Famciclovir
Ability to drive, famciclovir [2] ---> SmPC of [2] of eMC
Patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking Famciclovir Tablets should refrain from driving or operating machinery.
Aldehyde oxidase inhibitors, famciclovir [2] ---> SmPC of [2] of eMC
The aldehyde oxidase inhibition may prevent the transformation of famciclovir to penciclovir and decrease the efficacy of famciclovir
Breast-feeding, famciclovir [2] ---> SmPC of [2] of eMC
If the woman's condition mandates treatment with famciclovir, discontinuation of breast-feeding may be considered.
Emtricitabine/rilpivirine/tenofovir disoproxil [1], famciclovir ---> SmPC of [1] of EMA
No dosage adjustment necessary.
Emtricitabine/tenofovir disoproxil [1], famciclovir ---> SmPC of [1] of EMA
No dose adjustment of famciclovir is required.
Famciclovir [1], pregnancy ---> SmPC of [1] of eMC
Famciclovir should only be used during pregnancy when the potential benefits of treatment outweigh the potential risks.
Famciclovir [1], probenecide ---> SmPC of [1] of eMC
Concurrent use of probenecid may result in increased plasma concentrations of penciclovir, the active metabolite of famciclovir, by competing for elimination.
Famciclovir [1], raloxifene ---> SmPC of [1] of eMC
Raloxifene, strong aldehyde oxidase inhibitor, may prevent the transformation of famciclovir to penciclovir and decrease the efficacy of famciclovir
CONTRAINDICATIONS of Famciclovir
- Hypersensitivity to the active substance or to any of the excipients.
- Hypersensitivity to penciclovir
http://www.medicines.org.uk/emc/
Famotidine
Ability to drive, famotidine
Dizziness and headache may occur
Almasilate, famotidine
There are studies which describe an absorption reduction of the active principle co-administered with almasilate
Aluminium, famotidine
The aluminium salt decreases the absorption of the co-administered active principle. Separate administration by at least 2 hours
Antacids, famotidine
Decreased absorption of famotidine. Famotidine should be taken 1 to 2 hours before antacid.
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/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/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
Breast-feeding, famotidine
Famotidine passes into the mother milk. Lactation or treatment should be discontinued
Carbaldrate, famotidine
The aluminium salt decreases the absorption of the co-administered active principle. Separate administration by at least 2 hours
Daclatasvir [1], famotidine ---> SmPC of [1] of EMA
No dose adjustment is required
Darunavir/cobicistat [1], famotidine ---> SmPC of [1] of EMA
Based on theoretical considerations, no mechanistic interaction is expected. Darunavir/cobicistat can be co-administered with H2-receptor antagonists without dose adjustments.
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], famotidine ---> SmPC of [1] of EMA
Based on theoretical considerations, no mechanistic interaction is expected. Symtuza can be co-administered with H2-receptor antagonists without dose adjustments.
Dasatinib [1], famotidine ---> SmPC of [1] of EMA
Long-term suppression of gastric acid secretion by H2 antagonists or proton pump inhibitors (e.g. famotidine and omeprazole) is likely to reduce dasatinib exposure.
Dolutegravir/rilpivirine [1], famotidine ---> SmPC of [1] of EMA
Only H2-receptor antagonists that can be dosed once daily should be used. H2-receptor antagonists should be taken well separated in time from the administration of Juluca (minimum 4 hours after or 12 hours before)
Efavirenz [1], famotidine ---> SmPC of [1] of EMA
Co-administration of efavirenz with medicinal products that alter gastric pH would not be expected to affect efavirenz absorption.
Elbasvir/grazoprevir [1], famotidine ---> SmPC of [1] of EMA
No dose adjustment is required.
Elvitegravir [1], famotidine ---> SmPC of [1] of EMA
No dose adjustment is required when Vitekta is co-administered with famotidine.
Emtricitabine/rilpivirine/tenofovir alafenamide [1], famotidine ---> SmPC of [1] of EMA
Only H2-receptor antagonists that can be dosed once daily should be used. A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Odefsey should be used.
Emtricitabine/rilpivirine/tenofovir disoproxil [1], famotidine ---> SmPC of [1] of EMA
The increase of gastric pH decreases absorption, plasma level and effect of rilpivirine. The H2 antagonist should be administered at least 12 h before or 4 h after rilpivirine
Famotidine, itraconazol
Decreased absorption of itraconazol. Itraconazole should be administered 2 hours before famotidine
Famotidine, ketoconazole
Decreased absorption of ketoconazole. Ketoconazole should be administered 2 hours before famotidine
Famotidine, lamivudine/raltegravir [2] ---> SmPC of [2] of EMA
Co-administration of lamivudine/raltegravir with other agents that increase gastric pH may increase the rate of raltegravir absorption and result in increased plasma levels of raltegravir. No dose adjustment is required
Famotidine, ledipasvir/sofosbuvir [2] ---> SmPC of [2] of EMA
H2-receptor antagonists may be administered simultaneously with or staggered from ledipasvir/sofosbuvir at a dose that does not exceed doses comparable to famotidine 40 mg twice daily
Famotidine, nilotinib [2] ---> SmPC of [2] of EMA
When the concurrent use of a H2 blocker is necessary, it may be administered approximately 10 hours before and approximately 2 hours after the dose of Tasigna.
Famotidine, oxetacaine
Decreased absorption of famotidine
Famotidine, posaconazole [2] ---> SmPC of [2] of EMA
Co-administration of posaconazole with H2 receptor antagonists or with proton pump inhibitors should be avoided if possible.
Famotidine, pregnancy
Famotidine is not recommended during the pregnancy
Famotidine, probenecide
The co-administration may delay the elimination of famotidine and increase its plasma levels, effects and adverse reactions
Famotidine, rilpivirine [2] ---> SmPC of [2] of EMA
The increase of gastric pH decreases absorption, plasma level and effect of rilpivirine. The H2 antagonist should be administered at least 12 h before or 4 h after rilpivirine
Famotidine, sofosbuvir/velpatasvir [2] ---> SmPC of [2] of EMA
Increase in gastric pH. H2-receptor antagonists may be administered simultaneously with or staggered from Epclusa at a dose that does not exceed doses comparable to famotidine 40 mg twice daily.
Famotidine, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SmPC of [2] of EMA
Increase in gastric pH decreases velpatasvir solubility. H2-receptor antagonists may be administered simultaneously with or staggered from Vosevi at a dose that does not exceed doses comparable with famotidine 40 mg twice daily.
Famotidine, sucralfate
Sucralfate decreases the absorption of famotidine. Separate administration by at least 2 hours
Fampridine (Fampyra)
Ability to drive, fampridine [2] ---> SmPC of [2] of EMA
Fampyra has moderate influence on the ability to drive and use machines because Fampyra can cause dizziness.
Baclofen, fampridine [2] ---> SmPC of [2] of EMA
Fampridine has been administered concomitantly with baclofen and no pharmacokinetic medicinal product interactions were observed.
Beta interferon, fampridine [2] ---> SmPC of [2] of EMA
Fampridine has been administered concomitantly with interferon-beta and no pharmacokinetic medicinal product interactions were observed.
Breast-feeding, fampridine [2] ---> SmPC of [2] of EMA
It is unknown whether fampridine is excreted in human or animal milk. Fampyra is not recommended during breast-feeding
Carvedilol, fampridine [2] ---> SmPC of [2] of EMA
OCT2 is the transporter responsible for the active secretion of fampridine. Thus, concomitant use of fampridine with medicinal products that are substrates of OCT2 is cautioned
Cimetidine, fampridine [2] ---> SmPC of [2] of EMA
OCT2 is the transporter responsible for the active secretion of fampridine. Thus, the concomitant use of fampridine with medicinal products that are inhibitors of OCT2 for example, cimetidine is contraindicated
Dolutegravir [1], fampridine ---> SmPC of [1] of EMA
Fampridine co-administration with dolutegravir is contraindicated.
Fampridine [1], fertility ---> SmPC of [1] of EMA
In animal studies no effects on fertility were seen.
Fampridine [1], foods ---> SmPC of [1] of EMA
This medicine should be taken without food, on an empty stomach.
Fampridine [1], metformin ---> SmPC of [1] of EMA
OCT2 is the transporter responsible for the active secretion of fampridine. Thus, concomitant use of fampridine with medicinal products that are substrates of OCT2 is cautioned
Fampridine [1], OCT2 inhibitors ---> SmPC of [1] of EMA
OCT2 is the transporter responsible for the active secretion of fampridine. Thus, the concomitant use of fampridine with medicinal products that are inhibitors of OCT2 for example, cimetidine is contraindicated
Fampridine [1], OCT2 substrates ---> SmPC of [1] of EMA
OCT2 is the transporter responsible for the active secretion of fampridine. Thus, concomitant use of fampridine with medicinal products that are substrates of OCT2 is cautioned
Fampridine [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure it is preferable to avoid the use of fampridine in pregnancy.
Fampridine [1], propranolol ---> SmPC of [1] of EMA
OCT2 is the transporter responsible for the active secretion of fampridine. Thus, concomitant use of fampridine with medicinal products that are substrates of OCT2 is cautioned
Fampridine, fampridine [2] ---> SmPC of [2] of EMA
Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine) is contraindicated (see section 4.3).
CONTRAINDICATIONS of Fampridine (Fampyra)
- Hypersensitivity to fampridine or to any of the excipients listed in section 6.1.
- Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine).
- Patients with prior history or current presentation of seizure.
- Patients with moderate or severe renal impairment (creatinine clearances <50 ml/min).
- Concomitant use of fampridine with medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example, cimetidine.
https://www.ema.europa.eu/en/documents/product-information/fampyra-epar-product-information_en.pdf 07/10/2024
Other trade names: Fampridine Accord,
Faricimab (Vabysmo)
Ability to drive, faricimab [2] ---> SmPC of [2] of EMA
Temporary visual disturbances may occur following the intravitreal injection and the associated eye examination. Patients should not drive or use machines until visual function has recovered sufficiently.
Anti-VEGF medicinal product, faricimab [2] ---> SmPC of [2] of EMA
Faricimab should not be administered concurrently with other systemic or ocular anti-VEGF medicinal products
Breast-feeding, faricimab [2] ---> SmPC of [2] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from faricimab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Faricimab [1], fertility ---> SmPC of [1] of EMA
No effects on reproductive organs or fertility were observed in a 6-month cynomolgus monkey study with faricimab (see section 5.3).
Faricimab [1], pregnancy ---> SmPC of [1] of EMA
Faricimab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Faricimab [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential should use effective contraception during treatment and for at least 3 months following the last intravitreal injection of faricimab.
CONTRAINDICATIONS of Faricimab (Vabysmo)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Active or suspected ocular or periocular infections.
- Active intraocular inflammation.
https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf 06/01/2026
Febuxostat (Adenuric)
Ability to drive, febuxostat [2] ---> SmPC of [2] of EMA
Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that ADENURIC does not adversely affect performance.
Aminophylline, febuxostat
Febuxostat reduces clearance of theophylline and a reduced dosage may therefore be necessary to avoid side-effects
Antacids, febuxostat [2] ---> SmPC of [2] of EMA
Febuxostat may be taken without regard to antacid use.
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.
Breast-feeding, febuxostat [2] ---> SmPC of [2] of EMA
Febuxostat should not be used while breastfeeding.
Colchicine, febuxostat [2] ---> SmPC of [2] of EMA
Febuxostat can be co-administered with colchicine with no dose adjustment of febuxostat or colchicine being necessary.
CYP2C8 substrates, febuxostat [2] ---> SmPC of [2] of EMA
Co-administration of febuxostat with rosiglitazone or other CYP2C8 substrates is not expected to require any dose adjustment for those compounds.
CYP2D6 substrates, febuxostat [2] ---> SmPC of [2] of EMA
Co-administration of febuxostat with CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Cytotoxic chemotherapy, febuxostat [2] ---> SmPC of [2] of EMA
Drug interaction studies of febuxostat with cytotoxic chemotherapy have not been conducted. No data is available regarding the safety of febuxostat during cytotoxic therapy.
Desipramine, febuxostat [2] ---> SmPC of [2] of EMA
Co-administration of febuxostat with CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Drugs primarily metabolised by CYP2C8, febuxostat [2] ---> SmPC of [2] of EMA
Co-administration of febuxostat with CYP2C8 substrates is not expected to require any dose adjustment for those compounds.
Drugs primarily metabolised by CYP2D6, febuxostat [2] ---> SmPC of [2] of EMA
Co-administration of febuxostat with CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Emtricitabine/rilpivirine/tenofovir alafenamide [1], febuxostat ---> SmPC of [1] of EMA
Based on data from an in vitro study, co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g., febuxostat) is not expected to increase systemic exposure to tenofovir in vivo.
Emtricitabine/tenofovir alafenamide [1], febuxostat ---> SmPC of [1] of EMA
It is not known whether the co-administration of Descovy and xanthine oxidase inhibitors (e.g., febuxostat) would increase systemic exposure to tenofovir.
Febuxostat [1], fertility ---> SmPC of [1] of EMA
In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see section 5.3). The effect of ADENURIC on human fertility is unknown.
Febuxostat [1], glucuronidation inhibitors ---> SmPC of [1] of EMA
Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes. Medicinal products that inhibit glucuronidation, such as NSAIDs and probenecid, could in theory affect the elimination of febuxostat.
Febuxostat [1], hydrochlorothiazide ---> SmPC of [1] of EMA
No dose adjustment is necessary for febuxostat when administered with hydrochlorothiazide.
Febuxostat [1], indometacin ---> SmPC of [1] of EMA
Febuxostat can be co-administered with indomethacin with no dose adjustment of febuxostat or indomethacin being necessary.
Febuxostat [1], mercaptopurine ---> 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.
Febuxostat [1], naproxen ---> SmPC of [1] of EMA
Febuxostat can be co-administered with naproxen with no dose adjustment of febuxostat or naproxen being necessary.
Febuxostat [1], NSAID ---> SmPC of [1] of EMA
Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes. Medicinal products that inhibit glucuronidation, such as NSAIDs and probenecid, could in theory affect the elimination of febuxostat.
Febuxostat [1], pregnancy ---> SmPC of [1] of EMA
Febuxostat should not be used during pregnancy.
Febuxostat [1], probenecide ---> SmPC of [1] of EMA
Febuxostat metabolism depends on Uridine Glucuronosyl Transferase (UGT) enzymes. Medicinal products that inhibit glucuronidation, such as NSAIDs and probenecid, could in theory affect the elimination of febuxostat.
Febuxostat [1], rosiglitazone ---> SmPC of [1] of EMA
Co-administration of febuxostat with rosiglitazone or other CYP2C8 substrates is not expected to require any dose adjustment for those compounds.
Febuxostat [1], strong glucuronidation inductors ---> SmPC of [1] of EMA
Potent inducers of UGT enzymes might possibly lead to increased metabolism and decreased efficacy of febuxostat.
Febuxostat [1], theophylline ---> SmPC of [1] of EMA
The results of a study showed that the co-administration of febuxostat 80 mg QD with theophylline 400 mg single dose has no effect on the pharmacokinetics or safety of theophylline.
Febuxostat [1], warfarin ---> SmPC of [1] of EMA
No dose adjustment is necessary for warfarin when administered with febuxostat.
Febuxostat, lesinurad [2] ---> SmPC 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.
CONTRAINDICATIONS of Febuxostat (Adenuric)
- 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/adenuric-epar-product-information_en.pdf 13/09/2024
Other trade names: Febuxostat Krka, Febuxostat Mylan,
Fedratinib (Inrebic)
Ability to drive, fedratinib [2] ---> SmPC of [2] of EMA
Patients who experience dizziness after taking Inrebic should refrain from driving or using machines.
Breast-feeding, fedratinib [2] ---> SmPC of [2] of EMA
A risk to the breast-fed child cannot be excluded. Women should not breastfeed during treatment with Inrebic and for at least 1 month after the last dose of Inrebic.
CYP3A4 and CYP2C19 inhibitors, fedratinib [2] ---> SmPC of [2] of EMA
Agents that simultaneously inhibit CYP3A4 and CYP2C19 (e.g. fluconazole, fluvoxamine) or the combination of inhibitors of CYP3A4 and CYP2C19 may increase Inrebic exposure and should be avoided in patients receiving Inrebic (see section 4.5).
Dextromethorphan, fedratinib [2] ---> SmPC of [2] of EMA
If Inrebic is to be coadministered with substrate of CYP3A4, CYP2C19 or CYP2D6, dose modifications of coadministered medicines should be made as needed with close monitoring of safety and efficacy
Digoxin, fedratinib [2] ---> SmPC of [2] of EMA
Caution should be exercised and dose modifications should be made as needed for agents that are renally excreted via OCT2 and MATE1/2-K.
Diltiazem, fedratinib [2] ---> SmPC of [2] of EMA
Co-administration of moderate CYP3A4 inhibitors, erythromycin (500 mg three times daily) or diltiazem (120 mg twice daily), with fedratinib 400 mg once daily is predicted to increase fedratinib AUC at steady state by 1.1-fold.
Drugs primarily metabolised by CYP2C19, fedratinib [2] ---> SmPC of [2] of EMA
If Inrebic is to be coadministered with substrate of CYP3A4, CYP2C19 or CYP2D6, dose modifications of coadministered medicines should be made as needed with close monitoring of safety and efficacy
Drugs primarily metabolised by CYP2D6, fedratinib [2] ---> SmPC of [2] of EMA
If Inrebic is to be coadministered with substrate of CYP3A4, CYP2C19 or CYP2D6, dose modifications of coadministered medicines should be made as needed with close monitoring of safety and efficacy
Drugs primarily metabolised by CYP3A4, fedratinib [2] ---> SmPC of [2] of EMA
If Inrebic is to be coadministered with substrate of CYP3A4, CYP2C19 or CYP2D6, dose modifications of coadministered medicines should be made as needed with close monitoring of safety and efficacy
Efavirenz, fedratinib [2] ---> SmPC of [2] of EMA
Co-administration of rifampicin (strong CYP3A4 inducer: 600 mg once daily) or efavirenz (moderate CYP3A4 inducer: 600 mg once daily) with a single dose of fedratinib (500 mg) decreased AUCinf of fedratinib by approximately 80% or 50%, respectively.
Erythromycin, fedratinib [2] ---> SmPC of [2] of EMA
Co-administration of moderate CYP3A4 inhibitors, erythromycin (500 mg three times daily) or diltiazem (120 mg twice daily), with fedratinib 400 mg once daily is predicted to increase fedratinib AUC at steady state by 1.1-fold.
Fedratinib [1], fertility ---> SmPC of [1] of EMA
There are no human data on the effect of fedratinib on fertility. There are no data on effects on fertility in animals at clinically-relevant exposure levels (see section 5.3).
Fedratinib [1], fluconazole ---> SmPC of [1] of EMA
Agents that simultaneously inhibit CYP3A4 and CYP2C19 (e.g. fluconazole, fluvoxamine) or the combination of inhibitors of CYP3A4 and CYP2C19 may increase Inrebic exposure and should be avoided in patients receiving Inrebic (see section 4.5).
Fedratinib [1], fluvoxamine ---> SmPC of [1] of EMA
Agents that simultaneously inhibit CYP3A4 and CYP2C19 (e.g. fluconazole, fluvoxamine) or the combination of inhibitors of CYP3A4 and CYP2C19 may increase Inrebic exposure and should be avoided in patients receiving Inrebic (see section 4.5).
Fedratinib [1], foods ---> SmPC of [1] of EMA
Administration with a high fat meal may reduce the incidence of nausea and vomiting, therefore it is recommended to be taken with food.
Fedratinib [1], gastric pH increasing medication ---> SmPC of [1] of EMA
An increase in gastric pH is not expected to have clinically meaningful impact on fedratinib exposure and no dose adjustment is needed for concomitant administration of fedratinib with agents that increase gastric pH.
Fedratinib [1], ketoconazole ---> SmPC of [1] of EMA
If strong CYP3A4 inhibitors cannot be replaced, the dose of Inrebic should be reduced when administering with strong CYP3A4 inhibitors, (e.g. ketoconazole, ritonavir).
Fedratinib [1], mephenytoin ---> SmPC of [1] of EMA
If Inrebic is to be coadministered with substrate of CYP3A4, CYP2C19 or CYP2D6, dose modifications of coadministered medicines should be made as needed with close monitoring of safety and efficacy
Fedratinib [1], metformin ---> SmPC of [1] of EMA
Caution should be exercised and dose modifications should be made as needed for agents that are renally excreted via OCT2 and MATE1/2-K.
Fedratinib [1], metoprolol ---> SmPC of [1] of EMA
If Inrebic is to be coadministered with substrate of CYP3A4, CYP2C19 or CYP2D6, dose modifications of coadministered medicines should be made as needed with close monitoring of safety and efficacy
Fedratinib [1], midazolam ---> SmPC of [1] of EMA
If Inrebic is to be coadministered with substrate of CYP3A4, CYP2C19 or CYP2D6, dose modifications of coadministered medicines should be made as needed with close monitoring of safety and efficacy
Fedratinib [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration of rifampicin (strong CYP3A4 inducer: 600 mg once daily) or efavirenz (moderate CYP3A4 inducer: 600 mg once daily) with a single dose of fedratinib (500 mg) decreased AUCinf of fedratinib by approximately 80% or 50%, respectively.
Fedratinib [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
Adverse reactions following prolonged co-administration of a moderate CYP3A4 inhibitor cannot be excluded.
Fedratinib [1], omeprazole ---> SmPC of [1] of EMA
If Inrebic is to be coadministered with substrate of CYP3A4, CYP2C19 or CYP2D6, dose modifications of coadministered medicines should be made as needed with close monitoring of safety and efficacy
Fedratinib [1], phenytoin ---> SmPC of [1] of EMA
Co-administration of rifampicin (strong CYP3A4 inducer: 600 mg once daily) or efavirenz (moderate CYP3A4 inducer: 600 mg once daily) with a single dose of fedratinib (500 mg) decreased AUCinf of fedratinib by approximately 80% or 50%, respectively.
Fedratinib [1], pregnancy ---> SmPC of [1] of EMA
Inrebic is contraindicated during pregnancy. Women of childbearing potential have to use effective contraception during treatment and for at least 1 month after the last dose.
Fedratinib [1], pregnancy ---> SmPC of [1] of EMA
If Inrebic is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be advised of the potential hazard to the foetus.
Fedratinib [1], proton pump inhibitors ---> SmPC of [1] of EMA
An increase in gastric pH is not expected to have clinically meaningful impact on fedratinib exposure and no dose adjustment is needed for concomitant administration of fedratinib with agents that increase gastric pH.
Fedratinib [1], renal excretion ---> SmPC of [1] of EMA
Caution should be exercised and dose modifications should be made as needed for agents that are renally excreted via OCT2 and MATE1/2-K.
Fedratinib [1], rifampicin ---> SmPC of [1] of EMA
Co-administration of rifampicin (strong CYP3A4 inducer: 600 mg once daily) or efavirenz (moderate CYP3A4 inducer: 600 mg once daily) with a single dose of fedratinib (500 mg) decreased AUCinf of fedratinib by approximately 80% or 50%, respectively.
Fedratinib [1], ritonavir ---> SmPC of [1] of EMA
If strong CYP3A4 inhibitors cannot be replaced, the dose of Inrebic should be reduced when administering with strong CYP3A4 inhibitors, (e.g. ketoconazole, ritonavir).
Fedratinib [1], rosuvastatin ---> SmPC of [1] of EMA
Caution should be exercised and dose modifications should be made as needed for agents that are renally excreted via OCT2 and MATE1/2-K.
Fedratinib [1], simvastatine ---> SmPC of [1] of EMA
If Inrebic is to be coadministered with substrate of CYP3A4, CYP2C19 or CYP2D6, dose modifications of coadministered medicines should be made as needed with close monitoring of safety and efficacy
Fedratinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration of rifampicin (strong CYP3A4 inducer: 600 mg once daily) or efavirenz (moderate CYP3A4 inducer: 600 mg once daily) with a single dose of fedratinib (500 mg) decreased AUCinf of fedratinib by approximately 80% or 50%, respectively.
Fedratinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant administration of Inrebic with strong CYP3A4 inhibitors increases Inrebic exposure. Increased exposure of Inrebic may increase the risk of adverse reactions.
Fedratinib [1], women of childbearing potential ---> SmPC of [1] of EMA
Females of reproductive potential should be advised to avoid becoming pregnant whilst receiving Inrebic and should use effective contraception during treatment with Inrebic and for at least 1 month after the last dose.
CONTRAINDICATIONS of Fedratinib (Inrebic)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy (see section 4.6).
https://www.ema.europa.eu/en/documents/product-information/inrebic-epar-product-information_en.pdf 18/07/2024
Felodipine
Ability to drive, felodipine [2] ---> SmPC of [2] of eMC
Patients should know how they react to felodipine before they drive or use machines because occasionally dizziness or fatigue may occur.
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
Antihypertensives, felodipine
Enhancement of the hypotensive effect of felodipine
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.
Azole antifungals, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of felodipine
Barbiturates, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Betablockers, felodipine
The co-administration may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency
Bisoprolol [1], felodipine ---> SmPC of [1] 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
Boceprevir [1], felodipine ---> SmPC of [1] of EMA
Boceprevir, CYP3A4 inhibitor, may increase the plasma concentrations of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.
Breast-feeding, felodipine [2] ---> SmPC of [2] of eMC
Felodipine has been detected in breast milk. When taken in therapeutic doses by the nursing mother it is, however, not likely to affect the infant.
Carbamazepine, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
Carbamazepine, enzymatic inductor, may decrease the plasma levels of felodipine
Cimetidine, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
Enzyme inhibiting substances of cytochrome P450 isoenzyme 3A4 may increase in felodipine plasma concentrations
Cobicistat [1], felodipine ---> SmPC of [1] 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.
Cyclosporine, felodipine [2] ---> SmPC of [2] of eMC
Felodipine does not affect plasma concentrations of cyclosporine.
CYP3A4 inductors, felodipine [2] ---> SmPC of [2] of eMC
The CYP3A4 induction may decrease the plasma concentrations of felodipine
CYP3A4 inhibitors, felodipine [2] ---> SmPC of [2] of eMC
The CYP3A4 inhibition may increase the plasma concentrations of felodipine
Dabrafenib [1], felodipine ---> SmPC of [1] 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.
Darunavir/cobicistat [1], felodipine ---> SmPC of [1] of EMA
Darunavir/cobicistat is expected to increase the calcium channel blocker plasma concentrations. (CYP3A and/or CYP2D6 inhibition)
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], felodipine ---> SmPC of [1] of EMA
Based on theoretical considerations DRV/COBI is expected to increase this calcium channel blocker plasma concentrations. CYP3A inhibition
Darunavir/ritonavir, felodipine ---> SmPC of [darunavir] of EMA
Boosted darunavir can be expected to increase the plasma concentrations of calcium channel blocker. (CYP3A and/or CYP2D6 inhibition)
Digoxin, felodipine [2] ---> SmPC of [2] of eMC
The co-administration increases the plasma levels of digoxin
Diuretics, felodipine [2] ---> SmPC of [2] of eMC
Due to an initial saliuretic effect, felodipine can enhance a pre-existing hypokalemia when added to diuretic therapy.
Drugs with high protein binding, felodipine [2] ---> SmPC of [2] of eMC
The high degree of plasma protein binding of felodipine does not appear to affect the unbound fraction of other extensively plasma protein bound drugs
Efavirenz [1], felodipine ---> SmPC of [1] of EMA
Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist
Efavirenz/emtricitabine/tenofovir disoproxil [1], felodipine ---> SmPC of [1] of EMA
Efavirenz, CYP3A4 inductor, may decrease the plasma concentrations of calcium antagonist
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], felodipine ---> SmPC of [1] of EMA
Concentrations of calcium channel blocker may be increased when co-administered with cobicistat.
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [1], felodipine ---> SmPC of [1] of EMA
Concentrations of calcium channel blockers may be increased when co-administered with cobicistat.
Enzalutamide [1], felodipine ---> SmPC of [1] of EMA
Enzalutamide, enzymatic inductor, may increase the metabolism of felodipine and decrease its plasma levels and effect
Erythromycin, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of felodipine
Felodipine [1], grapefruit juice ---> SmPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of felodipine
Felodipine [1], hydrochlorothiazide ---> SmPC of [1] of eMC
Hydrochlorothiazide may enhance the anti-hypertensive effect of felodipine.
Felodipine [1], moderate CYP3A4 inductors ---> SmPC of [1] of eMC
The moderate CYP3A4 induction may decrease the plasma concentrations of felodipine
Felodipine [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of eMC
The moderate CYP3A4 inhibition may increase the plasma concentrations of felodipine
Felodipine [1], pregnancy ---> SmPC of [1] of eMC
Felodipine should not be given during pregnancy.
Felodipine [1], St. John's wort ---> SmPC of [1] of eMC
St. John's wort, enzymatic inductor, may decrease the plasma concentrations of calcium antagonist. St. John's Wort should be avoided
Felodipine [1], tacrolimus ---> SmPC of [1] of eMC
Felodipine may increase the plasma levels of tacrolimus
Felodipine [1], warfarin ---> SmPC of [1] of eMC
The high degree of plasma protein binding of felodipine does not appear to affect the unbound fraction of other extensively plasma protein bound drugs
Felodipine, fluconazole [2] ---> SmPC of [2] of eMC
Felodipine is metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of felodipine. Frequent monitoring for adverse events is recommended.
Felodipine, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA
Clinically significant increases in exposure were not observed for sensitive substrates of CYP3A (midazolam, felodipine) or UGT1A1 (raltegravir) when administered with Maviret.
Felodipine, idelalisib [2] ---> SmPC of [2] of EMA
The co-administration of idelalisib with felodipine may increase the serum concentrations of felodipine. Clinical monitoring of therapeutic effect and adverse reactions is recommended.
Felodipine, indinavir [2] ---> SmPC of [2] of EMA
Increased dihydropyridine calcium channel blocker concentration. Calcium channel blockers are metabolized by CYP3A4 which is inhibited by indinavir. Caution is warranted and clinical monitoring of patients is recommended.
Felodipine, ketoconazole [2] ---> SmPC of [2] of EMA
Concomitant therapy of ketoconazole with felodipine is contraindicated due to an increased risk of oedema and congestive heart failure
Felodipine, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA
Lopinavir/ritonavir, CYP3A4 inhibitors, may increase the plasma concentrations of felodipine. Clinical monitoring is recommended
Felodipine, metildigoxin
Increased plasma levels of metildigoxin
Felodipine, nebivolol [2] ---> SmPC 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.
Felodipine, nevirapine ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Felodipine, phenobarbital ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Felodipine, phenytoin ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Felodipine, protease inhibitors ---> SmPC of [felodipine/metoprolol] of eMC
Enzyme inhibiting substances of cytochrome P450 isoenzyme 3A4 may increase in felodipine plasma concentrations
Felodipine, rifampicin ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Felodipine, ritonavir ---> SmPC of [felodipine/metoprolol] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of felodipine
Felodipine, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA
Possible increase in the plasma concentrations of calcium channel antagonist. Careful monitoring of therapeutic and adverse effects is recommended.
Felodipine, simeprevir [2] ---> SmPC 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. Caution is warranted
Felodipine, strong CYP3A4 inductors ---> SmPC of [felodipine/metoprolol] of eMC
The strong CYP3A4 induction may decrease the plasma concentrations of felodipine
Felodipine, strong CYP3A4 inhibitors ---> SmPC of [felodipine/metoprolol] of eMC
Enzyme inhibiting substances of cytochrome P450 isoenzyme 3A4 may increase in felodipine plasma concentrations
Felodipine, telaprevir [2] ---> SmPC of [2] of EMA
Inhibition of CYP3A and/or effect on P-gp transport in the gut increases plasma concentration of calcium channel blocker. Caution is warranted and clinical monitoring of patients is recommended.
Felodipine, telithromycin [2] ---> SmPC of [2] of EMA
The strong CYP3A4 inhibition by telithromycin may increase the plasma concentrations of felodipine and may result in hypotension, bradycardia or loss of consciousness, and should therefore be avoided.
Felodipine, theophylline ---> SmPC of [felodipine/ramipril] of eMC
Concomitant administration of felodipine and oral theophylline reduces theophylline absorption by approximately 20%. This is probably of minor clinical importance.
Felodipine, tricyclic antidepressant
Enhancement of the hypotensive effect of felodipine
Felodipine/metoprolol, warfarin ---> SmPC of [felodipine] of eMC
The high degree of plasma protein binding of felodipine does not appear to affect the unbound fraction of other extensively plasma protein bound drugs
CONTRAINDICATIONS of Felodipine
Felodipine is contraindicated in patients:
- With known hypersensitivity to felodipine (or other dihydropyridines) or to any of the excipients
- With cardiogenic shock (as with other calcium channel blockers, treatment should be discontinued in patients who develop cardiogenic shock)
- With haemodynamically significant cardiac valvular obstruction
- With dynamic cardiac outflow obstruction
- With unstable angina pectoris
- Who have had an acute myocardial infarction (within 4-8 weeks of a myocardial infarction)
- With uncompensated heart failure
- During pregnancy
http://www.medicines.org.uk/emc/
Felodipine/metoprolol
Ability to drive, felodipine/metoprolol
Patients should be aware of how they might be affected by felodipine/metoprolol before driving or using machines.
Alcohol, felodipine/metoprolol [2] ---> SmPC of [2] of eMC
The concomitant ingestion of alcohol may enhance hypotensive effects.
Amiodarone, felodipine/metoprolol ---> SmPC of [metoprolol] of eMC
Class I anti-arrhythmic drugs may have potentiating effects on atrial-conduction time and induce negative inotropic effect of metoprolol.
Antiarrhythmics, felodipine/metoprolol
Class I anti-arrhythmic drugs may have potentiating effects on atrial-conduction time and induce negative inotropic effect of metoprolol.
Azole antifungals, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of felodipine
Barbiturates, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Barbiturates, felodipine/metoprolol
It has been shown that inductors of cytochrome P450-3A4 system decrease the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inductors should be avoided
Benzothiazepines, felodipine/metoprolol
Metoprolol 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, felodipine/metoprolol
Care should be taken when beta-blockers (e. g. eye drops) are given in combination other beta-blockers.
Breast-feeding, felodipine/metoprolol
Felodipine and metoprolol pass into the mother milk. When taken in therapeutic doses by the nursing mother it is, however, not likely to affect the infant.
Carbamazepine, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
Carbamazepine, enzymatic inductor, may decrease the plasma levels of felodipine
Carbamazepine, felodipine/metoprolol
It has been shown that inductors of cytochrome P450-3A4 system decrease the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inductors should be avoided
Celecoxib, felodipine/metoprolol
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Cimetidine, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
Enzyme inhibiting substances of cytochrome P450 isoenzyme 3A4 may increase in felodipine plasma concentrations
Cimetidine, felodipine/metoprolol
It has been shown that inhibitors of cytochrome P450-3A4 system increase the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inhibitors should be avoided
Cyclosporine, felodipine/metoprolol [2] ---> SmPC of [2] of eMC
Felodipine does not affect plasma concentrations of cyclosporine.
CYP2D6 inhibitors, felodipine/metoprolol
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Digital glycosides, felodipine/metoprolol
Digitalis glycosides in association with beta-blockers may increase auriculo-ventricular conduction time.
Diltiazem, felodipine/metoprolol
Metoprolol 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.
Diphenhydramine, felodipine/metoprolol
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Drugs with high protein binding, felodipine/metoprolol
The high degree of plasma protein binding of felodipine does not appear to affect the unbound fraction of other extensively plasma protein bound drugs
Efavirenz, felodipine/metoprolol
It has been shown that inductors of cytochrome P450-3A4 system decrease the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inductors should be avoided
Erythromycin, felodipine ---> SmPC of [felodipine/metoprolol] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of felodipine
Erythromycin, felodipine/metoprolol
It has been shown that inhibitors of cytochrome P450-3A4 system increase the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inhibitors should be avoided
Felodipine, nevirapine ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Felodipine, phenobarbital ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Felodipine, phenytoin ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Felodipine, protease inhibitors ---> SmPC of [felodipine/metoprolol] of eMC
Enzyme inhibiting substances of cytochrome P450 isoenzyme 3A4 may increase in felodipine plasma concentrations
Felodipine, rifampicin ---> SmPC of [felodipine/metoprolol] of eMC
The enzymatic induction may decrease the plasma levels of felodipine
Felodipine, ritonavir ---> SmPC of [felodipine/metoprolol] of eMC
The strong CYP3A4 inhibition may increase the plasma concentrations of felodipine
Felodipine, strong CYP3A4 inductors ---> SmPC of [felodipine/metoprolol] of eMC
The strong CYP3A4 induction may decrease the plasma concentrations of felodipine
Felodipine, strong CYP3A4 inhibitors ---> SmPC of [felodipine/metoprolol] of eMC
Enzyme inhibiting substances of cytochrome P450 isoenzyme 3A4 may increase in felodipine plasma concentrations
Felodipine/metoprolol [1], hydralazine ---> SmPC of [1] of eMC
Enzyme inhibitors (hydralazine) may increase plasma concentrations of hepatically metabolised beta-blockers.
Felodipine/metoprolol [1], tacrolimus ---> SmPC of [1] of eMC
Felodipine may increase the plasma levels of tacrolimus
Felodipine/metoprolol, fluoxetine
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Felodipine/metoprolol, ganglionic blockers
Care should be taken when beta-blockers are given in combination with sympathetic ganglion blocking agents
Felodipine/metoprolol, grapefruit juice
It has been shown that inhibitors of cytochrome P450-3A4 system increase the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inhibitors should be avoided
Felodipine/metoprolol, halogenated anaesthetics
In patients receiving beta-blocker therapy, inhalation anaesthetics enhance the cardiodepressant effect
Felodipine/metoprolol, IMAOs
Care should be taken when beta-blockers are given in combination MAO inhibitors.
Felodipine/metoprolol, indometacin
Indometacin or other prostaglandin synthetase inhibitors may reduce the antihypertensive effects of felodipine/metoprolol
Felodipine/metoprolol, insulin
The beta-blocker may increase the hypoglycaemic effect of antidiabetic agents
Felodipine/metoprolol, itraconazol
It has been shown that inhibitors of cytochrome P450-3A4 system increase the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inhibitors should be avoided
Felodipine/metoprolol, ketoconazole
It has been shown that inhibitors of cytochrome P450-3A4 system increase the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inhibitors should be avoided
Felodipine/metoprolol, nevirapine
It has been shown that inductors of cytochrome P450-3A4 system decrease the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inductors should be avoided
Felodipine/metoprolol, oral antidiabetics
The beta-blocker may increase the hypoglycaemic effect of antidiabetic agents
Felodipine/metoprolol, paroxetine
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Felodipine/metoprolol, phenylalkylamines
Metoprolol should not be given in combination with calcium channel blockers of verapamil type since this may cause bradycardia, hypotension, heart failure and asystole and may increase auriculo-ventricular conduction time.
Felodipine/metoprolol, phenytoin
It has been shown that inductors of cytochrome P450-3A4 system decrease the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inductors should be avoided
Felodipine/metoprolol, pregnancy
Felodipine/metoprolol should not be used during pregnancy
Felodipine/metoprolol, propafenone
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Felodipine/metoprolol, prostaglandin synthetase inhibitors
Indometacin or other prostaglandin synthetase inhibitors may reduce the antihypertensive effects of felodipine/metoprolol
Felodipine/metoprolol, protease inhibitors
It has been shown that inhibitors of cytochrome P450-3A4 system increase the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inhibitors should be avoided
Felodipine/metoprolol, quinidine
Class I anti-arrhythmic drugs may have potentiating effects on atrial-conduction time and induce negative inotropic effect of metoprolol.
Felodipine/metoprolol, rifampicin
It has been shown that CYP3A4 inductors decrease the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inductors should be avoided. Rifampicin, enzymatic inductor, may increase the metabolism of metoprolol
Felodipine/metoprolol, ritonavir
It has been shown that inhibitors of cytochrome P450-3A4 system increase the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inhibitors should be avoided
Felodipine/metoprolol, sertraline
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Felodipine/metoprolol, St. John's wort
It has been shown that inductors of cytochrome P450-3A4 system decrease the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inductors should be avoided
Felodipine/metoprolol, strong CYP2D6 inhibitors
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Felodipine/metoprolol, strong CYP3A4 inductors
It has been shown that inductors of cytochrome P450-3A4 system decrease the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inductors should be avoided
Felodipine/metoprolol, strong CYP3A4 inhibitors
It has been shown that inhibitors of cytochrome P450-3A4 system increase the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inhibitors should be avoided
Felodipine/metoprolol, telithromycin
It has been shown that inhibitors of cytochrome P450-3A4 system increase the plasma concentrations of felodipine. The concomitant use with strong CYP3A4 inhibitors should be avoided
Felodipine/metoprolol, terbinafine
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Felodipine/metoprolol, verapamil
Metoprolol should not be given in combination with calcium channel blockers of verapamil type since this may cause bradycardia, hypotension, heart failure and asystole and may increase auriculo-ventricular conduction time.
Felodipine/metoprolol, warfarin ---> SmPC of [felodipine] of eMC
The high degree of plasma protein binding of felodipine does not appear to affect the unbound fraction of other extensively plasma protein bound drugs
Metoprolol, sertraline
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Felodipine/ramipril
Ability to drive, felodipine/ramipril [2] ---> SmPC of [2] of eMC
Some symptoms of reduction in blood pressure such as dizziness may be accompanied by an impairment of the ability to concentrate and react.
AIIRA, felodipine/ramipril
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)
Alcohol, felodipine/ramipril [2] ---> SmPC of [2] of eMC
Increased vasodilatation. The antihypertensive effect may increase.
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
Allopurinol, felodipine/ramipril [2] ---> SmPC of [2] of eMC
Increased likelihood of haematological reactions.
Amiloride, felodipine/ramipril [2] ---> SmPC of [2] of eMC
The combination may increase the serum potassium concentration and requires close monitoring of serum potassium. The combination is not recommended
Anaesthetics, felodipine/ramipril [2] ---> SmPC of [2] of eMC
Potentiation of the antihypertensive effect is to be anticipated.
Antihypertensives, felodipine/ramipril [2] ---> SmPC of [2] of eMC
Potentiation of the antihypertensive effect is to be anticipated.
Azole antifungals, felodipine/ramipril [2] ---> SmPC of [2] of eMC
The strong CYP3A4 inhibition may increase the plasma levels of felodipine. The co-administration of felodipine with strong CYP3A4 inhibitors should be avoided
Biguanides, felodipine/ramipril [2] ---> SmPC of [2] of eMC
Concomitant treatment with ACE inhibitors and antidiabetic agents may cause a pronounced hypoglycaemic effect with the risk of hypoglycaemia.
Breast-feeding, felodipine/ramipril [2] ---> SmPC of [2] of eMC
Women must not breast-feed during treatment
Carbamazepine, felodipine/ramipril [2] ---> SmPC of [2] of eMC
The CYP3A4 induction may decrease the plasma levels of felodipine. The co-administration of felodipine with CYP3A4 inductors should be avoided
Corticosteroids, felodipine/ramipril [2] ---> SmPC of [2] of eMC
Increased likelihood of haematological reactions.
CYP3A4 inductors, felodipine/ramipril [2] ---> SmPC of [2] of eMC
The CYP3A4 induction may decrease the plasma levels of felodipine. The co-administration of felodipine with CYP3A4 inductors should be avoided
CYP3A4 inhibitors, felodipine/ramipril [2] ---> SmPC of [2] of eMC
The CYP3A4 inhibition may increase the plasma levels of felodipine.
Cytostatics, felodipine/ramipril [2] ---> SmPC of [2] of eMC
Increased likelihood of haematological reactions.
Erythromycin, felodipine/ramipril [2] ---> SmPC of [2] of eMC
The strong CYP3A4 inhibition may increase the plasma levels of felodipine. The co-administration of felodipine with strong CYP3A4 inhibitors should be avoided
Felodipine, theophylline ---> SmPC of [felodipine/ramipril] of eMC
Concomitant administration of felodipine and oral theophylline reduces theophylline absorption by approximately 20%. This is probably of minor clinical importance.
Felodipine/ramipril [1], grapefruit juice ---> SmPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma levels of felodipine. The co-administration of felodipine with strong CYP3A4 inhibitors should be avoided
Felodipine/ramipril [1], heparin ---> SmPC of [1] of eMC
Rise in serum potassium concentration possible.
Felodipine/ramipril [1], hypnotics ---> SmPC of [1] of eMC
Potentiation of the antihypertensive effect is to be anticipated.
Felodipine/ramipril [1], immunosuppressives ---> SmPC of [1] of eMC
Increased likelihood of haematological reactions.
Felodipine/ramipril [1], insulin ---> SmPC of [1] of eMC
Concomitant treatment with ACE inhibitors and antidiabetic agents may cause a pronounced hypoglycaemic effect with the risk of hypoglycaemia.
Felodipine/ramipril [1], itraconazol ---> SmPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma levels of felodipine. The co-administration of felodipine with strong CYP3A4 inhibitors should be avoided
Felodipine/ramipril [1], lithium ---> SmPC of [1] of eMC
Excretion of lithium may be reduced by ACE inhibitors, leading to lithium toxicity. Lithium levels must, therefore, be monitored.
Felodipine/ramipril [1], macrolide antibiotics ---> SmPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma levels of felodipine. The co-administration of felodipine with strong CYP3A4 inhibitors should be avoided
Felodipine/ramipril [1], metformin ---> SmPC of [1] of eMC
Concomitant treatment with ACE inhibitors and antidiabetic agents may cause a pronounced hypoglycaemic effect with the risk of hypoglycaemia.
Felodipine/ramipril [1], moderate CYP3A4 inductors ---> SmPC of [1] of eMC
The CYP3A4 induction may decrease the plasma levels of felodipine. The co-administration of felodipine with CYP3A4 inductors should be avoided
Felodipine/ramipril [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of eMC
The CYP3A4 inhibition may increase the plasma levels of felodipine.
Felodipine/ramipril [1], neuroleptics ---> SmPC of [1] of eMC
Potentiation of the antihypertensive effect is to be anticipated.
Felodipine/ramipril [1], NSAID ---> SmPC of [1] of eMC
The co-administration of ACE inhibitors with NSAIDs may decrease the ramipril effect, increase the risk of renal failure and cause hypercaliemia.
Felodipine/ramipril [1], oral antidiabetics ---> SmPC of [1] of eMC
Concomitant treatment with ACE inhibitors and antidiabetic agents may cause a pronounced hypoglycaemic effect with the risk of hypoglycaemia.
Felodipine/ramipril [1], organic nitrates ---> SmPC of [1] of eMC
Potentiation of the antihypertensive effect is to be anticipated.
Felodipine/ramipril [1], phenobarbital ---> SmPC of [1] of eMC
The CYP3A4 induction may decrease the plasma levels of felodipine. The co-administration of felodipine with CYP3A4 inductors should be avoided
Felodipine/ramipril [1], phenytoin ---> SmPC of [1] of eMC
The CYP3A4 induction may decrease the plasma levels of felodipine. The co-administration of felodipine with CYP3A4 inductors should be avoided
Felodipine/ramipril [1], potassium ---> SmPC of [1] of eMC
The combination may increase the serum potassium concentration and requires close monitoring of serum potassium. The combination is not recommended
Felodipine/ramipril [1], potassium-sparing diuretics ---> SmPC of [1] of eMC
The combination may increase the serum potassium concentration and requires close monitoring of serum potassium. The combination is not recommended
Felodipine/ramipril [1], pregnancy ---> SmPC of [1] of eMC
The product is contra-indicated in pregnancy.
Felodipine/ramipril [1], procainamide ---> SmPC of [1] of eMC
Increased likelihood of haematological reactions.
Felodipine/ramipril [1], protease inhibitors ---> SmPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma levels of felodipine. The co-administration of felodipine with strong CYP3A4 inhibitors should be avoided
Felodipine/ramipril [1], rifampicin ---> SmPC of [1] of eMC
The CYP3A4 induction may decrease the plasma levels of felodipine. The co-administration of felodipine with CYP3A4 inductors should be avoided
Felodipine/ramipril [1], sedatives ---> SmPC of [1] of eMC
Potentiation of the antihypertensive effect is to be anticipated.
Felodipine/ramipril [1], spironolactone ---> SmPC of [1] of eMC
The combination may increase the serum potassium concentration and requires close monitoring of serum potassium. The combination is not recommended
Felodipine/ramipril [1], St. John's wort ---> SmPC of [1] of eMC
The CYP3A4 induction may decrease the plasma levels of felodipine. The co-administration of felodipine with CYP3A4 inductors should be avoided
Felodipine/ramipril [1], strong CYP3A4 inductors ---> SmPC of [1] of eMC
The CYP3A4 induction may decrease the plasma levels of felodipine. The co-administration of felodipine with CYP3A4 inductors should be avoided
Felodipine/ramipril [1], strong CYP3A4 inhibitors ---> SmPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma levels of felodipine. The co-administration of felodipine with strong CYP3A4 inhibitors should be avoided
Felodipine/ramipril [1], sulfonylureas ---> SmPC of [1] of eMC
Concomitant treatment with ACE inhibitors and antidiabetic agents may cause a pronounced hypoglycaemic effect with the risk of hypoglycaemia.
Felodipine/ramipril [1], table salt ---> SmPC of [1] of eMC
Increased dietary salt intake may attenuate the antihypertensive effect
Felodipine/ramipril [1], tacrolimus ---> SmPC of [1] of eMC
Felodipine may increase the tacrolimus concentration. When used together, the tacrolimus serum concentration should be followed
Felodipine/ramipril [1], telithromycin ---> SmPC of [1] of eMC
The strong CYP3A4 inhibition may increase the plasma levels of felodipine. The co-administration of felodipine with strong CYP3A4 inhibitors should be avoided
Felodipine/ramipril [1], theophylline ---> SmPC of [1] of eMC
Concomitant administration of felodipine and oral theophylline reduces theophylline absorption by approximately 20%. This is probably of minor clinical importance.
