partly metabolised by CYP3A4 ---> SmPC of [1] of EMA
Caution is advised and additional monitoring may be appropriate in patients receiving medicinal products metabolised primarily or partly by CYP3A4 (see section 4.4).
Aprepitant [1], drugs primarily metabolised by CYP2C9 ---> SmPC of [1] of EMA
As a mild inducer of CYP2C9, CYP3A4 and glucuronidation, aprepitant can decrease plasma concentrations of substrates eliminated by these routes within 2 weeks following initiation and treatment.
Aprepitant [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA
As a moderate inhibitor of CYP3A4, aprepitant (125 mg/80 mg) can increase plasma concentrations of co-administered active substances that are metabolised through CYP3A4.
Aprepitant [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Aprepitant [1], ergot derivatives ---> SmPC of [1] of EMA
EMEND 40 mg should be used with caution with pimozide, terfenadine, astemizole, cisapride, or ergot derivatives. Inhibition of CYP3A4 by aprepitant could result in elevated plasma levels of these active substances, potentially causing serious reactions.
Aprepitant [1], ergotamine ---> SmPC of [1] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Aprepitant [1], etoposide ---> SmPC of [1] of EMA
An interaction of aprepitant with orally administered chemotherapeutic medicinal products metabolised primarily or in part by CYP3A4 cannot be excluded. Caution is advised
Aprepitant [1], etoposide ---> SmPC of [1] of EMA
An interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g., etoposide, vinorelbine) cannot be excluded.
Aprepitant [1], everolimus ---> SmPC of [1] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Aprepitant [1], fertility ---> SmPC of [1] of EMA
These fertility studies did not indicate direct or indirect harmful effects with respect to mating performance, fertility, embryonic/foetal development, or sperm count and motility (see section 5.3).
Aprepitant [1], granisetron ---> SmPC of [1] of EMA
In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
Aprepitant [1], ifosfamide ---> SmPC of [1] of EMA
Post-marketing events of neurotoxicity, a potential adverse reaction of ifosfamide, have been reported after aprepitant and ifosfamide co-administration.
Aprepitant [1], immunosuppressants metabolised by CYP3A4 ---> SmPC of [1] of EMA
Given the short duration of the 3-day regimen and the time-dependent limited changes in exposure, dose reduction of the immunosuppressant is not recommended during the 3 days of co-administration with EMEND.
Aprepitant [1], irinotecan ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with irinotecan should be approached with particular caution as the combination might result in increased toxicity.
Aprepitant [1], itraconazol ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously, as the combination is expected to result several-fold in increased plasma concentrations of aprepitant
Aprepitant [1], ketoconazole ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously, as the combination is expected to result several-fold in increased plasma concentrations of aprepitant
Aprepitant [1], liver insufficiency ---> SmPC of [1] of EMA
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment. EMEND should be used with caution in these patients (see section 5.2).
Aprepitant [1], methylprednisolone ---> SmPC of [1] of EMA
The usual intravenously administered methylprednisolone dose should be reduced approximately 25 %, and the usual oral methylprednisolone dose should be reduced approximately 50 % when co-administered with EMEND 125 mg/80 mg regimen.
Aprepitant [1], midazolam ---> SmPC of [1] of EMA
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these medicinal products with EMEND (125 mg/80 mg).
Aprepitant [1], nefazodone ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously, as the combination is expected to result several-fold in increased plasma concentrations of aprepitant
Aprepitant [1], ondansetron ---> SmPC of [1] of EMA
In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
Aprepitant [1], oral contraceptives ---> SmPC of [1] of EMA
The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of aprepitant
Aprepitant [1], oral contraceptives ---> SmPC of [1] of EMA
Alternative non-hormonal back-up methods of contraception should be used during treatment with EMEND and for 2 months following the last dose of EMEND.
Aprepitant [1], phenobarbital ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination results in reductions of the plasma concentrations of aprepitant that may result in decreased efficacy of aprepitant
Aprepitant [1], phenprocoumon ---> SmPC of [1] of EMA
Aprepitant, CYP2C9 inductor, may decrease the plasma concentrations of anticoagulant. Caution is advised
Aprepitant [1], phenytoin ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination results in reductions of the plasma concentrations of aprepitant that may result in decreased efficacy of aprepitant
Aprepitant [1], pimozide ---> SmPC of [1] of EMA
EMEND must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride (see section 4.3).
Aprepitant [1], posaconazole ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously, as the combination is expected to result several-fold in increased plasma concentrations of aprepitant
Aprepitant [1], pregnancy ---> SmPC of [1] of EMA
EMEND should not be used during pregnancy unless clearly necessary.
Aprepitant [1], protease inhibitors ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously, as the combination is expected to result several-fold in increased plasma concentrations of aprepitant
Aprepitant [1], quinidine ---> SmPC of [1] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Aprepitant [1], rifampicin ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination results in reductions of the plasma concentrations of aprepitant that may result in decreased efficacy of aprepitant
Aprepitant [1], sirolimus ---> SmPC of [1] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Aprepitant [1], St. John's wort ---> SmPC of [1] of EMA
Concomitant administration of EMEND with herbal preparations containing St. John's Wort (Hypericum perforatum) is not recommended.
Aprepitant [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination results in reductions of the plasma concentrations of aprepitant that may result in decreased efficacy of aprepitant
Aprepitant [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously, as the combination is expected to result several-fold in increased plasma concentrations of aprepitant
Aprepitant [1], tacrolimus ---> SmPC of [1] of EMA
Caution is advised during concomitant administration of aprepitant and orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range
Aprepitant [1], telithromycin ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously, as the combination is expected to result several-fold in increased plasma concentrations of aprepitant
Aprepitant [1], terfenadine ---> SmPC of [1] of EMA
EMEND must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride (see section 4.3).
Aprepitant [1], tolbutamide ---> SmPC of [1] of EMA
Aprepitant, CYP2C9 inductor, may decrease the plasma concentrations of tolbutamide. Caution is advised
Aprepitant [1], triazolam ---> SmPC of [1] of EMA
The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these medicinal products with EMEND (125 mg/80 mg).
Aprepitant [1], vinorelbine ---> SmPC of [1] of EMA
An interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g., etoposide, vinorelbine) cannot be excluded.
Aprepitant [1], voriconazole ---> SmPC of [1] of EMA
Concomitant administration of aprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously, as the combination is expected to result several-fold in increased plasma concentrations of aprepitant
Aprepitant [1], warfarin ---> SmPC of [1] of EMA
In patients on chronic warfarin therapy, the International Normalised Ratio (INR) should be monitored closely during treatment with EMEND and for 14 days following each 3-day course of EMEND (see section 4.5).
Aprepitant, avanafil [2] ---> SmPC of [2] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Aprepitant, bosutinib [2] ---> SmPC of [2] of EMA
The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.
Aprepitant, cabazitaxel [2] ---> SmPC of [2] of EMA
Concomitant administration of aprepitant, a moderate CYP3A inhibitor, had no effect on cabazitaxel clearance.
Aprepitant, capivasertib [2] ---> SmPC of [2] of EMA
Co-administration of TRUQAP with moderate CYP3A4 inhibitors increases capivasertib concentration, which may increase the risk of TRUQAP toxicity. TRUQAP dose should be reduced when co-administered with moderate CYP3A4 inhibitor
Aprepitant, clobazam
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
Aprepitant, clonazepam
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
Aprepitant, cyclophosphamide
The co-administration may delay the activation and decrease the efficacy of cyclophosphamide
Aprepitant, dapoxetine [2] ---> SmPC of [2] of eMC
Concomitant treatment of dapoxetine with moderate CYP3A4 inhibitors may give rise to significantly increased exposure of dapoxetine and desmethyldapoxetine, especially in CYP2D6 poor metabolizers.
Aprepitant, deflazacort
A transient moderate increase followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 is expected
Aprepitant, dextromethorphan/quinidine [2] ---> SmPC of [2] of EMA
Concomitant administration of medicines that inhibit CYP3A4 can be expected to increase plasma levels of quinidine, which could increase risk relating to QTc prolongation. Strong and moderate CYP3A4 inhibitors should be avoided during treatment.
Aprepitant, duvelisib [2] ---> SmPC of [2] of EMA
Dose reduction of duvelisib is not necessary when co-administered with moderate CYP3A4 inhibitors
Aprepitant, elacestrant [2] ---> SmPC of [2] of EMA
Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors should be avoided which may increase the risk of adverse reactions
Aprepitant, eliglustat [2] ---> SmPC of [2] of EMA
It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.
Aprepitant, eszoplicone
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
Aprepitant, ethinylestradiol/norgestimate [2] ---> SmPC of [2] of eMC
Drugs or herbal products that induce enzymes, especially CYP3A4, may decrease the plasma concentrations of contraceptive hormones, and may decrease their effectiveness and/or increase breakthrough bleeding.
Aprepitant, fentanyl [2] ---> SmPC of [2] of EMA
The concomitant use of Effentora with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression.
Aprepitant, fesoterodine
The CYP3A4 inhibition may increase the plasma concentrations of fesoterodine
Aprepitant, fingolimod
A transient moderate increase followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 is expected
Aprepitant, flunitrazepam
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
Aprepitant, flurazepam
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
Aprepitant, guanfacin [2] ---> SmPC of [2] of EMA
Co-administration of Intuniv with moderate and strong CYP3A4/5 inhibitors elevates plasma guanfacine concentrations and increases the risk of adverse reactions such as hypotension, bradycardia, and sedation.
Aprepitant, ibrutinib [2] ---> SmPC of [2] of EMA
Concomitant use of IMBRUVICA and medicinal products that strongly or moderately inhibit CYP3A4 can increase ibrutinib exposure and strong CYP3A4 inhibitors should be avoided.
Aprepitant, ifosfamide ---> SmPC of [fosaprepitant] of EMA
Postmarketing events of neurotoxicity, a potential adverse reaction of ifosfamide, have been reported after aprepitant and ifosfamide co-administration.
Aprepitant, isavuconazole [2] ---> SmPC of [2] of EMA
Co-administration with mild CYP3A4/5 inducers may result in mild to moderate decreases of isavuconazole plasma levels; co-administration with mild CYP3A4/5 inducers should be avoided unless the potential benefit is considered to outweigh the risk
Aprepitant, ivosidenib [2] ---> SmPC of [2] of EMA
Coadministration of moderate or strong CYP3A4 inhibitors increases ivosidenib plasma levels. This may increase the risk of QTc interval prolongation and suitable alternatives that are not moderate or strong CYP3A4 inhibitors should be considered
Aprepitant, ketoconazole [2] ---> SmPC of [2] of EMA
Careful monitoring. Dose adjustment of aprepitant may be required
Aprepitant, lurasidone [2] ---> SmPC of [2] of EMA
Coadministration of lurasidone with mild inducers of CYP3A4 would be expected to give a <2-fold reduction in lurasidone exposure during co-administration and for up to 2 weeks after discontinuation of mild or moderate CYP3A4 inducers.
Aprepitant, nitrazepam
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
Aprepitant, pimecrolimus
A transient moderate increase followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 is expected
Aprepitant, pralsetinib [2] ---> SmPC of [2] of EMA
Co-administration of pralsetinib with P-gp and/or strong or moderate CYP3A4 inhibitors may increase pralsetinib plasma concentrations, which may increase the risk of adverse reactions of pralsetinib. The coadministration should be avoided
Aprepitant, roflumilast
A transient moderate increase followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 is expected
Aprepitant, rolapitant [2] ---> SmPC of [2] of EMA
The efficacy and safety of rolapitant with concurrent use of another NK1 receptor antagonist (e.g. aprepitant and a combination of netupitant and palonosetron hydrochloride) is not established and therefore not recommended (see section 4.4).
Aprepitant, temsirolimus [2] ---> SmPC of [2] of EMA
Concomitant treatment with moderate CYP3A4 inhibitors should only be administered with caution in patients receiving 25 mg and should be avoided in patients receiving temsirolimus doses higher than 25 mg
Aprepitant, ticagrelor [2] ---> SmPC of [2] of EMA
Other moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, erythromycin and fluconazole) would be expected to have a similar effect and can as well be co-administered with ticagrelor.
Aprepitant, tolterodine
The co-administration may increase the plasma concentrations of tolterodine
Aprepitant, trabectedin [2] ---> SmPC of [2] of EMA
Concomitant use of a strong CYP3A4 inhibitor with trabectedin may increase the plasma exposure of trabectedin. Concomitant use should be avoided. If the combination is needed, close monitoring of toxicities
Aprepitant, zaleplon
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
Aprepitant, zanubrutinib [2] ---> SmPC of [2] of EMA
If a moderate CYP3A inhibitor must be used, reduce the BRUKINSA dose to 160 mg (two capsules) for the duration of the inhibitor use.
Aprepitant, zolpidem
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
Aprepitant, zopiclone
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
CONTRAINDICATIONS of Aprepitant (Emend)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Co-administration with pimozide, terfenadine, astemizole or cisapride (see section 4.5).
https://www.ema.europa.eu/en/documents/product-information/emend-epar-product-information_en.pdf 24/10/2025
Aprocitentan (Jeraygo)
Ability to drive, aprocitentan [2] ---> SmPC of [2] of EMA
Aprocitentan has negligible influence on the ability to drive and use machines. However, adverse reactions (e.g., headache or hypotension) may occasionally occur that may influence the ability to drive and use machines.
Aprocitentan [1], BCRP substrates ---> SmPC of [1] of EMA
Once daily dosing of aprocitentan increased Cmax of rosuvastatin by 40%; however, the total exposure to rosuvastatin expressed as AUC0-? was unchanged. Therefore, BCRP substrates can be administered with aprocitentan.
Aprocitentan [1], breast-feeding ---> SmPC of [1] of EMA
A risk to the breastfed infant cannot be excluded. JERAYGO is contraindicated during breast-feeding (see section 4.3).
Aprocitentan [1], cytochrome P450 ---> SmPC of [1] of EMA
Based on its pharmacokinetic (PK) profile, aprocitentan exposure is not expected to be impacted by other medicinal products that are inhibitors or inducers of transporters and/or CYP enzymes.
Aprocitentan [1], fertility ---> SmPC of [1] of EMA
It is not known if aprocitentan may adversely affect spermatogenesis in men. In female rats, aprocitentan slightly increased pre-implantation loss (see section 5.3).
Aprocitentan [1], hormonal contraceptives ---> SmPC of [1] of EMA
The potential interaction between aprocitentan and hormonal contraceptives has not been studied. Therefore, women using hormonal contraceptives should add a barrier method.
Aprocitentan [1], methotrexate ---> SmPC of [1] of EMA
Therefore, caution should be exercised when OAT3 substrates with a narrow therapeutic index (e.g., methotrexate) are given concomitantly.
Aprocitentan [1], midazolam ---> SmPC of [1] of EMA
leading to the conclusion of the absence of interaction with CYP enzymes, with the exception of the potential induction of CYP2B6 and CYP1A2 enzymes described below.
Aprocitentan [1], narrow therapeutic index CYP1A2 substrates ---> SmPC of [1] of EMA
Caution is recommended when aprocitentan is coadministered with CYP1A2 substrates with a narrow therapeutic index (e.g., tizanidine).
Aprocitentan [1], OAT3 substrates with narrow therapeutic window ---> SmPC of [1] of EMA
Therefore, caution should be exercised when OAT3 substrates with a narrow therapeutic index (e.g., methotrexate) are given concomitantly.
Aprocitentan [1], pharmacokinetics ---> SmPC of [1] of EMA
Aprocitentan does not impact the PK of medicinal products for which PK is dependent on active transport, with the exception of OAT3 substrates described below.
Aprocitentan [1], pregnancy ---> SmPC of [1] of EMA
There are no or limited amount of data on the use of aprocitentan in pregnant women. Since studies in animals with other ERAs have shown reproductive toxicity, JERAYGO is contraindicated during pregnancy (see section 4.3).
Aprocitentan [1], rosuvastatin ---> SmPC of [1] of EMA
Once daily dosing of aprocitentan increased Cmax of rosuvastatin by 40%; however, the total exposure to rosuvastatin expressed as AUC0-? was unchanged. Therefore, BCRP substrates can be administered with aprocitentan.
Aprocitentan [1], tizanidine ---> SmPC of [1] of EMA
Caution is recommended when aprocitentan is coadministered with CYP1A2 substrates with a narrow therapeutic index (e.g., tizanidine).
Aprocitentan [1], women of childbearing potential ---> SmPC of [1] of EMA
JERAYGO is contraindicated for use in women of childbearing potential not using contraception. If pregnancy is detected, JERAYGO must be discontinued (see sections 4.3 and 4.4).
Aprocitentan [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential must be advised to use reliable methods of contraception during treatment and for one month after treatment discontinuation, as women should not become pregnant during this time.
CONTRAINDICATIONS of Aprocitentan (Jeraygo)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy (see section 4.6).
- Women of childbearing potential who are not using reliable contraception (see sections 4.4 and
- Breast-feeding (see section 4.6).
- Patients with severe hepatic impairment (Child-Pugh class C; with or without cirrhosis) (see section 4.4).
https://www.ema.europa.eu/en/documents/product-information/jeraygo-epar-product-information_en.pdf 24/07/2024
Aprotinin
Alteplase, aprotinin
Aprotinin has a dose-dependent inhibitor effect on the effect of thrombolytic agents
Aprotinin, breast-feeding
Strict indication
Aprotinin, pregnancy
Aprotinin should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Aprotinin, streptokinase [2] ---> SPC of [2] of eMC
There is an increased risk of haemorrhage in patients who are receiving or who have recently been treated with anticoagulants or drugs which inhibit platelet formation or function
Aprotinin, streptokinase/streptodornase
There is an increased risk of haemorrhage in patients who are receiving or who have recently been treated with anticoagulants or drugs which inhibit platelet formation or function
Aprotinin, succinylcholine [2] ---> SPC of [2] of eMC
The decrease in the normal plasma cholinesterase activity may prolong the neuromuscular blocking effects of suxamethonium
Aprotinin, suxamethonium [2] ---> SPC of [2] of eMC
The decrease in the normal plasma cholinesterase activity may prolong the neuromuscular blocking effects of suxamethonium
Aprotinin, thrombolytics
Aprotinin has a dose-dependent inhibitor effect on the effect of thrombolytic agents
Aprotinin, tretinoin
There is a risk of thrombosis (both venous and arterial) which may involve any organ system, during the first month of treatment. Therefore, caution should be exercised when treating patients with the combination of tretinoin and anti-fibrinolytic agents
Aprotinin, urokinase
Aprotinin has a dose-dependent inhibitor effect on the effect of thrombolytic agents
Argatroban
Acenocoumarol, argatroban
Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended
Anticoagulants, argatroban [2] ---> SPC of [2] of eMC
Concomitant use of argatroban with other anticoagulants may increase the risk of bleeding.
Argatroban [1], breast-feeding ---> SPC of [1] of eMC
Breast feeding is not recommended during treatment.
Argatroban [1], platelet aggregation inhibitors ---> SPC of [1] of eMC
Concomitant use of argatroban with antiplatelet agents may increase the risk of bleeding.
Argatroban [1], pregnancy ---> SPC of [1] of eMC
Argatroban should be used during pregnancy only if treatment is clearly necessary.
Argatroban [1], thrombolytics ---> SPC of [1] of eMC
Concomitant use of argatroban with thrombolytics may increase the risk of bleeding.
Argatroban [1], vitamin K antagonists ---> SPC of [1] of eMC
Concomitant use of argatroban with other anticoagulants may increase the risk of bleeding.
CONTRAINDICATIONS of Argatroban
- Exembol is contraindicated in patients with uncontrolled bleeding.
- Hypersensitivity to argatroban or to any of the excipients.
- Severe hepatic impairment.
http://www.medicines.org.uk/emc/
Arginine/lysine (LysaKare)
Arginine/lysine [1], breast-feeding ---> SmPC of [1] of EMA
Arginine and lysine, being naturally occurring amino acids, are excreted in human milk, but effects on the breastfed newborns/infants are unlikely. Breast-feeding should be avoided during treatment with lutetium (177Lu) oxodotreotide.
Arginine/lysine [1], fertility ---> SmPC of [1] of EMA
There are no data on the effects of arginine and lysine on fertility.
Arginine/lysine [1], interactions ---> SmPC of [1] of EMA
No interaction studies have been performed. No interaction with other medicinal product is expected since there is no information that other drugs are re-absorbed by the same kidney re-absorption mechanism.
Arginine/lysine [1], men ---> SmPC of [1] of EMA
Males and females of reproductive potential should be advised to use effective contraception during treatment with lutetium (177Lu) oxodotreotide.
Arginine/lysine [1], pregnancy ---> SmPC of [1] of EMA
Lysakare is used with lutetium (177Lu) oxodotreotide, which is contraindicated during established or suspected pregnancy and when pregnancy has not been excluded due to the risk associated with the ionising radiation.
Arginine/lysine [1], women of childbearing potential ---> SmPC of [1] of EMA
Males and females of reproductive potential should be advised to use effective contraception during treatment with lutetium (177Lu) oxodotreotide.
CONTRAINDICATIONS of Arginine/lysine (LysaKare)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Pre-existing clinically significant hyperkalaemia if not adequately corrected before starting the LysaKare infusion (see section 4.4).
https://www.ema.europa.eu/en/documents/product-information/lysakare-epar-product-information_en.pdf 07/08/2025
Aripiprazole (Abilify Maintena)
Ability to drive, aripiprazole [2] ---> SmPC of [2] of EMA
Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see section 4.8).
Alcohol, aripiprazole [2] ---> SmPC of [2] of EMA
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is administered in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8).
Alfa1-adrenergic receptor blockers, aripiprazole [2] ---> SmPC of [2] of EMA
Due to its alfa1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Antihypertensives, aripiprazole [2] ---> SmPC of [2] of EMA
Due to its alfa1 -adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Aripiprazole [1], breast-feeding ---> SmPC of [1] of EMA
Aripiprazole/metabolites are excreted in the breast milk to such an extent that effects on the breast-fed infant are likely if Abilify Maintena is administered to breast-feeding women.
Aripiprazole [1], breast-feeding ---> SmPC of [1] of EMA
Patients currently under treatment or who have been treated in the past 34 weeks with Abilify Maintena should not breast feed.
Aripiprazole [1], carbamazepine ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], CNS depressants ---> SmPC of [1] of EMA
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is administered in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8).
Aripiprazole [1], CYP2D6 inhibitors ---> SmPC of [1] of EMA
When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Aripiprazole [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA
When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Aripiprazole [1], diltiazem ---> SmPC of [1] of EMA
When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Aripiprazole [1], efavirenz ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], electrolyte imbalance ---> SmPC of [1] of EMA
If aripiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.
Aripiprazole [1], escitalopram ---> SmPC of [1] of EMA
When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Aripiprazole [1], fertility ---> SmPC of [1] of EMA
Aripiprazole did not impair fertility based on data from reproductive toxicity studies.
Aripiprazole [1], fluoxetine ---> SmPC of [1] of EMA
Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reduction should, therefore, be applied (see section 4.2).
Aripiprazole [1], itraconazol ---> SmPC of [1] of EMA
Strong inhibitors of CYP3A4 may increase the AUC of aripiprazole. A dose reduction should, therefore, be applied
Aripiprazole [1], ketoconazole ---> SmPC of [1] of EMA
Strong inhibitors of CYP3A4 may increase the AUC of aripiprazole. A dose reduction should, therefore, be applied
Aripiprazole [1], nevirapine ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], paroxetine ---> SmPC of [1] of EMA
Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reduction should, therefore, be applied (see section 4.2).
Aripiprazole [1], phenobarbital ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], phenytoin ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], pregnancy ---> SmPC of [1] of EMA
Should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus
Aripiprazole [1], primidone ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], protease inhibitors ---> SmPC of [1] of EMA
Strong inhibitors of CYP3A4 may increase the AUC of aripiprazole. A dose reduction should, therefore, be applied
Aripiprazole [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
If aripiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.
Aripiprazole [1], quinidine ---> SmPC of [1] of EMA
Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reduction should, therefore, be applied (see section 4.2).
Aripiprazole [1], rifabutin ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], rifampicin ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], serotonergic medicines ---> SmPC of [1] of EMA
Cases of serotonin syndrome have been reported in patients taking aripiprazole, and in cases of concomitant use with other serotonergic medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Aripiprazole [1], SSRI ---> SmPC of [1] of EMA
Cases of serotonin syndrome have been reported in patients taking aripiprazole, and in cases of concomitant use with other serotonergic medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Aripiprazole [1], St. John's wort ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], strong CYP2D6 inhibitors ---> SmPC of [1] of EMA
Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reduction should, therefore, be applied (see section 4.2).
Aripiprazole [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Aripiprazole [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Strong inhibitors of CYP3A4 may increase the AUC of aripiprazole. A dose reduction should, therefore, be applied
Aripiprazole [1], triptans ---> SmPC of [1] of EMA
Cases of serotonin syndrome have been reported in patients taking aripiprazole, and in cases of concomitant use with other serotonergic medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Aripiprazole [1], venlafaxine ---> SmPC of [1] of EMA
When aripiprazole was administered concomitantly with venlafaxine, there was no clinically important change in concentrations of venlafaxine. Thus, no dosage adjustment is required
Aripiprazole [1], warfarin ---> SmPC of [1] of EMA
When aripiprazole was administered concomitantly with warfarin, there was no clinically important change in concentrations of warfarin. Thus, no dosage adjustment is required
Aripiprazole [1], women of childbearing potential ---> SmPC of [1] of EMA
Plasma exposure to aripiprazole after a single dose of Abilify Maintena is expected to remain for up to 34 weeks (see section 5.2).
Aripiprazole [1], women of childbearing potential ---> SmPC of [1] of EMA
Abilify Maintena should only be used in women planning to become pregnant if clearly necessary.
Aripiprazole, ketoconazole [2] ---> SmPC of [2] of EMA
Careful monitoring. Aripiprazole dose should be reduced to approximatively one-half of its prescribed dose.
Aripiprazole, miconazole
Oral miconazole is contraindicated with medicinal products that are metabolised by CYP3A4 and may prolong also the QT interval
Aripiprazole, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA
Dosage adjustment of aripiprazole and brexpiprazole is recommended. Refer to aripiprazole or brexpiprazole SmPCs for more information.
Aripiprazole, risperidone [2] ---> SmPC of [2] of EMA
Aripiprazole, a CYP2D6 and CYP3A4 substrate: Risperidone tablets or injections did not affect the pharmacokinetics of the sum of aripiprazole and its active metabolite, dehydroaripiprazole.
Aripiprazole, SNRIs [2] ---> SmPC of [2] of EMA
Cases of serotonin syndrome have been reported in patients taking aripiprazole, and in cases of concomitant use with other serotonergic medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Aripiprazole, vasodilators
Increased hypotensive effect
CONTRAINDICATIONS of Aripiprazole (Abilify Maintena)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Other trade names: Abilify, Apaloz, Aripiprazole Accord, Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen), Aripiprazole Sandoz, Aripiprazole Zentiva, Arizol,
Arsenic trioxide (Trisenox)
Amiodarone, arsenic trioxide [2] ---> SmPC of [2] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Amitriptyline, arsenic trioxide [2] ---> SmPC of [2] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Amphotericin B, arsenic trioxide [2] ---> SmPC of [2] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Anthracyclines, arsenic trioxide [2] ---> SmPC of [2] of EMA
The pretreatment with an anthracycline increases the risk of QT interval prolonging
Antileukaemic medicinal products, arsenic trioxide [2] ---> SmPC of [2] of EMA
The influence of TRISENOX on the efficacy of other antileukaemic medicinal products is unknown.
Arsenic trioxide [1], astemizole ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], breast-feeding ---> SmPC of [1] of EMA
Because of the potential for serious adverse reactions in breast-feeding infants and children from TRISENOX, breast-feeding must be discontinued prior to and throughout administration and for two weeks after the last dose.
Arsenic trioxide [1], cisapride ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], class IA antiarrhythmic agents ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], class III antiarrhythmic agents ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], dofetilide ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], erythromycin ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], fertility ---> SmPC of [1] of EMA
No clinical or non-clinical fertility studies have been conducted with TRISENOX.
Arsenic trioxide [1], hepatotoxic drugs ---> SmPC of [1] of EMA
Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when TRISENOX is coadministered with other medicinal products known to cause hepatotoxic effects
Arsenic trioxide [1], hypokalemia ---> SmPC of [1] of EMA
Patients who are receiving, or who have received, medicinal products known to cause hypokalemia or hypomagnesaemia, may be at higher risk for torsade de pointes.
Arsenic trioxide [1], hypomagnesemia ---> SmPC of [1] of EMA
Patients who are receiving, or who have received, medicinal products known to cause hypokalemia or hypomagnesaemia, may be at higher risk for torsade de pointes.
Arsenic trioxide [1], loop diuretics ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], men ---> SmPC of [1] of EMA
Men should use effective contraceptive measures and be advised to not father a child while receiving TRISENOX and for 3 months following completion of treatment.
Arsenic trioxide [1], pregnancy ---> SmPC of [1] of EMA
If this medicinal product is used during pregnancy or if the patient becomes pregnant while taking this product, the patient must be informed of the potential harm to the foetus.
Arsenic trioxide [1], pregnancy ---> SmPC of [1] of EMA
Arsenic trioxide has been shown to be embryotoxic and teratogenic in animal studies (see section 5.3). There are no studies in pregnant women using TRISENOX.
Arsenic trioxide [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], quinidine ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], sotalol ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], sparfloxacin ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], terfenadine ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], thiazides ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], thioridazine ---> SmPC of [1] of EMA
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide [1], women of childbearing potential ---> SmPC of [1] of EMA
Due to the genotoxic risk of arsenic compounds (see section 5.3), women of childbearing potential must use effective contraceptive measures during treatment with TRISENOX and for 6 months following completion of treatment.
Arsenic trioxide, delamanid [2] ---> SmPC of [2] of EMA
Treatment with delamanid should not be initiated in patients with risk factors like taking medicinal products that are known to prolong the QTc interval, unless the possible benefit is considered to outweigh the potential risks.
Arsenic trioxide, macrolide antibiotics
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsenic trioxide, piperaquine ---> SmPC of [piperaquine/artenimol] of EMA
The combination of piperaquine with drugs that are known to prolong the QTc interval is contraindicated: additive effect on the QTc interval
Arsenic trioxide, piperaquine/artenimol [2] ---> SmPC of [2] of EMA
The combination of piperaquine/dihydroartemisinin with drugs that are known to prolong the QTc interval is contraindicated: additive effect on the QTc interval
Arsenic trioxide, quinine
The co-administration of quinine with medicinal products that significant prolong the QT interval is contraindicated
Arsenic trioxide, ziprasidone
Additive QT-prolonging effects may increase the risk of severe arrhythmias. Concomitant therapy is contraindicated.
CONTRAINDICATIONS of Arsenic trioxide (Trisenox)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/trisenox-epar-product-information_en.pdf 25/05/2023
Other trade names: Arsenic trioxide Accord, Arsenic trioxide medac,
Artemether/Lumefantrine
QT interval prolonging drugs, artemether/lumefantrine [2] ---> SPC of [2] of eMC
Artemether/lumefantrine is contraindicated in patients taking drugs that are known to prolong the QTc interval.
Ability to drive, artemether/lumefantrine [2] ---> SPC of [2] of eMC
Patients should be warned that dizziness or fatigue/asthenia may occur in which case they should not drive or use machines.
Amitriptyline, artemether/lumefantrine [2] ---> SPC of [2] of eMC
Artemether/lumefantrine is contraindicated in patients who are taking any drug which is metabolised by the cytochrome enzyme CYP2D6. In vitro, lumefantrine significantly inhibits the activity of CYP2D6 at therapeutic plasma concentrations
Antimalarial agents, artemether/lumefantrine [2] ---> SPC of [2] of eMC
Due to some antimalarial agents may prolong the QTc interval, caution is advised when administering artemether/lumefantrine to patients in whom there may still be detectable concentrations of these drugs in the plasma.
Artemether/lumefantrine [1], astemizole ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients taking drugs that are known to prolong the QTc interval.
Artemether/lumefantrine [1], azole antifungals ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients taking drugs that are known to prolong the QTc interval.
Artemether/lumefantrine [1], breast-feeding ---> SPC of [1] of eMC
Women should not breastfeed during treatment. Due to the long elimination half-life of lumefantrine (4-6 days), it is recommended that breastfeeding should not resume until at least 1 week after the last dose unless benefits outweigh risks
Artemether/lumefantrine [1], cisapride ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients taking drugs that are known to prolong the QTc interval.
Artemether/lumefantrine [1], class IA antiarrhythmic agents ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients taking drugs that are known to prolong the QTc interval.
Artemether/lumefantrine [1], class III antiarrhythmic agents ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients taking drugs that are known to prolong the QTc interval.
Artemether/lumefantrine [1], clomipramine ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients who are taking any drug which is metabolised by the cytochrome enzyme CYP2D6. In vitro, lumefantrine significantly inhibits the activity of CYP2D6 at therapeutic plasma concentrations
Artemether/lumefantrine, darunavir/cobicistat [2] ---> SPC of [2] of EMA
REZOLSTA is expected to increase lumefantrine plasma concentrations. (CYP3A inhibition). REZOLSTA and artemether/lumefantrine can be used without dose adjustments
Artemether/lumefantrine, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Symtuza and artemether/lumefantrine can be used without dose adjustments; however, due to the increase in lumefantrine exposure, the combination should be used with caution.
Artemether/lumefantrine, darunavir/ritonavir ---> SPC of [darunavir] of EMA
The combination of boosted PREZISTA and artemether/lumefantrine can be used without dose adjustments; however, due to the increase in lumefantrine exposure, the combination should be used with caution.
Artemether/lumefantrine, dolutegravir/rilpivirine [2] ---> SPC of [2] of EMA
Decreased exposure of rilpivirine is expected (induction of CYP3A enzymes). The combination of Juluca and artemether/lumefantrine should be used with caution.
Artemether/lumefantrine [1], drugs primarily metabolised by CYP2D6 ---> SPC of [1] of eMC
Lumefantrine inhibits CYP2D6 in vitro. This may be of particular clinical relevance for compounds with a low therapeutic index. Co-administration of artemether/lumefantrine with drugs that are metabolised by CYP2D6 is contraindicated
Artemether/lumefantrine, efavirenz ---> SPC of [efavirenz/emtricitabine/tenofovir disoproxil] of EMA
Efavirenz, strong CYP3A4 inductor, may decrease the plasma concentrations of artemether and lumefantrine
Artemether/lumefantrine, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Since decreased concentrations of artemether, dihydroartemisinin, or lumefantrine may result in a decrease of antimalarial efficacy, caution is recommended when Atripla and artemether/lumefantrine tablets are co-administered.
Artemether/lumefantrine [1], electrolyte imbalance ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients with disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
Artemether/lumefantrine, etravirine [2] ---> SPC of [2] of EMA
Close monitoring of antimalarial response is warranted when co-administering etravirine and artemether/lumefantrine as a significant decrease in exposure of artemether and its active metabolite, dihydroartemisinin, may decrease antimalarial efficacy.
Artemether/lumefantrine [1], flecainide ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients who are taking any drug which is metabolised by the cytochrome enzyme CYP2D6. In vitro, lumefantrine significantly inhibits the activity of CYP2D6 at therapeutic plasma concentrations
Artemether/lumefantrine, flecainide
Artemether/lumefantrine is contraindicated in patients taking drugs that are known to prolong the QTc interval.
Artemether/lumefantrine [1], foods ---> SPC of [1] of eMC
Food enhances the absorption of both artemether and lumefantrine. Patients should be encouraged to take the medication with a normal diet as soon as food can be tolerated.
Artemether/lumefantrine [1], halofantrine ---> SPC of [1] of eMC
In patients previously treated with halofantrine, artemether/lumefantrine should be dosed at least 1 month after the last halofantrine dose.
Artemether/lumefantrine, hydroxychloroquine
The coadministration should be avoided
Artemether/lumefantrine [1], imipramine ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients who are taking any drug which is metabolised by the cytochrome enzyme CYP2D6. In vitro, lumefantrine significantly inhibits the activity of CYP2D6 at therapeutic plasma concentrations
Artemether/lumefantrine [1], ketoconazole ---> SPC of [1] of eMC
The concurrent oral administration of potent CYP3A4 inhibitors with artemether/lumefantrine led to a modest increase in artemether, DHA, and lumefantrine exposure. A dose adjustment is considered unnecessary
Artemether/lumefantrine [1], mefloquine ---> SPC of [1] of eMC
The pre-treatment with mefloquine caused significant reduction in plasma levels of lumefantrine. It is recommended to eat at dosing times to compensate for the decrease in bioavailability.
Artemether/lumefantrine [1], metoprolol ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients who are taking any drug which is metabolised by the cytochrome enzyme CYP2D6. In vitro, lumefantrine significantly inhibits the activity of CYP2D6 at therapeutic plasma concentrations
Artemether/lumefantrine [1], pregnancy ---> SPC of [1] of eMC
It must not be used during the 1st pregnancy trimester in situations where other suitable and effective antimalarials are available. During the 2nd and 3rd trimester, treatment should only be considered if the benefit outweighs the risk
Artemether/lumefantrine [1], protease inhibitors ---> SPC of [1] of eMC
Due to variable patterns of inhibition, induction or competition for CYP3A4 with protease inhibitor anti-retroviral drugs, use of such drugs concomitantly with artemether/lumefantrine requires clinical surveillance
Artemether/lumefantrine [1], quinine ---> SPC of [1] of eMC
The inherent risk of QTc prolongation associated with i.v. quinine was enhanced by prior administration of artemether/lumefantrine
Artemether/lumefantrine [1], quinolones ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients taking drugs that are known to prolong the QTc interval.
Artemether/lumefantrine [1], strong CYP3A4 inhibitors ---> SPC of [1] of eMC
The concurrent oral administration of potent CYP3A4 inhibitors with artemether/lumefantrine led to a modest increase in artemether, DHA, and lumefantrine exposure. A dose adjustment is considered unnecessary
Artemether/lumefantrine [1], terfenadine ---> SPC of [1] of eMC
Artemether/lumefantrine is contraindicated in patients taking drugs that are known to prolong the QTc interval.
CONTRAINDICATIONS of Artemether/lumefantrine
Riamet is contraindicated in:
- patients with known hypersensitivity to the active substances or to any of the excipients.
- patients with severe malaria according to WHO definition.
- patients who are taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitryptyline, clomipramine).
- patients with a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
- patients taking drugs that are known to prolong the QTc interval. These drugs include:
- antiarrhythmics of classes IA and III,
- neuroleptics, antidepressive agents,
- certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents,
- certain non-sedating antihistamines (terfenadine, astemizole),
- cisapride.
- patients with a history of symptomatic cardiac arrythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
- patients with disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
http://www.medicines.org.uk/emc/
Artesunate (Artesunate Amivas)
Ability to drive, artesunate [2] ---> SmPC of [2] of EMA
No studies on the effects on the ability to drive and use machines have been performed. Patients should be warned not to drive or use machines if they feel tired or dizzy.
Artesunate [1], axitinib ---> SmPC of [1] of EMA
Co-administration of intravenous artesunate with strong inhibitors of UGT enzymes (e.g. axitinib, vandetanib, imatinib, diclofenac) may increase plasma exposures to DHA. Co-administration should be avoided if possible.
Artesunate [1], breast-feeding ---> SmPC of [1] of EMA
DHA, a metabolite of artesunate, is present in human milk. The benefits of breastfeeding to mother and infant should be weighed against potential risk from infant exposure to DHA through breast milk.
Artesunate [1], carbamazepine ---> SmPC of [1] of EMA
Co-administration of Artesunate Amivas with UGT inducers (e.g. nevirapine, ritonavir, rifampicin, carbamazepine, phenytoin) may decrease DHA exposures, leading to a reduction in, or loss of, efficacy. Co-administration should be avoided.
Artesunate [1], CYP1A2 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
Limited data from studies have indicated that DHA induces CYP3A and inhibits CYP1A2. Caution is advised when co-administering intravenous artesunate with substrates of CYP3A4 or CYP1A2 that have narrow therapeutic windows.
Artesunate [1], diclofenac ---> SmPC of [1] of EMA
Co-administration of intravenous artesunate with strong inhibitors of UGT enzymes (e.g. axitinib, vandetanib, imatinib, diclofenac) may increase plasma exposures to DHA. Co-administration should be avoided if possible.
Artesunate [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA
Limited data from studies have indicated that DHA induces CYP3A and inhibits CYP1A2. Caution is advised when co-administering intravenous artesunate with substrates of CYP3A4 or CYP1A2 that have narrow therapeutic windows.
Artesunate [1], fertility ---> SmPC of [1] of EMA
No fertility data are available in humans. Animal studies have reported effects on the male reproductive organs
Artesunate [1], imatinib ---> SmPC of [1] of EMA
Co-administration of intravenous artesunate with strong inhibitors of UGT enzymes (e.g. axitinib, vandetanib, imatinib, diclofenac) may increase plasma exposures to DHA. Co-administration should be avoided if possible.
Artesunate [1], nevirapine ---> SmPC of [1] of EMA
Co-administration of Artesunate Amivas with UGT inducers (e.g. nevirapine, ritonavir, rifampicin, carbamazepine, phenytoin) may decrease DHA exposures, leading to a reduction in, or loss of, efficacy. Co-administration should be avoided.
Artesunate [1], phenytoin ---> SmPC of [1] of EMA
Co-administration of Artesunate Amivas with UGT inducers (e.g. nevirapine, ritonavir, rifampicin, carbamazepine, phenytoin) may decrease DHA exposures, leading to a reduction in, or loss of, efficacy. Co-administration should be avoided.
Artesunate [1], pregnancy ---> SmPC of [1] of EMA
The use of Artesunate Amivas in the first trimester is not recommended. As a precautionary measure, it is preferable to avoid the use of Artesunate Amivas during the second or third trimester of pregnancy
Artesunate [1], rifampicin ---> SmPC of [1] of EMA
Co-administration of Artesunate Amivas with UGT inducers (e.g. nevirapine, ritonavir, rifampicin, carbamazepine, phenytoin) may decrease DHA exposures, leading to a reduction in, or loss of, efficacy. Co-administration should be avoided.
Artesunate [1], ritonavir ---> SmPC of [1] of EMA
Co-administration of Artesunate Amivas with UGT inducers (e.g. nevirapine, ritonavir, rifampicin, carbamazepine, phenytoin) may decrease DHA exposures, leading to a reduction in, or loss of, efficacy. Co-administration should be avoided.
Artesunate [1], strong glucuronidation inductors ---> SmPC of [1] of EMA
Co-administration of Artesunate Amivas with UGT inducers (e.g. nevirapine, ritonavir, rifampicin, carbamazepine, phenytoin) may decrease DHA exposures, leading to a reduction in, or loss of, efficacy. Co-administration should be avoided.
Artesunate [1], strong glucuronidation inhibitors ---> SmPC of [1] of EMA
Co-administration of intravenous artesunate with strong inhibitors of UGT enzymes (e.g. axitinib, vandetanib, imatinib, diclofenac) may increase plasma exposures to DHA. Co-administration should be avoided if possible.
Artesunate [1], vandetanib ---> SmPC of [1] of EMA
Co-administration of intravenous artesunate with strong inhibitors of UGT enzymes (e.g. axitinib, vandetanib, imatinib, diclofenac) may increase plasma exposures to DHA. Co-administration should be avoided if possible.
CONTRAINDICATIONS of Artesunate (Artesunate Amivas)
- Hypersensitivity to the active substance, to any other artemisinin antimalarial agent or to any of the excipients listed in section 6.1.
Articaine/epinephrine
IMAOs, articaine/epinephrine
The sympathomimetic effect of epinephrine may be potentiated with the simultaneous intake of MAO inhibitors and are contraindicated
Ability to drive, articaine/epinephrine
The patient should not leave the dental clinic within 30 minutes after the injection
Acetylsalicylic acid, articaine/epinephrine
There is an increase in the tendency to bleed during the treatment with anticoagulant medicinal products
Acetylsalicylic acid, epinephrine
There is an increase in the tendency to bleed during the treatment with anticoagulant medicinal products
Adrenaline, phenothiazines
Phenothiazines may decrease or reverse the pressor effect of epinephrine.
Anticoagulants, articaine/epinephrine
There is an increase in the tendency to bleed during the treatment with anticoagulant medicinal products
Articaine/epinephrine, breast-feeding
Breast milk should be discarded following anaesthesia
Articaine/epinephrine, halothane
Halotane may sensitize the heart to catecholamines and induce arrythmias after using adrenaline
Articaine/epinephrine, heparin
There is an increase in the tendency to bleed during the treatment with anticoagulant medicinal products
Articaine/epinephrine, local anaesthetics
The combination of local anaesthetics has additive effects on CNS and cardiovascular system
Articaine/epinephrine, non-selective betablockers ---> SPC of [adrenaline] of eMC
Severe hypertension and bradycardia may occur when adrenaline (epinephrine) is administered with nonselective beta-blocking medicinal products.
Articaine/epinephrine, oral antidiabetics
Epinephrine may inhibit the insulin release in pancreas and so decrease the effect of oral antidiabetics
Articaine/epinephrine, phenothiazines
Phenothiazines may decrease or reverse the pressor effect of epinephrine.
Articaine/epinephrine, pregnancy
It may only be used during pregnancy after a careful benefit/risk assessment
Articaine/epinephrine, tricyclic antidepressant
The sympathomimetic effect of epinephrine may be potentiated with the simultaneous intake of tricyclic antidepressants and are contraindicated
Ascorbic acid
Acetylsalicylic acid, ascorbic acid
Concomitant administration of acetylsalicylic acid and ascorbic acid may interfere with absorption of ascorbic acid.
Algeldrate, ascorbic acid
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Algeldrate, vitamin C
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Aluminium hydroxide, ascorbic acid
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Aluminium hydroxide, vitamin C
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Aluminium oxide, vitamin C
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Anionic drugs, ascorbic acid
Ascorbic acid, urinary acidifying agent, decreases the elimination of the acidic (anionic) medicinal product
Antacids, ascorbic acid
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Antacids, vitamin C
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Ascorbic acid, bleomycin
Bleomycin may be in vitro inactivated by ascorbic acid
Ascorbic acid, breast-feeding
No problems are anticipated with the administration of ascorbic acid tablets during lactation.
Ascorbic acid, cationic drugs
Ascorbic acid, urinary acidifying agent, increases the elimination of the basic (cationic) medicinal product
Ascorbic acid, certoparin
The co-administration may weaken the pharmacological effects of certoparin
Ascorbic acid, cyanocobalamin
Large doses of ascorbic acid may reduce the available quantities of cyanocobalamin (vitamin B12) in plasma and the reserves. It is recommended to administer ascorbic acid at least 2 hours after eating
Ascorbic acid, cyclosporine
Ascorbic acid could decrease plasma levels of ciclosporin
Ascorbic acid, cyproterone/ethinylestradiol
Increase in plasma hormone levels associated with co-administered drug
Ascorbic acid, dalteparin [2] ---> SPC of [2] of eMC
A reduction of the anticoagulant effect may occur with concomitant administration of dalteparin with ascorbic acid
Ascorbic acid, deferoxamine [2]
Concurrent administration of ascorbic acid with desferrioxamine enhances urinary iron excretion.
Ascorbic acid, disulfiram
Chronic or high doses of ascorbic acid may interfere the efficacy of disulfiram
Ascorbic acid, enoxaparin
The co-administration may weaken the effect of enoxaparin
Ascorbic acid, ethinyl estradiol
Increase in plasma hormone levels associated with co-administered drug
Ascorbic acid, ethinylestradiol/chlormadinone
Active principles which inhibit ethinylestradiol sulphonation in the intestinal wall, e. g. ascorbic acid or paracetamol, may increase plasma concentrations of ethinylestradiol
Ascorbic acid, ethinylestradiol/gestodene
Active principles which inhibit ethinylestradiol sulphonation in the intestinal wall, e. g. paracetamol, may increase plasma concentrations of ethinylestradiol
Ascorbic acid, ethinylestradiol/norgestimate [2] ---> SPC of [2] of eMC
Increase in plasma hormone levels associated with co-administered drug
Ascorbic acid, hydroxycobalamin
Chemical incompatibility. These medicinal products must not be administered simultaneously through the same intravenous line as hydroxocobalamine
Ascorbic acid, indinavir
Ascorbic acid may decrease the plasma levels of indinavir
Ascorbic acid, iron
Vitamin C may increase the absorption of iron salts from the gastrointestinal tract
Ascorbic acid, lisdexamfetamine [2] ---> SPC of [2] of eMC
Ascorbic acid acidifies the urine and increases urinary excretion and decreases the half-life of amfetamine (basic medicinal product)
Ascorbic acid, magaldrate
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Ascorbic acid, magnesium hydroxide
The magnesium hydroxide, urinary alkalinizing agent, increases the pH of renal tubular urine and may counteract the effect of the urinary acidifying
Ascorbic acid, mytomicin
Possible increase of hepatic inactivation of mitomycin
Ascorbic acid, nadroparin
The co-administration may weaken the nadroparin effect
Ascorbic acid, oral anticoagulants
The action of oral anticoagulant may be modified by the ascorbic acid
Ascorbic acid, pregnancy
Ascorbic acid in doses greater than 1 g should not be administered during pregnancy as the effect of large doses on the foetus is not known.
Ascorbic acid, pyrazinamide
Decrease of ascorbic acid uricosuric effect
Ascorbic acid, sodium selenite
The solution should not be mixed with reductants due to a precipitation of elemental selene cannot be excluded
Ascorbic acid, vitamin B12
Large doses of ascorbic acid may reduce the available quantities of cyanocobalamin (vitamin B12) in plasma and the reserves. It is recommended to administer ascorbic acid at least 2 hours after eating
Ascorbic acid, warfarin
Vitamin C in high doses can decrease the anticoagulant effect
Iron, vitamin C
Vitamin C may increase the absorption of iron salts from the gastrointestinal tract
Magaldrate, vitamin C
The concomitant use of aluminium-containing antacids with ascorbic acid may increase the aluminium absorption and cause toxicity. The combination is not recommended
Oral anticoagulants, vitamin C
The action of oral anticoagulant may be modified by the ascorbic acid
CONTRAINDICATIONS of Ascorbic acid
Hyperoxaluria
http://www.medicines.org.uk/emc/
Asciminib (Scemblix)
Ability to drive, asciminib [2] ---> SmPC of [2] of EMA
It is recommended that patients experiencing dizziness, fatigue or other undesirable effects with a potential impact on the ability to drive or use machines safely should refrain from these activities as long as the undesirable effects persist.
Alfentanyl, asciminib [2] ---> SmPC of [2] of EMA
Caution should be exercised during concomitant administration of asciminib with CYP3A4 substrates known to have a narrow therapeutic index, including. Dose adjustment of asciminib is not required.
Asciminib [1], atorvastatin ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with substrates of OATP1B, BCRP or both transporters, including. No clinical drug interaction study was performed.
Asciminib [1], BCRP substrates ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with substrates of OATP1B, BCRP or both transporters, including. No clinical drug interaction study was performed.
Asciminib [1], bepridil ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes
Asciminib [1], breast-feeding ---> SmPC of [1] of EMA
Because of the potential for serious adverse reactions in the breast-fed newborn/infant, breast-feeding should be discontinued during treatment and for at least 3 days after stopping treatment with asciminib.
Asciminib [1], carbamazepine ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with strong CYP3A4 inducers, which may result in lower efficacy of asciminib.
Asciminib [1], chloroquine ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes
Asciminib [1], clarithromycin ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes
Asciminib [1], colchicine ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with P-gp substrates known to have a narrow therapeutic index, including, but not limited to digoxin, dabigatran and colchicine. Dose adjustment of asciminib is not required.
Asciminib [1], CYP2C9 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with CYP2C9 substrates known to have a narrow therapeutic index, including, but not limited to, phenytoin or warfarin. Dose adjustment of asciminib is not required.
Asciminib [1], CYP3A4 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with CYP3A4 substrates known to have a narrow therapeutic index, including. Dose adjustment of asciminib is not required.
Asciminib [1], dabigatran ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with P-gp substrates known to have a narrow therapeutic index, including, but not limited to digoxin, dabigatran and colchicine. Dose adjustment of asciminib is not required.
Asciminib [1], digoxin ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with P-gp substrates known to have a narrow therapeutic index, including, but not limited to digoxin, dabigatran and colchicine. Dose adjustment of asciminib is not required.
Asciminib [1], dihydroergotamine ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with CYP3A4 substrates known to have a narrow therapeutic index, including. Dose adjustment of asciminib is not required.
Asciminib [1], ergotamine ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with CYP3A4 substrates known to have a narrow therapeutic index, including. Dose adjustment of asciminib is not required.
Asciminib [1], fentanyl ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with CYP3A4 substrates known to have a narrow therapeutic index, including. Dose adjustment of asciminib is not required.
Asciminib [1], fertility ---> SmPC of [1] of EMA
Adverse effects on sperm motility and count were observed in rats at doses of 200 mg/kg/day. The relevance for humans is not known.
Asciminib [1], foods ---> SmPC of [1] of EMA
Food consumption should be avoided for at least 2 hours before and 1 hour after taking asciminib
Asciminib [1], halofantrine ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes
Asciminib [1], haloperidol ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes
Asciminib [1], methadone ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes
Asciminib [1], methotrexate ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with substrates of OATP1B, BCRP or both transporters, including. No clinical drug interaction study was performed.
Asciminib [1], midazolam ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with CYP3A4 substrates known to have a narrow therapeutic index, including. Dose adjustment of asciminib is not required.
Asciminib [1], moxifloxacin ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes
Asciminib [1], P-glycoprotein substrates with small therapeutic index ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with P-gp substrates known to have a narrow therapeutic index, including, but not limited to digoxin, dabigatran and colchicine. Dose adjustment of asciminib is not required.
Asciminib [1], phenobarbital ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with strong CYP3A4 inducers, which may result in lower efficacy of asciminib.
Asciminib [1], phenytoin ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with strong CYP3A4 inducers, which may result in lower efficacy of asciminib.
Asciminib [1], pimozide ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes
Asciminib [1], pitavastatin ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with substrates of OATP1B, BCRP or both transporters, including. No clinical drug interaction study was performed.
Asciminib [1], pravastatine ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with substrates of OATP1B, BCRP or both transporters, including. No clinical drug interaction study was performed.
Asciminib [1], pregnancy ---> SmPC of [1] of EMA
Asciminib is not recommended during pregnancy and in women of childbearing potential not using contraception.
Asciminib [1], pregnancy ---> SmPC of [1] of EMA
The patient should be advised of a potential risk to the foetus if asciminib is used during pregnancy or if the patient becomes pregnant while taking asciminib.
Asciminib [1], rifampicin ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with strong CYP3A4 inducers, which may result in lower efficacy of asciminib.
Asciminib [1], rosuvastatin ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with substrates of OATP1B, BCRP or both transporters, including. No clinical drug interaction study was performed.
Asciminib [1], simvastatine ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with substrates of OATP1B, BCRP or both transporters, including. No clinical drug interaction study was performed.
Asciminib [1], St. John's wort ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with strong CYP3A4 inducers, which may result in lower efficacy of asciminib.
Asciminib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with strong CYP3A4 inducers, which may result in lower efficacy of asciminib.
Asciminib [1], sulfasalazine ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with substrates of OATP1B, BCRP or both transporters, including. No clinical drug interaction study was performed.
Asciminib [1], torsades de pointes inducing drugs ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib and medicinal products with known risk of torsades de pointes
Asciminib [1], warfarin ---> SmPC of [1] of EMA
Caution should be exercised during concomitant administration of asciminib with CYP2C9 substrates known to have a narrow therapeutic index, including, but not limited to, phenytoin or warfarin. Dose adjustment of asciminib is not required.
Asciminib [1], women of childbearing potential ---> SmPC of [1] of EMA
Sexually-active women of childbearing potential should use effective contraception (methods that result in less than 1% pregnancy rates) during treatment with asciminib and for at least 3 days after stopping treatment.
CONTRAINDICATIONS of Asciminib (Scemblix)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf 08/12/2025
Asenapine (Sycrest)
Ability to drive, asenapine [2] ---> SmPC of [2] of EMA
Asenapine may cause somnolence and sedation. Therefore, patients should be cautioned about driving and using machines until they are reasonably certain that Sycrest therapy does not affect them adversely.
Alcohol, asenapine [2] ---> SmPC of [2] of EMA
Patients should be advised to avoid alcohol while taking Sycrest.
Alfa1-adrenergic receptor blockers, asenapine [2] ---> SmPC of [2] of EMA
Because of its alfa1-adrenergic antagonism with potential for inducing orthostatic hypotension (see section 4.4), Sycrest may enhance the effects of certain antihypertensive agents.
Antihypertensives, asenapine [2] ---> SmPC of [2] of EMA
Because of its alfa1-adrenergic antagonism with potential for inducing orthostatic hypotension, asenapine may enhance the effects of certain antihypertensive agents.
Asenapine [1], breast-feeding ---> SmPC of [1] of EMA
Breast-feeding should be discontinued during treatment with Sycrest.
Asenapine [1], centrally acting medicinal products ---> SmPC of [1] of EMA
Given the primary effects of asenapine on the central nervous system (CNS) (see section 4.8), caution should be used when it is taken in combination with other centrally acting medicinal products.
Asenapine [1], CNS depressants ---> SmPC of [1] of EMA
Caution should be used when asenapine is taken in combination with other centrally acting medicinal products.
Asenapine [1], dextromethorphan ---> SmPC of [1] of EMA
Indicative of CYP2D6 inhibition, treatment with asenapine 5 mg twice daily resulted in a fractional decrease in DX/DM ratio to 0.43.
Asenapine [1], dopamine agonists ---> SmPC of [1] of EMA
Asenapine may antagonise the effect of levodopa and dopamine agonists. If this combination is deemed necessary, the lowest effective dose of each treatment should be prescribed.
Asenapine [1], fertility ---> SmPC of [1] of EMA
No impairment of fertility has been observed in nonclinical studies (see section 5.3).
Asenapine [1], fluvoxamine ---> SmPC of [1] of EMA
The CYP1A2 inhibition by fluvoxamine may increase the plasma concentrations of asenapine. The concomitant use should be done with caution
Asenapine [1], foods ---> SmPC of [1] of EMA
To ensure optimal absorption, eating and drinking should be avoided for 10 minutes after administration.
Asenapine [1], imipramine ---> SmPC of [1] of EMA
In a separate study, co-administration of a single 75 mg dose of imipramine with a single 5 mg dose of asenapine did not affect the plasma concentrations of the metabolite desipramine (a CYP2D6 substrate).
Asenapine [1], levodopa ---> SmPC of [1] of EMA
Asenapine may antagonise the effect of levodopa and dopamine agonists. If this combination is deemed necessary, the lowest effective dose of each treatment should be prescribed.
Asenapine [1], paroxetine ---> SmPC of [1] of EMA
In vivo asenapine appears to be at most a weak inhibitor of CYP2D6. However, asenapine may enhance the inhibitory effects of paroxetine on its own metabolism.
Asenapine [1], pharmacokinetics ---> SmPC of [1] of EMA
Except for fluvoxamine, none of the interacting medicinal products resulted in clinically relevant alterations in asenapine pharmacokinetics.
Asenapine [1], pregnancy ---> SmPC of [1] of EMA
Sycrest should not be used during pregnancy unless the clinical condition of the woman requires treatment with asenapine and only if the potential benefit outweighs the potential risk to the foetus.
Asenapine [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Caution should be exercised when Sycrest is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval.
Asenapine [1], substrates and inhibitors for CYP2D6 ---> SmPC of [1] of EMA
Therefore, Sycrest should be co-administered cautiously with medicinal products that are both substrates and inhibitors for CYP2D6.
CONTRAINDICATIONS of Asenapine (Sycrest)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/sycrest-epar-product-information_en.pdf 07/12/2022
Asfotase alfa (Strensiq)
Asfotase alfa [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from asfotase alfa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Asfotase alfa [1], clinical laboratory ---> SmPC of [1] of EMA
The treating physician should inform the testing lab that the patient is treated with medication affecting the ALP levels.
Asfotase alfa [1], detection reagent ---> SmPC of [1] of EMA
Alkaline Phosphatase (ALP) is used as the detection reagent in many routine laboratory assays. If asfotase alfa is present in clinical laboratory samples, aberrant values could be reported.
Asfotase alfa [1], fertility ---> SmPC of [1] of EMA
Preclinical fertility studies were conducted and showed no evidence of effect on fertility and embryo-fetal development (see section 5.3).
Asfotase alfa [1], parathyroid hormone ---> SmPC of [1] of EMA
It is recommended that serum parathyroid hormone and calcium be monitored in patients treated with asfotase alfa.
Asfotase alfa [1], pharmacokinetics ---> SmPC of [1] of EMA
Based on its structure and pharmacokinetics, asfotase alfa is unlikely to affect Cytochrome P-450 related metabolism.
Asfotase alfa [1], pregnancy ---> SmPC of [1] of EMA
Asfotase alfa is not recommended during pregnancy and in women of childbearing potential not using contraception.
Asfotase alfa [1], results ---> SmPC of [1] of EMA
Asfotase alfa activity results must not be interpreted as the same measure as serum alkaline phosphatase activity owing to differences in enzyme characteristics.
CONTRAINDICATIONS of Asfotase alfa (Strensiq)
- Severe or life-threatening hypersensitivity to the active substance or to any of the excipients if hypersensitivity is not controllable (see section 4.4).
https://www.ema.europa.eu/en/documents/product-information/strensiq-epar-product-information_en.pdf 07/02/2024
Asparaginase (Spectrila)
Ability to drive, asparaginase [2] ---> SmPC of [2] of EMA
Spectrila has moderate influence on the ability to drive and use machines, especially through its potential effects on the nervous and gastrointestinal systems
Acetylsalicylic acid, asparaginase [2] ---> SmPC of [2] of EMA
Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4). This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Anticoagulants, asparaginase [2] ---> SmPC of [2] of EMA
Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4). This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Asparaginase [1], breast-feeding ---> SmPC of [1] of EMA
Because potential serious adverse reactions may occur in nursing infants, Spectrila should be discontinued during breast-feeding.
Asparaginase [1], coumarin anticoagulants ---> SmPC of [1] of EMA
Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4). This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Asparaginase [1], cytarabine ---> SmPC of [1] of EMA
The efficacy of high-dose cytarabine is reduced by prior administration of asparaginase. However, when asparaginase was given after cytarabine a synergistic effect was observed.
Asparaginase [1], dipyridamole ---> SmPC of [1] of EMA
Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4). This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Asparaginase [1], fertility ---> SmPC of [1] of EMA
No human data on the effect of asparaginase on fertility are available.
Asparaginase [1], glucocorticoids ---> SmPC of [1] of EMA
Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4). This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Asparaginase [1], heparin ---> SmPC of [1] of EMA
Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4). This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Asparaginase [1], hepatic metabolism ---> SmPC of [1] of EMA
Caution should be exercised in patients receiving other medicinal products metabolised by the liver.
Asparaginase [1], hepatotoxic drugs ---> SmPC of [1] of EMA
Asparaginase may increase the toxicity of other medicinal products through its effect on liver function, e.g. increased hepatotoxicity with potentially hepatotoxic medicines
Asparaginase [1], infection ---> SmPC of [1] of EMA
During treatment with asparaginase-containing regimens, myelosuppression, potentially affecting all three cell lines, and infections can occur.
Asparaginase [1], men ---> SmPC of [1] of EMA
Men should use effective contraceptive measures and be advised to not father a child while receiving asparaginase and for 4 months following completion of treatment.
Asparaginase [1], methotrexate ---> SmPC of [1] of EMA
Inhibition of protein synthesis secondary to the asparaginase-induced depletion of asparagine attenuates the cytotoxic effect of MTX. The antitumour effects of MTX are enhanced when asparaginase is administered 24 hours following MTX treatment.
Asparaginase [1], myelosuppressive agents ---> SmPC of [1] of EMA
During treatment with asparaginase-containing regimens, myelosuppression, potentially affecting all three cell lines, and infections can occur.
Asparaginase [1], NSAID ---> SmPC of [1] of EMA
Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4). This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Asparaginase [1], oral contraceptives ---> SmPC of [1] of EMA
Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe in such clinical situation
Asparaginase [1], pregnancy ---> SmPC of [1] of EMA
Spectrila should not be used during pregnancy unless the clinical condition of the woman requires treatment with asparaginase.
Asparaginase [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA
Concomitant vaccination with live vaccines increases the risk of serious infection. Immunisation with live vaccines should therefore take place at the earliest 3 months after completion of the course of antileukaemic treatment.
Asparaginase [1], vincristine ---> SmPC of [1] of EMA
The toxicity of vincristine may be additive with that of asparaginase if both agents are administered concomitantly. Therefore, vincristine should be given 3 to 24 hours before administration of asparaginase in order to minimise toxicity.
Asparaginase [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential have to use effective contraception and avoid becoming pregnant while being treated with asparaginase-containing chemotherapy and for 7 months following completion of treatment.
Asparaginase [1], women of childbearing potential ---> SmPC of [1] of EMA
A method other than oral contraceptives should be used in women of childbearing potential (see section 4.4).
Asparaginase, imatinib [2] ---> SmPC of [2] of EMA
The combination can be associated with increased hepatotoxicity
Asparaginase, prednisolone
The just before or concomitant treatment with prednisolone increases the risk of anaphylactic reactions
Asparaginase, vindesine
The co-administration may decrease the hepatic clearance of vindesine and cause accumulative toxicity
CONTRAINDICATIONS of Asparaginase (Spectrila)
- Hypersensitivity to the active substance, any native (non-pegylated) E. coli-asparaginase preparation or to any of the excipients listed in section 6.1.
- Pancreatitis.
- Severe hepatic impairment (bilirubin > 3 times upper limit of normal [ULN]; transaminases > 10 times ULN).
- Pre-existing known coagulopathy (e.g. haemophilia).
- History of pancreatitis, serious haemorrhage or serious thrombosis with prior asparaginase therapy.
https://www.ema.europa.eu/en/documents/product-information/spectrila-epar-product-information_en.pdf. 20/11/2023
Ataluren (Translarna)
Ability to drive, ataluren [2] ---> SmPC of [2] of EMA
Patients who experience dizziness should use caution when driving, cycling or using machines.
Aciclovir, ataluren [2] ---> SmPC of [2] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Adefovir, ataluren [2] ---> SmPC of [2] of EMA
In a separate clinical study, the extent of exposure for adefovir was 60% higher in the presence of ataluren. Caution should be exercised when ataluren is co-administered with adefovir.
Aminoglycoside antibiotics, ataluren [2] ---> SmPC of [2] of EMA
These findings suggested that co-administration of Translarna and intravenous aminoglycosides may potentiate the nephrotoxic effect of the aminoglycosides.
Aminoglycoside antibiotics, ataluren [2] ---> SmPC of [2] of EMA
Ataluren should not be co-administered with intravenous aminoglycosides, based on cases of decreased renal function observed in a clinical trial in patients with nmCF (see section 4.3).
Ataluren [1], atorvastatin ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], breast-feeding ---> SmPC of [1] of EMA
A risk to the breastfed new-borns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with ataluren.
Ataluren [1], bumetanide ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], captopril ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], ciprofloxacin ---> SmPC of [1] of EMA
Caution should also be exercised when ataluren is co-administered with OAT3 substrates (e.g. ciprofloxacin), especially those OAT3 substrates with a narrow therapeutic window.
Ataluren [1], corticosteroids ---> SmPC of [1] of EMA
Coadministration of corticosteroids (deflazacort, prednisone, or prednisolone) with ataluren did not affect the plasma concentrations of ataluren.
Ataluren [1], cytochrome P450 ---> SmPC of [1] of EMA
Based on the in vitro studies, ataluren is not expected to be an inhibitor of neither p-gp mediated transport nor of cytochrome P450 mediated metabolism. Similarly, ataluren is not expected in vivo to be an inducer of cytochrome P450 isoenzymes.
Ataluren [1], deflazacort ---> SmPC of [1] of EMA
Coadministration of corticosteroids (deflazacort, prednisone, or prednisolone) with ataluren did not affect the plasma concentrations of ataluren.
Ataluren [1], dehydratation ---> SmPC of [1] of EMA
Dehydration may be a contributing factor in some of these cases. Patients should maintain adequate hydration while taking ataluren (see section 4.4).
Ataluren [1], drugs metabolised by UGT1A9 ---> SmPC of [1] of EMA
Caution should be exercised when ataluren is co-administered with medicinal products that are substrates of UGT1A9 because of the risk of increase concentration of these medicinal products
Ataluren [1], fertility ---> SmPC of [1] of EMA
Non-clinical data revealed no hazard for humans based on a standard male and female fertility study in rats (see section 5.3).
Ataluren [1], furosemide ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], mycophenolate mofetil ---> SmPC of [1] of EMA
Co-administration of ataluren with mycophenolate mofetil in healthy subjects did not affect the exposure of its active metabolite, mycophenolic acid (a substrate of UGT1A9).
Ataluren [1], nephrotoxic substances ---> SmPC of [1] of EMA
Therefore, if treatment with intravenous aminoglycosides is necessary the treatment with Translarna should be stopped and can be resumed 2 days after administration of the aminoglycoside has ended.
Ataluren [1], nonsense mutation ---> SmPC of [1] of EMA
Patients who do not have a nonsense mutation should not receive ataluren.
Ataluren [1], OAT1 substrates ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], OAT3 substrates ---> SmPC of [1] of EMA
Caution should also be exercised when ataluren is co-administered with OAT3 substrates (e.g. ciprofloxacin), especially those OAT3 substrates with a narrow therapeutic window.
Ataluren [1], OATP1B3 substrates ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], oseltamivir ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
Based on the in vitro studies, ataluren is not expected to be an inhibitor of neither p-gp mediated transport nor of cytochrome P450 mediated metabolism.
Ataluren [1], P-gp inhibitors ---> SmPC of [1] of EMA
In vitro, ataluren is not a substrate for the p-glycoprotein transporter. The pharmacokinetics of ataluren are unlikely to be affected by medicinal products that inhibit the p-glycoprotein transporter.
Ataluren [1], pitavastatin ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], pravastatine ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], prednisolone ---> SmPC of [1] of EMA
Coadministration of corticosteroids (deflazacort, prednisone, or prednisolone) with ataluren did not affect the plasma concentrations of ataluren.
Ataluren [1], prednisone ---> SmPC of [1] of EMA
Coadministration of corticosteroids (deflazacort, prednisone, or prednisolone) with ataluren did not affect the plasma concentrations of ataluren.
Ataluren [1], pregnancy ---> SmPC of [1] of EMA
Studies in animals have shown reproductive toxicity only at doses that resulted in maternal toxicity (see section 5.3). As a precautionary measure, it is recommended to avoid the use of ataluren during pregnancy.
Ataluren [1], rifampicin ---> SmPC of [1] of EMA
Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9 (e.g. rifampicin).
Ataluren [1], rosuvastatin ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
Ataluren [1], telmisartan ---> SmPC of [1] of EMA
Ataluren increased the exposure to telmisartan by 28%. This effect is considered clinically not relevant. However, the magnitude of this effect could be larger for the 40 mg dose of telmisartan.
Ataluren [1], UGT1A9 inductors ---> SmPC of [1] of EMA
Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9 (e.g. rifampicin).
Ataluren [1], valsartan ---> SmPC of [1] of EMA
Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products
CONTRAINDICATIONS of Ataluren (Translarna)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Concomitant use of intravenous aminoglycosides
https://www.ema.europa.eu/en/documents/product-information/translarna-epar-product-information_en.pdf 16/04/2025 (withdrawn)
Atazanavir (Reyataz)
Abacavir, atazanavir [2] ---> SmPC of [2] of EMA
The co-administration of atazanavir with abacavir is not expected to significantly alter the exposure of abacavir.
Ability to drive, atazanavir [2] ---> SmPC of [2] of EMA
Patients should be informed that dizziness has been reported during treatment with regimens containing REYATAZ
Ability to drive, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Patients should be informed that dizziness has been reported during treatment with regimens containing atazanavir or cobicistat
Alfuzosin, atazanavir [2] ---> SmPC of [2] of EMA
Potential for increased alfuzosin concentrations which can result in hypotension. The mechanism of interaction is CYP3A4 inhibition by REYATAZ and/or ritonavir. Co-administration of alfuzosin with REYATAZ is contraindicated (see section 4.3)
Alfuzosin, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Amiodarone, atazanavir [2] ---> SmPC of [2] of EMA
Concentrations of these antiarrhythmics may be increased when co-administered with REYATAZ. The mechanism of amiodarone or systemic lidocaine/atazanavir interaction is CYP3A inhibition.
Amiodarone, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Amlodipine, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Antacids, atazanavir [2] ---> SmPC of [2] of EMA
REYATAZ should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Antacids, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids are administered with EVOTAZ. EVOTAZ should be administered 2 hours before or 1 hour after antacids
Apalutamide, atazanavir [2] ---> SmPC of [2] of EMA
Co-administration with REYATAZ (with or without ritonavir) is contraindicated due to the potential for decreased atazanavir and ritonavir plasma concentration with subsequent loss of virologic response
Apixaban, atazanavir [2] ---> SmPC of [2] of EMA
Potential for increased apixaban and rivaroxaban concentrations which can result in a higher risk of bleeding. The mechanism of interaction is inhibition of CYP3A4/and P-gp by REYATAZ/ritonavir.
Astemizole, atazanavir [2] ---> SmPC of [2] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Astemizole, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir [1], atorvastatin ---> SmPC of [1] of EMA
The risk of myopathy including rhabdomyolysis may be increased with atorvastatin, which is metabolised by CYP3A4. Concomitant use is not recommended
Atazanavir [1], avanafil ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Atazanavir [1], bepridil ---> SmPC of [1] of EMA
REYATAZ should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index. Co-administration with bepridil is contraindicated (see section 4.3)
Atazanavir [1], binimetinib ---> SmPC of [1] of EMA
UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.
Atazanavir [1], breast-feeding ---> SmPC of [1] of EMA
Atazanavir has been detected in human milk. In order to avoid transmission of HIV to the infant it is recommended that women living with HIV do not breast-feed their infants.
Atazanavir [1], budesonide ---> SmPC of [1] of EMA
A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g., beclomethasone).
Atazanavir [1], buprenorphine ---> SmPC of [1] of EMA
The mechanism of interaction is CYP3A4 and UGT1A1 inhibition. Concentrations of atazanavir (when given with ritonavir) were not significantly affected.
Atazanavir [1], cabazitaxel ---> SmPC of [1] of EMA
Repeated administration of ketoconazole, a strong CYP3A inhibitor, decreased cabazitaxel clearance. Therefore concomitant administration of strong CYP3A inhibitors should be avoided as an increase of plasma concentrations of cabazitaxel may occur
Atazanavir [1], carbamazepine ---> SmPC of [1] of EMA
REYATAZ may increase plasma levels of carbamazepine due to CYP3A4 inhibition. Due to carbamazepine inducing effect, a reduction on atazanavir/ritonavir exposure cannot be ruled out.
Atazanavir [1], cisapride ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], clarithromycin ---> SmPC of [1] of EMA
A dose reduction of clarithromycin may result in subtherapeutic concentrations of 14-OH clarithromycin. The mechanism of the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Atazanavir [1], clopidogrel ---> SmPC of [1] of EMA
The mechanism of the interaction is CYP3A4 inhibition by atazanavir and or/ritonavir. Co-administration with clopidogrel is not recommended due to potential reduction of the antiplatelet activity of clopidogrel.
Atazanavir [1], corticosteroids metabolized by CYP3A4 ---> SmPC of [1] of EMA
Co-administration with corticosteroids (all routes of administration) that are metabolized by CYP3A, particularly for long-term use, may increase the risk for development of systemic corticosteroid effects including Cushing's syndrome and adrenal suppression
Atazanavir [1], cyclosporine ---> SmPC of [1] of EMA
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ due to CYP3A4 inhibition. More frequent therapeutic concentration monitoring of these medicinal products is recommended until plasma levels have been stabilised
Atazanavir [1], CYP3A4 inductors ---> SmPC of [1] of EMA
Atazanavir is metabolised principally by CYP3A4. Co-administration of REYATAZ and medicinal products that induce CYP3A4 is not recommended
Atazanavir [1], dabigatran ---> SmPC of [1] of EMA
Potential for increased dabigatran concentrations which can result in a higher risk of bleeding. The mechanism of interaction is P-gp inhibition. Co-administration of dabigatran and REYATAZ with ritonavir is not recommended.
Atazanavir [1], dexamethasone ---> SmPC of [1] of EMA
Co-administration with corticosteroids (all routes of administration) that are metabolized by CYP3A, particularly for long-term use, may increase the risk for development of systemic corticosteroid effects including Cushing's syndrome and adrenal suppression
Atazanavir [1], didanosine ---> SmPC of [1] of EMA
No significant effect on atazanavir concentrations was observed when administered with enteric-coated didanosine, but administration with food decreased didanosine concentrations.
Atazanavir [1], didanosine/stavudine ---> SmPC of [1] of EMA
Didanosine should be taken at the fasted state 2 hours after REYATAZ taken with food. The co-administration of REYATAZ with stavudine is not expected to significantly alter the exposure of stavudine.
Atazanavir [1], dihydroergotamine ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], diltiazem ---> SmPC of [1] of EMA
The mechanism of diltiazem/atazanavir interaction is CYP3A4 inhibition. An initial dose reduction of diltiazem by 50% is recommended, with subsequent titration as needed and ECG monitoring.
Atazanavir [1], drugs inducing bradycardia ---> SmPC of [1] of EMA
Particular caution should be used when prescribing atazanavir to patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances)
Atazanavir [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], edoxaban ---> SmPC of [1] of EMA
Potential for increased edoxaban concentrations which can result in a higher risk of bleeding. The mechanism of interaction is P-gp inhibition by REYATAZ/ritonavir. Exercise caution when edoxaban is used with REYATAZ.
Atazanavir [1], efavirenz ---> SmPC of [1] of EMA
The mechanism of efavirenz/atazanavir interaction is CYP3A4 induction. Co-administration of efavirenz and REYATAZ is not recommended
Atazanavir [1], elagolix ---> SmPC of [1] of EMA
Concomitant use of elagolix 200 mg twice daily with REYATAZ (with or without ritonavir) for more than 1 month is not recommended due to the potential risk of adverse events such as bone loss and hepatic transaminase elevations.
Atazanavir [1], electrolyte imbalance ---> SmPC of [1] of EMA
Particular caution should be used when prescribing atazanavir to patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances)
Atazanavir [1], encorafenib ---> SmPC of [1] of EMA
Avoid co-administration of encorafenib with REYATAZ (with or without ritonavir) due to potential for increase in encorafenib plasma concentration and subsequent risk of serious adverse events such as QT interval prolongation.
Atazanavir [1], ergonovine ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], ergot derivatives ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], ergot derivatives ---> SmPC of [1] of EMA
Atazanavir, strong CYP3A4 inhibitor, may increase the plasma concentrations of the ergot derivate. Increased risk of ergotism. The concomitant use should be avoided
Atazanavir [1], ergotamine ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], ethinyl estradiol ---> SmPC of [1] of EMA
The UGT and CYP3A4 inhibition by atazanavir increased the concentration of ethinyloestradiol
Atazanavir [1], ethinylestradiol/norgestimate ---> SmPC of [1] of EMA
If an oral contraceptive is administered with REYATAZ/ritonavir, it is recommended that the oral contraceptive contain at least 30 µg of ethinyloestradiol and that the patient be reminded of strict compliance with this contraceptive dosing regimen.
Atazanavir [1], famotidine ---> SmPC of [1] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2-blockers.
Atazanavir [1], fertility ---> SmPC of [1] of EMA
In a nonclinical fertility and early embryonic development study in rats, atazanavir altered oestrus cycling with no effects on mating or fertility (see section 5.3).
Atazanavir [1], fluconazole ---> SmPC of [1] of EMA
Atazanavir and fluconazole concentrations were not significantly modified when REYATAZ/ritonavir was co-administered with fluconazole. No dosage adjustments are needed for fluconazole and REYATAZ.
Atazanavir [1], fluticasone furoate ---> SmPC of [1] of EMA
A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g., beclomethasone).
Atazanavir [1], fluvastatin ---> SmPC of [1] of EMA
Caution should be exercised.
Atazanavir [1], foods ---> SmPC of [1] of EMA
To enhance bioavailability and minimise variability, REYATAZ is to be taken with food.
Atazanavir [1], fostamatinib ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with REYATAZ may increase the plasma concentration of R406, the active metabolite of fostamatinib. Monitor for toxicities of R406 exposure resulting in dose-related adverse events
Atazanavir [1], gastric pH ---> SmPC of [1] of EMA
The absorption of atazanavir may be reduced in situations where gastric pH is increased irrespective of cause.
Atazanavir [1], grazoprevir ---> SmPC of [1] of EMA
Co-administration of REYATAZ with grazoprevir-containing products is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations
Atazanavir [1], irinotecan ---> SmPC of [1] of EMA
Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities. If REYATAZ is co-administered with irinotecan, patients should be closely monitored for adverse events related to irinotecan.
Atazanavir [1], ivosidenib ---> SmPC of [1] of EMA
Avoid co-administration of ivosidenib with REYATAZ (with or without ritonavir) due to potential for increase in ivosidenib plasma concentration and subsequent risk of serious adverse events such as QT interval prolongation.
Atazanavir [1], ketoconazole ---> SmPC of [1] of EMA
Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4. Ketoconazole and itraconazole should be used cautiously with REYATAZ/ritonavir, high doses of ketoconazole and itraconazole (> 200 mg/day) are not recommended.
Atazanavir [1], lamivudine/zidovudine ---> SmPC of [1] of EMA
The coadministration of these medicinal products and REYATAZ is not expected to significantly alter the exposure of the co-administered medicinal products.
Atazanavir [1], lamotrigine ---> SmPC of [1] of EMA
Co-administration of lamotrigine and REYATAZ/ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction. Lamotrigine should be used with caution in combination with REYATAZ/ritonavir.
Atazanavir [1], lidocaine ---> SmPC of [1] of EMA
Concentrations of these antiarrhythmics may be increased when co-administered with REYATAZ. The mechanism of amiodarone or systemic lidocaine/atazanavir interaction is CYP3A inhibition.