Felodipine/ramipril [1], triamterene ---> SmPC of [1] of eMC
The combination may increase the serum potassium concentration and requires close monitoring of serum potassium. The combination is not recommended
Felodipine/ramipril [1], vasopressor sympathomimetics ---> SmPC of [1] of eMC
The vasopressor sympathomimetic may reduce the antihypertensive effect. Particularly close blood pressure monitoring is recommended.
Felodipine/ramipril, vildagliptin
The co-administration of ACE inhibitors and vildagliptin may increase the risk of angioedema
CONTRAINDICATIONS of Felodipine/ramipril
Triapin must not be used
- in patients with hypersensitivity to felodipine (or other dihydropyridines), ramipril, other angiotensin converting enzyme (ACE) inhibitors or any of the excipients
- in patients with a history of angioedema.
- in unstable haemodynamic conditions: cardiovascular shock, untreated heart failure, acute myocardial infarction, unstable angina pectoris, stroke.
- in patients with AV block II or III.
- in patients with severely impaired hepatic function.
- in patients with severely impaired renal function (creatinine clearance less than 20 ml/min) and in patients on dialysis.
- during pregnancy.
- during lactation.
- with aliskiren-containing medicinal products in patients with diabetes or with moderate to severe renal impairment (creatinine clearance < 60 ml/min).
http://www.medicines.org.uk/emc/
Fenfluramine (Fintepla)
Ability to drive, fenfluramine [2] ---> SmPC of [2] of EMA
Patients should be advised not to drive or operate machinery until they have gained sufficient experience to gauge whether it adversely affects their abilities (see section 4.8).
Breast-feeding, fenfluramine [2] ---> SmPC of [2] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fintepla therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Cannabidiol, fenfluramine [2] ---> SmPC of [2] of EMA
No dose adjustment is necessary when fenfluramine is co-administered with cannabidiol.
Clobazam, fenfluramine [2] ---> SmPC of [2] of EMA
Co-administration of a single 0.7 mg/kg dose of fenfluramine, with a single dose of a stiripentol, clobazam, and valproic acid combination, did not affect the pharmacokinetics
CNS depressants, fenfluramine [2] ---> SmPC of [2] of EMA
Pharmacodynamic interactions with other central nervous system depressants increase the risk of aggravated central nervous system depression.
Cyproheptadine, fenfluramine [2] ---> SmPC of [2] of EMA
Cyproheptadine is a potent serotonin receptor antagonist and may therefore decrease the efficacy of fenfluramine.
Desipramine, fenfluramine [2] ---> SmPC of [2] of EMA
It has been reported that steady-state desipramine concentrations increase approximately 2-fold with concomitant administration of fenfluramine.
Drugs primarily metabolised by CYP2B6, fenfluramine [2] ---> SmPC of [2] of EMA
In vitro studies indicate that fenfluramine may induce CYP2B6 and may induce intestinal CYP3A4. Co-administration of fenfluramine with CYP2B6 substrates or CYP3A4 substrates may decrease their plasma concentrations.
Drugs primarily metabolised by CYP2D6, fenfluramine [2] ---> SmPC of [2] of EMA
In vitro studies indicate that fenfluramine may inhibit CYP2D6. Co-administration of fenfluramine with CYP2D6 substrates may increase their plasma concentrations.
Drugs primarily metabolised by CYP3A4, fenfluramine [2] ---> SmPC of [2] of EMA
In vitro studies indicate that fenfluramine may induce CYP2B6 and may induce intestinal CYP3A4. Co-administration of fenfluramine with CYP2B6 substrates or CYP3A4 substrates may decrease their plasma concentrations.
Fenfluramine [1], fertility ---> SmPC of [1] of EMA
Animal studies suggest that Fintepla may possibly affect female fertility
Fenfluramine [1], MATE1 substrates ---> SmPC of [1] of EMA
In vitro studies indicate that norfenfluramine (major and pharmacologically active metabolite) may inhibit MATE1 at clinically relevant concentrations. Co-administration of fenfluramine with MATE1 substrates may increase their plasma concentrations.
Fenfluramine [1], neuroleptics ---> SmPC of [1] of EMA
Pharmacodynamic interactions with other central nervous system depressants increase the risk of aggravated central nervous system depression.
Fenfluramine [1], phenelzine ---> SmPC of [1] of eMC
Phenelzine may potentiate the action of fenfluramine
Fenfluramine [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure, it is preferable to avoid the use of Fintepla during pregnancy.
Fenfluramine [1], rifampicin ---> SmPC of [1] of EMA
An increase in fenfluramine dose may be necessary when coadministered with rifampicin or a strong CYP1A2 or CYP2B6 inducer (see section 4.4).
Fenfluramine [1], serotonergic medicines ---> SmPC of [1] of EMA
Pharmacodynamic interactions with other central nervous system depressants increase the risk of aggravated central nervous system depression.
Fenfluramine [1], SNRIs ---> SmPC of [1] of EMA
Pharmacodynamic interactions with other central nervous system depressants increase the risk of aggravated central nervous system depression.
Fenfluramine [1], stiripentol ---> SmPC of [1] of EMA
Co-administration of a single 0.7 mg/kg dose of fenfluramine, with a single dose of a stiripentol, clobazam, and valproic acid combination, did not affect the pharmacokinetics
Fenfluramine [1], strong CYP1A2 inductors ---> SmPC of [1] of EMA
Co-administration with strong CYP1A2 inducers or CYP2B6 inducers may decrease fenfluramine plasma concentrations
Fenfluramine [1], strong CYP2B6 inductors ---> SmPC of [1] of EMA
Co-administration with strong CYP1A2 inducers or CYP2B6 inducers may decrease fenfluramine plasma concentrations
Fenfluramine [1], tricyclic antidepressant ---> SmPC of [1] of EMA
Pharmacodynamic interactions with other central nervous system depressants increase the risk of aggravated central nervous system depression.
Fenfluramine [1], triptans ---> SmPC of [1] of EMA
Pharmacodynamic interactions with other central nervous system depressants increase the risk of aggravated central nervous system depression.
Fenfluramine [1], valproic acid ---> SmPC of [1] of EMA
Co-administration of a single 0.7 mg/kg dose of fenfluramine, with a single dose of a stiripentol, clobazam, and valproic acid combination, did not affect the pharmacokinetics
Fenfluramine, glibenclamide [2] ---> SmPC of [2] of EMA
Potentiation of the blood-glucose lowering
Fenfluramine, glimepiride [2] ---> SmPC of [2] of eMC
Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia
Fenfluramine, gliquidone
Hypoglycemic reactions may occur as expression of enhancement effect of gliquidone with gliquidone is co-administered with fenfluramine
Fenfluramine, IMAOs
The co-administration should be avoided. In extreme cases interactions may result in severe hypertensive episodes
Fenfluramine, insulin
Possible reduction of the insulin requirements
Fenfluramine, isocarboxazid
Patients being treated with a monoamine oxidase inhibitor should not receive indirectly-acting sympathomimetic. In extreme cases interactions may result in severe hypertensive episodes.
Fenfluramine, pioglitazone/glimepiride [2] ---> SmPC of [2] of EMA
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur
Fenfluramine, sertraline [2] ---> SmPC of [2] of EMA
Co-administration of sertraline with other drugs which enhance the effects of serotonergic neurotransmission should be undertaken with caution and avoided whenever possible due to the potential for a pharmacodynamic interaction
Fenfluramine, SSRI
The co-administration increases the risk of serotonin syndrome and of neuroleptic malignant syndrome. The combination should be avoided
Fenfluramine, sulfonylureas
Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia
Fenfluramine, tryptophan
The co-administration can cause serotoninergic syndrome. The combination is contraindicated
CONTRAINDICATIONS of Fenfluramine (Fintepla)
- Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
- Aortic or mitral valvular heart disease.
- Pulmonary arterial hypertension.
- Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome.
https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf 02/05/2025
Fenofibrate
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.
Bile-acid sequestrants, fenofibrate ---> SmPC of [fenofibrate/pravastatine] of EMA
Bile acid binding resins frequently reduce the absorption of medicinal products and when resins are being co-administered, fenofibrate should be taken 1 hour before, or 4 to 6 hours after, the resin so as not to impede the absorption of fenofibrate.
Breast-feeding, fenofibrate [2] ---> SmPC of [2] of eMC
Fenofibrate should not be used during breast-feeding.
Colchicine, fenofibrate
Concomitant use of medicinal products that may cause rhabdomyolysis, in particular fibrates and statins, may increase the risk of rhabdomyolysis
Cyclosporine [1], fenofibrate ---> SmPC of [1] of eMC
Care should be taken when using ciclosporin together with other active substances that exhibit nephrotoxic synergy
CYP2C19 substrates with narrow therapeutic index [1], fenofibrate ---> SmPC of [1] of eMC
Patients co-administered fenofibrate and CYP2C19 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
CYP2C9 substrates with narrow therapeutic index [1], fenofibrate ---> SmPC of [1] of eMC
Patients co-administered fenofibrate and CYP2C9 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Drugs primarily metabolised by CYP2C9, fenofibrate
Fenofibrate, moderate CYP2C9 inhibitor, may increase the plasma concentrations of the medicinal products mainly metabolized by CYP2C9
Ezetimibe [1], fenofibrate ---> SmPC of [1] of eMC
In patients receiving fenofibrate and ezetimibe, physicians should be aware of the possible risk of cholelithiasis and gallbladder disease. Concomitant administration modestly increased total ezetimibe concentrations
Ezetimibe/atorvastatin [1], fenofibrate ---> SmPC of [1] of eMC
Concomitant fenofibrate/gemfibrozil administration increased total ezetimibe levels approx. 1.5- and 1.7-fold, respectively. Although these increases are not considered clinically significant, coadministration of ATOZET with fibrates is not recommended
Ezetimibe/simvastatine [1], fenofibrate ---> SmPC of [1] of eMC
Concomitant fenofibrate or gemfibrozil administration increased total ezetimibe concentrations approximately 1.5- and 1.7-fold, respectively.
Fenofibrate [1], fibrates ---> SmPC of [1] of eMC
The risk of serious muscle toxicity is increased if a fibrate is used concomitantly with other fibrates. Such combination therapy should be used with caution
Fenofibrate [1], foods ---> SmPC of [1] of eMC
Fenofibrate should always be taken with food, because it is less well absorbed from an empty stomach.
Fenofibrate [1], pregnancy ---> SmPC of [1] of eMC
Fenofibrate should only be used during pregnancy after a careful benefit/risk assessment.
Fenofibrate [1], statins ---> SmPC of [1] of eMC
The risk of serious muscle toxicity is increased if a fibrate is used concomitantly with HMG-CoA reductase inhibitors. Such combination therapy should be used with caution
Fenofibrate, furosemide
The co-administration may increase the plasma levels of fibrate and furosemide
Fenofibrate, lomitapide [2] ---> SmPC of [2] of EMA
No dose adjustments are required when co-administered with Lojuxta.
Fenofibrate, oral anticoagulants ---> SmPC of [fenofibrate/pravastatine] of EMA
Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding. The coadministration is not recommended
Fenofibrate, pravastatine [2] ---> SmPC of [2] of eMC
The use of fibrates alone is occasionally associated with myopathy. The adverse events with pravastatin cannot be excluded; therefore the combined use of pravastatin and fibrates should generally be avoided
Fenofibrate, rosuvastatin [2] ---> SmPC of [2] of eMC
Fibrates increase the risk of myopathy when given concomitantly with HMG-CoA reductase inhibitors, probably because they can produce myopathy when given alone. Concomitant use is contraindicated
Fenofibrate, simvastatine [2] ---> SmPC of [2] of eMC
Caution should be used when prescribing fenofibrate with simvastatin, as either agent can cause myopathy when given alone.
Fenofibrate, thiazolidinediones ---> SmPC of [fenofibrate/simvastatin] of EMA
Some cases of reversible paradoxical reduction of HDL-C have been reported during concomitant administration of fenofibrate and glitazones.
CONTRAINDICATIONS of Fenofibrate
Fenofibrate is contraindicated in patients with
- severe renal dysfunction,
- hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality e.g. persistent elevations in serum transaminases),
- gallbladder disease,
- in patients hypersensitive to fenofibrate or any component of this medication,
- known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
http://www.medicines.org.uk/emc/
Fenofibrate/pravastatine
Ability to drive, fenofibrate/pravastatine [2] ---> SmPC of [2] of EMA
Dizziness and visual disturbances may occur during treatment.
Bile-acid sequestrants, fenofibrate ---> SmPC of [fenofibrate/pravastatine] of EMA
Bile acid binding resins frequently reduce the absorption of medicinal products and when resins are being co-administered, fenofibrate should be taken 1 hour before, or 4 to 6 hours after, the resin so as not to impede the absorption of fenofibrate.
Bile-acid sequestrants, fenofibrate/pravastatine [2] ---> SmPC of [2] of EMA
Bile acid binding resins frequently reduce the absorption of medicinal products and when resins are being co-administered, fenofibrate should be taken 1 hour before, or 4 to 6 hours after, the resin so as not to impede the absorption of fenofibrate.
Breast-feeding, fenofibrate/pravastatine [2] ---> SmPC of [2] of EMA
Pravastatin is contraindicated during breastfeeding
Cholestyramine, fenofibrate/pravastatine [2] ---> SmPC of [2] of EMA
Concomitant administration decreased the bioavailability of statine. The statine should be taken 1 h before or 4 h after colestyramine
Colestipol, fenofibrate/pravastatine [2] ---> SmPC of [2] of EMA
Concomitant administration decreased the bioavailability of pravastatine. The statine should be taken 1 hour before colestipol
Cyclosporine, fenofibrate/pravastatine [2] ---> SmPC of [2] of EMA
Concomitant administration of pravastatin and ciclosporin leads to an approximately 4 fold increase in pravastatin systemic exposure.
Cyclosporine, pravastatine ---> SmPC of [fenofibrate/pravastatine] of EMA
Concomitant administration of pravastatin and ciclosporin leads to an approximately 4 fold increase in pravastatin systemic exposure.
Fenofibrate, oral anticoagulants ---> SmPC of [fenofibrate/pravastatine] of EMA
Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding. The coadministration is not recommended
Fenofibrate/pravastatine [1], foods ---> SmPC of [1] of EMA
Take with food, as this enhances the bioavailability of fenofibrate
Fenofibrate/pravastatine [1], fusidic acid ---> SmPC of [1] of EMA
The co-administration may cause increased plasma levels of pravastatine and fusidic acid and is contra-indicated. The risk of myopathy and rhabdomyolysis may increase
Fenofibrate/pravastatine [1], oral anticoagulants ---> SmPC of [1] of EMA
Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding. The coadministration is not recommended
Fenofibrate/pravastatine [1], pregnancy ---> SmPC of [1] of EMA
Pravastatin is contraindicated during pregnancy
Fusidic acid, pravastatine ---> SmPC of [fenofibrate/pravastatine] of EMA
The co-administration may cause increased plasma levels of pravastatine and fusidic acid and is contra-indicated. The risk of myopathy and rhabdomyolysis may increase
CONTRAINDICATIONS of Fenofibrate/pravastatine
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (including serum
transaminase elevation) exceeding 3 fold the upper limit of normal (ULN)
- Children and adolescents (age below 18 years).
- Moderate to severe renal impairment (defined as an estimated creatinine clearance < 60 ml/min).
- Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen.
- Gallbladder disease
- Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia
- Pregnancy and breast feeding
- Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase (CK) elevation above 5 times the upper limit of normal (ULN) under previous statin treatment
Fenofibrate/simvastatin (Cholib)
Ability to drive, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
Dizziness has been reported rarely in post-marketing experience with simvastatin. This adverse reaction should be taken into account when driving vehicles or using machines under Cholib therapy.
Amiodarone, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone with simvastatin 40 mg per day.
Amlodipine, 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.
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.
BCRP inhibitors, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
Concomitant administration of medicinal products that are inhibitors of BCRP, including products containing elbasvir or grazoprevir, may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy
Breast-feeding, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
It is unknown whether fenofibrate, simvastatin and/or their metabolites are excreted in human milk. Therefore, Cholib is contraindicated during breast-feeding (see section 4.3).
Clarithromycin, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Clarithromycin, simvastatine ---> SmPC of [fenofibrate/simvastatin] of EMA
The strong CYP3A4 inhibition may increase the plasma concentrations of simvastatine and the risk of myopathy and rhabdomyolysis. The co-administration is contraindicated
Cobicistat, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Colchicine, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
There have been reports of myopathy and rhabdomyolysis with the concomitant administration of colchicine and simvastatin in patients with renal insufficiency.
Colchicine, simvastatine ---> SmPC of [fenofibrate/simvastatin] of EMA
There have been reports of myopathy and rhabdomyolysis with the concomitant administration of colchicine and simvastatin in patients with renal insufficiency.
Cyclosporine, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
The risk of myopathy and rhabdomyolysis is increased by concomitant administration of ciclosporin and simvastatin. The co-administration is contraindicated
CYP2A6 substrates with narrow therapeutic index, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
Patients receiving co-administration of fenofibrate/simvastatine and drugs metabolised by CYP2A6 with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
CYP2C19 substrates with narrow therapeutic index, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
Patients receiving co-administration of fenofibrate/simvastatine and drugs metabolised by CYP2C19 with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
CYP2C9 substrates with narrow therapeutic index, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
Patients receiving co-administration of fenofibrate/simvastatine and drugs metabolised by CYP2C9 with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Danazol, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with simvastatin. The co-administration is contraindicated
Diltiazem, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
Caution should be exercised when combining fenofibrate/simvastatine with certain other less potent CYP 3A4 inhibitors. The risk of myopathy and rhabdomyolysis is increased by concomitant use of diltiazem with simvastatin 40 mg per day.
Elbasvir/grazoprevir, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
In patients taking products containing elbasvir or grazoprevir concomitantly with Cholib the dose of simvastatin should not exceed 20 mg/day.
Erythromycin, fenofibrate/simvastatin [2] ---> SmPC of [2] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Fenofibrate, thiazolidinediones ---> SmPC of [fenofibrate/simvastatin] of EMA
Some cases of reversible paradoxical reduction of HDL-C have been reported during concomitant administration of fenofibrate and glitazones.
Fenofibrate/simvastatin [1], fenofibric acid ---> SmPC of [1] of EMA
The repeated administration of simvastatin 40 or 80 mg, the highest dose registered, did not affect the plasma levels of fenofibric acid at steady state.
Fenofibrate/simvastatin [1], fertility ---> SmPC of [1] of EMA
Reversible effects on fertility have been observed in animals (see section 5.3). There are no clinical data on fertility from the use of Cholib.
Fenofibrate/simvastatin [1], fibrates ---> SmPC of [1] of EMA
The risk of rhabdomyolysis is increased in patients concomitantly receiving other fibrates. The co-administration is contraindicated
Fenofibrate/simvastatin [1], fluconazole ---> SmPC of [1] of EMA
Caution should be exercised when combining fenofibrate/simvastatine with certain other less potent CYP 3A4 inhibitors
Fenofibrate/simvastatin [1], fusidic acid ---> SmPC of [1] of EMA
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins. Co-administration of this combination may cause increased plasma concentrations of both agents.
Fenofibrate/simvastatin [1], gemfibrozil ---> SmPC of [1] of EMA
The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of gemfibrozil with simvastatin. The co-administration is contraindicated
Fenofibrate/simvastatin [1], glecaprevir/pibrentasvir ---> SmPC of [1] of EMA
Contraindicated with Cholib
Fenofibrate/simvastatin [1], glitazones ---> SmPC of [1] of EMA
Some cases of reversible paradoxical reduction of HDL-C have been reported during concomitant administration of fenofibrate and glitazones.
Fenofibrate/simvastatin [1], grapefruit juice ---> SmPC of [1] of EMA
The CYP3A4 inhibition by grapefruit juice may increase the plasma exposure to simvastatin acid. The intake of grapefruit juice should be avoided
Fenofibrate/simvastatin [1], itraconazol ---> SmPC of [1] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Fenofibrate/simvastatin [1], ketoconazole ---> SmPC of [1] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Fenofibrate/simvastatin [1], nefazodone ---> SmPC of [1] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Fenofibrate/simvastatin [1], nelfinavir ---> SmPC of [1] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Fenofibrate/simvastatin [1], niacin ---> SmPC of [1] of EMA
Cases of myopathy/rhabdomyolysis have been associated with concomitant administration of statins and niacin (nicotinic acid) at lipid-modifying doses (≥ 1 g/day), cause myopathy when given alone
Fenofibrate/simvastatin [1], posaconazole ---> SmPC of [1] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Fenofibrate/simvastatin [1], pregnancy ---> SmPC of [1] of EMA
As simvastatin is contraindicated during pregnancy (see hereafter), Cholib is contraindicated during pregnancy (see section 4.3).
Fenofibrate/simvastatin [1], protease inhibitors ---> SmPC of [1] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Fenofibrate/simvastatin [1], rifampicin ---> SmPC of [1] of EMA
Because rifampicin is a potent CYP 3A4 inducer that interferes with simvastatin metabolism, patients undertaking long-term rifampicin therapy may experience loss of efficacy of simvastatin.
Fenofibrate/simvastatin [1], statins ---> SmPC of [1] of EMA
The risk of rhabdomyolysis is increased in patients concomitantly receiving statins. The co-administration is contraindicated
Fenofibrate/simvastatin [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Fenofibrate/simvastatin [1], telithromycin ---> SmPC of [1] of EMA
Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Concomitant use is contraindicated
Fenofibrate/simvastatin [1], thiazolidinediones ---> SmPC of [1] of EMA
Some cases of reversible paradoxical reduction of HDL-C have been reported during concomitant administration of fenofibrate and glitazones.
Fenofibrate/simvastatin [1], verapamil ---> SmPC of [1] of EMA
Caution should be exercised when combining fenofibrate/simvastatine with certain other less potent CYP 3A4 inhibitors. The risk of myopathy and rhabdomyolysis is increased by concomitant use of verapamil with simvastatin 40 mg per day.
Fenofibrate/simvastatin [1], vitamin K antagonists ---> SmPC of [1] of EMA
Fenofibrate and simvastatin enhance effects of Vitamin K antagonists and may increase the risk of bleeding.
Fusidic acid, statins ---> SmPC of [fenofibrate/simvastatin] of EMA
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins. Co-administration of this combination may cause increased plasma concentrations of both agents.
Itraconazol, simvastatine ---> SmPC of [fenofibrate/simvastatin] of EMA
The strong CYP3A4 inhibition may increase the plasma concentrations of simvastatine and the risk of myopathy and rhabdomyolysis. The co-administration is contraindicated
Nefazodone, simvastatine ---> SmPC of [fenofibrate/simvastatin] of EMA
The strong CYP3A4 inhibition may increase the plasma concentrations of simvastatine and the risk of myopathy and rhabdomyolysis. The co-administration is contraindicated
Protease inhibitors, simvastatine ---> SmPC of [fenofibrate/simvastatin] of EMA
The strong CYP3A4 inhibition may increase the plasma concentrations of simvastatine and the risk of myopathy and rhabdomyolysis. The co-administration is contraindicated
Rifampicin, simvastatine ---> SmPC of [fenofibrate/simvastatin] of EMA
Because rifampicin is a potent CYP 3A4 inducer that interferes with simvastatin metabolism, patients undertaking long-term rifampicin therapy may experience loss of efficacy of simvastatin.
Simvastatine, strong CYP3A4 inhibitors ---> SmPC of [fenofibrate/simvastatin] of EMA
The strong CYP3A4 inhibition may increase the plasma concentrations of simvastatine and the risk of myopathy and rhabdomyolysis. The co-administration is contraindicated
Simvastatine, vitamin K antagonists ---> SmPC of [fenofibrate/simvastatin] of EMA
Fenofibrate and simvastatin enhance effects of Vitamin K antagonists and may increase the risk of bleeding.
CONTRAINDICATIONS of Fenofibrate/simvastatin (Cholib)
- Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in section 6.1.
- Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
- Active liver disease or unexplained persistent elevations of serum transaminases
- Known gallbladder disease
- Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia
- Moderate to severe renal insufficiency (estimated glomerular filtration rate < 60 mL/min/1.73 m²)
- Concomitant administration of potent CYP3A4 inhibitors (agents that increase AUC approximately 5 fold or greater) (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors (e.g. nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and medicinal products containing cobicistat) (see sections 4.4 and 4.5)
- Concomitant administration of glecaprevir/ pibrentasvir (see section 4.5)
- Paediatric population (age below 18 years)
- Pregnancy and breast-feeding
- Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous statin treatment
https://www.ema.europa.eu/en/documents/product-information/cholib-epar-product-information_en.pdf 06/03/2024
Fentanyl (Effentora)
Ability to drive, fentanyl [2] ---> SmPC of [2] of EMA
Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance while taking Effentora and not to drive or operate machinery until they know how they react.
Alcohol, fentanyl [2] ---> SmPC of [2] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Amiodarone, fentanyl [2] ---> SmPC of [2] of EMA
Amiodarone, CYP3A4 inhibitor, may increase the plasma concentrations of fentanyl
Amprenavir, 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, 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.
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.
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
Azole antifungals, fentanyl
The combination may increase the bioavailability of swallowed fentanyl and may decrease its systemic clearance
Baclofen, fentanyl
Concomitant use of intrathecal baclofen and general anaesthetic agents (e. g. fentanyl, propofol) may increase the risk of cardiac disorders and convulsions
Benzodiazepines, fentanyl [2] ---> SmPC of [2] of EMA
The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration should be limited
Berotralstat [1], fentanyl ---> SmPC of [1] of EMA
Refer to the SmPC for concomitant medicines that are predominantly metabolised by CYP3A4, particularly those with a narrow therapeutic index (e.g. cyclosporine, fentanyl). Dose adjustments of these medicines may be required
Breast-feeding, fentanyl [2] ---> SmPC of [2] of EMA
Fentanyl should not be used by breastfeeding women and breastfeeding should not be restarted until at least 5 days after the last administration of fentanyl.
Brigatinib [1], fentanyl ---> SmPC of [1] of EMA
Coadministration of Alunbrig with CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, fentanyl, quinidine, cyclosporine, sirolimus, tacrolimus) should be avoided as their effectiveness may be reduced.
Buprenorphine, fentanyl [2] ---> SmPC of [2] of EMA
The concomitant use of partial opioid agonists/antagonists is not recommended. They have high affinity to opioid receptors and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients
Butorfanol, fentanyl
Withdrawal symptoms may be precipitated
Caffeine, fentanyl
The combination may increase the bioavailability of swallowed fentanyl and may decrease its systemic clearance
Capivasertib [1], fentanyl ---> SmPC of [1] of EMA
Dose adjustment may be required for medicinal products that are primarily eliminated via CYP3A metabolism and have narrow therapeutic window (e.g. carbamazepine, cyclosporine, fentanyl, pimozide, simvastatin, tacrolimus).
Ceritinib [1], fentanyl ---> SmPC of [1] of EMA
Co-administration of ceritinib with substrates primarily metabolised by CYP3A or CYP3A substrates known to have narrow therapeutic indices should be avoided
Cimetidine, fentanyl
The CYP3A4 inhibition may increase plasma levels of fentanyl
Clarithromycin, 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.
CNS depressants, fentanyl [2] ---> SmPC of [2] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Crizotinib [1], fentanyl ---> SmPC of [1] 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.
CYP3A4 inductors, fentanyl [2] ---> SmPC of [2] of EMA
Co-administration with agents that induce 3A4 activity may reduce the efficacy of Effentora.
Dabrafenib [1], fentanyl ---> SmPC of [1] 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.
Darunavir [1], fentanyl ---> SmPC of [1] of EMA
Based on theoretical considerations boosted PREZISTA may increase plasma concentrations of these analgesics. (CYP2D6 and/or CYP3A inhibition)
Darunavir/cobicistat [1], fentanyl ---> SmPC of [1] of EMA
Based on theoretical considerations darunavir/cobicistat (CYP2D6 and/or CYP3A inhibition) may increase analgesic plasma concentrations. Clinical monitoring is recommended
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], fentanyl ---> SmPC of [1] of EMA
Based on theoretical considerations DRV/COBI may increase analgesic plasma concentrations. CYP2D6 and/or CYP3A inhibition
Dihydropyridines, fentanyl
The co-administration may decrease strongly the blood pressure
Diltiazem, 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.
Dronabinol, fentanyl
The CYP3A4 inhibition may increase plasma levels of fentanyl
Drugs inducing bradycardia, fentanyl [2] ---> SmPC of [2] of EMA
Fentanyl may produce bradycardia. Fentanyl should therefore be used with caution in patients with previous or pre-existing bradyarrhythmias.
Eluxadoline [1], fentanyl ---> SmPC of [1] of EMA
Loss of efficacy can occur, especially when medicinal products with low dose and narrow therapeutic index (e.g. alfentanil, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), are co-administered with Eluxadoline.
Entrectinib [1], fentanyl ---> SmPC of [1] of EMA
Caution is advised when entrectinib is administered together with sensitive CYP3A4 substrates with a narrow therapeutic range, due to the increased risk of adverse drug reactions.
Enzalutamide [1], fentanyl ---> SmPC of [1] of EMA
Enzalutamide, enzymatic inductor, may increase the metabolism of fentanyl and decrease its plasma levels and effect
Eribulin [1], fentanyl ---> SmPC of [1] 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
Erythromycin, 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.
Estrogens, fentanyl
The combination may increase plasma fentanyl up to toxic levels.
Etomidate [1], fentanyl ---> SmPC of [1] of eMC
The total plasma clearance and volume of distribution of etomidate is decreased by a factor of 2 to 3 without a change in half-life when administered with fentanyl IV.
Fentanyl [1], fertility ---> SmPC of [1] of EMA
There are no human data on fertility available. In animal studies, male fertility was impaired (See Section 5.3).
Fentanyl [1], fluconazole ---> SmPC of [1] 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.
Fentanyl [1], fosamprenavir ---> SmPC of [1] 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.
Fentanyl [1], gabapentin ---> SmPC of [1] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Fentanyl [1], general anesthetics ---> SmPC of [1] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Fentanyl [1], grapefruit juice ---> SmPC of [1] 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.
Fentanyl [1], hypnotics ---> SmPC of [1] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Fentanyl [1], IMAOs ---> SmPC of [1] of EMA
Co-administration of fentanyl with a serotoninergic agent may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Fentanyl [1], IMAOs ---> SmPC of [1] of EMA
Effentora is not recommended for use in patients who have received MAOIs within 14 days because severe and unpredictable potentiation by MAOIs has been reported with opioid analgesics.
Fentanyl [1], itraconazol ---> SmPC of [1] 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.
Fentanyl [1], ketoconazole ---> SmPC of [1] 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.
Fentanyl [1], moderate CYP3A4 inhibitors ---> SmPC of [1] 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.
Fentanyl [1], muscle relaxants ---> SmPC of [1] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Fentanyl [1], nalbuphine ---> SmPC of [1] of EMA
The concomitant use of partial opioid agonists/antagonists is not recommended. They have high affinity to opioid receptors and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients
Fentanyl [1], nelfinavir ---> SmPC of [1] 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.
Fentanyl [1], opiates ---> SmPC of [1] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Fentanyl [1], opioid agonist/antagonists ---> SmPC of [1] of EMA
The concomitant use of partial opioid agonists/antagonists is not recommended. They have high affinity to opioid receptors and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients
Fentanyl [1], pentazocine ---> SmPC of [1] of EMA
The concomitant use of partial opioid agonists/antagonists is not recommended. They have high affinity to opioid receptors and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients
Fentanyl [1], phenothiazines ---> SmPC of [1] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Fentanyl [1], pregabalin ---> SmPC of [1] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Fentanyl [1], pregnancy ---> SmPC of [1] of EMA
Effentora should not be used during pregnancy unless clearly necessary
Fentanyl [1], pregnancy ---> SmPC of [1] of EMA
If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available (see section 4.8).
Fentanyl [1], pregnancy ---> SmPC of [1] of EMA
It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the foetus.
Fentanyl [1], sedating antihistamines ---> SmPC of [1] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Fentanyl [1], sedatives ---> SmPC of [1] of EMA
The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration should be limited
Fentanyl [1], serotonergic medicines ---> SmPC of [1] of EMA
Co-administration of fentanyl with a serotoninergic agent may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Fentanyl [1], SNRIs ---> SmPC of [1] of EMA
Co-administration of fentanyl with a serotoninergic agent may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Fentanyl [1], sodium oxybate ---> SmPC of [1] of EMA
Concomitant use of medicinal products containing sodium oxybate and fentanyl is contraindicated (see section 4.3). The treatment with sodium oxybate should be discontinued before start of treatment with Effentora.
Fentanyl [1], SSRI ---> SmPC of [1] of EMA
Co-administration of fentanyl with a serotoninergic agent may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Fentanyl [1], St. John's wort ---> SmPC of [1] of EMA
The potent CYP3A4 induction may decrease plasma concentrations of fentanyl. St. John's Wort should be avoided
Fentanyl [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration with agents that induce 3A4 activity may reduce the efficacy of Effentora.
Fentanyl [1], strong CYP3A4 inhibitors ---> SmPC of [1] 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.
Fentanyl [1], tranquilizers ---> SmPC of [1] of EMA
Co-administration of fentanyl with other central nervous system depressants can produce additive depressant effects which may result in respiratory depression, hypotension, profound sedation, coma or a fatal outcome (see section 4.4).
Fentanyl [1], troleandomycin ---> SmPC of [1] 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.
Fentanyl [1], verapamil ---> SmPC of [1] 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.
Fentanyl, fluoxetine
The CYP3A4 inhibition may increase plasma levels of fentanyl
Fentanyl, fosaprepitant [2] ---> SmPC 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
Fentanyl, hydroxycobalamin
Physical incompatibility (particle formation). These medicinal products must not be administered simultaneously through the same intravenous line as hydroxocobalamine
Fentanyl, ibrutinib [2] ---> SmPC of [2] of EMA
Caution should be exercised if co-administering ibrutinib with CYP3A4 substrates administered orally with narrow therapeutic range (such as dihydroergotamine, ergotamine, fentanyl, cyclosporine, sirolimus and tacrolimus).
Fentanyl, idebenone [2] ---> SmPC of [2] of EMA
CYP3A4 substrates known to have a narrow therapeutic index should be administered with caution in patients receiving idebenone.
Fentanyl, idelalisib [2] ---> SmPC of [2] of EMA
The co-administration of idelalisib with fentanyl may increase the serum concentrations of fentanyl. Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.
Fentanyl, imatinib [2] ---> SmPC 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
Fentanyl, indinavir [2] ---> SmPC of [2] of EMA
Indinavir, CYP3A4 inhibitor, may increase the plasma concentrations of fentanyl. Careful monitoring is recommended
Fentanyl, indinavir/ritonavir ---> SmPC of [indinavir] of EMA
Indinavir/ritonavir, CYP3A4 inhibitors, may increase the plasma concentrations of fentanyl. Careful monitoring is recommended
Fentanyl, interferon
Caution should be used when administering interferon with medicines mainly metabolised by hepatic cytochrome P450 and have a narrow therapeutic window
Fentanyl, iptacopan [2] ---> SmPC of [2] of EMA
Caution should be exercised if co-administration of iptacopan with sensitive CYP3A4 substrates is required, especially for those with a narrow therapeutic index
Fentanyl, isavuconazole [2] ---> SmPC 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.
Fentanyl, isradipine
The co-administration may decrease strongly the blood pressure
Fentanyl, ivosidenib [2] ---> SmPC of [2] of EMA
Patients should be monitored for loss of substrate efficacy (substrate with a narrow therapeutic index) if use of such medicinal products cannot be avoided (see section 5.2).
Fentanyl, ketoconazole [2] ---> SmPC of [2] of EMA
Potential increase in plasma concentrations of alfentanil and fentanyl. Careful monitoring of adverse reactions (respiratory depression, sedation) is recommended. It may be necessary to lower the dose of alfentanil and fentanyl.
Fentanyl, larotrectinib [2] ---> SmPC of [2] of EMA
Exercise caution with concomitant use of CYP3A substrates with narrow therapeutic range (e.g. alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, or tacrolimus) in patients taking VITRAKVI.
Fentanyl, letermovir [2] ---> SmPC 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.
Fentanyl, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA
Lopinavir/ritonavir, CYP3A4 inhibitors, may increase the plasma concentrations of fentanyl. Careful monitoring of adverse effects (notably respiratory depression but also sedation)
Fentanyl, lorlatinib [2] ---> SmPC of [2] of EMA
Concurrent administration of lorlatinib with CYP3A4/5 substrates with narrow therapeutic indices, should be avoided since the concentration of these medicinal products may be reduced by lorlatinib
Fentanyl, macrolide antibiotics
The combination may increase the bioavailability of swallowed fentanyl and may decrease its systemic clearance
Fentanyl, methylthioninium chloride [2] ---> SmPC of [2] of EMA
Lumeblue may be coadministered with anaesthetics / analgesics and/or sedative / anxiolytic medicinal products, often used during colonoscopy which are cleared through hepatic CYPs reactions
Fentanyl, methylthioninium [2] ---> SmPC of [2] of EMA
Opioids, for example, tramadol, fentanyl, pethidine, and dextromethorphan, may also increase the risk of developing serotonin syndrome, when used in combination with methylthioninium chloride.
Fentanyl, midazolam [2] ---> SmPC of [2] of EMA
Fentanyl may reduce midazolam clearance.
Fentanyl, mitapivat [2] ---> SmPC of [2] of EMA
If co-administration of Pyrukynd with sensitive CYP3A4 substrates is unavoidable, patients should be carefully monitored especially for those substrates with a narrow therapeutic index
Fentanyl, moclobemide
Moclobemide potentiates the effects of opiates. Fentanyl should be used with caution and a dosage adjustment may be necessary
Fentanyl, netupitant/palonosetron [2] ---> SmPC 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
Fentanyl, nicardipine [2] ---> SmPC of [2] of eMC
Severe hypotension has been reported during fentanyl anaesthesia with concomitant use of a beta-blocker and calcium blockade.
Fentanyl, nicotine
Decreased plasma concentrations of fentanyl
Fentanyl, nilotinib [2] ---> SmPC 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.
Fentanyl, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA
Ritonavir dosed as a pharmacokinetic enhancer inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of fentanyl. Careful monitoring of therapeutic and adverse effects (including respiratory depression) is recommended
Fentanyl, olaparib [2] ---> SmPC of [2] of EMA
Olaparib inhibits CYP3A4 in vitro and is predicted to be a mild CYP3A inhibitor in vivo. Therefore, caution should be exercised when sensitive CYP3A substrates or substrates with a narrow therapeutic margin are combined with olaparib.
Fentanyl, opiate antagonists
Possible partial antagonism of analgesic effect of fentanyl
Fentanyl, oxcarbazepine
Oxcarbazepine, CYP3A4 inductor, may decrease the plasma concentrations of fentanyl
Fentanyl, palbociclib [2] ---> SmPC 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.
Fentanyl, pancuronium
The anaesthetic may potentiate the neuromuscular blocking activity of pancuronium
Fentanyl, parecoxib [2] ---> SmPC of [2] of EMA
Administration of IV parecoxib 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 substrates).
Fentanyl, propofol
Increased plasma levels of propofol and increased apnea frequency
Fentanyl, ribociclib [2] ---> SmPC 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
Fentanyl, ritonavir [2] ---> SmPC of [2] of EMA
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of fentanyl.
Fentanyl, rucaparib [2] ---> SmPC 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.
Fentanyl, saquinavir [2] ---> SmPC of [2] of EMA
Saquinavir, CYP3A4 inhibitor, may increase the plasma concentrations of fentanyl.
Fentanyl, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA
Saquinavir, CYP3A4 inhibitor, may increase the plasma concentrations of fentanyl. Contraindicated due to the potential for life threatening cardiac arrhythmia
Fentanyl, sevoflurane [2] ---> SmPC 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.
Fentanyl, sibutramine [2] ---> SmPC of [2] of eMC
As sibutramine inhibits serotonin reuptake (among other effects), sibutramine should not be used concomitantly with other drugs which also raise serotonin levels in the brain (serotonin syndrome)
Fentanyl, sotorasib [2] ---> SmPC of [2] of EMA
Avoid co-administration of LUMYKRAS with CYP3A4 substrates with narrow therapeutic indices. If co-administration cannot be avoided, adjust the CYP3A4 substrate dose in accordance with the current summary of product characteristics.
Fentanyl, telaprevir [2] ---> SmPC of [2] of EMA
The co-administration increases the fentanyl plasma levels. Careful monitoring of therapeutic and adverse effects is recommended
Fentanyl, voriconazole [2] ---> SmPC of [2] of EMA
Dose reduction of short-acting opiates similar in structure to alfentanil and metabolised by CYP3A4 should be considered. Extended and frequent monitoring for respiratory depression and other opiate-associated adverse reactions is recommended.
Fentanyl, zanubrutinib [2] ---> SmPC of [2] of EMA
Narrow therapeutic index medicinal products that are metabolised by CYP3A should be used with caution, as zanubrutinib may decrease the plasma exposures of these medicinal products.
CONTRAINDICATIONS of Fentanyl (Effentora)
Buccal tablet:
- Hypersensitivity to the active substance or to any of the excipients.
- Patients without opioid basic therapy, due to there is an increased risk of respiratory depression
- Severe respiratory depression or severe obstructive lung conditions.
- Treatment of acute pain different of breakthrough pain
- Patients being treated with medicinal products containing sodium oxybate.
https://www.ema.europa.eu/en/documents/product-information/effentora-epar-product-information_en.pdf 11/04/2025
Other trade names: Abstral, Actiq, Avaric, Breakyl, Durfenta, Durogesic, Fendivia, Fentanest, Instanyl, Ionsys, PecFent,
Fenticonazole
Breast-feeding, fenticonazole [2] ---> SmPC of [2] of eMC
Since there is no experience of use during pregnancy or lactation, fenticonazole should not be used unless the physician considers it essential to the welfare of the patient.
Fenticonazole [1], pregnancy ---> SmPC of [1] of eMC
Since there is no experience of use during pregnancy or lactation, fenticonazole should not be used unless the physician considers it essential to the welfare of the patient.
CONTRAINDICATIONS of Fenticonazole
- Ascertained hypersensitive to the product and to other imidazole derivatives.
http://www.medicines.org.uk/emc/
Ferric citrate coordination complex
Alendronate, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
Any medicinal product that has the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
Aluminium, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
Since citrate is known to increase aluminium absorption, aluminium-based compounds should be avoided while patients receive Fexeric.
Breast-feeding, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fexeric therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Cefdinir, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
Any medicinal product that has the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
Ciprofloxacin, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
Fexeric decreased the bioavailability of concomitantly administered ciprofloxacin by approximately 45%. Ciprofloxacin should not be taken at the same time, but at least 2 hours before or after Fexeric.
Clopidogrel, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Digoxin, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Diltiazem, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Doxycycline, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
Any medicinal product that has the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
Drugs with small therapeutic range, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
For concomitant treatment with products with a narrow therapeutic window, the clinical effect/adverse events should be monitored on initiation or dose adjustment of Fexeric or the concomitant product.
Erythropoiesis-stimulating agent, ferric citrate coordination complex [2] ---> SmPC of [2] of EMA
Reductions in intravenous iron and erythropoiesis-stimulating agent (ESA) use with this medicine have been observed. Therefore, patients may need reduction in, or discontinuation of, intravenous iron and/or ESAs.
Ferric citrate coordination complex [1], ferrotherapy ---> SmPC of [1] of EMA
Treatment with Fexeric may lead to elevations in iron stores, particularly in patients receiving concomitant intravenous iron therapy.
Ferric citrate coordination complex [1], glimepiride ---> SmPC of [1] of EMA
Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Ferric citrate coordination complex [1], iron ---> SmPC of [1] of EMA
Patients treated with Fexeric should not receive concomitant treatment with other oral iron preparations.
Ferric citrate coordination complex [1], levodopa ---> SmPC of [1] of EMA
Any medicinal product that has the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
Ferric citrate coordination complex [1], levothyroxine ---> SmPC of [1] of EMA
Since iron-based preparations are known to reduce the absorption of levothyroxine (thyroxine), physicians should consider monitoring suitable markers or clinical signs of efficacy if these medicinal products are concomitantly administered with Fexeric.
Ferric citrate coordination complex [1], losartan ---> SmPC of [1] of EMA
Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Ferric citrate coordination complex [1], methotrexate ---> SmPC of [1] of EMA
Any medicinal product that has the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
Ferric citrate coordination complex [1], pregnancy ---> SmPC of [1] of EMA
Fexeric is not recommended during pregnancy and in women of childbearing potential not using contraceptive methods.
Ferric citrate coordination complex [1], sertraline ---> SmPC of [1] of EMA
Any medicinal product that has the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
Ferric citrate coordination complex [1], sodium valproate ---> SmPC of [1] of EMA
Any medicinal product that has the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
CONTRAINDICATIONS of Ferric citrate coordination complex
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Hypophosphataemia
- Active severe gastrointestinal disorders (e.g. gastrointestinal bleeding)
- Haemochromatosis or laboratory tests indicating possible haemochromatosis
- Other iron overload (primary or secondary) syndromes
https://www.ema.europa.eu/en/documents/product-information/fexeric-epar-product-information_en.pdf. 09/10/2019
Ferric maltol (Feraccru)
Antibiotics, ferric maltol [2] ---> SmPC of [2] of EMA
Absorption of both iron and antibiotic may be reduced if oral iron is given with tetracycline. Administration of iron preparations and tetracyclines should be separated by 2 to 3 hours.
Biphosphonates, ferric maltol [2] ---> SmPC of [2] of EMA
Oral iron is known to reduce the absorption of biphosphonates. This medicinal product should be given at least 2 hours apart from Feraccru.
Breast-feeding, ferric maltol [2] ---> SmPC of [2] of EMA
Feraccru can be used during breast feeding if clinically needed.
Calcium, ferric maltol [2] ---> SmPC of [2] of EMA
Absorption of oral iron may be reduced by calcium and magnesium salts (such as magnesium trisilicate). Administration of iron preparations with such compounds should be separated by at least 2 hours.
Chloramphenicol, ferric maltol [2] ---> SmPC of [2] of EMA
Concomitant use of chloramphenicol with iron should be avoided as chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Chloramphenicol, iron ---> SmPC of [ferric maltol] of EMA
Concomitant use of chloramphenicol with iron should be avoided as chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Dimercaprol, ferric maltol [2] ---> SmPC of [2] of EMA
Concomitant use of iron with dimercaprol should be avoided as the combination of dimercaprol and iron is nephrotoxic.
Entacapone, ferric maltol [2] ---> SmPC of [2] of EMA
Oral iron is known to reduce the absorption of entacapone. This medicinal product should be given at least 2 hours apart from Feraccru.
Ferric maltol [1], fertility ---> SmPC of [1] of EMA
No effects on fertility are anticipated since systemic exposure to ferric maltol is negligible.
Ferric maltol [1], foods ---> SmPC of [1] of EMA
Feraccru capsules should be taken whole on an empty stomach (with half a glass of water), as the absorption of iron is reduced when Feraccru is taken with food
Ferric maltol [1], intravenous iron ---> SmPC of [1] of EMA
Concomitant administration of Feraccru and intravenous iron may induce hypotension or even collapse due to the fast release of iron resulting from saturation of transferrin caused by intravenous iron.
Ferric maltol [1], levodopa ---> SmPC of [1] of EMA
Oral iron is known to reduce the absorption of levodopa. This medicinal product should be given at least 2 hours apart from Feraccru.
Ferric maltol [1], levofloxacin ---> SmPC of [1] of EMA
Oral iron is known to reduce the absorption of levofloxacin. This medicinal product should be given at least 2 hours apart from Feraccru.
Ferric maltol [1], levothyroxine ---> SmPC of [1] of EMA
Oral iron is known to reduce the absorption of levothyroxine (thyroxine). This medicinal product should be given at least 2 hours apart from Feraccru.
Ferric maltol [1], magnesium salts ---> SmPC of [1] of EMA
Absorption of oral iron may be reduced by calcium and magnesium salts (such as magnesium trisilicate). Administration of iron preparations with such compounds should be separated by at least 2 hours.
Ferric maltol [1], methyldopa ---> SmPC of [1] of EMA
Concomitant use of iron with methyldopa should be avoided as oral iron may antagonise the hypotensive effect of methyldopa.
Ferric maltol [1], moxifloxacin ---> SmPC of [1] of EMA
Oral iron is known to reduce the absorption of moxifloxacine. This medicinal product should be given at least 2 hours apart from Feraccru.
Ferric maltol [1], mycophenolate ---> SmPC of [1] of EMA
Oral iron is known to reduce the absorption of mycophenolate. This medicinal product should be given at least 2 hours apart from Feraccru.
Ferric maltol [1], norfloxacin ---> SmPC of [1] of EMA
Oral iron is known to reduce the absorption of norfloxacin. This medicinal product should be given at least 2 hours apart from Feraccru.
Ferric maltol [1], ofloxacin ---> SmPC of [1] of EMA
Oral iron is known to reduce the absorption of ofloxacin. This medicinal product should be given at least 2 hours apart from Feraccru.
Ferric maltol [1], penicillamine ---> SmPC of [1] of EMA
Oral iron is known to reduce the absorption of penicillamine. This medicinal product should be given at least 2 hours apart from Feraccru.
Ferric maltol [1], pregnancy ---> SmPC of [1] of EMA
Feraccru may be considered during pregnancy if necessary.
Ferric maltol [1], tetracyclines ---> SmPC of [1] of EMA
Absorption of both iron and antibiotic may be reduced if oral iron is given with tetracycline. Administration of iron preparations and tetracyclines should be separated by 2 to 3 hours.
Iron, methyldopa ---> SmPC of [ferric maltol] of EMA
Concomitant use of iron with methyldopa should be avoided as oral iron may antagonise the hypotensive effect of methyldopa.
CONTRAINDICATIONS of Ferric maltol (Feraccru)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Haemochromatosis and other iron overload syndromes.