Atazanavir [1], lomitapide ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], lovastatine ---> SmPC of [1] of EMA
Co-administration of simvastatin or lovastatin with atazanavir is contraindicated due to an increased risk of myopathy including rhabdomyolysis.
Atazanavir [1], lovastatine ---> SmPC of [1] of EMA
Co-administration of simvastatin or lovastatin with REYATAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Atazanavir [1], lurasidone ---> SmPC of [1] of EMA
REYATAZ is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition. Co-administration of lurasidone with REYATAZ is contraindicated as this may increase lurasidone-related toxicity (see section 4.3).
Atazanavir [1], methadone ---> SmPC of [1] of EMA
No significant effect on methadone concentrations was observed. No dosage adjustment necessary.
Atazanavir [1], methylergonovine ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], midazolam ---> SmPC of [1] of EMA
Midazolam is extensively metabolized by CYP3A4. Co-administration with REYATAZ may cause a large increase in the concentration of midazolam. Co-administration of REYATAZ with orally administered midazolam is contraindicated
Atazanavir [1], nevirapine ---> SmPC of [1] of EMA
The mechanism of nevirapine/atazanavir interaction is CYP3A4 induction. Co-administration of nevirapine and REYATAZ is not recommended
Atazanavir [1], oral contraceptives ---> SmPC of [1] of EMA
Co-administration of REYATAZ with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate or norethindrone has not been studied, and therefore should be avoided
Atazanavir [1], PDE5 inhibitors ---> SmPC of [1] of EMA
Coadministration with REYATAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5- associated adverse events, including hypotension, visual changes, and priapism.
Atazanavir [1], phenobarbital ---> SmPC of [1] of EMA
Due to phenytoin/phenobarbital inducing effect, a reduction in REYATAZ exposure cannot be ruled out. Phenobarbital and phenytoin should be used with caution in combination with REYATAZ/ritonavir.
Atazanavir [1], phenytoin ---> SmPC of [1] of EMA
Due to phenytoin/phenobarbital inducing effect, a reduction in REYATAZ exposure cannot be ruled out. Phenobarbital and phenytoin should be used with caution in combination with REYATAZ/ritonavir.
Atazanavir [1], pimozide ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], PR interval prolonging drugs ---> SmPC of [1] of EMA
The combination of atazanavir with medicinal products known to prolong the PR interval should be used with caution
Atazanavir [1], prasugrel ---> SmPC of [1] of EMA
The mechanism of the interaction is CYP3A4 inhibition by atazanavir and or/ritonavir. No dose adjustment is needed when prasugrel is co-administered with REYATAZ (with or without ritonavir).
Atazanavir [1], pravastatine ---> SmPC of [1] of EMA
Caution should be exercised.
Atazanavir [1], pregnancy ---> SmPC of [1] of EMA
The use of REYATAZ with ritonavir may be considered during pregnancy only if the potential benefit justifies the potential risk.
Atazanavir [1], protease inhibitors ---> SmPC of [1] of EMA
The co-administration of REYATAZ/ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors. Therefore, such co-administration is not recommended.
Atazanavir [1], proton pump inhibitors ---> SmPC of [1] of EMA
This decrease in atazanavir exposure might negatively impact the efficacy of atazanavir. The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
Atazanavir [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Particular caution should be used when prescribing atazanavir in association with medicinal products which have the potential to increase the QT interval
Atazanavir [1], quetiapine ---> SmPC of [1] of EMA
Co-administration of quetiapine with REYATAZ is contraindicated as REYATAZ may increase quetiapine-related toxicity. Increased plasma concentrations of quetiapine may lead to coma (see section 4.3).
Atazanavir [1], quetiapine ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], quinidine ---> SmPC of [1] of EMA
Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ.
Atazanavir [1], raltegravir ---> SmPC of [1] of EMA
The mechanism is UGT1A1 inhibition. No dose adjustment required for raltegravir.
Atazanavir [1], rifabutin ---> SmPC of [1] of EMA
In previous studies, the pharmacokinetics of atazanavir was not altered by rifabutin. No dose adjustment is needed for REYATAZ.
Atazanavir [1], rifampicin ---> SmPC of [1] of EMA
Rifampicin is a strong CYP3A4 inducer and has been shown to cause a 72% decrease in atazanavir AUC which can result in virological failure and resistance development. The combination is contraindicated
Atazanavir [1], ritonavir ---> SmPC of [1] of EMA
The mechanism of interaction between atazanavir and ritonavir is CYP3A4 inhibition. Ritonavir 100 mg once daily is used as a booster of atazanavir pharmacokinetics.
Atazanavir [1], rivaroxaban ---> SmPC of [1] of EMA
Potential for increased apixaban and rivaroxaban concentrations which can result in a higher risk of bleeding. The mechanism of interaction is inhibition of CYP3A4/and P-gp by REYATAZ/ritonavir.
Atazanavir [1], salmeterol ---> SmPC of [1] of EMA
Co-administration with REYATAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events. The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or ritonavir.
Atazanavir [1], sildenafil ---> SmPC of [1] of EMA
Coadministration with REYATAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5- associated adverse events, including hypotension, visual changes, and priapism.
Atazanavir [1], simvastatine ---> SmPC of [1] of EMA
Co-administration of simvastatin or lovastatin with REYATAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Atazanavir [1], sirolimus ---> SmPC of [1] of EMA
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ due to CYP3A4 inhibition. More frequent therapeutic concentration monitoring of these medicinal products is recommended until plasma levels have been stabilised
Atazanavir [1], St. John's wort ---> SmPC of [1] of EMA
Concomitant use of St. John's wort (CYP3A4 induction) with atazanavir may be expected to result in significant reduction in atazanavir plasma levels. Co-administration is contraindicated.
Atazanavir [1], tacrolimus ---> SmPC of [1] of EMA
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ due to CYP3A4 inhibition. More frequent therapeutic concentration monitoring of these medicinal products is recommended until plasma levels have been stabilised
Atazanavir [1], tadalafil ---> SmPC of [1] of EMA
Coadministration with REYATAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5- associated adverse events, including hypotension, visual changes, and priapism.
Atazanavir [1], terfenadine ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], triazolam ---> SmPC of [1] of EMA
Atazanavir is metabolised in the liver through CYP3A4. It inhibits CYP3A4. Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index
Atazanavir [1], vardenafil ---> SmPC of [1] of EMA
Coadministration with REYATAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5- associated adverse events, including hypotension, visual changes, and priapism.
Atazanavir [1], verapamil ---> SmPC of [1] of EMA
The co-administration of atazanavir (CYP3A4 inhibitor) may increase the plasma concentrations of verapamil. Caution is warranted
Atazanavir [1], voriconazole ---> SmPC of [1] of EMA
In the majority of patients, a reduction in both voriconazole and atazanavir exposures are expected. In a small number of patients without a functional CYP2C19 allele, significantly increased voriconazole exposures are expected
Atazanavir [1], warfarin ---> SmPC of [1] of EMA
Possible increased or decreased of the INR. It is recommended that the INR be monitored carefully during treatment
Atazanavir, axitinib [2] ---> SmPC of [2] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Atazanavir, bictegravir/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Co-administration is not recommended.
Atazanavir, bosentan
Bosentan is metabolised by CYP2C9 and CYP3A4. Inhibition of these isoenzymes may increase the plasma concentration of bosentan. The combination should be used with caution.
Atazanavir, bosutinib [2] ---> SmPC of [2] of EMA
The concomitant use of bosutinib with moderate CYP3A inhibitors should be avoided, as an increase in bosutinib plasma levels will occur. Selection of an alternate concomitant medicine with no or minimal CYP3A enzyme inhibition potential is recommended.
Atazanavir, cabotegravir [2] ---> SmPC of [2] of EMA
No dosing adjustments for Vocabria are, therefore, recommended in the presence of UGT1A1 inhibitors (e.g. atazanavir, erlotinib, sorafenib).
Atazanavir, cimetidine [2] ---> SmPC of [2] of eMC
Cimetidine increases the pH und the absorption of atazanavir.
Atazanavir, clomipramine
Atazanavir may increase the effect and toxicity of the clomipramine
Atazanavir, cobicistat [2] ---> SmPC of [2] of EMA
Cobicistat is a strong mechanism-based CYP3A inhibitor. Increased plasma concentrations of medicinal products that are metabolised by CYP3A (including atazanavir and darunavir) are observed on co-administration with cobicistat.
Atazanavir, colchicine [2] ---> SmPC of [2] of eMC
Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a strong CYP3A4 inhibitor
Atazanavir, crizotinib [2] ---> SmPC of [2] of EMA
Coadministration of crizotinib with strong CYP3A inhibitors may increase crizotinib plasma concentrations. Therefore, the concomitant use of strong CYP3A inhibitors should be avoided.
Atazanavir, dabrafenib [2] ---> SmPC of [2] of EMA
Dabrafenib is a substrate for the metabolising enzymes CYP3A4. Medicines that are strong inhibitors of CYP3A4 are therefore likely to increase dabrafenib concentrations. Use caution if strong inhibitors are coadministered with dabrafenib.
Atazanavir, dapoxetine [2] ---> SmPC of [2] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of dapoxetine. Concomitant use of dapoxetine and potent CYP3A4 inhibitors is contraindicated
Atazanavir, darunavir/ritonavir ---> SmPC of [darunavir] of EMA
The combination can be used without dose adjustments.
Atazanavir, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SmPC of [dasabuvir] of EMA
Atazanavir can be used in combination with dasabuvir with ombitasvir/paritaprevir/ritonavir if administered at the same time. To be noted, atazanavir should be taken without ritonavir
Atazanavir, dextromethorphan/quinidine [2] ---> SmPC of [2] of EMA
Concomitant administration of medicines that inhibit CYP3A4 can be expected to increase plasma levels of quinidine, which could increase risk relating to QTc prolongation. Strong and moderate CYP3A4 inhibitors should be avoided during treatment.
Atazanavir, dolutegravir [2] ---> SmPC of [2] of EMA
Increased dolutegravir plasma levels. No dosage adjustment necessary. (Inhibition of UGT1A1 and CYP3A enzymes)
Atazanavir, dolutegravir/abacavir/lamivudine [2] ---> SmPC of [2] of EMA
Increased dolutegravir plasma levels. No dosage adjustment necessary. (Inhibition of UGT1A1 and CYP3A enzymes)
Atazanavir, dolutegravir/lamivudine [2] ---> SmPC of [2] of EMA
No dose adjustment is necessary.
Atazanavir, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA
Co-administration of REYATAZ with grazoprevir-containing products is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations
Atazanavir, eliglustat [2] ---> SmPC of [2] of EMA
It is predicted that concomitant use of moderate CYP3A inhibitors would increase eliglustat exposure approximately up to 3-fold. Caution should be used with moderate CYP3A inhibitors in intermediate and extensive metabolisers.
Atazanavir, eluxadoline [2] ---> SmPC of [2] of EMA
Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products
Atazanavir, eravacycline [2] ---> SmPC of [2] of EMA
A drug-drug interaction in vivo cannot be excluded and co-administration of eravacycline and other medicinal products that inhibit gp-P, OATP1B1 y OATP1B3 transporters may increase the eravacycline plasma concentration.
Atazanavir, esomeprazole [2] ---> SmPC of [2] of EMA
For atazanavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended.
Atazanavir, everolimus [2] ---> SmPC of [2] of EMA
Large increase in everolimus concentration is expected. Concomitant treatment of everolimus and potent CYP3A4 inhibitors is not recommended.
Atazanavir, ezetimibe/atorvastatin [2] ---> SmPC of [2] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Coadministration of potent CYP3A4 inhibitors should be avoided if possible.
Atazanavir, fesoterodine [2] ---> SmPC of [2] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Atazanavir, flunitrazepam
The strong CYP3A4 inhibition may increase the plasma concentrations of flunitrazepam
Atazanavir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
No dosage adjustment necessary.
Atazanavir, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA
Co-administration of REYATAZ with glecaprevir/pibrentasvir is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3)
Atazanavir, guanfacin [2] ---> SmPC of [2] of EMA
Co-administration of Intuniv with moderate and strong CYP3A4/5 inhibitors elevates plasma guanfacine concentrations and increases the risk of adverse reactions such as hypotension, bradycardia, and sedation.
Atazanavir, ibrutinib [2] ---> SmPC of [2] of EMA
Ibrutinib is primarily metabolised by cytochrome P450 enzyme 3A4. Concomitant use of ibrutinib and medicinal products that moderately inhibit CYP3A4 can increase ibrutinib exposure and should be avoided.
Atazanavir, indinavir [2] ---> SmPC of [2] of EMA
Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT. Co-administration of REYATAZ and indinavir is not recommended (see section 4.4).
Atazanavir, ixabepilone
The strong CYP3A4 inhibition may increase the plasma concentrations of ixabepilone. The coadministration should be avoided
Atazanavir, lamivudine/raltegravir [2] ---> SmPC of [2] of EMA
Co-administration of lamivudine/raltegravir with medicinal products that are known to be potent UGT1A1 inhibitors (e.g., atazanavir) may increase plasma levels of raltegravir.
Atazanavir, lansoprazole [2] ---> SmPC of [2] of eMC
A study has shown that co-administration of lansoprazole with atazanavir to healthy volunteers resulted in a substantial reduction in atazanavir exposure. Lansoprazole should not be co-administered with atazanavir
Atazanavir, larotrectinib [2] ---> SmPC of [2] of EMA
Larotrectinib is a substrate of cytochrome P450 (CYP) 3A, P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Co-administration of VITRAKVI with strong CYP3A inhibitors, P-gp and BCRP inhibitors may increase larotrectinib plasma levels
Atazanavir, letermovir [2] ---> SmPC of [2] of EMA
Co-administration of PREVYMIS with medicinal products that are inhibitors of OATP1B1/3 transporters may result in increased letermovir plasma concentrations.
Atazanavir, maraviroc [2] ---> SmPC of [2] of EMA
The CYP3A4 inhibition may increase the AUC of maraviroc. Dose adjustment of maraviroc is recommended
Atazanavir, naproxen/esomeprazole [2] ---> SmPC of [2] of eMC
Naproxen/esomeprazole must not be used concomitantly with atazanavir
Atazanavir, neratinib [2] ---> SmPC of [2] of EMA
Concomitant use of strong CYP3A4/Pgp inhibitors should be avoided.
Atazanavir, pantoprazole [2] ---> SmPC of [2] of EMA
The co-administration may cause a substantial reduction in the bioavailability of atazanavir. The combination is contraindicated.
Atazanavir, pazopanib [2] ---> SmPC of [2] of EMA
Concomitant treatment with strong inhibitors of CYP3A4 should be avoided due to risk of increased exposure to pazopanib
Atazanavir, piperaquine/artenimol [2] ---> SmPC of [2] of EMA
Concomitant treatment with medicinal products which inhibit CYP3A4 may lead to a marked increase of piperaquine plasma concentration resulting in an exacerbation of the effect on QTc
Atazanavir, posaconazole [2] ---> SmPC of [2] of EMA
Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during co- administration with posaconazole.
Atazanavir, rabeprazole [2] ---> SmPC of [2] of eMC
Co-administration of atazanavir with rabeprazole is not recommended
Atazanavir, raltegravir
Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4. Ketoconazole and itraconazole should be used cautiously with REYATAZ/ritonavir, high doses of ketoconazole and itraconazole (> 200 mg/day) are not recommended.
Atazanavir, rilpivirine [2] ---> SmPC of [2] of EMA
Not studied. Increased exposure (inhibition of CYP3A enzymes) of rilpivirine is expected. No dose adjustment is required.
Atazanavir, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA
Increased ritonavir and saquinavir plasma concentrations. Contraindicated due to the potential for life threatening cardiac arrhythmia
Atazanavir, simeprevir [2] ---> SmPC of [2] of EMA
The CYP3A4 enzyme induction or inhibition may alter plasma concentrations of simeprevir. It is not recommended to co-administer simeprevir with any HIV PI, with or without ritonavir.
Atazanavir, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SmPC of [2] of EMA
Co-administration of REYATAZ with voxilaprevir-containing products is expected to increase the concentration of voxilaprevir. Coadministration of REYATAZ with voxilaprevir-containing regimens is not recommended.
Atazanavir, tenofovir disoproxil [2] ---> SmPC of [2] of EMA
Patients should be closely monitored for tenofovir disoproxil fumarate-associated adverse reactions, including renal disorders.
Atazanavir, ticagrelor [2] ---> SmPC of [2] of EMA
The mechanism of the interaction is CYP3A4 inhibition by atazanavir and/or ritonavir. Co-administration of REYATAZ with ticagrelor is not recommended due to potential increase in the antiplatelet activity of ticagrelor.
Atazanavir, trastuzumab emtansine [2] ---> SmPC of [2] of EMA
Concomitant use of strong CYP3A4 inhibitors with trastuzumab emtansine should be avoided due to the potential for an increase in DM1 exposure and toxicity.
Atazanavir, vemurafenib [2] ---> SmPC of [2] of EMA
Vemurafenib should be used with caution in combination with potent inhibitors of CYP3A4, glucuronidation and/or transport proteins
Atazanavir, venlafaxine [2] ---> SmPC of [2] of eMC
Concomitant use of CYP3A4 inhibitors and venlafaxine may increase levels of venlafaxine and O-desmethylvenlafaxine. Therefore, caution is advised if a patient's therapy includes a CYP3A4 inhibitor and venlafaxine concomitantly.
Atazanavir/cobicistat [1], atorvastatin ---> SmPC of [1] of EMA
The risk of myopathy including rhabdomyolysis may be increased with atorvastatin, which is metabolised by CYP3A4. Co-administration of atorvastatin with EVOTAZ is not recommended.
Atazanavir/cobicistat [1], avanafil ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], BCRP substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], bepridil ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], betamethasone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], boceprevir ---> SmPC of [1] of EMA
Coadministration (not recommended) of EVOTAZ with moderate to weak inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir
Atazanavir/cobicistat [1], bosentan ---> SmPC of [1] of EMA
Coadministration (not recommended) of EVOTAZ with moderate to weak inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir
Atazanavir/cobicistat [1], breast-feeding ---> SmPC of [1] of EMA
Because of both the potential for HIV transmission and the potential for serious adverse reactions in breastfeeding infants, women should be instructed not to breast-feed if they are receiving EVOTAZ.
Atazanavir/cobicistat [1], budesonide ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], buprenorphine ---> SmPC of [1] of EMA
Concomitant use may increase buprenorphine exposition. The mechanism of interaction is CYP3A4 and UGT1A1 inhibition by atazanavir. Co-administration warrants clinical monitoring for sedation and cognitive effects.
Atazanavir/cobicistat [1], buprenorphine/naloxone ---> SmPC of [1] of EMA
Concomitant use may increase buprenorphine exposition. The mechanism of interaction is CYP3A4 inhibition by cobicistat. Co-administration warrants clinical monitoring for sedation and cognitive effects.
Atazanavir/cobicistat [1], buspirone ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], carbamazepine ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], cisapride ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], clarithromycin ---> SmPC of [1] of EMA
Clarithromycin may increase atazanavir and cobicistat concentrations. Exposure to clarithromycin is expected to increase if co-administered with EVOTAZ. The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or cobicistat and clarithromycin.
Atazanavir/cobicistat [1], clorazepate ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], cobicistat ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products containing ritonavir or cobicistat, which are strong inhibitors of CYP3A, may result in additional boosting and increased plasma concentration of atazanavir. Concomitant use not recommended
Atazanavir/cobicistat [1], colchicine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], corticosteroids primarily metabolised by CYP3A ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], cyclosporine ---> SmPC of [1] of EMA
Concentrations of the immunosuppressant may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Atazanavir/cobicistat [1], CYP3A4 inductors ---> SmPC of [1] of EMA
Coadministration (not recommended) of EVOTAZ with moderate to weak inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir
Atazanavir/cobicistat [1], CYP3A4 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], dabigatran ---> SmPC of [1] of EMA
Concentrations of dabigatran may be affected upon coadministration with EVOTAZ. The mechanism of interaction is P-gp inhibition by atazanavir and cobicistat. Clinical monitoring is recommended when dabigatran is co-administered with P-gp inhibitors.
Atazanavir/cobicistat [1], dasatinib ---> SmPC of [1] of EMA
Concentrations of the antineoplastic may be increased when coadministered with EVOTAZ resulting in the potential for increased adverse events. The mechanism of interaction is CYP3A4 inhibition by cobicistat.
Atazanavir/cobicistat [1], diazepam ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], didanosine ---> SmPC of [1] of EMA
No significant effect on atazanavir concentrations was observed when administered with enteric-coated didanosine, but administration with food decreased didanosine concentrations.
Atazanavir/cobicistat [1], didanosine/stavudine ---> SmPC of [1] of EMA
Didanosine should be taken in the fasted state 2 hours after EVOTAZ taken with food. The coadministration of EVOTAZ with stavudine is not expected to significantly alter the exposure of stavudine.
Atazanavir/cobicistat [1], digoxin ---> SmPC of [1] of EMA
Plasma concentrations of digoxin may be increased when coadministered with EVOTAZ. The mechanism of interaction is inhibition of P-gp by cobicistat. The lowest dose of digoxin should initially be prescribed.
Atazanavir/cobicistat [1], dihydroergotamine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], diltiazem ---> SmPC of [1] of EMA
Exposure to diltiazem is increased when diltiazem is coadministered with atazanavir, a component of EVOTAZ. An initial dose reduction of diltiazem by 50% should be considered, and electrocardiogram monitoring is recommended.
Atazanavir/cobicistat [1], disopyramide ---> SmPC of [1] of EMA
Concentrations of the antiarrhythmic may be increased when co-administered with EVOTAZ. The mechanism is CYP3A inhibition by atazanavir and cobicistat. Co-administration has the potential to produce serious and/or life-threatening adverse reactions.
Atazanavir/cobicistat [1], dolutegravir ---> SmPC of [1] of EMA
Co-administration with EVOTAZ is expected to increase dolutegravir plasma concentrations. The mechanism of interaction is inhibition of UGT1A1 by atazanavir. EVOTAZ and dolutegravir can be used without dose adjustments.
Atazanavir/cobicistat [1], dronedarone ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], drugs inducing bradycardia ---> SmPC of [1] of EMA
Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors
Atazanavir/cobicistat [1], drugs primarily metabolised by CYP2C8 ---> SmPC of [1] of EMA
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Atazanavir/cobicistat [1], drugs primarily metabolised by CYP2D6 ---> SmPC of [1] of EMA
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Atazanavir/cobicistat [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Atazanavir/cobicistat [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], drugs primarily metabolised by UGT1A1 ---> SmPC of [1] of EMA
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Atazanavir/cobicistat [1], efavirenz ---> SmPC of [1] of EMA
Coadministration (not recommended) of EVOTAZ with moderate to weak inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir
Atazanavir/cobicistat [1], electrolyte imbalance ---> SmPC of [1] of EMA
Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors
Atazanavir/cobicistat [1], ergometrine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], ergot derivatives ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], ergotamine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], estazolam ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], etravirine ---> SmPC of [1] of EMA
Coadministration (not recommended) of EVOTAZ with moderate to weak inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir
Atazanavir/cobicistat [1], famotidine ---> SmPC of [1] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2 blockers. It is not recommended to co-administer EVOTAZ with an H2-receptor antagonist.
Atazanavir/cobicistat [1], felodipine ---> SmPC of [1] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Atazanavir/cobicistat [1], flecainide ---> SmPC of [1] of EMA
Concentrations of the antiarrhythmic may be increased when co-administered with EVOTAZ. The mechanism is CYP3A inhibition by atazanavir and cobicistat. Co-administration has the potential to produce serious and/or life-threatening adverse reactions.
Atazanavir/cobicistat [1], fluconazole ---> SmPC of [1] of EMA
Concentration of fluconazole may be increased if co-administered with cobicistat. Clinical monitoring is recommended upon coadministration with EVOTAZ.
Atazanavir/cobicistat [1], flurazepam ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], fluticasone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal
Atazanavir/cobicistat [1], fluvastatin ---> SmPC of [1] of EMA
There is a potential for an increase in fluvastatin exposure when co-administered with protease inhibitors. Caution should be exercised.
Atazanavir/cobicistat [1], foods ---> SmPC of [1] of EMA
To enhance bioavailability, EVOTAZ is to be taken with food.
Atazanavir/cobicistat [1], glucocorticoids metabolized by CYP3A4 ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal
Atazanavir/cobicistat [1], H2 antagonists ---> SmPC of [1] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2 blockers. It is not recommended to co-administer EVOTAZ with an H2-receptor antagonist.
Atazanavir/cobicistat [1], hormonal contraceptives ---> SmPC of [1] of EMA
Co-administration of EVOTAZ and hormonal contraceptives should be avoided. An alternate (non-hormonal) reliable method of contraception is recommended.
Atazanavir/cobicistat [1], indinavir ---> SmPC of [1] of EMA
Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT. Co-administration of EVOTAZ and indinavir is not recommended
Atazanavir/cobicistat [1], irinotecan ---> SmPC of [1] of EMA
Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities. If EVOTAZ is co-administered with irinotecan, patients should be closely monitored for adverse reactions related to irinotecan.
Atazanavir/cobicistat [1], itraconazol ---> SmPC of [1] of EMA
Itraconazole is a potent inhibitor and a substrate of CYP3A4. Itraconazole, and/or cobicistat levels may be increased with coadministration of itraconazole with EVOTAZ. The mechanism is CYP3A4 inhibition by atazanavir, cobicistat and itraconazole.
Atazanavir/cobicistat [1], ketoconazole ---> SmPC of [1] of EMA
Ketoconazole is a potent inhibitor and a substrate of CYP3A4. Ketoconazole, and/or cobicistat levels may be increased with coadministration of ketoconazole with EVOTAZ. The mechanism is CYP3A4 inhibition by atazanavir, cobicistat and ketoconazole.
Atazanavir/cobicistat [1], lamivudine/zidovudine ---> SmPC of [1] of EMA
No significant effect on lamivudine and zidovudine concentrations was observed when co-administered with atazanavir.
Atazanavir/cobicistat [1], lidocaine ---> SmPC of [1] of EMA
Systemic lidocaine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by EVOTAZ
Atazanavir/cobicistat [1], lovastatine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], maraviroc ---> SmPC of [1] of EMA
Maraviroc is a substrate of CYP3A and its plasma concentration increases when coadministered with potent CYP3A inhibitors. The mechanism of interaction is CYP3A4 inhibition by atazanavir and cobicistat.
Atazanavir/cobicistat [1], MATE1 substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], metformin ---> SmPC of [1] of EMA
Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with EVOTAZ. Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking EVOTAZ.
Atazanavir/cobicistat [1], methadone ---> SmPC of [1] of EMA
No dosage adjustment is necessary if methadone is co-administered with EVOTAZ.
Atazanavir/cobicistat [1], methylergonovine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], metoprolol ---> SmPC of [1] of EMA
Concentrations of the beta-blocker may be increased when coadministered with EVOTAZ. The mechanism of interaction is inhibition of CYP2D6 by cobicistat. A dose reduction of the beta-blocker may be necessary.
Atazanavir/cobicistat [1], mexiletine ---> SmPC of [1] of EMA
Concentrations of the antiarrhythmic may be increased when co-administered with EVOTAZ. The mechanism is CYP3A inhibition by atazanavir and cobicistat. Co-administration has the potential to produce serious and/or life-threatening adverse reactions.
Atazanavir/cobicistat [1], midazolam ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA
Coadministration (not recommended) of EVOTAZ with moderate to weak inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir
Atazanavir/cobicistat [1], mometasone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], neuroleptics ---> SmPC of [1] of EMA
Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics. The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat
Atazanavir/cobicistat [1], nevirapine ---> SmPC of [1] of EMA
Coadministration (not recommended) of EVOTAZ with moderate to weak inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir
Atazanavir/cobicistat [1], nicardipine ---> SmPC of [1] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Atazanavir/cobicistat [1], nifedipine ---> SmPC of [1] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Atazanavir/cobicistat [1], nilotinib ---> SmPC of [1] of EMA
Concentrations of the antineoplastic may be increased when coadministered with EVOTAZ resulting in the potential for increased adverse events. The mechanism of interaction is CYP3A4 inhibition by cobicistat.
Atazanavir/cobicistat [1], OATP1B1 substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], OATP1B3 substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], omeprazole ---> SmPC of [1] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors. Co-administration of EVOTAZ with proton pump inhibitors is not recommended.
Atazanavir/cobicistat [1], oral contraceptives ---> SmPC of [1] of EMA
Co-administration of EVOTAZ and hormonal contraceptives should be avoided. An alternate (non-hormonal) reliable method of contraception is recommended.
Atazanavir/cobicistat [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], PDE5 inhibitors ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with PDE5-inhibitors is expected to substantially increase their concentrations and may result in PDE5-associated adverse reactions such as hypotension, visual changes and priapism
Atazanavir/cobicistat [1], perphenazine ---> SmPC of [1] of EMA
Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics. The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat
Atazanavir/cobicistat [1], phenobarbital ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], phenytoin ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], pimozide ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], pitavastatin ---> SmPC of [1] of EMA
Plasma concentrations of pitavastatin may be increased if co-administered with EVOTAZ. Caution should be exercised.
Atazanavir/cobicistat [1], pravastatine ---> SmPC of [1] of EMA
There is a potential for an increase in pravastatin exposure when co-administered with protease inhibitors. Caution should be exercised.
Atazanavir/cobicistat [1], prednisone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], pregnancy ---> SmPC of [1] of EMA
The use of EVOTAZ may be considered during pregnancy only if the potential benefit justifies the potential risk.
Atazanavir/cobicistat [1], propafenone ---> SmPC of [1] of EMA
Concentrations of the antiarrhythmic may be increased when co-administered with EVOTAZ. The mechanism is CYP3A inhibition by atazanavir and cobicistat. Co-administration has the potential to produce serious and/or life-threatening adverse reactions.
Atazanavir/cobicistat [1], protease inhibitors ---> SmPC of [1] of EMA
EVOTAZ in combination with other protease inhibitors is not recommended because coadministration may not provide adequate protease inhibitor exposure.
Atazanavir/cobicistat [1], proton pump inhibitors ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with proton pump inhibitors (PPIs) is not recommended due to the decreased solubility of atazanavir as intra-gastric pH increase with PPIs
Atazanavir/cobicistat [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors
Atazanavir/cobicistat [1], quetiapine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], quinidine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], raltegravir ---> SmPC of [1] of EMA
Concomitant use may increase AUC, Cmax and C12h. The mechanism is UGT1A1 inhibition by atazanavir. No dose adjustment is required for raltegravir if co-administered with EVOTAZ.
Atazanavir/cobicistat [1], rifabutin ---> SmPC of [1] of EMA
CYP3A4 inhibition by atazanavir and cobicistat may increase rifabutin exposition. Co-administration of EVOTAZ and rifabutin is not recommended.
Atazanavir/cobicistat [1], rifampicin ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], rilpivirine ---> SmPC of [1] of EMA
EVOTAZ is expected to increase rilpivirine plasma concentrations. The mechanism of interaction is CYP3A inhibition. Co-administration of EVOTAZ and rilpivirine can be used without dose adjustments
Atazanavir/cobicistat [1], risperidone ---> SmPC of [1] of EMA
Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics. The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat
Atazanavir/cobicistat [1], ritonavir ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products containing ritonavir or cobicistat, which are strong inhibitors of CYP3A, may result in additional boosting and increased plasma concentration of atazanavir. Concomitant use not recommended
Atazanavir/cobicistat [1], rivaroxaban ---> SmPC of [1] of EMA
Co-administration of EVOTAZ and rivaroxaban may result in increased exposure to rivaroxaban and may lead to increased bleeding. The mechanism of interaction is CYP3A4 and P-gp inhibition by cobicistat. Avoid concomitant use of EVOTAZ and rivaroxaban.
Atazanavir/cobicistat [1], rosuvastatin ---> SmPC of [1] of EMA
Concomitant use may increase rosuvastatin exposition. The mechanism of interaction is potential inhibition of the transporter OATP1B1 by cobicistat. The risk of myopathy, including rhabdomyolysis, may be increased.
Atazanavir/cobicistat [1], salmeterol ---> SmPC of [1] of EMA
Coadministration with EVOTAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events. The mechanism of interaction is CYP3A4 inhibition by atazanavir and cobicistat. Coadministration is not recommended
Atazanavir/cobicistat [1], sildenafil ---> SmPC of [1] of EMA
Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor. The mechanism of interaction is CYP3A4 inhibition by atazanavir. Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated
Atazanavir/cobicistat [1], simeprevir ---> SmPC of [1] of EMA
EVOTAZ is expected to increase simeprevir plasma concentrations. Simeprevir may increase atazanavir and/or cobicistat plasma concentrations. The mechanism of interaction is CYP3A inhibition. It is not recommended to coadminister EVOTAZ with simeprevir.
Atazanavir/cobicistat [1], simvastatine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], sirolimus ---> SmPC of [1] of EMA
Concentrations of the immunosuppressant may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Atazanavir/cobicistat [1], St. John's wort ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products that inhibit CYP3A may result in increased plasma concentration of atazanavir and/or cobicistat.
Atazanavir/cobicistat [1], strong P-gp inhibitors ---> SmPC of [1] of EMA
Concentrations of dabigatran may be affected upon coadministration with EVOTAZ. The mechanism of interaction is P-gp inhibition by atazanavir and cobicistat. Clinical monitoring is recommended when dabigatran is co-administered with P-gp inhibitors.
Atazanavir/cobicistat [1], tacrolimus ---> SmPC of [1] of EMA
Concentrations of the immunosuppressant may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Atazanavir/cobicistat [1], tadalafil ---> SmPC of [1] of EMA
Tadalafil is metabolised by CYP3A4. Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor. The mechanism of this interaction is CYP3A4 inhibition by atazanavir and cobicistat.
Atazanavir/cobicistat [1], telaprevir ---> SmPC of [1] of EMA
No dose adjustment is required for telaprevir if co-administered with EVOTAZ. Clinical and laboratory monitoring for hyperbilirubinaemia is recommended.
Atazanavir/cobicistat [1], tenofovir disoproxil ---> SmPC of [1] of EMA
Tenofovir may decrease the AUC and Cmin of atazanavir. When coadministered with tenofovir, it is recommended that EVOTAZ and tenofovir 300 mg be given together with food. Atazanavir increases tenofovir concentrations.
Atazanavir/cobicistat [1], terfenadine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], thioridazine ---> SmPC of [1] of EMA
Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics. The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat
Atazanavir/cobicistat [1], ticagrelor ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], timolol ---> SmPC of [1] of EMA
Concentrations of the beta-blocker may be increased when coadministered with EVOTAZ. The mechanism of interaction is inhibition of CYP2D6 by cobicistat. A dose reduction of the beta-blocker may be necessary.
Atazanavir/cobicistat [1], trazodone ---> SmPC of [1] of EMA
Plasma concentrations of trazodone may be increased when co-administered with EVOTAZ. The mechanism is CYP3A4 inhibition by atazanavir and cobicistat. If trazodone is co-administered with EVOTAZ, the combination should be used with caution.
Atazanavir/cobicistat [1], triamcinolone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], triazolam ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], vardenafil ---> SmPC of [1] of EMA
Vardenafil is metabolised by CYP3A4. Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor. The mechanism of this interaction is CYP3A4 inhibition by atazanavir and cobicistat.
Atazanavir/cobicistat [1], verapamil ---> SmPC of [1] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Atazanavir/cobicistat [1], vinblastine ---> SmPC of [1] of EMA
Concentrations of the antineoplastic may be increased when coadministered with EVOTAZ resulting in the potential for increased adverse events. The mechanism of interaction is CYP3A4 inhibition by cobicistat.
Atazanavir/cobicistat [1], vincristine ---> SmPC of [1] of EMA
Concentrations of the antineoplastic may be increased when coadministered with EVOTAZ resulting in the potential for increased adverse events. The mechanism of interaction is CYP3A4 inhibition by cobicistat.
Atazanavir/cobicistat [1], voriconazole ---> SmPC of [1] of EMA
Voriconazole should not be coadministered with EVOTAZ unless the benefit/risk assessment justifies the use of voriconazole. Clinical monitoring may be needed upon coadministration with EVOTAZ.
Atazanavir/cobicistat [1], warfarin ---> SmPC of [1] of EMA
Co-administration with EVOTAZ has the potential to increase warfarin plasma concentrations. The mechanism of interaction is CYP3A4 inhibition by atazanavir and cobicistat. It is recommended that the INR be monitored.
Atazanavir/cobicistat [1], zolpidem ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat, daclatasvir [2] ---> SmPC of [2] of EMA
Strong inhibitors of CYP3A4 may increase the plasma levels of daclatasvir. Dose adjustment of daclatasvir is recommended when coadministered with strong inhibitors of CYP3A4
Atazanavir/cobicistat, emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
The recommended dose of Descovy is 200/10 mg once daily.
Atazanavir/cobicistat, lenacapavir [2] ---> SmPC of [2] of EMA
Strong inhibitors of CYP3A, P-gp and UGT1A1 together (i.e., all 3 pathways), such as atazanavir/cobicistat, may significantly increase plasma concentrations of lenacapavir, therefore co-administration is not recommended
Atazanavir/cobicistat, tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Co-administration is not recommended.
Atazanavir/ritonavir + emtricitabine/tenofovir, ledipasvir/sofosbuvir [2] ---> SmPC of [2] of EMA
Concomitant use caused an increase in atazanavir and tenofovir concentration
Atazanavir/ritonavir [1], H2 antagonists ---> SmPC of [1] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2-blockers.
Atazanavir/ritonavir, boceprevir [2] ---> SmPC of [2] of EMA
Co-administration of atazanavir/ritonavir with boceprevir resulted in lower exposure of atazanavir which may be associated with lower efficacy and loss of HIV control.
Atazanavir/ritonavir, breast-feeding ---> SmPC of [atazanavir] of EMA
As a general rule, it is recommended that HIV infected women not breast-feed their infants in order to avoid transmission of HIV
Atazanavir/ritonavir, buprenorphine ---> SmPC of [atazanavir] of EMA
The CYP3A4 and UGT1A1 inhibition may increase the buprenorphine plasma levels. Co-administration warrants clinical monitoring for sedation and cognitive effects.
Atazanavir/ritonavir, daclatasvir [2] ---> SmPC of [2] of EMA
Strong inhibitors of CYP3A4 may increase the plasma levels of daclatasvir. Dose adjustment of daclatasvir is recommended when coadministered with strong inhibitors of CYP3A4
Atazanavir/ritonavir, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SmPC of [ombitasvir/paritaprevir/ritonavir
The combination carries an increased risk for hyperbilirubinemia (including ocular icterus), in particular when ribavirin is part of the hepatitis C regimen.
Atazanavir/ritonavir, didanosine ---> SmPC of [atazanavir] of EMA
Didanosine should be taken at the fasted state 2 hours after atazanavir/ritonavir taken with food.
Atazanavir/ritonavir, diltiazem ---> SmPC of [atazanavir] of EMA
The co-administration of atazanavir/ritonavir (strong CYP3A4 inhibitors) may increase the plasma concentrations of diltiazem and desacetyl-diltiazem. Caution is warranted
Atazanavir/ritonavir, dolutegravir [2] ---> SmPC of [2] of EMA
Increased dolutegravir plasma levels. No dosage adjustment necessary. (Inhibition of UGT1A1 and CYP3A enzymes)
Atazanavir/ritonavir, dolutegravir/abacavir/lamivudine [2] ---> SmPC of [2] of EMA
No dosage adjustment necessary.
Atazanavir/ritonavir, dolutegravir/lamivudine [2] ---> SmPC of [2] of EMA
No dose adjustment is necessary.
Atazanavir/ritonavir, dronedarone
The co-administration of atazanavir/ritonavir (strong CYP3A4 inhibitors) may increase the plasma concentrations of the antiarrhythmic. Caution is warranted
Atazanavir/ritonavir, efavirenz [2] ---> SmPC of [2] of EMA
The CYP3A4 induction by efavirenz may decrease the exposition of atazanavir. Co-administration of efavirenz with atazanavir/ritonavir is not recommended
Atazanavir/ritonavir, elbasvir/grazoprevir [2] ---> SmPC of [2] of EMA
Combination of OATP1B and CYP3A inhibition. Co-administration is contraindicated.
Atazanavir/ritonavir, elvitegravir [2] ---> SmPC of [2] of EMA
Co-administration of elvitegravir with medicinal products that are potent inhibitors of UGT1A1/3 may result in increased elvitegravir plasma concentrations and dose modifications may be required.
Atazanavir/ritonavir, emtricitabine/rilpivirine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA
Concomitant use of Eviplera with ritonavir boosted PIs causes an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). No dose adjustment is required.
Atazanavir/ritonavir, emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
The recommended dose of Descovy is 200/10 mg once daily.
Atazanavir/ritonavir, emtricitabine/tenofovir disoproxil [2] ---> SmPC of [2] of EMA
No dose adjustment is recommended. The increased exposure of tenofovir could potentiate tenofovir associated adverse events, including renal disorders. Renal function should be closely monitored
Atazanavir/ritonavir, emtricitabine/tenofovir disoproxil/sofosbuvir/velpatasvir ---> SmPC of [sofosbuvir/velpatasv
No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/tenofovir disoproxil fumarate is required.