- Patients receiving repeated blood transfusions.
https://www.ema.europa.eu/en/documents/product-information/feraccru-epar-product-information_en.pdf. 18/12/2023
Ferumoxytol (Rienso)
Ability to drive, ferumoxytol [2] ---> SmPC of [2] of EMA
In the case of symptoms of dizziness, confusion or light headedness following the administration of Rienso, patients should not drive or use machinery until the symptoms have ceased.
Breast-feeding, ferumoxytol [2] ---> SmPC of [2] of EMA
A decision must 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 the therapy for the mother.
Fertility, ferumoxytol [2] ---> SmPC of [2] of EMA
In a prenatal and postnatal developmental study in rats adverse effects on sexual maturation and on the ability to produce a litter were noted in the F1-generation (see section 5.3).
Ferumoxytol [1], iron ---> SmPC of [1] of EMA
As with all parenteral iron preparations the absorption of oral iron is reduced when administered concomitantly.
Ferumoxytol [1], pregnancy ---> SmPC of [1] of EMA
A careful risk/benefit evaluation is therefore required before use during pregnancy and Rienso should not be used during pregnancy unless clearly necessary
Ferumoxytol [1], second and third trimesters of pregnancy ---> SmPC of [1] of EMA
Treatment with Rienso should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Ferumoxytol [1], women of childbearing potential ---> SmPC of [1] of EMA
Rienso is not recommended in women of childbearing potential not using adequate contraception.
CONTRAINDICATIONS of Ferumoxytol (Rienso)
The use of Rienso is contraindicated in cases of:
- Hypersensitivity to the active substance, to Rienso or any of its excipients listed in section 6.1.
- Patients with any known history of drug allergy including hypersensitivity to other parenteral iron products
- Evidence of iron overload
- Anaemia not caused by iron deficiency
https://www.ema.europa.eu/en/documents/product-information/rienso-epar-product-information_en.pdf 13/07/2015 (withdrawn)
Fesoterodine (Toviaz)
Ability to drive, fesoterodine [2] ---> SmPC of [2] of EMA
TOVIAZ has minor influence on the ability to drive and use machines. Caution should be exercised when driving or using machines due to possible occurrence of side effects such as blurred vision, dizziness, and somnolence
Anticholinergics, fesoterodine [2] ---> SmPC 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
Antimuscarinic agents, fesoterodine [2] ---> SmPC 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
Aprepitant, fesoterodine
The CYP3A4 inhibition may increase the plasma concentrations of fesoterodine
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
Breast-feeding, fesoterodine [2] ---> SmPC of [2] of EMA
Breast-feeding is not recommended during treatment with TOVIAZ.
Carbamazepine, fesoterodine [2] ---> SmPC of [2] of EMA
Induction of CYP3A4 may lead to subtherapeutic plasma levels. Concomitant use (of fesoterodine) with CYP3A4 inducers is not recommended
Cimetidine, fesoterodine [2] ---> SmPC of [2] of EMA
The effect of weak CYP3A4 inhibitors (e.g. cimetidine) on fesoterodine, was not examined; it is not expected to be in excess of the effect of moderate inhibitor.
Clarithromycin, 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
Clozapine, fesoterodine
Caution should be exercised. The combination may lead to more pronounced therapeutic and side effects
CYP3A4 inductors, fesoterodine [2] ---> SmPC of [2] of EMA
Induction of CYP3A4 may lead to subtherapeutic plasma levels. Concomitant use (of fesoterodine) with CYP3A4 inducers is not recommended
CYP3A4 inhibitors, fesoterodine [2] ---> SmPC of [2] of EMA
The effect of weak CYP3A4 inhibitors (e.g. cimetidine) on fesoterodine, was not examined; it is not expected to be in excess of the effect of moderate inhibitor.
Diltiazem, fesoterodine [2] ---> SmPC of [2] of EMA
Caution should be exercised when prescribing fesoterodine to patients in whom an increased exposure to the active metabolite is expected, e. g. coadministration of moderate CYP3A4 inhibitors. No dosing adjustments are recommended
Drugs inducing bradycardia, fesoterodine [2] ---> SmPC of [2] of EMA
TOVIAZ should be used with caution in patients with risk for QT prolongation (e.g. hypokalaemia, bradycardia and concomitant administration of medicines known to prolong QT interval) and relevant pre-existing cardiac diseases
Erythromycin, fesoterodine [2] ---> SmPC of [2] of EMA
Caution should be exercised when prescribing fesoterodine to patients in whom an increased exposure to the active metabolite is expected, e. g. coadministration of moderate CYP3A4 inhibitors. No dosing adjustments are recommended
Ethinyl estradiol, fesoterodine [2] ---> SmPC of [2] of EMA
In the presence of fesoterodine there are no changes in the plasma concentrations of combined oral contraceptives containing ethinylestradiol and levonorgestrel.
Fertility, fesoterodine [2] ---> SmPC of [2] of EMA
Findings in mice at exposures approximately 5 to 19 times those at the MRHD show an effect on female fertility, however, the clinical implications of these animal findings are not known (see section 5.3).
Fesoterodine [1], fluconazole ---> SmPC of [1] of EMA
Caution should be exercised when prescribing fesoterodine to patients in whom an increased exposure to the active metabolite is expected, e. g. coadministration of moderate CYP3A4 inhibitors. No dosing adjustments are recommended
Fesoterodine [1], grapefruit juice ---> SmPC of [1] of EMA
Caution should be exercised when prescribing fesoterodine to patients in whom an increased exposure to the active metabolite is expected, e. g. coadministration of moderate CYP3A4 inhibitors. No dosing adjustments are recommended
Fesoterodine [1], hypokalemia ---> SmPC of [1] of EMA
TOVIAZ should be used with caution in patients with risk for QT prolongation (e.g. hypokalaemia, bradycardia and concomitant administration of medicines known to prolong QT interval) and relevant pre-existing cardiac diseases
Fesoterodine [1], indinavir ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], itraconazol ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], ketoconazole ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], levonorgestrel ---> SmPC of [1] of EMA
In the presence of fesoterodine there are no changes in the plasma concentrations of combined oral contraceptives containing ethinylestradiol and levonorgestrel.
Fesoterodine [1], metoclopramide ---> SmPC of [1] of EMA
Fesoterodine may reduce the effect of medicinal products that stimulate the motility of the gastro-intestinal tract
Fesoterodine [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
Caution should be exercised when prescribing fesoterodine to patients in whom an increased exposure to the active metabolite is expected, e. g. coadministration of moderate CYP3A4 inhibitors. No dosing adjustments are recommended
Fesoterodine [1], nefazodone ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], nelfinavir ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], oral contraceptives ---> SmPC of [1] of EMA
Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception. In the presence of fesoterodine there are no changes in the plasma concentrations of combined oral contraceptives containing ethinylestradiol and levonorgestrel.
Fesoterodine [1], pharmacokinetics ---> SmPC of [1] of EMA
In vitro data demonstrate that the active metabolite of fesoterodine does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, or induce CYP1A2, 2B6, 2C9, 2C19, or 3A4 at clinically relevant plasma concentrations.
Fesoterodine [1], phenobarbital ---> SmPC of [1] of EMA
Induction of CYP3A4 may lead to subtherapeutic plasma levels. Concomitant use (of fesoterodine) with CYP3A4 inducers is not recommended
Fesoterodine [1], phenytoin ---> SmPC of [1] of EMA
Induction of CYP3A4 may lead to subtherapeutic plasma levels. Concomitant use (of fesoterodine) with CYP3A4 inducers is not recommended
Fesoterodine [1], pregnancy ---> SmPC of [1] of EMA
TOVIAZ is not recommended during pregnancy.
Fesoterodine [1], prokinetics ---> SmPC of [1] of EMA
Fesoterodine may reduce the effect of medicinal products that stimulate the motility of the gastro-intestinal tract
Fesoterodine [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
TOVIAZ should be used with caution in patients with risk for QT prolongation (e.g. hypokalaemia, bradycardia and concomitant administration of medicines known to prolong QT interval) and relevant pre-existing cardiac diseases
Fesoterodine [1], rifampicin ---> SmPC of [1] of EMA
Induction of CYP3A4 may lead to subtherapeutic plasma levels. Concomitant use (of fesoterodine) with CYP3A4 inducers is not recommended
Fesoterodine [1], ritonavir ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], ritonavir-boosted protease inhibitors ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], saquinavir ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], St. John's wort ---> SmPC of [1] of EMA
Induction of CYP3A4 may lead to subtherapeutic plasma levels. Concomitant use (of fesoterodine) with CYP3A4 inducers is not recommended
Fesoterodine [1], strong CYP2D6 inhibitors ---> SmPC of [1] of EMA
Co-administration of fesoterodine and a potent CYP2D6 inhibitor may result in increased exposure and adverse events. A dose reduction to 4 mg may be needed
Fesoterodine [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Induction of CYP3A4 may lead to subtherapeutic plasma levels. Concomitant use (of fesoterodine) with CYP3A4 inducers is not recommended
Fesoterodine [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], telithromycin ---> SmPC of [1] of EMA
The maximum dose of fesoterodine should be restricted to 4 mg when used concomitantly with potent CYP3A4 inhibitors
Fesoterodine [1], tricyclic antidepressant ---> SmPC of [1] 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
Fesoterodine [1], verapamil ---> SmPC of [1] of EMA
Caution should be exercised when prescribing fesoterodine to patients in whom an increased exposure to the active metabolite is expected, e. g. coadministration of moderate CYP3A4 inhibitors. No dosing adjustments are recommended
Fesoterodine [1], warfarin ---> SmPC of [1] of EMA
A clinical study in healthy volunteers has shown that fesoterodine 8 mg once daily has no significant effect on the pharmacokinetics or the anticoagulant activity of a single dose of warfarin.
Fesoterodine [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of child bearing potential should be made aware of the lack of human fertility data, and TOVIAZ should only be given after consideration of individual risks and benefits.
Fesoterodine, olanzapine
Caution should be exercised. The combination may lead to more pronounced therapeutic and side effects
CONTRAINDICATIONS of Fesoterodine (Toviaz)
- Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1.
- Urinary retention
- Gastric retention
- Uncontrolled narrow angle glaucoma
- Myasthenia gravis
- Severe hepatic impairment (Child Pugh C)
- Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
- Severe ulcerative colitis
- Toxic megacolon.
https://www.ema.europa.eu/en/documents/product-information/toviaz-epar-product-information_en.pdf. 08/12/2023
Fexofenadine
Ability to drive, fexofenadine [2] ---> SmPC of [2] of eMC
It is advisable to check the individual response before driving or performing complicated tasks.
Aluminium hydroxide, fexofenadine [2] ---> SmPC of [2] of eMC
Decreased bioavailability of fexofenadine. Separate administration by at least 2 hours
Breast-feeding, fexofenadine [2] ---> SmPC of [2] of eMC
Fexofenadine hydrochloride is not recommended for mothers breast-feeding their babies.
Cabozantinib [1], fexofenadine ---> SmPC of [1] 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.
Dasabuvir with ombitasvir/paritaprevir/ritonavir, fexofenadine ---> SmPC of [ombitasvir/paritaprevir/ritonavir] of
Co-administration of ombitasvir/paritaprevir/ritonavir with or without dasabuvir with medicinal products that are substrates of OATP1B1, OATP1B3, OATP2B1 or OCT1 may increase plasma concentrations of these transporter substrates
Erythromycin, fexofenadine [2] ---> SmPC of [2] of eMC
The co-administration increases the plasma levels of fexofenadine
Fexofenadine [1], ketoconazole ---> SmPC of [1] of eMC
The co-administration increases the plasma levels of fexofenadine
Fexofenadine [1], magnesium hydroxide ---> SmPC of [1] of eMC
Decreased bioavailability of fexofenadine. Separate administration by at least 2 hours
Fexofenadine [1], pregnancy ---> SmPC of [1] of eMC
Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.
Fexofenadine, indinavir/ritonavir ---> SmPC of [indinavir] of EMA
Ritonavir, P-glycoprotein inhibitor, may increase the plasma levels of fexofenadine. Careful monitoring is recommended
Fexofenadine, lomitapide [2] ---> SmPC of [2] of EMA
Lomitapide, P-glycoprotein inhibitor, may increase the absorption of the P-glycoprotein substrate
Fexofenadine, lumacaftor/ivacaftor [2] ---> SmPC of [2] of EMA
Due to potential induction or inhibition of P-gp. Dose adjustment of fexofenadine may be required to obtain the desired clinical effect. Lumacaftor/ivacaftor may alter the exposure of fexofenadine.
Fexofenadine, neratinib [2] ---> SmPC of [2] of EMA
This pre-systemic interaction of neratinib with digoxin might be clinically relevant for P-gp substrates with a narrow therapeutic window (e.g. dabigatran, digoxin, and fexofenadine).
Fexofenadine, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC of [2] of EMA
Co-administration of ombitasvir/paritaprevir/ritonavir with or without dasabuvir with medicinal products that are substrates of OATP1B1, OATP1B3, OATP2B1 or OCT1 may increase plasma concentrations of these transporter substrates
Fexofenadine, rifampicin
Rifampicin, enzymatic inductor, may increase the metabolism of fexofenadine and decrease its plasma levels and effect
Fexofenadine, ritonavir [2] ---> SmPC of [2] of EMA
Ritonavir, P-glycoprotein inhibitor, may increase the plasma levels of fexofenadine.
Fexofenadine, ulipristal [2] ---> SmPC of [2] of EMA
In vitro data indicate that ulipristal may be an inhibitor of P-gp in the gastrointestinal wall during absorption. It is recommended that co-administration of ulipristal acetate and P-gp substrates should be separated in time by at least 1.5 hours.
Fexofenadine, 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 Fexofenadine
Hypersensitivity to the active substance or to any of the excipients
http://www.medicines.org.uk/emc/
Fezolinetant (Veoza)
Breast-feeding, fezolinetant [2] ---> SmPC of [2] of EMA
Veoza is not indicated during lactation. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Veoza therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Contraceptives, fezolinetant [2] ---> SmPC of [2] of EMA
Concomitant use of moderate or strong CYP1A2 inhibitors with Veoza is contraindicated (see section 4.3).
CYP1A2 inhibitors, fezolinetant [2] ---> SmPC of [2] of EMA
The increase in fezolinetant exposure was however not predicted to be clinically relevant following concomitant use with weak CYP1A2 inhibitors.
Ethinyl estradiol, fezolinetant [2] ---> SmPC of [2] of EMA
Concomitant use of fezolinetant with medicinal products that are moderate or strong inhibitors of CYP1A2 (e.g., ethinyl oestradiol containing contraceptives, mexiletine, enoxacin, fluvoxamine) increase the plasma Cmax and AUC of fezolinetant.
Fertility, fezolinetant [2] ---> SmPC of [2] of EMA
There are no data on the effect of fezolinetant on human fertility. In the fertility study in female rats, fezolinetant did not affect fertility (see section 5.3).
Fezolinetant [1], fluvoxamine ---> SmPC of [1] of EMA
Co-administration with fluvoxamine, a strong CYP1A2 inhibitor, resulted in an overall 1.8-fold increase in fezolinetant Cmax and 9.4-fold increase in AUC; no change in tmax was observed.
Fezolinetant [1], mexiletine ---> SmPC of [1] of EMA
Concomitant use of fezolinetant with medicinal products that are moderate or strong inhibitors of CYP1A2 (e.g., ethinyl oestradiol containing contraceptives, mexiletine, enoxacin, fluvoxamine) increase the plasma Cmax and AUC of fezolinetant.
Fezolinetant [1], moderate CYP1A2 inhibitors ---> SmPC of [1] of EMA
Concomitant use of moderate or strong CYP1A2 inhibitors with Veoza is contraindicated (see section 4.3).
Fezolinetant [1], pregnancy ---> SmPC of [1] of EMA
Veoza is contraindicated during pregnancy (see section 4.3). If pregnancy occurs during use with Veoza, treatment should be withdrawn immediately.
Fezolinetant [1], strong CYP1A2 inhibitors ---> SmPC of [1] of EMA
Concomitant use of fezolinetant with medicinal products that are moderate or strong inhibitors of CYP1A2 (e.g., ethinyl oestradiol containing contraceptives, mexiletine, enoxacin, fluvoxamine) increase the plasma Cmax and AUC of fezolinetant.
Fezolinetant [1], tobacco ---> SmPC of [1] of EMA
Smoking (moderate inducer of CYP1A2) decreased fezolinetant Cmax to a geometric LS mean ratio of 71.74%, while AUC decreased to a geometric LS mean ratio of 48.29%.
Fezolinetant [1], women of childbearing potential ---> SmPC of [1] of EMA
Perimenopausal women of childbearing potential should use effective contraception. Non-hormonal contraceptives are recommended for this population.
CONTRAINDICATIONS of Fezolinetant (Veoza)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Concomitant use of moderate or strong CYP1A2 inhibitors (see section 4.5).
- Known or suspected pregnancy (see section 4.6).
https://www.ema.europa.eu/en/documents/product-information/veoza-epar-product-information_en.pdf 21/03/2025
Human fibrinogen/human thrombin (Evarrest)
Alcohol, human fibrinogen/human thrombin [2] ---> SmPC of [2] of EMA
Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing alcohol
Alcohol, thrombin ---> SmPC of [human fibrinogen/human thrombin] of EMA
Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing alcohol
Breast-feeding, human fibrinogen/human thrombin [2] ---> SmPC of [2] of EMA
This medicinal product should be administered to breast-feeding women only if clinically indicated.
Human fibrinogen/human thrombin [1], iodine ---> SmPC of [1] of EMA
Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing iodine
Human fibrinogen/human thrombin [1], pregnancy ---> SmPC of [1] of EMA
This medicinal product should be administered to pregnant women only if clinically indicated.
Human fibrinogen/human thrombin [1], solutions containing heavy metals ---> SmPC of [1] of EMA
Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing heavy metals
Iodine, thrombin ---> SmPC of [human fibrinogen/human thrombin] of EMA
Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing iodine
Solutions containing heavy metals, thrombin ---> SmPC of [human fibrinogen/human thrombin] of EMA
Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing heavy metals
CONTRAINDICATIONS of Human fibrinogen/human thrombin (Evarrest)
- EVARREST must not be applied intravascularly.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- EVARREST must not be used to treat severe bleeding from large defects in large arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST to blood flow and/or pressure during healing and absorption of the product.
- EVARREST must not be used in closed spaces (e.g., in, around, or in proximity to foramina in bone or areas of bony confine) since swelling may cause nerve or blood vessel compression.
- EVARREST must not be used in the presence of active infection or in contaminated areas of the body because infection may occur.
https://www.ema.europa.eu/en/documents/product-information/evarrest-epar-product-information_en.pdf 03/04/2018
Other trade names: Evicel, Raplixa, TachoSil, VeraSeal,
Fibrinogen
Breast-feeding, fibrinogen
A decision must be made to either discontinue breast-feeding or to discontinue/abstain from therapy
Fibrinogen, pregnancy
Strict indication
Fidanacogene elaparvovec (Beqvez (previously Durveqtix))
Ability to drive, fidanacogene elaparvovec [2] ---> SmPC of [2] of EMA
Patients should be advised to use caution when driving and operating machinery until they are certain that this medicinal product does not adversely affect them (see section 4.8).
Breast-feeding, fidanacogene elaparvovec [2] ---> SmPC of [2] of EMA
It is unknown whether fidanacogene elaparvovec is excreted in human milk. A risk to the newborns/infants cannot be excluded. BEQVEZ should not be used during breast-feeding.
Corticosteroids, fidanacogene elaparvovec [2] ---> SmPC of [2] of EMA
Medicinal products that may reduce or increase the plasma concentration of corticosteroids (e.g., medicinal products that induce or inhibit cytochrome P450 3A4) can decrease the efficacy of the corticosteroid regimen or increase their side effects
Fertility, fidanacogene elaparvovec [2] ---> SmPC of [2] of EMA
No information is available on the effects of fidanacogene elaparvovec on female or male fertility (see section 5.3).
Fidanacogene elaparvovec [1], hepatotoxic drugs ---> SmPC of [1] of EMA
The efficacy of fidanacogene elaparvovec may be reduced, and the risk of serious hepatic reactions may increase following fidanacogene elaparvovec administration.
Fidanacogene elaparvovec [1], medicinal products ---> SmPC of [1] of EMA
When a new medication is started, close monitoring of ALT and factor IX activity levels (e.g., weekly to every 2 weeks for the first month) is recommended to assess potential effects on both levels.
Fidanacogene elaparvovec [1], men ---> SmPC of [1] of EMA
Males treated with fidanacogene elaparvovec must not donate semen to minimise the potential risk of paternal germline transmission (see section 4.4).
Fidanacogene elaparvovec [1], pregnancy ---> SmPC of [1] of EMA
For 6 months after administration of fidanacogene elaparvovec, treated patients of reproductive potential and their female partners of childbearing potential must prevent or postpone pregnancy using barrier contraception
Fidanacogene elaparvovec [1], pregnancy ---> SmPC of [1] of EMA
Experience regarding the use of this medicinal product during pregnancy is not available. Animal reproduction studies have not been conducted. Fidanacogene elaparvovec is not recommended during pregnancy.
Fidanacogene elaparvovec [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA
Live vaccines should not be administered to patients while on immunomodulatory therapy.
Fidanacogene elaparvovec [1], women of childbearing potential ---> SmPC of [1] of EMA
Moreover, no data are available to recommend a specific duration of contraceptive measures in women of childbearing potential. Therefore, BEQVEZ is not recommended in women of childbearing potential.
CONTRAINDICATIONS of Fidanacogene elaparvovec (Beqvez (previously Durveqtix))
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Active infections, either acute or uncontrolled chronic (see section 4.4).
- Advanced hepatic fibrosis or advanced hepatic cirrhosis (see section 4.4).
https://www.ema.europa.eu/en/documents/product-information/beqvez-epar-product-information_en.pdf 23/10/2024
Fidaxomicin (Dificlir)
Amiodarone, fidaxomicin [2] ---> SmPC 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.
Breast-feeding, fidaxomicin [2] ---> SmPC of [2] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from fidaxomicin therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Clarithromycin, fidaxomicin [2] ---> SmPC 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.
Cyclosporine, fidaxomicin [2] ---> SmPC 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.
Dabigatran etexilate, fidaxomicin [2] ---> SmPC of [2] of EMA
A larger effect on P-gp substrates with lower bioavailability more sensitive to intestinal P-gp inhibition such as dabigatran etexilate cannot be excluded.
Digoxin, fidaxomicin [2] ---> SmPC of [2] of EMA
Fidaxomicin had a small but not clinically relevant effect on digoxin exposure.
Dronedarone, fidaxomicin [2] ---> SmPC 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.
Erythromycin, fidaxomicin [2] ---> SmPC 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.
Fertility, fidaxomicin [2] ---> SmPC of [2] of EMA
Fidaxomicin had no effects on fertility when evaluated in rats (see section 5.3).
Fidaxomicin [1], inhibitors of intestinal P-gp ---> SmPC of [1] of EMA
The inhibition of intestinal P-glycoprotein may increase the exposure to fidaxomicin
Fidaxomicin [1], ketoconazole ---> SmPC of [1] 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.
Fidaxomicin [1], P-gp inhibitors ---> SmPC of [1] of EMA
The inhibition of P-glycoprotein may lead to increased exposure to fidaxomicin
Fidaxomicin [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure, it is preferable to avoid the use of fidaxomicin during pregnancy.
Fidaxomicin [1], quinidine ---> SmPC of [1] 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.
Fidaxomicin [1], rosuvastatin ---> SmPC of [1] of EMA
Fidaxomicin does not have a clinically significant effect on the exposure of rosuvastatin, a substrate for the transporters OATP2B1 and BCRP.
Fidaxomicin [1], strong P-gp inhibitors ---> SmPC of [1] 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.
Fidaxomicin [1], verapamil ---> SmPC of [1] 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.
Fidaxomicin, rilpivirine
The inhibition of intestinal P-glycoprotein may increase the exposure to fidaxomicin
CONTRAINDICATIONS of Fidaxomicin (Dificlir)
- 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/dificlir-epar-product-information_en.pdf 30/09/2024
Filgotinib (Jyseleca)
Ability to drive, filgotinib [2] ---> SmPC of [2] of EMA
Filgotinib has minor influence on the ability to drive and use machines. Patients should be advised that dizziness and vertigo has been reported during treatment with Jyseleca (see section 4.8).
Breast-feeding, filgotinib [2] ---> SmPC of [2] of EMA
It is unknown whether filgotinib is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. Therefore, Jyseleca should not be used during breast-feeding.
Carvedilol, filgotinib [2] ---> SmPC of [2] of EMA
Filgotinib is primarily metabolised by carboxylesterase 2 (CES2), which can be inhibited in vitro by medicinal products such as fenofibrate, carvedilol, diltiazem or simvastatin. The clinical relevance of this interaction is unknown.
Cyclosporine, filgotinib [2] ---> SmPC of [2] of EMA
Combination of filgotinib with other potent immunosuppressants such as ciclosporin, tacrolimus, biologics or other Janus kinase (JAK) inhibitors is not recommended as a risk of additive immunosuppression cannot be excluded.
CYP1A2 substrates with narrow therapeutic index, filgotinib [2] ---> SmPC of [2] of EMA
Caution is recommended when filgotinib is co-administered with CYP1A2 substrates with a narrow therapeutic index.
CYP2B6 inductors, filgotinib [2] ---> SmPC of [2] of EMA
In vitro studies are inconclusive regarding the potential of filgotinib to induce CYP2B6. In vivo induction cannot be excluded.
Cytochrome P450, filgotinib [2] ---> SmPC of [2] of EMA
Filgotinib is not a clinically relevant inhibitor or inducer of most enzymes or transporters commonly involved in interactions such as cytochrome P450 (CYP) enzymes and UDP-glucuronosyltransferases (UGT).
Deep venous thrombosis, filgotinib [2] ---> SmPC of [2] of EMA
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including filgotinib.
Diltiazem, filgotinib [2] ---> SmPC of [2] of EMA
Filgotinib is primarily metabolised by carboxylesterase 2 (CES2), which can be inhibited in vitro by medicinal products such as fenofibrate, carvedilol, diltiazem or simvastatin. The clinical relevance of this interaction is unknown.
Fenofibrate, filgotinib [2] ---> SmPC of [2] of EMA
Filgotinib is primarily metabolised by carboxylesterase 2 (CES2), which can be inhibited in vitro by medicinal products such as fenofibrate, carvedilol, diltiazem or simvastatin. The clinical relevance of this interaction is unknown.
Fertility, filgotinib [2] ---> SmPC of [2] of EMA
Overall, these clinical data were not suggestive of filgotinib-related effects on testicular function. Animal studies did not indicate effects with respect to fertility in females.
Filgotinib [1], haematology ---> SmPC of [1] of EMA
Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 × 109 cells/L, ALC < 0.5 × 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management (see section 4.2).
Filgotinib [1], immunosuppressives ---> SmPC of [1] of EMA
Combination of filgotinib with other potent immunosuppressants such as ciclosporin, tacrolimus, biologics or other Janus kinase (JAK) inhibitors is not recommended as a risk of additive immunosuppression cannot be excluded.
Filgotinib [1], infection ---> SmPC of [1] of EMA
Infections, including serious infections, have been reported in patients receiving filgotinib.
Filgotinib [1], lipids ---> SmPC of [1] of EMA
Treatment with filgotinib was associated with dose-dependent increases in lipid parameters, including total cholesterol, and high-density lipoprotein (HDL) levels, while low-density lipoprotein (LDL) levels were slightly increased
Filgotinib [1], major adverse cardiovascular events ---> SmPC of [1] of EMA
Events of MACE have been observed in patients taking filgotinib.
Filgotinib [1], neoplasia ---> SmPC of [1] of EMA
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including filgotinib.
Filgotinib [1], non-melanoma skin cancer ---> SmPC of [1] of EMA
NMSCs have been reported in patients treated with filgotinib. Periodic skin examination is recommended for all patients, particularly those who are at increased risk for skin cancer.
Filgotinib [1], oral contraceptives ---> SmPC of [1] of EMA
In a clinical pharmacology study, there was no effect on the pharmacokinetics of the combined contraceptive ethinyl estradiol and levonorgestrel when co-administered with filgotinib; thus no dose adjustment of oral contraceptives is required.
Filgotinib [1], pregnancy ---> SmPC of [1] of EMA
Based on findings in animals, filgotinib may cause foetal harm and is therefore contraindicated during pregnancy
Filgotinib [1], simvastatine ---> SmPC of [1] of EMA
Filgotinib is primarily metabolised by carboxylesterase 2 (CES2), which can be inhibited in vitro by medicinal products such as fenofibrate, carvedilol, diltiazem or simvastatin. The clinical relevance of this interaction is unknown.
Filgotinib [1], statins ---> SmPC of [1] of EMA
LDL cholesterol returned to pre-treatment levels in the majority of patients who started statin therapy while taking filgotinib.
Filgotinib [1], tacrolimus ---> SmPC of [1] of EMA
Combination of filgotinib with other potent immunosuppressants such as ciclosporin, tacrolimus, biologics or other Janus kinase (JAK) inhibitors is not recommended as a risk of additive immunosuppression cannot be excluded.
Filgotinib [1], tuberculosis ---> SmPC of [1] of EMA
Patients should be screened for TB before initiating filgotinib. Filgotinib should not be administered to patients with active TB (see section 4.3).
Filgotinib [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA
Use of live vaccines during, or immediately prior to, filgotinib treatment is not recommended. It is recommended that immunisations be updated in agreement with current immunisation guidelines prior to initiating filgotinib treatment
Filgotinib [1], viral reactivation ---> SmPC of [1] of EMA
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies (see section 4.8).
Filgotinib [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential have to use effective contraception during and for at least 1 week after cessation of filgotinib treatment.
CONTRAINDICATIONS of Filgotinib (Jyseleca)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Active tuberculosis (TB) or active serious infections (see section 4.4).
- Pregnancy (see section 4.6).
https://www.ema.europa.eu/en/documents/product-information/jyseleca-epar-product-information_en.pdf 10/06/2025
Filgrastim (Grastofil)
Ability to drive, filgrastim [2] ---> SmPC of [2] of EMA
Grastofil has minor or moderate influence on the ability to drive and use machines. Caution is advised when driving a car or operating machinery.
Breast-feeding, filgrastim [2] ---> SmPC of [2] of EMA
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from filgrastim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Cytotoxic chemotherapy, filgrastim [2] ---> SmPC of [2] of EMA
In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, the use of filgrastim is not recommended in the period from 24 hours before to 24 hours after chemotherapy.
Fertility, filgrastim [2] ---> SmPC of [2] of EMA
Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Filgrastim [1], fluorouracil ---> SmPC of [1] of EMA
Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-Fluorouracil indicates that the severity of neutropenia may be exacerbated.
Filgrastim [1], lithium ---> SmPC of [1] of EMA
Since lithium promotes the release of neutrophils, lithium is likely to potentiate the effect of filgrastim. Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Filgrastim [1], pregnancy ---> SmPC of [1] of EMA
There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated. Filgrastim is not recommended during pregnancy.
CONTRAINDICATIONS of Filgrastim (Grastofil)
- 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/grastofil-epar-product-information_en.pdf 31/08/2023 (withdrawn)
Other trade names: Accofil, Biograstim, Filgrastim Hexal, Filgrastim ratiopharm, Grastofil, Nivestim, Ratiograstim, Tevagrastim, Zarzio,
Finasteride
Bexarotene [1], finasteride ---> SmPC of [1] of EMA
Caution is advised in case of combination of bexarotene with CYP3A4-metabolised cytotoxics
Breast-feeding, finasteride [2] ---> SmPC of [2] of eMC
Finasteride is not indicated for use in women.
CYP3A4 inductors, finasteride [2] ---> SmPC of [2] of eMC
It is probable that inhibitors and inducers of CYP3A4 will affect the plasma concentration of finasteride. However, based on established safety margins, any increase due to concomitant use of such inhibitors is unlikely to be of clinical significance.
CYP3A4 inhibitors, finasteride [2] ---> SmPC of [2] of eMC
It is probable that inhibitors and inducers of CYP3A4 will affect the plasma concentration of finasteride. However, based on established safety margins, any increase due to concomitant use of such inhibitors is unlikely to be of clinical significance.
Finasteride [1], pregnancy ---> SmPC of [1] of eMC
Finasteride is contraindicated for use in women when they are or may potentially be pregnant
Finasteride [1], strong CYP3A4 inductors ---> SmPC of [1] of eMC
It is probable that inhibitors and inducers of CYP3A4 will affect the plasma concentration of finasteride. However, based on established safety margins, any increase due to concomitant use of such inhibitors is unlikely to be of clinical significance.
Finasteride [1], strong CYP3A4 inhibitors ---> SmPC of [1] of eMC
It is probable that inhibitors and inducers of CYP3A4 will affect the plasma concentration of finasteride. However, based on established safety margins, any increase due to concomitant use of such inhibitors is unlikely to be of clinical significance.
Finasteride, tadalafil [2] ---> SmPC of [2] of EMA
In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified.
CONTRAINDICATIONS of Finasteride
Finasteride is not indicated for use in women or children.
Finasteride is contraindicated in the following:
- Hypersensitivity to any component of this product
- Pregnancy - Use in women when they are or may potentially be pregnant (see 4.6 Pregnancy and lactation, Exposure to finasteride - risk to male foetus).
http://www.medicines.org.uk/emc/
Finerenone (Kerendia)
Ability to drive, finerenone [2] ---> SmPC of [2] of EMA
Kerendia has no influence on the ability to drive and use machines.
Amiloride, finerenone [2] ---> SmPC of [2] of EMA
Kerendia should not be used concomitantly with potassium-sparing diuretics and other MRAs (e.g., eplerenone, esaxerenone, spironolactone, canrenone). It is anticipated that these medicinal products increase the risk for hyperkalaemia (see section 4.4)
Antihypertensives, finerenone [2] ---> SmPC of [2] of EMA
The risk for hypotension increases with concomitant use of multiple other antihypertensive medicinal products. In these patients, blood pressure monitoring is recommended.
Breast-feeding, finerenone [2] ---> SmPC of [2] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Kerendia therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman (see section 4.4).
Canrenone, finerenone [2] ---> SmPC of [2] of EMA
Kerendia should not be used concomitantly with potassium-sparing diuretics and other MRAs (e.g., eplerenone, esaxerenone, spironolactone, canrenone). It is anticipated that these medicinal products increase the risk for hyperkalaemia (see section 4.4)
Carbamazepine, finerenone [2] ---> SmPC of [2] of EMA
Kerendia should not be used concomitantly with strong or moderate CYP3A4 inducers. These CYP3A4 inducers are expected to markedly decrease finerenone plasma concentration and result in reduced therapeutic effect (see section 4.4).
Clarithromycin, finerenone [2] ---> SmPC of [2] of EMA
Concomitant use of Kerendia with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone) is contraindicated (see section 4.3), since a marked increase in finerenone exposure is expected.
Cobicistat, finerenone [2] ---> SmPC of [2] of EMA
Concomitant use of Kerendia with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone) is contraindicated (see section 4.3), since a marked increase in finerenone exposure is expected.
CYP3A4 inhibitors, finerenone [2] ---> SmPC of [2] of EMA
Serum potassium should be monitored during concomitant use of finerenone with moderate or weak CYP3A4 inhibitors
Efavirenz, finerenone [2] ---> SmPC of [2] of EMA
Kerendia should not be used concomitantly with strong or moderate CYP3A4 inducers. These CYP3A4 inducers are expected to markedly decrease finerenone plasma concentration and result in reduced therapeutic effect (see section 4.4).
Eplerenone, finerenone [2] ---> SmPC of [2] of EMA
Kerendia should not be used concomitantly with potassium-sparing diuretics and other MRAs (e.g., eplerenone, esaxerenone, spironolactone, canrenone). It is anticipated that these medicinal products increase the risk for hyperkalaemia (see section 4.4)
Erythromycin, finerenone [2] ---> SmPC of [2] of EMA
In a clinical study, concomitant use of erythromycin (500 mg three times a day) led to a 3.5-fold increase in finerenone AUC and 1.9-fold increase in its Cmax.
Esaxerenone, finerenone [2] ---> SmPC of [2] of EMA
Kerendia should not be used concomitantly with potassium-sparing diuretics and other MRAs (e.g., eplerenone, esaxerenone, spironolactone, canrenone). It is anticipated that these medicinal products increase the risk for hyperkalaemia (see section 4.4)
Fertility, finerenone [2] ---> SmPC of [2] of EMA
There are no data on the effect of finerenone on human fertility. Animal studies have shown impaired female fertility at exposures considered in excess to the maximum human exposure, indicating low clinical relevance
Finerenone [1], fluvoxamine ---> SmPC of [1] of EMA
The physiologically based pharmacokinetic (PBPK) simulations suggest that fluvoxamine (100 mg twice daily), increases finerenone AUC (1.6-fold) and Cmax (1.4-fold).
Finerenone [1], grapefruit ---> SmPC of [1] of EMA
Grapefruit or grapefruit juice should not be consumed during finerenone treatment, as it is expected to increase the plasma concentrations of finerenone through inhibition of CYP3A4 (see sections 4.2 and 4.4).
Finerenone [1], hyperkalemia ---> SmPC of [1] of EMA
Concomitant use of Kerendia with potassium supplements and trimethoprim, or trimethoprim/sulfamethoxazole is anticipated to increase the risk of hyperkalaemia. Monitoring of serum potassium is required.
Finerenone [1], itraconazol ---> SmPC of [1] of EMA
Concomitant use of Kerendia with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone) is contraindicated (see section 4.3), since a marked increase in finerenone exposure is expected.
Finerenone [1], ketoconazole ---> SmPC of [1] of EMA
Concomitant use of Kerendia with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone) is contraindicated (see section 4.3), since a marked increase in finerenone exposure is expected.
Finerenone [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA
Kerendia should not be used concomitantly with strong or moderate CYP3A4 inducers. These CYP3A4 inducers are expected to markedly decrease finerenone plasma concentration and result in reduced therapeutic effect (see section 4.4).
Finerenone [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA
Serum potassium should be monitored during concomitant use of finerenone with moderate or weak CYP3A4 inhibitors
Finerenone [1], nefazodone ---> SmPC of [1] of EMA
Concomitant use of Kerendia with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone) is contraindicated (see section 4.3), since a marked increase in finerenone exposure is expected.
Finerenone [1], nelfinavir ---> SmPC of [1] of EMA
Concomitant use of Kerendia with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone) is contraindicated (see section 4.3), since a marked increase in finerenone exposure is expected.
Finerenone [1], phenobarbital ---> SmPC of [1] of EMA
Kerendia should not be used concomitantly with strong or moderate CYP3A4 inducers. These CYP3A4 inducers are expected to markedly decrease finerenone plasma concentration and result in reduced therapeutic effect (see section 4.4).
Finerenone [1], phenytoin ---> SmPC of [1] of EMA
Kerendia should not be used concomitantly with strong or moderate CYP3A4 inducers. These CYP3A4 inducers are expected to markedly decrease finerenone plasma concentration and result in reduced therapeutic effect (see section 4.4).
Finerenone [1], potassium ---> SmPC of [1] of EMA
Concomitant use of Kerendia with potassium supplements and trimethoprim, or trimethoprim/sulfamethoxazole is anticipated to increase the risk of hyperkalaemia. Monitoring of serum potassium is required.
Finerenone [1], potassium-sparing diuretics ---> SmPC of [1] of EMA
Kerendia should not be used concomitantly with potassium-sparing diuretics and other MRAs (e.g., eplerenone, esaxerenone, spironolactone, canrenone). It is anticipated that these medicinal products increase the risk for hyperkalaemia (see section 4.4)
Finerenone [1], pregnancy ---> SmPC of [1] of EMA
If a woman becomes pregnant while taking finerenone, she should be informed of potential risks to the foetus. Women of childbearing potential should be advised to use effective contraception during treatment with finerenone.
Finerenone [1], pregnancy ---> SmPC of [1] of EMA
Kerendia should not be used during pregnancy unless the clinical condition of the woman requires treatment with finerenone.
Finerenone [1], rifampicin ---> SmPC of [1] of EMA
Kerendia should not be used concomitantly with strong or moderate CYP3A4 inducers. These CYP3A4 inducers are expected to markedly decrease finerenone plasma concentration and result in reduced therapeutic effect (see section 4.4).
Finerenone [1], ritonavir ---> SmPC of [1] of EMA
Concomitant use of Kerendia with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone) is contraindicated (see section 4.3), since a marked increase in finerenone exposure is expected.
Finerenone [1], serum potassium ---> SmPC of [1] of EMA
Serum potassium may increase, and therefore, monitoring of serum potassium is recommended, especially during initiation or changes to dosing of finerenone or the CYP3A4 inhibitor (see sections 4.2 and 4.4).
Finerenone [1], spironolactone ---> SmPC of [1] of EMA
Kerendia should not be used concomitantly with potassium-sparing diuretics and other MRAs (e.g., eplerenone, esaxerenone, spironolactone, canrenone). It is anticipated that these medicinal products increase the risk for hyperkalaemia (see section 4.4)
Finerenone [1], St. John's wort ---> SmPC of [1] of EMA
Kerendia should not be used concomitantly with strong or moderate CYP3A4 inducers. These CYP3A4 inducers are expected to markedly decrease finerenone plasma concentration and result in reduced therapeutic effect (see section 4.4).
Finerenone [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Kerendia should not be used concomitantly with strong or moderate CYP3A4 inducers. These CYP3A4 inducers are expected to markedly decrease finerenone plasma concentration and result in reduced therapeutic effect (see section 4.4).
Finerenone [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant use of Kerendia with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone) is contraindicated (see section 4.3), since a marked increase in finerenone exposure is expected.
Finerenone [1], telithromycin ---> SmPC of [1] of EMA
Concomitant use of Kerendia with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone) is contraindicated (see section 4.3), since a marked increase in finerenone exposure is expected.
Finerenone [1], triamterene ---> SmPC of [1] of EMA
Kerendia should not be used concomitantly with potassium-sparing diuretics and other MRAs (e.g., eplerenone, esaxerenone, spironolactone, canrenone). It is anticipated that these medicinal products increase the risk for hyperkalaemia (see section 4.4)
Finerenone [1], trimethoprim ---> SmPC of [1] of EMA
Concomitant use of Kerendia with potassium supplements and trimethoprim, or trimethoprim/sulfamethoxazole is anticipated to increase the risk of hyperkalaemia. Monitoring of serum potassium is required.
Finerenone [1], trimethoprim/sulfamethoxazol ---> SmPC of [1] of EMA
Concomitant use of Kerendia with potassium supplements and trimethoprim, or trimethoprim/sulfamethoxazole is anticipated to increase the risk of hyperkalaemia. Monitoring of serum potassium is required.
Finerenone [1], verapamil ---> SmPC of [1] of EMA
In another clinical study, verapamil (240 mg controlled-release tablet once daily) led to a 2.7- and 2.2-fold increase in finerenone AUC and Cmax, respectively.
Finerenone [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential should use effective contraception during finerenone treatment (see section 4.4).
Finerenone, grapefruit juice [2] ---> SmPC of [2] of EMA
Grapefruit or grapefruit juice should not be consumed during finerenone treatment, as it is expected to increase the plasma concentrations of finerenone through inhibition of CYP3A4 (see sections 4.2 and 4.4).
Finerenone, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA
Coadministration contraindicated due to potential for serious adverse reactions including hyperkalemia, hypotension and hyponatremia (see section 4.3).
Finerenone, patiromer [2] ---> SmPC of [2] of EMA
In vitro studies have shown no potential interaction of patiromer with the other active substances
Finerenone, sparsentan [2] ---> SmPC of [2] of EMA
Coadministration of sparsentan with mineralocorticoid (aldosterone) receptor inhibitors such as spironolactone and finerenone is expected to be associated with increased risk of hyperkalaemia.
CONTRAINDICATIONS of Finerenone (Kerendia)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Concomitant treatment with strong inhibitors of CYP3A4 (see section 4.5), e.g.,
- itraconazole
- ketoconazole
- ritonavir
- nelfinavir
- cobicistat
- clarithromycin
- telithromycin
- nefazodone
- Addison's disease
https://www.ema.europa.eu/en/documents/product-information/kerendia-epar-product-information_en.pdf 16/01/2026
Fingolimod (Gilenya)
Ability to drive, fingolimod [2] ---> SmPC of [2] of EMA
However, dizziness or drowsiness may occasionally occur when initiating treatment. On initiation of Gilenya it is recommended that patients be observed for a period of 6 hours (see section 4.4, Bradyarrhythmia).
Anticholinesterase, fingolimod [2] ---> SmPC 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
Antineoplastics, fingolimod [2] ---> SmPC of [2] of EMA
Anti-neoplastic, immunomodulatory or immunosuppressive therapies should not be co-administered due to the risk of additive immune system effects
Aprepitant, fingolimod
A transient moderate increase followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 is expected
Atenolol, fingolimod [2] ---> SmPC 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
Azole antifungals, fingolimod [2] ---> SmPC of [2] of EMA
Co-administration of fingolimod with CYP3A4 inhibitors may increase the fingolimod exposure. Caution should be exercised with substances that may inhibit CYP3A4
Betablockers, fingolimod [2] ---> SmPC 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
Breast-feeding, fingolimod [2] ---> SmPC of [2] of EMA
Due to the potential for serious adverse reactions to fingolimod in nursing infants, women receiving Gilenya should not breastfeed.
Calcium antagonists, fingolimod [2] ---> SmPC 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
Carbamazepine, fingolimod [2] ---> SmPC of [2] of EMA
Co-administration of fingolimod with strong CYP3A4 enzyme inducers may reduce the AUC of fingolimod and its metabolite. The co-administration should be used with caution.
Cardiologist, fingolimod [2] ---> SmPC of [2] of EMA
If treatment with Gilenya is considered in such patients, advice from a cardiologist should be sought regarding the switch to non-heart-rate lowering medicinal products or appropriate monitoring for treatment initiation, at least overnight monitoring is
Carteolol, fingolimod
Enhancement of bradycardia, which can have serious outcomes
Clarithromycin, fingolimod [2] ---> SmPC of [2] of EMA
Co-administration of fingolimod with CYP3A4 inhibitors may increase the fingolimod exposure. Caution should be exercised with substances that may inhibit CYP3A4
Class IA antiarrhythmic agents, fingolimod [2] ---> SmPC 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
Class III antiarrhythmic agents, fingolimod [2] ---> SmPC 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
Corticosteroids, fingolimod [2] ---> SmPC of [2] of EMA
In multiple sclerosis clinical studies the concomitant treatment of relapses with a short course of corticosteroids was not associated with an increased rate of infection.
Cyclosporine, fingolimod [2] ---> SmPC of [2] of EMA
Co-administration of fingolimod with ciclosporin did not elicit any change in the ciclosporin or fingolimod exposure. Therefore, fingolimod is not expected to alter the pharmacokinetics of medicinal products that are CYP3A4 substrates.
CYP450 enzymes, fingolimod [2] ---> SmPC of [2] of EMA
Fingolimod is unlikely to interact with substances mainly cleared by the CYP450 enzymes or by substrates of the main transporter proteins.
Digoxin, fingolimod [2] ---> SmPC 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
Diltiazem, fingolimod [2] ---> SmPC 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
Drugs inducing bradycardia, fingolimod [2] ---> SmPC 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
Efavirenz, fingolimod [2] ---> SmPC of [2] of EMA
Co-administration of fingolimod with strong CYP3A4 enzyme inducers may reduce the AUC of fingolimod and its metabolite. The co-administration should be used with caution.
Fertility, fingolimod [2] ---> SmPC of [2] of EMA
Data from preclinical studies do not suggest that fingolimod would be associated with an increased risk of reduced fertility (see section 5.3).
Fingolimod [1], hypokalemia ---> SmPC of [1] of EMA
Medicinal products that may prolong QTc interval are best avoided in patients with relevant risk factors, for example, hypokalaemia or congenital QT prolongation.
Fingolimod [1], immunomodulatory agents ---> SmPC of [1] of EMA
Anti-neoplastic, immunomodulatory or immunosuppressive therapies should not be co-administered due to the risk of additive immune system effects
Fingolimod [1], immunosuppressives ---> SmPC of [1] of EMA
Anti-neoplastic, immunomodulatory or immunosuppressive therapies should not be co-administered due to the risk of additive immune system effects
Fingolimod [1], ivabradine ---> SmPC of [1] 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
Fingolimod [1], ketoconazole ---> SmPC of [1] of EMA
Co-administration of fingolimod with CYP3A4 inhibitors may increase the fingolimod exposure. Caution should be exercised with substances that may inhibit CYP3A4
Fingolimod [1], mitoxantrone ---> SmPC of [1] of EMA
Caution should also be exercised when switching patients from long-acting therapies with immune effects such as natalizumab, teriflunomide or mitoxantrone (see section 4.4).
Fingolimod [1], natalizumab ---> SmPC of [1] of EMA
Caution should also be exercised when switching patients from long-acting therapies with immune effects such as natalizumab, teriflunomide or mitoxantrone (see section 4.4).
Fingolimod [1], oral contraceptives ---> SmPC of [1] of EMA
Co-administration of fingolimod with oral contraceptives (ethinylestradiol and levonorgestrel) did not elicit any change in oral contraceptive exposure.
Fingolimod [1], phenobarbital ---> SmPC of [1] of EMA
Co-administration of fingolimod with strong CYP3A4 enzyme inducers may reduce the AUC of fingolimod and its metabolite. The co-administration should be used with caution.
Fingolimod [1], pilocarpine ---> SmPC of [1] 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
Fingolimod [1], planning a pregnancy ---> SmPC of [1] of EMA
When stopping fingolimod therapy for planning a pregnancy the possible return of disease activity should be considered (see section 4.4).
Fingolimod [1], pregnancy ---> SmPC of [1] of EMA
Consequently, fingolimod is contraindicated during pregnancy (see section 4.3). Fingolimod should be stopped 2 months before planning a pregnancy (see section 4.4).