Atazanavir/ritonavir, esomeprazole [2] ---> SmPC of [2] of EMA
For atazanavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended.
Atazanavir/ritonavir, ethinyl estradiol ---> SmPC of [atazanavir] of EMA
The net effect of atazanavir/ritonavir is a decrease in ethinyloestradiol levels because of the inducing effect of ritonavir.
Atazanavir/ritonavir, ethinylestradiol/norgestimate ---> SmPC of [atazanavir] of EMA
The net effect of atazanavir/ritonavir is a decrease in ethinyloestradiol levels because of the inducing effect of ritonavir.
Atazanavir/ritonavir, etravirine [2] ---> SmPC of [2] of EMA
INTELENCE and atazanavir/ritonavir can be used without dose adjustment.
Atazanavir/ritonavir, famotidine ---> SmPC of [atazanavir] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2 blockers.
Atazanavir/ritonavir, fluconazole ---> SmPC of [atazanavir] of EMA
Atazanavir and fluconazole concentrations were not significantly modified. No dosage adjustment necessary.
Atazanavir/ritonavir, fluticasone ---> SmPC of [atazanavir] of EMA
Concomitant use of atazanavir/ritonavir and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects
Atazanavir/ritonavir, foods ---> SmPC of [atazanavir] of EMA
To enhance bioavailability and minimise variability, REYATAZ is to be taken with food.
Atazanavir/ritonavir, fosamprenavir [2] ---> SmPC of [2] of EMA
No dosage adjustment necessary
Atazanavir/ritonavir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
No dosage adjustment necessary
Atazanavir/ritonavir, fostemsavir [2] ---> SmPC of [2] of EMA
Atazanavir/ritonavir increased temsavir concentrations. No dose adjustment of either medicinal product is necessary.
Atazanavir/ritonavir, gestagens ---> SmPC of [atazanavir] of EMA
Co-administration of atazanavir/ritonavir with other oral contraceptives containing progestogens has not been studied, and therefore should be avoided.
Atazanavir/ritonavir, glucocorticoids metabolized by CYP3A4 ---> SmPC of [atazanavir] of EMA
Concomitant use of atazanavir/ritonavir and glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects
Atazanavir/ritonavir, indinavir ---> SmPC of [atazanavir] of EMA
Combination of atazanavir with or without ritonavir and Crixivan are not recommended due to increased risk of hyperbilirubinemia
Atazanavir/ritonavir, itraconazol ---> SmPC of [atazanavir] of EMA
Atazanavir/ritonavir is expected to increase itraconazole concentrations.
Atazanavir/ritonavir, ketoconazole ---> SmPC of [atazanavir] of EMA
Atazanavir/ritonavir is expected to increase ketoconazole concentrations.
Atazanavir/ritonavir, lamivudine/raltegravir [2] ---> SmPC of [2] of EMA
The inhibition of UGT1A1 may increase raltegravir exposition. No dosage adjustment necessary.
Atazanavir/ritonavir, lamivudine/zidovudine ---> SmPC of [atazanavir] of EMA
No significant effect on lamivudine and zidovudine concentrations was observed.
Atazanavir/ritonavir, lamotrigine ---> SmPC of [atazanavir] of EMA
Co-administration of lamotrigine and atazanavir/ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction.
Atazanavir/ritonavir, ledipasvir/sofosbuvir [2] ---> SmPC of [2] of EMA
No dose adjustment is required
Atazanavir/ritonavir, maraviroc [2] ---> SmPC of [2] of EMA
The CYP3A4 inhibition may increase the AUC of maraviroc. Dose adjustment of maraviroc is recommended
Atazanavir/ritonavir, nevirapine [2] ---> SmPC of [2] of EMA
Co-administration of nevirapine with atazanavir/ritonavir is not recommended
Atazanavir/ritonavir, nucleoside and nucleotide reverse transcriptase inhibitors ---> SmPC of [atazanavir] of EMA
The co-administration of atazanavir/ritonavir with NRTIs is not expected to significantly alter the exposure of the coadministered drugs.
Atazanavir/ritonavir, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC of [2] of EMA
The combination carries an increased risk for hyperbilirubinemia (including ocular icterus), in particular when ribavirin is part of the hepatitis C regimen.
Atazanavir/ritonavir, omeprazole ---> SmPC of [esomeprazole] of EMA
For atazanavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended.
Atazanavir/ritonavir, PDE5 inhibitors ---> SmPC of [atazanavir] of EMA
The CYP3A4 inhibition may increase substantially the plasma concentrations of the PDE5 inhibitor. Particular caution should be used
Atazanavir/ritonavir, phenobarbital ---> SmPC of [atazanavir] of EMA
The CYP2C9 and CYP2C19 induction by ritonavir may decrease the phenobarbital plasma levels. The induction by phenobarbital may decrease the atazanavir/ritonavir exposure
Atazanavir/ritonavir, phenytoin ---> SmPC of [atazanavir] of EMA
The CYP2C9 and CYP2C19 induction by ritonavir may decrease the phenytoin plasma levels. The induction by phenytoin may decrease the atazanavir/ritonavir exposure
Atazanavir/ritonavir, posaconazole [2] ---> SmPC of [2] of EMA
Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during co- administration with posaconazole.
Atazanavir/ritonavir, pregnancy ---> SmPC of [atazanavir] of EMA
The use of REYATAZ with ritonavir may be considered during pregnancy only if the potential benefit justifies the potential risk.
Atazanavir/ritonavir, propafenone
The co-administration of atazanavir/ritonavir (strong CYP3A4 inhibitors) may increase the plasma concentrations of the antiarrhythmic. Caution is warranted
Atazanavir/ritonavir, protease inhibitors ---> SmPC of [atazanavir] of EMA
The co-administration of REYATAZ/ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors. Therefore, such co-administration is not recommended.
Atazanavir/ritonavir, proton pump inhibitors ---> SmPC of [atazanavir] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors. Co-administration of atazanavir/ritonavir with proton pump inhibitors is not recommended.
Atazanavir/ritonavir, rifabutin ---> SmPC of [atazanavir] of EMA
Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Atazanavir/ritonavir, rilpivirine [2] ---> SmPC of [2] of EMA
Not studied. Concomitant use of rilpivirine with ritonavir-boosted PIs (inhibition of CYP3A enzymes) causes an increase in the plasma concentrations of rilpivirine, but no dose adjustment is required.
Atazanavir/ritonavir, rosuvastatin [2] ---> SmPC of [2] of eMC
Increased systemic exposure to rosuvastatin has been observed in subjects receiving rosuvastatin concomitantly with various protease inhibitors in combination with ritonavir.
Atazanavir/ritonavir, simeprevir [2] ---> SmPC of [2] of EMA
The CYP3A4 enzyme induction or inhibition may alter plasma concentrations of simeprevir. It is not recommended to co-administer simeprevir with any HIV PI, with or without ritonavir.
Atazanavir/ritonavir, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SmPC of [2] of EMA
Inhibition of OATP1B, P-gp and CYP3A. Co-administration of Vosevi with atazanavir is expected to increase the concentration of voxilaprevir. Co-administration of Vosevi with atazanavir-containing regimens is not recommended.
Atazanavir/ritonavir, telaprevir [2] ---> SmPC of [2] of EMA
Increased/decreased plasma concentrations of atazanavir/telaprevir. Hyperbilirubinaemia is frequent with this combination. Clinical and laboratory monitoring for hyperbilirubinaemia is recommended
Atazanavir/ritonavir, tenofovir ---> SmPC of [atazanavir] of EMA
The efficacy of atazanavir/ritonavir in combination with tenofovir in treatment-experienced patients has been demonstrated in clinical study 045 and in treatment naīve patients in clinical study 138
Atazanavir/ritonavir, tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Co-administration is not recommended.
Atazanavir/ritonavir, tenofovir disoproxil [2] ---> SmPC of [2] of EMA
No dose adjustment is recommended. The increased exposure of tenofovir could potentiate tenofovir-associated adverse events, including renal disorders. Renal function should be closely monitored renal disorders.
Atazanavir/ritonavir, tipranavir/ritonavir ---> SmPC of [tipranavir] of EMA
Significant decrease in plasma concentrations of atazanavir and a marked increase of tipranavir concentrations. Concomitant use is not recommended
Atazanavir/ritonavir, voriconazole ---> SmPC of [atazanavir] of EMA
Co-administration of voriconazole and atazanavir/ritonavir is not recommended unless an assessment of the benefit/risk to the patient justifies the use of voriconazole
Atazanavir/ritonavir/tenofovir, famotidine ---> SmPC of [atazanavir] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2 blockers. Co-administration of atazanavir/ritonavir in combination with tenofovir and an H2-receptor antagonist should be avoided
Atazanavir/ritonavir/tenofovir, H2 antagonists
This decrease in atazanavir exposure might negatively impact the efficacy of atazanavir. The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
CONTRAINDICATIONS of Atazanavir (Reyataz)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- REYATAZ is contraindicated in patients with severe hepatic insufficiency. REYATAZ with ritonavir is contraindicated in patients with moderate hepatic insufficiency
- Co-administration with simvastatin or lovastatin (see section 4.5).
- Combination of rifampicin (see section 4.5).
- Combination of the PDE5 inhibitor sildenafil when used for the treatment of pulmonary arterial hypertension (PAH) only (see section 4.5). For co-administration of sildenafil for the treatment of erectile dysfunction see sections 4.4 and 4.5.
- Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), lomitapide and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine).
- Co-administration with medicinal products that are strong inducers of CYP3A4 due to the potential for loss of therapeutic effect and development of possible resistance (e.g., rifampicin, St. John's wort, apalutamide, encorafenib, ivosidenib, carbamazepine, phenobarbital and phenytoin) (see section 4.5).
- Co-administration with grazoprevir-containing products, including elbasvir/grazoprevir fixed-dose combination (see section 4.5).
- Co-administration with glecaprevir/pibrentasvir fixed-dose combination (see section 4.5).
https://www.ema.europa.eu/en/documents/product-information/reyataz-epar-product-information_en.pdf 16/10/2024
Other trade names: Atazanavir Krka, Atazanavir Viatris (previously Atazanavir Mylan),
Atazanavir/cobicistat (Evotaz)
Ability to drive, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
EVOTAZ has a minor influence on the ability to drive or use machines. Dizziness may occur following administration of regimens containing atazanavir and cobicistat (see section 4.8).
Alfuzosin, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Amiodarone, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Amlodipine, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Antacids, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids are administered with EVOTAZ. EVOTAZ should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Apixaban, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Co-administration with EVOTAZ may result in increased plasma concentrations of the DOACs, which may lead to an increased risk of bleeding. The mechanism of interaction is CYP3A4 and/or P-gp inhibition by cobicistat. Co-administration is not recommended
Astemizole, atazanavir/cobicistat [2] ---> SmPC of [2] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], atorvastatin ---> SmPC of [1] of EMA
The risk of myopathy including rhabdomyolysis may be increased with atorvastatin, which is metabolised by CYP3A4. Co-administration of atorvastatin with EVOTAZ is not recommended.
Atazanavir/cobicistat [1], avanafil ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], BCRP substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], bepridil ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], betamethasone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], boceprevir ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect
Atazanavir/cobicistat [1], bosentan ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect
Atazanavir/cobicistat [1], breast-feeding ---> SmPC of [1] of EMA
Because of both the potential for HIV transmission and the potential for serious adverse reactions in breastfeeding infants, women should be instructed not to breast-feed if they are receiving EVOTAZ.
Atazanavir/cobicistat [1], budesonide ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], buffered medicinal product ---> SmPC of [1] of EMA
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids are administered with EVOTAZ. EVOTAZ should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Atazanavir/cobicistat [1], buprenorphine ---> SmPC of [1] of EMA
Concomitant use may increase buprenorphine exposition. The mechanism of interaction is CYP3A4 and UGT1A1 inhibition by atazanavir. Co-administration warrants clinical monitoring for sedation and cognitive effects.
Atazanavir/cobicistat [1], buprenorphine/naloxone ---> SmPC of [1] of EMA
Concomitant use may increase buprenorphine exposition. The mechanism of interaction is CYP3A4 inhibition by cobicistat. Co-administration warrants clinical monitoring for sedation and cognitive effects.
Atazanavir/cobicistat [1], buspirone ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], carbamazepine ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], cisapride ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], clarithromycin ---> SmPC of [1] of EMA
Clarithromycin may increase atazanavir and cobicistat concentrations. Exposure to clarithromycin is expected to increase if co-administered with EVOTAZ. The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or cobicistat and clarithromycin.
Atazanavir/cobicistat [1], clopidogrel ---> SmPC of [1] of EMA
Concomitant administration of EVOTAZ with clopidogrel is not recommended. Use of other antiplatelets not affected by CYP inhibition or induction (e.g., prasugrel) is recommended.
Atazanavir/cobicistat [1], clorazepate ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], cobicistat ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products containing ritonavir or cobicistat, which are strong inhibitors of CYP3A, may result in additional boosting and increased plasma concentration of atazanavir. Concomitant use not recommended
Atazanavir/cobicistat [1], colchicine ---> SmPC of [1] of EMA
A dose reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with EVOTAZ is required.
Atazanavir/cobicistat [1], corticosteroids primarily metabolised by CYP3A ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], cyclosporine ---> SmPC of [1] of EMA
Concentrations of the immunosuppressant may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Atazanavir/cobicistat [1], CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect
Atazanavir/cobicistat [1], CYP3A4 substrates with narrow therapeutic index ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], dabigatran ---> SmPC of [1] of EMA
Co-administration with dabigatran, a substrate of P-gp, is contraindicated.
Atazanavir/cobicistat [1], dasatinib ---> SmPC of [1] of EMA
Concentrations of the antineoplastic may be increased when coadministered with EVOTAZ resulting in the potential for increased adverse events. The mechanism of interaction is CYP3A4 inhibition by cobicistat.
Atazanavir/cobicistat [1], dexamethasone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], diazepam ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], didanosine ---> SmPC of [1] of EMA
No significant effect on atazanavir concentrations was observed when administered with enteric-coated didanosine, but administration with food decreased didanosine concentrations.
Atazanavir/cobicistat [1], didanosine/stavudine ---> SmPC of [1] of EMA
Didanosine should be taken in the fasted state 2 hours after EVOTAZ taken with food. The coadministration of EVOTAZ with stavudine is not expected to significantly alter the exposure of stavudine.
Atazanavir/cobicistat [1], digoxin ---> SmPC of [1] of EMA
Plasma concentrations of digoxin may be increased when coadministered with EVOTAZ. The mechanism of interaction is inhibition of P-gp by cobicistat. The lowest dose of digoxin should initially be prescribed.
Atazanavir/cobicistat [1], dihydroergotamine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], diltiazem ---> SmPC of [1] of EMA
Exposure to diltiazem is increased when diltiazem is coadministered with atazanavir, a component of EVOTAZ. An initial dose reduction of diltiazem by 50% should be considered, and electrocardiogram monitoring is recommended.
Atazanavir/cobicistat [1], disopyramide ---> SmPC of [1] of EMA
Concentrations of the antiarrhythmic may be increased when co-administered with EVOTAZ. The mechanism is CYP3A inhibition by atazanavir and cobicistat. Co-administration has the potential to produce serious and/or life-threatening adverse reactions.
Atazanavir/cobicistat [1], dolutegravir ---> SmPC of [1] of EMA
Co-administration with EVOTAZ is expected to increase dolutegravir plasma concentrations. The mechanism of interaction is inhibition of UGT1A1 by atazanavir. EVOTAZ and dolutegravir can be used without dose adjustments.
Atazanavir/cobicistat [1], dronedarone ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], drospirenone/ethinylestradiol ---> SmPC of [1] of EMA
Plasma concentrations of drospirenone are increased following co-administration. If drospirenone/ethinyloestradiol is co-administered with atazanavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Atazanavir/cobicistat [1], drugs inducing bradycardia ---> SmPC of [1] of EMA
Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors
Atazanavir/cobicistat [1], drugs primarily metabolised by CYP2C8 ---> SmPC of [1] of EMA
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Atazanavir/cobicistat [1], drugs primarily metabolised by CYP2D6 ---> SmPC of [1] of EMA
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Atazanavir/cobicistat [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Atazanavir/cobicistat [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], drugs primarily metabolised by UGT1A1 ---> SmPC of [1] of EMA
Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Atazanavir/cobicistat [1], edoxaban ---> SmPC of [1] of EMA
Co-administration with EVOTAZ may result in increased plasma concentrations of the DOACs, which may lead to an increased risk of bleeding. The mechanism of interaction is CYP3A4 and/or P-gp inhibition by cobicistat. Co-administration is not recommended
Atazanavir/cobicistat [1], efavirenz ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect
Atazanavir/cobicistat [1], electrolyte imbalance ---> SmPC of [1] of EMA
Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors
Atazanavir/cobicistat [1], ergometrine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], ergot derivatives ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], ergotamine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], estazolam ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], etravirine ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect
Atazanavir/cobicistat [1], famotidine ---> SmPC of [1] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2 blockers. It is not recommended to co-administer EVOTAZ with an H2-receptor antagonist.
Atazanavir/cobicistat [1], felodipine ---> SmPC of [1] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Atazanavir/cobicistat [1], fertility ---> SmPC of [1] of EMA
In a nonclinical fertility and early embryonic development study in rats, atazanavir altered oestrus cycling. No human data on the effect of cobicistat on fertility are available. Animal studies do not indicate harmful effects of cobicistat on fertility.
Atazanavir/cobicistat [1], flecainide ---> SmPC of [1] of EMA
Concentrations of the antiarrhythmic may be increased when co-administered with EVOTAZ. The mechanism is CYP3A inhibition by atazanavir and cobicistat. Co-administration has the potential to produce serious and/or life-threatening adverse reactions.
Atazanavir/cobicistat [1], fluconazole ---> SmPC of [1] of EMA
Concentration of fluconazole may be increased if co-administered with cobicistat. Clinical monitoring is recommended upon coadministration with EVOTAZ.
Atazanavir/cobicistat [1], flurazepam ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat [1], fluticasone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal
Atazanavir/cobicistat [1], fluvastatin ---> SmPC of [1] of EMA
There is a potential for an increase in fluvastatin exposure when co-administered with protease inhibitors. Caution should be exercised.
Atazanavir/cobicistat [1], foods ---> SmPC of [1] of EMA
To enhance bioavailability, EVOTAZ is to be taken with food.
Atazanavir/cobicistat [1], glecaprevir/pibrentasvir ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations
Atazanavir/cobicistat [1], glucocorticoids metabolized by CYP3A4 ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal
Atazanavir/cobicistat [1], grazoprevir ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations
Atazanavir/cobicistat [1], H2 antagonists ---> SmPC of [1] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2 blockers. It is not recommended to co-administer EVOTAZ with an H2-receptor antagonist.
Atazanavir/cobicistat [1], hormonal contraceptives ---> SmPC of [1] of EMA
Co-administration of EVOTAZ and hormonal contraceptives should be avoided. An alternate (non-hormonal) reliable method of contraception is recommended.
Atazanavir/cobicistat [1], indinavir ---> SmPC of [1] of EMA
Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT. Co-administration of EVOTAZ and indinavir is not recommended
Atazanavir/cobicistat [1], irinotecan ---> SmPC of [1] of EMA
Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities. If EVOTAZ is co-administered with irinotecan, patients should be closely monitored for adverse reactions related to irinotecan.
Atazanavir/cobicistat [1], itraconazol ---> SmPC of [1] of EMA
Itraconazole is a potent inhibitor and a substrate of CYP3A4. Itraconazole, and/or cobicistat levels may be increased with coadministration of itraconazole with EVOTAZ. The mechanism is CYP3A4 inhibition by atazanavir, cobicistat and itraconazole.
Atazanavir/cobicistat [1], ketoconazole ---> SmPC of [1] of EMA
Ketoconazole is a potent inhibitor and a substrate of CYP3A4. Ketoconazole, and/or cobicistat levels may be increased with coadministration of ketoconazole with EVOTAZ. The mechanism is CYP3A4 inhibition by atazanavir, cobicistat and ketoconazole.
Atazanavir/cobicistat [1], lamivudine/zidovudine ---> SmPC of [1] of EMA
No significant effect on lamivudine and zidovudine concentrations was observed when co-administered with atazanavir.
Atazanavir/cobicistat [1], lidocaine ---> SmPC of [1] of EMA
Systemic lidocaine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by EVOTAZ
Atazanavir/cobicistat [1], lomitapide ---> SmPC of [1] of EMA
Lomitapide is highly dependent on CYP3A4 for its metabolism and co-administration with EVOTAZ may result in increased concentrations of lomitapide. Co-administration of lomitapide with EVOTAZ is contraindicated (see section 4.3).
Atazanavir/cobicistat [1], lovastatine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], lurasidone ---> SmPC of [1] of EMA
The mechanism of interaction is CYP3A inhibition by atazanavir and cobicistat. The combination of pimozide, quetiapine or lurasidone and EVOTAZ is contraindicated (see section 4.3).
Atazanavir/cobicistat [1], maraviroc ---> SmPC of [1] of EMA
Maraviroc is a substrate of CYP3A and its plasma concentration increases when coadministered with potent CYP3A inhibitors. The mechanism of interaction is CYP3A4 inhibition by atazanavir and cobicistat.
Atazanavir/cobicistat [1], MATE1 substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], metformin ---> SmPC of [1] of EMA
Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with EVOTAZ. Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking EVOTAZ.
Atazanavir/cobicistat [1], methadone ---> SmPC of [1] of EMA
No dosage adjustment is necessary if methadone is co-administered with EVOTAZ.
Atazanavir/cobicistat [1], methylergonovine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], metoprolol ---> SmPC of [1] of EMA
Concentrations of the beta-blocker may be increased when coadministered with EVOTAZ. The mechanism of interaction is inhibition of CYP2D6 by cobicistat. A dose reduction of the beta-blocker may be necessary.
Atazanavir/cobicistat [1], mexiletine ---> SmPC of [1] of EMA
Concentrations of the antiarrhythmic may be increased when co-administered with EVOTAZ. The mechanism is CYP3A inhibition by atazanavir and cobicistat. Co-administration has the potential to produce serious and/or life-threatening adverse reactions.
Atazanavir/cobicistat [1], midazolam ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect
Atazanavir/cobicistat [1], mometasone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], neuroleptics ---> SmPC of [1] of EMA
Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics. The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat
Atazanavir/cobicistat [1], nevirapine ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect
Atazanavir/cobicistat [1], nicardipine ---> SmPC of [1] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Atazanavir/cobicistat [1], nifedipine ---> SmPC of [1] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Atazanavir/cobicistat [1], nilotinib ---> SmPC of [1] of EMA
Concentrations of the antineoplastic may be increased when coadministered with EVOTAZ resulting in the potential for increased adverse events. The mechanism of interaction is CYP3A4 inhibition by cobicistat.
Atazanavir/cobicistat [1], OATP1B1 substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], OATP1B3 substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], omeprazole ---> SmPC of [1] of EMA
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors. Co-administration of EVOTAZ with proton pump inhibitors is not recommended.
Atazanavir/cobicistat [1], oral contraceptives ---> SmPC of [1] of EMA
Co-administration of EVOTAZ and hormonal contraceptives should be avoided. An alternate (non-hormonal) reliable method of contraception is recommended.
Atazanavir/cobicistat [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the coadministered medicinal products
Atazanavir/cobicistat [1], PDE5 inhibitors ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with PDE5-inhibitors is expected to substantially increase their concentrations and may result in PDE5-associated adverse reactions such as hypotension, visual changes and priapism
Atazanavir/cobicistat [1], perphenazine ---> SmPC of [1] of EMA
Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics. The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat
Atazanavir/cobicistat [1], phenobarbital ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], phenytoin ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], pimozide ---> SmPC of [1] of EMA
The mechanism of interaction is CYP3A inhibition by atazanavir and cobicistat. The combination of pimozide, quetiapine or lurasidone and EVOTAZ is contraindicated (see section 4.3).
Atazanavir/cobicistat [1], pitavastatin ---> SmPC of [1] of EMA
Plasma concentrations of pitavastatin may be increased if co-administered with EVOTAZ. Caution should be exercised.
Atazanavir/cobicistat [1], prasugrel ---> SmPC of [1] of EMA
The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or cobicistat. Antiplatelet activity is expected to be adequate. No dose adjustment of prasugrel is required.
Atazanavir/cobicistat [1], pravastatine ---> SmPC of [1] of EMA
There is a potential for an increase in pravastatin exposure when co-administered with protease inhibitors. Caution should be exercised.
Atazanavir/cobicistat [1], prednisone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], pregnancy ---> SmPC of [1] of EMA
EVOTAZ is not recommended during pregnancy nor should it be initiated in pregnant patients; an alternative regimen is recommended (see sections 4.2 and 4.4).
Atazanavir/cobicistat [1], propafenone ---> SmPC of [1] of EMA
Concentrations of the antiarrhythmic may be increased when co-administered with EVOTAZ. The mechanism is CYP3A inhibition by atazanavir and cobicistat. Co-administration has the potential to produce serious and/or life-threatening adverse reactions.
Atazanavir/cobicistat [1], protease inhibitors ---> SmPC of [1] of EMA
EVOTAZ in combination with other protease inhibitors is not recommended because coadministration may not provide adequate protease inhibitor exposure.
Atazanavir/cobicistat [1], proton pump inhibitors ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with proton pump inhibitors (PPIs) is not recommended due to the decreased solubility of atazanavir as intra-gastric pH increase with PPIs
Atazanavir/cobicistat [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors
Atazanavir/cobicistat [1], quetiapine ---> SmPC of [1] of EMA
The mechanism of interaction is CYP3A inhibition by atazanavir and cobicistat. The combination of pimozide, quetiapine or lurasidone and EVOTAZ is contraindicated (see section 4.3).
Atazanavir/cobicistat [1], quinidine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], raltegravir ---> SmPC of [1] of EMA
Concomitant use may increase AUC, Cmax and C12h. The mechanism is UGT1A1 inhibition by atazanavir. No dose adjustment is required for raltegravir if co-administered with EVOTAZ.
Atazanavir/cobicistat [1], rifabutin ---> SmPC of [1] of EMA
CYP3A4 inhibition by atazanavir and cobicistat may increase rifabutin exposition. Co-administration of EVOTAZ and rifabutin is not recommended.
Atazanavir/cobicistat [1], rifampicin ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], rilpivirine ---> SmPC of [1] of EMA
EVOTAZ is expected to increase rilpivirine plasma concentrations. The mechanism of interaction is CYP3A inhibition. Co-administration of EVOTAZ and rilpivirine can be used without dose adjustments
Atazanavir/cobicistat [1], risperidone ---> SmPC of [1] of EMA
Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics. The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat
Atazanavir/cobicistat [1], ritonavir ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products containing ritonavir or cobicistat, which are strong inhibitors of CYP3A, may result in additional boosting and increased plasma concentration of atazanavir. Concomitant use not recommended
Atazanavir/cobicistat [1], rivaroxaban ---> SmPC of [1] of EMA
Co-administration with EVOTAZ may result in increased plasma concentrations of the DOACs, which may lead to an increased risk of bleeding. The mechanism of interaction is CYP3A4 and/or P-gp inhibition by cobicistat. Co-administration is not recommended
Atazanavir/cobicistat [1], rosuvastatin ---> SmPC of [1] of EMA
When co-administration is necessary, do not exceed 10 mg rosuvastatin daily, and clinical monitoring for safety (e.g., myopathy) is recommended.
Atazanavir/cobicistat [1], salmeterol ---> SmPC of [1] of EMA
Coadministration with EVOTAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events. The mechanism of interaction is CYP3A4 inhibition by atazanavir and cobicistat. Coadministration is not recommended
Atazanavir/cobicistat [1], sildenafil ---> SmPC of [1] of EMA
Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor. The mechanism of interaction is CYP3A4 inhibition by atazanavir. Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated
Atazanavir/cobicistat [1], simeprevir ---> SmPC of [1] of EMA
EVOTAZ is expected to increase simeprevir plasma concentrations. Simeprevir may increase atazanavir and/or cobicistat plasma concentrations. The mechanism of interaction is CYP3A inhibition. It is not recommended to coadminister EVOTAZ with simeprevir.
Atazanavir/cobicistat [1], simvastatine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], sirolimus ---> SmPC of [1] of EMA
Concentrations of the immunosuppressant may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Atazanavir/cobicistat [1], sofosbuvir/velpatasvir/voxilaprevir ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with voxilaprevir-containing products is expected to increase the concentration of voxilaprevir. Coadministration of EVOTAZ with voxilaprevir-containing regimens is not recommended.
Atazanavir/cobicistat [1], St. John's wort ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Coadministration (contraindicated) of EVOTAZ with strong inducers of CYP3A may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Atazanavir/cobicistat [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Co-administration of EVOTAZ with medicinal products containing ritonavir or cobicistat, which are strong inhibitors of CYP3A, may result in additional boosting and increased plasma concentration of atazanavir.
Atazanavir/cobicistat [1], strong P-gp inhibitors ---> SmPC of [1] of EMA
Concentrations of dabigatran may be affected upon coadministration with EVOTAZ. The mechanism of interaction is P-gp inhibition by atazanavir and cobicistat. Clinical monitoring is recommended when dabigatran is co-administered with P-gp inhibitors.
Atazanavir/cobicistat [1], tacrolimus ---> SmPC of [1] of EMA
Concentrations of the immunosuppressant may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Atazanavir/cobicistat [1], tadalafil ---> SmPC of [1] of EMA
Tadalafil is metabolised by CYP3A4. Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor. The mechanism of this interaction is CYP3A4 inhibition by atazanavir and cobicistat.
Atazanavir/cobicistat [1], telaprevir ---> SmPC of [1] of EMA
No dose adjustment is required for telaprevir if co-administered with EVOTAZ. Clinical and laboratory monitoring for hyperbilirubinaemia is recommended.
Atazanavir/cobicistat [1], tenofovir disoproxil ---> SmPC of [1] of EMA
Tenofovir may decrease the AUC and Cmin of atazanavir. When coadministered with tenofovir, it is recommended that EVOTAZ and tenofovir 300 mg be given together with food. Atazanavir increases tenofovir concentrations.
Atazanavir/cobicistat [1], terfenadine ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], thioridazine ---> SmPC of [1] of EMA
Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics. The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat
Atazanavir/cobicistat [1], ticagrelor ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], timolol ---> SmPC of [1] of EMA
Concentrations of the beta-blocker may be increased when coadministered with EVOTAZ. The mechanism of interaction is inhibition of CYP2D6 by cobicistat. A dose reduction of the beta-blocker may be necessary.
Atazanavir/cobicistat [1], trazodone ---> SmPC of [1] of EMA
Plasma concentrations of trazodone may be increased when co-administered with EVOTAZ. The mechanism is CYP3A4 inhibition by atazanavir and cobicistat. If trazodone is co-administered with EVOTAZ, the combination should be used with caution.
Atazanavir/cobicistat [1], triamcinolone ---> SmPC of [1] of EMA
Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Atazanavir/cobicistat [1], triazolam ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Atazanavir/cobicistat [1], vardenafil ---> SmPC of [1] of EMA
Vardenafil is metabolised by CYP3A4. Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor. The mechanism of this interaction is CYP3A4 inhibition by atazanavir and cobicistat.
Atazanavir/cobicistat [1], verapamil ---> SmPC of [1] of EMA
Concentrations of the calcium channel blocker may be increased when co-administered with EVOTAZ. The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat. Caution is warranted.
Atazanavir/cobicistat [1], vinblastine ---> SmPC of [1] of EMA
Concentrations of the antineoplastic may be increased when coadministered with EVOTAZ resulting in the potential for increased adverse events. The mechanism of interaction is CYP3A4 inhibition by cobicistat.
Atazanavir/cobicistat [1], vincristine ---> SmPC of [1] of EMA
Concentrations of the antineoplastic may be increased when coadministered with EVOTAZ resulting in the potential for increased adverse events. The mechanism of interaction is CYP3A4 inhibition by cobicistat.
Atazanavir/cobicistat [1], voriconazole ---> SmPC of [1] of EMA
Voriconazole should not be coadministered with EVOTAZ unless the benefit/risk assessment justifies the use of voriconazole. Clinical monitoring may be needed upon coadministration with EVOTAZ.
Atazanavir/cobicistat [1], warfarin ---> SmPC of [1] of EMA
Co-administration with EVOTAZ has the potential to produce serious and/or life-threatening bleeding due to increased exposure to warfarin and has not been studied. It is recommended that the INR be monitored.
Atazanavir/cobicistat [1], zolpidem ---> SmPC of [1] of EMA
Concentrations of the sedative/hypnotic may be increased when co-administered with EVOTAZ. The mechanism is inhibition of CYP3A4 by cobicistat. For the sedative/hypnotic, dose reduction may be necessary and concentration monitoring is recommended.
Atazanavir/cobicistat, daclatasvir [2] ---> SmPC of [2] of EMA
Strong inhibitors of CYP3A4 may increase the plasma levels of daclatasvir. Dose adjustment of daclatasvir is recommended when coadministered with strong inhibitors of CYP3A4
Atazanavir/cobicistat, emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
The recommended dose of Descovy is 200/10 mg once daily.
Atazanavir/cobicistat, lenacapavir [2] ---> SmPC of [2] of EMA
Strong inhibitors of CYP3A, P-gp and UGT1A1 together (i.e., all 3 pathways), such as atazanavir/cobicistat, may significantly increase plasma concentrations of lenacapavir, therefore co-administration is not recommended
Atazanavir/cobicistat, tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Co-administration of EVOTAZ and tenofovir alafenamide 25 mg for treatment of HBV infection is not recommended
CONTRAINDICATIONS of Atazanavir/cobicistat (Evotaz)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Co-administration with medicinal products that are strong inducers of the CYP3A4 isoform of cytochrome P450 due to the potential for loss of therapeutic effect and development of possible resistance (see section 4.5); co-administration is contraindicated with, but not limited to, the following medicines:
- carbamazepine, phenobarbital, phenytoin (antiepileptics)
- St John's wort (Hypericum perforatum) (herbal product)
- rifampicin (antimycobacterial)
- apalutamide, encorafenib, ivosidenib (antineoplastics)
- Co-administration with the following medicinal products due to the potential for serious and/or life-threatening adverse reactions (see section 4.5); co-administration is contraindicated with, but not limited to, the following medicines:
- colchicine, when used in patients with renal and/or hepatic impairment (antigout) (see section 4.5)
- sildenafil - when used for the treatment of pulmonary arterial hypertension (see sections 4.5 and 4.4) for co-administration for the treatment of erectile dysfunction), avanafil (PDE5 inhibitors)
- dabigatran (anticoagulant)
- simvastatin and lovastatin (HMG-CoA reductase inhibitors) (see section 4.5)
- lomitapide (lipid-modifying agent)
-grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection) (see section 4.5)
- glecaprevir/pibrentasvir fixed dose combination (see section
- substrates of CYP3A4 or the UGT1A1 isoform of UDP-glucuronyltransferase and have narrow therapeutic windows; co-administration is contraindicated with, but not limited to, the following medicines:
- alfuzosin (alpha-1-adrenoreceptor antagonist)
- amiodarone, bepridil, dronedarone, quinidine, systemic
- lidocaine (antiarrhythmics/antianginals)
- astemizole, terfenadine (antihistamines)
- cisapride (gastrointestinal motility agent)
- ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - pimozide, quetiapine, lurasidone (antipsychotics/neuroleptics) (see section 4.5)
- ticagrelor (platelet aggregation inhibitor)
- triazolam, midazolam administered orally (sedatives/hypnotics) (for caution on parenterally administered midazolam, see section 4.5).
- Moderate to severe hepatic impairment.
https://www.ema.europa.eu/en/documents/product-information/evotaz-epar-product-information_en.pdf 10/07/2025
Atenolol
IMAOs, atenolol
Combination of a MAO inhibitor with a beta-blocker can cause an increase of the pharmacodynamic effects and an increase in blood pressure up to hypertension crises.
NSAID, atenolol [2] ---> SPC of [2] of eMC
Non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. indometacin) may reduce the hypotensive effect of beta-blockers.
Ability to drive, atenolol [2] ---> SPC of [2] of eMC
When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.
Adrenaline, atenolol [2] ---> SPC of [2] of eMC
Alfa- and beta-adrenergic agonists in combination with atenolol may unmask the alpha-adrenoceptor-mediated vasoconstrictor effects of these agents leading to blood pressure increase and exacerbated intermittent claudication.
Adrenaline, betablockers ---> SPC of [atenolol] of eMC
Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the effect of beta-blockers.
Algeldrate/magnesium hydroxide, atenolol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Alpha-methyldopa, atenolol
Bradycardia, delayed conduction of cardiac stimulus
Aluminium hydroxide, atenolol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Aluminium oxide/magnesium hydroxide, atenolol
The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs. It is recommended to separate the times of administration by at least 2 hours
Amiodarone, atenolol [2] ---> SPC of [2] of eMC
Amiodarone with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Amiodarone, atenolol/nifedipine ---> SPC of [atenolol] of eMC
Amiodarone with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Ampicillin, atenolol
The co-administration may decrease the bioavailability of atenolol
Anaesthetics, atenolol [2] ---> SPC of [2] of eMC
Use of beta-blockers with anaesthetic drugs may result in attenuation of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing myocardial depression are best avoided.
Anaesthetics, betablockers ---> SPC of [atenolol] of eMC
Use of beta-blockers with anaesthetic drugs may result in attenuation of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing myocardial depression are best avoided.
Antiarrhythmics, atenolol
Enhanced cardiodepressant effect of atenolol
Antihypertensives, atenolol
Concomitant use of atenolol with antihypertensive agents as well as other drugs with blood pressure lowering potential may increase the risk of hypotension.
Atenolol, baclofen
The co-administration may potentiate the hypotensive effect
Atenolol, barbiturates
Concomitant use of atenolol with antihypertensive agents as well as other drugs with blood pressure lowering potential may increase the risk of hypotension.
Atenolol, beta-adrenergic agonists
Beta-sympathomimetic agents (e.g. isoprenaline, dobutamine) in combination with atenolol may reduce effects of both agents.
Atenolol [1], breast-feeding ---> SPC of [1] of eMC
There is significant accumulation of atenolol in breast milk. Breast feeding is therefore not recommended during administration of these compounds.
Atenolol, carbaldrate
The aluminium salt decreases the absorption of the co-administered active principle. Separate administration by at least 2 hours
Atenolol, cardiodepressants
Concomitant use should be avoided
Atenolol [1], class IA antiarrhythmic agents ---> SPC of [1] of eMC
Caution should be exercised when prescribing a beta-adrenoceptor blocking drug with class I antiarrhythmic agents.
Atenolol [1], class IB antiarrhythmic agents ---> SPC of [1] of eMC
Caution should be exercised when prescribing a beta-adrenoceptor blocking drug with class I antiarrhythmic agents.
Atenolol [1], class IC antiarrhythmic agents ---> SPC of [1] of eMC
Caution should be exercised when prescribing a beta-adrenoceptor blocking drug with class I antiarrhythmic agents.
Atenolol, clonidine
Bradycardia, delayed conduction of cardiac stimulus. Atenolol may exacerbate the rebound hypertension after withdrawing clonidine
Atenolol, clopidogrel [2] ---> SPC of [2] of EMA
No clinically significant pharmacodynamic interactions were observed when clopidogrel was co-administered with atenolol, nifedipine, or both atenolol and nifedipine.
Atenolol [1], digital glycosides ---> SPC of [1] of eMC
Digitalis glycosides in association with beta-blockers may increase auriculo-ventricular conduction time.
Atenolol [1], dihydropyridines ---> SPC of [1] of eMC
Concomitant administration of atenolol und dihydropyridine derivatives may increase the risk of hypotension, and in patients with latent cardiac insufficiency, treatment with beta-blocking agents may lead to cardiac failure.
Atenolol [1], diltiazem ---> SPC of [1] of eMC
Combination should be used with caution in patients with impaired ventricular function, and not at all in patients with conduction abnormalities. May result in severe hypotension, bradycardia and cardiac failure.
Atenolol [1], disopyramide ---> SPC of [1] of eMC
Class I anti-arrhythmic drugs with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Atenolol, diuretics
Concomitant use of atenolol with antihypertensive agents as well as other drugs with blood pressure lowering potential may increase the risk of hypotension.
Atenolol, fingolimod [2] ---> SPC of [2] of EMA
Treatment with Gilenya should not be initiated in patients receiving beta blockers, or other substances which may decrease heart rate because of the potential additive effects on heart rate
Atenolol, floctafenine
Atenolol may impede the compensatory cardiovascular reactions associated with hypotension/shock that may be induced by floctafenine. The combination is contraindicated
Atenolol, fluvoxamine [2] ---> SPC of [2] of eMC
Fluvoxamine does not influence plasma concentrations of atenolol.
Atenolol, guanfacin
Bradycardia, delayed conduction of cardiac stimulus
Atenolol [1], ibuprofen ---> SPC of [1] of eMC
Concomitant use of prostaglandin synthetase-inhibiting drugs may decrease the hypotensive effects of beta-blockers.
Atenolol [1], indometacin ---> SPC of [1] of eMC
Concomitant use of prostaglandin synthetase-inhibiting drugs may decrease the hypotensive effects of beta-blockers.
Atenolol, insulin
Concomitant use of atenolol with insulin and oral antidiabetic drugs may intensify the blood sugar lowering effect. Beta-adrenergic blockade may prevent the appearance of signs of hypoglycaemia (tachycardia).
Atenolol, iodinated contrast media
Atenolol may impede the compensatory cardiovascular reactions associated with hypotension/shock that may be induced by iodinated contrast. Caution is recommended
Atenolol, magnesium hydroxide
The co-administration of magnesium hydroxide may decrease the absorption of atenolol. Separate administration by 2-3 hours
Atenolol, mebezonium
Enhancement and prolongation of the muscle relaxant effect
Atenolol, methyldopa
Bradycardia, delayed conduction of cardiac stimulus
Atenolol, narcotics
Enhancement of hypotensive effect. Addition of the negative inotrope effect
Atenolol [1], nifedipine ---> SPC of [1] of eMC
Concomitant administration of atenolol und dihydropyridine derivatives may increase the risk of hypotension, and in patients with latent cardiac insufficiency, treatment with beta-blocking agents may lead to cardiac failure.
Atenolol, noradrenaline
Alfa- and beta-adrenergic agonists in combination with atenolol may unmask the alpha-adrenoceptor-mediated vasoconstrictor effects of these agents leading to blood pressure increase and exacerbated intermittent claudication.
Atenolol, oral antidiabetics
Concomitant use of atenolol with insulin and oral antidiabetic drugs may intensify the blood sugar lowering effect. Beta-adrenergic blockade may prevent the appearance of signs of hypoglycaemia (tachycardia).
Atenolol, oxetacaine
Decreased absorption of atenolol
Atenolol, pancuronium
Enhancement and prolongation of the muscle relaxant effect
Atenolol, peripheral muscle relaxants
Enhancement and prolongation of the muscle relaxant effect
Atenolol, phenothiazines
Concomitant use of atenolol with antihypertensive agents as well as other drugs with blood pressure lowering potential may increase the risk of hypotension.
Atenolol, phenylalkylamines
Negative influence on the contractility and AV conduction. Combination contraindicated.
Atenolol [1], pregnancy ---> SPC of [1] of eMC
Atenolol crosses the placental barrier. Adverse effects (especially hypoglycaemia and bradycardia) may occur in foetus and neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period.
Atenolol [1], prostaglandin synthesis inhibitors ---> SPC of [1] of eMC
NSAIDs (especially indometacin) may reduce the antihypertensive effects of beta-blockers possibly by inhibiting renal prostaglandin synthesis and/or causing sodium and fluid retention.
Atenolol, quinidine
Caution should be exercised when prescribing a beta-adrenoceptor blocking drug with class I antiarrhythmic agents.
Atenolol, reserpine
Bradycardia, delayed conduction of cardiac stimulus
Atenolol, rifampicin
Rifampicin, enzymatic inductor, may increase the metabolism of atenolol and decrease its plasma levels and effect
Atenolol, succinylcholine
The co-administration may enhance or prolong the neuromuscular blocking effects of suxamethonium
Atenolol, sulfonylureas
Enhancement of the hypoglycaemic effect. Blockade of beta-adrenoreceptors may mask the symptoms of hypoglycaemia
Atenolol, sultopride
Increased risk of ventricular arrhythmias. Concomitant use should be avoided
Atenolol, suxamethonium
The co-administration may enhance or prolong the neuromuscular blocking effects of suxamethonium
Atenolol [1], sympathomimetics ---> SPC of [1] of eMC
Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the effect of beta-blockers.
Atenolol, tricyclic antidepressants
Concomitant use of atenolol with antihypertensive agents as well as other drugs with blood pressure lowering potential may increase the risk of hypotension.
Atenolol, tubocuranine
Enhancement and prolongation of the muscle relaxant effect
Atenolol, valsartan [2] ---> SPC of [2] of eMC
In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan and atenolol
Atenolol, vasodilators
Concomitant use of atenolol with antihypertensive agents as well as other drugs with blood pressure lowering potential may increase the risk of hypotension.
Atenolol [1], verapamil ---> SPC of [1] of eMC
Combination should be used with caution in patients with impaired ventricular function, and not at all in patients with conduction abnormalities. May result in severe hypotension, bradycardia and cardiac failure.
Atenolol/nifedipine, benzothiazepines ---> SPC of [atenolol] of eMC
Atenolol/nifedipine must not be used in conjunction with calcium channel blockers with negative inotropic effects since this can lead to an exaggeration of these effects. It may result in severe hypotension, bradycardia and cardiac failure
Atenolol/nifedipine, diltiazem ---> SPC of [atenolol] of eMC
Atenolol/nifedipine must not be used in conjunction with calcium channel blockers with negative inotropic effects since this can lead to an exaggeration of these effects. It may result in severe hypotension, bradycardia and cardiac failure
Atenolol/nifedipine, phenylalkylamines ---> SPC of [atenolol] of eMC
Atenolol/nifedipine must not be used in conjunction with calcium channel blockers with negative inotropic effects since this can lead to an exaggeration of these effects. It may result in severe hypotension, bradycardia and cardiac failure
Atenolol/nifedipine, verapamil ---> SPC of [atenolol] of eMC
Atenolol/nifedipine must not be used in conjunction with calcium channel blockers with negative inotropic effects since this can lead to an exaggeration of these effects. It may result in severe hypotension, bradycardia and cardiac failure
Benzothiazepines, betablockers ---> SPC of [atenolol] of eMC
Beta-blockers should not be given in combination with calcium channel blockers of diltiazem type since this may cause bradycardia, hypotension, heart failure and asystole and may increase auriculo-ventricular conduction time.
Betablockers, general anesthetics ---> SPC of [atenolol] of eMC
Use of beta-blockers with anaesthetic drugs may result in attenuation of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing myocardial depression are best avoided.
Betablockers, prostaglandin synthesis inhibitors ---> SPC of [atenolol] of eMC
NSAIDs (especially indometacin) may reduce the antihypertensive effects of beta-blockers possibly by inhibiting renal prostaglandin synthesis and/or causing sodium and fluid retention.
CONTRAINDICATIONS of Atenolol
Atenolol, as with other beta-blockers, should not be used in patients with any of the following:
- Second or third degree heart block
- Cardiogenic shock
- Uncontrolled heart failure
- Sick sinus syndrome (including sino-atrial block)
- Untreated phaeochromocytoma
- Metabolic acidosis
- Bradycardia (less than 45-50 beats per minute)
- Hypotension
- Hypersensitivity to atenolol or any of the excipients
- Severe peripheral circulatory disturbances.
http://www.medicines.org.uk/emc/
Atenolol/chlortalidone
ACE inhibitors, atenolol/chlortalidone
Diuretics potentiate the action of antihypertensive drugs
ACTH, atenolol/chlortalidone
The hypokalaemic effect of diuretics may be potentiated by ACTH
IMAOs, atenolol/chlortalidone
Excessive increase of the blood pressure (except MAO B)
NSAID, atenolol/chlortalidone [2] ---> SPC of [2] of eMC
Concomitant use of prostaglandin synthetase-inhibiting drugs may decrease the hypotensive effects of beta-blockers.
Ability to drive, atenolol/chlortalidone [2] ---> SPC of [2] of eMC
It should be taken into account that occasionally dizziness or fatigue may occur.
Adrenaline, atenolol/chlortalidone [2] ---> SPC of [2] of eMC
Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the effect of beta-blockers.
Alcohol, atenolol/chlortalidone
Enhanced antihypertensive effect
Alpha-methyldopa, atenolol/chlortalidone
Enhanced antihypertensive effect and bradycardia
Amiodarone, atenolol/chlortalidone [2] ---> SPC of [2] of eMC
Amiodarone with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Amphotericin, atenolol/chlortalidone
Increased loss of potassium and/or magnesium.
Anaesthetics, atenolol/chlortalidone [2] ---> SPC of [2] of eMC
Use of beta-blockers with anaesthetic drugs may result in attenuation of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing myocardial depression are best avoided.
Antigout preparations, atenolol/chlortalidone
Decreased uric acid lowering effect
Antihypertensives, atenolol/chlortalidone
Enhanced antihypertensive effect
Atenolol/chlortalidone [1], baclofen ---> SPC of [1] of eMC
Concomitant use of baclofen may increase the antihypertensive effect making dose adjustments necessary.
Atenolol/chlortalidone, barbiturates
Enhanced antihypertensive effect
Atenolol/chlortalidone [1], benzothiazepines ---> SPC of [1] of eMC
Combined use of beta-blockers and calcium channel blockers with negative inotropic effects can lead to an exaggeration of these effects. This may result in severe hypotension, bradycardia and cardiac failure.
Atenolol/chlortalidone, biguanides
Concomitant use with insulin and oral antidiabetic drugs may lead to the intensification of the blood sugar lowering effects of these drugs.
Atenolol/chlortalidone [1], breast-feeding ---> SPC of [1] of eMC
It must not be given during lactation.
Atenolol/chlortalidone, calcium
Increased serum calcium
Atenolol/chlortalidone, carbenoxolone
Increased loss of potassium and/or magnesium.
Atenolol/chlortalidone, cholestyramine
Decreased absorption of atenolol/chlortalidone
Atenolol/chlortalidone [1], class IA antiarrhythmic agents ---> SPC of [1] of eMC
Class I anti-arrhythmic drugs with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Atenolol/chlortalidone [1], class IB antiarrhythmic agents ---> SPC of [1] of eMC
Class I anti-arrhythmic drugs with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Atenolol/chlortalidone [1], class IC antiarrhythmic agents ---> SPC of [1] of eMC
Class I anti-arrhythmic drugs with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Atenolol/chlortalidone, clonidine
Enhanced antihypertensive effect and bradycardia
Atenolol/chlortalidone, colestipol
Decreased absorption of atenolol/chlortalidone
Atenolol/chlortalidone, curare-type muscle relaxants
Diuretics potentiate the action of curare derivatives
Atenolol/chlortalidone, cyclophosphamide
Increased bone marrow toxicity (especially granulocytopenia)
Atenolol/chlortalidone, cytostatics
Increased bone marrow toxicity (especially granulocytopenia)
Atenolol/chlortalidone [1], digital glycosides ---> SPC of [1] of eMC
Digitalis glycosides, in association with beta-blockers, may increase atrio-ventricular conduction time.
Atenolol/chlortalidone [1], dihydropyridines ---> SPC of [1] of eMC
Concomitant therapy with dihydropyridines may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.
Atenolol/chlortalidone [1], diltiazem ---> SPC of [1] of eMC
Combined use of beta-blockers and calcium channel blockers with negative inotropic effects can lead to an exaggeration of these effects. This may result in severe hypotension, bradycardia and cardiac failure.
Atenolol/chlortalidone [1], disopyramide ---> SPC of [1] of eMC
Class I anti-arrhythmic drugs with atenolol may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.
Atenolol/chlortalidone, diuretics
Enhanced antihypertensive effect
Atenolol/chlortalidone, fluorouracil
Increased bone marrow toxicity (especially granulocytopenia)
Atenolol/chlortalidone, furosemide
Increased loss of potassium and/or magnesium.
Atenolol/chlortalidone, glucocorticoids
Increased loss of potassium and/or magnesium.
Atenolol/chlortalidone, guanfacin
Enhanced antihypertensive effect and bradycardia
Atenolol/chlortalidone [1], ibuprofen ---> SPC of [1] of eMC
Concomitant use of prostaglandin synthetase-inhibiting drugs may decrease the hypotensive effects of beta-blockers.
Atenolol/chlortalidone [1], indometacin ---> SPC of [1] of eMC
Concomitant use of prostaglandin synthetase-inhibiting drugs may decrease the hypotensive effects of beta-blockers.
Atenolol/chlortalidone, insulin
Concomitant use with insulin and oral antidiabetic drugs may lead to the intensification of the blood sugar lowering effects of these drugs.
Atenolol/chlortalidone, kaliuretic medicines
Increased loss of potassium and/or magnesium.
Atenolol/chlortalidone, laxatives
Increased loss of potassium and/or magnesium.
Atenolol/chlortalidone [1], lithium ---> SPC of [1] of eMC
The chlortalidone component may reduce the renal clearance of lithium leading to increased serum concentrations. Dose adjustments of lithium may therefore be necessary.
Atenolol/chlortalidone, methotrexate
Increased bone marrow toxicity (especially granulocytopenia)
Atenolol/chlortalidone, methyldopa
Enhanced antihypertensive effect and bradycardia
Atenolol/chlortalidone [1], nifedipine ---> SPC of [1] of eMC
Concomitant therapy with dihydropyridines may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.
Atenolol/chlortalidone, oral antidiabetics
Concomitant use with insulin and oral antidiabetic drugs may lead to the intensification of the blood sugar lowering effects of these drugs.
Atenolol/chlortalidone, phenothiazines
Enhanced antihypertensive effect
Atenolol/chlortalidone [1], phenylalkylamines ---> SPC of [1] of eMC
Combined use of beta-blockers and calcium channel blockers with negative inotropic effects can lead to an exaggeration of these effects. This may result in severe hypotension, bradycardia and cardiac failure.
Atenolol/chlortalidone [1], pregnancy ---> SPC of [1] of eMC
It must not be given during pregnancy
Atenolol/chlortalidone [1], prostaglandin synthesis inhibitors ---> SPC of [1] of eMC
NSAIDs (especially indometacin) may reduce the antihypertensive effects of beta-blockers possibly by inhibiting renal prostaglandin synthesis and/or causing sodium and fluid retention.
Atenolol/chlortalidone, reserpine
Enhanced antihypertensive effect and bradycardia
Atenolol/chlortalidone, sulfonylureas
Concomitant use with insulin and oral antidiabetic drugs may lead to the intensification of the blood sugar lowering effects of these drugs.
Atenolol/chlortalidone [1], sympathomimetics ---> SPC of [1] of eMC
Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the effect of beta-blockers.
Atenolol/chlortalidone, tricyclic antidepressant
Enhanced antihypertensive effect
Atenolol/chlortalidone, vasodilators
Enhanced antihypertensive effect
Atenolol/chlortalidone [1], verapamil ---> SPC of [1] of eMC
Combined use of beta-blockers and calcium channel blockers with negative inotropic effects can lead to an exaggeration of these effects. This may result in severe hypotension, bradycardia and cardiac failure.
Atenolol/chlortalidone, vitamin D
Increased serum calcium
Betablockers, ibuprofen ---> SPC of [atenolol/chlortalidone] of eMC
Concomitant use of prostaglandin synthetase-inhibiting drugs may decrease the hypotensive effects of beta-blockers.
Betablockers, indometacin ---> SPC of [atenolol/chlortalidone] of eMC
Concomitant use of prostaglandin synthetase-inhibiting drugs may decrease the hypotensive effects of beta-blockers.
CONTRAINDICATIONS of Atenolol/chlortalidone
- known hypersensitivity to atenolol and chlortalidone (or to sulphonamide derived medicinal products) or any other component of the product
- bradycardia;
- cardiogenic shock;
- hypotension;
- metabolic acidosis;
- severe peripheral arterial circulatory disturbances;
- second- or third-degree heart block;
- sick sinus syndrome;
- untreated phaeochromocytoma;
- severe renal failure;
- uncontrolled heart failure.
Tenoret tablets must not be given during pregnancy or lactation.
http://www.medicines.org.uk/emc/
Atezolizumab (Tecentriq)
Ability to drive, atezolizumab [2] ---> SmPC of [2] of EMA
Tecentriq has minor influence on the ability to drive and use machines. Patients experiencing fatigue should be advised not to drive and use machines until symptoms abate (see section 4.8).
Atezolizumab [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue Tecentriq therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Atezolizumab [1], corticosteroids ---> SmPC of [1] of EMA
The use of systemic corticosteroids or immunosuppressants before starting atezolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of atezolizumab.
Atezolizumab [1], fertility ---> SmPC of [1] of EMA
Based on the 26-week repeat dose toxicity study, atezolizumab had an effect on menstrual cycles at an estimated AUC approximately 6 times the AUC in patients receiving the recommended dose and was reversible
Atezolizumab [1], immunosuppressives ---> SmPC of [1] of EMA
The use of systemic corticosteroids or immunosuppressants before starting atezolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of atezolizumab.
Atezolizumab [1], pregnancy ---> SmPC of [1] of EMA
Atezolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with atezolizumab.
Atezolizumab [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential have to use effective contraception during and for 5 months after treatment with atezolizumab.
CONTRAINDICATIONS of Atezolizumab (Tecentriq)
- Hypersensitivity to atezolizumab or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf 18/11/2025
Atidarsagene (Libmeldy)
Ability to drive, atidarsagene [2] ---> SmPC of [2] of EMA
The effect of the mobilisation agents and the myeloablative conditioning agent on the ability to drive or use machines must be considered.
Antiretrovirals, atidarsagene [2] ---> SmPC of [2] of EMA
Patients should not take anti-retroviral medicinal products from at least one month prior to mobilisation until at least 7 days after Libmeldy infusion (see section 4.4).
Atidarsagene [1], fertility ---> SmPC of [1] of EMA
It should be noted that the treating physician should inform the patient's parents/carers about options for cryopreservation of spermatogonial stem cells or ovarian tissue.
Atidarsagene [1], pharmacokinetics ---> SmPC of [1] of EMA
The nature of Libmeldy is such that no pharmacokinetic interactions are expected with other medicinal products.
Atidarsagene [1], pregnancy ---> SmPC of [1] of EMA
As Libmeldy is not intended for use in adults, human data on use during pregnancy or lactation and animal reproduction studies are not available.
Atidarsagene [1], vaccinations ---> SmPC of [1] of EMA
Vaccination with live virus vaccines is not recommended during the 6 weeks preceding the start of myeloablative conditioning, and until haematological recovery following treatment with Libmeldy.
CONTRAINDICATIONS of Atidarsagene (Libmeldy)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Previous treatment with haematopoietic stem cells gene therapy.
- Contraindications to the mobilisation and the myeloablative medicinal products must be considered.
https://www.ema.europa.eu/en/documents/product-information/libmeldy-epar-product-information_en.pdf 28/07/2025
Atogepant (Aquipta)
Ability to drive, atogepant [2] ---> SmPC of [2] of EMA
Patients should exercise caution before driving or using machinery until they are reasonably certain that atogepant does not adversely affect performance.
Atogepant [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from atogepant therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Atogepant [1], clarithromycin ---> SmPC of [1] of EMA
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) can significantly increase systemic exposure to atogepant.
Atogepant [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA
Changes in atogepant exposure when co-administered with weak or moderate CYP3A4 inhibitors are not expected to be clinically significant.
Atogepant [1], esomeprazole ---> SmPC of [1] of EMA
Co-administration with famotidine or esomeprazole did not result in clinically relevant changes of atogepant exposure.
Atogepant [1], ethinyl estradiol/levonorgestrel ---> SmPC of [1] of EMA
Co-administration of atogepant with paracetamol, naproxen, sumatriptan, or ubrogepant did not result in significant pharmacokinetic interactions for either atogepant or co-administered medicinal products.
Atogepant [1], famotidine ---> SmPC of [1] of EMA
Co-administration with famotidine or esomeprazole did not result in clinically relevant changes of atogepant exposure.
Atogepant [1], fertility ---> SmPC of [1] of EMA
Animal studies showed no impact on female and male fertility with atogepant treatment (see section 5.3).
Atogepant [1], itraconazol ---> SmPC of [1] of EMA
Co-administration of atogepant with itraconazole resulted in increased exposure (Cmax by 2.15-fold and AUC by 5.5-fold) of atogepant in healthy subjects (see section 4.2).
Atogepant [1], ketoconazole ---> SmPC of [1] of EMA
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) can significantly increase systemic exposure to atogepant.
Atogepant [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
Changes in atogepant exposure when co-administered with weak or moderate CYP3A4 inhibitors are not expected to be clinically significant.
Atogepant [1], naproxen ---> SmPC of [1] of EMA
Co-administration of atogepant with paracetamol, naproxen, sumatriptan, or ubrogepant did not result in significant pharmacokinetic interactions for either atogepant or co-administered medicinal products.
Atogepant [1], OATP inhibitors ---> SmPC of [1] of EMA
Organic anion transporting polypeptide (OATP) inhibitors (e.g., rifampicin, ciclosporin, ritonavir) can significantly increase systemic exposure to atogepant.
Atogepant [1], paracetamol ---> SmPC of [1] of EMA
Co-administration of atogepant with paracetamol, naproxen, sumatriptan, or ubrogepant did not result in significant pharmacokinetic interactions for either atogepant or co-administered medicinal products.
Atogepant [1], pregnancy ---> SmPC of [1] of EMA
Atogepant is not recommended during pregnancy and in women of childbearing potential not using contraception.
Atogepant [1], rifampicin ---> SmPC of [1] of EMA
Co-administration of atogepant with single dose rifampicin resulted in increased exposure (Cmax by 2.23-fold and AUC by 2.85-fold) of atogepant in healthy subjects (see section 4.2).
Atogepant [1], ritonavir ---> SmPC of [1] of EMA
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) can significantly increase systemic exposure to atogepant.
Atogepant [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) can significantly increase systemic exposure to atogepant.
Atogepant [1], sumatriptan ---> SmPC of [1] of EMA
Co-administration of atogepant with paracetamol, naproxen, sumatriptan, or ubrogepant did not result in significant pharmacokinetic interactions for either atogepant or co-administered medicinal products.
CONTRAINDICATIONS of Atogepant (Aquipta)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/aquipta-epar-product-information_en.pdf. 25/08/2023
Atomoxetine
IMAOs, atomoxetine
Atomoxetine should not be used in combination with MAOIs. Atomoxetine should not be used within a minimum of 2 weeks before initiation nor 2 weeks after discontinuing therapy with MAOI
QT interval prolonging drugs, atomoxetine
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs
SSRI, atomoxetine
Seizures are a potential risk with atomoxetine. Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold
Ability to drive, atomoxetine
Atomoxetine was associated with increased rates of fatigue relative to placebo.
Antihypertensives, atomoxetine
Atomoxetine may decrease the hypotensive effect and increase the blood pressure. Monitor closely the blood pressure.
Atomoxetine, bendroflumethiazide
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with drugs that cause electrolyte imbalance (such as thiazide diuretics)
Atomoxetine, beta2-adrenergic agonists
Atomoxetine should be administered with caution with high dose nebulised or systemically administered (oral/IV) salbutamol (or other ß2-agonists) because the action of salbutamol on the cardiovascular system can be potentiated.
Atomoxetine, breast-feeding
Because of the lack of data, atomoxetine should be avoided during breastfeeding.
Atomoxetine, bupropion
Seizures are a potential risk with atomoxetine. Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold
Atomoxetine, butyrophenones
Seizures are a potential risk with atomoxetine. Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold
Atomoxetine, chloroquine
Seizures are a potential risk with atomoxetine. Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold
Atomoxetine, cisapride
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs
Atomoxetine, class IA antiarrhythmic agents
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs
Atomoxetine, class III antiarrhythmic agents
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs
Atomoxetine, dextromethorphan/quinidine [2] ---> SPC of [2] of EMA
Quinidine is a potent inhibitor of CYP2D6. Treatment with dextromethorphan/quinidine may therefore result in elevated plasma levels and accumulation of co-administered medicinal products that undergo extensive CYP2D6 metabolism.
Atomoxetine, electrolyte imbalance
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with drugs that cause electrolyte imbalance (such as thiazide diuretics)
Atomoxetine, eliglustat [2] ---> SPC of [2] of EMA
Concomitant administration of eliglustat with CYP2D6 substrates may increase the exposition of these substrates. Lower doses of medicinal products that are CYP2D6 substrates may be required.
Atomoxetine, erythromycin
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs
Atomoxetine, fluoxetine
The CYP2D6 inhibition may increase the AUC of atomoxetine ca. 6- to 8-fold. There is the potential for an increased risk of QT interval prolongation
Atomoxetine, hypertensive drugs
Atomoxetine may increase more the blood pressure. Atomoxetine should be used cautiously with pressor agents.
Atomoxetine, imipramine
Drugs that affect noradrenaline should be used cautiously when co-administered with atomoxetine because of the potential for additive or synergistic pharmacological effects.
Atomoxetine, lithium
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs
Atomoxetine, mefloquine
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs. There is also a risk of lowering the seizure threshold
Atomoxetine, methadone
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs
Atomoxetine, mirtazapine
Drugs that affect noradrenaline should be used cautiously when co-administered with atomoxetine because of the potential for additive or synergistic pharmacological effects.
Atomoxetine, moxifloxacin
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs
Atomoxetine, non-potassium-sparing diuretics
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with drugs that cause electrolyte imbalance (such as thiazide diuretics)
Atomoxetine, noradrenaline
Drugs that affect noradrenaline should be used cautiously when co-administered with atomoxetine because of the potential for additive or synergistic pharmacological effects.
Atomoxetine, norepinephrine
Drugs that affect noradrenaline should be used cautiously when co-administered with atomoxetine because of the potential for additive or synergistic pharmacological effects.
Atomoxetine, panobinostat [2] ---> SPC of [2] of EMA
Panobinostat increased the Cmax and the AUC of dextromethorphan (a substrate of CYP2D6) by 1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate.
Atomoxetine, paroxetine [2] ---> SPC of [2] of eMC
Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.
Atomoxetine, phenothiazines
Seizures are a potential risk with atomoxetine. Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold
Atomoxetine, phenylephrine
Drugs that affect noradrenaline should be used cautiously when co-administered with atomoxetine because of the potential for additive or synergistic pharmacological effects.
Atomoxetine, pregnancy
Atomoxetine should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Atomoxetine, pseudoephedrine
Drugs that affect noradrenaline should be used cautiously when co-administered with atomoxetine because of the potential for additive or synergistic pharmacological effects.
Atomoxetine, quinidine
The CYP2D6 inhibition may increase the AUC of atomoxetine ca. 6- to 8-fold. There is the potential for an increased risk of QT interval prolongation
Atomoxetine, salbutamol
Atomoxetine should be administered with caution with high dose nebulised or systemically administered (oral/IV) salbutamol (or other ß2-agonists) because the action of salbutamol on the cardiovascular system can be potentiated.
Atomoxetine, seizure-threshold lowering drugs
Seizures are a potential risk with atomoxetine. Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold
Atomoxetine, strong CYP2D6 inhibitors
The CYP2D6 inhibition may increase the AUC of atomoxetine ca. 6- to 8-fold. There is the potential for an increased risk of QT interval prolongation
Atomoxetine, terbinafine
The CYP2D6 inhibition may increase the AUC of atomoxetine ca. 6- to 8-fold. There is the potential for an increased risk of QT interval prolongation
Atomoxetine, thiazides
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with drugs that cause electrolyte imbalance (such as thiazide diuretics)
Atomoxetine, tramadol
Seizures are a potential risk with atomoxetine. Caution is advised with concomitant use of medicinal drugs which are known to lower the seizure threshold
Atomoxetine, triamterene
Hypokalaemia caused by diuretics increases risk of ventricular arrhythmias with atomoxetine
Atomoxetine, tricyclic antidepressants
There is the potential for an increased risk of QT interval prolongation when atomoxetine is administered with other QT prolonging drugs. There is also a risk of lowering the seizure threshold
Atomoxetine, venlafaxine
Drugs that affect noradrenaline should be used cautiously when co-administered with atomoxetine because of the potential for additive or synergistic pharmacological effects.
Atorvastatin
OATP1B1 inhibitors, atorvastatin [2] ---> SPC of [2] of eMC
Inhibitors of transport proteins can increase the systemic exposure of atorvastatin
P-gp inductors, atorvastatin
The induction of the P-glycoprotein can decrease the bioavailability of atorvastatin
St. John's wort, atorvastatin [2] ---> SPC of [2] of eMC
Concomitant administration of atorvastatin with inducers of cytochrome P450 3A can lead to variable reductions in plasma concentrations of atorvastatin.
Acenocoumarol [1], atorvastatin ---> SPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Aliskiren, atorvastatin ---> SPC of [aliskiren/amlodipine] of EMA
Coadministration of aliskiren had no significant impact on atorvastatin pharmacokinetics. As a result no dose adjustment is necessary.
Aliskiren/amlodipine [1], atorvastatin ---> SPC of [1] of EMA
Coadministration of aliskiren had no significant impact on atorvastatin pharmacokinetics. As a result no dose adjustment is necessary.
Aluminium hydroxide, atorvastatin
Concomitant use of aluminium hydroxide may decrease the absorption and effect of atorvastatin. Separate administration by at least 2-3 hours
Amiodarone [1], atorvastatin ---> SPC of [1] of eMC
The risk of muscular toxicity is increased by concomitant administration of amiodarone with statins metabolised by CYP 3A4 such as simvastatin, atorvastatin and lovastatin.
Amlodipine, atorvastatin [2] ---> SPC of [2] of eMC
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin
Amlodipine/valsartan [1], atorvastatin ---> SPC of [1] of EMA
In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.
Amprenavir [1], atorvastatin ---> SPC of [1] of EMA
Amprenavir, strong CYP3A4 inhibitor, must not be administered with drugs with narrow therapeutic range that are substrates of CYP3A4. Possible serious adverse events
Amprenavir/ritonavir, atorvastatin ---> SPC of [amprenavir] of EMA
Amprenavir/ritonavir, CYP3A4 inhibitors, increase the plasma concentrations of atorvastatin. Doses of atorvastatin no greater than 20 mg/day should be administered
Ataluren [1], atorvastatin ---> SPC of [1] of EMA
Caution should be exercised when ataluren is co-administered with medicinal products that are substrates of UGT1A9, OAT1, OAT3, or OATP1B3 because of the risk of increase concentration of these medicinal products
Atazanavir [1], atorvastatin ---> SPC of [1] of EMA
The risk of myopathy including rhabdomyolysis may be increased with atorvastatin, which is metabolised by CYP3A4. Concomitant use is not recommended
Atazanavir/cobicistat [1], atorvastatin ---> SPC of [1] of EMA
The risk of myopathy including rhabdomyolysis may be increased with atorvastatin, which is metabolised by CYP3A4. Co-administration of atorvastatin with EVOTAZ is not recommended.
Atorvastatin [1], azole antifungals ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin, bazedoxifene ---> SPC of [conjugated oestrogens/bazedoxifene] of EMA
There were no significant pharmacokinetic interactions between bazedoxifene and atorvastatin
Atorvastatin, bexarotene [2] ---> SPC of [2] of EMA
Data from clinical studies indicate that bexarotene concentrations were not affected by concomitant administration of atorvastatin.
Atorvastatin, boceprevir [2] ---> SPC of [2] of EMA
Exposure to atorvastatin was increased when administered with Victrelis. When co-administration is required, starting with the lowest possible dose of atorvastatin should be considered with titration up to desired clinical effect while monitoring for saf
Atorvastatin, boceprevir
Exposure to atorvastatin was increased when administered with boceprevir.
Atorvastatin [1], breast-feeding ---> SPC of [1] of eMC
Atorvastatin is contraindicated during breastfeeding
Atorvastatin [1], carbamazepine ---> SPC of [1] of eMC
Carbamazepine may lower the plasma level of atorvastatin
Atorvastatin, cilostazol [2] ---> SPC of [2] of EMA
Caution is advised in case of co-administration of cilostazol (CYP3A4 inhibitor) with statins metabolised by CYP3A4
Atorvastatin [1], clarithromycin ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin, cobicistat [2] ---> SPC of [2] of EMA
Co-administration of atorvastatin with cobicistat is not recommended. If the use of atorvastatin is considered strictly necessary, the lowest possible dose of atorvastatin should be administered with careful monitoring.
Atorvastatin, colchicine
Concomitant use of medicinal products that may cause rhabdomyolysis, in particular fibrates and statins, may increase the risk of rhabdomyolysis
Atorvastatin, colchicine
Cases of myopathy have been reported with atorvastatin coadministered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine
Atorvastatin [1], colestipol ---> SPC of [1] of eMC
The co-administration reduces plasma levels of atorvastatin. However, lipid effects were greater when atorvastatin and colestipol were co-administered than when either medicinal product was given alone.
Atorvastatin, conjugated oestrogens/bazedoxifene [2] ---> SPC of [2] of EMA
There were no significant pharmacokinetic interactions between bazedoxifene and atorvastatin
Atorvastatin [1], coumarin anticoagulants ---> SPC of [1] of eMC
Prothrombin time should be determined before starting atorvastatin in patients taking coumarin anticoagulants and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs.
Atorvastatin [1], cyclosporine ---> SPC of [1] of eMC
Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of atorvastatin such as potent inhibitors of CYP3A4 or transport proteins
Atorvastatin, cyproterone [2] ---> SPC of [2] of eMC
The risk of statin-associated myopathy or rhabdomyolysis may be increased when those statins which are mainly metabolised by CYP3A4 are co-administered with high therapeutic cyproterone doses, since they share the same metabolic pathway.
Atorvastatin, cyproterone/ethinylestradiol
Atorvastatin may increase plasma concentrations of ethinylestradiol
Atorvastatin, dabrafenib [2] ---> SPC of [2] of EMA
Interactions with many medicinal products eliminated through metabolism or active transport is expected. These medicinal products are to be avoided or used with caution.
Atorvastatin, daclatasvir [2] ---> SPC of [2] of EMA
Inhibition of OATP 1B1 and/or BCRP by daclatasvir may increase plasma concentration of statin. Caution should be used when daclatasvir is coadministered with rosuvastatin or other substrates of OATP 1B1 or BCRP.
Atorvastatin, danazol [2] ---> SPC of [2] of eMC
The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins metabolised by CYP3A4
Atorvastatin [1], darunavir ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin, darunavir/cobicistat [2] ---> SPC of [2] of EMA
Concomitant use of a HMG CoA reductase inhibitor and darunavir/cobicistat may increase plasma concentrations of the lipid lowering agent, which may lead to adverse events such as myopathy.
Atorvastatin, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Based on theoretical considerations DRV/COBI is expected to increase these HMG Co-A reductase inhibitor plasma concentrations. CYP3A inhibition and/or transport
Atorvastatin, darunavir/ritonavir ---> SPC of [darunavir] of EMA
The co-administration may increase the plasma levels of atorvastatin
Atorvastatin, dasabuvir with ombitasvir/paritaprevir/ritonavir ---> SPC of [ombitasvir/paritaprevir/ritonavir] of
Ritonavir is a strong inhibitor of CYP3A. Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events are contraindicated
Atorvastatin [1], delavirdine ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin [1], digoxin ---> SPC of [1] of eMC
When multiple doses of digoxin and 10 mg atorvastatin were co-administered, steady-state digoxin concentrations increased slightly. Patients taking digoxin should be monitored appropriately.
Atorvastatin, digoxin
When multiple doses of digoxin and 10 mg atorvastatin were coadministered, steady-state digoxin concentrations increased slightly. Patients taking digoxin should be monitored appropriately.
Atorvastatin [1], diltiazem ---> SPC of [1] of eMC
Moderate CYP3A4 inhibitors may increase plasma concentrations of atorvastatin. Appropriate clinical monitoring of the patient is recommended when concomitantly used of atorvastatin with moderate CYP3A4 inhibitors.
Atorvastatin, dolutegravir/rilpivirine [2] ---> SPC of [2] of EMA
No dose adjustment is required.
Atorvastatin, dronedarone [2] ---> SPC of [2] of EMA
Dronedarone can increase exposure of statins that are substrates of CYP 3A4 and/or P-gp substrates or transported by OATP. Concomitant use of statins should be undertaken with caution.
Atorvastatin, dulaglutide [2] ---> SPC of [2] of EMA
No dose adjustment of atorvastatin is necessary when administered with dulaglutide.
Atorvastatin, efavirenz [2] ---> SPC of [2] of EMA
Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of atorvastatin. Cholesterol levels should be periodically monitored.
Atorvastatin, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Cholesterol levels should be periodically monitored. Dosage adjustments of atorvastatin may be required when co-administered with Atripla
Atorvastatin, elbasvir/grazoprevir [2] ---> SPC of [2] of EMA
Primarily due to intestinal BCRP inhibition. The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Atorvastatin, eltrombopag [2] ---> SPC of [2] of EMA
When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken
Atorvastatin, eluxadoline [2] ---> SPC of [2] of EMA
Eluxadoline increases the exposure of the co-administered OATP1B1 substrate; rosuvastatin by up to 40% of the total exposure which is usually not considered to be clinically relevant.
Atorvastatin, eluxadoline [2] ---> SPC of [2] of EMA
The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin and atorvastatin), however, may be more pronounced.
Atorvastatin, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Concentrations of atorvastatin and pitavastatin may be increased when administered with elvitegravir and cobicistat. Co-administration of atorvastatin with Genvoya is not recommended.
Atorvastatin, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
The co-administration may increase the plasma levels of statine. The co-administration is not advisable
Atorvastatin, emtricitabine/rilpivirine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
No dose adjustment is required.
Atorvastatin, emtricitabine/rilpivirine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
No dosage adjustment necessary.
Atorvastatin, encorafenib [2] ---> SPC of [2] of EMA
Concomitant agents that are substrates of UGT1A1 (e.g. raltegravir, atorvastatin, dolutegravir) may have increased exposure and should be therefore administered with caution.
Atorvastatin, enzalutamide [2] ---> SPC of [2] of EMA
Enzalutamide, a strong inducer of CYP3A4, can affect the statins metabolized by CYP3A4
Atorvastatin [1], erythromycin ---> SPC of [1] of eMC
Moderate CYP3A4 inhibitors may increase plasma concentrations of atorvastatin. Appropriate clinical monitoring of the patient is recommended when concomitantly used of atorvastatin with moderate CYP3A4 inhibitors.
Atorvastatin [1], ethinyl estradiol ---> SPC of [1] of eMC
Co-administration of atorvastatin with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Atorvastatin, ethinylestradiol/chlormadinone
Atorvastatin increases the AUC of ethinylestradiol about 20%
Atorvastatin, ethinylestradiol/gestodene
Atorvastatin may increase the plasma concentrations of ethinylestradiol
Atorvastatin, ethinylestradiol/norgestimate [2] ---> SPC of [2] of eMC
Increase in plasma hormone levels associated with co-administered drug
Atorvastatin, etravirine [2] ---> SPC of [2] of EMA
The combination of etravirine and atorvastatin can be given without any dose adjustments, however, the dose of atorvastatin may need to be altered based on clinical response.
Atorvastatin [1], ezetimibe ---> SPC of [1] of eMC
The use of ezetimibe alone is occasionally associated with muscle related events, including rhabdomyolysis. The risk of these events may be increased with the concomitant use of ezetimibe and atorvastatin.
Atorvastatin, ezetimibe
The use of ezetimibe alone is associated with muscle-related events, including rhabdomyolysis. The risk of these events may therefore be increased with concomitant use of ezetimibe and atorvastatin.
Atorvastatin [1], fibrates ---> SPC of [1] of eMC
The use of fibrates alone is occasionally associated with muscle related events, including rhabdomyolysis. The risk of these events may be increased with the concomitant use of fibric acid derivatives and atorvastatin.
Atorvastatin, fibrates
The use of fibrates alone is occasionally associated with muscle-related events, including rhabdomyolysis. The risk of these events may be increased with the concomitant use of fibric acid derivatives and atorvastatin.
Atorvastatin, fluconazole [2] ---> SPC of [2] of eMC
The risk of myopathy and rhabdomyolysis increases when fluconazole is coadministered with HMG-CoA reductase inhibitors metabolised through CYP3A4, such as atorvastatin and simvastatin, or through CYP2C9, such as fluvastatin.
Atorvastatin, fosamprenavir/ritonavir ---> SPC of [fosamprenavir] of EMA
Fosamprenavir/ritonavir, CYP3A4 inhibitors, may increase the exposition of atorvastatin. Doses of atorvastatin no greater than 20 mg/day should be administered, with careful monitoring for atorvastatin toxicity.
Atorvastatin [1], fusidic acid ---> SPC of [1] of eMC
As with other statins, muscle related events, including rhabdomyolysis, have been reported in post-marketing experience with atorvastatin and fusidic acid given concurrently. The concurrent use of atorvastatin and fusidic acid is not recommended
Atorvastatin [1], gemfibrozil ---> SPC of [1] of eMC
The use of fibrates alone is occasionally associated with muscle related events, including rhabdomyolysis. The risk of these events may be increased with the concomitant use of fibric acid derivatives and atorvastatin.
Atorvastatin, gemfibrozil
The use of fibrates alone is occasionally associated with muscle-related events, including rhabdomyolysis. The risk of these events may be increased with the concomitant use of fibric acid derivatives and atorvastatin.
Atorvastatin, glecaprevir/pibrentasvir [2] ---> SPC of [2] of EMA
Co-administration with atorvastatin and simvastatin is contraindicated
Atorvastatin [1], grapefruit juice ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin, idelalisib [2] ---> SPC of [2] of EMA
The co-administration of idelalisib with atorvastatin may increase the serum concentrations of atorvastatin. Clinical monitoring is recommended and a lower starting dose of atorvastatin may be considered.
Atorvastatin, indinavir [2] ---> SPC of [2] of EMA
Increased atorvastatin concentration. Atorvastatin is less dependent on CYP3A4 for metabolism than lovastatin or simvastatin. Use the lowest possible dose of atorvastatin with careful monitoring. Caution is advised.