Fingolimod [1], pregnancy ---> SmPC of [1] of EMA
If a woman becomes pregnant during treatment, fingolimod must be discontinued. Medical advice should be given regarding the risk of harmful effects to the foetus associated with treatment and ultrasonography examinations should be performed.
Fingolimod [1], protease inhibitors ---> SmPC of [1] of EMA
Co-administration of fingolimod with CYP3A4 inhibitors may increase the fingolimod exposure. Caution should be exercised with substances that may inhibit CYP3A4
Fingolimod [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Medicinal products that may prolong QTc interval are best avoided in patients with relevant risk factors, for example, hypokalaemia or congenital QT prolongation.
Fingolimod [1], rifampicin ---> SmPC of [1] of EMA
Co-administration of fingolimod with strong CYP3A4 enzyme inducers may reduce the AUC of fingolimod and its metabolite. The co-administration should be used with caution.
Fingolimod [1], St. John's wort ---> SmPC of [1] of EMA
Co-administration of fingolimod with strong CYP3A4 enzyme inducers may reduce the AUC of fingolimod and its metabolite. Concomitant administration with St. John's Wort is not recommended
Fingolimod [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration of fingolimod with strong CYP3A4 enzyme inducers may reduce the AUC of fingolimod and its metabolite. The co-administration should be used with caution.
Fingolimod [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Co-administration of fingolimod with CYP3A4 inhibitors may increase the fingolimod exposure. Caution should be exercised with substances that may inhibit CYP3A4
Fingolimod [1], telithromycin ---> SmPC of [1] of EMA
Co-administration of fingolimod with CYP3A4 inhibitors may increase the fingolimod exposure. Caution should be exercised with substances that may inhibit CYP3A4
Fingolimod [1], teriflunomide ---> SmPC of [1] of EMA
Caution should also be exercised when switching patients from long-acting therapies with immune effects such as natalizumab, teriflunomide or mitoxantrone (see section 4.4).
Fingolimod [1], vaccinations ---> SmPC of [1] of EMA
During and for up to two months after treatment with Gilenya vaccination may be less effective.
Fingolimod [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA
The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided (see sections 4.4 and 4.8).
Fingolimod [1], verapamil ---> SmPC of [1] 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
Fingolimod [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential must use effective contraception during treatment and for 2 months after discontinuation of Gilenya, since fingolimod takes approximately 2 months to eliminate from the body after treatment discontinuation
Fingolimod, propranolol
Enhancement of bradycardic effects with possible fatal outcome
CONTRAINDICATIONS of Fingolimod (Gilenya)
- Immunodeficiency syndrome.
- Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
- Suspected or confirmed progressive multifocal leukoencephalopathy (PML) (see section 4.4).
- Severe active infections, active chronic infections (hepatitis, tuberculosis).
- Active malignancies.
- Severe liver impairment (Child-Pugh class C).
- Patients who in the previous 6 months had myocardial infarction (MI), unstable angina pectoris, stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure (see section 4.4).
- Patients with severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or class III anti-arrhythmic medicinal products (see section 4.4).
- Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, or sick-sinus syndrome, if they do not wear a pacemaker (see section 4.4).
- Patients with a baseline QTc interval >= 500 msec (see section 4.4).
- During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6).
- 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/gilenya-epar-product-information_en.pdf 03/02/2026
Other trade names: Fingolimod Accord,
Flecainide
Ability to drive, flecainide [2] ---> SmPC of [2] of eMC
Driving ability, operation of machinery and work without a secure fit may be affected by adverse reactions such as dizziness and visual disturbances, if present.
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.
Acetazolamide, flecainide
Acetazolamide, urinary alkalinizing agent, increases the pH of renal tubular urine and decreases the urinary excretion of flecainide
Amiodarone [1], flecainide ---> SmPC of [1] of eMC
Amiodarone, CYP2D6 inhibitor, may increase the plasma concentrations of flecainide
Amprenavir/ritonavir, flecainide ---> SmPC 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.
Artemether/lumefantrine [1], flecainide ---> SmPC 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.
Astemizole, flecainide [2] ---> SmPC of [2] of eMC
Increased risk of ventricular arrhythmias with astemizole (avoid concomitant use)
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.
Bendroflumethiazide [1], flecainide ---> SmPC of [1] of eMC
The cardiac toxicity of flecainide is increased if hypokalaemia occurs.
Betablockers, flecainide [2] ---> SmPC of [2] of eMC
The possibility of additive negative inotropic effects of Class II antiarrhythmics, i.e. beta-blockers, with flecainide should be recognised.
Bisoprolol [1], flecainide ---> SmPC of [1] of eMC
Class I antiarrhythmic may potentiate the effect on atrio-ventricular conduction time and increase the negative inotropic effect
Breast-feeding, flecainide [2] ---> SmPC of [2] of eMC
Flecainide is excreted in human milk. Although the risk of adverse effects to the nursing infant is very small, flecainide should only be used during lactation if the benefit outweighs the risks.
Bupropion [1], flecainide ---> SmPC of [1] of eMC
Concomitant therapy of bupropion with medicinal products with narrow therapeutic indices that are mainly metabolised by CYP2D6 (bupropion inhibits CYP2D6) should be initiated at the lower end of the dose range of the concomitant medicine.
Calcium antagonists, flecainide [2] ---> SmPC of [2] of eMC
The use of flecainide with calcium channel blockers, e.g. verapamil, should be considered with caution.
Carbamazepine, flecainide [2] ---> SmPC of [2] of eMC
Limited data in patients receiving known enzyme inducers of CYP2D6 (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.
Cimetidine, flecainide [2] ---> SmPC of [2] of eMC
The H2 antagonist cimetidine inhibits metabolism of flecainide.
Cinacalcet [1], flecainide ---> SmPC of [1] of EMA
Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments of concomitant medicinal products may be required when cinacalcet is administered with narrow therapeutic index substances that are predominantly metabolised by CYP2D6
Citalopram [1], flecainide ---> SmPC of [1] of eMC
Caution is recommended when citalopram is co-administered with medicinal products that are mainly metabolised by CYP2D6, and that have a narrow therapeutic index
Class IA antiarrhythmic agents, flecainide [2] ---> SmPC of [2] of eMC
Flecainide should not be administered concomitantly with other class I antiarrhythmics.
Class IB antiarrhythmic agents, flecainide [2] ---> SmPC of [2] of eMC
Flecainide should not be administered concomitantly with other class I antiarrhythmics.
Class IC antiarrhythmic agents, flecainide [2] ---> SmPC of [2] of eMC
Flecainide should not be administered concomitantly with other class I antiarrhythmics.
Class II antiarrhythmic agents, flecainide [2] ---> SmPC of [2] of eMC
The possibility of additive negative inotropic effects of class II antiarrhythmics, i.e. beta-blockers, with flecainide should be recognised.
Clozapine, flecainide [2] ---> SmPC of [2] of eMC
Increased risk of arrhythmias.
Cobicistat [1], flecainide ---> SmPC of [1] of EMA
The co-administration with cobicistat may increase the concentrations of antiarrhythmic
CYP2D6 inductors, flecainide [2] ---> SmPC of [2] of eMC
Concurrent use of drugs inducing the iso-enzyme CYP2D6 can decrease plasma concentrations of flecainide
CYP2D6 inhibitors, flecainide [2] ---> SmPC of [2] of eMC
Concurrent use of drugs inhibiting the iso-enzyme CYP2D6 can increase plasma concentrations of flecainide
Daclatasvir [1], flecainide ---> SmPC of [1] of EMA
No clinically relevant effects on the pharmacokinetics of either medicinal product are expected when daclatasvir is coadministered with the other medicinal product
Darifenacin [1], flecainide ---> SmPC of [1] of EMA
Darifenacin is a moderate inhibitor of the enzyme CYP2D6. Caution should be exercised when darifenacin is used concomitantly with medicinal products that are predominantly metabolised by CYP2D6 and which have a narrow therapeutic window
Darunavir/cobicistat [1], flecainide ---> SmPC of [1] of EMA
Based on theoretical considerations darunavir/cobicistat (CYP3A inhibition) is expected to increase the antiarrhythmic plasma concentrations. Caution is warranted
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], flecainide ---> SmPC of [1] of EMA
It is expected to increase these antiarrhythmic plasma concentrations. CYP3A inhibition. Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when co-administered with Symtuza.
Darunavir/ritonavir, flecainide ---> SmPC of [darunavir] of EMA
Co-administration of darunavir/ritonavir with medicinal products primarily metabolised by CYP2D6 may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Dextromethorphan/quinidine [1], flecainide ---> SmPC of [1] of EMA
Concomitant use of dextromethorphan/quinidine and flecainide, CYP2D6 substrate that also prolongs QT interval, requires caution
Digital glycosides, flecainide
The co-administration may have additive effect. Caution is recommended
Digoxin [1], flecainide ---> SmPC of [1] of eMC
Serum levels of digoxin may be increased by concomitant administration of flecainide
Diuretics, flecainide [2] ---> SmPC of [2] of eMC
Class effect due to hypokalaemia giving rise to cardiotoxicity.
Drugs inducing bradycardia, flecainide
The co-administration may have additive effect. Caution is recommended
Duloxetine [1], flecainide ---> SmPC of [1] of EMA
Duloxetine is a moderate inhibitor of CYP2D6. Caution is advised if duloxetine is co-administered with medicinal products that are predominantly metabolised by CYP2D6, particularly if they have a narrow therapeutic index
Electrolyte imbalance, flecainide [2] ---> SmPC of [2] of eMC
Hypokalaemia but also hyperkalaemia or other electrolyte disturbances should be corrected before administration of flecainide. Hypokalaemia may result from the concomitant use of diuretics, corticosteroids or laxatives.
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], flecainide ---> SmPC of [1] of EMA
Concentrations of this antiarrhythmic drug may be increased when co-administered with cobicistat.
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [1], flecainide ---> SmPC of [1] of EMA
The co-administration with cobicistat may increase the concentrations of antiarrhythmic
Escitalopram [1], flecainide ---> SmPC of [1] of eMC
Caution should be observed when co-administering escitalopram (CYP2D6 inhibitor) and drugs that are mainly metabolised by CYP2D6 and that have a narrow therapeutic index. Dosage adjustment may be warranted.
Etravirine [1], flecainide ---> SmPC of [1] 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.
Flecainide [1], halofantrine ---> SmPC of [1] of eMC
Halofantrine increases plasma concentrations of flecainide.
Flecainide [1], hyperkalemia ---> SmPC of [1] of eMC
Hypokalaemia but also hyperkalaemia or other electrolyte disturbances should be corrected before administration of flecainide. Hypokalaemia may result from the concomitant use of diuretics, corticosteroids or laxatives.
Flecainide [1], hypokalemia ---> SmPC of [1] of eMC
Hypokalaemia but also hyperkalaemia or other electrolyte disturbances should be corrected before administration of flecainide. Hypokalaemia may result from the concomitant use of diuretics, corticosteroids or laxatives.
Flecainide [1], indinavir ---> SmPC of [1] of eMC
Plasma concentrations are increased by ritonavir, lopinavir and indinavir (increased risk of ventricular arrhythmias) (avoid concomitant use).
Flecainide [1], loop diuretics ---> SmPC of [1] of eMC
Class effect due to hypokalaemia giving rise to cardiotoxicity.
Flecainide [1], lopinavir ---> SmPC of [1] of eMC
Plasma concentrations are increased by ritonavir, lopinavir and indinavir (increased risk of ventricular arrhythmias) (avoid concomitant use).
Flecainide [1], mizolastine ---> SmPC of [1] of eMC
Increased risk of ventricular arrhythmias. The co-administration should be avoided
Flecainide [1], oral anticoagulants ---> SmPC of [1] of eMC
The treatment with flecainide is compatible with the use of oral anticoagulants
Flecainide [1], phenobarbital ---> SmPC of [1] of eMC
Limited data in patients receiving known enzyme inducers of CYP2D6 (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.
Flecainide [1], phenytoin ---> SmPC of [1] of eMC
Limited data in patients receiving known enzyme inducers of CYP2D6 (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.
Flecainide [1], pregnancy ---> SmPC of [1] of eMC
Flecainide should only be used in pregnancy if the benefit outweighs the risks.
Flecainide [1], propranolol ---> SmPC of [1] of eMC
Concurrent use of drugs inhibiting the iso-enzyme CYP2D6 can increase plasma concentrations of flecainide
Flecainide [1], QT interval prolonging drugs ---> SmPC of [1] of eMC
Flecainide prolongs the QT interval and widens the QRS complex by 12-20 %.
Flecainide [1], quinine ---> SmPC of [1] of eMC
Quinine increases plasma concentrations of flecainide.
Flecainide [1], strong CYP2D6 inductors ---> SmPC of [1] of eMC
Concurrent use of drugs inducing the iso-enzyme CYP2D6 can decrease plasma concentrations of flecainide
Flecainide [1], strong CYP2D6 inhibitors ---> SmPC of [1] of eMC
Concurrent use of drugs inhibiting the iso-enzyme CYP2D6 can increase plasma concentrations of flecainide
Flecainide [1], terbinafine ---> SmPC of [1] of eMC
Terbinafine may increase plasma concentrations of flecainide resulting from its inhibition of CYP2D6 activity.
Flecainide [1], terfenadine ---> SmPC of [1] of eMC
Increased risk of ventricular arrhythmias. The co-administration should be avoided
Flecainide [1], thiazides ---> SmPC of [1] of eMC
Class effect due to hypokalaemia giving rise to cardiotoxicity.
Flecainide [1], tricyclic antidepressant ---> SmPC of [1] of eMC
Increased risk of arrhythmias
Flecainide [1], verapamil ---> SmPC of [1] of eMC
The use of flecainide with calcium channel blockers, e.g. verapamil, should be considered with caution.
Flecainide, fluoxetine [2] ---> SmPC of [2] of eMC
Concomitant therapy of flecainide with drugs predominantly metabolised by CYP2D6, and which have a narrow therapeutic index, should be initiated at or adjusted to the low end of their dose range.
Flecainide, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] 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.
Flecainide, gefitinib
The CYP2D6 inhibition may increase the plasma levels of flecainide
Flecainide, indinavir/ritonavir ---> SmPC of [indinavir] of EMA
Indinavir/ritonavir should not be administered with flecainide
Flecainide, interferon
Caution should be used when administering interferon with medicines mainly metabolised by hepatic cytochrome P450 and have a narrow therapeutic window
Flecainide, levomepromazine [2] ---> SmPC of [2] of eMC
Co-administration of levomepromazine and drugs primarily metabolised by the CYP2D6 may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic or adverse effects of those drugs.
Flecainide, metildigoxin
Increased plasma levels of metildigoxin
Flecainide, mirabegron [2] ---> SmPC of [2] of EMA
Caution is advised if mirabegron is co-administered with medicinal products with a narrow therapeutic index and significantly metabolised by CYP2D6. Caution is also advised with CYP2D6 substrates that are individually dose titrated.
Flecainide, moclobemide
The CYP2D6 inhibition may increase plasma concentrations of flecainide
Flecainide, naltrexone/bupropion [2] ---> SmPC of [2] of EMA
Co-administration of bupropion with drugs that are metabolised by CYP2D6 isozyme should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medicinal product.
Flecainide, nebivolol [2] ---> SmPC of [2] of eMC
Combination not recommended as the effect on atrio-ventricular conduction time may be potentiated and the negative inotropic effect increased
Flecainide, negative inotropic drugs
The co-administration may have additive effect. Caution is recommended
Flecainide, nicotine
Nicotine may increase the metabolism of flecainide and decrease its plasma concentrations
Flecainide, parecoxib [2] ---> SmPC of [2] of EMA
Caution should be observed when co-administering parecoxib and medicinal products that are predominantly metabolised by CYP2D6 and which have narrow therapeutic margins
Flecainide, paroxetine [2] ---> SmPC 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.
Flecainide, phenylalkylamines
The co-administration may have additive effect. Caution is recommended
Flecainide, ranolazine [2] ---> SmPC of [2] of EMA
Available data suggest that ranolazine is a mild inhibitor of CYP2D6. Therefore the exposure to CYP2D6 substrates may be increased during co-administration with ranolazine, and lower doses of these medicinal products may be required.
Flecainide, ritonavir [2] ---> SmPC of [2] of EMA
Ritonavir co-administration with flecainide is likely to result in increased plasma concentrations of flecainide and is therefore contraindicated
Flecainide, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA
The combination is contraindicated due to the potential for life threatening cardiac arrhythmia
Flecainide, sertraline [2] ---> SmPC of [2] of EMA
Clinical relevant interactions may occur with other CYP 2D6 substrates with a narrow therapeutic index, especially at higher sertraline dose levels.
Flecainide, simeprevir [2] ---> SmPC of [2] of EMA
Simeprevir, inhibitor of intestinal CYP3A4, may increase the plasma levels of this antiarrhythmic drug.
Flecainide, sodium channel blockers [2] ---> SmPC of [2] of eMC
Use of flecainide with other sodium channel blockers is not recommended.
Flecainide, tedisamil
Tedisamil, strong CYP2D6 inhibitor, may increase the plasma concentrations of flecainide
Flecainide, telaprevir [2] ---> SmPC of [2] of EMA
Telaprevir should be used with caution with Class Ic antiarrhythmic flecainide, including appropriate clinical and ECG monitoring
Flecainide, tipranavir/ritonavir ---> SmPC of [tipranavir] of EMA
The co-administration of tipranavir and low dose ritonavir with drugs that are highly dependent on CYP2D6 for clearance is contraindicated
Flecainide, urinary alkalinizing agents
The urinary alkalinizing agent, increases the pH of renal tubular urine and decreases the urinary excretion of flecainide
Flecainide, valdecoxib [2] ---> SmPC of [2] of EMA
Caution should be observed when co-administering valdecoxib and medicinal products that are predominantly metabolised by CYP2D6 and which have narrow therapeutic margins
CONTRAINDICATIONS of Flecainide
- Hypersensitivity to flecainide or to any of the excipients.
- Flecainide is contraindicated in cardiac failure and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia.
- It is also contraindicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm; in patients with reduced or impaired ventricular function, cardiogenic shock, severe bradycardia (less than 50 bpm), severe hypotension; use in combination with disopyramide, and in patients with haemodynamically significant valvular heart disease.
- Known Brugada syndrome.
- Unless pacing rescue is available, flecainide should not be given to patients with sinus node dysfunction, atrial condition defects, second degree or greater atrio-ventricular block, bundle branch block or distal block.
- Patients with asymptomatic or mildly symptomatic ventricular arrhythmias should not be given flecainide.
http://www.medicines.org.uk/emc/
Florbetaben (Neuraceq)
Breast-feeding, florbetaben [2] ---> SmPC of [2] of EMA
If the administration is considered necessary, breast-feeding should be interrupted for 24 hours and the expressed feeds discarded. Close contact with infants should be restricted during the initial 24 hours following injection.
Breast-feeding, florbetaben [2] ---> SmPC of [2] of EMA
It should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and to what is the most appropriate choice of radiopharmaceuticals
CYP450 substrates, florbetaben [2] ---> SmPC of [2] of EMA
In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P450 enzyme system.
Fertility, florbetaben [2] ---> SmPC of [2] of EMA
No fertility studies have been performed.
Florbetaben [1], pregnancy ---> SmPC of [1] of EMA
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus
Florbetaben [1], transporters ---> SmPC of [1] of EMA
In radioligand binding assays using a broad panel of animal and human receptors, ion channels and transporters no significant binding was found.
Florbetaben [1], women of childbearing potential ---> SmPC of [1] of EMA
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
CONTRAINDICATIONS of Florbetaben (Neuraceq)
- 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/neuraceq-epar-product-information_en.pdf 21/11/2025
Florbetapir (Amyvid)
Breast-feeding, florbetapir [2] ---> SmPC of [2] of EMA
If the administration is considered necessary, breast-feeding should be interrupted for 24 hours and the expressed feeds discarded
Close contact with infants, florbetapir [2] ---> SmPC of [2] of EMA
Close contact with infants should be restricted during the initial 24 hours following injection.
Fertility, florbetapir [2] ---> SmPC of [2] of EMA
No studies on fertility have been performed.
Florbetapir [1], medicinal products ---> SmPC of [1] of EMA
In vitro binding studies have not shown interference of florbetapir (18F)binding to ß-amyloid plaques in the presence of other common medicinal products taken by AD patients.
Florbetapir [1], pregnancy ---> SmPC of [1] of EMA
Only essential investigations should be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus
Florbetapir [1], women of childbearing potential ---> SmPC of [1] of EMA
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
CONTRAINDICATIONS of Florbetapir (Amyvid)
- 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/amyvid-epar-product-information_en.pdf 21/10/2024
Flortaucipir (Tauvid)
Breast-feeding, flortaucipir [2] ---> SmPC of [2] of EMA
Close contact with infants, toddlers, children and pregnant women should be restricted during the initial 4 hours following injection.
Breast-feeding, flortaucipir [2] ---> SmPC of [2] of EMA
If the administration is considered necessary, breastfeeding should be interrupted for 24 hours and the expressed feeds discarded.
Fertility, flortaucipir [2] ---> SmPC of [2] of EMA
It is not known if flortaucipir (18F) has any effect on fertility.
Flortaucipir [1], pharmacokinetics ---> SmPC of [1] of EMA
Similarly, flortaucipir (18F) is not expected to affect the pharmacokinetics of other medicinal products.
Flortaucipir [1], pregnancy ---> SmPC of [1] of EMA
Use of flortaucipir (18F) is not recommended in pregnant women. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Flortaucipir [1], women of childbearing potential ---> SmPC of [1] of EMA
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Flortaucipir [1], women of childbearing potential ---> SmPC of [1] of EMA
It is recommended that women of reproductive potential, unless using effective birth control, should abstain from intercourse for 24 hours (> 10 half-lives of radioactive decay for the 18F isotope) following flortaucipir (18F) administration.
CONTRAINDICATIONS of Flortaucipir (Tauvid)
- 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/tauvid-epar-product-information_en.pdf 13/09/2024
Fluciclovine (18F) (Axumin)
Breast-feeding, fluciclovine (18F) [2] ---> SmPC of [2] of EMA
Fluciclovine (18F) is not indicated for use in women
Colony stimulating factors, fluciclovine (18F) [2] ---> SmPC of [2] of EMA
The impact of anti-mitotic agents and colony stimulating factors on uptake of fluciclovine in patients with prostate cancer has not been studied.
Fertility, fluciclovine (18F) [2] ---> SmPC of [2] of EMA
No studies on fertility have been performed.
Fluciclovine (18F) [1], pregnancy ---> SmPC of [1] of EMA
Fluciclovine (18F) is not indicated for use in women
CONTRAINDICATIONS of Fluciclovine (18F) (Axumin)
- 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/axumin-epar-product-information_en.pdf 13/05/2024
Fluconazole
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.
Ability to drive, fluconazole [2] ---> SmPC of [2] of eMC
Patients should be warned about the potential for dizziness or seizures while taking fluconazole and should be advised not to drive or operate machines if any of these symptoms occur.
Agomelatine [1], fluconazole ---> SmPC of [1] of EMA
No evidence of pharmacokinetic or pharmacodynamic interaction was found in phase I clinical trials
Alfentanyl, fluconazole [2] ---> SmPC 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
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.
Aminophylline [1], fluconazole ---> SmPC of [1] of eMC
Fluconazole may decrease aminophylline clearance resulting in increased plasma theophylline concentrations and the potential for increased toxicity
Amitriptyline, fluconazole [2] ---> SmPC of [2] of eMC
Fluconazole increases the effect of amitriptyline. Dosage of amitriptyline should be adjusted, if necessary
Amitriptylinoxide, fluconazole
The combination may increase the plasma levels of amitriptylinoxide or of the metabolites amitriptyline and nortriptyline
Amlodipine, fluconazole [2] ---> SmPC 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.
Astemizole, fluconazole [2] ---> SmPC of [2] of eMC
Co-administration of fluconazole and astemizole may decrease the astemizole clearance. Resulting increased astemizole plasma levels can lead to QT prolongation and rare occurrences of torsade de pointes. Coadministration is contraindicated
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/ritonavir, fluconazole ---> SmPC of [atazanavir] of EMA
Atazanavir and fluconazole concentrations were not significantly modified. No dosage adjustment necessary.
Atenolol/nifedipine [1], fluconazole ---> SmPC of [1] of eMC
Drugs known to inhibit the cytochrome P450 3A4 system when administered orally with nifedipine may substantial increase the systemic bioavailability of nifedipine due to a decreased first pass metabolism and a decreased elimination
Atorvastatin, fluconazole [2] ---> SmPC 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.
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
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.
Azithromycin, fluconazole [2] ---> SmPC of [2] of eMC
There was no significant pharmacokinetic interaction between fluconazole and azithromycin.
Bedaquiline [1], fluconazole ---> SmPC of [1] of EMA
Due to the potential risk of adverse reactions due to an increase in systemic exposure, prolonged co-administration of bedaquiline and moderate or strong CYP3A4 inhibitors used systemically for more than 14 consecutive days should be avoided.
Benzodiazepines, fluconazole [2] ---> SmPC of [2] of eMC
If concomitant benzodiazepine therapy is necessary in patients being treated with fluconazole, consideration should be given to decreasing the benzodiazepine dose, and the patients should be appropriately monitored.
Bosentan [1], fluconazole ---> SmPC of [1] of EMA
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.
Bosutinib [1], fluconazole ---> SmPC of [1] 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.
Breast-feeding, fluconazole [2] ---> SmPC of [2] of eMC
Breast-feeding may be maintained after a single use of a standard dose 200 mg fluconazole or less. Breast-feeding is not recommended after repeated use or after high dose fluconazole.
Brivaracetam [1], fluconazole ---> SmPC of [1] of EMA
Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low.
Budipine, fluconazole
The co-administration of budipine with drugs known to prolong QT interval is contraindicated
Calcium antagonists, fluconazole [2] ---> SmPC of [2] of eMC
Certain calcium channel antagonists are metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of the calcium channel antagonists.
Carbamazepine, fluconazole [2] ---> SmPC of [2] of eMC
Fluconazole inhibits the metabolism of carbamazepine and an increase in serum carbamazepine of 30% has been observed. There is a risk of developing carbamazepine toxicity. Dose adjustment of carbamazepine may be necessary
Cariprazine [1], fluconazole ---> SmPC of [1] of EMA
Metabolism of cariprazine and its major active metabolites is mediated mainly by CYP3A4. The co-administration of cariprazine with strong or moderate inhibitors of CYP3A4 is contraindicated
Ceftriaxone [1], fluconazole ---> SmPC of [1] of eMC
Based on literature reports ceftriaxone is incompatible with fluconazole
Celecoxib, fluconazole [2] ---> SmPC of [2] of eMC
During concomitant treatment with fluconazole and celecoxib the celecoxib Cmax and AUC increased by 68% and 134%, respectively. Half of the celecoxib dose may be necessary when combined with fluconazole.
Chlorpropamide, fluconazole [2] ---> SmPC of [2] of eMC
Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas in healthy volunteers. Frequent monitoring of blood glucose is recommended during coadministration.
Cinitapride, fluconazole
The strong CYP3A4 inhibition may increase the plasma concentrations of cinitapride
Cisapride, fluconazole [2] ---> SmPC of [2] of eMC
Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated in patients receiving fluconazole
Clarithromycin, fluconazole
Strong CYP3A4 inhibitors may increase the plasma concentrations of clarithromycin
Class I antiarrhythmic agents, fluconazole
Cases of QTc interval prolongation and/ or torsades de pointes may occur after concomitant use of fluconazole with some anti-arrhythmics.
Class IA antiarrhythmic agents, fluconazole
Cases of QTc interval prolongation and/ or torsades de pointes may occur after concomitant use of fluconazole with some anti-arrhythmics
Class III antiarrhythmic agents, fluconazole
Cases of QTc interval prolongation and/ or torsades de pointes may occur after concomitant use of fluconazole with some anti-arrhythmics
Clobazam [1], fluconazole ---> SmPC of [1] of eMC
The potent CYP2C19 inhibition may increase the exposure to the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary
Clopidogrel [1], fluconazole ---> SmPC of [1] of EMA
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Clopidogrel/acetylsalicylic acid [1], fluconazole ---> SmPC of [1] of EMA
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Cobicistat [1], fluconazole ---> SmPC of [1] of EMA
Concentrations of fluconazole may be increased when co-administered with cobicistat.
Cobimetinib [1], fluconazole ---> SmPC of [1] 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.
Coumarin anticoagulants, fluconazole [2] ---> SmPC of [2] of eMC
In patients receiving coumarin-type anticoagulants concurrently with fluconazole the prothrombin time should be carefully monitored.
Cyclophosphamide, fluconazole [2] ---> SmPC of [2] of eMC
Combination therapy with cyclophosphamide and fluconazole results in an increase in serum bilirubin and serum creatinine. The combination may be used while taking increased consideration to the risk of increased serum bilirubin and serum creatinine.
Cyclosporine, fluconazole [2] ---> SmPC of [2] of eMC
Fluconazole significantly increases the concentration and AUC of ciclosporin. This combination may be used by reducing the dose of ciclosporin depending on ciclosporin concentration.
CYP2C19 substrates with narrow therapeutic index, fluconazole [2] ---> SmPC of [2] of eMC
Fluconazole is a CYP2C19 inhibitor. Fluconazole treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C19 should be monitored
CYP2C9 substrates with narrow therapeutic index, fluconazole [2] ---> SmPC of [2] of eMC
Fluconazole is a potent CYP2C9 inhibitor. Fluconazole treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C9 should be monitored
Daclatasvir [1], fluconazole ---> SmPC of [1] of EMA
Modest increases in concentrations of daclatasvir are expected, but no dose adjustment of daclatasvir or fluconazole is required.
Dapoxetine [1], fluconazole ---> SmPC of [1] 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.
Darifenacin [1], fluconazole ---> SmPC of [1] of EMA
When co-administered with moderate CYP3A4 inhibitors the recommended starting dose of darifenacin should be 7.5 mg daily.
Darunavir/cobicistat [1], fluconazole ---> SmPC of [1] of EMA
Based on theoretical considerations darunavir/cobicistat (CYP3A inhibition) is expected to increase the antifungal plasma concentrations, and darunavir and/or cobicistat plasma concentrations may be increased by the antifungal (CYP3A inhibition)
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], fluconazole ---> SmPC of [1] of EMA
Based on theoretical considerations DRV/COBI is expected to increase this antifungal plasma concentration, and darunavir, cobicistat and/or tenofovir alafenamide plasma concentrations may be increased by the antifungals. CYP3A and/or P-gp inhibition
Darunavir/ritonavir, fluconazole ---> SmPC of [darunavir] of EMA
Boosted darunavir may increase antifungal plasma concentrations (P-gp inhibition) and fluconazole may increase darunavir concentrations (CYP3A inhibition)
Dextromethorphan/quinidine [1], fluconazole ---> SmPC of [1] 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.
Diclofenac, fluconazole [2] ---> SmPC of [2] of eMC
Fluconazole has the potential to increase the systemic exposure of NSAIDs that are metabolized by CYP2C9. Frequent monitoring for adverse events and toxicity related to NSAIDs is recommended. Adjustment of dose of NSAIDs may be needed.
Dihydropyridines, fluconazole
Fluconazole, moderate CYP3A4 inhibitor, may increase the plasma concentrations of dihydropyridine
Dipotassium clorazepate, fluconazole
Fluconazole may increase the effect of the clorazepate
Dolutegravir [1], fluconazole ---> SmPC of [1] of EMA
The inhibition of CYP3A4 may increase plasma levels of dolutegravir. No dose adjustment is necessary. Based on data from other CYP3A4 inhibitors, a marked increase is not expected.
Dolutegravir/rilpivirine [1], fluconazole ---> SmPC of [1] of EMA
May cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). No dose adjustment is required.
Droperidol [1], fluconazole ---> SmPC of [1] of eMC
Substances inhibiting the activity of cytochrome P450 iso-enzyme CYP3A4 could decrease the rate at which droperidol is metabolised and prolong its pharmacological action.
Drugs primarily metabolised by CYP2C9, fluconazole [2] ---> SmPC of [2] of eMC
There is a risk of increased plasma concentration of other compounds metabolized by CYP2C9 co-administered with fluconazole. Therefore caution should be exercised when using these combinations and the patients should be carefully monitored.
Drugs primarily metabolised by CYP3A4 with narrow therapeutic index, fluconazole [2] ---> SmPC of [2] of eMC
Fluconazole is a moderate CYP3A4 inhibitor. Fluconazole treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP3A4 should be monitored
Drugs primarily metabolised by CYP3A4, fluconazole [2] ---> SmPC of [2] of eMC
There is a risk of increased plasma concentration of other compounds metabolized by CYP3A4 co-administered with fluconazole. Therefore caution should be exercised when using these combinations and the patients should be carefully monitored.
Efavirenz [1], fluconazole ---> SmPC of [1] of EMA
No clinically significant pharmacokinetic interaction. No dose adjustment is necessary for either medicinal product.
Eliglustat [1], fluconazole ---> SmPC of [1] 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.
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], fluconazole ---> SmPC of [1] of EMA
Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat.
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [1], fluconazole ---> SmPC of [1] of EMA
Concentrations of fluconazole may be increased when co-administered with cobicistat.
Emtricitabine/rilpivirine/tenofovir alafenamide [1], fluconazole ---> SmPC of [1] of EMA
Co-administration of this antifungal agent is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp). Co-administration is not recommended.
Emtricitabine/rilpivirine/tenofovir disoproxil [1], fluconazole ---> SmPC of [1] of EMA
Concomitant use of Eviplera with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). At a dose of 25 mg of rilpivirine, dose adjustment is required.
Emtricitabine/tenofovir alafenamide [1], fluconazole ---> SmPC of [1] of EMA
Co-administration of fluconazole or isavuconazole may increase plasma concentrations of tenofovir alafenamide.
Encorafenib [1], fluconazole ---> SmPC of [1] 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.
Eplerenone [1], fluconazole ---> SmPC of [1] 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
Ergot derivatives, fluconazole
The concurrent use of fluconazole and ergot derivatives is contraindicated, because of the potential for serious toxicity.
Erythromycin, fluconazole [2] ---> SmPC of [2] of eMC
Concomitant use of fluconazole and erythromycin has the potential to increase the risk of cardiotoxicity (prolonged QT interval, Torsades de Pointes) and consequently sudden heart death. Coadministration is contraindicated
Ethinyl estradiol, fluconazole [2] ---> SmPC of [2] of eMC
Fluconazole 200 mg daily increased the AUCs of ethinyl estradiol and levonorgestrel 40% and 24%, respectively. Multiple dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.
Ethinylestradiol/chlormadinone, fluconazole
Active principles which inhibit hepatic microsomal enzymes may increase plasma concentrations of ethinylestradiol
Ethinylestradiol/gestodene, fluconazole
Substances which inhibit the CYP3A4 may increase the plasma concentrations of ethinylestradiol
Ethinylestradiol/norgestimate [1], fluconazole ---> SmPC of [1] of eMC
Increase in plasma hormone levels associated with co-administered drug
Ethotoin, fluconazole
Increase in the effect of ethotoin
Etravirine [1], fluconazole ---> SmPC of [1] of EMA
Possible increase of plasma concentrations of etravirine. The co-administration can be used without dose adjustments.
Everolimus [1], fluconazole ---> SmPC of [1] of EMA
Increase in everolimus concentration is expected. Use caution when co-administration of moderate CYP3A4 inhibitors or PgP inhibitors cannot be avoided.
Ezetimibe/atorvastatin [1], fluconazole ---> SmPC of [1] of eMC
Moderate CYP3A4 inhibitors may increase plasma concentrations of atorvastatin. Appropriate clinical monitoring of the patient is recommended when concomitantly used with moderate CYP3A4 inhibitors.
Felodipine, fluconazole [2] ---> SmPC of [2] of eMC
Felodipine is metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of felodipine. Frequent monitoring for adverse events is recommended.
Fenofibrate/simvastatin [1], fluconazole ---> SmPC of [1] of EMA
Caution should be exercised when combining fenofibrate/simvastatine with certain other less potent CYP 3A4 inhibitors
Fentanyl [1], fluconazole ---> SmPC of [1] 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.
Fesoterodine [1], fluconazole ---> SmPC of [1] of EMA
Caution should be exercised when prescribing fesoterodine to patients in whom an increased exposure to the active metabolite is expected, e. g. coadministration of moderate CYP3A4 inhibitors. No dosing adjustments are recommended
Fluconazole [1], flurbiprofen ---> SmPC of [1] of eMC
The C max and AUC of flurbiprofen was increased by 23% and 81%, respectively, when coadministered with fluconazole compared to administration of flurbiprofen alone.
Fluconazole [1], fluvastatin ---> SmPC of [1] 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.
Fluconazole [1], glibenclamide ---> SmPC of [1] of eMC
Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas in healthy volunteers. Frequent monitoring of blood glucose is recommended during coadministration.
Fluconazole [1], glipizide ---> SmPC of [1] of eMC
Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas in healthy volunteers. Frequent monitoring of blood glucose is recommended during coadministration.
Fluconazole [1], halofantrine ---> SmPC of [1] of eMC
Concomitant use of fluconazole and halofantrine has the potential to increase the risk of cardiotoxicity (prolonged QT interval, torsades de pointes) and consequently sudden heart death. This combination should be avoided
Fluconazole [1], ibuprofen ---> SmPC of [1] of eMC
The Cmax and AUC of the pharmacologically active isomer [S (+)ibuprofen] was increased by 15%% and 82%, respectively, when fluconazole was coadministered with racemic ibuprofen (400 mg) compared to administration of racemic ibuprofen alone.
Fluconazole [1], isradipine ---> SmPC of [1] of eMC
Isradipine is metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of isradipine. Frequent monitoring for adverse events is recommended.
Fluconazole [1], levonorgestrel ---> SmPC of [1] of eMC
Fluconazole 200 mg daily increased the AUCs of ethinyl estradiol and levonorgestrel 40% and 24%, respectively. Multiple dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.
Fluconazole [1], lornoxicam ---> SmPC of [1] of eMC
Fluconazole has the potential to increase the systemic exposure of NSAIDs that are metabolized by CYP2C9. Frequent monitoring for adverse events and toxicity related to NSAIDs is recommended. Adjustment of dose of NSAIDs may be needed.
Fluconazole [1], meloxicam ---> SmPC of [1] of eMC
Fluconazole has the potential to increase the systemic exposure of NSAIDs that are metabolized by CYP2C9. Frequent monitoring for adverse events and toxicity related to NSAIDs is recommended. Adjustment of dose of NSAIDs may be needed.
Fluconazole [1], metabolized by CYP2C9 and CYP3A4 ---> SmPC of [1] of eMC
Fluconazole is a potent inhibitor of cytochrome P450 (CYP) isoenzyme 2C9 and a moderate inhibitor of CYP3A4. There is a risk of increased plasma concentration of other compounds metabolized by CYP2C9 and CYP3A4 co-administered with fluconazole.
Fluconazole [1], metabolized by CYP3A4 and prolong QT ---> SmPC of [1] of eMC
Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated in patients receiving fluconazole
Fluconazole [1], methadone ---> SmPC of [1] of eMC
Fluconazole may enhance the serum concentration of methadone. Dose adjustment of methadone may be necessary.
Fluconazole [1], midazolam ---> SmPC of [1] of eMC
Following oral administration of midazolam, fluconazole resulted in substantial increases in midazolam concentrations and psychomotor effects.
Fluconazole [1], naproxen ---> SmPC of [1] of eMC
Fluconazole has the potential to increase the systemic exposure of NSAIDs that are metabolized by CYP2C9. Frequent monitoring for adverse events and toxicity related to NSAIDs is recommended. Adjustment of dose of NSAIDs may be needed.
Fluconazole [1], nifedipine ---> SmPC of [1] of eMC
Nifedipine is metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of amlodipine. Frequent monitoring for adverse events is recommended.
Fluconazole [1], nortriptyline ---> SmPC of [1] of eMC
Fluconazole increases the effect of nortriptyline. Dosage of nortriptyline should be adjusted, if necessary
Fluconazole [1], NSAIDs metabolized by CYP2C9 ---> SmPC of [1] of eMC
Fluconazole has the potential to increase the systemic exposure of NSAIDs that are metabolized by CYP2C9. Frequent monitoring for adverse events and toxicity related to NSAIDs is recommended. Adjustment of dose of NSAIDs may be needed.
Fluconazole [1], oral contraceptives ---> SmPC of [1] of eMC
Fluconazole 200 mg daily increased the AUCs of ethinyl estradiol and levonorgestrel 40% and 24%, respectively. Multiple dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.
Fluconazole [1], phenytoin ---> SmPC of [1] of eMC
Fluconazole inhibits the hepatic metabolism of phenytoin. With coadministration, serum phenytoin concentration levels should be monitored in order to avoid phenytoin toxicity.
Fluconazole [1], pimozide ---> SmPC of [1] of eMC
Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated in patients receiving fluconazole
Fluconazole [1], prednisone ---> SmPC of [1] of eMC
There was a case report that a liver-transplanted patient treated with prednisone developed acute adrenal cortex insufficiency when a three month therapy with fluconazole (CYP3A4 inhibitor) was discontinued.
Fluconazole [1], pregnancy ---> SmPC of [1] of eMC
Fluconazole in standard doses and short-term treatments should not be used in pregnancy unless clearly necessary.
Fluconazole [1], quinidine ---> SmPC of [1] of eMC
Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 are contraindicated in patients receiving fluconazole
Fluconazole [1], rifabutin ---> SmPC of [1] of eMC
Fluconazole increases serum concentrations of rifabutin, leading to increase in the AUC of rifabutin up to 80%. There have been reports of uveitis in patients to whom fluconazole and rifabutin were coadministered.
Fluconazole [1], rifampicin ---> SmPC of [1] of eMC
Concomitant administration of fluconazole and rifampicin resulted in a 25% decrease in the AUC and 20% shorter half-life of fluconazole. In patients receiving concomitant rifampicin, an increase in the fluconazole dose should be considered
Fluconazole [1], saquinavir ---> SmPC of [1] of eMC
Fluconazole increases the AUC and Cmax of saquinavir with approximately 50% and 55% respectively, due to inhibition of saquinavir's hepatic metabolism by CYP3A4 and inhibition of P-glycoprotein.
Fluconazole [1], sulfonylureas ---> SmPC of [1] of eMC
Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas in healthy volunteers. Frequent monitoring of blood glucose is recommended during coadministration.
Fluconazole [1], tacrolimus ---> SmPC of [1] of eMC
Fluconazole may increase the serum concentrations of orally administered tacrolimus up to 5 times due to inhibition of tacrolimus metabolism through CYP3A4 in the intestines. Increased tacrolimus levels have been associated with nephrotoxicity.
Fluconazole [1], terfenadine ---> SmPC of [1] of eMC
The combined use of fluconazole at doses of 400 mg or greater with terfenadine is contraindicated. The coadministration of fluconazole at doses lower than 400 mg per day with terfenadine should be carefully monitored.
Fluconazole [1], theophylline ---> SmPC of [1] of eMC
In a placebo controlled interaction study, the administration of fluconazole 200 mg for 14 days resulted in an 18% decrease in the mean plasma clearance rate of theophylline.
Fluconazole [1], tolbutamide ---> SmPC of [1] of eMC
Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas in healthy volunteers. Frequent monitoring of blood glucose is recommended during coadministration.
Fluconazole [1], triazolam ---> SmPC of [1] of eMC
Potentiated and prolonged effects of triazolam have been observed at concomitant treatment with fluconazole.
Fluconazole [1], verapamil ---> SmPC of [1] of eMC
Verapamil is metabolized by CYP3A4. Fluconazole has the potential to increase the systemic exposure of verapamil. Frequent monitoring for adverse events is recommended.
Fluconazole [1], vinblastine ---> SmPC of [1] of eMC
Fluconazole may increase the plasma levels of the vinca alkaloids and lead to neurotoxicity, which is possibly due to an inhibitory effect on CYP3A4.
Fluconazole [1], vinca alkaloids ---> SmPC of [1] of eMC
Fluconazole may increase the plasma levels of the vinca alkaloids and lead to neurotoxicity, which is possibly due to an inhibitory effect on CYP3A4.
Fluconazole [1], vincristine ---> SmPC of [1] of eMC
Fluconazole may increase the plasma levels of the vinca alkaloids and lead to neurotoxicity, which is possibly due to an inhibitory effect on CYP3A4.
Fluconazole [1], vitamin A ---> SmPC of [1] of eMC
Based on a case-report in one patient receiving combination therapy with all trans-retinoid acid (an acid form of vitamin A) and fluconazole, CNS related undesirable effects have developed in the form of pseudotumour cerebri
Fluconazole [1], warfarin ---> SmPC of [1] of eMC
During concomitant treatment with fluconazole and warfarin the prothrombin time was prolonged up to 2-fold, probably due to an inhibition of the warfarin metabolism through CYP2C9.
Fluconazole [1], zidovudine ---> SmPC of [1] of eMC
Fluconazole increases Cmax and AUC of zidovudine by 84% and 74%, respectively, due to an approx. 45% decrease in oral zidovudine clearance.
Fluconazole, flunitrazepam
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Fluconazole, fosphenytoin [2] ---> SmPC of [2] of eMC
CYP2C9 inhibition may increase plasma phenytoin concentrations
Fluconazole, gliclazide [2] ---> SmPC of [2] of eMC
Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when fluconazole is taken
Fluconazole, glimepiride [2] ---> SmPC of [2] of eMC
Results from an in vivo interaction study reported in literature show that glimepiride AUC is increased approximately 2-fold by fluconazole, one of the most potent CYP2C9 inhibitors.
Fluconazole, 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.
Fluconazole, hydrochlorothiazide
The co-administration may increase the plasma levels of fluconazole and an adjustment of dose may be needed
Fluconazole, 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.
Fluconazole, indinavir [2] ---> SmPC of [2] of EMA
Indinavir and fluconazole can be coadministered without dose adjustment.
Fluconazole, ivabradine [2] ---> SmPC of [2] of EMA
The concomitant use of ivabradine with moderate CYP3A4 inhibitors may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate.
Fluconazole, ivacaftor [2] ---> SmPC of [2] of EMA
Ivacaftor is a sensitive CYP3A substrate. A reduction of the Kalydeco dose to 150 mg once daily is recommended for patients taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin.
Fluconazole, ixabepilone
The moderate CYP3A4 inhibition may increase the plasma concentrations of ixabepilone. Caution is recommended
Fluconazole, lacosamide [2] ---> SmPC of [2] of EMA
Caution is recommended in concomitant treatment of lacosamide with strong inhibitors of CYP2C9, which may lead to increased systemic exposure of lacosamide.
Fluconazole, lamivudine/zidovudine [2] ---> SmPC of [2] of EMA
The UGT inhibition may increase the zidovudine exposition. Monitor for signs of zidovudine toxicity
Fluconazole, lesinurad [2] ---> SmPC 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.
Fluconazole, letermovir [2] ---> SmPC of [2] of EMA
No dose adjustment required.
Fluconazole, lomitapide [2] ---> SmPC of [2] of EMA
The strong CYP3A4 inhibition may increase lomitapide AUC. The combination of lomitapide with strong CYP3A4 inhibitors is contra-indicated
Fluconazole, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA
Based on known metabolic profiles, clinically significant interactions are not expected between Kaletra and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole.
Fluconazole, losartan [2] ---> SmPC of [2] of eMC
Fluconazole (inhibitor of CYP2C9) decreases the exposure to the active metabolite of losartan by approximately 50%.
Fluconazole, losartan/hydrochlorothiazide [2] ---> SmPC of [2] of eMC
Fluconazole has been reported to reduce levels of active metabolite.
Fluconazole, lumacaftor/ivacaftor [2] ---> SmPC of [2] of EMA
No dose adjustment of lumacaftor/ivacaftor is recommended when co-administered with fluconazole. Lumacaftor/ivacaftor may decrease the exposure of fluconazole, which may reduce its efficacy.
Fluconazole, lurasidone [2] ---> SmPC of [2] of EMA
Coadministration of lurasidone with medicinal products that moderately inhibit CYP3A4 may increase exposure to lurasidone.
Fluconazole, maraviroc [2] ---> SmPC of [2] of EMA
Fluconazole is considered to be a moderate CYP3A4 inhibitor. Population PK studies suggest that a dose adjustment of maraviroc is not required
Fluconazole, mephenytoin
The co-administration increases the effect of the mephenytoin
Fluconazole, nalmefene [2] ---> SmPC of [2] of EMA
Co-administration with medicinal products that are potent inhibitors of the UGT2B7 enzyme may significantly increase the exposure to nalmefene.
Fluconazole, nateglinide [2] ---> SmPC of [2] of EMA
Particular caution is recommended when nateglinide is co-administered with potent inhibitors of CYP2C9, or in patients known to be poor metabolisers for CYP2C9.
Fluconazole, nelfinavir [2] ---> SmPC of [2] of EMA
Co-administration of nelfinavir with inhibitors of CYP2C19 may be expected to reduce the conversion of nelfinavir to its major active metabolite M8 (tert-butyl hydroxy nelfinavir) with a concomitant increase in plasma nelfinavir levels
Fluconazole, neratinib [2] ---> SmPC of [2] of EMA
Co-administration of neratinib with moderate CYP3A4/P-gp inhibitors is contraindicated
Fluconazole, nevirapine [2] ---> SmPC of [2] of EMA
Because of the risk of increased exposure to nevirapine, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely
Fluconazole, nisoldipine
The co-administration of nisoldipine with medicinal products that inhibit the cytochrome P450 3A4-system may increase the bioavailability of nisoldipine. Concomitant use is contraindicated
Fluconazole, norgestimate
The strong CYP3A4 inhibition may increase the plasma concentrations of norgestimate
Fluconazole, olaparib [2] ---> SmPC of [2] of EMA
Known strong or moderate CYP3A inhibitors are not recommended with olaparib
Fluconazole, oral antidiabetics
Clinically significant hypoglycemia may be precipitated by the use of fluconazole with oral hypoglycemic agents.