Atorvastatin, indinavir/ritonavir ---> SPC of [indinavir] of EMA
Indinavir with or without ritonavir should not be administered with medicinal products with narrow therapeutic ranges and which are CYP3A4 substrates. The elevated plasma concentrations of these medicines may cause serious or life-threatening reactions.
Atorvastatin, insulin degludec/liraglutide [2] ---> SPC of [2] of EMA
Liraglutide did not change the overall exposure of atorvastatin to a clinically relevant degree following single dose administration of atorvastatin. Therefore, no dose adjustment of atorvastatin is required when given with liraglutide.
Atorvastatin, insulin glargine/lixisenatide [2] ---> SPC of [2] of EMA
The changes are not clinically relevant and, therefore, no dose adjustment for atorvastatin is required when co-administered with lixisenatide.
Atorvastatin, isavuconazole [2] ---> SPC of [2] of EMA
No CRESEMBA dose adjustment necessary. Based on results with atorvastatin, no statin dose adjustment required. Monitoring of adverse reactions typical of statins is advised.
Atorvastatin [1], itraconazol ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin, ketoconazole [2] ---> SPC of [2] of EMA
Potential increasing in plasma concentrations of the statin. Contraindicated due to an increased risk of skeletal muscle toxicity, including rhabdomyolysis
Atorvastatin, leflunomide [2] ---> SPC of [2] of EMA
For substrates of OATP family, especially statins, concomitant administration with leflunomide should also be undertaken with caution. Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products
Atorvastatin, letermovir [2] ---> SPC of [2] of EMA
Statin-associated adverse events such as myopathy should be closely monitored. When PREVYMIS is co-administered with cyclosporine, atorvastatin is contraindicated.
Atorvastatin, liraglutide [2] ---> SPC of [2] of EMA
Liraglutide did not change the overall exposure of atorvastatin to a clinically relevant degree following single dose administration of atorvastatin. Therefore, no dose adjustment of atorvastatin is required when given with liraglutide.
Atorvastatin, lixisenatide [2] ---> SPC of [2] of EMA
No dose adjustment for atorvastatin is required when co-administered with lixisenatide
Atorvastatin, lomitapide [2] ---> SPC of [2] of EMA
Weak CYP3A4 inhibitors are expected to increase the exposure of lomitapide when taken simultaneously. Separate the dose of the medications by 12 hours OR decrease the dose of Lojuxta by half.
Atorvastatin [1], lopinavir ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin, lopinavir/ritonavir [2] ---> SPC of [2] of EMA
Lopinavir/ritonavir, CYP3A4 inhibitors, may increase the plasma concentrations of atorvastatin. Co-administration is not recommended
Atorvastatin [1], macrolide antibiotics ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin, magnesium hydroxide
Concomitant use decreases atorvastatin AUC
Atorvastatin, metildigoxin
Increased plasma levels of metildigoxin
Atorvastatin, metreleptin [2] ---> SPC of [2] of EMA
The effect of metreleptin on CYP450 enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted.
Atorvastatin, midazolam [2] ---> SPC of [2] of EMA
Atorvastatin showed a 1.4-fold increase in plasma concentrations of intravenous midazolam compared to control group.
Atorvastatin, midostaurin [2] ---> SPC of [2] of EMA
Medicinal products with a narrow therapeutic range that are substrates of P-gp should be used with caution when administered concomitantly with midostaurin and may need dose adjustment to maintain optimal exposure
Atorvastatin, modafinil [2] ---> SPC of [2] of eMC
The CYP3A4 induction may decrease the plasma levels of statine
Atorvastatin [1], moderate CYP3A4 inhibitors ---> SPC of [1] of eMC
Moderate CYP3A4 inhibitors may increase plasma concentrations of atorvastatin. Appropriate clinical monitoring of the patient is recommended when concomitantly used of atorvastatin with moderate CYP3A4 inhibitors.
Atorvastatin [1], myopathy ---> SPC of [1] of eMC
The risk of myopathy might be increased at concomitant administration of atorvastatin with other medicinal products that have a potential to induce myopathy
Atorvastatin, naloxegol [2] ---> SPC of [2] of EMA
No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin)
Atorvastatin [1], nefazodone ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin, nelfinavir [2] ---> SPC of [2] of EMA
Increased AUC of atorvastatin. Atorvastatin is less dependent on CYP3A4 for metabolism. When used with nelfinavir, the lowest possible dose of atorvastatin should be administered.
Atorvastatin [1], nevirapine ---> SPC of [1] of eMC
Concomitant administration of atorvastatin with inducers of cytochrome P450 3A can lead to variable reductions in plasma concentrations of atorvastatin.
Atorvastatin [1], niacin ---> SPC of [1] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors together with niacin. The combination should only be used with caution
Atorvastatin [1], nicotinates ---> SPC of [1] of eMC
The risk of myopathy might be increased at concomitant administration of atorvastatin with other medicinal products that have a potential to induce myopathy
Atorvastatin [1], norethindrone ---> SPC of [1] of eMC
Co-administration of atorvastatin with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Atorvastatin [1], norethisterone ---> SPC of [1] of eMC
Co-administration of atorvastatin with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Atorvastatin, norgestimate
The CYP3A4 inhibition may increase the plasma concentrations of norgestimate
Atorvastatin, ombitasvir/paritaprevir/ritonavir [2] ---> SPC of [2] of EMA
Ritonavir is a strong inhibitor of CYP3A. Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events are contraindicated
Atorvastatin [1], oral contraceptives ---> SPC of [1] of eMC
Co-administration of atorvastatin with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Atorvastatin, oral contraceptives
Coadministration of atorvastatin with an oral contraceptive produced increases in plasma concentrations of norethisterone and ethinyl estradiol.
Atorvastatin, padeliporfin [2] ---> SPC of [2] of EMA
The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.
Atorvastatin, phenytoin
Phenytoin, CYP3A4-inducer, may decrease the plasma concentrations of atorvastatin
Atorvastatin, piperaquine ---> SPC of [piperaquine/artenimol] of EMA
Piperaquine is metabolised by, and is an inhibitor of CYP3A4. Therefore, it has the potential to increase plasma concentrations of other substrates for this enzyme with the risk of increased toxicity.
Atorvastatin, piperaquine/artenimol [2] ---> SPC of [2] of EMA
Piperaquine is metabolised by, and is an inhibitor of CYP3A4. Therefore, it has the potential to increase plasma concentrations of other substrates for this enzyme with the risk of increased toxicity.
Atorvastatin, posaconazole [2] ---> SPC of [2] of EMA
Posaconazole may substantially increase plasma levels of statins metabolised by CYP3A4. Treatment with these statins should be discontinued during treatment with posaconazole as increased levels have been associated with rhabdomyolysis
Atorvastatin, prasugrel [2] ---> SPC of [2] of EMA
Atorvastatin (80 mg daily) did not alter the pharmacokinetics of prasugrel and its inhibition of platelet aggregation.
Atorvastatin [1], pregnancy ---> SPC of [1] of eMC
Atorvastatin is contraindicated during pregnancy
Atorvastatin, ranolazine [2] ---> SPC of [2] of EMA
Ranolazine increased Cmax and AUC of atorvastatin. Dose limitation of atorvastatin and appropriate clinical monitoring may be considered when taking ranolazine.
Atorvastatin, regorafenib [2] ---> SPC of [2] of EMA
Co-administration of regorafenib may increase the plasma concentrations of other concomitant BCRP substrates (e.g. methotrexate, fluvastatin, atorvastatin).
Atorvastatin [1], rifampicin ---> SPC of [1] of eMC
Concomitant administration of atorvastatin with inducers of cytochrome P450 3A can lead to variable reductions in plasma concentrations of atorvastatin.
Atorvastatin, rilpivirine [2] ---> SPC of [2] of EMA
No dose adjustment is required.
Atorvastatin, ritonavir [2] ---> SPC of [2] of EMA
Caution must also be exercised and reduced doses should be considered if ritonavir is used concurrently with atorvastatin, which is metabolised to a lesser extent by CYP3A.
Atorvastatin, rivaroxaban [2] ---> SPC of [2] of EMA
No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with atorvastatin
Atorvastatin, saquinavir/ritonavir ---> SPC of [saquinavir] of EMA
When used with saquinavir/ritonavir, the lowest possible dose of atorvastatin should be administered and the patient should be carefully monitored for signs/symptoms of myopathy
Atorvastatin, semaglutide [2] ---> SPC of [2] of EMA
Semaglutide did not change the overall exposure of atorvastatin following a single dose administration of atorvastatin (40 mg).
Atorvastatin, simeprevir [2] ---> SPC of [2] of EMA
The OATP1B1 transporter and/or CYP3A4 enzyme inhibition may increase the exposition to atorvastatin. Increased simeprevir concentrations may occur due to inhibition of OATP1B1 by atorvastatin.
Atorvastatin, sitaxentan [2] ---> SPC of [2] of EMA
The extent of interaction with other OATP inhibitors (except cyclosporine) is unknown but could result in raised plasma levels of sitaxentan.
Atorvastatin, sodium zirconium cyclosilicate [2] ---> SPC of [2] of EMA
In a clinical drug-drug interaction study conducted in healthy subjects co-administration did not result in clinically meaningful drug-drug interactions and no dose adjustments are required.
Atorvastatin, stiripentol [2] ---> SPC of [2] of EMA
Decreased hepatic metabolism of statine and increased risk of dose-dependent adverse reactions such as rhabdomyolysis. Undesirable combination (to be avoided unless strictly necessary)
Atorvastatin [1], strong CYP3A4 inductors ---> SPC of [1] of eMC
Concomitant administration of atorvastatin with inducers of cytochrome P450 3A can lead to variable reductions in plasma concentrations of atorvastatin.
Atorvastatin [1], strong CYP3A4 inhibitors ---> SPC of [1] of eMC
Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin. Co-administration of potent CYP3A4 inhibitors should be avoided if possible.
Atorvastatin [1], strong P-gp inhibitors ---> SPC of [1] of eMC
Inhibitors of transport proteins can increase the systemic exposure of atorvastatin
Atorvastatin, sucroferric oxyhydroxide [2] ---> SPC of [2] of EMA
Data from clinical studies have shown that Velphoro does not affect the lipid lowering effects of HMG-CoA reductase inhibitors (e.g., atorvastatin and simvastatin).
Atorvastatin, telaprevir [2] ---> SPC of [2] of EMA
The inhibition of CYP3A and OATPs by telaprevir may increase atorvastatin concentration. Co-administration of atorvastatin and telaprevir is contraindicated
Atorvastatin, telithromycin [2] ---> SPC of [2] of EMA
Concomitant administration with simvastatin, atorvastatin, or lovastatin is contraindicated. Treatment with these agents should be interrupted during telithromycin treatment
Atorvastatin, temsirolimus [2] ---> SPC of [2] of EMA
It is possible that combined administration of temsirolimus with other amphiphilic agents such as amiodarone or statins could result in an increased risk of amphiphilic pulmonary toxicity.
Atorvastatin, teriflunomide [2] ---> SPC of [2] of EMA
Teriflunomide, OATP inhibitor, may increase the AUC of OATP substrate. The co-administration should be undertaken with caution
Atorvastatin, ticagrelor [2] ---> SPC of [2] of EMA
Co-administration of atorvastatin and ticagrelor increased atorvastatin acid Cmax by 23% and AUC by 36%. These increases are not considered clinically significant.
Atorvastatin, tipranavir [2] ---> SPC of [2] of EMA
The CYP3A4 inhibition may increase the plasma levels of atorvastatin. Concomitant use is not recommended
Atorvastatin, tipranavir/ritonavir ---> SPC of [tipranavir] of EMA
Tipranavir, co-administered with low dose ritonavir (inhibition of CYP 3A4 by tipranavir/ritonavir), increases the plasma concentrations of atorvastatin. The combination is not recommended.
Atorvastatin, tocilizumab [2] ---> SPC of [2] of EMA
When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 should be monitored as doses may need to be increased to maintain therapeutic effect.
Atorvastatin, trandolapril/verapamil [2] ---> SPC of [2] of eMC
Increase in serum exposure (and the myopathy and rhabdomyolysis risk) has been reported for simvastatin when concomitantly administered with verapamil. The dose of simvastatin (and other statins also metabolised by CYP3A4) should be adapted accordingly.
Atorvastatin, ulinastatin
The strong CYP3A4 and OATP 1B1 inhibition may increase the exposition of atorvastatin. The concomitant use should be done with special caution
Atorvastatin [1], verapamil ---> SPC of [1] of eMC
Moderate CYP3A4 inhibitors may increase plasma concentrations of atorvastatin. Appropriate clinical monitoring of the patient is recommended when concomitantly used of atorvastatin with moderate CYP3A4 inhibitors.
Atorvastatin, voriconazole [2] ---> SPC of [2] of EMA
Voriconazole is likely to increase the plasma concentrations of statins that are metabolised by CYP3A4 and could lead to rhabdomyolysis.
Atorvastatin [1], warfarin ---> SPC of [1] of eMC
Prothrombin time should be determined before starting atorvastatin in patients taking coumarin anticoagulants and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs.
CONTRAINDICATIONS of Atorvastatin
Atorvastatin is contraindicated in patients:
- with hypersensitivity to the active substance or to any of the excipients of this medicinal product
- with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal
- during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures
http://www.medicines.org.uk/emc/
Atosiban (Tractocile)
CYP450 substrates, atosiban [2] ---> SPC of [2] of EMA
Atosiban is not a substrate for the cytochrome P450 system, and does not inhibit the drug metabolising cytochrome P450 enzymes.
Atosiban [1], betamethasone ---> SPC of [1] of EMA
Interaction studies have been performed with labetalol and betamethasone in healthy, female volunteers. No clinically relevant interaction was found between atosiban and betamethasone or labetalol.
Atosiban [1], breast-feeding ---> SPC of [1] of EMA
In atosiban clinical trials no effects were observed on breast breast-feeding. Small amounts of atosiban have been shown to pass from plasma into the breast milk
Atosiban [1], pregnancy ---> SPC of [1] of EMA
Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation
CONTRAINDICATIONS of Atosiban (Tractocile)
Tractocile must not be used in the following conditions:
- Gestational age below 24 or over 33 completed weeks
- Premature rupture of the membranes >30 weeks of gestation
- Abnormal foetal heart rate
- Antepartum uterine haemorrhage requiring immediate delivery
- Eclampsia and severe pre pre-eclampsia requiring delivery
- Intrauterine foetal death
- Suspected intrauterine infection
- Placenta praevia
- Abruptio placenta
- Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous
- Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Atovaquone
Abacavir/lamivudine/zidovudine [1], atovaquone ---> SPC of [1] of EMA
Increased zidovudine AUC. As only limited data available the clinical significance is unknown.
Atovaquone [1], boosted protease-inhibitors ---> SPC of [1] of eMC
When given with efavirenz or boosted protease-inhibitors, atovaquone concentrations have been observed to decrease as much as 75%. This combination should be avoided whenever possible
Atovaquone [1], breast-feeding ---> SPC of [1] of eMC
It is not known whether atovaquone is excreted in human milk, and therefore breast feeding is not recommended.
Atovaquone [1], didanosine ---> SPC of [1] of eMC
There was a 24% decrease in the AUC for ddI when co-administered with atovaquone which is unlikely to be of clinical significance.
Atovaquone [1], efavirenz ---> SPC of [1] of eMC
When given with efavirenz or boosted protease-inhibitors, atovaquone concentrations have been observed to decrease as much as 75%. This combination should be avoided whenever possible
Atovaquone [1], etoposide ---> SPC of [1] of eMC
The co-administration of atovaquone was found to increase the plasma concentrations (AUC) of etoposide and its metabolite etoposide catechol. Caution should be advised in patients receiving concomitant therapy with etoposide
Atovaquone [1], foods ---> SPC of [1] of eMC
The importance of taking the full prescribed dose with food should be stressed to patients. The presence of food, particularly high fat food, increases bioavailability two to three fold.
Atovaquone, glucuronidation inductors
The glucuronidation induction may decrease the plasma concentrations of atovaquone
Atovaquone [1], high plasma protein binding with narrow therapeutic indices ---> SPC of [1] of eMC
Caution should be used when administering atovaquone concurrently with other highly plasma protein bound drugs with narrow therapeutic indices.
Atovaquone [1], indinavir ---> SPC of [1] of eMC
Concomitant administration of atovaquone and indinavir results in a significant decrease in the C min of indinavir and the AUC. Caution should be exercised on the potential risk of failure of indinavir treatment if co-administered with atovaquone.
Atovaquone, indinavir/ritonavir ---> SPC of [indinavir] of EMA
The glucuronidation induction by ritonavir may decrease plasma concentrations of atovaquone. Careful monitoring is recommended
Atovaquone, lamivudine/zidovudine [2] ---> SPC of [2] of EMA
Increase in plasma zidovudine AUC. As only limited data available the clinical significance is unknown.
Atovaquone [1], metoclopramide ---> SPC of [1] of eMC
Concomitant treatment with metoclopramide has been associated with a significant decrease (about 50 %) in plasma concentrations of atovaquone
Atovaquone [1], pregnancy ---> SPC of [1] of eMC
Atovaquone should not be used during pregnancy unless the benefit of treatment to the mother outweighs any possible risk to the developing foetus.
Atovaquone [1], rifabutin ---> SPC of [1] of eMC
Concomitant administration of rifampicin or rifabutin is not recommended as it is known to reduce plasma concentrations of atovaquone
Atovaquone [1], rifampicin ---> SPC of [1] of eMC
When the two drugs were taken concomitantly, decreased concentrations of atovaquone and increased concentrations of rifampicin were observed.
Atovaquone, ritonavir [2] ---> SPC of [2] of EMA
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent induces glucuronidation and as a result is expected to decrease the plasma concentrations of atovaquone.
Atovaquone [1], tetracyclines ---> SPC of [1] of eMC
Concomitant treatment with tetracycline has been associated with decreases in plasma concentrations of atovaquone.
Atovaquone [1], zidovudine ---> SPC of [1] of eMC
Pharmacokinetic data have shown that atovaquone appears to decrease the rate of metabolism of zidovudine to its glucuronide metabolite
CONTRAINDICATIONS of Atovaquone
Wellvone Suspension is contra-indicated in individuals with known hypersensitivity to atovaquone or to any of the excipients
http://www.medicines.org.uk/emc/
Atovaquone/proguanil
Ability to drive, atovaquone/proguanil [2] ---> SPC of [2] of eMC
Dizziness has been reported.
Atovaquone/proguanil [1], boosted protease-inhibitors ---> SPC of [1] of eMC
When given with efavirenz or boosted protease-inhibitors, atovaquone concentrations have been observed to decrease as much as 75%. This combination should be avoided whenever possible
Atovaquone/proguanil [1], breast-feeding ---> SPC of [1] of eMC
It should not be taken by breast-feeding women.
Atovaquone/proguanil [1], coumarin anticoagulants ---> SPC of [1] of eMC
Proguanil may potentiate the effect of warfarin and other coumarin based anticoagulants which may lead to an increase in the risk of haemorrhage.
Atovaquone/proguanil, dolutegravir/rilpivirine [2] ---> SPC of [2] of EMA
No dose adjustment is required.
Atovaquone/proguanil, efavirenz [2] ---> SPC of [2] of EMA
The co-administration decreases the plasma concentrations of atovaquone and proguanil. Concomitant administration of atovaquone/proguanil with efavirenz should be avoided whenever possible.
Atovaquone/proguanil, efavirenz/emtricitabine/tenofovir disoproxil [2] ---> SPC of [2] of EMA
Concomitant administration of atovaquone/proguanil with Atripla should be avoided whenever possible.
Atovaquone/proguanil [1], etoposide ---> SPC of [1] of eMC
The co-administration of atovaquone was found to increase the plasma concentrations (AUC) of etoposide and its metabolite etoposide catechol. Caution should be advised in patients receiving concomitant therapy with etoposide
Atovaquone/proguanil [1], metoclopramide ---> SPC of [1] of eMC
Concomitant treatment with metoclopramide has been associated with a significant decrease (about 50 %) in plasma concentrations of atovaquone
Atovaquone/proguanil [1], pregnancy ---> SPC of [1] of eMC
The use in pregnancy should only be considered if the expected benefit to the mother outweighs any potential risk to the foetus.
Atovaquone/proguanil [1], rifabutin ---> SPC of [1] of eMC
Concomitant administration of rifampicin or rifabutin is not recommended as it is known to reduce plasma concentrations of atovaquone
Atovaquone/proguanil [1], rifampicin ---> SPC of [1] of eMC
Concomitant administration of rifampicin is not recommended as it is known to reduce plasma concentrations of atovaquone
Atovaquone/proguanil [1], tetracyclines ---> SPC of [1] of eMC
Concomitant treatment with tetracycline has been associated with decreases in plasma concentrations of atovaquone.
Atovaquone/proguanil [1], warfarin ---> SPC of [1] of eMC
Proguanil may potentiate the effect of warfarin and other coumarin based anticoagulants which may lead to an increase in the risk of haemorrhage.
CONTRAINDICATIONS of Atovaquone/proguanil
- Hypersensitivity to the active substances or to any of the excipients
- Malarone is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance < 30 mL/min).
http://www.medicines.org.uk/emc/
Atracurium
Ability to drive, atracurium [2] ---> SPC of [2] of eMC
As the medicinal product is administered under general anaesthesia, the patient must not drive, operate machinery or work in exposed situations after anaesthesia.
Acetazolamide, atracurium [2] ---> SPC of [2] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with diuretics
Acetazolamide, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with diuretics
Aminoglycoside antibiotics, atracurium [2] ---> SPC of [2] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Aminoglycoside antibiotics, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Anaesthetics, atracurium
The co-administration may enhance and/or prolong the neuromuscular block of atracurium
Anionic drugs, atracurium
Do not mix atracurium with alkalizing solutions due to atracurium can be inactivated
Antiarrhythmics, atracurium [2] ---> SPC of [2] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antiarrhythmic medicinal products
Antiarrhythmics, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antiarrhythmic medicinal products
Anticholinesterase, atracurium [2] ---> SPC of [2] of eMC
Treatment with anticholinesterases, commonly used in the treatment of Alzheimer's disease e.g. donepezil, may shorten the duration and diminish the magnitude of neuromuscular blockade with atracurium.
Antiepileptics, atracurium [2] ---> SPC of [2] of eMC
The onset of non-depolarising neuromuscular block is likely to be lengthened and the duration of block shortened in patients receiving chronic anticonvulsant therapy (phenytoin, carbamazepine).
Atracurium [1], betablockers ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with beta-blockers
Atracurium [1], breast-feeding ---> SPC of [1] of eMC
It is not known whether atracurium besilate passes into breast milk. As precaution restart breast-feeding 24 hours after administration of atracurium besilate.
Atracurium [1], calcium antagonists ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with calcium antagonists
Atracurium [1], carbamazepine ---> SPC of [1] of eMC
The onset of non-depolarising neuromuscular block is likely to be lengthened and the duration of block shortened in patients receiving chronic anticonvulsant therapy (phenytoin, carbamazepine).
Atracurium [1], chloroquine ---> SPC of [1] of eMC
Chloroquine may increase the sensitivity to atracurium and aggravate or unmask latent myasthenia gravis or induce a myasthenic syndrome
Atracurium [1], chlorpromazine ---> SPC of [1] of eMC
Chlorpromazine may increase the sensitivity to atracurium and aggravate or unmask latent myasthenia gravis or induce a myasthenic syndrome
Atracurium, clindamycin [2] ---> SPC of [2] of eMC
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. It should be used with caution
Atracurium, colistimethate [2] ---> SPC of [2] of EMA
Concomitant use of inhaled colistimethate sodium with neuromuscular blocking products should be undertaken with caution.
Atracurium, dantrolene
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with dantrolene
Atracurium [1], depolarizing muscle relaxants ---> SPC of [1] of eMC
A depolarising muscle relaxant should not be administered to prolong the neuromuscular blocking effects of non-depolarising blocking agents, as this may result in a prolonged and complex block
Atracurium [1], diuretics ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with diuretics
Atracurium [1], donepezil ---> SPC of [1] of eMC
Treatment with anticholinesterases, commonly used in the treatment of Alzheimer's disease e.g. donepezil, may shorten the duration and diminish the magnitude of neuromuscular blockade with atracurium.
Atracurium [1], electrolyte imbalance ---> SPC of [1] of eMC
Atracurium may have profound effects in myasthenia gravis, or other neuromuscular diseases in which potentiation of non-depolarising neuromuscular blocking agents has been noted. Precautions should be taken in severe electrolyte imbalance
Atracurium [1], enflurane ---> SPC of [1] of eMC
The neuromuscular block produced by atracurium besilate may be increased by the concomitant use of inhalational anaesthetics
Atracurium [1], furosemide ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with diuretics
Atracurium [1], ganglionic blockers ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with ganglion blocking agents
Atracurium [1], halogenated anaesthetics ---> SPC of [1] of eMC
The neuromuscular block produced by atracurium besilate may be increased by the concomitant use of inhalational anaesthetics
Atracurium [1], halothane ---> SPC of [1] of eMC
The neuromuscular block produced by atracurium besilate may be increased by the concomitant use of inhalational anaesthetics
Atracurium [1], hexametonium ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with ganglion blocking agents
Atracurium [1], isoflurane ---> SPC of [1] of eMC
The neuromuscular block produced by atracurium besilate may be increased by the concomitant use of inhalational anaesthetics
Atracurium, ketamine [2] ---> SPC of [2] of eMC
Ketamine may potentiate the neuromuscular blocking effects of atracurium and tubocurarine including respiratory depression with apnoea.
Atracurium [1], lidocaine ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antiarrhythmic medicinal products
Atracurium [1], lincomycin ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Atracurium [1], lithium ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with lithium salts
Atracurium, magnesium
The co-administration may enhance and/or prolong the neuromuscular block of atracurium
Atracurium [1], magnesium sulfate ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with magnesium sulfate
Atracurium [1], mannitol ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with diuretics
Atracurium, mercaptopurine
Decreased effect of the muscle relaxant
Atracurium [1], muscle relaxants (non-depolarizing) ---> SPC of [1] of eMC
The combination of non-depolarising neuromuscular blocking agents with atracurium may produce a degree of neuromuscular blockade in excess of that which might be expected were an equipotent total dose of atracurium besilate administered.
Atracurium [1], oxprenolol ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with beta-blockers
Atracurium [1], penicillamine ---> SPC of [1] of eMC
Penicillamine may increase the sensitivity to atracurium and aggravate or unmask latent myasthenia gravis or induce a myasthenic syndrome
Atracurium [1], phenytoin ---> SPC of [1] of eMC
Phenytoin may increase the sensitivity to atracurium and aggravate or unmask latent myasthenia gravis or induce a myasthenic syndrome
Atracurium [1], polymyxin ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Atracurium [1], pregnancy ---> SPC of [1] of eMC
Atracurium besilate should only be administered during pregnancy after careful risk-benefit assessment.
Atracurium [1], procainamide ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antiarrhythmic medicinal products
Atracurium [1], propranolol ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with beta-blockers
Atracurium [1], quinidine ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antiarrhythmic medicinal products
Atracurium, sevoflurane [2] ---> SPC of [2] of eMC
When used to supplement alfentanil-N2O anaesthesia, sevoflurane potentiates neuromuscular block induced with atracurium.
Atracurium [1], spectinomycin ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Atracurium [1], steroids ---> SPC of [1] of eMC
Steroids may increase the sensitivity to atracurium and aggravate or unmask latent myasthenia gravis or induce a myasthenic syndrome
Atracurium [1], succinylcholine ---> SPC of [1] of eMC
A depolarising muscle relaxant should not be administered to prolong the neuromuscular blocking effects of non-depolarising blocking agents, as this may result in a prolonged and complex block
Atracurium [1], suxamethonium ---> SPC of [1] of eMC
A depolarising muscle relaxant should not be administered to prolong the neuromuscular blocking effects of non-depolarising blocking agents, as this may result in a prolonged and complex block
Atracurium [1], tetracyclines ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Atracurium [1], thiazides ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with diuretics
Atracurium, thiopental
Do not mix atracurium with alkalizing solutions due to atracurium can be inactivated
Atracurium [1], trimetaphan ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with ganglion blocking agents
Atracurium [1], vancomycin ---> SPC of [1] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Betablockers, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with beta-blockers
Calcium antagonists, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with calcium antagonists
Clindamycin, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Depolarizing muscle relaxants, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
A depolarising muscle relaxant should not be administered to prolong the neuromuscular blocking effects of non-depolarising blocking agents, as this may result in a prolonged and complex block
Diuretics, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with diuretics
Furosemide, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with diuretics
Ganglionic blockers, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with ganglion blocking agents
Hexametonium, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with ganglion blocking agents
Ketamine, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with ketamine
Lincomycin, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Lithium, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with lithium salts
Magnesium sulfate, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with magnesium sulfate
Mannitol, muscle relaxants (non-depolarizing) ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with diuretics
Muscle relaxants (non-depolarizing), polymyxin ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Muscle relaxants (non-depolarizing), spectinomycin ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Muscle relaxants (non-depolarizing), tetracyclines ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Muscle relaxants (non-depolarizing), vancomycin ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antibiotics
Muscle relaxants (non-depolarizing), procainamide ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antiarrhythmic medicinal products
Muscle relaxants (non-depolarizing), quinidine ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with antiarrhythmic medicinal products
Muscle relaxants (non-depolarizing), propranolol ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with beta-blockers
Muscle relaxants (non-depolarizing), trimetaphan ---> SPC of [atracurium] of eMC
As with all non-depolarising neuromuscular blocking agents the magnitude and/or duration of a non-depolarising neuromuscular block may be increased as a result of interaction with ganglion blocking agents
Muscle relaxants (non-depolarizing), suxamethonium ---> SPC of [atracurium] of eMC
A depolarising muscle relaxant should not be administered to prolong the neuromuscular blocking effects of non-depolarising blocking agents, as this may result in a prolonged and complex block
Muscle relaxants (non-depolarizing), neomycin ---> SPC of [atracurium] of eMC
The effect of non-depolarising muscle relaxants may be enhanced by aminoglycosides.
Muscle relaxants (non-depolarizing), succinylcholine ---> SPC of [atracurium] of eMC
A depolarising muscle relaxant should not be administered to prolong the neuromuscular blocking effects of non-depolarising blocking agents, as this may result in a prolonged and complex block
CONTRAINDICATIONS of Atracurium
- Atracurium is contraindicated in patients known to be hypersensitive to atracurium, cisatracurium or benzenesulphonic acid.
http://www.medicines.org.uk/emc/
Atropine (Ryjunea)
Ability to drive, atropine [2] ---> SmPC of [2] of EMA
Patients should be advised not to ride bikes, drive or use machines until their vision has cleared. This effect may last up to 14 days after stopping treatment (see section 4.4).
Acetylcysteine, atropine
Dangerous secretory congestion due to cough reflex inhibition. Co-administration is not recommended
Adrenaline [1], atropine ---> SmPC of [1] of EMA
The effects of adrenaline may be potentiated
Adrenaline, atropine [2] ---> SmPC of [2] of EMA
But it should be used with precaution when used in combination sympathomimetics like dobutamine, dopamine, norepinephrine, epinephrine or isoproterenol because mydriasis may be enhanced (see section 4.4).
Alcohol, atropine
Anticholinergic drugs may enhance the depressive effect of alcohol on the central nervous system
Aliskiren/amlodipine/hydrochlorothiazide [1], atropine ---> SmPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Aliskiren/hydrochlorothiazide [1], atropine ---> SmPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Amantadine [1], atropine ---> SmPC of [1] of eMC
Concurrent administration of amantadine and anticholinergic agents may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects
Amantadine, atropine [2] ---> SmPC of [2] of EMA
The use concurrent of other anticholinergics or medicinal products with anticholinergic activity may result in potentiated anticholinergic effects.
Amlodipine/valsartan/hydrochlorothiazide [1], atropine ---> SmPC of [1] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Anticholinergics, atropine [2] ---> SmPC of [2] of EMA
The use concurrent of other anticholinergics or medicinal products with anticholinergic activity may result in potentiated anticholinergic effects.
Anticholinesterase, atropine
The co-administration may decrease the antiglaucomatous effect
Antiemetics, atropine [2] ---> SmPC of [2] of EMA
If significant absorption of systemic atropine sulfate occurs, concurrent use of medicinal products having CNS effects, such as antiemetic agents, phenothiazines, or barbiturates, may result in opisthotonos, convulsions, coma, and extrapyramidal symptoms
Antihistamines, atropine [2] ---> SmPC of [2] of EMA
The use concurrent of other anticholinergics or medicinal products with anticholinergic activity may result in potentiated anticholinergic effects.
Antimyasthenic medicinal product, atropine [2] ---> SmPC of [2] of EMA
If significant systemic absorption of ophthalmic atropine sulfate occurs, concurrent use may increase the chance of toxicity and/or side effects because of the anticholinergic induced slowing of gastrointestinal motility.
Atropine [1], barbiturates ---> SmPC of [1] of EMA
If significant absorption of systemic atropine sulfate occurs, concurrent use of medicinal products having CNS effects, such as antiemetic agents, phenothiazines, or barbiturates, may result in opisthotonos, convulsions, coma, and extrapyramidal symptoms
Atropine [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Ryjunea therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Atropine [1], butyrophenones ---> SmPC of [1] of eMC
Combination of atropine with other drugs with anticholinergic activity may increase the risk of atropinic adverse effects (urinary retention, constipation, dry mouth).
Atropine [1], carbachol ---> SmPC of [1] of EMA
Concurrent use with atropine sulfate may interfere with the antiglaucoma action of carbachol, physostigmine or pilocarpine (see also section 4.3). Also, concurrent use may counteract the mydriatic effect of atropine sulfate.
Atropine [1], disopyramide ---> SmPC of [1] of EMA
The use concurrent of other anticholinergics or medicinal products with anticholinergic activity may result in potentiated anticholinergic effects.
Atropine [1], dopamine ---> SmPC of [1] of EMA
But it should be used with precaution when used in combination sympathomimetics like dobutamine, dopamine, norepinephrine, epinephrine or isoproterenol because mydriasis may be enhanced (see section 4.4).
Atropine [1], doubutamine ---> SmPC of [1] of EMA
But it should be used with precaution when used in combination sympathomimetics like dobutamine, dopamine, norepinephrine, epinephrine or isoproterenol because mydriasis may be enhanced (see section 4.4).
Atropine [1], fertility ---> SmPC of [1] of EMA
There are no data on the effects of atropine eye drops on human fertility.
Atropine [1], isoproterenol ---> SmPC of [1] of EMA
But it should be used with precaution when used in combination sympathomimetics like dobutamine, dopamine, norepinephrine, epinephrine or isoproterenol because mydriasis may be enhanced (see section 4.4).
Atropine [1], metoclopramide ---> SmPC of [1] of EMA
The use concurrent of other anticholinergics or medicinal products with anticholinergic activity may result in potentiated anticholinergic effects.
Atropine [1], neostigmine ---> SmPC of [1] of EMA
If significant systemic absorption of ophthalmic atropine sulfate occurs, concurrent use may increase the chance of toxicity and/or side effects because of the anticholinergic induced slowing of gastrointestinal motility.
Atropine [1], neuroleptics ---> SmPC of [1] of eMC
Combination of atropine with other drugs with anticholinergic activity may increase the risk of atropinic adverse effects (urinary retention, constipation, dry mouth).
Atropine [1], noradrenaline ---> SmPC of [1] of EMA
But it should be used with precaution when used in combination sympathomimetics like dobutamine, dopamine, norepinephrine, epinephrine or isoproterenol because mydriasis may be enhanced (see section 4.4).
Atropine [1], phenothiazines ---> SmPC of [1] of EMA
The use concurrent of other anticholinergics or medicinal products with anticholinergic activity may result in potentiated anticholinergic effects.
Atropine [1], physostigmine ---> SmPC of [1] of EMA
Concurrent use with atropine sulfate may interfere with the antiglaucoma action of carbachol, physostigmine or pilocarpine (see also section 4.3). Also, concurrent use may counteract the mydriatic effect of atropine sulfate.
Atropine [1], pilocarpine ---> SmPC of [1] of EMA
Concurrent use with atropine sulfate may interfere with the antiglaucoma action of carbachol, physostigmine or pilocarpine (see also section 4.3). Also, concurrent use may counteract the mydriatic effect of atropine sulfate.
Atropine [1], potassium citrate ---> SmPC of [1] of EMA
If significant systemic absorption of ophthalmic atropine sulfate occurs, concurrent use may increase the chance of toxicity and/or side effects because of the anticholinergic induced slowing of gastrointestinal motility.
Atropine [1], pregnancy ---> SmPC of [1] of EMA
Atropine sulfate rapidly crosses the placenta. Since atropine sulfate may be systemically absorbed after ocular administration, Ryjunea should only be used if absolutely necessary, especially during the last 3 months of pregnancy.
Atropine [1], procainamide ---> SmPC of [1] of eMC
Combination of atropine with other drugs with anticholinergic activity may increase the risk of atropinic adverse effects (urinary retention, constipation, dry mouth).
Atropine [1], pyridostigmine ---> SmPC of [1] of EMA
If significant systemic absorption of ophthalmic atropine sulfate occurs, concurrent use may increase the chance of toxicity and/or side effects because of the anticholinergic induced slowing of gastrointestinal motility.
Atropine [1], quinidine ---> SmPC of [1] of EMA
The use concurrent of other anticholinergics or medicinal products with anticholinergic activity may result in potentiated anticholinergic effects.
Atropine [1], quinidine ---> SmPC of [1] of eMC
Combination of atropine with other drugs with anticholinergic activity may increase the risk of atropinic adverse effects (urinary retention, constipation, dry mouth).
Atropine [1], sympathomimetics ---> SmPC of [1] of EMA
But it should be used with precaution when used in combination sympathomimetics like dobutamine, dopamine, norepinephrine, epinephrine or isoproterenol because mydriasis may be enhanced (see section 4.4).
Atropine [1], tricyclic antidepressant ---> SmPC of [1] of EMA
The use concurrent of other anticholinergics or medicinal products with anticholinergic activity may result in potentiated anticholinergic effects.
Atropine, bamethane
Possible enhancement of sympathomimetic effect by atropinic drugs
Atropine, bromperidol
Combination of atropine with other drugs with anticholinergic activity may increase the risk of atropinic adverse effects (urinary retention, constipation, dry mouth).
Atropine, butylscopolamine [2] ---> SmPC of [2] of eMC
The anticholinergic effect may be intensified by hyoscine butylbromide
Atropine, chlorpromazine [2] ---> SmPC of [2] of eMC
The co-administration causes addition of atropinic adverse effects e. g. retention of urine, dry mouth, obstipation
Atropine, cinitapride
Decreased effects of cinitapride on the digestive canal
Atropine, cisapride
Suppression of the cisapride effect
Atropine, clomipramine [2] ---> SmPC of [2] of eMC
Tricyclic antidepressants may potentiate the effects of anticholinergic agents on the eye, central nervous system, bowel and bladder.
Atropine, cloprednol
Additional increase in the intraocular pressure
Atropine, corticosteroids
Corticosteroids enhance the effect and toxicity of atropine
Atropine, deflazacort
Additional increase in the intraocular pressure
Atropine, dexamethasone
Additional increase in the intraocular pressure
Atropine, dexchlorpheniramine
Additive anticholinergic effects
Atropine, diamorphine
The risk of severe constipation and/or urinary retention is increased by administration of antimuscarinic drugs
Atropine, digoxin
The decrease of the gut motility caused by atropine increases the absorption of the co-administrated digoxin
Atropine, diphenhydramine [2] ---> SmPC of [2] of eMC
As diphenhydramine has some antimuscarinic activity, the effects of anticholinergic drugs may be potentiated therefore medical advice should be sought before taking diphenhydramine with such medicines.
Atropine, disopyramide [2] ---> SmPC of [2] of eMC
Atropine and other anticholinergic drugs, including phenothiazines, may potentiate the atropine-like effects of disopyramide.
Atropine, distigmine
The co-administration may antagonize the muscarinic effects of distigmine
Atropine, dopamine antagonists
Dopamine antagonists may enhance the anticholinergic effects
Atropine, doxylamine
The combination of doxylamine with other anticholinergic medicinal products may enhance the anticholinergic effects
Atropine, ephedrine
Atropine increases the pressor response of ephedrine
Atropine, eserine
The co-administration may decrease the atropine effect
Atropine, etilefrine
The co-administration may increase effects of etilefrine and the heart frequency
Atropine, fluocortolone
Additional increase in the intraocular pressure
Atropine, galantamine [2] ---> SmPC of [2] of eMC
Galantamine has the potential to antagonise the effect of anticholinergic medicinal products. Should anticholinergic medicinal products such as atropine be abruptly stopped there is a potential risk that galantamine's effect could be exace
Atropine, glucocorticoids
Additional increase in the intraocular pressure
Atropine, haloperidol
The co-administration may enhance the anticholinergic effect
Atropine, hydrochlorothiazide ---> SmPC of [aliskiren/hydrochlorothiazide] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents, apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Atropine, hydrocortisone
Additional increase in the intraocular pressure
Atropine, IMAOs
Monoamine oxidase inhibitors enhance the effect and toxicity of atropine
Atropine, imipramine [2] ---> SmPC of [2] of eMC
Tricyclic antidepressants may potentiate the effects of anticholinergic agents on the eye, central nervous system, bowel and bladder.
Atropine, irbesartan/hydrochlorothiazide [2] ---> SmPC of [2] of EMA
Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of thiazidetype diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Atropine, isoniazid
Increased toxicity of atropine
Atropine, levodopa
The decrease of the gut motility caused by atropine decreases the absorption of the co-administrated levodopa
Atropine, lofepramine
Lofepramine may potentiate the effects of anticholinergic drugs on the central nervous system, eye, bowel and bladder.
Atropine, losartan/hydrochlorothiazide [2] ---> SmPC of [2] of eMC
The anticholinergic increases the bioavailability to thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Atropine, macimorelin [2] ---> SmPC of [2] of EMA
Medicinal products that may blunt the growth hormone response to macimorelin. Concomitant use is to be avoided
Atropine, maprotiline
The combination of maprotiline with anticholinergic agents may potentiate the central and peripheral effects (especially delirium)
Atropine, mequitazine
The co-administration of mequitazine and other anticholinergic drugs may enhance the anticholinergic effects of mequitazine
Atropine, methylphenidate
Methylphenidate may enhance the anticholinergic effect
Atropine, methylprednisolone [2] ---> SmPC of [2] of eMC
An acute myopathy has been reported with the concomitant use of high doses of corticosteroids and anticholinergics, such as neuromuscular blocking drugs.
Atropine, metildigoxin
Increased plasma levels of metildigoxin
Atropine, midodrine
Increased vasoconstrictor effect of midodrine and decreased bradycardiac effect of midodrine
Atropine, nitrofurantoin
The decrease of the gut motility caused by atropine increases the absorption of the co-administrated nitrofurantoin
Atropine, norepinephrine
The use of noradrenaline with parasympatholytic drugs is not recommended because severe, prolonged hypertension and possible arrhythmias may result
Atropine, norfenefrine
Atropine abolishes the reflex bradycardia and may cause exaggerated hypertension
Atropine, organic nitrates ---> SmPC of [nitroglycerine] of eMC
There is a potential for drugs that cause dry mouth to reduce the effectiveness of sublingual nitrates.
Atropine, orphenadrine
Concomitant use of other antimuscarinic drugs can lead to an increase in side effects such as dry mouth and urine retention.
Atropine, oxybutynine [2] ---> SmPC of [2] of EMA
The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or medicinal products with anticholinergic activity
Atropine, pethidine [2] ---> SmPC of [2] of eMC
Use of pethidine concomitantly with anticholinergics may result in neurotoxicity in patients with renal failure, cancer, and sickle cell anaemia.
Atropine, phenylephrine ---> SmPC of [phenylephrine/ketorolac] of EMA
Concomitant use of phenylephrine and atropine may enhance pressor effects and induce tachycardia in some patients.
Atropine, phenylephrine/ketorolac [2] ---> SmPC of [2] of EMA
Concomitant use of phenylephrine and atropine may enhance pressor effects and induce tachycardia in some patients.
Atropine, pilocarpine [2] ---> SmPC of [2] of eMC
Pilocarpine might antagonise the anticholinergic effects of other drugs used concomitantly
Atropine, pipotiazine [2] ---> SmPC of [2] of eMC
The mild anticholinergic effect of neuroleptics may be enhanced by other anticholinergic drugs possibly leading to constipation, heat stroke, etc.
Atropine, pramlintide
Co-administration is not recommended. Both active principles delay the gastric emptying
Atropine, prednisolone
The co-administration may increase an existing intraocular tension
Atropine, prednisone [2] ---> SmPC of [2] of eMC
The concurrent use may result in additional increases in intraocular pressure.
Atropine, promethazine [2] ---> SmPC of [2] of eMC
Promethazine will enhance the action of any anticholinergic agent
Atropine, ritodrine
Concomitant use of ritodrine and parasympatholytic agents may cause an additive sympathomimetic efect and increase the possibility of developing adverse effects, including hypertension or heart problems
Atropine, scopolamine
Scopolamine may enhance the anticholinergic effect
Atropine, somatorelin [2] ---> SmPC of [2] of eMC
Concomitant use of somatorelin and substances influencing the release of growth hormone should be avoided.
Atropine, succinylcholine
The co-administration may enhance the effect and increase the blood pressure
Atropine, suxamethonium
The co-administration may enhance the effect and increase the blood pressure
Atropine, tetracyclic antidepressant [2] ---> SmPC of [2] of EMA
The use concurrent of other anticholinergics or medicinal products with anticholinergic activity may result in potentiated anticholinergic effects.
Atropine, thiazides ---> SmPC of [aliskiren/hydrochlorothiazide] of EMA
The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Atropine, thiazides ---> SmPC of [telmisartan/hydrochlorothiazide] of EMA
Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Atropine, thioridazine
The combination with phenothiazines may exacerbate anticholinergic side effects, including atropine-like psychoses, paralytic ileus, and hyperpyretic effects until heat stroke
Atropine, triamcinolone
Additional increase in the intraocular pressure
Atropine, triamcinolone acetonide
Additional increase in the intraocular pressure
Atropine, urinary acidifying agents
The urinary acidifying agent increases the elimination of atropine
Atropine, urinary alkalinizing agents
The urinary alkalinizing agent decreases the renal elimination of atropine
Atropine, verapamil
Possible enhancement of induced tachycardia by atropine, as anticholinergics increase the effect of verapamil on the cardiac rhythm
CONTRAINDICATIONS of Atropine (Ryjunea)
- Hypersensitivity to atropine sulfate or to any of the excipients listed in section 6.1.
- Known hypersensitivity to other anticholinergics like ipratropium and tiotropium.
- Patients with primary glaucoma or angle-closure glaucoma.
https://www.ema.europa.eu/en/documents/product-information/ryjunea-epar-product-information_en.pdf 11/09/2025
Other trade names: ATROPINA SULFATO SERRA PAMIES,
Aurothiomalate
ACE inhibitors, aurothiomalate ---> SPC of [enalapril] of eMC
Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy
Aurothiomalate, benazepril [2]
Nitritoid reactions following injectable gold have been reported more frequently in patients receiving ACE inhibitor therapy.
Aurothiomalate, breast-feeding
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made
Aurothiomalate, chloroquine
The co-administration of aurothiomalate with photosensitizing agents should be avoided
Aurothiomalate, chlorpromazine
The co-administration of aurothiomalate with photosensitizing agents should be avoided
Aurothiomalate, cytotoxic agents
The safety of aurothiomalate and cytotoxic agents has not been established.
Aurothiomalate, enalapril [2] ---> SPC of [2] of eMC
Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy
Aurothiomalate, enalapril/hydrochlorothiazide [2] ---> SPC of [2] of eMC
Nitritoid reactions have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including enalapril.
Aurothiomalate, hepatotoxic drugs
The co-administration may have an additive hepatotoxic effect
Aurothiomalate, medicines with myelotoxic effects
The co-administration may have an additive myelotoxic effect
Aurothiomalate, naproxen
Naproxen may enhance the immunosuppressive toxic effects
Aurothiomalate, nephrotoxic substances
The co-administration may have an additive nephrotoxic effect
Aurothiomalate, penicillamine
The co-administration may increase the risk of serious hematologic and/or renal adverse effects
Aurothiomalate, perindopril [2] ---> SPC of [2] of eMC
Nitritoid reactions following injectable gold have been reported more frequently in patients receiving ACE inhibitor therapy.
Aurothiomalate, phenylbutazone
The co-administration of aurothiomalate with photosensitizing agents should be avoided
Aurothiomalate, photosensitizing agents
The co-administration of aurothiomalate with photosensitizing agents should be avoided
Aurothiomalate, pregnancy
Aurothiomalate should not be used during pregnancy because gold crosses the placenta
Aurothiomalate, quinapril [2] ---> SPC of [2] of eMC
Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (e.g. sodium aurothiomalate) and concomitant ACE inhibitor therapy
Aurothiomalate, sulphamides
The co-administration of aurothiomalate with photosensitizing agents should be avoided
Aurothiomalate, sulphonamides
The co-administration of aurothiomalate with photosensitizing agents should be avoided
Aurothiomalate, sun
Patients should be advised to avoid extensive exposure to sunlight.
Aurothiomalate, zofenopril
Nitritoid reactions following injectable gold (for example, sodium aurothiomalate) have been reported more frequently in patients receiving ACE inhibitor therapy.
Autologous anti-CD19-transduced CD3+ cells (Tecartus)
Ability to drive, autologous anti-CD19-transduced CD3+ cells [2] ---> SmPC of [2] of EMA
Due to the potential for neurologic events, including altered mental status/seizures, patients should not drive or operate heavy or potentially dangerous machines until at least 8 weeks after infusion or until resolution of neurologic adverse reactions.
Autologous anti-CD19-transduced CD3+ cells [1], breast-feeding ---> SmPC of [1] of EMA
It is unknown whether Tecartus is excreted in human milk or transferred to the breast-feeding child. Breast-feeding women should be advised of the potential risk to the breast-fed child.
Autologous anti-CD19-transduced CD3+ cells [1], breast-feeding ---> SmPC of [1] of EMA
It is unknown whether Tecartus is excreted in human milk or transferred to the breast-feeding child. Breast-feeding women must be advised of the potential risk to the breast-fed child.
Autologous anti-CD19-transduced CD3+ cells [1], corticosteroids ---> SmPC of [1] of EMA
Prophylactic use of systemic corticosteroids may interfere with the activity of Tecartus. Prophylactic use of systemic corticosteroids is therefore not recommended before infusion
Autologous anti-CD19-transduced CD3+ cells [1], fertility ---> SmPC of [1] of EMA
No clinical data on the effect of Tecartus on fertility are available. Effects on male and female fertility have not been evaluated in animal studies.
Autologous anti-CD19-transduced CD3+ cells [1], nursing ---> SmPC of [1] of EMA
Assessment of immunoglobulin levels and B-cells in newborn infants of mothers treated with Tecartus must be considered.
Autologous anti-CD19-transduced CD3+ cells [1], pregnancy ---> SmPC of [1] of EMA
Tecartus is not recommended for women who are pregnant, or for women of childbearing potential not using contraception. Pregnant women should be advised on the potential risks to the foetus.
Autologous anti-CD19-transduced CD3+ cells [1], pregnancy ---> SmPC of [1] of EMA
Therefore, Tecartus is not recommended for women who are pregnant, or for women of childbearing potential not using contraception. Pregnant women must be advised on the potential risks to the foetus.
Autologous anti-CD19-transduced CD3+ cells [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA
Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment.
Autologous anti-CD19-transduced CD3+ cells [1], women of childbearing potential ---> SmPC of [1] of EMA
The pregnancy status of women of childbearing potential must be verified before starting Tecartus treatment.
CONTRAINDICATIONS of Autologous anti-CD19-transduced CD3+ cells (Tecartus)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Contraindications of the lymphodepleting chemotherapy must be considered.
https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf 16/08/2024
Avacopan (Tavneos)
Alfentanyl, avacopan [2] ---> SmPC of [2] of EMA
Avacopan is a weak inhibitor of CYP3A4 in vivo and may increase the plasma exposures of concomitant medicinal products that are CYP3A4 substrates with a narrow therapeutic index
Avacopan [1], boceprevir ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], bosentan ---> SmPC of [1] of EMA
Exercise caution when using moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, and modafinil) prescribed as concomitant medicinal product with avacopan and carefully evaluate the benefit/risk of avacopan.
Avacopan [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy with avacopan, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Avacopan [1], carbamazepine ---> SmPC of [1] of EMA
The use of strong CYP3A4 enzyme inducers with avacopan is to be avoided. Patients anticipated to require long-term administration of these medicinal products are not to be treated with avacopan.
Avacopan [1], clarithromycin ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], conivaptan ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], cyclosporine ---> SmPC of [1] of EMA
Avacopan is a weak inhibitor of CYP3A4 in vivo and may increase the plasma exposures of concomitant medicinal products that are CYP3A4 substrates with a narrow therapeutic index
Avacopan [1], dabigatran etexilate ---> SmPC of [1] of EMA
A clinically relevant effect of the excipient macrogolglycerol hydroxystearate on sensitive P-gp substrates with relatively low bioavailability (e.g., dabigatran etexilate) cannot be excluded.
Avacopan [1], dihydroergotamine ---> SmPC of [1] of EMA
Avacopan is a weak inhibitor of CYP3A4 in vivo and may increase the plasma exposures of concomitant medicinal products that are CYP3A4 substrates with a narrow therapeutic index
Avacopan [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA
Avacopan is a weak inhibitor of CYP3A4 in vivo and may increase the plasma exposures of concomitant medicinal products that are CYP3A4 substrates with a narrow therapeutic index
Avacopan [1], efavirenz ---> SmPC of [1] of EMA
Exercise caution when using moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, and modafinil) prescribed as concomitant medicinal product with avacopan and carefully evaluate the benefit/risk of avacopan.
Avacopan [1], enzalutamide ---> SmPC of [1] of EMA
The use of strong CYP3A4 enzyme inducers with avacopan is to be avoided. Patients anticipated to require long-term administration of these medicinal products are not to be treated with avacopan.
Avacopan [1], ergotamine ---> SmPC of [1] of EMA
Avacopan is a weak inhibitor of CYP3A4 in vivo and may increase the plasma exposures of concomitant medicinal products that are CYP3A4 substrates with a narrow therapeutic index
Avacopan [1], etravirine ---> SmPC of [1] of EMA
Exercise caution when using moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, and modafinil) prescribed as concomitant medicinal product with avacopan and carefully evaluate the benefit/risk of avacopan.
Avacopan [1], fentanyl ---> SmPC of [1] of EMA
Avacopan is a weak inhibitor of CYP3A4 in vivo and may increase the plasma exposures of concomitant medicinal products that are CYP3A4 substrates with a narrow therapeutic index
Avacopan [1], fertility ---> SmPC of [1] of EMA
There are no data on the effects of avacopan on human fertility. Animal data did not indicate any impairment of male or female fertility (see section 5.3).
Avacopan [1], foods ---> SmPC of [1] of EMA
The hard capsules are to be taken with food and swallowed whole with water and must not be crushed, chewed, or opened.
Avacopan [1], grapefruit ---> SmPC of [1] of EMA
Grapefruit and grapefruit juice can increase the concentration of avacopan; therefore, grapefruit and grapefruit juice are to be avoided in patients treated with avacopan.
Avacopan [1], grapefruit juice ---> SmPC of [1] of EMA
Grapefruit and grapefruit juice can increase the concentration of avacopan; therefore, grapefruit and grapefruit juice are to be avoided in patients treated with avacopan.
Avacopan [1], indinavir ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], itraconazol ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], ketoconazole ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], lopinavir/ritonavir ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], mibefradil ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], mitotane ---> SmPC of [1] of EMA
The use of strong CYP3A4 enzyme inducers with avacopan is to be avoided. Patients anticipated to require long-term administration of these medicinal products are not to be treated with avacopan.
Avacopan [1], modafinil ---> SmPC of [1] of EMA
Exercise caution when using moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, and modafinil) prescribed as concomitant medicinal product with avacopan and carefully evaluate the benefit/risk of avacopan.
Avacopan [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA
Exercise caution when using moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, and modafinil) prescribed as concomitant medicinal product with avacopan and carefully evaluate the benefit/risk of avacopan.
Avacopan [1], nefazodone ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], nelfinavir ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
A clinically relevant effect of the excipient macrogolglycerol hydroxystearate on sensitive P-gp substrates with relatively low bioavailability (e.g., dabigatran etexilate) cannot be excluded.
Avacopan [1], phenobarbital ---> SmPC of [1] of EMA
The use of strong CYP3A4 enzyme inducers with avacopan is to be avoided. Patients anticipated to require long-term administration of these medicinal products are not to be treated with avacopan.
Avacopan [1], phenytoin ---> SmPC of [1] of EMA
The use of strong CYP3A4 enzyme inducers with avacopan is to be avoided. Patients anticipated to require long-term administration of these medicinal products are not to be treated with avacopan.
Avacopan [1], posaconazole ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], pregnancy ---> SmPC of [1] of EMA
Avacopan is not recommended during pregnancy and in women of childbearing potential not using contraception.
Avacopan [1], rifampicin ---> SmPC of [1] of EMA
The use of strong CYP3A4 enzyme inducers with avacopan is to be avoided. Patients anticipated to require long-term administration of these medicinal products are not to be treated with avacopan.
Avacopan [1], ritonavir ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], saquinavir ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], sirolimus ---> SmPC of [1] of EMA
Avacopan is a weak inhibitor of CYP3A4 in vivo and may increase the plasma exposures of concomitant medicinal products that are CYP3A4 substrates with a narrow therapeutic index
Avacopan [1], St. John's wort ---> SmPC of [1] of EMA
The use of strong CYP3A4 enzyme inducers with avacopan is to be avoided. Patients anticipated to require long-term administration of these medicinal products are not to be treated with avacopan.
Avacopan [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
The use of strong CYP3A4 enzyme inducers with avacopan is to be avoided. Patients anticipated to require long-term administration of these medicinal products are not to be treated with avacopan.
Avacopan [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], tacrolimus ---> SmPC of [1] of EMA
Avacopan is a weak inhibitor of CYP3A4 in vivo and may increase the plasma exposures of concomitant medicinal products that are CYP3A4 substrates with a narrow therapeutic index
Avacopan [1], telaprevir ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], telithromycin ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
Avacopan [1], vaccinations ---> SmPC of [1] of EMA
Administer vaccinations preferably prior to initiation of treatment with avacopan or during quiescent phase of the disease.
Avacopan [1], voriconazole ---> SmPC of [1] of EMA
Strong CYP3A4 enzyme inhibitors should be used with caution in patients who are being treated with avacopan.
CONTRAINDICATIONS of Avacopan (Tavneos)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/tavneos-epar-product-information_en.pdf 31/01/2025
Avalglucosidase alfa (Nexviadyme)
Ability to drive, avalglucosidase alfa [2] ---> SmPC of [2] of EMA
Because dizziness, hypotension and somnolence have been reported as IARs, this may affect the ability to drive and use machines on the day of the infusion
Avalglucosidase alfa [1], breast-feeding ---> SmPC of [1] of EMA
Nexviadyme should be used during breast-feeding only if the potential benefits to the mother outweigh the potential risks, including those to the breast-fed child
Avalglucosidase alfa [1], cytochrome P450 ---> SmPC of [1] of EMA
Because it is a recombinant human protein, avalglucosidase alfa is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Avalglucosidase alfa, fertility ---> SmPC of [1] of EMA
There are no clinical data on the effects of Nexviadyme on human fertility. Animal studies in mice showed no impairment of male or female fertility (see section 5.3).
Avalglucosidase alfa [1], pregnancy ---> SmPC of [1] of EMA
Nexviadyme should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the foetus.
CONTRAINDICATIONS of avalglucosidase alfa (Nexviadyme)
- Life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 when re-challenge was unsuccessful.
Avanafil (Spedra)
Ability to drive, avanafil [2] ---> SmPC of [2] of EMA
As dizziness and altered vision were reported in clinical trials with avanafil, patients should be aware of how they react to Spedra before driving or using machines.
Alcohol, avanafil [2] ---> SmPC of [2] of EMA
The mean maximum reduction in diastolic blood pressure was significantly greater following avanafil administered in combination with alcohol than following avanafil alone (3.2 mmHg) or alcohol alone
Alpha-blockers, avanafil [2] ---> SmPC of [2] of EMA
The concomitant use of alpha-blockers and avanafil may lead to symptomatic hypotension in some patients due to additive vasodilatory effects
Amlodipine, avanafil [2] ---> SmPC of [2] of EMA
Avanafil may potentiate the pressure-lowering effects. There was no effect of a single dose of avanafil on amlodipine plasma levels.
Amprenavir [1], avanafil ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Amyl nitrite, avanafil [2] ---> SmPC of [2] of EMA
Avanafil was shown to augment the hypotensive effects of nitrates. Therefore, administration of avanafil to patients who are using any form of organic nitrate or nitric oxide donor (such as amyl nitrite) is contraindicated
Antihypertensives, avanafil [2] ---> SmPC of [2] of EMA
If avanafil is used in combination with another medicinal product which reduces systemic blood pressure, the additive effects may result in symptomatic hypotension (e.g. dizziness, light-headedness, syncope or near-syncope)
Apixaban, avanafil [2] ---> SmPC of [2] of EMA
Although specific interactions of avanafil with rivaroxaban and apixaban (both CYP3A4 substrates) have not been studied, an interaction is not expected.
Aprepitant, avanafil [2] ---> SmPC of [2] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Atazanavir [1], avanafil ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Atazanavir/cobicistat [1], avanafil ---> SmPC of [1] of EMA
Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indexes and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Avanafil [1], BCRP inhibitors ---> SmPC of [1] of EMA
Based on in vitro data, at clinically relevant concentrations avanafil could be an inhibitor of BCRP. At clinically relevant concentrations avanafil is not an inhibitor of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 and BSEP.
Avanafil [1], bosentan ---> SmPC of [1] of EMA
The potential effect of CYP inducers, especially inducers of CYP3A4 on the pharmacokinetics and efficacy of avanafil has not been evaluated. The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil.
Avanafil [1], breast-feeding ---> SmPC of [1] of EMA
There are no data on the use of avanafil during breast-feeding.
Avanafil [1], carbamazepine ---> SmPC of [1] of EMA
The potential effect of CYP inducers, especially inducers of CYP3A4 on the pharmacokinetics and efficacy of avanafil has not been evaluated. The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil.
Avanafil [1], clarithromycin ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], CYP3A4 inhibitors ---> SmPC of [1] of EMA
Other CYP3A4 inhibitors would likely increase avanafil exposure.
Avanafil [1], CYP450 inductors ---> SmPC of [1] of EMA
The potential effect of CYP inducers, especially inducers of CYP3A4 on the pharmacokinetics and efficacy of avanafil has not been evaluated. The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil.
Avanafil [1], desipramine ---> SmPC of [1] of EMA
Further clinical studies using omeprazole, rosiglitazone and desipramine did not reveal clinically relevant interactions with CYPs 2C19, 2C8/9 and 2D6.
Avanafil [1], digoxin ---> SmPC of [1] of EMA
In vitro results showed for avanafil a modest potential for acting as P-gp substrate and P-gp inhibitor with digoxin as a substrate at concentrations lower than the calculated intestinal concentration.
Avanafil [1], diltiazem ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Avanafil [1], doxazosin ---> SmPC of [1] of EMA
The concomitant use of alpha-blockers and avanafil may lead to symptomatic hypotension in some patients due to additive vasodilatory effects
Avanafil [1], efavirenz ---> SmPC of [1] of EMA
The potential effect of CYP inducers, especially inducers of CYP3A4 on the pharmacokinetics and efficacy of avanafil has not been evaluated. The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil.
Avanafil [1], enalapril ---> SmPC of [1] of EMA
Avanafil may potentiate the pressure-lowering effects
Avanafil [1], erythromycin ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Avanafil [1], fertility ---> SmPC of [1] of EMA
There was no effect on sperm motility or morphology after single 200 mg oral doses of avanafil in healthy volunteers.
Avanafil [1], fluconazole ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Avanafil [1], fosamprenavir ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Avanafil [1], grapefruit juice ---> SmPC of [1] of EMA
Other CYP3A4 inhibitors, including grapefruit juice would likely increase avanafil exposure. Patients should be advised to avoid grapefruit juice within 24 hours prior to taking avanafil.
Avanafil [1], guanylate cyclase stimulators ---> SmPC of [1] of EMA
The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension
Avanafil [1], indinavir ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], itraconazol ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], ketoconazole ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], metabolized by cytochrome P450 ---> SmPC of [1] of EMA
Based on these data avanafil is not anticipated to have a significant effect on other medicinal products metabolised by these enzymes.
Avanafil [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Avanafil [1], nefazodone ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], nelfinavir ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], nitric oxide donors ---> SmPC of [1] of EMA
Avanafil was shown to augment the hypotensive effects of nitrates. Therefore, administration of avanafil to patients who are using any form of organic nitrate or nitric oxide donor (such as amyl nitrite) is contraindicated
Avanafil [1], omeprazole ---> SmPC of [1] of EMA
Further clinical studies using omeprazole, rosiglitazone and desipramine did not reveal clinically relevant interactions with CYPs 2C19, 2C8/9 and 2D6.
Avanafil [1], organic nitrates ---> SmPC of [1] of EMA
Avanafil was shown to augment the hypotensive effects of nitrates. Therefore, administration of avanafil to patients who are using any form of organic nitrate or nitric oxide donor (such as amyl nitrite) is contraindicated
Avanafil [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
In vitro results showed for avanafil a modest potential for acting as P-gp substrate and P-gp inhibitor with digoxin as a substrate at concentrations lower than the calculated intestinal concentration.
Avanafil [1], PDE5 inhibitors ---> SmPC of [1] of EMA
The safety and efficacy of combinations of avanafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. Patients should be informed not to take avanafil in such combinations.
Avanafil [1], phenobarbital ---> SmPC of [1] of EMA
The potential effect of CYP inducers, especially inducers of CYP3A4 on the pharmacokinetics and efficacy of avanafil has not been evaluated. The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil.
Avanafil [1], pregnancy ---> SmPC of [1] of EMA
Spedra is not indicated for use in women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development (see section 5.3).
Avanafil [1], rifampicin ---> SmPC of [1] of EMA
The potential effect of CYP inducers, especially inducers of CYP3A4 on the pharmacokinetics and efficacy of avanafil has not been evaluated. The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil.
Avanafil [1], riociguat ---> SmPC of [1] of EMA
The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension
Avanafil [1], ritonavir ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], rivaroxaban ---> SmPC of [1] of EMA
Although specific interactions of avanafil with rivaroxaban and apixaban (both CYP3A4 substrates) have not been studied, an interaction is not expected.
Avanafil [1], rosiglitazone ---> SmPC of [1] of EMA
Further clinical studies using omeprazole, rosiglitazone and desipramine did not reveal clinically relevant interactions with CYPs 2C19, 2C8/9 and 2D6.
Avanafil [1], saquinavir ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], sperm ---> SmPC of [1] of EMA
The daily administration of avanafil 100 mg oral doses over a period of 26 weeks was not associated with any untoward effects on sperm concentration, count, motility, or morphology.
Avanafil [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], tamsulosin ---> SmPC of [1] of EMA
The concomitant use of alpha-blockers and avanafil may lead to symptomatic hypotension in some patients due to additive vasodilatory effects
Avanafil [1], telithromycin ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil [1], vasodilators ---> SmPC of [1] of EMA
If avanafil is used in combination with another medicinal product which reduces systemic blood pressure, the additive effects may result in symptomatic hypotension (e.g. dizziness, light-headedness, syncope or near-syncope)
Avanafil [1], vasodilators ---> SmPC of [1] of EMA
Patients with left ventricular outflow obstruction and those with severely impaired autonomic control of blood pressure can be particularly sensitive to the actions of vasodilators including avanafil
Avanafil [1], verapamil ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The moderate CYP3A4 inhibitors may increase the exposition of avanafil. The maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours
Avanafil [1], voriconazole ---> SmPC of [1] of EMA
Avanafil is predominantly metabolised by CYP3A4. The strong CYP3A4 inhibitors may increase the exposition of avanafil. Co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated
Avanafil, darunavir/cobicistat [2] ---> SmPC of [2] of EMA
Co-administration of darunavir/cobicistat with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated
Avanafil, darunavir/cobicistat/emtricitabine/tenofovir alafenamide [2] ---> SmPC of [2] of EMA
Co-administration is contraindicated due to the potential for serious and/or life-threatening adverse reactions
Avanafil, darunavir/ritonavir ---> SmPC of [darunavir] of EMA
Co-administration of darunavir boosted with ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events is contraindicated
Avanafil, duvelisib [2] ---> SmPC of [2] of EMA
Dose reduction of CYP3A4 substrate should be considered when co-administered with duvelisib, especially for medicinal products with narrow therapeutic index.
Avanafil, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA
Due to CYP3A inhibition by lopinavir/ritonavir. The use of avanafil with Kaletra is contraindicated
Avanafil, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA
Concomitant use of avanafil with Paxlovid is contraindicated
Avanafil, selpercatinib [2] ---> SmPC of [2] of EMA
Selpercatinib increased Cmax and AUC of midazolam (a CYP3A4 substrate) by approximately 39% and 54%, respectively. Therefore, concomitant use with sensitive CYP3A4 substrates should be avoided.
Avanafil, tucatinib [2] ---> SmPC of [2] of EMA
Co-administration of tucatinib with sensitive CYP3A substrates may increase their systemic exposures which may increase the toxicity associated with a CYP3A substrate.
CYP3A4 inductors [1], avanafil ---> SmPC of [1] of EMA
The potential induction of CYP1A2, CYP2B6 and CYP3A4 by avanafil evaluated in primary human hepatocytes in vitro did not reveal any potential interaction at clinically relevant concentrations.
Guanylate cyclase stimulators, PDE5 inhibitors ---> SmPC of [avanafil] of EMA
The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension
CONTRAINDICATIONS of Avanafil (Spedra)
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite)
The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension
Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease before prescribing Spedra.
The use of avanafil is contraindicated in:
- Patients who have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;
- Patients with resting hypotension (blood pressure < 90/50 mmHg) or hypertension (blood pressure > 170/100 mmHg);
- Patients with unstable angina, angina with sexual intercourse, or congestive heart failure categorised as New York Heart Association Class 2 or greater.
- Patients with severe hepatic impairment (Child-Pugh C).
- Patients with severe renal impairment (creatinine clearance < 30 mL/min).
- Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure
- Patients with known hereditary degenerative retinal disorders.
- Patients who are using potent CYP3A4 inhibitors (ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir a. telithromycin)
https://www.ema.europa.eu/en/documents/product-information/spedra-epar-product-information_en.pdf 24/04/2024
Avapritinib (Ayvakyt)
Ability to drive, avapritinib [2] ---> SmPC of [2] of EMA
Patients should be made aware of the potential for adverse reactions that affect their ability to concentrate and react.
Avapritinib [1], azole antifungals ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], BCRP substrates ---> SmPC of [1] of EMA
Avapritinib is an inhibitor of P-gp, BCRP, MATE1, MATE2-K, and BSEP in vitro. Therefore, avapritinib has the potential to alter concentrations of co-administered substrates of these transporters.
Avapritinib [1], boceprevir ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], bosentan ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], breast-feeding ---> SmPC of [1] of EMA
A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with AYVAKYT and for 2 weeks following the final dose.
Avapritinib [1], carbamazepine ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], clarithromycin ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], cobicistat ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], conivaptan ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], dabrafenib ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], dexamethasone ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], drugs primarily metabolised by CYP3A4 ---> SmPC of [1] of EMA
Studies proved that avapritinib is a CYP3A-inhibitor/inductor. Therefore, avapritinib may have the potential to increase/decrease plasma concentrations of co-administered medicinal products that are substrates of CYP3A.
Avapritinib [1], drugs primarily metabolised by CYP3A4 with narrow therapeutic index ---> SmPC of [1] of EMA
Caution should be exercised with co-administration of avapritinib with narrow therapeutic index CYP3A substrates as their plasma concentrations may be altered.
Avapritinib [1], efavirenz ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], erythromycin ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], etravirine ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], fertility ---> SmPC of [1] of EMA
There are no data on the effect of AYVAKYT on human fertility. No relevant effects on fertility were observed in a rat fertility study (see section 5.3).
Avapritinib [1], fosphenytoin ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], grapefruit ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], grapefruit juice ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], indinavir ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], itraconazol ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], ketoconazole ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], lopinavir ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], men ---> SmPC of [1] of EMA
Women of childbearing potential and males with female partners of childbearing potential must use effective contraception during treatment and for 1 month after the last dose of AYVAKYT.
Avapritinib [1], modafinil ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], nafcillin ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], nelfinavir ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
Avapritinib is an inhibitor of P-gp, BCRP, MATE1, MATE2-K, and BSEP in vitro. Therefore, avapritinib has the potential to alter concentrations of co-administered substrates of these transporters.
Avapritinib [1], phenobarbital ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], phenytoin ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], photosensitizing agents ---> SmPC of [1] of EMA
Exposure to direct sunlight should be avoided or minimised due to the risk of phototoxicity associated with AYVAKYT. Patients should be instructed to use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Avapritinib [1], posaconazole ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], pregnancy ---> SmPC of [1] of EMA
AYVAKYT is not recommended during pregnancy and in women of childbearing potential not using contraception. The patient should be advised of the potential risk to the foetus.
Avapritinib [1], pregnancy ---> SmPC of [1] of EMA
Patients must be advised to contact their healthcare professional immediately if they become pregnant, or if pregnancy is suspected, while taking AYVAKYT.
Avapritinib [1], primidone ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib, QT interval prolonging drugs ---> SmPC of [1] of EMA
AYVAKYT should be used with caution in patients with known QT interval prolongation or at risk of QT interval prolongation (e.g. due to concomitant medicinal products, pre-existing cardiac disease and/or electrolyte disturbances).
Avapritinib [1], rifampicin ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], ritonavir ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], saquinavir ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], St. John's wort ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inducers should be avoided because it may decrease the plasma concentrations of avapritinib
Avapritinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], telithromycin ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], voriconazole ---> SmPC of [1] of EMA
Co-administration with strong or moderate CYP3A inhibitors should be avoided because it may increase the plasma concentration of avapritinib
Avapritinib [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential must be informed that avapritinib may cause foetal harm (see section 5.3). The pregnancy status of women of reproductive potential must be verified prior to initiating AYVAKYT treatment.
CONTRAINDICATIONS of Avapritinib (Ayvakyt)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/ayvakyt-epar-product-information_en.pdf 09/01/2026
Avatrombopag (Doptelet)
Avatrombopag [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Doptelet therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Avatrombopag [1], chronic immune thrombocytopenia ---> SmPC of [1] of EMA
Reduce the starting dose of avatrombopag when used concomitantly with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4/5 (see Table 4 and section 4.2).
Avatrombopag [1], chronic immune thrombocytopenia ---> SmPC of [1] of EMA
Reduction of the starting dose should also be considered for patients receiving a moderate or strong CYP2C9 inhibitor.
Avatrombopag [1], chronic immune thrombocytopenia ---> SmPC of [1] of EMA
Bei Anwendung zusammen mit einem moderaten oder starken dualen Induktor von CYP2C9 und CYP3A4/5 wird empfohlen, die Anfangsdosis von Doptelet zu erhöhen (siehe Tabelle 4 und Abschnitt 4.2).
Avatrombopag [1], chronic liver disease ---> SmPC of [1] of EMA
The increase in avatrombopag exposure is not expected to have a clinically important effect on platelet counts due to the 5-day treatment duration, and no dose adjustment is recommended.
Avatrombopag [1], chronic liver disease ---> SmPC of [1] of EMA
The decrease in avatrombopag exposure is not expected to have a clinically important effect on platelet counts due to the 5-day treatment duration. No dose adjustment is recommended (see section 5.2).
Avatrombopag [1], enzalutamide ---> SmPC of [1] of EMA
Concomitant use of moderate or strong CYP3A4/5 and CYP2C9 dual inducers (e.g., rifampicin, enzalutamide) reduces avatrombopag exposure, and may result in a decreased effect on platelet counts.
Avatrombopag [1], fertility ---> SmPC of [1] of EMA
The effect of avatrombopag on human fertility has not been established, and a risk cannot be ruled out. In animal studies, avatrombopag had no effect on male and female fertility or early embryogenesis in rats (see section 5.3).
Avatrombopag [1], fluconazole ---> SmPC of [1] of EMA
Concomitant use of avatrombopag with moderate or strong CYP3A4/5 and CYP2C9 dual inhibitors (e.g., fluconazole) increases avatrombopag exposure.
Avatrombopag [1], foods ---> SmPC of [1] of EMA
Avatrombopag is recommended to be administered with food
Avatrombopag [1], immune thrombocytopenia ---> SmPC of [1] of EMA
Medicinal products used in the treatment of ITP in combination with avatrombopag in clinical trials included corticosteroids, danazol, dapsone, and intravenous immunoglobulin (IVIg).
Avatrombopag [1], interferon ---> SmPC of [1] of EMA
Interferon preparations have been known to reduce platelet counts, therefore, this should be considered when co-administering avatrombopag with interferon preparations.
Avatrombopag [1], moderate or strong CYP2C9 inducers ---> SmPC of [1] of EMA
Concomitant use of avatrombopag with moderate or strong CYP2C9 inducers is expected to reduce avatrombopag exposure.
Avatrombopag [1], moderate or strong CYP3A4/5 and CYP2C9 dual inducers ---> SmPC of [1] of EMA
Concomitant use of moderate or strong CYP3A4/5 and CYP2C9 dual inducers (e.g., rifampicin, enzalutamide) reduces avatrombopag exposure, and may result in a decreased effect on platelet counts.
Avatrombopag [1], moderate or strong CYP3A4/5 and CYP2C9 dual inhibitors ---> SmPC of [1] of EMA
Concomitant use of avatrombopag with moderate or strong CYP3A4/5 and CYP2C9 dual inhibitors (e.g., fluconazole) increases avatrombopag exposure.
Avatrombopag [1], P-gp inhibitors ---> SmPC of [1] of EMA
Avatrombopag is a substrate for p-glycoprotein (P-gp) mediated transport, although no clinically important differences in platelet count elevations are expected when avatrombopag is co-administered with a strong P-gp inhibitor
Avatrombopag [1], pregnancy ---> SmPC of [1] of EMA
Doptelet is not recommended during pregnancy and in women of childbearing potential not using contraception.
Avatrombopag [1], rifampicin ---> SmPC of [1] of EMA
Concomitant use of moderate or strong CYP3A4/5 and CYP2C9 dual inducers (e.g., rifampicin, enzalutamide) reduces avatrombopag exposure, and may result in a decreased effect on platelet counts.
CONTRAINDICATIONS of Avatrombopag (Doptelet)
- Hypersensitivity to avatrombopag or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/doptelet-epar-product-information_en.pdf 27/02/2024
Avelumab (Bavencio)
Ability to drive, avelumab [2] ---> SmPC of [2] of EMA
Fatigue has been reported following administration of avelumab (see section 4.8). Patients should be advised to use caution when driving or operating machinery until they are certain that avelumab does not adversely affect them.
Avelumab [1], breast-feeding ---> SmPC of [1] of EMA
Breast-feeding women should be advised not to breast-feed during treatment and for at least 1 month after the last dose due to the potential for serious adverse reactions in breast-fed infants.
Avelumab [1], fertility ---> SmPC of [1] of EMA
The effect of avelumab on male and female fertility is unknown.
Avelumab [1], pregnancy ---> SmPC of [1] of EMA
It is not recommended to use avelumab during pregnancy unless the clinical condition of the woman requires treatment with avelumab.
Avelumab [1], via catabolic ---> SmPC of [1] of EMA
Avelumab is primarily metabolised through catabolic pathways, therefore, it is not expected that avelumab will have pharmacokinetic drug-drug interactions with other medicinal products.
Avelumab [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential should be advised to avoid becoming pregnant while receiving avelumab and should use effective contraception during treatment with avelumab and for at least 1 month after the last dose of avelumab.
CONTRAINDICATIONS of Avelumab (Bavencio)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/bavencio-epar-product-information_en.pdf 22/01/2026
Axicabtagene ciloleucel (Yescarta)
Ability to drive, axicabtagene ciloleucel [2] ---> SmPC of [2] of EMA
Due to the potential for neurologic events, including altered mental status or seizures, patients must refrain from driving or operating heavy or potentially dangerous machines until at least 8 weeks after infusion/until resolution of neurologic reaction
Axicabtagene ciloleucel [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Yescarta therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Axicabtagene ciloleucel [1], fertility ---> SmPC of [1] of EMA
No clinical data on the effect of Yescarta on fertility are available. Effects on male and female fertility have not been evaluated in animal studies.
Axicabtagene ciloleucel [1], pregnancy ---> SmPC of [1] of EMA
Yescarta is not recommended for women who are pregnant, or for women of childbearing potential not using contraception. Pregnant women must be advised on the potential risks to the foetus.
Axicabtagene ciloleucel [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA
Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment with YESCARTA.
Axicabtagene ciloleucel [1], women of childbearing potential ---> SmPC of [1] of EMA
The pregnancy status of women of child bearing potential must be verified before starting Yescarta treatment.
CONTRAINDICATIONS of Axicabtagene ciloleucel (Yescarta)
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Contraindications of the lymphodepleting chemotherapy must be considered
https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf 08/12/2025
Axitinib (Inlyta)
Ability to drive, axitinib [2] ---> SmPC of [2] of EMA
Axitinib has a minor influence on the ability to drive and use machines. Patients should be advised that they may experience events such as dizziness and/or fatigue during treatment with axitinib.
Antihypertensives, axitinib [2] ---> SmPC of [2] of EMA
Patients receiving antihypertensive medicinal products should be monitored for hypotension
Artesunate [1], axitinib ---> SmPC of [1] of EMA
Co-administration of intravenous artesunate with strong inhibitors of UGT enzymes (e.g. axitinib, vandetanib, imatinib, diclofenac) may increase plasma exposures to DHA. Co-administration should be avoided if possible.