Fluconazole, ospemifene [2] ---> SmPC of [2] of EMA
Co-administration of ospemifene with any medicinal products that inhibit both CYP3A4 and CYP2C9 activity (e.g. fluconazole) would be expected to increase the exposure of ospemifene.
Fluconazole, parecoxib [2] ---> SmPC of [2] of EMA
Plasma exposure (AUC and Cmax) to valdecoxib was increased (62% and 19%, respectively) when co-administered with fluconazole (predominantly a CYP2C9 inhibitor)
Fluconazole, pioglitazone/glimepiride [2] ---> SmPC of [2] of EMA
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur
Fluconazole, pirfenidone [2] ---> SmPC 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
Fluconazole, QT interval prolonging drugs
The co-administration may increase the risk of cardiotoxicity (QTc prolongation, Torsades de pointes, syncope, cardiac arrest).
Fluconazole, ramelteon
Fluconazole may increase the serum levels and toxicity of ramelteon.
Fluconazole, ranolazine [2] ---> SmPC of [2] of EMA
Careful dose titration of ranolazine is recommended in patients treated with moderately potent CYP3A4 inhibitors. Down-titration of ranolazine may be required
Fluconazole, rilpivirine [2] ---> SmPC of [2] of EMA
Not studied. Concomitant use of rilpivirine with azole antifungal agents (inhibition of CYP3A enzymes) may cause an increase in the plasma concentrations of rilpivirine. No dose adjustment is required.
Fluconazole, rivaroxaban [2] ---> SmPC of [2] of EMA
Active substances strongly inhibiting only one of the rivaroxaban elimination pathways, either CYP3A4 or P-gp, are expected to increase rivaroxaban plasma concentrations. This increase is not considered clinically relevant.
Fluconazole, rosuvastatin [2] ---> SmPC of [2] of eMC
No clinically relevant interactions have been observed between rosuvastatin and fluconazole (an inhibitor of CYP2C9 and CYP3A4)
Fluconazole, roxithromycin
Caution is warranted for concomitant use of roxitromycin with other QT interval prolonging medicines
Fluconazole, rupatadine [2] ---> SmPC of [2] of eMC
The concomitant administration of rupatadine with inhibitors of the isozyme CYP3A4 increases the systemic exposure to rupatadine. Rupatadine should be used with caution when it is administered concomitantly with inhibitors of CYP3A4.
Fluconazole, ruxolitinib [2] ---> SmPC of [2] of EMA
On the basis of in silico modelling 50% dose reduction should be considered when using medicinal products which are dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole).
Fluconazole, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA
Fluconazole is CYP3A4 inhibitors and may increase the plasma concentration of saquinavir. Use with caution due to possible cardiac arrhythmias. Monitoring for saquinavir toxicity recommended
Fluconazole, selexipag [2] ---> SmPC of [2] of EMA
The effect of strong inhibitors of UGT1A3 and UGT2B7 (valproic acid, probenecid, and fluconazole) on the exposure to selexipag has not been studied. A potential pharmacokinetic interaction with strong inhibitors of UGT1A3 and UGT2B7 cannot be excluded.
Fluconazole, simeprevir [2] ---> SmPC of [2] of EMA
Co-administration of simeprevir with moderate or strong inhibitors of CYP3A4 may significantly increase the plasma exposure of simeprevir. Co-administration of simeprevir with these inhibitors is not recommended.
Fluconazole, simvastatine [2] ---> SmPC of [2] of eMC
Rare cases of rhabdomyolysis associated with concomitant administration of simvastatin and fluconazole have been reported
Fluconazole, sirolimus [2] ---> SmPC of [2] of EMA
Inhibitors of CYP3A4 may decrease the metabolism of sirolimus and increase sirolimus blood levels.
Fluconazole, sitaxentan [2] ---> SmPC of [2] of EMA
Co-administration of sitaxentan and fluconazole had no effect on the clearance of sitaxentan sodium.
Fluconazole, tapentadol [2] ---> SmPC of [2] of eMC
Concomitant administration of tapentadol with strong inhibitors of UGT2B7 may lead to increased systemic exposure of tapentadol
Fluconazole, telithromycin [2] ---> SmPC 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
Fluconazole, 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
Fluconazole, terbinafine [2] ---> SmPC of [2] of eMC
Co-administration of terbinafine with drugs that inhibit CYP2C9 and CYP3A4 may increase the exposure to terbinafine
Fluconazole, ticagrelor [2] ---> SmPC 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.
Fluconazole, tipranavir [2] ---> SmPC of [2] of EMA
Increased plasma concentrations of tipranavir. No dosage adjustments are recommended. Fluconazole doses > 200 mg/day are not recommended.
Fluconazole, tofacitinib [2] ---> SmPC of [2] of EMA
XELJANZ exposure is increased when one or more concomitant medications results in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole)
Fluconazole, tolbutamine
Fluconazole, strong inhibitor of CYP2C9, increases the plasma concentrations of sulfonylurea
Fluconazole, 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
Fluconazole, tricyclic antidepressant
Possible increase of plasma levels and toxicity of tricyclic antidepressant
Fluconazole, trimetrexate
Fluconazole, moderate inhibitor of CYP3A4, may increase the plasma concentrations of trimetrexate
Fluconazole, trofosfamide
The inhibition of CYP3A4 may increase the formation of a trofosfamide metabolite which is related with nephrotoxicity and CNS toxicity
Fluconazole, valdecoxib [2] ---> SmPC of [2] of EMA
The strong CYP2C9 inhibition may increase the plasma levels of valdecoxib
Fluconazole, venetoclax [2] ---> SmPC of [2] of EMA
At initiation and during the dose-titration phase, concomitant use of venetoclax with moderate CYP3A inhibitors should be avoided. Alternative treatments should be considered.
Fluconazole, voriconazole [2] ---> SmPC of [2] of EMA
The inhibition of CYP2C9, CYP2C19 and CYP3A4 by fluconazole increases the oral voriconazole plasma levels significantly. The combination should be avoided
Fluconazole, vortioxetine [2] ---> SmPC of [2] of EMA
The strong CYP2C9 inhibition may increase the AUC of vortioxetine. It is caution recommended with CYP2D6 poor metabolisers
Fluconazole, zafirlukast [2] ---> SmPC of [2] of eMC
Co-administration with fluconazole, a moderate CYP2C9 inhibitor, resulted in increased plasma levels of zafirlukast, by approximately 60%.
CONTRAINDICATIONS of Fluconazole
- Hypersensitivity to the active substance, to related azole substances, or to any of the excipients
- Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg per day or higher based upon results of a multiple dose interaction study. Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin are contraindicated in patients receiving fluconazole
http://www.medicines.org.uk/emc/
Fludarabine
Ability to drive, fludarabine [2] ---> SmPC of [2] of eMC
Fludarabine may reduce the ability to drive and use machines, since e.g. fatigue, weakness, visual disturbances, confusion, agitation and seizures have been observed.
Breast-feeding, fludarabine [2] ---> SmPC of [2] of eMC
Because of the potential for serious adverse reactions in breast-fed infants. Fludarabine is contraindicated in nursing mothers
Daunorubicin, fludarabine
Incompatibility
Dipyridamole, fludarabine [2] ---> SmPC of [2] of eMC
Dipyridamole and other inhibitors of adenosine uptake may reduce the therapeutic efficacy of fludarabine.
Fludarabine [1], inhibitors of adenosine uptake ---> SmPC of [1] of eMC
Dipyridamole and other inhibitors of adenosine uptake may reduce the therapeutic efficacy of fludarabine.
Fludarabine [1], pregnancy ---> SmPC of [1] of eMC
Fludarabine should not be used during pregnancy unless clearly necessary
Fludarabine [1], vaccinations with live organism vaccines ---> SmPC of [1] of eMC
During and after treatment with fludarabine vaccination with live vaccines should be avoided.
Fludarabine, ibritumomab tiuxetan [2] ---> SmPC of [2] of EMA
The risk of haematological toxicity may be increased when ibritumomab tiuxetan is administered shortly (< 4 months) after fludarabine-containing regimens
Fludarabine, pentostatine [2] ---> SmPC of [2] of eMC
The combined use of pentostatin and fludarabine phosphate is not recommended because it has been associated with an increased risk of fatal pulmonary toxicity.
Fludarabine, rituximab [2] ---> SmPC of [2] of EMA
In CLL patients, co-administration with rituximab did not appear to have an effect on the pharmacokinetics of fludarabine. In addition, there was no apparent effect of fludarabine on the pharmacokinetics of rituximab.
Fludarabine, thiotepa [2] ---> SmPC of [2] of EMA
The concomitant use of thiotepa and other myelosuppressive or myelotoxic agents may potentiate the risk of haematologic adverse reactions due to overlapping toxicity profiles of these medicinal products.
CONTRAINDICATIONS of Fludarabine
- Hypersensitivity to the active substance or to any of the excipients
- Renal impairment with creatinine clearance < 30 ml/min
- Decompensated haemolytic anaemia
- Lactation
http://www.medicines.org.uk/emc/
Flumazenil
Ability to drive, flumazenil [2] ---> SmPC of [2] of eMC
Patients who have received flumazenil to reverse the effects of benzodiazepine sedation should be warned not to drive, to operate machinery or to engage in any other physically or mentally demanding activity for at least 24 hours
Benzodiazepine analogues, flumazenil [2] ---> SmPC of [2] of eMC
Flumazenil antagonizes the central effects of benzodiazepine analog by competitive interaction at the receptor
Benzodiazepines, flumazenil [2] ---> SmPC of [2] of eMC
Flumazenil antagonizes the central effects of benzodiazepines by competitive interaction at the receptor
Breast-feeding, flumazenil [2] ---> SmPC of [2] of eMC
Like other benzodiazepine compounds, Flumazenil Injection is expected to enter into breast milk, although the total quantities involved would be small. Emergency use of Flumazenil Injection during lactation is not contraindicated.
Flumazenil [1], pregnancy ---> SmPC of [1] of eMC
Like other benzodiazepine compounds, Flumazenil Injection is expected to cross the placenta.
CONTRAINDICATIONS of Flumazenil
- Flumazenil Injection is contraindicated in patients with known hypersensitivity to flumazenil, benzodiazepines or any of the excipients.
- Flumazenil Injection is contraindicated in patients who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g. control of intracranial pressure or status epilepticus).
- In mixed intoxications with benzodiazepines and tricyclic and/or tetracyclic antidepressants, the toxicity of the antidepressants can be masked by protective benzodiazepine effects. In the presence of autonomic (anticholinergic), neurological (motor abnormalities) or cardiovascular symptoms of severe intoxication with tricyclics/tetracyclics,
Flumazenil Injection should not be used to reverse benzodiazepine effects.
http://www.medicines.org.uk/emc/
Flunarizine
Ability to drive, flunarizine
Somnolence may occur
Alcohol, flunarizine
Concomitant use of flunarizine with alcohol, hypnotics or other tranquilizers may enhance the sedative effect of flunarizine
Antiepileptics, flunarizine
Concomitant use of anticonvulsivant drugs may accelerate the metabolism of flunarizine
Breast-feeding, flunarizine
A decision must be made whether to discontinue breastfeeding or to abstain from flunarizine therapy
Ethinylestradiol/gestodene, flunarizine
It has been observed that concomitant use of flunarizine and oral contraceptives increases the risk of galactorrhea
Flunarizine, hypnotics
Concomitant use of flunarizine with alcohol, hypnotics or other tranquilizers may enhance the sedative effect of flunarizine
Flunarizine, oral contraceptives
It has been observed that concomitant use of flunarizine and oral contraceptives increases the risk of galactorrhea
Flunarizine, pregnancy
As a precautionary measure, it is preferable to avoid the use of flunarizine during pregnancy.
Flunarizine, sumatriptan [2] ---> SmPC of [2] of eMC
Studies in healthy subjects show that sumatriptan does not interact with flunarizine
Flunarizine, tranquilizers
Concomitant use of flunarizine with alcohol, hypnotics or other tranquilizers may enhance the sedative effect of flunarizine
Flunitrazepam
Ability to drive, flunitrazepam
Sedation, amnesia, decreased concentration ability and muscle function alteration may occur
Alcohol, flunitrazepam
The alcohol consumption should be avoided during the treatment
Antidepressants, flunitrazepam
The co-administration may cause a mutual potentiation of effects
Antiepileptics, flunitrazepam
The co-administration may cause a mutual potentiation of effects
Anxiolytics, flunitrazepam
The co-administration may cause a mutual potentiation of effects
Aprepitant, flunitrazepam
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
Atazanavir, flunitrazepam
The strong CYP3A4 inhibition may increase the plasma concentrations of flunitrazepam
Azole antifungals, flunitrazepam
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Breast-feeding, flunitrazepam
Contraindicated
Cimetidine, flunitrazepam
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Clarithromycin, flunitrazepam
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
CNS depressants, flunitrazepam
The co-administration may cause a mutual potentiation of effects
Darunavir, flunitrazepam
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Enzyme inhibitors, flunitrazepam
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines.
Erythromycin, flunitrazepam
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Fluconazole, flunitrazepam
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam [1], pregnancy ---> SmPC of [1] of eMC
Strict indication
Flunitrazepam, gemfibrozil
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, grapefruit juice
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, hypnotics
The co-administration may cause a mutual potentiation of effects.
Flunitrazepam, itraconazol
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, ketoconazole
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, levomethadone
The enzymatic induction may decrease the plasma levels of levomethadone and abstinence syndrome may occur
Flunitrazepam, lithium
The co-administration may cause a mutual potentiation of effects
Flunitrazepam, macrolide antibiotics
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, muscle relaxants
The co-administration may enhance the muscle relaxant effect
Flunitrazepam, narcotic analgesics
The co-administration may enhance the effects, increase euphoria and contribute to an increase in psychical dependence. A respiratory depression cannot be excluded
Flunitrazepam, nefazodone
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, neuroleptics
The co-administration may cause a mutual potentiation of effects
Flunitrazepam, protease inhibitors
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, sedating antihistamines
The co-administration may cause a mutual potentiation of effects
Flunitrazepam, sedatives
The co-administration may cause a mutual potentiation of effects
Flunitrazepam, strong CYP3A4 inhibitors
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, telithromycin
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, tipranavir
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Flunitrazepam, verapamil
Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded
Fluocinolone
Breast-feeding, fluocinolone
Should not be used in breast-feeding unless clearly necessary
Fluocinolone acetonide, pregnancy
Use in pregnancy is not recommended unless clearly necessary
Fluocinolone, pregnancy
Use in pregnancy is not recommended unless clearly necessary
Fluorescein
Ability to drive, fluorescein [2] ---> SmPC of [2] of eMC
If mydriasis is necessary for the examination with fluorescence angiography visual acuity is influenced and thus affects the ability to react in traffic or use machinery.
Betablockers, fluorescein [2] ---> SmPC of [2] of eMC
The concomitant use of fluorescein solution for injection with beta-blocking agents (including eye-drops solutions) may rarely provoke severe anaphylactic reactions
Breast-feeding, fluorescein [2] ---> SmPC of [2] of eMC
Fluorescein sodium is excreted in human milk for up to 4 days. Following fluorescein angiography, breast-feeding should therefore be discontinued for 4 days and the milk should be pumped off and discarded during this period.
Fluorescein [1], OAT inhibitors ---> SmPC of [1] of eMC
Compounds that inhibit or compete with the active transport of organic anions may affect the systemic profile of fluorescein.
Fluorescein [1], OAT1 inhibitors ---> SmPC of [1] of eMC
Compounds that inhibit or compete with the active transport of organic anions may affect the systemic profile of fluorescein.
Fluorescein [1], OAT2 inhibitors ---> SmPC of [1] of eMC
Compounds that inhibit or compete with the active transport of organic anions may affect the systemic profile of fluorescein.
Fluorescein [1], OAT3 inhibitors ---> SmPC of [1] of eMC
Compounds that inhibit or compete with the active transport of organic anions may affect the systemic profile of fluorescein.
Fluorescein [1], pregnancy ---> SmPC of [1] of eMC
Due to limited experience, caution should be exercised when considering the use of solution for injection during pregnancy.
Fluorescein [1], probenecide ---> SmPC of [1] of eMC
Compounds that inhibit or compete with the active transport of organic anions may affect the systemic profile of fluorescein.
CONTRAINDICATIONS of Fluorescein
- Hypersensitivity to the active substance or to any of the excipients.
- Anatera 100 mg/ml solution for injection should not be injected intrathecally or intra-arterial.
http://www.medicines.org.uk/emc/
Fluorouracil
Ability to drive, fluorouracil [2] ---> SmPC of [2] of eMC
Fluorouracil may induce side effects such as nausea and vomiting. It can also produce adverse event on nervous system and visual changes which could interfere driving or the usage of heavy machinery.
Allopurinol, fluorouracil
Allopurinol may decrease the efficacy and toxicity of fluorouracil
Amiloride/hydrochlorothiazide, fluorouracil
The co-administration of amiloride/hydrochlorothiazide and cytostatic agents may increase the risk of myelotoxicity (particularly granulocytopenia)
Aminophenazone, fluorouracil
It is not recommended to administer aminophenazone neither before nor during the treatment with fluorouracil
Anthracyclines, fluorouracil [2] ---> SmPC of [2] of eMC
The cardiotoxicity of anthracyclines may be increased.
Atenolol/chlortalidone, fluorouracil
Increased bone marrow toxicity (especially granulocytopenia)
Breast-feeding, fluorouracil [2] ---> SmPC of [2] of eMC
Since it is not known whether fluorouracil passes into breast milk, breast-feeding must be discontinued if the mother is treated with fluorouracil.
Brivudine, fluorouracil
Co-administration of brivudine with chemotherapeutic drugs (particularly 5-FU, including its topic preparations and prodrugs) and other 5-fluoropyrimidines is contraindicated
Bromelain, fluorouracil
Bromelain may enhance the actions of fluorouracil
Carmustine, fluorouracil
The co-administration of carmustine with other myelosuppressive agents may increase the myelotoxicity (thrombopenia and leucopenia)
Chlordiazepoxide, fluorouracil
The co-administration may enhance the effect of fluorouracil
Cimetidine, fluorouracil [2] ---> SmPC of [2] of eMC
Cimetidine may increase the plasma level of 5-fluorouracil, thereby increasing the toxicity of 5-fluorouracil.
Cisplatin, fluorouracil
The co-administration may increase the efficacy and toxicity of fluorouracil
Clozapine, fluorouracil [2] ---> SmPC of [2] of eMC
Fluorouracil should be avoided in combination with clozapine due to increased risk of agranulocytosis.
Cyclophosphamide, fluorouracil
The co-administration may increase the efficacy and toxicity of fluorouracil
Cytostatics, fluorouracil [2] ---> SmPC of [2] of eMC
Fluorouracil enhances the action of other cytostatic drugs
Dihydropyrimidine dehydrogenase inhibitors, fluorouracil ---> SmPC of [capecitabine] of EMA
The inhibition of dihydropyrimidine dehydrogenase increases the plasma levels of fluorouracil. Contraindicated. A period of at least 4 weeks should elapse between them.
Disulfiram, fluorouracil
The co-administration may enhance the effect of fluorouracil
Doxorubicine [1], fluorouracil ---> SmPC of [1] of eMC
Doxorubicin cardiotoxicity is enhanced by previous or concurrent use of other potentially cardiotoxic drugs. When doxorubicin is used together, cardiac function must be followed carefully.
Enalapril/hydrochlorothiazide [1], fluorouracil ---> SmPC of [1] of eMC
Thiazides may reduce the renal excretion of cytotoxic drugs and potentiate their myelosuppressive effects.
Epirubicin [1], fluorouracil ---> SmPC of [1] of eMC
The use of epirubicin in combination chemotherapy with other potentially cardiotoxic drugs requires monitoring of cardiac function throughout treatment.
Filgrastim [1], fluorouracil ---> SmPC of [1] of EMA
Preliminary evidence from a small number of patients treated concomitantly with filgrastim and 5-Fluorouracil indicates that the severity of neutropenia may be exacerbated.
Fluorouracil [1], folinic acid ---> SmPC of [1] of eMC
The toxicity profile of 5-fluorouracil may be enhanced or shifted by folinic acid The most common manifestations are leucopenia, mucositis, stomatitis and/or diarrhoea which may be dose limiting.
Fluorouracil [1], interferon ---> SmPC of [1] of eMC
Interferons may increase the plasma level of 5-fluorouracil, thereby increasing the toxicity of 5-fluorouracil.
Fluorouracil [1], levamisole ---> SmPC of [1] of eMC
Hepatotoxicity (increase in alkaline phosphatases, transaminases or bilirubin) has been observed commonly in patients receiving 5-fluorouracil in combination with levamisole.
Fluorouracil [1], metronidazole ---> SmPC of [1] of eMC
Metronidazole may increase the plasma level of 5-fluorouracil, thereby increasing the toxicity of 5-fluorouracil.
Fluorouracil [1], myelosuppressive agents ---> SmPC of [1] of eMC
In combination with other myelosuppressive substances, dosage adjustment is necessary.
Fluorouracil [1], nucleoside analogues ---> SmPC of [1] of eMC
In the case of accidental administration of nucleoside analogues to patients treated with fluorouracil, effective measures should be taken to reduce fluorouracil toxicity. Immediate hospitalisation is recommended.
Fluorouracil [1], pregnancy ---> SmPC of [1] of eMC
There are no adequate and well-controlled studies in pregnant women, however, fetal defects and miscarriages have been reported.
Fluorouracil [1], radiotherapy ---> SmPC of [1] of eMC
Concomitant or previous radiation therapy may require dosage reduction
Fluorouracil [1], sorivudine ---> SmPC of [1] of eMC
Nucleoside analogues, e.g. brivudine and sorivudine, which affect DPD activity may cause increased plasma concentrations and increased toxicity of fluoropyrimidines. Therefore, an interval of at least 4 weeks between administrations should be kept.
Fluorouracil [1], thiazides ---> SmPC of [1] of eMC
Addition of thiazide diuretics resulted in a more pronounced decrease of the number of granulocytes
Fluorouracil [1], vaccinations with live organism vaccines ---> SmPC of [1] of eMC
Vaccination with live vaccines should be avoided in immunocompromised patients.
Fluorouracil [1], vinorelbine ---> SmPC of [1] of eMC
Serious, potentially life-threatening mucositis may occur following co-administration of vinorelbine and 5-fluorouracil/folinic acid.
Fluorouracil, folic acid
Folic acid enhances the activity of fluorouracil in colorectal cancer
Fluorouracil, fosphenytoin [2] ---> SmPC of [2] of eMC
CYP2C9 inhibition may increase plasma phenytoin concentrations
Fluorouracil, griseofulvin
The co-administration may enhance the effect of fluorouracil
Fluorouracil, interferon alfa
The co-administration may increase the efficacy and toxicity of fluorouracil
Fluorouracil, irinotecan [2] ---> SmPC of [2] of eMC
Coadministration of 5-fluorouracil/folinic acid in the combination regimen does not change the pharmacokinetics of irinotecan.
Fluorouracil, isoniazid
The co-administration may enhance the effect of fluorouracil
Fluorouracil, levofolinate
The combination is contraindicated in existing contraindications against fluorouracil and severe diarrhoea
Fluorouracil, methotrexate [2] ---> SmPC of [2] of EMA
One should be aware of pharmacokinetic interactions between methotrexate, anticonvulsant medicinal products (reduced methotrexate blood levels), and 5-fluorouracil (increased t½ of 5-fluorouracil).
Fluorouracil, mytomicin
The long-term co-administration may cause a hemolytic uremic syndrome
Fluorouracil, oral anticoagulants
Fluorouracil may increase the anticoagulant effect
Fluorouracil, pegfilgrastim [2] ---> SmPC of [2] of EMA
In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Fluorouracil, phenylbutazone
It is not recommended to administer phenylbutazone neither before nor during the treatment with fluorouracil
Fluorouracil, phenytoin [2] ---> SmPC of [2] of eMC
In patients receiving phenytoin and fluorouracil concomitantly, an increase of phenytoin plasma concentration has been reported resulting in symptoms of phenytoin toxicity.
Fluorouracil, proteolytic enzymes enriched in bromelain [2] ---> SmPC of [2] of EMA
Bromelain may enhance the actions of fluorouracil
Fluorouracil, sulphamides
It is not recommended to administer sulfonamides neither before nor during the treatment with fluorouracil
Fluorouracil, sulphonamides
It is not recommended to administer sulfonamides neither before nor during the treatment with fluorouracil
Fluorouracil, tamoxifen
Fluorouracil may increase the plasma levels of tamoxifen.
Fluorouracil, tegafur/gimeracil/oteracil [2] ---> SmPC of [2] of EMA
Co-administration of other fluoropyrimidines can lead to additive toxicities, and is contraindicated. A minimum washout period of 7 days is recommended between administration of tegafur/gimeracil/oteracil and other fluoropyrimidines.
Fluorouracil, thiamine
Fluorouracil inactivates thiamine due to fluorouracil inhibits competitively the phosphorylation of thiamine to thiamine pyrophosphate
Fluorouracil, triamterene/hydrochlorothiazide
The co-administration of hydrochlorothiazide und cytostatic agents (e. g. cyclophosphamide, fluorouracil, methotrexate) may increase the myelotoxicity (particularly granulocytopenia)
Fluorouracil, vincristine
The co-administration may increase the efficacy and toxicity of fluorouracil
Fluorouracil, vitamin B1
Fluorouracil inactivates thiamine due to fluorouracil inhibits competitively the phosphorylation of thiamine to thiamine pyrophosphate
Fluorouracil, warfarin [2] ---> SmPC of [2] of eMC
Marked elevations of prothrombin time and INR have been reported in a few patients stabilised on warfarin therapy following initiation of fluorouracil regimes.
Fluorouracil, xipamide
Risk of enhanced bone marrow toxicity
CONTRAINDICATIONS of Fluorouracil
Hypersensitivity to the fluorouracil or to any of the excipients.
Fluorouracil is contraindicated in the following
- Serious infections (e.g. Herpes zoster, chickenpox).
- Seriously debilitated patients.
- Bone marrow depression after radiotherapy or treatment with other antineoplastic agents.
- Management of non-malignant disease
- Serious liver impairment
- Fluorouracil (5-FU) must not be given in combination with brivudin, sorivudin and analogues. Brivudin, sorivudin und analogues are potent inhibitors of the 5-FU-metabolising enzyme dihydropyrimidine dehydrogenase (DPD)
- Fluorouracil (5-FU) must not be given to patients homozygotic for dihydropyrimidine dehydrogenase (DPD).
- Fluorouracil is strictly contraindicated in pregnant or breast feeding women.
http://www.medicines.org.uk/emc/
Fluoxetine
Ability to drive, fluoxetine [2] ---> SmPC of [2] of eMC
Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive drug may impair judgement or skills.
Acenocoumarol [1], fluoxetine ---> SmPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Acetylsalicylic acid, fluoxetine [2] ---> SmPC 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.
Alcohol, fluoxetine [2] ---> SmPC of [2] of eMC
In formal testing, fluoxetine did not raise blood alcohol levels or enhance the effects of alcohol. However, the combination of SSRI treatment and alcohol is not advisable.
Alcohol, SSRI ---> SmPC of [fluoxetine] of eMC
In formal testing, fluoxetine did not raise blood alcohol levels or enhance the effects of alcohol. However, the combination of SSRI treatment and alcohol is not advisable.
Alprazolam, fluoxetine
Concomitant use of alprazolam and strong CYP3A4 inhibitors should be done with caution a significant dose reduction should be considered
Amitriptyline [1], fluoxetine ---> SmPC of [1] of eMC
Plasma concentrations of amitriptyline are increased by cimetidine (inhibition of metabolism).
Aripiprazole [1], fluoxetine ---> SmPC of [1] of EMA
Strong inhibitors of CYP2D6 may increase the AUC of aripiprazole. A dose reduction should, therefore, be applied
Atenolol/nifedipine [1], fluoxetine ---> SmPC of [1] of eMC
The CYP3A4 inhibition may increase the plasma concentrations of nifedipine
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
Atypical neuroleptics, fluoxetine [2] ---> SmPC 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.
Benperidol, fluoxetine [2] ---> SmPC of [2] of eMC
Fluoxetine may cause an increase in the plasma concentration of benperidol necessitating a dose modification.
Bimatoprost/timolol [1], fluoxetine ---> SmPC of [1] of EMA
Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.
Breast-feeding, fluoxetine [2] ---> SmPC of [2] of eMC
If treatment with fluoxetine is considered necessary, discontinuation of breastfeeding should be considered; however, if breastfeeding is continued, the lowest effective dose of fluoxetine should be prescribed.
Brinzolamide/timolol [1], fluoxetine ---> SmPC of [1] of EMA
Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.
Bromperidol, fluoxetine
The co-administration may increase the plasma levels of bromperidol
Buflomedil, fluoxetine
The risk of neurological adverse effects increases if buflomedil is administered with CYP2D6 inhibitors to patients with renal or hepatic disorder
Carbamazepine, fluoxetine [2] ---> SmPC of [2] of eMC
Concomitant therapy of flecainide with drugs predominantly metabolised by CYP2D6, and which have a narrow therapeutic index, should be initiated at or adjusted to the low end of their dose range.
Carvedilol [1], fluoxetine ---> SmPC of [1] of eMC
The enzymatic inhibition may increase the plasma levels of carvedilol
Chloral hydrate, fluoxetine
The co-administration prolongs the effect of chloral hydrate
Clomipramine [1], fluoxetine ---> SmPC of [1] of eMC
SSRIs which are inhibitors of CYP2D6, such as fluoxetine, paroxetine, or sertraline, and of others including CYP1A2 and CYP2C19 (e.g. fluvoxamine), may increase plasma concentrations of clomipramine, with corresponding adverse effects.
Clopidogrel [1], fluoxetine ---> SmPC of [1] of EMA
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Clopidogrel/acetylsalicylic acid [1], fluoxetine ---> SmPC of [1] of EMA
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Clozapine [1], fluoxetine ---> SmPC of [1] of eMC
Concomitant administration of substances known to inhibit the activity of some cytochrome P450 isozymes (CYP2D6) may increase the levels of clozapine, and the dose of clozapine may need to be reduced to prevent undesirable effects.
Cyclophosphamide, fluoxetine
The CYP2B6 and CYP3A4 inhibition may decrease the efficacy of cyclophosphamide (prodrug)
Dapoxetine [1], fluoxetine ---> SmPC of [1] of eMC
The Cmax of the active fraction may be increased by approximately 50% and the AUC of the active fraction may be doubled if taken dapoxetine with potent CYP2D6 inhibitors
Dextromethorphan, fluoxetine
The CYP2D6 inhibition may increase the plasma concentrations of dextromethorphan
Diazepam [1], fluoxetine ---> SmPC of [1] of eMC
The CYP 2C19 inhibition may increase the plasma levels of diazepam
Digitoxin, fluoxetine
The CYP3A4 inhibition may increase the plasma levels of digitoxin
Donepezil [1], fluoxetine ---> SmPC of [1] of eMC
The strong CYP2D6 inhibition may increase the plasma concentrations of donepezil.
Dorzolamide/timolol [1], fluoxetine ---> SmPC of [1] of eMC
Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.
Droperidol [1], fluoxetine ---> SmPC of [1] of eMC
Medicinal products known to prolong the QTc interval should not be concomitantly administered with droperidol.
Drugs primarily metabolised by CYP2D6 with narrow therapeutic index, fluoxetine [2] ---> SmPC of [2] of eMC
Concomitant therapy of flecainide with drugs predominantly metabolised by CYP2D6, and which have a narrow therapeutic index, should be initiated at or adjusted to the low end of their dose range.
Drugs primarily metabolised by CYP2D6, fluoxetine [2] ---> SmPC of [2] of eMC
Because fluoxetine's metabolism involves the hepatic cytochrome CYP2D6 isoenzyme system, concomitant therapy with drugs also metabolised by this enzyme system may lead to drug interactions.
Drugs with high protein binding, fluoxetine
The co-administration may displace fluoxetine from its protein-bound
Efavirenz [1], fluoxetine ---> SmPC of [1] of EMA
No dose adjustment is necessary for either medicinal product.
Efavirenz/emtricitabine/tenofovir disoproxil [1], fluoxetine ---> SmPC of [1] of EMA
No dosage adjustment necessary.
Electroconvulsive therapy, fluoxetine [2] ---> SmPC of [2] of eMC
There have been rare reports of prolonged seizures in patients on fluoxetine receiving electroconvulsive therapy treatment, therefore caution is advisable.
Eliglustat [1], fluoxetine ---> SmPC of [1] of EMA
A dose of eliglustat 84 mg once daily should be considered when a strong CYP2D6 inhibitor is used concomitantly in intermediate and extensive metabolisers
Encainide, fluoxetine [2] ---> SmPC of [2] of eMC
Concomitant therapy of flecainide with drugs predominantly metabolised by CYP2D6, and which have a narrow therapeutic index, should be initiated at or adjusted to the low end of their dose range.
Felodipine/metoprolol, fluoxetine
CYP2D6 inhibitors may increase the plasma levels of metoprolol
Fentanyl, fluoxetine
The CYP3A4 inhibition may increase plasma levels of fentanyl
Flecainide, fluoxetine [2] ---> SmPC of [2] of eMC
Concomitant therapy of flecainide with drugs predominantly metabolised by CYP2D6, and which have a narrow therapeutic index, should be initiated at or adjusted to the low end of their dose range.
Fluoxetine [1], fosphenytoin ---> SmPC of [1] of eMC
Changes in blood levels of phenytoin have been observed when combined with fluoxetine. In some cases manifestations of toxicity have occurred.
Fluoxetine [1], haloperidol ---> SmPC of [1] of eMC
Inhibition of the CYP2D6 by another drug may result in increased haloperidol concentrations and an increased risk of adverse events, including QT-prolongation.
Fluoxetine [1], IMAOs ---> SmPC of [1] of eMC
Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with MAOI, and in patients who have recently discontinued an SSRI and have started on a MAOI.
Fluoxetine [1], insulin ---> SmPC of [1] of eMC
In patients with diabetes, treatment with an SSRI may alter glycaemic control. Hypoglycaemia has occurred during therapy with fluoxetine and hyperglycaemia has developed following discontinuation.
Fluoxetine [1], irreversible MAO-inhibitors ---> SmPC of [1] of eMC
Treatment of fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI
Fluoxetine [1], irreversible non-selective MAO-inhibitors ---> SmPC of [1] of eMC
Fluoxetine is contra-indicated in combination with a non-selective MAOI. Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI
Fluoxetine [1], irreversible selective MAO-B inhibitors ---> SmPC of [1] of eMC
The co-administration may increase the risk of serotoninergic syndrome. Clinical monitoring is recommended.
Fluoxetine [1], lithium ---> SmPC of [1] of eMC
There have been reports of serotonin syndrome when SSRIs have been given with lithium or tryptophan
Fluoxetine [1], lithium carbonate ---> SmPC of [1] of eMC
There have been reports of serotonin syndrome when SSRIs have been given with lithium or tryptophan
Fluoxetine [1], moclobemide ---> SmPC of [1] of eMC
The combination of fluoxetine with a reversible MAOI is not recommended. Treatment with fluoxetine can be initiated the following day after discontinuation of a reversible MAOI (e.g. moclobemide).
Fluoxetine [1], NSAID ---> SmPC of [1] 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.
Fluoxetine [1], oral anticoagulants ---> SmPC of [1] of eMC
Altered anti-coagulant effects (laboratory values and/or clinical signs and symptoms), with no consistent pattern, but including increased bleeding, have been reported uncommonly when fluoxetine is co-administered with oral anticoagulants.
Fluoxetine [1], oral antidiabetics ---> SmPC of [1] of eMC
In patients with diabetes, treatment with an SSRI may alter glycaemic control. Hypoglycaemia has occurred during therapy with fluoxetine and hyperglycaemia has developed following discontinuation.
Fluoxetine [1], phenothiazines ---> SmPC of [1] 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.
Fluoxetine [1], phenytoin ---> SmPC of [1] of eMC
Changes in blood levels of phenytoin have been observed when combined with fluoxetine. In some cases manifestations of toxicity have occurred.
Fluoxetine [1], platelet aggregation inhibitors ---> SmPC of [1] 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.
Fluoxetine [1], pregnancy ---> SmPC of [1] of eMC
Fluoxetine can be used during pregnancy, but caution should be exercised, especially during late pregnancy or just prior to the onset of labour since the following effects have been reported in neonates
Fluoxetine [1], reversible non-selective MAO-inhibitors ---> SmPC of [1] of eMC
Fluoxetine is contra-indicated in combination with a non-selective MAOI. Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI
Fluoxetine [1], selegiline ---> SmPC of [1] of eMC
The co-administration may increase the risk of serotoninergic syndrome. Clinical monitoring is recommended.
Fluoxetine [1], serotonergic medicines ---> SmPC of [1] of eMC
Co-administration of fluoxetine with serotonergic drugs may increase the risk of serotonin syndrome.
Fluoxetine [1], serotonin agonists ---> SmPC of [1] of eMC
Co-administration of fluoxetine with serotonergic drugs may increase the risk of serotonin syndrome.
Fluoxetine [1], St. John's wort ---> SmPC of [1] of eMC
An increase in serotonergic effects, such as serotonin syndrome, may occur when selective serotonin reuptake inhibitors and herbal preparations containing St John's Wort (Hypericum perforatum) are used together.
Fluoxetine [1], tramadol ---> SmPC of [1] of eMC
Co-administration of fluoxetine with serotonergic drugs may increase the risk of serotonin syndrome.
Fluoxetine [1], tricyclic antidepressant ---> SmPC of [1] of eMC
Concomitant therapy of flecainide with drugs predominantly metabolised by CYP2D6, and which have a narrow therapeutic index, should be initiated at or adjusted to the low end of their dose range.
Fluoxetine [1], triptans ---> SmPC of [1] of eMC
Co-administration of fluoxetine with serotonergic drugs may increase the risk of serotonin syndrome. Use with triptans carries the additional risk of coronary vasoconstriction and hypertension.
Fluoxetine [1], tryptophan ---> SmPC of [1] of eMC
There have been reports of serotonin syndrome when SSRIs have been given with lithium or tryptophan
Fluoxetine [1], warfarin ---> SmPC of [1] of eMC
Altered anti-coagulant effects (laboratory values and/or clinical signs and symptoms), with no consistent pattern, but including increased bleeding, have been reported uncommonly when fluoxetine is co-administered with oral anticoagulants.
Fluoxetine, fluphenazine
The co-administration of fluphenazine with drugs that may increase the plasma levels of fluphenazine should be avoided
Fluoxetine, frovatriptan [2] ---> SmPC of [2] of eMC
Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome. Strict adherence to the recommended dose is an essential factor to prevent this syndrome.
Fluoxetine, galantamine [2] ---> SmPC of [2] of eMC
The co-administration of galantamine with strong CYP2D6 inhibitors may increase the bioavailability of galantamine and the incidence of cholinergic adverse reactions, predominantly nausea and vomiting.
Fluoxetine, glibenclamide [2] ---> SmPC of [2] of EMA
The co-administration may enhance the hypoglycemic effect
Fluoxetine, glimepiride [2] ---> SmPC of [2] of eMC
Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia
Fluoxetine, hydroxyzine
Hydroxyzine is an inhibitor of CYP2D6 and may cause drug-drug interactions with CYP2D6 substrates.
Fluoxetine, imipramine [2] ---> SmPC of [2] of eMC
Combination of SSRIs a. imipramine may lead to additive effects on the serotonergic system. Fluoxetine may increase imipramine plasma levels, resulting in increased plasma levels of tricyclic antidepressants, a lowered convulsion threshold
Fluoxetine, insulin glargin [2] ---> SmPC of [2] of EMA
Enhanced blood-glucose-lowering effect and increased susceptibility to hypoglycaemia
Fluoxetine, insulin glargine/lixisenatide [2] ---> SmPC of [2] of EMA
This substance may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia.
Fluoxetine, insulin glulisin [2] ---> SmPC of [2] of EMA
Possible enhancement of blood-glucose-lowering activity and increased susceptibility to hypoglycaemia
Fluoxetine, iproniazid
Fluoxetine is contra-indicated in combination with a non-selective MAOI. Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI
Fluoxetine, latanoprost/timolol [2] ---> SmPC of [2] of eMC
Potentiated systemic beta-blockade (e.g. decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.
Fluoxetine, lercanidipine [2] ---> SmPC of [2] of eMC
An interaction study with fluoxetine (an inhibitor of CYP2D6 and CYP3A4) has shown no clinically relevant modification of the pharmacokinetics of lercanidipine.
Fluoxetine, levomepromazine [2] ---> SmPC of [2] of eMC
Co-administration of levomepromazine and drugs primarily metabolised by the CYP2D6 may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic or adverse effects of those drugs.
Fluoxetine, lofepramine [2] ---> SmPC of [2] of eMC
Co-medication of lofepramine with SSRI inhibitors may lead to additive effects on the serotonergic system. Coadministration with fluoxetine may increase lofepramine plasma levels resulting in a lowered convulsion threshold and seizures.
Fluoxetine, lomitapide [2] ---> SmPC 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.
Fluoxetine, mequitazine
Mequitazine should not be used with CYP2D6 inhibitor drugs. The increased plasma levels of mequitazine may increase the risk of QT interval prolongation
Fluoxetine, metoclopramide
The strong CYP2D6 inhibition may increase the plasma levels of metoclopramide
Fluoxetine, nebivolol [2] ---> SmPC of [2] of eMC
The CYP2D6 inhibition may lead to increased plasma levels of nebivolol (metabolized by CYP2D6) that is associated with an increased risk of excessive bradycardia and adverse events.
Fluoxetine, nelfinavir [2] ---> SmPC of [2] of EMA
Co-administration of nelfinavir with inhibitors of CYP2C19 may be expected to reduce the conversion of nelfinavir to its major active metabolite M8 (tert-butyl hydroxy nelfinavir) with a concomitant increase in plasma nelfinavir levels
Fluoxetine, nifedipine [2] ---> SmPC of [2] of eMC
The CYP3A4 inhibition may increase the plasma concentrations of nifedipine
Fluoxetine, nimodipine [2] ---> SmPC of [2] of eMC
Upon co-administration of nimodipine with CYP3A4 inhibitors the blood pressure should be monitored and, if necessary, an adaptation in the nimodipine dose should be considered.
Fluoxetine, nisoldipine
The CYP3A4 inhibition may increase the plasma concentrations of nisoldipine
Fluoxetine, nitrendipine
The CYP3A4 inhibition may increase the plasma concentrations of nitrendipine
Fluoxetine, olanzapine [2] ---> SmPC of [2] of EMA
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Fluoxetine, opipramol
The co-administration may increase the plasma levels of tricyclic antidepressant and potentiated the adverse effects
Fluoxetine, paclitaxel [2] ---> SmPC of [2] of EMA
The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4. Therefore, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4.
Fluoxetine, pimozide [2] ---> SmPC of [2] of eMC
Pimozide is contraindicated with concomitant use of serotonin uptake inhibitors
Fluoxetine, pioglitazone/glimepiride [2] ---> SmPC of [2] of EMA
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur
Fluoxetine, pirfenidone [2] ---> SmPC 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
Fluoxetine, pitolisant [2] ---> SmPC of [2] of EMA
Given the 2-fold increase of pitolisant exposure, its coadministration with CYP2D6 inhibitors should be done with caution. A dosage adjustment during the combination could eventually be considered.
Fluoxetine, propafenone
Elevated levels of plasma propafenone may occur when propafenone is used concomitantly with selective serotonin reuptake inhibitors. Lower doses of propafenone may be sufficient to achieve the desired therapeutic response.
Fluoxetine, quetiapine [2] ---> SmPC of [2] of eMC
The pharmacokinetics of quetiapine were not significantly altered by co-administration of the antidepressants imipramine (a known CYP 2D6 inhibitor) or fluoxetine (a known CYP 3A4 and CYP 2D6 inhibitor)
Fluoxetine, rasagiline [2] ---> SmPC of [2] of EMA
At least 5 weeks should elapse between discontinuation of fluoxetine and initiation of treatment with rasagiline. At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine.
Fluoxetine, reboxetine [2] ---> SmPC of [2] of eMC
In an in vivo study performed in healthy volunteers, no clinically significant interaction between fluoxetine and reboxetine was observed. In patients, a different effect and safety profile upon combination of reboxetine and fluoxetine cannot be excluded
Fluoxetine, risperidone [2] ---> SmPC of [2] of eMC
Fluoxetine, CYP 2D6 inhibitor, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction.
Fluoxetine, ritonavir [2] ---> SmPC of [2] of EMA
Ritonavir dosed as an antiretroviral agent is likely to inhibit CYP2D6 and as a result is expected to increase concentrations of imipramine, amitriptyline, nortriptyline, fluoxetine, paroxetine or sertraline.
Fluoxetine, safinamide [2] ---> SmPC of [2] of EMA
The concomitant use of safinamide and fluoxetine should be avoided, this precaution is based on the occurrence of rare serious adverse reactions (e.g. serotonin syndrome) that have occurred when SSRIs have been used with MAO inhibitors.
Fluoxetine, sertindole
The plasma concentration of sertindole is increased in patients concurrently taking potent CYP2D6 inhibitors; sertindole should therefore only be used concomitantly with CYP2D6 inhibitors with extreme caution.
Fluoxetine, sodium valproate
The co-administration may increase the plasma levels of valproate or sometimes decrease them
Fluoxetine, stiripentol [2] ---> SmPC of [2] of EMA
Stiripentol is an inhibitor of the enzymes CYP2D6 and may markedly increase the plasma concentrations of substances metabolised by these enzymes and increase the risk of adverse reactions
Fluoxetine, strong CYP2D6 inhibitors
The strong CYP2D6 inhibition may increase plasma concentrations of fluoxetine
Fluoxetine, tamoxifen [2] ---> SmPC of [2] of eMC
Concomitant medications that inhibit CYP2D6 may lead to reduced concentrations of the active metabolite endoxifen. Therefore, potent inhibitors of CYP2D6 should whenever possible be avoided during tamoxifen treatment
Fluoxetine, tedisamil
Tedisamil, strong CYP2D6 inhibitor, may increase the plasma concentrations of fluoxetine
Fluoxetine, terfenadine
The CYP3A4 inhibition may increase the terfenadine plasma levels and prolong the QT interval (risk of life-threatening arrythmias). The combination is contraindicated
Fluoxetine, tetrabenazine [2] ---> SmPC of [2] of eMC
Inhibitors of CYP2D6 may result in increased plasma concentrations of the active metabolite dihydrotetrabenazine, why they should only be combined with caution. A reduction of the tetrabenazine dose may be necessary.
Fluoxetine, thioridazine
The CYP2D6 inhibition may increase the plasma levels of thioridazine and the risk of QT interval prolongation. The co-administration is contraindicated
Fluoxetine, timolol ---> SmPC of [travoprost/timolol] of EMA
Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.
Fluoxetine, tolterodine [2] ---> SmPC of [2] of eMC
Concomitant treatment with fluoxetine (a potent CYP2D6 inhibitor) does not result in a clinically significant interaction since tolterodine and its CYP2D6-dependent metabolite, 5-hydroxymethyl tolterodine are equipotent.
Fluoxetine, travoprost/timolol [2] ---> SmPC of [2] of EMA
Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.
Fluoxetine, trazodone [2] ---> SmPC of [2] of eMC
Rare cases have been reported of elevated trazodone plasma levels and adverse effects when trazodone had been combined with fluoxetine, a CYP1A2/2D6 inhibitor. A pharmacodynamic interaction (serotonine syndrome) could not be excluded.
Fluoxetine, trimipramine
The previous or concomitant treatment of SSRIs with trimipramine may increase the plasma levels of both antidepressants by substrate competition
Fluoxetine, valproic acid
The co-administration may increase the plasma levels of valproate or sometimes decrease them
Fluoxetine, vortioxetine [2] ---> SmPC of [2] of EMA
Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor is added to vortioxetine treatment
IMAOs, SSRI ---> SmPC of [fluoxetine] of eMC
Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with MAOI, and in patients who have recently discontinued an SSRI and have started on a MAOI.
Lithium, SSRI ---> SmPC of [fluoxetine] of eMC
There have been reports of serotonin syndrome when SSRIs have been given with lithium or tryptophan
SSRI, tryptophan ---> SmPC of [fluoxetine] of eMC
There have been reports of serotonin syndrome when SSRIs have been given with lithium or tryptophan
CONTRAINDICATIONS of Fluoxetine
- Hypersensitivity to fluoxetine or to any of its excipients.
- Monoamine Oxidase Inhibitors: Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued an SSRI and have started on a MAOI. Treatment of fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI and the following day after discontinuation of a reversible MAOI-A.
- Some cases presented with features resembling serotonin syndrome (which may resemble and be diagnosed as neuroleptic malignant syndrome). Cyproheptadine or dantrolene may benefit patients experiencing such reactions. Symptoms of a drug interaction with a MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma.
- Therefore, fluoxetine is contra-indicated in combination with a non-selective MAOI. Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI. If fluoxetine has been prescribed chronically and/or at a high dose, a longer interval should be considered.
- The combination of fluoxetine with a reversible MAOI is not recommended. Treatment with fluoxetine can be initiated the following day after discontinuation of a reversible MAOI (e.g. moclobemide).
http://www.medicines.org.uk/emc/
Flupentixol
Ability to drive, flupentixol [2] ---> SmPC of [2] of eMC
Alertness may be impaired, especially at the start of treatment, or following the consumption of alcohol. Patients should not drive if they have blurred vision.
Adrenaline, flupentixol
The co-administration may cause hypotension (paradoxical effect)
Alcohol, flupentixol [2] ---> SmPC of [2] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Alizapride, flupentixol
The co-administration may enhance the extrapyramidal adverse effects
Alpha-methyldopa, flupentixol [2] ---> SmPC of [2] of eMC
Antipsychotics may reverse the antihypertensive effects
Anaesthetics [1], flupentixol ---> SmPC of [1] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Anticholinergics, flupentixol
The anticholinergic effects of other drugs with anticholinergic properties may be increased.