Atazanavir, axitinib [2] ---> SmPC of [2] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], breast-feeding ---> SmPC of [1] of EMA
It is unknown whether axitinib is excreted in human milk. A risk to the suckling child cannot be excluded. Axitinib should not be used during breast-feeding.
Axitinib [1], carbamazepine ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Axitinib [1], clarithromycin ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], cytochrome P450 ---> SmPC of [1] of EMA
In vitro studies indicated that axitinib does not inhibit CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, or UGT1A1 at therapeutic plasma concentrations.
Axitinib [1], cytochrome P450 ---> SmPC of [1] of EMA
Therefore co-administration of axitinib is not expected to reduce the plasma concentration of co-administered CYP1A1, CYP1A2, or CYP3A4/5 substrates in vivo.
Axitinib [1], dexamethasone ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Axitinib [1], digoxin ---> SmPC of [1] of EMA
In vitro studies indicated that axitinib inhibits P-glycoprotein. The co-administration of axitinib is not expected to increase the plasma concentration of digoxin, or other P-glycoprotein substrates, in vivo.
Axitinib [1], drugs primarily metabolised by CYP1A2 ---> SmPC of [1] of EMA
In vitro studies indicated that axitinib has a potential to inhibit CYP1A2. Therefore, co-administration of axitinib with CYP1A2 substrates may result in increased plasma concentrations of CYP1A2 substrates
Axitinib [1], enzyme inductors ---> SmPC of [1] of EMA
In vitro studies indicated that axitinib does not induce CYP1A1, CYP1A2, or CYP3A4/5. Therefore co-administration of axitinib is not expected to reduce the plasma concentration of co-administered CYP1A1, CYP1A2, or CYP3A4/5 substrates in vivo.
Axitinib [1], erythromycin ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], fertility ---> SmPC of [1] of EMA
Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans (see section 5.3).
Axitinib [1], grapefruit juice ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], indinavir ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], itraconazol ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], ketoconazole ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], nefazodone ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], nelfinavir ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
In vitro studies indicated that axitinib inhibits P-glycoprotein. The co-administration of axitinib is not expected to increase the plasma concentration of digoxin, or other P-glycoprotein substrates, in vivo.
Axitinib [1], paclitaxel ---> SmPC of [1] of EMA
Co-administration of axitinib with paclitaxel, a known CYP2C8 substrate, did not result in increased plasma concentrations of paclitaxel in patients with advanced cancer, indicating lack of clinical CYP2C8 inhibition.
Axitinib [1], phenobarbital ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Axitinib [1], phenytoin ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Axitinib [1], pregnancy ---> SmPC of [1] of EMA
Axitinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with this medicinal product.
Axitinib [1], rifabutin ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Axitinib [1], rifampicin ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Axitinib [1], rifapentine ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Axitinib [1], ritonavir ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], saquinavir ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], St. John's wort ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Axitinib [1], strong CYP1A2 inhibitors ---> SmPC of [1] of EMA
CYP1A2 and CYP2C19 constitute minor (< 10%) pathways in axitinib metabolism. Caution should be exercised due to the risk of increased axitinib plasma concentrations in patients taking strong inhibitors of these isozymes.
Axitinib [1], strong CYP2C19 inhibitors ---> SmPC of [1] of EMA
CYP1A2 and CYP2C19 constitute minor (< 10%) pathways in axitinib metabolism. Caution should be exercised due to the risk of increased axitinib plasma concentrations in patients taking strong inhibitors of these isozymes.
Axitinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Axitinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], telithromycin ---> SmPC of [1] of EMA
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations. Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Axitinib [1], theophylline ---> SmPC of [1] of EMA
In vitro studies indicated that axitinib has a potential to inhibit CYP1A2. Therefore, co-administration of axitinib with CYP1A2 substrates may result in increased plasma concentrations of CYP1A2 substrates
Axitinib [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential must use effective contraception during and up to 1 week after treatment.
Axitinib, voriconazole [2] ---> SmPC of [2] of EMA
Voriconazole may increase plasma concentrations of tyrosine kinase inhibitors metabolised by CYP3A4. If concomitant use cannot be avoided, dose reduction of the tyrosine kinase inhibitor is recommended (see section 4.4).
CONTRAINDICATIONS of Axitinib (Inlyta)
- Hypersensitivity to axitinib or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/inlyta-epar-product-information_en.pdf 21/01/2025
Other trade names: Axitinib Accord,
Azacitidine (Vidaza)
Ability to drive, azacitidine [2] ---> SmPC of [2] of EMA
Fatigue has been reported with the use of azacitidine. Therefore, caution is recommended when driving or operating machines.
Azacitidine [1], breast-feeding ---> SmPC of [1] of EMA
Due to the potential serious adverse reactions in the nursing child, breastfeeding is contraindicated during azacitidine therapy.
Azacitidine [1], cytochrome P450 ---> SmPC of [1] of EMA
Clinically significant inhibitory or inductive effects of azacitidine on cytochrome P450 enzymes are unlikely (see section 5.2).
Azacitidine [1], fertility ---> SmPC of [1] of EMA
There are no human data on the effect of azacitidine on fertility. In animals, adverse reactions with azacitidine use on male fertility have been documented (see section 5.3).
Azacitidine [1], men ---> SmPC of [1] of EMA
Men should be advised not to father a child while receiving treatment and must use effective contraception during and for at least 3 months after treatment.
Azacitidine [1], pregnancy ---> SmPC of [1] of EMA
Azacitidine should not be used during pregnancy, especially during the first trimester, unless clearly necessary.
Azacitidine [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential have to use effective contraception during and for at least 6 months after treatment.
Azacitidine, decitabine/cedazuridine [2] ---> SmPC of [2] of EMA
Concomitant administration of Inaqovi with medicinal products metabolised by CDA (i.e., cytarabine, gemcitabine, azacitidine) may result in increased systemic exposure with a potential for increased toxicity of these medicinal products.
CONTRAINDICATIONS of Azacitidine (Vidaza)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Advanced malignant hepatic tumours
- Breast-feeding
https://www.ema.europa.eu/en/documents/product-information/vidaza-epar-product-information_en.pdf 05/11/2024
Other trade names: Azacitidine Accord, Azacitidine betapharm, Azacitidine Celgene, Azacitidine Mylan, Onureg,
Azathioprine (Jayempi)
Ability to drive, azathioprine [2] ---> SmPC of [2] of EMA
Jayempi has no or negligible influence on the ability to drive and use machines.
ACE inhibitors, azathioprine [2] ---> SmPC of [2] of EMA
There have been case reports suggesting that haematological abnormalities may develop due to the concomitant administration of azathioprine and ACE Inhibitors.
Acenocoumarol, azathioprine [2] ---> SmPC of [2] of eMC
Inhibition of the anticoagulant effect of warfarin and acenocoumarol has been reported when co-administered with azathioprine. Coagulation tests should be closely monitored when anticoagulants are coadministered with azathioprine.
Allopurinol, azathioprine [2] ---> SmPC of [2] of EMA
Xanthine oxidase activity is inhibited by allopurinol, oxipurinol and thiopurinol which results in reduced conversion of biologically active 6-thioinosinic acid to biologically inactive 6-thiouric acid.
Allopurinol, mercaptopurine ---> SmPC of [azathioprine] of EMA
When allopurinol, oxipurinol and/or thiopurinol are given concomitantly with 6-mercaptopurine or azathioprine, the dose of 6-mercaptopurine and azathioprine should be reduced to one quarter of the original dose
Allopurinol/lesinurad [1], azathioprine ---> SmPC of [1] of EMA
Serum concentrations of 6-mercaptopurine and azathioprine can reach toxic levels unless dose reduction is undertaken.
Aminosalicylates, azathioprine [2] ---> SmPC of [2] of EMA
There is in vitro and in vivo evidence that aminosalicylate derivatives inhibit the TPMT enzyme. Therefore, lower doses of azathioprine should be considered when administered concomitantly with aminosalicylate derivatives
Atracurium, azathioprine [2] ---> SmPC of [2] of EMA
Special caution is required when azathioprine is given concomitantly with neuromuscular blocking agents such as atracurium, rocuronium, cisatracurium or suxamethonium (also known as succinylcholine) (see section 4.5).
Attenuated vaccines, azathioprine
Immunosuppressed patients must not be vaccinated with live vaccines, since they are at risk of infection from the live vaccine (see section 4.4).
Attenuated vaccines, azathioprine [2] ---> SmPC of [2] of EMA
Therefore, it is recommended that patients do not receive live vaccines until at least 3 months after the end of treatment with azathioprine (see section 4.4).
Azathioprine [1], breast-feeding ---> SmPC of [1] of EMA
Breast-feeding and concomitant use of azathioprine are contra-indicated (see section 4.3). If treatment with azathioprine is unavoidable, breast-feeding should be discontinued.
Azathioprine [1], cimetidine ---> SmPC of [1] of EMA
It has been suggested that cimetidine and indomethacin may have myelosuppressive effects which may be enhanced by concomitant administration of azathioprine.
Azathioprine [1], cisatracurium ---> SmPC of [1] of EMA
Special caution is required when azathioprine is given concomitantly with neuromuscular blocking agents such as atracurium, rocuronium, cisatracurium or suxamethonium (also known as succinylcholine) (see section 4.5).
Azathioprine [1], contraceptives ---> SmPC of [1] of EMA
Both male and female patients of reproductive age should use contraceptive methods while using azathioprine.
Azathioprine [1], cotrimoxazole ---> SmPC of [1] of EMA
There are conflicting clinical reports of interactions, resulting in serious haematological abnormalities, between azathioprine and trimethoprim/sulfamethoxazole.
Azathioprine [1], count ---> SmPC of [1] of EMA
Azathioprine should only be prescribed if the patient can be adequately monitored for haematological and hepatic effects throughout the duration of therapy.
Azathioprine [1], cytotoxic agents ---> SmPC of [1] of EMA
Where possible, concomitant administration of cytostatic medicinal products, or medicinal products which may have a myelosuppressive effect, such as penicillamine, should be avoided (see section 4.4).
Azathioprine [1], fertility ---> SmPC of [1] of EMA
No preclinical or clinical data is available on the possible influence of azathioprine on male and female fertility (see section 4.4).
Azathioprine [1], foods ---> SmPC of [1] of EMA
Jayempi should be taken at least 1 hour before or 2 hours after a meal or milk. Water should be taken after each dose in order to ensure accurate and consistent dose delivery to the stomach.
Azathioprine [1], immunosuppressives ---> SmPC of [1] of EMA
Infection with varicella zoster virus (VZV; chickenpox and herpes zoster) may become severe during the administration of immunosuppressants (see section 4.8).
Azathioprine [1], immunosuppressives ---> SmPC of [1] of EMA
PML, an opportunistic infection caused by the JC virus, has been reported in patients receiving azathioprine with other immunosuppressive agents (see section 4.8).
Azathioprine [1], immunosuppressives ---> SmPC of [1] of EMA
A treatment regimen containing multiple immunosuppressants (including thiopurines) should therefore be used with caution as this could lead to lymphoproliferative disorders, some with reported fatalities.
Azathioprine [1], inactivated vaccines ---> SmPC of [1] of EMA
A decreased immune response to inactivated or toxoid vaccines is likely.
Azathioprine [1], indometacin ---> SmPC of [1] of EMA
It has been suggested that cimetidine and indomethacin may have myelosuppressive effects which may be enhanced by concomitant administration of azathioprine.
Azathioprine [1], infection ---> SmPC of [1] of EMA
Patients receiving azathioprine must be advised to inform their doctor immediately about any evidence of infection, unexpected bruising or bleeding or other signs of myelosuppression.
Azathioprine [1], infliximab ---> SmPC of [1] of EMA
Patients receiving ongoing azathioprine experienced transient increases in thioguanine nucleotide levels (an active metabolite of azathioprine) and a decrease in the mean leukocyte count in the initial weeks following infliximab infusion
Azathioprine [1], intrauterine device ---> SmPC of [1] of EMA
Azathioprine has been reported to interfere with the effectiveness of intrauterine contraceptive devices (coil or T-shaped 'copper coil'). Therefore, it is recommended to use other or additional contraceptive measures
Azathioprine [1], jaundice ---> SmPC of [1] of EMA
The patients should be advised to discontinue azathioprine immediately if jaundice occurs.
Azathioprine [1], Lesch-Nyhan syndrome ---> SmPC of [1] of EMA
Limited data indicate that azathioprine is not effective in patients with hereditary hypoxanthine-guanine-phosphoribosyl transferase deficiency (Lesch-Nyhan syndrome). Therefore, azathioprine should not be used in these patients.
Azathioprine [1], liver ---> SmPC of [1] of EMA
In particular, patients with impaired liver function require special monitoring when using azathioprine, as life-threatening liver damages have been reported (see section 4.8).
Azathioprine [1], macrophage activation syndrome ---> SmPC of [1] of EMA
Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.
Azathioprine [1], men ---> SmPC of [1] of EMA
Men should not father children during and up to 6 months after the end of treatment. This also applies to patients with reduced fertility due to chronic uraemia
Azathioprine [1], mesalazine ---> SmPC of [1] of EMA
There is in vitro and in vivo evidence that aminosalicylate derivatives inhibit the TPMT enzyme. Therefore, lower doses of azathioprine should be considered when administered concomitantly with aminosalicylate derivatives
Azathioprine [1], methotrexate ---> SmPC of [1] of EMA
Therefore, when azathioprine is administered concomitantly with high-dose methotrexate, the dose should be adjusted to maintain a suitable white blood cell count.
Azathioprine [1], muscle relaxants (non-depolarizing) ---> SmPC of [1] of EMA
Special caution is required when azathioprine is given concomitantly with neuromuscular blocking agents such as atracurium, rocuronium, cisatracurium or suxamethonium (also known as succinylcholine) (see section 4.5).
Azathioprine [1], mutagenicity ---> SmPC of [1] of EMA
Chromosomal abnormalities have been demonstrated in both male and female patients treated with azathioprine. It is difficult to assess the role of azathioprine in the development of these abnormalities.
Azathioprine [1], myelosuppressive agents ---> SmPC of [1] of EMA
Where possible, concomitant administration of cytostatic medicinal products, or medicinal products which may have a myelosuppressive effect, such as penicillamine, should be avoided (see section 4.4).
Azathioprine [1], olsalazine ---> SmPC of [1] of EMA
There is in vitro and in vivo evidence that aminosalicylate derivatives inhibit the TPMT enzyme. Therefore, lower doses of azathioprine should be considered when administered concomitantly with aminosalicylate derivatives
Azathioprine [1], oxipurinol ---> SmPC of [1] of EMA
Xanthine oxidase activity is inhibited by allopurinol, oxipurinol and thiopurinol which results in reduced conversion of biologically active 6-thioinosinic acid to biologically inactive 6-thiouric acid.
Azathioprine [1], penicillamine ---> SmPC of [1] of EMA
Where possible, concomitant administration of cytostatic medicinal products, or medicinal products which may have a myelosuppressive effect, such as penicillamine, should be avoided (see section 4.4).
Azathioprine [1], phenprocoumon ---> SmPC of [1] of EMA
A reduction of the anticoagulant effect of warfarin was described following the simultaneous use of azathioprine.
Azathioprine [1], polyvalent pneumococcal vaccine ---> SmPC of [1] of EMA
A small clinical study has indicated that standard therapeutic doses of azathioprine do not deleteriously affect the immune response to a polyvalent pneumococcal vaccine
Azathioprine [1], pregnancy ---> SmPC of [1] of EMA
Azathioprine must only be used during pregnancy after a careful benefit/risk analysis.
Azathioprine [1], ribavirin ---> SmPC of [1] of EMA
Severe myelosuppression has been reported following concomitant administration of azathioprine and ribavirin; therefore, co-administration is not advised (see sections 4.4 and 5.2).
Azathioprine [1], rocuronium ---> SmPC of [1] of EMA
Special caution is required when azathioprine is given concomitantly with neuromuscular blocking agents such as atracurium, rocuronium, cisatracurium or suxamethonium (also known as succinylcholine) (see section 4.5).
Azathioprine [1], succinylcholine ---> SmPC of [1] of eMC
Enhancement or prolongation of the neuromuscular effects of suxamethonium by mechanisms unrelated to plasma cholinesterase activity.
Azathioprine [1], sulfasalazine ---> SmPC of [1] of EMA
There is in vitro and in vivo evidence that aminosalicylate derivatives inhibit the TPMT enzyme. Therefore, lower doses of azathioprine should be considered when administered concomitantly with aminosalicylate derivatives
Azathioprine [1], sunlight ---> SmPC of [1] of EMA
Exposure to sunlight and UV light should be limited and patients should wear protective clothing and use a sunscreen with a high protection factor to minimise the risk of skin cancer and photosensitivity
Azathioprine [1], suxamethonium ---> SmPC of [1] of EMA
Special caution is required when azathioprine is given concomitantly with neuromuscular blocking agents such as atracurium, rocuronium, cisatracurium or suxamethonium (also known as succinylcholine) (see section 4.5).
Azathioprine [1], thiopurine methyl transferase inhibitors ---> SmPC of [1] of EMA
There is in vitro and in vivo evidence that aminosalicylate derivatives inhibit the TPMT enzyme. Therefore, lower doses of azathioprine should be considered when administered concomitantly with aminosalicylate derivatives
Azathioprine [1], thiopurinol ---> SmPC of [1] of EMA
Xanthine oxidase activity is inhibited by allopurinol, oxipurinol and thiopurinol which results in reduced conversion of biologically active 6-thioinosinic acid to biologically inactive 6-thiouric acid.
Azathioprine [1], TNF inhibitors ---> SmPC of [1] of EMA
There are reports of hepatosplenic T-cell lymphoma in IBD patients who use azathioprine concomitantly with anti-TNF medicinal products.
Azathioprine [1], toxoid vaccine ---> SmPC of [1] of EMA
A decreased immune response to inactivated or toxoid vaccines is likely.
Azathioprine [1], trimethoprim/sulfamethoxazol ---> SmPC of [1] of EMA
There are conflicting clinical reports of interactions, resulting in serious haematological abnormalities, between azathioprine and trimethoprim/sulfamethoxazole.
Azathioprine [1], UV-A radiation ---> SmPC of [1] of EMA
Exposure to sunlight and UV light should be limited and patients should wear protective clothing and use a sunscreen with a high protection factor to minimise the risk of skin cancer and photosensitivity
Azathioprine [1], vaccinations with live organism vaccines ---> SmPC of [1] of eMC
The immunosuppressive activity of azathioprine could result in an atypical and potentially deleterious response to live vaccines and so the administration of live vaccines to patients receiving azathioprine therapy is not recommended
Azathioprine [1], warfarin ---> SmPC of [1] of EMA
A reduction of the anticoagulant effect of warfarin was described following the simultaneous use of azathioprine.
Azathioprine [1], women of childbearing potential ---> SmPC of [1] of EMA
Contraceptive measures must be taken by both male and female patients of reproductive age during azathioprine therapy for at least six months after the end of azathioprine therapy.
Azathioprine [1], xanthine oxidase inhibitors ---> SmPC of [1] of EMA
On the basis of the mechanism of action of febuxostat on XO inhibition concomitant use is not recommended. Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to myelotoxicity.
Azathioprine, basiliximab [2] ---> SmPC of [2] of EMA
The use of basiliximab in a triple therapy regimen including azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab group as compared to placebo
Azathioprine, cyclosporine
The co-administration may increase the risk of an excessive immunsuppression
Azathioprine, febuxostat [2] ---> SmPC of [2] of EMA
On the basis of the mechanism of action of febuxostat on XO inhibition concomitant use is not recommended. Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to myelotoxicity.
Azathioprine, hepatotoxic drugs
Azathioprine is hepatotoxic, thus regular liver function tests should be repeated during the treatment.
Azathioprine, infliximab
Interactions between azathioprine and infliximab in the treatment of Crohn disease have been reported
Azathioprine, methotrexate [2] ---> SmPC of [2] of EMA
Patients taking potentially hepatotoxic and haematoxic medicinal products during methotrexate therapy should be closely monitored for possibly increased hepatotoxicity.
Azathioprine, mirikizumab [2] ---> SmPC of [2] of EMA
Population pharmacokinetic data analyses indicated that the clearance of mirikizumab was not impacted by concomitant administration in patients with ulcerative colitis.
Azathioprine, mycophenolate mofetil [2] ---> SmPC of [2] of EMA
It is recommended that mycophenolate mofetil should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Azathioprine, natalizumab [2] ---> SmPC of [2] of EMA
Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine). These medicinal products have the potential to cause prolonged immunosuppression, even after dosing is discontinued.
Azathioprine, peginterferon alfa-2a/ribavirin ---> SmPC of [peginterferon alfa-2a] of EMA
Ribavirin, inosine monophosphate dehydrogenase inhibitor, may interfere with azathioprine metabolism with possible myelotoxicity. The use of peginterferon alfa-2a and ribavirin concomitantly with azathioprine should be avoided.
Azathioprine, peginterferon/ribavirin ---> SmPC of [ribavirin] of EMA
Pancytopenia and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the administration of a peginterferon and ribavirin concomitantly with azathioprine.
Azathioprine, pegylated interferon alfa/ribavirin ---> SmPC of [ribavirin] of EMA
The use of pegylated alpha interferons and ribavirin concomitantly with azathioprine should be avoided.
Azathioprine, ribavirin [2] ---> SmPC of [2] of EMA
Rebetol, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-MTIMP, which has been associated with myelotoxicity in patients treated with azathioprine
Azathioprine, romiplostim [2] ---> SmPC of [2] of EMA
Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1).
Azathioprine, satralizumab [2] ---> SmPC of [2] of EMA
Population pharmacokinetic (PK) analyses did not detect any effect of azathioprine (AZA), oral corticosteroids (OCs) or mycophenolate mofetil (MMF) on the clearance of satralizumab.
Azathioprine, tacrolimus
The co-administration may increase the risk of an excessive immunsuppression
Azathioprine, upadacitinib [2] ---> SmPC of [2] of EMA
Combination with other potent immunosuppressants has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.
Azathioprine, ustekinumab [2] ---> SmPC of [2] of EMA
The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease or ulcerative colitis
Mercaptopurine, oxipurinol ---> SmPC of [azathioprine] of EMA
When allopurinol, oxipurinol and/or thiopurinol are given concomitantly with 6-mercaptopurine or azathioprine, the dose of 6-mercaptopurine and azathioprine should be reduced to one quarter of the original dose
Mercaptopurine, thiopurinol ---> SmPC of [azathioprine] of EMA
When allopurinol, oxipurinol and/or thiopurinol are given concomitantly with 6-mercaptopurine or azathioprine, the dose of 6-mercaptopurine and azathioprine should be reduced to one quarter of the original dose
CONTRAINDICATIONS of Azathioprine (Jayempi)
-Hypersensitivity to the active substance azathioprine, 6-mercaptopurine (metabolite of azathioprine) or to any of the excipients listed in section 6.1.
-Any live vaccine, especially BCG, smallpox, yellow fever (see section 4.5)
-Lactation (see section 4.6).
https://www.ema.europa.eu/en/documents/product-information/jayempi-epar-product-information_en.pdf 22/09/2025
Other trade names: Immunoprin, Imurel,
Azelastine
CNS depressants, azelastine
Azelastine may enhance sedation effects of other medicinal products as tranquilizers, hypnotics and alcohol
Ability to drive, azelastine [2] ---> SPC of [2] of eMC
If there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating machinery.
Alcohol, azelastine
Azelastine may enhance sedation effects of other medicinal products as tranquilizers, hypnotics and alcohol
Azelastine, benzodiazepines
Azelastine may enhance sedation effects of other medicinal products as tranquilizers, hypnotics and alcohol
Azelastine [1], breast-feeding ---> SPC of [1] of eMC
Azelastine is excreted into the milk in low quantities. For that reason azelastine is not recommended during lactation.
Azelastine, cimetidine
The CYP2D6 inhibition by cimetidine may increase the plasma concentrations and the adverse effects of azelastine. Concomitant use should be avoided
Azelastine, hypnotics
Azelastine may enhance sedation effects of other medicinal products as tranquilizers, hypnotics and alcohol
Azelastine [1], pregnancy ---> SPC of [1] of eMC
Caution should be exercised when using azelastine during pregnancy.
Azelastine, sedatives
Azelastine may enhance sedation effects of other medicinal products as tranquilizers, hypnotics and alcohol
Azelastine, strong CYP2D6 inhibitors
Patients treated with known CYP2D6 inhibitors should be controlled due to the probability of experiencing side effects.
CONTRAINDICATIONS of Azelastine
Hypersensitivity to the active substance or to any of the excipients.
http://www.medicines.org.uk/emc/
Azilsartan medoxomil (Edarbi)
Ability to drive, azilsartan medoxomil [2] ---> SmPC of [2] of EMA
Azilsartan medoxomil has no or negligible influence on the ability to drive and use machines. However it should be taken into account that occasionally dizziness or tiredness may occur.
ACE inhibitors, AIIRA ---> SmPC of [azilsartan medoxomil] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
ACE inhibitors, azilsartan medoxomil [2] ---> SmPC of [2] of EMA
The dual blockade of the RAA-system through the combined use of ACE-inhibitors, AIIRA or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure)
ACE inhibitors, lithium ---> SmPC of [azilsartan medoxomil] of EMA
Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of lithium and angiotensin-converting enzyme inhibitors.
Acetylsalicylic acid, azilsartan medoxomil [2] ---> SmPC of [2] of EMA
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may attenuate the antihypertensive effect, lead to an increased risk of worsening of renal function and an increase in serum potassium.
AIIRA, NSAID ---> SmPC of [azilsartan medoxomil] of EMA
Furthermore, concomitant use of angiotensin II receptor antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
AIIRA, NSAID ---> SmPC of [azilsartan medoxomil] of EMA
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may attenuate the antihypertensive effect, lead to an increased risk of worsening of renal function and an increase in serum potassium.
Aliskiren, azilsartan medoxomil [2] ---> SmPC of [2] of EMA
Concomitant use of azilsartan medoxomil with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) is contraindicated and is not recommended in other patients
Amlodipine, azilsartan medoxomil [2] ---> SmPC of [2] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Antacids, azilsartan medoxomil [2] ---> SmPC of [2] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Azilsartan medoxomil [1], breast-feeding ---> SmPC of [1] of EMA
Edarbi is not recommended during breastfeeding and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Azilsartan medoxomil [1], caffeine ---> SmPC of [1] of EMA
Following administration with a mixture of cytochrome P450 (CYP) probe substrates, no clinically significant drug interactions were observed with caffeine (CYP1A2), tolbutamide (CYP2C9), dextromethorphan (CYP2D6), or midazolam (CYP3A4).
Azilsartan medoxomil [1], chlortalidone ---> SmPC of [1] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Azilsartan medoxomil [1], digoxin ---> SmPC of [1] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Azilsartan medoxomil [1], fertility ---> SmPC of [1] of EMA
No data are available on the effect of azilsartan medoxomil on human fertility. Nonclinical studies demonstrated that azilsartan did not appear to affect male or female fertility in the rat (see section 5.3).
Azilsartan medoxomil [1], fluconazole ---> SmPC of [1] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Azilsartan medoxomil [1], glyburide ---> SmPC of [1] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Azilsartan medoxomil [1], heparin ---> SmPC of [1] of EMA
Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products (e.g. heparin) may increase potassium levels. Monitoring of serum potassium should be undertaken as appropriate
Azilsartan medoxomil [1], hyperkalemia ---> SmPC of [1] of EMA
Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products (e.g. heparin) may increase potassium levels. Monitoring of serum potassium should be undertaken as appropriate
Azilsartan medoxomil [1], ketoconazole ---> SmPC of [1] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Azilsartan medoxomil [1], lithium ---> SmPC of [1] of EMA
Due to the lack of experience with concomitant use of azilsartan medoxomil and lithium, this combination is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Azilsartan medoxomil [1], metformin ---> SmPC of [1] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Azilsartan medoxomil [1], NSAID ---> SmPC of [1] of EMA
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may attenuate the antihypertensive effect, lead to an increased risk of worsening of renal function and an increase in serum potassium.
Azilsartan medoxomil [1], potassium ---> SmPC of [1] of EMA
Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products (e.g. heparin) may increase potassium levels. Monitoring of serum potassium should be undertaken as appropriate
Azilsartan medoxomil [1], potassium-sparing diuretics ---> SmPC of [1] of EMA
Concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products (e.g. heparin) may increase potassium levels. Monitoring of serum potassium should be undertaken as appropriate
Azilsartan medoxomil [1], pregnancy ---> SmPC of [1] of EMA
The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy. The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy
Azilsartan medoxomil [1], warfarin ---> SmPC of [1] of EMA
No clinically significant interactions have been reported in studies of azilsartan medoxomil or azilsartan given with amlodipine, antacids, chlortalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin, and warfarin.
Azilsartan medoxomil, coxibs ---> SmPC of [azilsartan medoxomil] of EMA
The combination of AIIRAs and AIIRAs (selective COX-2 inhibitors, ASA (> 3 g/day) and non-selective NSAIDs) may attenuate the antihypertensive effect, lead to an increased risk of worsening of renal function and an increase in serum potassium.
CONTRAINDICATIONS of Azilsartan medoxomil (Edarbi)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Second and third trimesters of pregnancy
- The concomitant use of Edarbi with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²)
https://www.ema.europa.eu/en/documents/product-information/edarbi-epar-product-information_en.pdf 29/01/2025
Other trade names: Ipreziv,
Azithromycin
P-glycoprotein substrates, azithromycin
Azithromycin, P-gp inhibitor, may increase the plasma levels of P-gp substrate
QT interval prolonging drugs, azithromycin [2] ---> SPC of [2] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Ability to drive, azithromycin [2] ---> SPC of [2] of eMC
Dizziness and convulsions may occur
Amiodarone, azithromycin [2] ---> SPC of [2] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Antacids, azithromycin [2] ---> SPC of [2] of eMC
Decreased peak serum concentrations of azithromycin. Azithromycin should be administered at least 1 hour before or 2 hours after antacid
Apomorphine, azithromycin
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Astemizole, azithromycin
Caution should be used when administering azithromycin with medicines mainly metabolised by CYP3A4 and narrow therapeutic window
Azithromycin, bazedoxifene ---> SPC of [conjugated oestrogens/bazedoxifene] of EMA
There were no significant pharmacokinetic interactions between bazedoxifene and azithromycin
Azithromycin, betablockers
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin, bictegravir/emtricitabine/tenofovir alafenamide [2] ---> SPC of [2] of EMA
Interaction not studied. Coadministration of azithromycin or clarithromycin may increase bictegravir plasma concentrations.
Azithromycin [1], breast-feeding ---> SPC of [1] of eMC
Azithromycin passes into the milk. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. Nursing may be resumed thereafter
Azithromycin, chloroquine
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin, chlorpromazine [2] ---> SPC of [2] of eMC
There is an increased risk of arrhythmias when chlorpromazine is used concomitant with QT prolonging drugs. The combination is not recommended
Azithromycin, ciprofloxacin
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin [1], cisapride ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin [1], citalopram ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin, clarithromycin
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin [1], class IA antiarrhythmic agents ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin [1], class III antiarrhythmic agents ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin, colistimethate [2] ---> SPC of [2] of EMA
Co-treatment should be undertaken with caution in patients with myasthenia gravis
Azithromycin, conjugated oestrogens/bazedoxifene [2] ---> SPC of [2] of EMA
There were no significant pharmacokinetic interactions between bazedoxifene and azithromycin
Azithromycin, contraceptives
Azithromycin may decrease contraceptive's efficacy of oral contraceptives.
Azithromycin [1], coumarin anticoagulants ---> SPC of [1] of eMC
Potentiation of the anticoagulant effect. Careful monitor the prothrombin time
Azithromycin, cyclosporine
Caution should be used when administering azithromycin with medicines mainly metabolised by CYP3A4 and narrow therapeutic window
Azithromycin, daclatasvir [2] ---> SPC of [2] of EMA
No dose adjustment is required
Azithromycin, dasatinib
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin [1], didanosine ---> SPC of [1] of eMC
Coadministration of 1200 mg/day azithromycin with 400 mg/day didanosine in 6 HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared with placebo.
Azithromycin [1], digoxin ---> SPC of [1] of eMC
Concomitant administration azithromycin with digoxin may result in increased serum levels of the digoxin.
Azithromycin [1], dofetilide ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin [1], dolasetron ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin, droperidol
Medicinal products known to prolong the QTc interval should not be concomitantly administered with droperidol.
Azithromycin, drugs primarily metabolised by CYP3A4 with narrow therapeutic index
Caution should be used when administering azithromycin with medicines mainly metabolised by CYP3A4 and narrow therapeutic window
Azithromycin, efavirenz [2] ---> SPC of [2] of EMA
No clinically significant pharmacokinetic interaction. No dose adjustment is necessary for either medicinal product.
Azithromycin [1], electrolyte imbalance ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances that cause electrolyte imbalance
Azithromycin [1], ergot derivatives ---> SPC of [1] of eMC
Due to the theoretical possibility of ergotism, the concurrent use of azithromycin with ergot derivatives is not recommended
Azithromycin [1], ergotamine ---> SPC of [1] of eMC
Due to the theoretical possibility of ergotism, the concurrent use of azithromycin with ergot derivatives is not recommended
Azithromycin, erythromycin
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin, etravirine [2] ---> SPC of [2] of EMA
Based on the biliary elimination pathway of azithromycin, no drug interactions are expected. INTELENCE and azithromycin can be used without dose adjustments.
Azithromycin, fluconazole [2] ---> SPC of [2] of eMC
There was no significant pharmacokinetic interaction between fluconazole and azithromycin.
Azithromycin, foods
Take on empty stomach, 1 hour before or 2 hours after meals.
Azithromycin, haloperidol
The concomitant use may increase the risk of cardiac arrhythmia.
Azithromycin, hexobarbital
Your doctor should careful monitor your hexobarbital levels in blood if you are being treated with azithromycin concomitantly.
Azithromycin [1], hypokalemia ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances that cause electrolyte imbalance
Azithromycin [1], hypomagnesemia ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances that cause electrolyte imbalance
Azithromycin, ibrutinib [2] ---> SPC of [2] of EMA
The mild CYP3A4 inhibitors azithromycin and fluvoxamine may increase the AUC of ibrutinib by a factor of < 2-fold. No dose adjustment is required in combination with mild inhibitors.
Azithromycin, letermovir [2] ---> SPC of [2] of EMA
Caution is advised if P-gp/BCRP inhibitors are added to letermovir combined with cyclosporine.
Azithromycin [1], levofloxacin ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin, levomepromazine [2] ---> SPC of [2] of eMC
There is an increased risk of arrhythmias when neuroleptics are used with drugs that prolong the QT interval
Azithromycin, lomitapide [2] ---> SPC of [2] of EMA
Weak CYP3A4 inhibitors are expected to increase the exposure of lomitapide when taken simultaneously. Separate the dose of the medications by 12 hours OR decrease the dose of Lojuxta by half.
Azithromycin, lopinavir/ritonavir [2] ---> SPC of [2] of EMA
Based on known metabolic profiles, clinically significant interactions are not expected between Kaletra and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole.
Azithromycin, melagatran
The inhibition of P-glycoprotein may increase the exposure to melagatran
Azithromycin, methadone
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin [1], moxifloxacin ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin, mycophenolate mofetil
The concomitant use may decrease their efficacy.
Azithromycin, mycophenolic acid
The concomitant use may decrease their efficacy.
Azithromycin, nelfinavir
Increased plasma concentrations of azithromycin
Azithromycin, nifedipine
Azithromycin doesn't inhibit the CYP3A4
Azithromycin, pentamidine
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin, phenothiazines
The simultaneous use is contraindicated.
Azithromycin, phenytoin
Your doctor should careful monitor your phenytoin levels in blood if you are being treated with azithromycin concomitantly.
Azithromycin [1], pimozide ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin [1], pregnancy ---> SPC of [1] of eMC
Azithromycin should only be used during pregnancy if the benefit outweighs the risk.
Azithromycin [1], procainamide ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin [1], quinidine ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin, ranolazine
The simultaneous use is contraindicated.
Azithromycin [1], rifabutin ---> SPC of [1] of eMC
Coadministration of azithromycin and rifabutin did not affect the serum concentrations of either drug. Neutropenia was observed in subjects receiving concomitant treatment of azithromycin and rifabutin.
Azithromycin, simeprevir [2] ---> SPC of [2] of EMA
Based on the elimination pathway of azithromycin, no drug interactions are expected between azithromycin and simeprevir. No dose adjustment is required.
Azithromycin [1], sotalol ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin, tacrolimus
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin, telithromycin
The concomitant use with azithromycin may increase the risk of cardiac arrhythmia.
Azithromycin [1], terfenadine ---> SPC of [1] of eMC
Azithromycin should be used with caution in patients currently receiving treatment with other active substances known to prolong QT interval
Azithromycin, theophylline [2] ---> SPC of [2] of eMC
The macrolide antibiotics reduce clearance of theophylline and a reduced dosage may therefore be necessary to avoid side-effects
Azithromycin, venlafaxine
The concomitant use may increase the risk of cardiac arrhythmia.
Azithromycin, voriconazole [2] ---> SPC of [2] of EMA
The effect of voriconazole on either erythromycin or azithromycin is unknown.
Azithromycin [1], warfarin ---> SPC of [1] of eMC
Potentiation of the anticoagulant effect. Careful monitor the prothrombin time
Azithromycin [1], zidovudine ---> SPC of [1] of eMC
Administration of azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients.
Azithromycin, ziprasidone
Additive QT-prolonging effects may increase the risk of severe arrhythmias. Concomitant therapy is contraindicated.
Ergot derivatives, macrolide antibiotics ---> SPC of [azithromycin] of eMC
Due to the theoretical possibility of ergotism, the concurrent use of azithromycin with ergot derivatives is not recommended
CONTRAINDICATIONS of Azithromycin
- The use of this product is contraindicated in patients with hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipients listed in section 6.1.
http://www.medicines.org.uk/emc/
Aztreonam (Cayston)
Azithromycin, aztreonam [2] ---> SmPC of [2] of EMA
No evidence of any drug interactions were identified from clinical studies in which Cayston was taken
Aztreonam [1], breast-feeding ---> SmPC of [1] of EMA
Cayston can be used during breast-feeding.
Aztreonam [1], bronchodilatators ---> SmPC of [1] of EMA
No evidence of any drug interactions were identified from clinical studies in which Cayston was taken concomitantly with bronchodilators, pancreatic enzymes, oral steroids (less than 10 mg daily/20 mg every other day) and inhaled steroids.
Aztreonam [1], dornase alfa ---> SmPC of [1] of EMA
No evidence of any drug interactions were identified from clinical studies in which Cayston was taken
Aztreonam [1], fertility ---> SmPC of [1] of EMA
Non-clinical data for aztreonam for injection about fertility do not indicate any adverse effects.
Aztreonam [1], pregnancy ---> SmPC of [1] of EMA
Cayston should not be used during pregnancy unless the clinical condition of the woman requires treatment with aztreonam.
Aztreonam [1], tobramycin ---> SmPC of [1] of EMA
No evidence of any drug interactions were identified from clinical studies in which Cayston was taken
Aztreonam, daunorubicin
Incompatibility
Aztreonam, telavancin [2] ---> SmPC of [2] of EMA
The pharmacokinetics of telavancin was not significantly altered by simultaneous administration of aztreonam or piperacillin-tazobactam. Also, the pharmacokinetics of aztreonam or piperacillin tazobactam was not altered by telavancin.
CONTRAINDICATIONS of Aztreonam (Cayston)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/cayston-epar-product-information_en.pdf 12/07/2024
Aztreonam/avibactam (Emblaveo)
Ability to drive, aztreonam/avibactam [2] ---> SmPC of [2] of EMA
Undesirable effects may occur (e.g. dizziness) which may have a minor influence on the ability to drive or use machines (see section 4.8).
Aztreonam/avibactam [1], breast-feeding ---> SmPC of [1] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from aztreonam/avibactam therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Aztreonam/avibactam [1], cytochrome P450 ---> SmPC of [1] of EMA
Aztreonam is not metabolized by cytochrome P450 enzymes. In vitro, avibactam showed no significant inhibition of cytochrome P450 enzymes and no cytochrome P450 induction in the clinically relevant exposure range.
Aztreonam/avibactam [1], fertility ---> SmPC of [1] of EMA
No human data on the effect of aztreonam/avibactam on fertility are available. Animal studies with aztreonam or avibactam do not indicate harmful effects with respect to fertility (see section 5.3).
Aztreonam/avibactam [1], pregnancy ---> SmPC of [1] of EMA
Aztreonam/avibactam should only be used during pregnancy when clearly indicated and only if the benefit for the mother outweighs the risk for the child.
Aztreonam/avibactam [1], probenecide ---> SmPC of [1] of EMA
Probenecid (a potent OAT inhibitor) inhibits uptake of avibactam by 56% to 70% in vitro and, therefore, has the potential to alter the elimination of avibactam when co-administered. Co-dosing with probenecid is not recommended.
CONTRAINDICATIONS of Aztreonam/avibactam (Emblaveo)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins, cephalosporins or carbapenems).
https://www.ema.europa.eu/en/documents/product-information/emblaveo-epar-product-information_en.pdf 07/05/2024