Antidepressants [1], flupentixol ---> SmPC of [1] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Antiepileptics [1], flupentixol ---> SmPC of [1] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Antihypertensives, flupentixol
Increased hypotensive effect
Anxiolytics [1], flupentixol ---> SmPC of [1] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Astemizole, flupentixol
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.
Barbiturates, flupentixol
The enzymatic induction may decrease the plasma levels of flupentixol
Benzatropine, flupentixol
The anticholinergic effects of other drugs with anticholinergic properties may be increased.
Betanidine, flupentixol [2] ---> SmPC of [2] of eMC
Antipsychotics may reverse the antihypertensive effects
Biperiden, flupentixol
The co-administration may weaken the flupentixol effect
Breast-feeding, flupentixol [2] ---> SmPC of [2] of eMC
Flupentixol is excreted into the breast milk. If the use of flupentixol is considered essential, nursing mothers should be advised to stop breast-feeding.
Bromocriptine, flupentixol
The co-administration may weaken the effect of dopamine agonist
Bromopride, flupentixol
The co-administration may enhance the extrapyramidal adverse effects
Caffeine, flupentixol
The co-administration may weaken the neuroleptic effect
Carbamazepine, flupentixol
The enzymatic induction may decrease the plasma levels of flupentixol
Centrally-acting antihypertensives, flupentixol
Decreased antihypertensive effect
Cisapride, flupentixol
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.
Class IA antiarrhythmic agents [1], flupentixol ---> SmPC of [1] 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.
Class III antiarrhythmic agents [1], flupentixol ---> SmPC of [1] 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.
Clonidine, flupentixol [2] ---> SmPC of [2] of eMC
Antipsychotics may reverse the antihypertensive effects
CNS depressants [1], flupentixol ---> SmPC of [1] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Dofetilide, flupentixol
The co-administration of drugs that can prolong the QT interval should be avoided
Dopamine agonists, flupentixol
The co-administration may weaken the effect of dopamine agonist
Dopamine antagonists, flupentixol
The co-administration may enhance the extrapyramidal adverse effects
Electrolyte imbalance, flupentixol
Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) should also be used with caution as they may increase the risk of QT prolongation and malignant arrythmias
Enzyme inductors, flupentixol
The enzymatic induction may decrease the plasma levels of flupentixol
Erythromycin, flupentixol [2] ---> SmPC 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.
Flupentixol [1], guanethidine ---> SmPC of [1] of eMC
Antipsychotics may reverse the antihypertensive effects
Flupentixol [1], hypnotics ---> SmPC of [1] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Flupentixol [1], methyldopa ---> SmPC of [1] of eMC
Antipsychotics may reverse the antihypertensive effects
Flupentixol [1], metoclopramide ---> SmPC of [1] of eMC
Concomitant use of flupentixol with metoclopramide may increase the risk of extrapyramidal effects such as tardive dyskinesia.
Flupentixol [1], neuroleptics ---> SmPC of [1] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Flupentixol [1], pregnancy ---> SmPC of [1] of eMC
As the safety of this drug during pregnancy has not been established, use during pregnancy, especially the first and last trimesters, should be avoided, unless the expected benefit to the patient outweighs the potential risk to the foetus.
Flupentixol [1], quinidine ---> SmPC of [1] 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.
Flupentixol [1], sedatives ---> SmPC of [1] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Flupentixol [1], sotalol ---> SmPC of [1] 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.
Flupentixol, gatifloxacin
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.
Flupentixol, gonadorelin
The co-administration may weaken the gonadorelin effect
Flupentixol, hypokalemia
Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) should also be used with caution as they may increase the risk of QT prolongation and malignant arrythmias
Flupentixol, IMAOs
Caution is recommended with combine flupentixol and MAO inhibitors
Flupentixol, levodopa
The co-administration may weaken the effect of dopamine agonist
Flupentixol, lithium
Combined use of antipsychotics and lithium has been associated with an increased risk of neurotoxicity.
Flupentixol, non-potassium-sparing diuretics
Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) should also be used with caution as they may increase the risk of QT prolongation and malignant arrythmias
Flupentixol, opioid analgesics [2] ---> SmPC of [2] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Flupentixol, phenytoin
Increased plasma levels of phenytoin
Flupentixol, piperazine
Concomitant use of flupentixol with piperazine may increase the risk of extrapyramidal effects such as tardive dyskinesia.
Flupentixol, polypeptide antibiotics
The respiratory depression caused by the polypeptide antibiotic may be enhanced by flupentixol
Flupentixol, propranolol
Mutual increase of plasma levels cannot be excluded
Flupentixol, QT interval prolonging drugs [2] ---> SmPC 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.
Flupentixol, reserpine
The concomitant use is not recommended
Flupentixol, sedating antihistamines [2] ---> SmPC of [2] of eMC
In common with other antipsychotics, flupentixol enhances the response to other CNS depressants.
Flupentixol, terfenadine
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.
Flupentixol, thiazides
Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) should also be used with caution as they may increase the risk of QT prolongation and malignant arrythmias
Flupentixol, thioridazine
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.
Flupentixol, tiapride
Tiapride should not be combined with drugs that prolong the QT interval. These drugs (with the exception of anti-infectious) should be discontinued, if possible, if they induce torsades de pointes
Flupentixol, tricyclic antidepressant
The metabolism of tricyclic antidepressants may be inhibited
CONTRAINDICATIONS of Flupentixol
- Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma.
- Not recommended for excitable or agitated patients.
http://www.medicines.org.uk/emc/
Fluphenazine
Ability to drive, fluphenazine [2] ---> SmPC of [2] of eMC
The use of this drug may impair the mental and physical abilities required for driving a car or operating heavy machinery.
ACE inhibitors, fluphenazine [2] ---> SmPC of [2] of eMC
Concurrent use of phenothiazines and ACE inhibitors may result in severe postural hypotension.
Adrenaline, fluphenazine [2] ---> SmPC of [2] of eMC
Fluphenazine antagonizes the action of adrenaline and other sympathomimetic agents
Adrenoceptor antagonists, fluphenazine [2] ---> SmPC of [2] of eMC
Fluphenazine reverses the blood-pressure lowering effects of adrenergic-blocking agents such as guanethidine and clonidine.
Alcohol, fluphenazine
The co-administration may cause a mutual potentiation of effects
Alizapride, fluphenazine
The co-administration of neuroleptic drugs with dopamine antagonists may enhance the extrapyramidal adverse effects
Alpha-methyldopa, fluphenazine
Decreased antihypertensive effect
Amitriptyline, fluphenazine [2] ---> SmPC of [2] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Amphetamine, fluphenazine [2] ---> SmPC of [2] of eMC
Concurrent use of phenothiazines and amfetamine/anorectic agents may produce antagonistic pharmacological effects.
Analgesics, fluphenazine [2] ---> SmPC of [2] of eMC
Phenothiazines may increase the central nervous system depression produced by other CNS depressants
Anorexics, fluphenazine [2] ---> SmPC of [2] of eMC
Concurrent use of phenothiazines and amfetamine/anorectic agents may produce antagonistic pharmacological effects.
Antacids, fluphenazine
The co-administration of antacids and fluphenazine may decrease the absorption of fluphenazine
Anticholinergics, fluphenazine [2] ---> SmPC of [2] of eMC
Anticholinergic effects may be enhanced by other anticholinergic drugs.
Anticoagulants, fluphenazine [2] ---> SmPC of [2] of eMC
Phenothiazines may impair the action of anti-convulsants.
Anticoagulants, phenothiazines ---> SmPC of [fluphenazine] of eMC
Phenothiazines may impair the action of anti-convulsants.
Antidiabetics, fluphenazine [2] ---> SmPC of [2] of eMC
Phenothiazines may impair the control of diabetes.
Antidiabetics, phenothiazines ---> SmPC of [fluphenazine] of eMC
Phenothiazines may impair the control of diabetes.
Antiepileptics, fluphenazine [2] ---> SmPC of [2] of eMC
Phenothiazines may impair the action of anti-convulsants.
Antihistamines, fluphenazine [2] ---> SmPC of [2] of eMC
Phenothiazines may increase the central nervous system depression produced by other CNS depressants
Antihypertensives, fluphenazine
Increased hypotensive effect
Barbiturates, fluphenazine [2] ---> SmPC of [2] of eMC
Concomitant use of barbiturates with phenothiazines may result in reduced serum levels of both drugs, and an increased response if one of the drugs is withdrawn.
Betablockers, fluphenazine
Betablockers: Plasma levels of both active principles may be increased. It is recommended to reduce the doses of both active principles
Breast-feeding, fluphenazine [2] ---> SmPC of [2] of eMC
Breast feeding is not recommended during treatment with depot fluphenazine, owing to the possibility that fluphenazine is excreted in the breast milk.
Bromocriptine, fluphenazine
The co-administration may weaken the effect of dopamine agonist
Bromopride, fluphenazine
The co-administration of neuroleptic drugs with dopamine antagonists may enhance the extrapyramidal adverse effects
Caffeine, fluphenazine
The co-administration may weaken the neuroleptic effect
Carbamazepine, fluphenazine
The enzymatic induction may decrease the plasma levels of fluphenazine
Cimetidine, fluphenazine
The co-administration of cimetidine and fluphenazine may decrease the plasma levels of fluphenazine
Class IA antiarrhythmic agents, fluphenazine [2] ---> SmPC of [2] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Class III antiarrhythmic agents, fluphenazine [2] ---> SmPC of [2] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Clonidine, fluphenazine [2] ---> SmPC of [2] of eMC
Fluphenazine reverses the blood-pressure lowering effects of adrenergic-blocking agents such as guanethidine and clonidine.
Clonidine, phenothiazines ---> SmPC of [fluphenazine] of eMC
The action of clonidine may be opposed by the phenothiazine
CNS depressants, fluphenazine [2] ---> SmPC of [2] of eMC
The co-administration may cause a mutual potentiation of effects
Corticosteroids, fluphenazine [2] ---> SmPC of [2] of eMC
Phenothiazines may enhance the absorption of corticosteroids
Disopyramide, fluphenazine [2] ---> SmPC of [2] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Dopamine agonists, fluphenazine
The co-administration may weaken the effect of dopamine agonist
Dopamine antagonists, fluphenazine
The co-administration of neuroleptic drugs with dopamine antagonists may enhance the extrapyramidal adverse effects
Electrolyte imbalance, fluphenazine [2] ---> SmPC of [2] of eMC
Electrolyte imbalance, particularly hypokalaemia, greatly increases the risk of QT interval prolongation. Therefore, concurrent use of fluphenazine and drugs that cause electrolyte imbalance should be avoided.
Epinephrine, fluphenazine [2] ---> SmPC of [2] of eMC
Fluphenazine antagonizes the action of adrenaline and other sympathomimetic agents
Evening primrose oil, fluphenazine
Increased risk of convulsive seizures
Fluoxetine, fluphenazine
The co-administration of fluphenazine with drugs that may increase the plasma levels of fluphenazine should be avoided
Fluphenazine [1], general anesthetics ---> SmPC of [1] of eMC
Phenothiazines may increase the central nervous system depression produced by other CNS depressants
Fluphenazine [1], guanethidine ---> SmPC of [1] of eMC
Fluphenazine reverses the blood-pressure lowering effects of adrenergic-blocking agents such as guanethidine and clonidine.
Fluphenazine [1], hypnotics ---> SmPC of [1] of eMC
Phenothiazines may increase the central nervous system depression produced by other CNS depressants
Fluphenazine [1], hypokalemia ---> SmPC of [1] of eMC
Electrolyte imbalance, particularly hypokalaemia, greatly increases the risk of QT interval prolongation. Therefore, concurrent use of fluphenazine and drugs that cause electrolyte imbalance should be avoided.
Fluphenazine [1], levodopa ---> SmPC of [1] of eMC
Phenothiazines may impair the anti-parkinsonian effect of L-dopa
Fluphenazine [1], lithium ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], macrolide antibiotics ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], maprotiline ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], metrizamide ---> SmPC of [1] of eMC
Phenothiazines may predispose to metrizamide-induced seizures.
Fluphenazine [1], muscle relaxants ---> SmPC of [1] of eMC
Phenothiazines may enhance the absorption of neuromuscular blocking agents.
Fluphenazine [1], narcotic analgesics ---> SmPC of [1] of eMC
Phenothiazines may increase the central nervous system depression produced by other CNS depressants
Fluphenazine [1], pentamidine ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], pimozide ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], pregnancy ---> SmPC of [1] of eMC
The safety for the use of this drug during pregnancy has not been established; therefore, the possible hazards should be weighed against the potential benefits when administering this drug to pregnant patients.
Fluphenazine [1], procainamide ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], QT interval prolonging drugs ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], quinidine ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], quinine ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], sedating antihistamines ---> SmPC of [1] of eMC
Phenothiazines may increase the central nervous system depression produced by other CNS depressants
Fluphenazine [1], sedatives ---> SmPC of [1] of eMC
Phenothiazines may increase the central nervous system depression produced by other CNS depressants
Fluphenazine [1], sotalol ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], sympathomimetics ---> SmPC of [1] of eMC
Phenothiazines may antagonise the action of sympathomimetic agents
Fluphenazine [1], terfenadine ---> SmPC of [1] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine [1], thiazides ---> SmPC of [1] of eMC
Electrolyte imbalance, particularly hypokalaemia, greatly increases the risk of QT interval prolongation. Therefore, concurrent use of fluphenazine and drugs that cause electrolyte imbalance should be avoided.
Fluphenazine, gonadorelin
The co-administration may weaken the gonadorelin effect
Fluphenazine, IMAOs [2] ---> SmPC of [2] of eMC
Concurrent use of fluphenazine and MAO inhibitors may increase sedation, constipation, dry mouth and hypotension.
Fluphenazine, metoclopramide
The co-administration of neuroleptic drugs with dopamine antagonists may enhance the extrapyramidal adverse effects
Fluphenazine, paroxetine
The co-administration of fluphenazine with drugs that may increase the plasma levels of fluphenazine should be avoided
Fluphenazine, pasireotide [2] ---> SmPC of [2] of EMA
Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval
Fluphenazine, pentetrazol
Concomitant use of fluphenazine and pentetrazol may cause cerebral seizures
Fluphenazine, phenothiazines [2] ---> SmPC of [2] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine, phenytoin [2] ---> SmPC of [2] of eMC
Serum levels of phenytoin may be increased or decreased.
Fluphenazine, piperazine
The co-administration of neuroleptic drugs with piperazine-containing drugs may enhance the extrapyramidal adverse effects
Fluphenazine, polypeptide antibiotics
The respiratory depression caused by the polypeptide antibiotic may be enhanced by fluphenazine
Fluphenazine, propranolol
Betablockers: Plasma levels of both active principles may be increased. It is recommended to reduce the doses of both active principles
Fluphenazine, reserpine
The co-administration may enhance the extrapyramidal adverse effects. The concomitant use is not recommended
Fluphenazine, sparfloxacin [2] ---> SmPC of [2] of eMC
The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated.
Fluphenazine, SSRI [2] ---> SmPC of [2] of eMC
There have been rare reports of acute Parkinsonism when an SSRI has been used in combination with a phenothiazine.
Fluphenazine, strong CYP2D6 inhibitors
The co-administration of fluphenazine with drugs that may increase the plasma levels of fluphenazine should be avoided
Fluphenazine, tiapride
Tiapride should not be combined with drugs that prolong the QT interval. These drugs (with the exception of anti-infectious) should be discontinued, if possible, if they induce torsades de pointes
Fluphenazine, trazodone [2] ---> SmPC of [2] of eMC
Severe orthostatic hypotension has been observed in case of concomitant use of trazodone und phenothiazines
Fluphenazine, tricyclic antidepressant
The combination of tricyclic antidepressants with phenothiazines increases the antidepressant levels. It can increase the toxicity of both active principles (anticholinergic effects, decreased seizure threshold, QT prolongation)
Insulin, phenothiazines ---> SmPC of [fluphenazine] of eMC
Phenothiazines may impair the control of diabetes.
Metrizamide, phenothiazines ---> SmPC of [fluphenazine] of eMC
Phenothiazines may predispose to metrizamide-induced seizures.
Oral antidiabetics, phenothiazines ---> SmPC of [fluphenazine] of eMC
Phenothiazines may impair the control of diabetes.
Phenothiazines, sympathomimetics ---> SmPC of [fluphenazine] of eMC
Phenothiazines may antagonise the action of sympathomimetic agents
CONTRAINDICATIONS of Fluphenazine
The product is contraindicated in the following cases:
- Comatose states
- Marked cerebral atherosclerosis
- Phaeochromocytoma
- Renal failure
- Liver failure
- Severe cardiac insufficiency
- Severely depressed states
- Existing blood dyscrasias
- Hypersensitivity to Fluphenazine Decanoate or to any of the excipients
- Because of the content of benzyl alcohol Modecate injection must not be given to newborns or premature neonates.
http://www.medicines.org.uk/emc/
Flurazepam
Ability to drive, flurazepam [2] ---> SmPC of [2] of eMC
Patients should be advised that, flurazepam might modify patients' performance at skilled tasks (driving, operating machinery, etc.) to a varying degree depending upon dosage, administration, and sleep pattern and individual susceptibility
Alcohol, flurazepam [2] ---> SmPC of [2] of eMC
Concomitant intake with alcohol should be avoided. The sedative effect may be enhanced when the product is used in combination with alcohol.
Aminophylline, flurazepam
The use of theophylline or aminophylline may decrease the sedative effects of benzodiazepines
Anaesthetics, flurazepam [2] ---> SmPC of [2] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Analgesics, flurazepam [2] ---> SmPC of [2] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Antidepressants, flurazepam [2] ---> SmPC of [2] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Antiepileptics, flurazepam [2] ---> SmPC of [2] of eMC
When flurazepam is used in conjunction with anti-epileptic drugs, side-effects and toxicity may be more evident, particularly with hydantoins or barbiturates
Antihypertensives, flurazepam [2] ---> SmPC of [2] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Anxiolytics, flurazepam [2] ---> SmPC of [2] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Aprepitant, flurazepam
Possible increase of plasma concentrations of benzodiazepines metabolised via CYP3A4. Caution is advised
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.
Barbiturates, flurazepam [2] ---> SmPC of [2] of eMC
When flurazepam is used in conjunction with anti-epileptic drugs, side-effects and toxicity may be more evident, particularly with hydantoins or barbiturates
Betablockers, flurazepam [2] ---> SmPC of [2] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Breast-feeding, flurazepam [2] ---> SmPC of [2] of eMC
In common with other benzodiazepines, its passage into breast milk might be expected. The use of flurazepam in mothers who are breast-feeding is not recommended.
Cimetidine, flurazepam [2] ---> SmPC of [2] of eMC
Known inhibitors of hepatic enzymes, eg cimetidine, have been shown to reduce the clearance of benzodiazepines and may potentiate their action
CNS depressants, flurazepam [2] ---> SmPC of [2] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Cobicistat [1], flurazepam ---> SmPC of [1] of EMA
Concentrations of this sedative/hypnotic may be increased when co-administered with cobicistat.
Darunavir/cobicistat [1], flurazepam ---> SmPC of [1] of EMA
REZOLSTA is expected to increase the sedative/hypnotic plasma concentrations. (CYP3A inhibition). Clinical monitoring is recommended when co-administering REZOLSTA with this sedative/hypnotic and a lower dose of the sedative/hypnotic should be considered
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], flurazepam ---> SmPC of [1] of EMA
Based on theoretical considerations DRV/COBI is expected to increase this sedative/hypnotic plasma concentrations. CYP3A inhibition
Darunavir/ritonavir, flurazepam ---> SmPC of [darunavir] of EMA
Sedative/hypnotics are extensively metabolised by CYP3A. Co-administration with boosted darunavir may cause a large increase in the concentration of these medicines.
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], flurazepam ---> SmPC of [1] of EMA
Concentrations of other benzodiazepines, including diazepam, may be increased when administered with Genvoya. With other sedatives/hypnotics, dose reduction may be necessary and concentration monitoring is recommended.
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [1], flurazepam ---> SmPC of [1] of EMA
The co-administration may increase the plasma concentrations of sedative. Dose reduction may be necessary and concentration monitoring is recommended.
Enzyme inductors [1], flurazepam ---> SmPC of [1] of eMC
Known inducers of hepatic enzymes, eg rifampicin, may increase the clearance of benzodiazepines.
Enzyme inhibitors, flurazepam [2] ---> SmPC of [2] of eMC
Known inhibitors of hepatic enzymes, eg cimetidine, have been shown to reduce the clearance of benzodiazepines and may potentiate their action
Flurazepam [1], hydantoins ---> SmPC of [1] of eMC
When flurazepam is used in conjunction with anti-epileptic drugs, side-effects and toxicity may be more evident, particularly with hydantoins or barbiturates
Flurazepam [1], hypnotics ---> SmPC of [1] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Flurazepam [1], narcotic analgesics ---> SmPC of [1] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs. Enhancement of the euphoria may occur leading to an increase in psychological dependence.
Flurazepam [1], neuroleptics ---> SmPC of [1] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Flurazepam [1], pregnancy ---> SmPC of [1] of eMC
Do not use during pregnancy, especially during the first and last trimesters, unless there are compelling reasons.
Flurazepam [1], rifampicin ---> SmPC of [1] of eMC
Known inducers of hepatic enzymes, eg rifampicin, may increase the clearance of benzodiazepines.
Flurazepam [1], sedating antihistamines ---> SmPC of [1] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Flurazepam [1], sedatives ---> SmPC of [1] of eMC
Enhancement of the central depressive effect may occur if benzodiazepines are combined with centrally-acting drugs
Flurazepam, idelalisib [2] ---> SmPC of [2] of EMA
The co-administration of idelalisib with flurazepam may increase the serum concentrations of flurazepam. Concentration monitoring of flurazepam is recommended and dose reduction may be considered.
Flurazepam, indinavir/ritonavir ---> SmPC of [indinavir] of EMA
Indinavir/ritonavir should not be administered with flurazepam
Flurazepam, muscle relaxants
Enhancement of the muscle relaxant effect
Flurazepam, nitrous oxide
Enhancement of the laughing gas effect
Flurazepam, ritonavir [2] ---> SmPC of [2] of EMA
Increased plasma concentrations of flurazepam, increasing the risk of extreme sedation and respiratory depression and is therefore contraindicated
Flurazepam, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA
Increased benzodiazepine plasma concentrations. Careful monitoring of patients with regard to sedative effects is warranted.
Flurazepam, sodium oxybate [2] ---> SmPC of [2] of EMA
Given the possibility of increasing the risk of respiratory depression, the concomitant use of benzodiazepines and sodium oxybate should be avoided.
Flurazepam, strong CYP3A4 inhibitors
The strong CYP3A4 inhibition may increase the plasma concentrations of flurazepam
Flurazepam, telithromycin
The CYP3A4 inhibition may increase the plasma levels of flurazepam. Oral coadministration should be avoided
Flurazepam, theophylline
The use of theophylline or aminophylline may decrease the sedative effects of benzodiazepines
CONTRAINDICATIONS of Flurazepam
Dalmane is contraindicated in:
- Patients with known hypersensitivity to flurazepam, other benzodiazepines or to any of the excipients
- myasthenia gravis;
- severe pulmonary insufficiency;
- respiratory depression;
- phobic or obsessional states;
- chronic psychosis;
- sleep apnoea syndrome;
- severe hepatic insufficiency;
- use in children.
http://www.medicines.org.uk/emc/
Flurbiprofen
ACE inhibitors, cyclooxygenase inhibitors ---> SmPC of [flurbiprofen] of eMC
In some patients with compromised renal function the co-administration of an ACE inhibitor and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure
ACE inhibitors, flurbiprofen [2] ---> SmPC of [2] of eMC
In some patients with compromised renal function the co-administration of an ACE inhibitor and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure
Acetylsalicylic acid, flurbiprofen [2] ---> SmPC 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.
AIIRA, cyclooxygenase inhibitors ---> SmPC of [flurbiprofen] of eMC
In some patients with compromised renal function the co-administration of an angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure
AIIRA, flurbiprofen [2] ---> SmPC of [2] of eMC
In some patients with compromised renal function the co-administration of an angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure
Alcohol, flurbiprofen
Alcohol may enhance the risk of adverse effects, especially those of the gastrointestinal tract
Anticoagulants, flurbiprofen [2] ---> SmPC of [2] of eMC
NSAIDs may enhance the effects of anticoagulants such as warfarin
Antihypertensives, flurbiprofen [2] ---> SmPC of [2] of eMC
NSAIDs may reduce the effect of antihypertensive drugs
Breast-feeding, flurbiprofen [2] ---> SmPC of [2] of eMC
In the limited studies so far available, NSAIDs can appear in the breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.
Cardiac glycosides, flurbiprofen [2] ---> SmPC of [2] of eMC
NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.
Cardiac glycosides, nabumetone ---> SmPC of [flurbiprofen] of eMC
NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Corticosteroids, flurbiprofen [2] ---> SmPC of [2] of eMC
Corticosteroids with NSAIDs may increase the risk of gastrointestinal ulceration or bleeding with NSAIDs
Coxibs, flurbiprofen [2] ---> SmPC of [2] of eMC
Avoid concomitant use of two or more NSAIDs, including Cox-2 inhibitors, as this may increase the risk of adverse effects
Cyclosporine, flurbiprofen [2] ---> SmPC of [2] of eMC
Increased risk of nephrotoxicity.
Diuretics, flurbiprofen [2] ---> SmPC of [2] of eMC
NSAIDs may reduce the effect of diuretics
Fluconazole [1], flurbiprofen ---> SmPC of [1] of eMC
The C max and AUC of flurbiprofen was increased by 23% and 81%, respectively, when coadministered with fluconazole compared to administration of flurbiprofen alone.
Flurbiprofen [1], lithium ---> SmPC of [1] of eMC
Decreased elimination of lithium.
Flurbiprofen [1], methotrexate ---> SmPC of [1] of eMC
Caution is advised in the concomitant administration of flurbiprofen and methotrexate since NSAIDs may increase methotrexate levels.
Flurbiprofen [1], mifepristone ---> SmPC of [1] of eMC
NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.
Flurbiprofen [1], NSAID ---> SmPC of [1] of eMC
Avoid concomitant use of two or more NSAIDs, including Cox-2 inhibitors, as this may increase the risk of adverse effects
Flurbiprofen [1], oral antidiabetics ---> SmPC of [1] of eMC
Hypoglycaemic and hyperglycaemic effects.
Flurbiprofen [1], platelet aggregation inhibitors ---> SmPC of [1] of eMC
Anti-platelet agents with NSAID increase risk of gastrointestinal bleeding with NSAIDs
Flurbiprofen [1], potassium-sparing diuretics ---> SmPC of [1] of eMC
Concomitant administration of NSAIDs and potassium-sparing agents may cause hyperkalemia
Flurbiprofen [1], pregnancy ---> SmPC of [1] of eMC
During the first and second trimester of pregnancy, flurbiprofen should not be given unless clearly necessary. Flurbiprofen is contraindicated during the third trimester of pregnancy.
Flurbiprofen [1], SSRI ---> SmPC of [1] of eMC
The combination of selective serotonin reuptake inhibitors (SSRIs) and NSAIDs increases the risk of gastrointestinal bleeding
Flurbiprofen [1], tacrolimus ---> SmPC of [1] of eMC
Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Flurbiprofen [1], warfarin ---> SmPC of [1] of eMC
NSAIDs may enhance the effects of anticoagulants such as warfarin
Flurbiprofen [1], zidovudine ---> SmPC of [1] of eMC
Increased risk of haematological toxicity when NSAIDs are given with zidovudine
Flurbiprofen, foods
Take with food to reduce gastric irritation.
Flurbiprofen, magnesium hydroxide
The co-administration may increase the absorption rate of flurbiprofen
Flurbiprofen, phenytoin
The NSAID may enhance the effects of phenytoin
Flurbiprofen, probenecide
The co-administration may delay the elimination of flurbiprofen and increase its plasma levels, effects and adverse reactions
Flurbiprofen, sulfinpyrazone
Sulfinpyrazone delays the elimination of NSAID
Ibuprofen, zidovudine ---> SmPC of [flurbiprofen] of eMC
Increased risk of haematological toxicity when NSAIDs are given with zidovudine
NSAID, oral anticoagulants ---> SmPC of [flurbiprofen] of eMC
NSAIDs may enhance the effects of anticoagulants such as warfarin
NSAID, quinolones ---> SmPC of [flurbiprofen] of eMC
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.
NSAID, zidovudine ---> SmPC of [flurbiprofen] of eMC
Increased risk of haematological toxicity when NSAIDs are given with zidovudine
CONTRAINDICATIONS of Flurbiprofen
- Flurbiprofen is contraindicated in patients with hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the inactive ingredients.
- Flurbiprofen is contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to flurbiprofen, aspirin or other NSAIDs.
- Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Flurbiprofen should not be used in patients with active, or history of, ulcerative colitis, Crohn's disease, recurrent peptic ulceration or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding).
- Flurbiprofen is contraindicated in patients with severe heart failure, hepatic failure and renal failure
- Flurbiprofen is contraindicated during the last trimester of pregnancy
http://www.medicines.org.uk/emc/
Flutamide
Ability to drive, flutamide
Fatigue, dizziness and confusion may occur
Alcohol, flutamide
Alcohol intake should be avoided due to potential liver and renal toxicity
Breast-feeding, flutamide
Flutamide is intended for male patients only
Flutamide, leuprorelin
There were no interactions between flutamide and leuprolide. In the concurrent use of flutamide and LH-RH agonists the adverse effects of both active principles should be taken into account
Flutamide, medicines with hepatotoxic effects
The co-administration of flutamide with other potentially hepatotoxic medicinal products should be done only after careful assessment of the benefit-risk
Flutamide, oral anticoagulants
In concomitant use with oral anticoagulants have been reported increases in prothrombin time after beginning the treatment with flutamide
Flutamide, pregnancy
Flutamide is intended for male patients only
Flutamide, theophylline
The co-administration may increase the plasma levels of theophylline
Flutamide, warfarin
Flutamide may increase the prothrombin time
LH-RH agonists, flutamide
In the concurrent use of flutamide and LH-RH agonists the adverse effects of both active principles should be taken into account
Flutemetamol (18 F) (Vizamyl)
Ability to drive, flutemetamol (18 F) [2] ---> SmPC of [2] of EMA
VIZAMYL may cause transient dizziness and vertigo.
Breast-feeding, flutemetamol (18 F) [2] ---> SmPC of [2] of EMA
If the administration is considered necessary, breast-feeding should be interrupted for 24 hours and the expressed feeds discarded.
Close contact with infants, flutemetamol (18 F) [2] ---> SmPC of [2] of EMA
Close contact with infants should be restricted during the initial 24 hours following injection.
Fertility, flutemetamol (18 F) [2] ---> SmPC of [2] of EMA
No studies on fertility have been performed.
Flutemetamol (18 F) [1], pregnancy ---> SmPC of [1] of EMA
Only essential investigations should be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Flutemetamol (18 F) [1], pregnancy ---> SmPC of [1] of EMA
Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Flutemetamol (18 F) [1], women of childbearing potential ---> SmPC of [1] of EMA
If in doubt about her potential pregnancy (if the woman has missed a period, if the period is irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
CONTRAINDICATIONS of Flutemetamol (18 F) (Vizamyl)
- 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/vizamyl-epar-product-information_en.pdf 23/09/2025
Fluticasone furoate (Avamys)
Atazanavir [1], fluticasone furoate ---> SmPC of [1] of EMA
Atazanavir, strong CYP3A4 inhibitor, may increase the plasma concentrations of the glucocorticoid, with risk of systemic effects. Concomitant use not recommended
Breast-feeding, fluticasone furoate [2] ---> SmPC of [2] of EMA
Administration of fluticasone furoate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Cobicistat, fluticasone furoate [2] ---> SmPC of [2] of EMA
Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistat-containing products as an increase in the risk of systemic side effects is expected.
Cytochrome P450 3A4, fluticasone furoate [2] ---> SmPC of [2] of EMA
Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.
Fertility, fluticasone furoate [2] ---> SmPC of [2] of EMA
There are no fertility data in humans.
Fluticasone furoate [1], ketoconazole ---> SmPC of [1] of EMA
This small increase in exposure did not result in a statistically significant difference in 24 hour serum cortisol levels between the two groups.
Fluticasone furoate [1], pregnancy ---> SmPC of [1] of EMA
Fluticasone furoate should be used in pregnancy only if the benefits to the mother outweigh the potential risks to the foetus or child.
Fluticasone furoate [1], ritonavir ---> SmPC of [1] of EMA
Coadministration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.
Fluticasone furoate [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistat-containing products as an increase in the risk of systemic side effects is expected.
Fluticasone furoate [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Coadministration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.
CONTRAINDICATIONS of Fluticasone furoate (Avamys)
- 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/avamys-epar-product-information_en.pdf 27/06/2025
Fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta)
Betablockers, fluticasone furoate/umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA
Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol. If beta-blockers are required, cardioselective beta-blockers should be considered, however, caution should be exercised during concurrent use
Breast-feeding, fluticasone furoate/umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue Trelegy Ellipta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Cobicistat, fluticasone furoate/umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA
Caution is advised when co-administering with strong CYP 3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol.
Concentration, fluticasone furoate/umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA
Clinically significant drug interactions mediated by fluticasone furoate/umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
CYP2D6 inhibitors, fluticasone furoate/umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA
No clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients who are genetically deficient in CYP2D6 activity (poor metabolisers).
Fertility, fluticasone furoate/umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA
There are no data on the effects of fluticasone furoate/umeclidinium/vilanterol on human fertility. Animal studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see section 5.3).
Fluticasone furoate/umeclidinium/vilanterol [1], hypokalemia ---> SmPC of [1] of EMA
Caution should be exercised when Trelegy Ellipta is used with other medicinal products that also have the potential to cause hypokalaemia
Fluticasone furoate/umeclidinium/vilanterol [1], ketoconazole ---> SmPC of [1] of EMA
Caution is advised when co-administering with strong CYP 3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol.
Fluticasone furoate/umeclidinium/vilanterol [1], muscarinic agents ---> SmPC of [1] of EMA
Co-administration of Trelegy Ellipta with other long-acting muscarinic antagonists or long-acting beta2- adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions
Fluticasone furoate/umeclidinium/vilanterol [1], P-gp inhibitors ---> SmPC of [1] of EMA
Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with P-gp inhibitors.
Fluticasone furoate/umeclidinium/vilanterol [1], potassium-sparing diuretics ---> SmPC of [1] of EMA
Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution should be exercised
Fluticasone furoate/umeclidinium/vilanterol [1], pregnancy ---> SmPC of [1] of EMA
Administration of Trelegy Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Fluticasone furoate/umeclidinium/vilanterol [1], ritonavir ---> SmPC of [1] of EMA
Caution is advised when co-administering with strong CYP 3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol.
Fluticasone furoate/umeclidinium/vilanterol [1], steroids ---> SmPC of [1] of EMA
Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution should be exercised
Fluticasone furoate/umeclidinium/vilanterol [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Caution is advised when co-administering with strong CYP 3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol.
Fluticasone furoate/umeclidinium/vilanterol [1], xanthines ---> SmPC of [1] of EMA
Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution should be exercised
CONTRAINDICATIONS of Fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Other trade names: Elebrato Ellipta, Temybric Ellipta,
Fluticasone furoate/vilanterol (Relvar Ellipta)
Beta2-adrenergic agonists, beta2-adrenergic receptor blockers ---> SmPC of [fluticasone furoate/vilanterol] of EMA
Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists. Concurrent use of both non-selective and selective beta2-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Breast-feeding, fluticasone furoate/vilanterol [2] ---> SmPC of [2] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue fluticasone furoate/vilanterol therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Cobicistat, fluticasone furoate/vilanterol [2] ---> SmPC of [2] of EMA
Caution is advised when co-administering with strong CYP 3A4 inhibitors as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol, and concomitant use should be avoided.
Corticosteroids, fluticasone furoate/vilanterol [2] ---> SmPC of [2] of EMA
Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid undesirable effects, in which case patients should be monitored for systemic corticosteroid undesirable effects.
Fertility, fluticasone furoate/vilanterol [2] ---> SmPC of [2] of EMA
There are no fertility data in humans. Animal studies showed no effect of fluticasone furoate/vilanterol trifenatate on fertility (see section 5.3).
Fluticasone furoate/vilanterol [1], ketoconazole ---> SmPC of [1] of EMA
Caution is advised when co-administering with strong CYP 3A4 inhibitors as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol, and concomitant use should be avoided.
Fluticasone furoate/vilanterol [1], pregnancy ---> SmPC of [1] of EMA
Administration of fluticasone furoate/vilanterol to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Fluticasone furoate/vilanterol [1], ritonavir ---> SmPC of [1] of EMA
Caution is advised when co-administering with strong CYP 3A4 inhibitors as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol, and concomitant use should be avoided.
Fluticasone furoate/vilanterol [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Caution is advised when co-administering with strong CYP 3A4 inhibitors as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol, and concomitant use should be avoided.
Fluticasone furoate/vilanterol [1], strong P-gp inhibitors ---> SmPC of [1] of EMA
Clinical pharmacology studies with a specific P-gp inhibitor and fluticasone furoate have not been conducted.
Fluticasone furoate/vilanterol [1], sympathomimetics ---> SmPC of [1] of EMA
Concomitant administration of vilanterol and other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate the adverse reactions of fluticasone furoate/vilanterol.
Fluticasone furoate/vilanterol [1], verapamil ---> SmPC of [1] of EMA
A clinical pharmacology study in healthy subjects with co-administered vilanterol and the potent P-gp and moderate CYP3A4 inhibitor verapamil did not show any significant effect on the pharmacokinetics of vilanterol.
CONTRAINDICATIONS of Fluticasone furoate/vilanterol (Relvar Ellipta)
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Other trade names: Revinty Ellipta,
Fluvastatin
ACE inhibitors, fluvastatin
No clinically significant pharmacokinetic interactions occur when fluvastatin is concomitantly administered with ACE inhibitors.
Acenocoumarol [1], fluvastatin ---> SmPC of [1] of eMC
The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk
Amlodipine, fluvastatin [2] ---> SmPC of [2] of eMC
No clinically significant pharmacokinetic interactions occur when fluvastatin is concomitantly administered with amlodipine.
Atazanavir [1], fluvastatin ---> SmPC of [1] of EMA
There is a potential for an increase in fluvastatin exposure when coadministered with protease inhibitors.
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.
Bezafibrate, fluvastatin [2] ---> SmPC of [2] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors together with bezafibrate
Bile-acid sequestrants, fluvastatin [2] ---> SmPC of [2] of eMC
Fluvastatin should be administered at least 4 hours after the resin (e.g. cholestyramine) to avoid a significant interaction due to drug binding of the resin.
Breast-feeding, fluvastatin [2] ---> SmPC of [2] of eMC
Fluvastatin is contraindicated in breastfeeding women.
Cholestyramine, fluvastatin [2] ---> SmPC of [2] of eMC
Fluvastatin should be administered at least 4 hours after the cholestyramine to avoid a significant interaction due to drug binding of the resin.
Cimetidine, fluvastatin [2] ---> SmPC of [2] of eMC
Concomitant administration of fluvastatin with cimetidine results in an increase in the bioavailability of fluvastatin, which, however, is of no clinical relevance.
Ciprofibrate, fluvastatin [2] ---> SmPC of [2] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors together with ciprofibrate
Cobicistat [1], fluvastatin ---> SmPC of [1] of EMA
Plasma concentrations of HMG Co-A reductase inhibitor may be increased when co-administered with cobicistat.
Colchicine, fluvastatin [2] ---> SmPC of [2] of eMC
Myotoxicity, including muscle pain and weakness and rhabdomyolysis, has been reported in isolated cases with concomitant administration of colchicines.
Coumarin anticoagulants, fluvastatin [2] ---> SmPC of [2] of eMC
Isolated incidences of bleeding episodes and/or increases prothrombin times have been reported very rarely in patients on fluvastatin receiving concomitant warfarin or other coumarin derivatives.
Cyclosporine, fluvastatin [2] ---> SmPC of [2] of eMC
Isolated cases of myopathy have been reported post-marketing for concomitant administration of fluvastatin with ciclosporin
CYP2C9 inhibitors, fluvastatin [2] ---> SmPC of [2] of eMC
There are multiple, alternative cytochrome P450 (CYP450) pathways for fluvastatin biotransformation and thus fluvastatin metabolism is relatively insensitive to CYP450 inhibition.
CYP3A4 inhibitors, fluvastatin [2] ---> SmPC of [2] of eMC
Given the minimal involvement of the enzyme CYP3A4 in the metabolism of fluvastatin, it is expected that CYP3A4 inhibitors (e.g. ketoconazole, ciclosporin) are unlikely to affect the bioavailability of fluvastatin.
Daclatasvir [1], fluvastatin ---> SmPC of [1] 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.
Darunavir/cobicistat [1], fluvastatin ---> SmPC of [1] 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.
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], fluvastatin ---> SmPC of [1] 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
Dasabuvir with ombitasvir/paritaprevir/ritonavir, fluvastatin ---> SmPC of [dasabuvir] of EMA
OATP1B/BCRP inhibition by paritaprevir. A temporary suspension of fluvastatin is recommended for the duration of treatment.
Digoxin, fluvastatin [2] ---> SmPC of [2] of eMC
No clinically significant pharmacokinetic interactions occur when fluvastatin is concomitantly administered with digoxin.
Drugs primarily metabolised by CYP2C9, fluvastatin [2] ---> SmPC of [2] of eMC
Despite the potential that exists for competitive interaction between fluvastatin and compounds that are CYP2C9 substrates, clinical data indicate that this interaction is unlikely.
Elbasvir/grazoprevir [1], fluvastatin ---> SmPC of [1] of EMA
Primarily due to intestinal BCRP inhibition. The dose of fluvastatin, lovastatin, or simvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Eltrombopag [1], fluvastatin ---> SmPC of [1] 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
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [1], fluvastatin ---> SmPC of [1] of EMA
Concentrations of fluvastatin y pravastatine are expected to transiently increase when administered with elvitegravir and cobicistat. Dose modifications are not necessary when administered in combination with Genvoya.
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [1], fluvastatin ---> SmPC of [1] of EMA
Concentrations of the HMG Co-A reductase inhibitor are expected to transiently increase when administered with elvitegravir and cobicistat. Dose modifications are not necessary
Erythromycin, fluvastatin [2] ---> SmPC of [2] of eMC
Concomitant administration of fluvastatin with the potent cytochrome P450 (CYP) 3A4 inhibitors itraconazole and erythromycin has minimal effects on the bioavailability of fluvastatin.
Erythromycin, statins ---> SmPC of [fluvastatin] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors (except fluvastatin) together with erythromycin. The combination should only be used with caution
Etravirine [1], fluvastatin ---> SmPC of [1] of EMA
Fluvastatin is metabolised by CYP2C9 and co-administration with etravirine may result in higher plasma concentrations of the HMG Co-A reductase inhibitor. Dose adjustments for this HMG Co-A reductase inhibitor may be necessary.
Fibrates, fluvastatin [2] ---> SmPC of [2] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors together with fibrates. The combination should only be used with caution
Fibrates, pitavastatin ---> SmPC of [fluvastatin] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors (except fluvastatin) together with fibrates. The combination should only be used with caution
Fibrates, statins ---> SmPC of [fluvastatin] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors (except fluvastatin) together with fibrates. The combination should only be used with caution
Fluconazole [1], fluvastatin ---> SmPC of [1] 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.
Fluvastatin [1], gemfibrozil ---> SmPC of [1] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors together with gemfibrozil
Fluvastatin [1], glibenclamide ---> SmPC of [1] of eMC
Patients on concomitant therapy with glibenclamide (glyburide) and fluvastatin should continue to be monitored appropriately when their fluvastatin dose is increased to 80 mg per day.
Fluvastatin [1], grapefruit juice ---> SmPC of [1] of eMC
Based on the lack of interaction of fluvastatin with other CYP3A4 substrates, fluvastatin is not expected to interact with grapefruit juice.
Fluvastatin [1], itraconazol ---> SmPC of [1] of eMC
Concomitant administration of fluvastatin with the potent cytochrome P450 (CYP) 3A4 inhibitors itraconazole and erythromycin has minimal effects on the bioavailability of fluvastatin.
Fluvastatin [1], losartan ---> SmPC of [1] of eMC
No clinically significant pharmacokinetic interactions occur when fluvastatin is concomitantly administered with losartan.
Fluvastatin [1], niacin ---> SmPC 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
Fluvastatin [1], omeprazole ---> SmPC of [1] of eMC
Concomitant administration of fluvastatin with omeprazole results in an increase in the bioavailability of fluvastatin, which, however, is of no clinical relevance.
Fluvastatin [1], phenytoin ---> SmPC of [1] of eMC
The overall magnitude of the changes in phenytoin pharmacokinetics during co-administration with fluvastatin is relatively small and not clinically significant. Thus routine monitoring of phenytoin plasma levels is sufficient
Fluvastatin [1], pregnancy ---> SmPC of [1] of eMC
Fluvastatin is contraindicated during pregnancy
Fluvastatin [1], propranolol ---> SmPC of [1] of eMC
No clinically significant pharmacokinetic interactions occur when fluvastatin is concomitantly administered with propranolol.
Fluvastatin [1], ranitidine ---> SmPC of [1] of eMC
Concomitant administration of fluvastatin with ranitidine results in an increase in the bioavailability of fluvastatin, which, however, is of no clinical relevance.
Fluvastatin [1], rifampicin ---> SmPC of [1] of eMC
Administration of fluvastatin to healthy volunteers pre-treated with rifampicin resulted in a reduction of the bioavailability of fluvastatin by about 50%.
Fluvastatin [1], strong CYP2C9 inhibitors ---> SmPC of [1] of eMC
There are multiple, alternative cytochrome P450 (CYP450) pathways for fluvastatin biotransformation and thus fluvastatin metabolism is relatively insensitive to CYP450 inhibition.
Fluvastatin [1], strong CYP3A4 inhibitors ---> SmPC of [1] of eMC
Given the minimal involvement of the enzyme CYP3A4 in the metabolism of fluvastatin, it is expected that CYP3A4 inhibitors (e.g. ketoconazole, ciclosporin) are unlikely to affect the bioavailability of fluvastatin.
Fluvastatin, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA
Interactions with fluvastatin and pitavastatin are likely and caution is recommended during the combination.
Fluvastatin, indinavir [2] ---> SmPC of [2] of EMA
Interaction via effects on transport proteins cannot be excluded.
Fluvastatin, interferon
Caution should be used when administering interferon with medicines mainly metabolised by hepatic cytochrome P450 and have a narrow therapeutic window
Fluvastatin, letermovir [2] ---> SmPC of [2] of EMA
Letermovir may increase statin plasma concentrations. When PREVYMIS is co-administered with these statins, a statin dose reduction may be necessary. Statin-associated adverse events such as myopathy should be closely monitored.
Fluvastatin, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA
No clinical relevant interaction expected. Fluvastatin is partially metabolised by CYP2C9. If treatment with an HMG-CoA reductase inhibitor is indicated, fluvastatin or pravastatin is recommended.
Fluvastatin, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC of [2] of EMA
OATP1B/BCRP inhibition by paritaprevir. A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment with Viekirax.
Fluvastatin, proteolytic enzymes enriched in bromelain [2] ---> SmPC 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 CYP2C9 substrates
Fluvastatin, regorafenib [2] ---> SmPC of [2] of EMA
Co-administration of regorafenib may increase the plasma concentrations of other concomitant BCRP substrates (e.g. methotrexate, fluvastatin, atorvastatin).
Fluvastatin, ritonavir [2] ---> SmPC of [2] of EMA
The metabolism of pravastatin and fluvastatin is not dependent on CYP3A, and interactions are not expected with ritonavir. If treatment with an HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended.
Fluvastatin, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA
Metabolism of fluvastatin is not dependent on CYP3A4. Interaction via effects on transport proteins cannot be excluded.
Fluvastatin, simeprevir [2] ---> SmPC of [2] of EMA
No clinically relevant drug-drug interaction is expected. No dose adjustment is required.
Fluvastatin, telaprevir [2] ---> SmPC of [2] of EMA
The inhibition of CYP3A and OATPs by telaprevir may increase statin concentration. Caution is warranted and clinical monitoring is recommended.
Fluvastatin, telithromycin [2] ---> SmPC of [2] of EMA
The exposure of pravastatin, rosuvastatin and, to a lesser extent fluvastatin, may be increased due to possible involvement of transporters proteins. Patients should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis
Fluvastatin, warfarin [2] ---> SmPC of [2] of eMC
Isolated incidences of bleeding episodes and/or increases prothrombin times have been reported very rarely in patients on fluvastatin receiving concomitant warfarin or other coumarin derivatives.
Fusidic acid, statins
As with other statins, muscle-related events, including rhabdomyolysis, have been reported in post-marketing experience with atorvastatin and fusidic acid given concurrently.
Immunosuppressives, statins ---> SmPC of [fluvastatin] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors (except fluvastatin) together with immunosuppressors. The combination should only be used with caution
Niacin, pitavastatin ---> SmPC of [fluvastatin] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors (except fluvastatin) together with nicotinic acid (niacin). The combination should only be used with caution
Niacin, statins ---> SmPC of [fluvastatin] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors (except fluvastatin) together with nicotinic acid (niacin). The combination should only be used with caution
Nicotinic acid, statins ---> SmPC of [fluvastatin] of eMC
An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors (except fluvastatin) together with nicotinic acid (niacin). The combination should only be used with caution
CONTRAINDICATIONS of Fluvastatin
Fluvastatin is contraindicated:
- in patients with known hypersensitivity to the active substance or to any of the excipients
- in patients with active liver disease, or unexplained, persistent elevations in serum transaminases
- during pregnancy and lactation
http://www.medicines.org.uk/emc/
Fluvoxamine
Ability to drive, fluvoxamine [2] ---> SmPC of [2] of eMC
Somnolence has been reported during treatment with fluvoxamine. Therefore, caution is recommended until the individual response to the drug has been determined.
Acetylsalicylic acid, fluvoxamine [2] ---> SmPC 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
Agomelatine [1], fluvoxamine ---> SmPC of [1] of EMA
The strong CYP1A2 and CYP2C9 inhibition may increase plasma concentrations of agomelatine. Co-administration of agomelatine with potent CYP1A2 inhibitors is contraindicated.
Alcohol, fluvoxamine [2] ---> SmPC of [2] of eMC
As with other psychotropic drugs, patients should be advised to avoid alcohol use while taking fluvoxamine.
Alprazolam, fluvoxamine [2] ---> SmPC 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.
Aminophylline, fluvoxamine
Fluvoxamine reduces clearance of theophylline and a reduced dosage may therefore be necessary to avoid side-effects
Amitriptyline, fluvoxamine [2] ---> SmPC of [2] of eMC
An increase in previously stable plasma levels of medicinal products which are largely metabolised through cytochrome P450 1A2 when given together with fluvoxamine, has been reported.
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.
Antidiabetics, fluvoxamine [2] ---> SmPC of [2] of eMC
Glycaemic control may be disturbed (i.e., hyperglycemia, hypoglycemia, decreased glucose tolerance), especially in the early stages of treatment. The dosage of anti-diabetic drugs may need to be adjusted.
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
Astemizole, fluvoxamine [2] ---> SmPC of [2] of eMC
Fluvoxamine should not be co-administered with astemizole as plasma concentrations may be increased resulting in a higher risk for QT-prolongation/Torsade de Pointes.
Atenolol, fluvoxamine [2] ---> SmPC of [2] of eMC
Fluvoxamine does not influence plasma concentrations of atenolol.
Atypical neuroleptics, fluvoxamine [2] ---> SmPC 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
Bendamustine [1], fluvoxamine ---> SmPC of [1] of eMC
Bendamustine metabolism involves cytochrome P450 (CYP) 1A2 isoenzyme. Therefore, the potential for interaction with CYP1A2 inhibitors
Breast-feeding, fluvoxamine [2] ---> SmPC of [2] of eMC
Fluvoxamine is excreted via human milk in small quantities. Therefore, the drug should not be used by women who breast feed.
Brivaracetam [1], fluvoxamine ---> SmPC of [1] of EMA
Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low.
Buspirone [1], fluvoxamine ---> SmPC of [1] of eMC
In short-term treatment with fluvoxamine and buspirone doubled buspirone plasma concentrations are observed
Caffeine, fluvoxamine [2] ---> SmPC of [2] of eMC
Caffeine plasma levels are likely to be increased during co-administration with fluvoxamine.
Carbamazepine, fluvoxamine [2] ---> SmPC of [2] of eMC
Patients co-administered fluvoxamine and CYP3A4 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Cinacalcet [1], fluvoxamine ---> SmPC of [1] of EMA
In vitro data indicate that cinacalcet is in part metabolised by CYP1A2. Smoking induces CYP1A2. Dose adjustment may be necessary when concomitant treatment with strong CYP1A2 inhibitors is initiated or discontinued.
Cisapride, fluvoxamine [2] ---> SmPC of [2] of eMC
Fluvoxamine should not be co-administered with cisapride as plasma concentrations may be increased resulting in a higher risk for QT-prolongation/Torsade de Pointes.
Citalopram [1], fluvoxamine ---> SmPC of [1] of eMC
Caution is recommended when citalopram is co-administered with medicinal products that are mainly metabolised by CYP2D6, and that have a narrow therapeutic index
Clobazam [1], fluvoxamine ---> SmPC of [1] of eMC
The potent CYP2C19 inhibition may increase the exposure to the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary
Clomipramine [1], fluvoxamine ---> SmPC of [1] of eMC
SSRIs which are inhibitors of CYP2D6, such as fluoxetine, paroxetine, or sertraline, and of others including CYP1A2 and CYP2C19 (e.g. fluvoxamine), may increase plasma concentrations of clomipramine, with corresponding adverse effects.
Clopidogrel [1], fluvoxamine ---> SmPC of [1] of EMA
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Clopidogrel/acetylsalicylic acid [1], fluvoxamine ---> SmPC of [1] of EMA
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Clozapine [1], fluvoxamine ---> SmPC of [1] of eMC
Concomitant administration of substances known to inhibit the activity of some cytochrome P450 isozymes (CYP1A2) may increase the levels of clozapine, and the dose of clozapine may need to be reduced to prevent undesirable effects.
Cyclosporine, fluvoxamine [2] ---> SmPC of [2] of eMC
Patients co-administered fluvoxamine and CYP3A4 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
CYP1A2 substrates with narrow therapeutic index, fluvoxamine [2] ---> SmPC of [2] of eMC
Patients co-administered fluvoxamine and CYP1A2 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
CYP2C19 substrates with narrow therapeutic index, fluvoxamine [2] ---> SmPC of [2] of eMC
Drugs which are largely metabolised via CYP2C19 are eliminated slower and may have higher plasma concentrations when co-administered with fluvoxamine. This is particularly relevant for drugs with a narrow therapeutic index.
CYP2C9 substrates with narrow therapeutic index, fluvoxamine [2] ---> SmPC of [2] of eMC
Drugs which are largely metabolised via CYP2C9 are eliminated slower and may have higher plasma concentrations when co-administered with fluvoxamine. This is particularly relevant for drugs with a narrow therapeutic index.
Diazepam, fluvoxamine [2] ---> SmPC 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.
Digoxin, fluvoxamine [2] ---> SmPC of [2] of eMC
Fluvoxamine does not influence plasma concentrations of digoxin.
Droperidol [1], fluvoxamine ---> SmPC of [1] of eMC
Medicinal products known to prolong the QTc interval should not be concomitantly administered with droperidol.
Drugs primarily metabolised by CYP1A2, fluvoxamine [2] ---> SmPC of [2] of eMC
An increase in previously stable plasma levels of medicinal products which are largely metabolised through cytochrome P450 1A2 when given together with fluvoxamine, has been reported.
Drugs primarily metabolised by CYP2C19, fluvoxamine [2] ---> SmPC of [2] of eMC
Drugs which are largely metabolised via CYP2C19 are eliminated slower and may have higher plasma concentrations when co-administered with fluvoxamine.
Drugs primarily metabolised by CYP2C9, fluvoxamine [2] ---> SmPC of [2] of eMC
Drugs which are largely metabolised via CYP2C9 are eliminated slower and may have higher plasma concentrations when co-administered with fluvoxamine.
Drugs primarily metabolised by CYP3A4 with narrow therapeutic index, fluvoxamine [2] ---> SmPC of [2] of eMC
Patients co-administered fluvoxamine and CYP3A4 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Drugs primarily metabolised by CYP3A4, fluvoxamine [2] ---> SmPC of [2] of eMC
Drugs which are largely metabolised via CYP3A4 are eliminated slower and may have higher plasma concentrations when co-administered with fluvoxamine.
Duloxetine [1], fluvoxamine ---> SmPC of [1] of EMA
YENTREVE should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin or enoxacin since the combination results in elevated plasma concentrations of duloxetine
Electroconvulsive therapy, fluvoxamine [2] ---> SmPC of [2] of eMC
There is limited clinical experience of concomitant administration of fluvoxamine and ECT therefore caution is advisable.
Eliglustat [1], fluvoxamine ---> SmPC of [1] of EMA
Caution should be used with weak CYP3A inhibitors in poor metabolisers.
Eltrombopag [1], fluvoxamine ---> SmPC of [1] of EMA
Medicinal products that inhibit multiple enzymes have the potential to increase eltrombopag concentrations.
Erlotinib [1], fluvoxamine ---> SmPC of [1] of EMA
Caution should be exercised when potent CYP1A2 inhibitors are combined with erlotinib. If adverse reactions related to erlotinib are observed, the dose of erlotinib may be reduced.
Escitalopram [1], fluvoxamine ---> SmPC of [1] of eMC
Caution should be exercised when used escitalopram concomitantly with CYP2C19 inhibitors. A reduction in the dose of escitalopram may be necessary based on monitoring of side-effects during concomitant treatment.
Fluvoxamine [1], IMAOs ---> SmPC of [1] of eMC
Fluvoxamine should not be used in combination with MAOIs
Fluvoxamine [1], linezolid ---> SmPC of [1] of eMC
Fluvoxamine should not be used in combination with MAOIs. The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents
Fluvoxamine [1], lithium ---> SmPC of [1] of eMC
Lithium enhances the serotonergic effects of fluvoxamine.
Fluvoxamine [1], mexiletine ---> SmPC of [1] of eMC
Patients co-administered fluvoxamine and CYP1A2 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Fluvoxamine [1], midazolam ---> SmPC of [1] 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.
Fluvoxamine [1], NSAID ---> SmPC of [1] 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
Fluvoxamine [1], oral anticoagulants ---> SmPC of [1] of eMC
In patients on oral anticoagulants and fluvoxamine, the risk for haemorrhage may increase and these patients should therefore be closely monitored.
Fluvoxamine [1], oxidative metabolism ---> SmPC of [1] 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.
Fluvoxamine [1], phenothiazines ---> SmPC of [1] 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
Fluvoxamine [1], phenytoin ---> SmPC of [1] of eMC
Patients co-administered fluvoxamine and CYP2C metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Fluvoxamine [1], platelet aggregation inhibitors ---> SmPC of [1] 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
Fluvoxamine [1], pregnancy ---> SmPC of [1] of eMC
Fluvoxamine should not be used during pregnancy unless the clinical condition of the woman requires treatment
Fluvoxamine [1], propranolol ---> SmPC of [1] of eMC
As plasma concentrations of propranolol are increased in combination with fluvoxamine, the propranolol dose may need to be lowered.
Fluvoxamine [1], quetiapine ---> SmPC of [1] of eMC
An increase in previously stable plasma levels of medicinal products which are largely metabolised through cytochrome P450 1A2 when given together with fluvoxamine, has been reported. (N.B.: I think that quetiapine is mainly metabolized by CYP3A4)
Fluvoxamine [1], ropinirole ---> SmPC of [1] of eMC
As plasma concentrations of ropinirole may be increased in combination with fluvoxamine thus increasing the risk of overdose
Fluvoxamine [1], serotonergic medicines ---> SmPC of [1] of eMC
The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents
Fluvoxamine [1], SSRI ---> SmPC of [1] of eMC
The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents
Fluvoxamine [1], St. John's wort ---> SmPC of [1] of eMC
The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents
Fluvoxamine [1], tacrine ---> SmPC of [1] of eMC
Patients co-administered fluvoxamine and CYP1A2 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Fluvoxamine [1], terfenadine ---> SmPC of [1] of eMC
Fluvoxamine should not be co-administered with terfenadine as plasma concentrations may be increased resulting in a higher risk for QT-prolongation/Torsade de Pointes.
Fluvoxamine [1], thioridazine ---> SmPC of [1] of eMC
Isolated cases of cardiac toxicity have been reported when fluvoxamine was combined with thioridazine.
Fluvoxamine [1], tramadol ---> SmPC of [1] of eMC
The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents
Fluvoxamine [1], triazolam ---> SmPC of [1] 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.
Fluvoxamine [1], triptans ---> SmPC of [1] of eMC
The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents
Fluvoxamine [1], tryptophan ---> SmPC of [1] of eMC
Tryptophan possibly enhances the serotonergic effects of fluvoxamine.
Fluvoxamine [1], warfarin ---> SmPC of [1] of eMC
When given with fluvoxamine, warfarin plasma concentrations were significantly increased and prothrombin times prolonged.
Fluvoxamine, fosphenytoin [2] ---> SmPC of [2] of eMC
CYP2C9/2C19 inhibition may increase plasma phenytoin concentrations
Fluvoxamine, frovatriptan [2] ---> SmPC of [2] of eMC
Fluvoxamine is a potent inhibitor of cytochrome CYP1A2 and has been shown to increase the blood levels of frovatriptan by 27-49%.
Fluvoxamine, haloperidol [2] ---> SmPC of [2] of eMC
Inhibition of the CYP2D6 by another drug may result in increased haloperidol concentrations and an increased risk of adverse events, including QT-prolongation.
Fluvoxamine, hydantoins
Increases the effect of hydantoin
Fluvoxamine, ibrutinib [2] ---> SmPC 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.
Fluvoxamine, imipramine [2] ---> SmPC of [2] of eMC
Combination of SSRIs a. imipramine may lead to additive effects on serotonergic system. Fluvoxamine may increase imipramine plasma levels, resulting in increased plasma levels of tricyclic antidepressants, a lowered convulsion threshold
Fluvoxamine, interferon
Caution should be used when administering interferon with medicines mainly metabolised by hepatic cytochrome P450 and have a narrow therapeutic window
Fluvoxamine, lansoprazole [2] ---> SmPC of [2] of eMC
A dose reduction may be considered when combining Lansoprazole with the CYP2C19 inhibitor fluvoxamine. The plasma concentrations of Lansoprazole increase up to 4-fold.
Fluvoxamine, letermovir [2] ---> SmPC of [2] of EMA
Caution is advised if P-gp/BCRP inhibitors are added to letermovir combined with cyclosporine.
Fluvoxamine, levomepromazine [2] ---> SmPC of [2] of eMC
Co-administration of levomepromazine and drugs primarily metabolised by the CYP2D6 may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic or adverse effects of those drugs.
Fluvoxamine, lofepramine [2] ---> SmPC of [2] of eMC
Co-medication of lofepramine with SSRI inhibitors may lead to additive effects on the serotonergic system. Coadministration with fluvoxamine may increase lofepramine plasma levels resulting in a lowered convulsion threshold and seizures.
Fluvoxamine, lomitapide [2] ---> SmPC 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.
Fluvoxamine, loxapine [2] ---> SmPC of [2] of EMA
Concomitant use of loxapine with CYP1A2 inhibitors should be avoided, if possible.
Fluvoxamine, melatonin [2] ---> SmPC of [2] of EMA
Caution should be exercised in patients on fluvoxamine, which increases melatonin levels by inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19. The combination should be avoided.
Fluvoxamine, mesoridazine
Increased risk of cardiotoxicity and arrhythmias
Fluvoxamine, methadone
It has been demonstrated that fluvoxamine increases plasma concentrations of both enantiomers of methadone
Fluvoxamine, nicotine
Nicotine, strong CYP1A2 inductor, may decrease the plasma concentrations of fluvoxamine
Fluvoxamine, olanzapine [2] ---> SmPC of [2] of EMA
Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Fluvoxamine, opipramol
The co-administration may increase the plasma levels of tricyclic antidepressant and potentiated the adverse effects
Fluvoxamine, pirfenidone [2] ---> SmPC of [2] of EMA
The potent CYP1A2 inhibition and the inhibition of CYP2C9, 2C19 and 2D6 increases exposition of pirfenidone. The co-administration is contraindicated
Fluvoxamine, pomalidomide [2] ---> SmPC of [2] of EMA
If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50%.
Fluvoxamine, propafenone
Elevated levels of plasma propafenone may occur when propafenone is used concomitantly with selective serotonin reuptake inhibitors. Lower doses of propafenone may be sufficient to achieve the desired therapeutic response.
Fluvoxamine, rasagiline [2] ---> SmPC of [2] of EMA
At least 5 weeks should elapse between discontinuation of fluoxetine and initiation of treatment with rasagiline. At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine.
Fluvoxamine, reboxetine [2] ---> SmPC of [2] of eMC
The CYP3A4 inhibition may increase the plasma levels of reboxetine (narrow therapeutic margin and primarily metabolised by the CYP3A4). Reboxetine should not be given together with drugs known to inhibit CYP3A4
Fluvoxamine, riluzole [2] ---> SmPC of [2] of EMA
In vitro studies suggest that CYP1A2 is the principal isozyme involved in the initial oxidative metabolism of riluzole. Inhibitors of CYP1A2 could potentially decrease the rate of riluzole elimination
Fluvoxamine, roflumilast [2] ---> SmPC of [2] of EMA
A combination of roflumilast with fluvoxamine might lead to an increase of exposure and persistent intolerability. In this case, roflumilast treatment should be reassessed
Fluvoxamine, ropivacaine [2] ---> SmPC of [2] of eMC
The strong CYP1A2 inhibition may decrease the plasma clearance of ropivacaine. Prolonged administration of ropivacaine with strong CYP1A2 inhibitors should be avoided
Fluvoxamine, safinamide [2] ---> SmPC of [2] of EMA
The concomitant use of safinamide and fluvoxamine should be avoided, this precaution is based on the occurrence of rare serious adverse reactions (e.g. serotonin syndrome) that have occurred when SSRIs have been used with MAO inhibitors.
Fluvoxamine, tasimelteon [2] ---> SmPC of [2] of EMA
Caution should be used when administering tasimelteon in combination with strong CYP1A2 inhibitors because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions
Fluvoxamine, terbinafine
Terbinafine may increase the plasma levels of fluvoxamine.
Fluvoxamine, theophylline [2] ---> SmPC of [2] of eMC
Fluvoxamine reduces clearance of theophylline and a reduced dosage may therefore be necessary to avoid side-effects
Fluvoxamine, tizanidine [2] ---> SmPC of [2] of eMC
Concomitant administration of drugs known to inhibit the activity of CYP1A2 may increase the plasma levels of tizanidine. Concomitant use of tizanidine with fluvoxamine, CYP450 1A2 inhibitor in man, is contraindicated
Fluvoxamine, trimipramine
The previous or concomitant treatment of SSRIs with trimipramine may increase the plasma levels of both antidepressants by substrate competition
Fluvoxamine, zolmitriptan [2] ---> SmPC of [2] of eMC
Based on the overall interaction profile, an interaction of zolmitriptan with inhibitors of the cytochrome P450 isoenzyme CYP1A2 cannot be excluded.
Fluvoxamine, zolpidem
Concomitant use of fluvoxamine may increase plasma concentrations of zolpidem. Concomitant use is not recommended
CONTRAINDICATIONS of Fluvoxamine
Faverin tablets are contraindicated in combination with tizanidine and monoamine oxidase inhibitors (MAOIs)
Treatment with fluvoxamine can be initiated:
- two weeks after discontinuation of an irreversible MAOI, or
- the following day after discontinuation of a reversible MAOI (e.g. moclobemide, linezolid).
See section 4.4 for precautions in the exceptional case linezolid needs to be given in combination with fluvoxamine.
At least one week should elapse between discontinuation of fluvoxamine and initiation of therapy with any MAOI.
Hypersensitivity to the active substance or to any of the excipients.
http://www.medicines.org.uk/emc/
Folic acid
Alcohol, folic acid
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Almasilate, folic acid
The antacid can decrease the gastrointestinal absorption of folic acid
Aminopterin, folic acid
The co-administration may decrease or neutralize the efficacy of folic acid antagonist
Antacids, folic acid
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Antiepileptics, folic acid
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Antimalarial agents, folic acid
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Breast-feeding, folic acid [2] ---> SmPC of [2] of eMC
No adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.
Capecitabine [1], folic acid ---> SmPC of [1] of EMA
Folinic acid has an effect on the pharmacodynamics of capecitabine and its toxicity may be enhanced by folinic acid. This may also be relevant with folic acid supplementation for folate deficiency due to the similarity between folinic acid and folic acid
Carbamazepine, folic acid
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Chloramphenicol, folic acid [2] ---> SmPC of [2] of eMC
Chloramphenicol may interfere with folate metabolism.
Cholestyramine, folic acid
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Colestipol, folic acid
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Cotrimoxazole, folic acid
Acid folic effect can be decreased or nullified in the treatment of megaloblastic anemia with the co-administration of cotrimoxazole
Fluorouracil, folic acid
Folic acid enhances the activity of fluorouracil in colorectal cancer
Folates, methotrexate ---> SmPC of [folic acid] of eMC
Folic acid may interfere with the toxic and therapeutic effects of methotrexate.
Folates, oral contraceptives
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Folic acid [1], fosphenytoin ---> SmPC of [1] of eMC
If folic acid supplements are given to treat folate deficiency, which can be caused by the use of antiepileptics, the serum antiepileptic levels may fall, leading to decreased seizure control in some patients.
Folic acid [1], phenobarbital ---> SmPC of [1] of eMC
If folic acid supplements are given to treat folate deficiency, which can be caused by the use of antiepileptics, the serum antiepileptic levels may fall, leading to decreased seizure control in some patients.
Folic acid [1], phenytoin ---> SmPC of [1] of eMC
If folic acid supplements are given to treat folate deficiency, which can be caused by the use of antiepileptics, the serum antiepileptic levels may fall, leading to decreased seizure control in some patients.
Folic acid [1], pregnancy ---> SmPC of [1] of eMC
There are no known hazards to the use of folic acid in pregnancy, supplements of folic acid are often beneficial.
Folic acid [1], primidone ---> SmPC of [1] of eMC
If folic acid supplements are given to treat folate deficiency, which can be caused by the use of antiepileptics, the serum antiepileptic levels may fall, leading to decreased seizure control in some patients.
Folic acid, folic acid antagonists
The co-administration may decrease or neutralize the efficacy of folic acid antagonist
Folic acid, magnesium hydroxide
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Folic acid, methotrexate [2] ---> SmPC of [2] of EMA
Concomitant administration of folinic acid containing drugs or of vitamin preparations, which contain folic acid or derivatives, may impair methotrexate efficacy.
Folic acid, oral contraceptives
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Folic acid, proguanil
The co-administration may decrease or neutralize the efficacy of folic acid antagonist
Folic acid, pyrimethamine
The co-administration may decrease or neutralize the efficacy of folic acid antagonist
Folic acid, raltitrexed [2] ---> SmPC of [2] of eMC
Leucovorin (folinic acid), folic acid or vitamin preparations containing these agents must not be given immediately prior to or during administration of raltitrexed, since they may interfere with its action.
Folic acid, sulfasalazine [2] ---> SmPC of [2] of eMC
Oral sulfasalazine inhibits the absorption and metabolism of folic acid and may cause folic acid deficiency
Folic acid, sulphonamides
The co-administration may decrease or neutralize the efficacy of folic acid antagonist
Folic acid, triamterene
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Folic acid, trimethoprim
The co-administration may decrease or neutralize the efficacy of folic acid antagonist
Folic acid, trimethoprim/sulfamethoxazol
Acid folic effect can be decreased or nullified in the treatment of megaloblastic anemia with the co-administration of cotrimoxazole
Folic acid, valproic acid
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
Folic acid, zinc
Drugs that may adversely affect the absorption or metabolism of folic acid may cause statuses of folate deficiency
CONTRAINDICATIONS of Folic acid
- Long-term folate therapy is contraindicated in any patient with untreated cobalamin deficiency. This can be untreated pernicious anaemia or other cause of cobalamin deficiency, including lifelong vegetarians. In elderly people, a cobalamin absorption test should be done before long-term folate therapy. Folate given to such patients for 3 months or longer has precipitated cobalamin neuropathy. No harm results from short courses of folate
- Folic acid should never be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B12 deficiency states because it may precipitate the onset of subacute combined degeneration of the spinal cord
- Folic acid should not be used in malignant disease unless megaloblastic anaemia owing to folate deficiency is an important complication.
- Known hypersensitivity to the active ingredient or any of the excipients.
http://www.medicines.org.uk/emc/
Follitropin alfa (Ovaleap)
Breast-feeding, follitropin alfa [2] ---> SmPC of [2] of EMA
Ovaleap is not indicated during breast-feeding.
Breast-feeding, follitropin alfa/lutropin alfa [2] ---> SmPC of [2] of EMA
It is not indicated during breastfeeding.
Chorionic gonadotrophin, follitropin alfa [2] ---> SmPC of [2] of EMA
Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response
Clomiphene, follitropin alfa [2] ---> SmPC of [2] of EMA
Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response
Fertility, follitropin alfa [2] ---> SmPC of [2] of EMA
Ovaleap is indicated for use in infertility (see section 4.1).
Follitropin alfa [1], GnRH agonists ---> SmPC of [1] of EMA
Concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitropin alfa needed to elicit an adequate ovarian response.
Follitropin alfa [1], GnRH antagonists ---> SmPC of [1] of EMA
Concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitropin alfa needed to elicit an adequate ovarian response.
Follitropin alfa [1], human chorionic gonadotrophin ---> SmPC of [1] of EMA
Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response
Follitropin alfa [1], medicinal products used to stimulate ovulation ---> SmPC of [1] of EMA
Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response
Follitropin alfa [1], pregnancy ---> SmPC of [1] of EMA
There is no indication for use of Ovaleap during pregnancy.
Follitropin alfa/lutropin alfa [1], pregnancy ---> SmPC of [1] of EMA
There is no indication for the use during pregnancy.
CONTRAINDICATIONS of Follitropin alfa (Ovaleap)
- Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients
- tumours of the hypothalamus or pituitary gland;
- ovarian enlargement or ovarian cyst not due to polycystic ovarian disease and of unknown origin;
- gynaecological haemorrhages of unknown aetiology;
- ovarian, uterine or mammary carcinoma.
Ovaleap must not be used when an effective response cannot be obtained, such as:
- primary ovarian failure;
- malformations of sexual organs incompatible with pregnancy;
- fibroid tumours of the uterus incompatible with pregnancy;
- primary testicular insufficiency.
https://www.ema.europa.eu/en/documents/product-information/ovaleap-epar-product-information_en.pdf 27/05/2025
Other trade names: Bemfola, Gonal-F, GONAL-f,
Follitropin alfa/lutropin alfa (Pergoveris)
Breast-feeding, follitropin alfa/lutropin alfa [2] ---> SmPC of [2] of EMA
It is not indicated during breastfeeding.
Fertility, follitropin alfa/lutropin alfa [2] ---> SmPC of [2] of EMA
Pergoveris is indicated for use in infertility (see section 4.1).
Follitropin alfa/lutropin alfa [1], pregnancy ---> SmPC of [1] of EMA
There is no indication for the use of Pergoveris during pregnancy. In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Pergoveris.
CONTRAINDICATIONS of Follitropin alfa/lutropin alfa (Pergoveris)
Pergoveris is contraindicated in patients with:
- hypersensitivity to the active substances or to any of the excipients
- tumours of the hypothalamus and pituitary gland
- ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin
- gynaecological haemorrhages of unknown origin
- ovarian, uterine or mammary carcinoma
Pergoveris must not be used when an effective response cannot be obtained, such as:
- primary ovarian failure
- malformations of sexual organs incompatible with pregnancy
- fibroid tumours of the uterus incompatible with pregnancy
Follitropin beta (Fertavid)
Breast-feeding, follitropin beta [2] ---> SmPC of [2] of EMA
If follitropin beta would be excreted in human milk, it would be degraded in the gastrointestinal tract of the child. Follitropin beta may affect milk production.
Clomiphene, follitropin beta [2] ---> SmPC of [2] of EMA
Concomitant use of Fertavid and clomifene citrate may enhance the follicular response.
Fertility, follitropin beta [2] ---> SmPC of [2] of EMA
Fertavid is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes.
Follitropin beta [1], GnRH agonists ---> SmPC of [1] of EMA
After pituitary desensitisation induced by a GnRH agonist, a higher dose of follitropin beta may be necessary to achieve an adequate follicular response.
Follitropin beta [1], men ---> SmPC of [1] of EMA
In males Fertavid is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism. For posology and method of administration, see section 4.2.
Follitropin beta [1], pregnancy ---> SmPC of [1] of EMA
The use of Fertavid during pregnancy is not indicated. In case of inadvertent exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.
CONTRAINDICATIONS of Follitropin beta (Fertavid)
For males and females
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus.
- Primary gonadal failure
----
Additionally for females
- Undiagnosed vaginal bleeding.
- Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS).
- Malformations of the reproductive organs incompatible with pregnancy.
- Fibroid tumours of the uterus incompatible with pregnancy.
https://www.ema.europa.eu/en/documents/product-information/fertavid-epar-product-information_en.pdf 23/06/2020 (withdrawn)
Other trade names: Puregon,
Follitropin beta (Puregon)
Breast-feeding, follitropin beta [2] ---> SmPC of [2] of EMA
If follitropin beta would be excreted in human milk, it would be degraded in the gastrointestinal tract of the child. Follitropin beta may affect milk production.
Clomiphene, follitropin beta [2] ---> SmPC of [2] of EMA
Concomitant use of Puregon and clomifene citrate may enhance the follicular response.
Fertility, follitropin beta [2] ---> SmPC of [2] of EMA
Puregon is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes.
Follitropin beta [1], GnRH agonists ---> SmPC of [1] of EMA
After pituitary desensitisation induced by a GnRH agonist, a higher dose of follitropin beta may be necessary to achieve an adequate follicular response.
Follitropin beta [1], men ---> SmPC of [1] of EMA
In males Puregon is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism. For posology and method of administration, see section 4.2.
Follitropin beta [1], pregnancy ---> SmPC of [1] of EMA
The use of Puregon during pregnancy is not indicated. In case of inadvertent exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.
CONTRAINDICATIONS of Follitropin beta (Puregon)
For males and females
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus.
- Primary gonadal failure
----
Additionally for females
- Undiagnosed vaginal bleeding.
- Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS).
- Malformations of the reproductive organs incompatible with pregnancy.
- Fibroid tumours of the uterus incompatible with pregnancy.
https://www.ema.europa.eu/en/documents/product-information/puregon-epar-product-information_en.pdf 18/12/2025
Other trade names: Fertavid (withdrawn),
Follitropin delta (Rekovelle)
Breast-feeding, follitropin delta [2] ---> SmPC of [2] of EMA
REKOVELLE is not indicated during breastfeeding.
Fertility, follitropin delta [2] ---> SmPC of [2] of EMA
REKOVELLE is indicated for use in infertility (see section 4.1).
Follitropin delta [1], interactions ---> SmPC of [1] of EMA
Clinically significant interactions with other medicinal products have neither been reported during REKOVELLE therapy, nor are expected.
Follitropin delta [1], pregnancy ---> SmPC of [1] of EMA
REKOVELLE is not indicated during pregnancy. Studies in animals have shown reproductive toxicity with REKOVELLE doses above the recommended maximal dose in humans (section 5.3).
CONTRAINDICATIONS of Follitropin delta (Rekovelle)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- tumours of the hypothalamus or pituitary gland
- ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
- gynaecological haemorrhages of unknown aetiology (see section 4.4)
- ovarian, uterine or mammary carcinoma (see section 4.4)
In the following situations, treatment outcome is unlikely to be favourable, and therefore REKOVELLE should not be administered:
- primary ovarian failure
- malformations of sexual organs incompatible with pregnancy
- fibroid tumours of the uterus incompatible with pregnancy
https://www.ema.europa.eu/en/documents/product-information/rekovelle-epar-product-information_en.pdf. 03/10/2023
Fondaparinux (Arixtra)
Ability to drive, fondaparinux [2] ---> SmPC of [2] of EMA
No studies on the effect on the ability to drive and to use machines have been performed.
Acetylsalicylic acid, fondaparinux [2] ---> SmPC of [2] of EMA
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.
Anaesthetics, fondaparinux [2] ---> SmPC of [2] of EMA
In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long-term or permanent paralysis cannot be excluded with the concurrent use of fondaparinux and spinal/epidural anaesthesia or spinal puncture.
Apixaban [1], fondaparinux ---> SmPC of [1] of EMA
Due to an increased bleeding risk, concomitant treatment of apixaban with any other anticoagulants is contraindicated
Bleeding risk, fondaparinux [2] ---> SmPC of [2] of EMA
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4).
Breast-feeding, fondaparinux [2] ---> SmPC of [2] of EMA
Breast-feeding is not recommended during treatment with fondaparinux. Oral absorption by the child is however unlikely.
Cangrelor [1], fondaparinux ---> SmPC of [1] 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.
Certoparin, fondaparinux
The co-administration may enhance the pharmacological effects of certoparin
Clopidogrel, fondaparinux [2] ---> SmPC of [2] of EMA
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.
Dabigatran etexilate [1], fondaparinux ---> SmPC of [1] 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
Desirudin, fondaparinux [2] ---> SmPC of [2] of EMA
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Dipyridamole, fondaparinux [2] ---> SmPC of [2] of EMA
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.
Fertility, fondaparinux [2] ---> SmPC of [2] of EMA
There are no data available on the effect of fondaparinux on human fertility. Animal studies do not show any effect on fertility.
Follow-up treatment, fondaparinux [2] ---> SmPC of [2] of EMA
If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general rule, be given one day after the last fondaparinux injection.
Fondaparinux [1], GP IIb/IIIa inhibitors ---> SmPC of [1] of EMA
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Fondaparinux [1], heparin ---> SmPC of [1] of EMA
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Fondaparinux [1], heparinoids ---> SmPC of [1] of EMA
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Fondaparinux [1], low molecular weight heparins ---> SmPC of [1] of EMA
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Fondaparinux [1], NSAID ---> SmPC of [1] of EMA
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.
Fondaparinux [1], pharmacokinetics ---> SmPC of [1] of EMA
Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Fondaparinux [1], platelet aggregation inhibitors ---> SmPC of [1] of EMA
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.
Fondaparinux [1], pregnancy ---> SmPC of [1] of EMA
Fondaparinux should not be prescribed to pregnant women unless clearly necessary.
Fondaparinux [1], sulfinpyrazone ---> SmPC of [1] of EMA
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.
Fondaparinux [1], thrombolytics ---> SmPC of [1] of EMA
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Fondaparinux [1], ticlopidine ---> SmPC of [1] of EMA
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. If co-administration is essential, close monitoring is necessary.
Fondaparinux [1], vitamin K antagonists ---> SmPC of [1] of EMA
If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.
Fondaparinux [1], warfarin ---> SmPC of [1] of EMA
Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Fondaparinux, melagatran
The co-administration may significantly increase the bleeding risk
Fondaparinux, phenindione
The co-administration is not recommended since it may increase the intensity of bleedings
Fondaparinux, retinol
Concomitant use of parenteral anticoagulants with vitamin A may increase the anticoagulant effect and the risk of bleeding
Fondaparinux, rivaroxaban [2] ---> SmPC of [2] of EMA
Concomitant treatment 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.
Fondaparinux, vitamin A
Concomitant use of parenteral anticoagulants with vitamin A may increase the anticoagulant effect and the risk of bleeding
Fondaparinux, ximelagatran
The co-administration may significantly increase the bleeding risk
CONTRAINDICATIONS of Fondaparinux (Arixtra)
- hypersensitivity to the active substance or to any of the excipients
- active clinically significant bleeding
- acute bacterial endocarditis
- severe renal impairment defined by creatinine clearance < 20 ml/min.
https://www.ema.europa.eu/en/documents/product-information/arixtra-epar-product-information_en.pdf 27/03/2024
Formoterol
Ability to drive, formoterol [2] ---> SmPC of [2] of eMC
Patients experiencing dizziness or other similar side effects should be advised to refrain from driving or using machines.
Alcohol, formoterol ---> SmPC of [budesonide/formoterol] of EMA
Alcohol can impair cardiac tolerance towards beta2 sympathomimetics.
Anticholinergics, formoterol ---> SmPC of [budesonide/formoterol] of EMA
Concomitant use of beta adrenergic medicinal products and anticholinergic medicinal products can have a potentially additive bronchodilating effect.
Antidiabetics, formoterol [2] ---> SmPC of [2] of eMC
Due to the hyperglycaemic effect of beta2-stimulants, including formoterol, additional blood glucose controls are recommended in diabetic patients.
Antihistamines, formoterol [2] ---> SmPC of [2] of eMC
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Beta-adrenergic receptor blockers, formoterol ---> SmPC of [budesonide/formoterol] of EMA
Beta-adrenergic blockers can weaken or inhibit the effect of formoterol.
Beta2-adrenergic agonists, formoterol [2] ---> SmPC of [2] of eMC
Concomitant administration of formoterol with other sympathomimetic agents may potentiate the undesirable effects of formoterol and may require titration of the dose.
Betablockers, formoterol [2] ---> SmPC of [2] of eMC
Beta-adrenergic blockers may weaken or antagonise the effect of formoterol. Therefore formoterol should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Breast-feeding, formoterol [2] ---> SmPC of [2] of eMC
Mothers using formoterol should refrain from breast feeding their infants.
Corticosteroids, formoterol
Concomitant treatment may potentiate a possible hypokalaemic effect of beta2-agonists.
Digital glycosides, formoterol ---> SmPC of [budesonide/formoterol] of EMA
Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Disopyramide, formoterol [2] ---> SmPC of [2] of eMC
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Diuretics, formoterol [2] ---> SmPC of [2] of eMC
Concomitant treatment may potentiate a possible hypokalaemic effect of beta2-agonists.
Ephedrine, formoterol
Concomitant administration of formoterol with other sympathomimetic agents may potentiate the undesirable effects of formoterol and may require titration of the dose.
Erythromycin, formoterol [2] ---> SmPC of [2] of eMC
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Formoterol [1], hypokalemia ---> SmPC of [1] of eMC
Concomitant treatment may potentiate a possible hypokalaemic effect of beta2-agonists.
Formoterol [1], loop diuretics ---> SmPC of [1] of eMC
Concomitant treatment may potentiate a possible hypokalaemic effect of beta2-agonists.
Formoterol [1], phenothiazines ---> SmPC of [1] of eMC
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Formoterol [1], pregnancy ---> SmPC of [1] of eMC
Until further experience is gained, formoterol is not recommended for use during pregnancy (particularly at the end of pregnancy or during labour) unless there is no more established alternative.
Formoterol [1], procainamide ---> SmPC of [1] of eMC
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Formoterol [1], QT interval prolonging drugs ---> SmPC of [1] of eMC
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Formoterol [1], quinidine ---> SmPC of [1] of eMC
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Formoterol [1], steroids ---> SmPC of [1] of eMC
Concomitant treatment may potentiate a possible hypokalaemic effect of beta2-agonists.
Formoterol [1], sympathomimetics ---> SmPC of [1] of eMC
Concomitant administration of formoterol with other sympathomimetic agents may potentiate the undesirable effects of formoterol and may require titration of the dose.
Formoterol [1], thiazides ---> SmPC of [1] of eMC
Concomitant treatment may potentiate a possible hypokalaemic effect of beta2-agonists.
Formoterol [1], tricyclic antidepressant ---> SmPC of [1] of eMC
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Formoterol [1], xanthines ---> SmPC of [1] of eMC
Concomitant treatment may potentiate a possible hypokalaemic effect of beta2-agonists.
Formoterol, halogenated anaesthetics ---> SmPC of [budesonide/formoterol] of EMA
There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons and formoterol.
Formoterol, IMAOs ---> SmPC of [budesonide/formoterol] of EMA
Concomitant treatment of formoterol with MAO inhibitors may prolong the QTc-interval and increase the risk of ventricular arrhythmias and also precipitate hypertensive reactions.
Formoterol, levodopa ---> SmPC of [budesonide/formoterol] of EMA
L-Dopa can impair cardiac tolerance towards beta2 sympathomimetics.
Formoterol, levothyroxine ---> SmPC of [budesonide/formoterol] of EMA
L-thyroxine can impair cardiac tolerance towards beta2 sympathomimetics.
Formoterol, mizolastine
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Formoterol, oxytocin ---> SmPC of [budesonide/formoterol] of EMA
Oxytocin can impair cardiac tolerance towards beta2 sympathomimetics.
Formoterol, terfenadine
Caution should be observed in patients treated with drugs that may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia
Formoterol, theophylline
The co-administration may mutually potentiate the effects and also the side effects such as cardiac dysrhythmia
CONTRAINDICATIONS of Formoterol
- Known hypersensitivity to formoterol, to lactose (which contains small amount of milk proteins) or to any of the other excipients
http://www.medicines.org.uk/emc/
Formoterol/glycopyrronium/budesonide (Trixeo Aerosphere)
Ability to drive, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
Dizziness is an uncommon side effect which should be taken into account when driving or using machines.
Alcohol, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
In addition, L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.
Anaesthetics, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Anticholinergics, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
Co-administration of this medicinal product is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions
Antihistamines, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
Concomitant treatment can prolong the QT interval and increase the risk of ventricular arrhythmias.
Beta-adrenergic agonists, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects; therefore, caution is required when other beta-adrenergic medicinal products are prescribed concomitantly with formoterol.
Betablockers, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
Beta-adrenergic blockers (including eye drops) can weaken or inhibit the effect of formoterol. Concurrent use of beta-adrenergic blockers should be avoided unless the expected benefit outweighs the potential risk.
Breast-feeding, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
Administration of this medicinal product to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Cardiac glycosides, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.
Cimetidine, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
The effect of cimetidine on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 22% and a slight decrease in renal clearance by 23% due to co-administration of cimetidine.
Cobicistat, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
The metabolism of budesonide is primarily mediated by CYP3A4. Co-treatment with strong CYP3A inhibitors are expected to increase the risk of systemic side effects, and should be avoided
Cytochrome P450, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
Formoterol does not inhibit the CYP450 enzymes at therapeutically relevant concentrations (see section 5.2). Budesonide and glycopyrronium do not inhibit or induce CYP450 enzymes at therapeutically relevant concentrations.
Disopyramide, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
Concomitant treatment can prolong the QT interval and increase the risk of ventricular arrhythmias.
Fertility, formoterol/glycopyrronium/budesonide [2] ---> SmPC of [2] of EMA
It is unlikely that this medicinal product administered at the recommended dose will affect fertility in humans.
Formoterol/glycopyrronium/budesonide [1], furazolidone ---> SmPC of [1] of EMA
Concomitant treatment may precipitate hypertensive reactions.
Formoterol/glycopyrronium/budesonide [1], IMAOs ---> SmPC of [1] of EMA
Concomitant treatment can prolong the QT interval and increase the risk of ventricular arrhythmias. Concomitant treatment with monoamine oxidase inhibitors may precipitate hypertensive reactions.
Formoterol/glycopyrronium/budesonide [1], itraconazol ---> SmPC of [1] of EMA
The metabolism of budesonide is primarily mediated by CYP3A4. Co-treatment with strong CYP3A inhibitors are expected to increase the risk of systemic side effects, and should be avoided
Formoterol/glycopyrronium/budesonide [1], ketoconazole ---> SmPC of [1] of EMA
The metabolism of budesonide is primarily mediated by CYP3A4. Co-treatment with strong CYP3A inhibitors are expected to increase the risk of systemic side effects, and should be avoided
Formoterol/glycopyrronium/budesonide [1], levodopa ---> SmPC of [1] of EMA
In addition, L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.
Formoterol/glycopyrronium/budesonide [1], levothyroxine ---> SmPC of [1] of EMA
In addition, L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.
Formoterol/glycopyrronium/budesonide [1], oxytocin ---> SmPC of [1] of EMA
In addition, L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.
Formoterol/glycopyrronium/budesonide [1], phenothiazines ---> SmPC of [1] of EMA
Concomitant treatment can prolong the QT interval and increase the risk of ventricular arrhythmias.
Formoterol/glycopyrronium/budesonide [1], potassium-sparing diuretics ---> SmPC of [1] of EMA
Possible initial hypokalaemia may be potentiated by concomitant medicinal products, including xanthine derivatives, steroids and non-potassium sparing diuretics
Formoterol/glycopyrronium/budesonide [1], pregnancy ---> SmPC of [1] of EMA
Administration of this medicinal product to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Formoterol/glycopyrronium/budesonide [1], procainamide ---> SmPC of [1] of EMA
Concomitant treatment can prolong the QT interval and increase the risk of ventricular arrhythmias.
Formoterol/glycopyrronium/budesonide [1], procarbazine ---> SmPC of [1] of EMA
Concomitant treatment may precipitate hypertensive reactions.
Formoterol/glycopyrronium/budesonide [1], protease inhibitors ---> SmPC of [1] of EMA
The metabolism of budesonide is primarily mediated by CYP3A4. Co-treatment with strong CYP3A inhibitors are expected to increase the risk of systemic side effects, and should be avoided
Formoterol/glycopyrronium/budesonide [1], quinidine ---> SmPC of [1] of EMA
Concomitant treatment can prolong the QT interval and increase the risk of ventricular arrhythmias.
Formoterol/glycopyrronium/budesonide [1], renal excretion ---> SmPC of [1] of EMA
Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms.
Formoterol/glycopyrronium/budesonide [1], steroids ---> SmPC of [1] of EMA
Possible initial hypokalaemia may be potentiated by concomitant medicinal products, including xanthine derivatives, steroids and non-potassium sparing diuretics
Formoterol/glycopyrronium/budesonide [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
The metabolism of budesonide is primarily mediated by CYP3A4. Co-treatment with strong CYP3A inhibitors are expected to increase the risk of systemic side effects, and should be avoided
Formoterol/glycopyrronium/budesonide [1], tricyclic antidepressant ---> SmPC of [1] of EMA
Concomitant treatment can prolong the QT interval and increase the risk of ventricular arrhythmias.
Formoterol/glycopyrronium/budesonide [1], xanthines ---> SmPC of [1] of EMA
Possible initial hypokalaemia may be potentiated by concomitant medicinal products, including xanthine derivatives, steroids and non-potassium sparing diuretics
CONTRAINDICATIONS of Formoterol/glycopyrronium/budesonide (Trixeo Aerosphere)
- Hypersensitivity to the active substances or any of the excipients listed in section 6.1.
Other trade names: Riltrava Aerosphere,
Fosamprenavir (Telzir)
Abacavir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
No clinically significant interaction is observed. No dosage adjustment necessary.
Ability to drive, fosamprenavir [2] ---> SmPC of [2] of EMA
The adverse reaction profile of Telzir should be borne in mind when considering the patient's ability to drive or operate machinery
Alfuzosin, fosamprenavir/ritonavir ---> SmPC 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
Amiodarone, fosamprenavir/ritonavir ---> SmPC 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.
Antacids, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
The increase in gastric pH decreases the fosamprenavir absorption. No dosage adjustment necessary
Astemizole, fosamprenavir/ritonavir ---> SmPC 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.
Atazanavir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
No dosage adjustment necessary.
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
Atorvastatin, fosamprenavir/ritonavir ---> SmPC 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.
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
Bepridil, fosamprenavir/ritonavir ---> SmPC 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.
Boceprevir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
Co-administration of fosamprenavir with ritonavir and the HCV protease inhibitor boceprevir may lead to subtherapeutic levels of both, fosamprenavir and boceprevir. Thus, co-administration is not recommended
Bosutinib [1], fosamprenavir ---> SmPC of [1] 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.
Breast-feeding, fosamprenavir [2] ---> SmPC of [2] of EMA
It is recommended that mothers being treated with fosamprenavir do not breast-feed their infants under any circumstances to avoid transmission of HIV.
Carbamazepine, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
It is expected that the modest CYP3A4 induction by carbamazepine reduces amprenavir concentration. Use with caution
Cisapride, fosamprenavir/ritonavir ---> SmPC 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.
Clarithromycin, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
The CYP3A4 inhibition may moderately increase the clarithromycin exposition. Use with caution
Cobimetinib [1], fosamprenavir ---> SmPC of [1] 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.
Cyclosporine, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] 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
Dabrafenib [1], fosamprenavir ---> SmPC of [1] 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.
Daclatasvir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
Coadministration with fosamprenavir/ritonavir is likely to lead to increased plasma exposures of daclatasvir due to CYP3A4 enzyme inhibition. Not recommended
Dapoxetine [1], fosamprenavir ---> SmPC of [1] 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.
Dasabuvir with ombitasvir/paritaprevir/ritonavir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
Co-administration of paritaprevir and fosamprenavir/ritonavir is contraindicated due to the expected increase of paritaprevir exposure and the lack of clinical data assessing the magnitude of this increase
Desipramine, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
Careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they are concomitantly administered with amprenavir
Dextromethorphan/quinidine [1], fosamprenavir ---> SmPC of [1] 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.
Didanosine, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
No clinically significant interaction is observed. No dose separation or dosage adjustment necessary
Dihydroergotamine, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
CYP3A4 inhibition by fosamprenavir/ritonavir may increase ergot derivate plasma levels. Combination is contraindicated. Potential for serious and/or life-threatening reactions such as acute ergot toxicity
Dolutegravir, fosamprenavir/ritonavir
The induction of UGT1A1 and CYP3A may decrease dolutegravir plasma levels. No dose adjustment is necessary in the absence of integrase class resistance. In the presence of resistance, alternative combinations should be considered.
Dolutegravir, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
No dosage adjustment of fosamprenavir or dolutegravir is recommended based on observed exposure-response relationships of clinical data.
Dolutegravir/abacavir/lamivudine [1], fosamprenavir/ritonavir ---> SmPC of [1] of EMA
Fosamprenavir/ritonavir decreases dolutegravir concentrations, but based on limited data, did not result in decreased efficacy in Phase III studies. No dose adjustment is necessary.
Dolutegravir/lamivudine [1], fosamprenavir/ritonavir ---> SmPC of [1] of EMA
Fosamprenavir/ritonavir decreases dolutegravir concentrations, but based on limited data, did not result in decreased efficacy in Phase III studies. No dose adjustment is necessary. Induction of UGT1A1 and CYP3A enzymes
Drugs primarily metabolised by CYP2D6 with narrow therapeutic index, fosamprenavir/ritonavir ---> SmPC of [fosampr
Fosamprenavir with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism
Drugs primarily metabolised by CYP3A4 with narrow therapeutic index, fosamprenavir [2] ---> SmPC 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).
Drugs primarily metabolised by CYP3A4 with narrow therapeutic index, fosamprenavir/ritonavir ---> SmPC of [fosampr
The combination of amprenavir/ritonavir, CYP3A4 inhibitors, with drugs mainly metabolized by CYP3A4 and have narrow therapeutic index is contraindicated
Drugs primarily metabolised by CYP3A4, fosamprenavir/ritonavir
Amprenavir/ritonavir, CYP3A4 inhibitor, may increase the plasma levels of drugs mainly metabolized by CYP3A4 (contraindicated if these have narrow therapeutic index)
Efavirenz [1], fosamprenavir/nelfinavir ---> SmPC of [1] of EMA
No dose adjustment is necessary for any of these medicinal products.
Efavirenz [1], fosamprenavir/saquinavir ---> SmPC of [1] of EMA
Not recommended as the exposure to both PIs is expected to be significantly decreased.
Efavirenz, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
No clinically significant pharmacokinetic interaction. No dosage adjustment necessary.
Eliglustat [1], fosamprenavir ---> SmPC of [1] 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.
Ergonovine, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
CYP3A4 inhibition by fosamprenavir/ritonavir may increase ergot derivate plasma levels. Combination is contraindicated. Potential for serious and/or life-threatening reactions such as acute ergot toxicity
Ergotamine, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
CYP3A4 inhibition by fosamprenavir/ritonavir may increase ergot derivate plasma levels. Combination is contraindicated. Potential for serious and/or life-threatening reactions such as acute ergot toxicity
Erythromycin, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
The CYP3A4 inhibition by fosamprenavir and ritonavir may increase the erythromycin exposition. Use with caution
Esomeprazole, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
The increase in gastric pH decreases the fosamprenavir absorption. No dosage adjustment necessary
Ethinyl estradiol, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
Because there may be an increased risk of hormonal levels may be altered with co-administration of fosamprenavir, ritonavir and oral contraceptives, alternative non-hormonal methods of contraception are recommended for women of childbearing potential
Etravirine, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
Increased AUC of amprenavir. Fosamprenavir may require dose reduction
Everolimus [1], fosamprenavir ---> SmPC of [1] of EMA
Increase in everolimus concentration is expected. Use caution when co-administration of moderate CYP3A4 inhibitors or PgP inhibitors cannot be avoided.
Fentanyl [1], fosamprenavir ---> SmPC of [1] 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.
Fertility, fosamprenavir [2] ---> SmPC of [2] of EMA
No human data on the effect of fosamprenavir on fertility are available. In rats, there was no major effect on fertillty or reproductive performance with fosamprenavir (see section 5.3).
Flecainide, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] 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.
Fluticasone, fosamprenavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
Fosamprenavir/ritonavir, CYP3A4 inhibitors, may increase the concentrations of fluticasone. Concomitant use is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects
Fosamprenavir [1], pregnancy ---> SmPC of [1] of EMA
Telzir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Fosamprenavir, 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.
Fosamprenavir, 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.
Fosamprenavir, isavuconazole [2] ---> SmPC of [2] of EMA
No isavuconazole dose adjustment necessary. Protease inhibitors: careful monitoring for any occurrence of drug toxicity and /or lack of antiviral efficacy, and dose adjustment if required.
Fosamprenavir, lanthanum carbonate
Decreased absorption of fosamprenavir. Separate administration by at least 2 hours
Fosamprenavir, nevirapine [2] ---> SmPC of [2] of EMA
It is not recommended to co-administer fosamprenavir and nevirapine if fosamprenavir is not co-administered with ritonavir
Fosamprenavir, posaconazole [2] ---> SmPC of [2] of EMA
Combining fosamprenavir with posaconazole may lead to decreased posaconazole plasma concentrations. If concomitant administration is required, close monitoring for breakthrough fungal infections is recommended.
Fosamprenavir, ritonavir
When fosamprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
Fosamprenavir, ritonavir [2] ---> SmPC of [2] of EMA
Ritonavir increases the serum levels of amprenavir (from fosamprenavir) as a result of CYP3A4 inhibition. Fosamprenavir must be given with ritonavir to ensure its therapeutic effect.
Fosamprenavir, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA
Decreased saquinavir concentration. No dose adjustment required for Invirase/ritonavir.
Fosamprenavir, 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.
Fosamprenavir, strong CYP3A4 inductors
The strong CYP3A4 induction may decrease the plasma levels of amprenavir
Fosamprenavir, strong CYP3A4 inhibitors
The strong CYP3A4 inhibition may increase the plasma concentrations of amprenavir
Fosamprenavir/ritonavir, glucocorticoids metabolized by CYP3A4 ---> SmPC of [fosamprenavir] of EMA
Concomitant use of fosamprenavir with ritonavir and glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects
Fosamprenavir/ritonavir, H2 antagonists ---> SmPC of [fosamprenavir] of EMA
The increase in gastric pH decreases the fosamprenavir absorption. No dosage adjustment necessary
Fosamprenavir/ritonavir, halofantrine ---> SmPC of [fosamprenavir] of EMA
It is expected that the CYP3A4 inhibition by fosamprenavir/ritonavir increases halofantrine concentration. Concomitant use is not recommended. It may cause serious adverse reactions
Fosamprenavir/ritonavir, indinavir ---> SmPC of [fosamprenavir] of EMA
No dose recommendations can be given.
Fosamprenavir/ritonavir, itraconazol ---> SmPC of [fosamprenavir] of EMA
The CYP3A4 inhibition by fosamprenavir/ritonavir may increase the plasma concentrations of itraconazole
Fosamprenavir/ritonavir, ketoconazole ---> SmPC of [fosamprenavir] of EMA
The CYP3A4 inhibition by fosamprenavir/ritonavir may increase the plasma concentrations of ketoconazole
Fosamprenavir/ritonavir, lamivudine ---> SmPC of [fosamprenavir] of EMA
No clinically significant interaction is observed. No dosage adjustment necessary.
Fosamprenavir/ritonavir, lanthanum carbonate [2] ---> SmPC of [2] of EMA
Decreased absorption of fosamprenavir. Separate administration by at least 2 hours
Fosamprenavir/ritonavir, lidocaine ---> SmPC of [fosamprenavir] of EMA
It is expected that the CYP3A4 inhibition by fosamprenavir/ritonavir increases lidocaine concentration. Concomitant use is not recommended. It may cause serious adverse reactions
Fosamprenavir/ritonavir, lopinavir/ritonavir ---> SmPC of [fosamprenavir] of EMA
Increased exposition of lopinavir and decreased exposition of amprenavir (mixed CYP3A4 induction/inhibition, P-gp induction). Concomitant use is not recommended
Fosamprenavir/ritonavir, lovastatine ---> SmPC of [fosamprenavir] 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
Fosamprenavir/ritonavir, maraviroc ---> SmPC of [fosamprenavir] of EMA
Concomitant use is not recommended. Significant reductions in amprenavir Cmin observed may result in virological failure in patients.
Fosamprenavir/ritonavir, methadone ---> SmPC of [fosamprenavir] of EMA
CYP induction by fosamprenavir/ritonavir may decrease methadone exposition. As a precaution, patients should be monitored for withdrawal syndrome.
Fosamprenavir/ritonavir, methylergonovine ---> SmPC of [fosamprenavir] of EMA
CYP3A4 inhibition by fosamprenavir/ritonavir may increase ergot derivate plasma levels. Combination is contraindicated. Potential for serious and/or life-threatening reactions such as acute ergot toxicity
Fosamprenavir/ritonavir, midazolam ---> SmPC of [fosamprenavir] of EMA
Fosamprenavir/ritonavir, CYP3A4 inhibitors, increase the plasma concentrations of midazolam. Fosamprenavir/ritonavir should not be co-administered with orally administered midazolam
Fosamprenavir/ritonavir, nelfinavir ---> SmPC of [fosamprenavir] of EMA
No dose recommendations can be given.
Fosamprenavir/ritonavir, nevirapine [2] ---> SmPC of [2] of EMA
Fosamprenavir/ritonavir and nevirapine can be co-administered without dose adjustments
Fosamprenavir/ritonavir, norethisterone ---> SmPC of [fosamprenavir] of EMA
Because there may be an increased risk of hormonal levels may be altered with co-administration of fosamprenavir, ritonavir and oral contraceptives, alternative non-hormonal methods of contraception are recommended for women of childbearing potential
Fosamprenavir/ritonavir, nortriptyline ---> SmPC of [fosamprenavir] of EMA
Careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when they are concomitantly administered with amprenavir
Fosamprenavir/ritonavir, ombitasvir/paritaprevir/ritonavir ---> SmPC of [fosamprenavir] of EMA
Co-administration of paritaprevir and fosamprenavir/ritonavir is contraindicated due to the expected increase of paritaprevir exposure and the lack of clinical data assessing the magnitude of this increase
Fosamprenavir/ritonavir, omeprazole ---> SmPC of [fosamprenavir] of EMA
The increase in gastric pH decreases the fosamprenavir absorption. No dosage adjustment necessary
Fosamprenavir/ritonavir, oral anticoagulants ---> SmPC of [fosamprenavir] 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
Fosamprenavir/ritonavir, oral contraceptives ---> SmPC of [fosamprenavir] of EMA
Because there may be an increased risk of hormonal levels may be altered with co-administration of fosamprenavir, ritonavir and oral contraceptives, alternative non-hormonal methods of contraception are recommended for women of childbearing potential
Fosamprenavir/ritonavir, paroxetine ---> SmPC of [fosamprenavir] of EMA
Concomitant use may decrease paroxetine exposition. Dose titration of paroxetine based on a clinical assessment of antidepressant response is recommended.
Fosamprenavir/ritonavir, PDE5 inhibitors ---> SmPC of [fosamprenavir] of EMA
Fosamprenavir/ritonavir, CYP3A4 inhibitors, may increase PDE5 inhibitor plasma concentrations. Concomitant use is not recommended
Fosamprenavir/ritonavir, phenobarbital ---> SmPC of [fosamprenavir] of EMA
It is expected that the modest CYP3A4 induction by phenobarbital reduces amprenavir concentration. Use with caution
Fosamprenavir/ritonavir, phenytoin ---> SmPC of [fosamprenavir] of EMA
It is recommended that phenytoin plasma concentrations be monitored and phenytoin dose increased as appropriate. (Modest induction of CYP3A4 by fosamprenavir/ritonavir)
Fosamprenavir/ritonavir, pimozide ---> SmPC 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.
Fosamprenavir/ritonavir, propafenone ---> SmPC of [fosamprenavir] 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.
Fosamprenavir/ritonavir, protease inhibitors ---> SmPC of [fosamprenavir] of EMA
According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended.
Fosamprenavir/ritonavir, quetiapine ---> SmPC of [fosamprenavir] of EMA
The CYP3A inhibition by amprenavir can increase the concentrations of quetiapine (which may lead to coma). Concomitant administration of amprenavir and quetiapine is contraindicated as it may increase quetiapine-related toxicity.
Fosamprenavir/ritonavir, quinidine ---> SmPC 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.
Fosamprenavir/ritonavir, raltegravir ---> SmPC of [fosamprenavir] of EMA
Concomitant use is not recommended. Significant reductions in exposure and Cmin observed for both amprenavir and raltegravir (especially in fed conditions) may result in virological failure in patients.
Fosamprenavir/ritonavir, ranitidine ---> SmPC of [fosamprenavir] of EMA
The increase in gastric pH decreases the fosamprenavir absorption. No dosage adjustment necessary
Fosamprenavir/ritonavir, rapamycin ---> SmPC of [fosamprenavir] 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
Fosamprenavir/ritonavir, rifabutin ---> SmPC of [fosamprenavir] of EMA
The increase of 25-O-desacetylrifabutin (active metabolite) (mixed CYP3A4 induction/inhibition) could potentially lead to an increase of rifabutin related adverse events, notably uveitis. A reduction in the rifabutin dosage by at least 75% is recommended
Fosamprenavir/ritonavir, rifampicin ---> SmPC of [fosamprenavir] 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
Fosamprenavir/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.
Fosamprenavir/ritonavir, saquinavir ---> SmPC of [fosamprenavir] of EMA
No dose recommendations can be given.
Fosamprenavir/ritonavir, sildenafil ---> SmPC of [fosamprenavir] of EMA
Fosamprenavir/ritonavir, CYP3A4 inhibitors, may increase plasma concentrations of sildenafil, which is contraindicated for the treatment of pulmonary arterial hypertension
Fosamprenavir/ritonavir, simeprevir ---> SmPC of [fosamprenavir] of EMA
Coadministration with fosamprenavir/ritonavir is likely to lead to increased plasma exposures of simeprevir due to CYP3A4 enzyme inhibition. Not recommended
Fosamprenavir/ritonavir, simvastatine ---> SmPC of [fosamprenavir] of EMA
Concomitant use of amprenavir with simvastatin is contraindicated because of increased plasma concentrations of simvastatin which can increase the risk of myopathy, including rhabdomyolysis
Fosamprenavir/ritonavir, St. John's wort ---> SmPC of [fosamprenavir] of EMA
CYP3A4 induction by St. John's wort may decrease exposition of amprenavir. Herbal preparations containing St John's wort must not be combined with fosamprenavir
Fosamprenavir/ritonavir, tacrolimus ---> SmPC of [fosamprenavir] 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
Fosamprenavir/ritonavir, tadalafil ---> SmPC of [fosamprenavir] of EMA
Fosamprenavir/ritonavir, CYP3A4 inhibitors, may increase the tadalafil plasma levels and cause hypotension, visual changes and priapism. The combination is not recommended
Fosamprenavir/ritonavir, telaprevir ---> SmPC of [fosamprenavir] of EMA
Co-administration of fosamprenavir with ritonavir and the HCV protease inhibitor telaprevir may lead to subtherapeutic levels of both, fosamprenavir and telaprevir. Thus, co-administration is not recommended
Fosamprenavir/ritonavir, tenofovir ---> SmPC of [fosamprenavir] of EMA
No clinically significant interaction is observed. No dosage adjustment necessary.
Fosamprenavir/ritonavir, terfenadine ---> SmPC 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.
Fosamprenavir/ritonavir, triazolam ---> SmPC of [fosamprenavir] of EMA
Fosamprenavir/ritonavir, CYP3A4 inhibitors, increase the plasma concentrations of triazolam. They should not be co-administered with orally administered triazolam
Fosamprenavir/ritonavir, tricyclic antidepressant ---> SmPC of [fosamprenavir] of EMA
Careful monitoring of the therapeutic and adverse reactions of tricyclic antidepressants is recommended when coadministered with fosamprenavir
Fosamprenavir/ritonavir, vardenafil ---> SmPC of [fosamprenavir] of EMA
Fosamprenavir, CYP3A4 inhibitor, may increase the vardenafil plasma levels and cause hypotension, visual changes and priapism. The combination is not recommended
Fosamprenavir/ritonavir, warfarin ---> SmPC of [fosamprenavir] 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
Fosamprenavir/ritonavir, zidovudine ---> SmPC of [fosamprenavir] of EMA
No clinically significant interaction is observed. No dosage adjustment necessary.
CONTRAINDICATIONS of Fosamprenavir (Telzir)
- Hypersensitivity to fosamprenavir, amprenavir, or ritonavir, or to any of the excipients
- Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4), e.g. alfuzosin, amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quetiapine, quinidine, terfenadine, oral midazolam (for caution on parenterally administered midazolam), oral triazolam, sildenafil used for the treatment of pulmonary arterial hypertension (for use of sildenafil in patients with erectile dysfunction
- Co-administration of the antipsychotic medicinal product lurasidone and fosamprenavir/ritonavir (FPV/RTV) is contraindicated (see section 4.5).
- Co-administration of paritaprevir and fosamprenavir/ritonavir is contraindicated due to the expected increase of paritaprevir exposure and the lack of clinical data assessing the magnitude of this increase
- Concomitant use of Telzir with simvastatin or lovastatin is contraindicated because of increased plasma concentrations of lovastatin and simvastatin which can increase the risk of myopathy, including rhabdomyolysis
- Combination of rifampicin with Telzir with concomitant low-dose ritonavir is contraindicated
- Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking Telzir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir
https://www.ema.europa.eu/en/documents/product-information/telzir-epar-product-information_en.pdf 23/08/2022
Fosaprepitant (Ivemend)
5-HT3 receptor antagonists, fosaprepitant [2] ---> SmPC of [2] of EMA
There is no evidence of interaction with the use of IVEMEND 150 mg and 5-HT3 antagonists.
Ability to drive, fosaprepitant [2] ---> SmPC of [2] of EMA
IVEMEND may have minor influence on the ability to drive and use machines. Dizziness and fatigue may occur following administration of IVEMEND (see section 4.8).
Acenocoumarol, fosaprepitant [2] ---> SmPC of [2] of EMA
Fosaprepitant, CYP2C9 inductor, may decrease the plasma concentrations of anticoagulant. Caution is advised
Alfentanyl, fosaprepitant [2] ---> SmPC 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
Alprazolam, fosaprepitant [2] ---> SmPC 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.
Alternative method of contraception, fosaprepitant [2] ---> SmPC of [2] of EMA
Alternative non-hormonalback-up methods of contraception should be used during treatment with fosaprepitant and for 2 months following the last dose of fosaprepitant (see sections 4.4 and 4.5).
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.
Astemizole, fosaprepitant [2] ---> SmPC of [2] of EMA
Inhibition of CYP3A4 by fosaprepitant could result in elevated plasma concentrations of astemizole, potentially causing serious or life-threatening reactions. Concomitant use is contraindicated
Benzodiazepine primarily metabolised by CYP3A4, fosaprepitant [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 IVEMEND.
Breast-feeding, fosaprepitant [2] ---> SmPC of [2] of EMA
Breast-feeding is not recommended during treatment with IVEMEND
Carbamazepine, fosaprepitant [2] ---> SmPC of [2] of EMA
Concomitant administration of fosaprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination could result in reductions of the plasma concentrations of aprepitant
Chemotherapeutic agents that are substrates for CYP3A4, fosaprepitant [2] ---> SmPC of [2] of EMA
An interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g. etoposide, vinorelbine) cannot be excluded.
Cisapride, fosaprepitant [2] ---> SmPC of [2] of EMA
Inhibition of CYP3A4 by fosaprepitant could result in elevated plasma concentrations of cisapride, potentially causing serious or life-threatening reactions. Concomitant use is contraindicated
Clarithromycin, fosaprepitant [2] ---> SmPC of [2] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Cyclosporine, fosaprepitant [2] ---> SmPC 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
CYP3A4 inhibitors, fosaprepitant [2] ---> SmPC of [2] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Dexamethasone, fosaprepitant [2] ---> SmPC of [2] of EMA
The CYP3A4 inhibition may increase the plasma levels of dexamethasone. The usual oral dexamethasone dose should be reduced
Diazepam, fosaprepitant
The CYP3A4 and CYP2C19 inhibition may increase the plasma levels of diazepam
Digoxin, fosaprepitant [2] ---> SmPC of [2] of EMA
Fosaprepitant does not seem to interact with the P-glycoprotein transporter, as demonstrated by the lack of interaction of oral aprepitant with digoxin.
Dihydroergotamine, fosaprepitant [2] ---> SmPC 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
Diltiazem, fosaprepitant [2] ---> SmPC of [2] of EMA
In patients with mild to moderate hypertension, infusion of fosaprepitant over 15 minutes with diltiazem resulted in a 1.4-fold increase in diltiazem AUC and a small but clinically meaningful decrease in blood pressure
Docetaxel, fosaprepitant [2] ---> SmPC of [2] of EMA
Based on studies with oral aprepitant and docetaxel and vinorelbine, IVEMEND 150 mg is not expected to have a clinically relevant interaction with intravenously administered docetaxel and vinorelbine.
Drugs primarily metabolised by CYP2C9, fosaprepitant [2] ---> SmPC of [2] of EMA
Aprepitant, CYP2C9 inductor, may decrease the plasma concentrations of the medicinal products metabolized by CYP2C9. Caution is advised
Drugs primarily metabolised by CYP3A4 with narrow therapeutic index, fosaprepitant [2] ---> SmPC 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
Drugs primarily metabolised by CYP3A4, fosaprepitant [2] ---> SmPC of [2] of EMA
As a weak inhibitor of CYP3A4, the fosaprepitant 150 mg single dose can cause a transient increase in plasma concentrations of co-administered active substances that are metabolised through CYP3A4.
Ergot derivatives, fosaprepitant [2] ---> SmPC of [2] of EMA
The CYP3A4 inhibition by fosaprepitant may increase the plasma levels of ergot derivate. Therefore, caution is advised due to the potential risk of ergot-related toxicity.
Ergotamine, fosaprepitant [2] ---> SmPC 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
Ethinylestradiol/norgestimate [1], fosaprepitant ---> SmPC of [1] 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.
Etoposide, fosaprepitant [2] ---> SmPC of [2] of EMA
An interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g. etoposide, vinorelbine) cannot be excluded.
Everolimus, fosaprepitant [2] ---> SmPC 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
Fentanyl, fosaprepitant [2] ---> SmPC 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
Fertility, fosaprepitant [2] ---> SmPC of [2] 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).
Fosaprepitant [1], immunosuppressants metabolised by CYP3A4 ---> SmPC of [1] of EMA
Following a single 150 mg fosaprepitant dose, a transient moderate increase for two days possibly followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 (e.g. cyclosporine, tacrolimus, everolimus and sirolimus) is expected.
Fosaprepitant [1], immunosuppressants metabolised by CYP3A4 ---> SmPC of [1] of EMA
Following a single 150 mg fosaprepitant dose, a transient moderate increase for two days possibly followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 (e.g., ciclosporin, tacrolimus, everolimus and sirolimus) is expected.
Fosaprepitant [1], irinotecan ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with irinotecan should be approached with particular caution as the combination might result in increased toxicity.
Fosaprepitant [1], itraconazol ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Fosaprepitant [1], ketoconazole ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Fosaprepitant [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 IVEMEND.
Fosaprepitant [1], nefazodone ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Fosaprepitant [1], oral contraceptives ---> SmPC of [1] of EMA
The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of fosaprepitant.
Fosaprepitant [1], phenobarbital ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination could result in reductions of the plasma concentrations of aprepitant
Fosaprepitant [1], phenytoin ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination could result in reductions of the plasma concentrations of aprepitant
Fosaprepitant [1], pimozide ---> SmPC of [1] of EMA
Inhibition of CYP3A4 by fosaprepitant could result in elevated plasma concentrations of pimozide, potentially causing serious or life-threatening reactions. Concomitant use is contraindicated
Fosaprepitant [1], posaconazole ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Fosaprepitant [1], pregnancy ---> SmPC of [1] of EMA
IVEMEND should not be used during pregnancy unless clearly necessary.
Fosaprepitant [1], protease inhibitors ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Fosaprepitant [1], quinidine ---> SmPC of [1] 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
Fosaprepitant [1], rifampicin ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination could result in reductions of the plasma concentrations of aprepitant
Fosaprepitant [1], ritonavir ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Fosaprepitant [1], sirolimus ---> SmPC of [1] 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
Fosaprepitant [1], St. John's wort ---> SmPC of [1] of EMA
The strong CYP3A4 induction may decrease the plasma concentrations of fosaprepitant. Concomitant administration of fosaprepitant with herbal preparations containing St. John's Wort is not recommended.
Fosaprepitant [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that strongly induce CYP3A4 activity should be avoided as the combination could result in reductions of the plasma concentrations of aprepitant
Fosaprepitant [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Fosaprepitant [1], tacrolimus ---> SmPC of [1] 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
Fosaprepitant [1], telithromycin ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Fosaprepitant [1], terfenadine ---> SmPC of [1] of EMA
Inhibition of CYP3A4 by fosaprepitant could result in elevated plasma concentrations of terfenadine, potentially causing serious or life-threatening reactions. Concomitant use is contraindicated
Fosaprepitant [1], tolbutamide ---> SmPC of [1] of EMA
Fosaprepitant, CYP2C9 inductor, may decrease the plasma concentrations of tolbutamide. Caution is advised
Fosaprepitant [1], triazolam ---> SmPC of [1] 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.
Fosaprepitant [1], vinorelbine ---> SmPC of [1] of EMA
Based on studies with oral aprepitant and docetaxel and vinorelbine, IVEMEND 150 mg is not expected to have a clinically relevant interaction with intravenously administered docetaxel and vinorelbine.
Fosaprepitant [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.
Fosaprepitant [1], voriconazole ---> SmPC of [1] of EMA
Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity should be approached cautiously as the combination is expected to result in increased plasma concentrations of aprepitant
Fosaprepitant [1], warfarin ---> SmPC of [1] of EMA
In patients on chronic warfarin therapy, the prothrombin time (INR) should be monitored closely during treatment with and for 14 days following the use of IVEMEND for the prevention of chemotherapy induced nausea and vomiting
Fosaprepitant, lomitapide [2] ---> SmPC 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.
Fosaprepitant, methylprednisolone
The usual intravenously administered methylprednisolone dose should be reduced
Fosaprepitant, tolterodine
The co-administration may increase the plasma concentrations of tolterodine
Fosaprepitant, 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
CONTRAINDICATIONS of Fosaprepitant (Ivemend)
- Hypersensitivity to the active substance or to polysorbate 80 or any of the other excipients listed in section 6.1.
- Co-administration with pimozide, terfenadine, astemizole or cisapride
https://www.ema.europa.eu/en/documents/product-information/ivemend-epar-product-information_en.pdf 08/03/2024
Foscarnet
Ability to drive, foscarnet [2] ---> SmPC of [2] of eMC
Due to the disease itself and possible undesirable effects of foscarnet (such as dizziness and convulsions), the ability to drive and use machines can be impaired.
Aciclovir, foscarnet [2] ---> SmPC of [2] of eMC
Since foscarnet can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs
Adefovir dipivoxil [1], foscarnet ---> SmPC 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
Aminoglycoside antibiotics, foscarnet [2] ---> SmPC of [2] of eMC
Since foscarnet can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs
Amphotericin, foscarnet [2] ---> SmPC of [2] of eMC
Since foscarnet can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs
Breast-feeding, foscarnet [2] ---> SmPC of [2] of eMC
Foscarnet should not be used during breast-feeding.
Clofarabine [1], foscarnet ---> SmPC of [1] of EMA
The concomitant use of medicinal products eliminated by tubular secretion should be avoided
Cyclosporine, foscarnet [2] ---> SmPC of [2] of eMC
Since foscarnet can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs
Didanosine, foscarnet [2] ---> SmPC of [2] of eMC
There is no pharmacokinetic interaction between foscarnet and didanosine
Efavirenz/emtricitabine/tenofovir disoproxil [1], foscarnet ---> SmPC of [1] of EMA
Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [1], foscarnet ---> SmPC of [1] of EMA
Use of emtricitabine/rilpivirine/tenofovir should be avoided with concurrent or recent use of a nephrotoxic medicinal product
Emtricitabine/rilpivirine/tenofovir disoproxil [1], foscarnet ---> SmPC of [1] of EMA
Use of emtricitabine/rilpivirine/tenofovir should be avoided with concurrent or recent use of a nephrotoxic medicinal product
Emtricitabine/tenofovir disoproxil [1], foscarnet ---> SmPC of [1] of EMA
Use of Truvada should be avoided with concurrent or recent use of a nephrotoxic medicinal product
Foscarnet [1], hypocalcemia ---> SmPC of [1] of eMC
Since foscarnet can reduce serum levels of ionised calcium, extreme caution is advised when used concurrently with other drugs known to influence serum calcium levels, like i.v. pentamidine.
Foscarnet [1], methotrexate ---> SmPC of [1] of eMC
Since foscarnet can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs
Foscarnet [1], nephrotoxic substances ---> SmPC of [1] of eMC
Since foscarnet can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs
Foscarnet [1], pentamidine ---> SmPC of [1] of eMC
Renal impairment and symptomatic hypocalcaemia (Trousseau's and Chvostek's signs) have been observed during concurrent treatment with foscarnet and i.v. pentamidine.
Foscarnet [1], pregnancy ---> SmPC of [1] of eMC
Foscarnet is not recommended during pregnancy
Foscarnet [1], ritonavir ---> SmPC of [1] of eMC
Abnormal renal function has been reported in connection with the use of foscarnet in combination with ritonavir
Foscarnet [1], saquinavir ---> SmPC of [1] of eMC
Abnormal renal function has been reported in connection with the use of foscarnet in combination with saquinavir
Foscarnet [1], tacrolimus ---> SmPC of [1] of eMC
Since foscarnet can impair renal function, additive toxicity may occur when used in combination with other nephrotoxic drugs
Foscarnet [1], zalcitabine ---> SmPC of [1] of eMC
There is no pharmacokinetic interaction between foscarnet and zalcitabine
Foscarnet [1], zidovudine ---> SmPC of [1] of eMC
There is no pharmacokinetic interaction between foscarnet and zidovudine (AZT)
Foscarnet, ganciclovir [2] ---> SmPC of [2] of eMC
Since ganciclovir is renal excreted, toxicity may be enhanced during coadministration of valganciclovir with drugs that might reduce the renal clearance of ganciclovir: nephrotoxicity and competitive inhibition of active tubular secretion
Foscarnet, lamivudine
Co-administration intravenous is not recommended
Foscarnet, tenofovir disoproxil [2] ---> SmPC of [2] of EMA
Use of tenofovir should be avoided with recent or concurrent use of a nephrotoxic medicinal product
Foscarnet, valaciclovir [2] ---> SmPC of [2] of eMC
The combination of valaciclovir with nephrotoxic medicinal products should be made with caution, especially in subjects with impaired renal function, and warrants regular monitoring of renal function.
Foscarnet, valganciclovir [2] ---> SmPC of [2] of eMC
The renal clearance of ganciclovir may be inhibited due to nephrotoxicity caused by drugs. Concomitant use of valganciclovir with these drugs should be considered only if the potential benefits outweigh the potential risks
CONTRAINDICATIONS of Foscarnet
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
http://www.medicines.org.uk/emc/
Fosdenopterin (Nulibry)
Breast-feeding, fosdenopterin [2] ---> SmPC of [2] of EMA
A decision must be made whether to discontinue breast-feeding or to discontinue from NULIBRY therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility, fosdenopterin [2] ---> SmPC of [2] of EMA
Fertility studies have not been conducted with fosdenopterin.
Fosdenopterin [1], pharmacokinetics ---> SmPC of [1] of EMA
The likelihood of metabolism-based and transporter-based drug-drug interactions with fosdenopterin are minimal, and co-administration of other medicinal products is not likely to affect the pharmacokinetics of fosdenopterin
Fosdenopterin [1], phototherapy ---> SmPC of [1] of EMA
The likelihood of metabolism-based and transporter-based drug-drug interactions with fosdenopterin are minimal, and co-administration of other medicinal products is not likely to affect the pharmacokinetics of fosdenopterin (see section 5.2).
Fosdenopterin [1], pregnancy ---> SmPC of [1] of EMA
NULIBRY is not recommended during pregnancy and in women of childbearing potential not using contraception.
Fosdenopterin [1], sun ---> SmPC of [1] of EMA
The likelihood of metabolism-based and transporter-based drug-drug interactions with fosdenopterin are minimal, and co-administration of other medicinal products is not likely to affect the pharmacokinetics of fosdenopterin (see section 5.2).
Fosdenopterin [1], vitamin D ---> SmPC of [1] of EMA
Physicians should consider Vitamin D supplementation due to the use of sunscreens and sun protective clothing and advise the caregiver/patients accordingly.
CONTRAINDICATIONS of Fosdenopterin (Nulibry)
- 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/nulibry-epar-product-information_en.pdf 25/07/2024
Fosfomycin
Ability to drive, fosfomycin
Dizziness may occur
Aminoglycoside antibiotics, fosfomycin
The combination of fosfomycin with aminoglycoside antibiotics usually shows an additive to synergistic effect.
Beta-lactam antibiotics, fosfomycin [2] ---> SmPC of [2] of eMC
In-vitro tests have shown that the combination of fosfomycin with a beta-lactam antibiotics
Breast-feeding, fosfomycin [2] ---> SmPC of [2] of eMC
Fosfomycin should not be administered during lactation, unless the benefit outweighs the risk.
Calcium, fosfomycin
The co-administration forms insoluble chelates. Administer fosfomycin 2 hours before or 4-6 hours after calcium salt.
Carbapeneme, fosfomycin [2] ---> SmPC of [2] of eMC
The combination of fosfomycin with carbapenems may have an additive to synergistic effect.
Chloramphenicol, fosfomycin
The combination of fosfomycin with cloramfenicol may have an additive to synergistic effect.
Colistin, fosfomycin
The combination of fosfomycin with colistin may have an additive to synergistic effect.
Erythromycin, fosfomycin
The combination of fosfomycin with erythromycin may have an additive to synergistic effect.
Fosfomycin [1], moxifloxacin ---> SmPC of [1] of eMC
The combination of fosfomycin with moxifloxacin may have an additive to synergistic effect.
Fosfomycin [1], pregnancy ---> SmPC of [1] of eMC
Fosfomycin should not be prescribed to pregnant women unless the benefit outweighs the risk.
Fosfomycin, metoclopramide
The co-administration of fosfomycin and metoclopramide may decrease the absorption of fosfomycin. Separate administration by at least 2-3 hours
Fosfomycin, prokinetics
The co-administration of fosfomycin and prokinetic agents may decrease the absorption of fosfomycin. Separate administration by at least 2-3 hours
Fosfomycin, tetracyclines
The combination of fosfomycin with tetracyclines may have an additive to synergistic effect.
Fosfomycin, trimethoprim
The combination of fosfomycin with trimethoprim may have an additive to synergistic effect.
Fosfomycin, vancomycin
The combination of fosfomycin with vancomycin may have an additive to synergistic effect.
CONTRAINDICATIONS of Fosfomycin
- Hypersensitivity to the active substance, fosfomycin, or to any of the excipients
http://www.medicines.org.uk/emc/
Fosinopril
Ability to drive, fosinopril [2] ---> SmPC of [2] of eMC
It can cause adverse effects such as dizziness, vertigo or hypotension. Patients should make sure they are not affected before driving or operating machinery.
ACE inhibitors, dextran sulphate ---> SmPC of [fosinopril] of eMC
Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
ACE inhibitors, potassium-sparing diuretics ---> SmPC of [fosinopril] 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.
AIIRA, 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, 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)
Aluminium hydroxide, fosinopril [2] ---> SmPC of [2] of eMC
Antacids may impair absorption of fosinopril. Administration of fosinopril sodium and antacids should be separated by at least 2 hours.
Amiloride, fosinopril [2] ---> SmPC 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.
Anaesthetics, fosinopril [2] ---> SmPC of [2] of eMC
Concomitant use of certain anaesthetic medicinal products with ACE inhibitors may result in further reduction of blood pressure
Antacids, fosinopril [2] ---> SmPC of [2] of eMC
Antacids may impair absorption of fosinopril. Administration of fosinopril sodium and antacids should be separated by at least 2 hours.
Antihypertensives, fosinopril [2] ---> SmPC of [2] of eMC
Combination with of fosinopril with other anti-hypertensive agents may increase the anti-hypertensive effect.
Betablockers, fosinopril [2] ---> SmPC of [2] of eMC
Combination with of fosinopril with other anti-hypertensive agents may increase the anti-hypertensive effect.
Breast-feeding, fosinopril [2] ---> SmPC of [2] of eMC
Fosinopril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Calcium antagonists, fosinopril [2] ---> SmPC of [2] of eMC
Combination with of fosinopril with other anti-hypertensive agents may increase the anti-hypertensive effect.
Corticosteroids, fosinopril
Concomitant administration of systemic corticosteroids with ACE inhibitors may lead to an increased risk of leucopenia.
Cytostatics, fosinopril [2] ---> SmPC of [2] of eMC
Concomitant administration of cytostatics with ACE inhibitors may lead to an increased risk for leucopenia especially when the latter are used at higher than currently recommended doses.
Dextran sulphate, fosinopril [2] ---> SmPC of [2] of eMC
Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
Diuretics, fosinopril [2] ---> SmPC of [2] of eMC
Combination with of fosinopril with other anti-hypertensive agents may increase the anti-hypertensive effect.
Fosinopril [1], heparin ---> SmPC of [1] 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.
Fosinopril [1], hyperkalemia ---> SmPC of [1] 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.
Fosinopril [1], immunosuppressives ---> SmPC of [1] of eMC
Concomitant use of fosinopril with immunosuppressants (e.g. azathioprine) may increase the risk of leucopenia developing.
Fosinopril [1], insulin ---> SmPC of [1] of eMC
Concomitant treatment with ACE inhibitors and antidiabetic agents may cause a pronounced hypoglycaemic effect with the risk of hypoglycaemia.
Fosinopril [1], lithium ---> SmPC of [1] of eMC
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Fosinopril [1], magnesium hydroxide ---> SmPC of [1] of eMC
Antacids may impair absorption of fosinopril. Administration of fosinopril sodium and antacids should be separated by at least 2 hours.
Fosinopril [1], methyldopa ---> SmPC of [1] of eMC
Combination with of fosinopril with other anti-hypertensive agents may increase the anti-hypertensive effect.
Fosinopril [1], neuroleptics ---> SmPC of [1] of eMC
Concomitant use of antipsychotics with ACE inhibitors may result in further reduction of blood pressure
Fosinopril [1], nitroglycerine ---> SmPC of [1] of eMC
The co-administration of fosinopril with glycerol trinitrate and other nitrates or other vasodilatators may further decrease the blood pressure
Fosinopril [1], NSAID ---> SmPC of [1] of eMC
NSAIDs may interfere with the antihypertensive effect. As with any ACE inhibitor, in some patients with compromised renal function the co-administration of fosinopril and NSAIDs may result in a further deterioration of renal function.
Fosinopril [1], oral antidiabetics ---> SmPC of [1] of eMC
Concomitant treatment with ACE inhibitors and antidiabetic agents may cause a pronounced hypoglycaemic effect with the risk of hypoglycaemia.
Fosinopril [1], organic nitrates ---> SmPC of [1] of eMC
The co-administration of fosinopril with glycerol trinitrate and other nitrates or other vasodilatators may further decrease the blood pressure
Fosinopril [1], potassium ---> SmPC of [1] 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.
Fosinopril [1], potassium-sparing diuretics ---> SmPC of [1] 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.
Fosinopril [1], pregnancy ---> SmPC of [1] of eMC
The use of ACE inhibitors is not recommended during the 1st trimester of pregnancy and are contraindicated during the 2nd and 3rd trimester of pregnancy.
Fosinopril [1], procainamide ---> SmPC of [1] of eMC
Concomitant administration of procainamide with ACE inhibitors may lead to an increased risk for leucopenia especially when the latter are used at higher than currently recommended doses.
Fosinopril [1], simeticone ---> SmPC of [1] of eMC
Antacids may impair absorption of fosinopril. Administration of fosinopril sodium and antacids should be separated by at least 2 hours.
Fosinopril [1], sympathomimetics ---> SmPC of [1] of eMC
Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Fosinopril [1], triamterene ---> SmPC of [1] 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.
Fosinopril [1], tricyclic antidepressant ---> SmPC of [1] of eMC
Concomitant use of tricyclic antidepressants with ACE inhibitors may result in further reduction of blood pressure
Fosinopril [1], vasodilators ---> SmPC of [1] of eMC
The co-administration of fosinopril with glycerol trinitrate and other nitrates or other vasodilatators may further decrease the blood pressure
CONTRAINDICATIONS of Fosinopril
- A history of hypersensitivity to fosinopril or any of the tablet excipients.
- History of angioneurotic oedema
- Renal artery stenosis (bilateral or unilateral in single kidney), and
- Cardiogenic shock.
- Second and third trimesters of pregnancy
http://www.medicines.org.uk/emc/
Fosphenytoin
Ability to drive, fosphenytoin [2] ---> SmPC of [2] of eMC
Treatment with fosphenytoin may cause central nervous system adverse effects such as dizziness and drowsiness
Alcohol, fosphenytoin [2] ---> SmPC of [2] of eMC
Acute alcohol intake may increase phenytoin serum levels while chronic alcoholism may decrease serum levels.
Aminophylline, fosphenytoin
The acceleration of metabolism and/or decrease of bioavailibility of aminophylline may decrease its effect
Amiodarone [1], fosphenytoin ---> SmPC of [1] of eMC
Amiodarone, CYP2C9 inhibitor, may increase the plasma concentrations of phenytoin
Amlodipine, fosphenytoin ---> SmPC 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/valsartan [1], fosphenytoin ---> SmPC 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.
Amlodipine/valsartan/hydrochlorothiazide [1], fosphenytoin ---> SmPC 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.
Amphotericin, fosphenytoin [2] ---> SmPC of [2] of eMC
The phenytoin plasma concentrations can increase
Anticoagulants, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of anticoagulants (warfarin) may be altered by phenytoin
Antineoplastics, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of antineoplastic agents may be altered by phenytoin
Antineoplastics, phenytoin ---> SmPC of [fosphenytoin] of eMC
Blood levels and/or effects of antineoplastic agents may be altered by phenytoin
Azapropazone, fosphenytoin [2] ---> SmPC of [2] of eMC
CYP2C9/2C19 inhibition may increase plasma phenytoin concentrations
Azole antifungals, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of azole antifungals may be altered by phenytoin
Bleomycin, fosphenytoin
The combination may decrease the absorption of phenytoin and exacerbate the convulsions. Phenytoin may increase the toxicity or decrease the effect of the cytotoxic agent
Breast-feeding, fosphenytoin [2] ---> SmPC of [2] of eMC
Breast-feeding is not recommended for women receiving fosphenytoin.
Carbamazepine [1], fosphenytoin ---> SmPC of [1] of eMC
The carbamazepine plasma levels may be decreased. Carbamazepine may lower or increase the plasma level of phenytoin
Chloramphenicol, fosphenytoin ---> SmPC of [phenytoin] of eMC
Chloramphenicol may increase phenytoin serum levels
Chlordiazepoxide, fosphenytoin [2] ---> SmPC of [2] of eMC
Chlordiazepoxide may increase or decrease phenytoin serum levels
Chlorpropamide, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of chlorpropamide may be altered by phenytoin (CYP2C9/2C19 induction)
Ciprofloxacin [1], fosphenytoin ---> SmPC of [1] of eMC
Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
Clozapine, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of clozapine may be altered by phenytoin
Corticosteroids, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of corticosteroids may be altered by phenytoin
Cyclosporine, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of ciclosporin may be altered by phenytoin (CYP3A4 induction)
Diazepam, fosphenytoin [2] ---> SmPC of [2] of eMC
Diazepam may increase or decrease phenytoin serum levels
Diazoxide, fosphenytoin [2] ---> SmPC of [2] of eMC
Diazoxide may decrease phenytoin serum levels
Digoxin, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of digoxine may be altered by phenytoin
Diltiazem, fosphenytoin
Co-administration of diltiazem with a CYP3A4 inducer may result in a decrease of diltiazem plasma concentrations.
Disulfiram, fosphenytoin [2] ---> SmPC of [2] of eMC
Disulfiram may increase phenytoin serum levels
Doxycycline, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of doxycycline may be altered by phenytoin
Drugs with high albumin binding, fosphenytoin [2] ---> SmPC of [2] of eMC
Drugs highly bound to albumin could also increase the fosphenytoin unbound fraction with the potential to increase the rate of conversion of fosphenytoin to phenytoin.
Drugs with high protein binding, fosphenytoin [2] ---> SmPC of [2] of eMC
Drugs highly bound to albumin could also increase the fosphenytoin unbound fraction with the potential to increase the rate of conversion of fosphenytoin to phenytoin.
Erythromycin, fosphenytoin [2] ---> SmPC of [2] of eMC
Blood levels and/or effects of erythromycin may be altered by phenytoin
Erythromycin, phenytoin ---> SmPC of [fosphenytoin] of eMC
Blood levels and/or effects of erythromycin may be altered by phenytoin
Estrogens, fosphenytoin [2] ---> SmPC of [2] of eMC
Estrogens may increase phenytoin serum levels. Blood levels and/or effects of estrogens may be altered by phenytoin
Ethosuximide, fosphenytoin
Ethosuximide may increase the plasma levels of phenytoin
Felbamate, fosphenytoin [2] ---> SmPC of [2] of eMC
CYP2C19 inhibition may increase plasma phenytoin concentrations
Felbamate, phenytoin ---> SmPC of [fosphenytoin] of eMC
CYP2C19 inhibition may increase plasma phenytoin concentrations
Fluconazole, fosphenytoin [2] ---> SmPC of [2] of eMC
CYP2C9 inhibition may increase plasma phenytoin concentrations
Fluorouracil, fosphenytoin [2] ---> SmPC of [2] of eMC
CYP2C9 inhibition may increase plasma phenytoin concentrations
Fluoxetine [1], fosphenytoin ---> SmPC of [1] of eMC
Changes in blood levels of phenytoin have been observed when combined with fluoxetine. In some cases manifestations of toxicity have occurred.
Fluvoxamine, fosphenytoin [2] ---> SmPC of [2] of eMC
CYP2C9/2C19 inhibition may increase plasma phenytoin concentrations
Folates, fosphenytoin [2] ---> SmPC of [2] of eMC
Phenytoin has the potential to lower serum folate levels.
Folates, phenytoin ---> SmPC of [fosphenytoin] of eMC
Phenytoin has the potential to lower serum folate levels.
Folic acid [1], fosphenytoin ---> SmPC of [1] of eMC
If folic acid supplements are given to treat folate deficiency, which can be caused by the use of antiepileptics, the serum antiepileptic levels may fall, leading to decreased seizure control in some patients.
Fosphenytoin [1], furosemide ---> SmPC of [1] of eMC
Blood levels and/or effects of furosemide may be altered by phenytoin
Fosphenytoin [1], glibenclamide ---> SmPC of [1] of eMC
CYP2C9 inhibition may increase plasma phenytoin concentrations. Phenytoin may increase serum glucose levels and therefore adjustment for insulin or oral antidiabetic agents may be necessary.
Fosphenytoin [1], halothane ---> SmPC of [1] of eMC
Halothane may increase phenytoin serum levels
Fosphenytoin [1], insulin ---> SmPC of [1] of eMC
Phenytoin may increase serum glucose levels and therefore adjustment for insulin or oral antidiabetic agents may be necessary.
Fosphenytoin [1], isoniazid ---> SmPC of [1] of eMC
Isoniazid may increase phenytoin serum levels
Fosphenytoin [1], itraconazol ---> SmPC of [1] of eMC
CYP2C9 inhibition may increase plasma phenytoin concentrations
Fosphenytoin [1], ketoconazole ---> SmPC of [1] of eMC
CYP2C9 inhibition may increase plasma phenytoin concentrations
Fosphenytoin [1], lamotrigine ---> SmPC of [1] of eMC
Blood levels and/or effects of lamotrigine may be altered by phenytoin
Fosphenytoin [1], methylphenidate ---> SmPC of [1] of eMC
Methylphenidate may increase phenytoin serum levels
Fosphenytoin [1], nelfinavir ---> SmPC of [1] of eMC
Nelfinavir may decrease phenytoin serum levels
Fosphenytoin [1], nicardipine ---> SmPC of [1] of eMC
Blood levels and/or effects of nicardipine may be altered by phenytoin (CYP3A4 induction)
Fosphenytoin [1], nifedipine ---> SmPC of [1] of eMC
Blood levels and/or effects of nifedipine may be altered by phenytoin (CYP3A4 induction)
Fosphenytoin [1], nimodipine ---> SmPC of [1] of eMC
Blood levels and/or effects of nimodipine may be altered by phenytoin
Fosphenytoin [1], omeprazole ---> SmPC of [1] of eMC
Omeprazole may increase plasma phenytoin concentrations
Fosphenytoin [1], oral antidiabetics ---> SmPC of [1] of eMC
Phenytoin may increase serum glucose levels and therefore adjustment for insulin or oral antidiabetic agents may be necessary.
Fosphenytoin [1], paroxetine ---> SmPC of [1] of eMC
Concomitant use of paroxetine with phenytoin may lower the seizure threshold. Blood levels and/or effects of paroxetine may be altered by phenytoin
Fosphenytoin [1], phenobarbital ---> SmPC of [1] of eMC
Phenobarbital may either increase or decrease phenytoin serum levels. Similarly, the effect of phenytoin on phenobarbital serum levels is unpredictable.
Fosphenytoin [1], phenothiazines ---> SmPC of [1] of eMC
Phenothiazines may increase phenytoin serum levels
Fosphenytoin [1], phenylbutazone ---> SmPC of [1] of eMC
Plasma phenytoin concentrations can increase
Fosphenytoin [1], praziquantel ---> SmPC of [1] of eMC
Blood levels and/or effects of praziquantel may be altered by phenytoin (CYP3A4 induction)
Fosphenytoin [1], pregnancy ---> SmPC of [1] of eMC
If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential harm to the foetus.
Fosphenytoin [1], quinidine ---> SmPC of [1] of eMC
Blood levels and/or effects of quinidine may be altered by phenytoin
Fosphenytoin [1], rifampicin ---> SmPC of [1] of eMC
CYP2C9/2C19 induction may decrease plasma phenytoin concentrations. Blood levels and/or effects of rifampicin may be altered by phenytoin
Fosphenytoin [1], salicylates ---> SmPC of [1] of eMC
Plasma phenytoin concentrations can increase
Fosphenytoin [1], sertraline ---> SmPC of [1] of eMC
Concomitant use of sertraline with phenytoin may lower the seizure threshold.
Fosphenytoin [1], St. John's wort ---> SmPC of [1] of eMC
Serum levels of phenytoin can be reduced by concomitant use of the herbal preparations containing St John's wort
Fosphenytoin [1], strong CYP2C19 inductors ---> SmPC of [1] of eMC
Phenytoin is mainly metabolized in the liver by the cytochrome P450 CYP2C9 and CYP2C19 enzymes. Phenytoin clearance, thus plasma levels, might be affected by inductors of these enzymes.
Fosphenytoin [1], strong CYP2C19 inhibitors ---> SmPC of [1] of eMC
Phenytoin is mainly metabolized in the liver by the CYP2C9 and CYP2C19 enzymes. Inhibition of phenytoin metabolism may produce significant increases in plasma phenytoin concentrations and increase the risk of phenytoin toxicity.
Fosphenytoin [1], strong CYP2C9 inductors ---> SmPC of [1] of eMC
Phenytoin is mainly metabolized in the liver by the cytochrome P450 CYP2C9 and CYP2C19 enzymes. Phenytoin clearance, thus plasma levels, might be affected by inductors of these enzymes.
Fosphenytoin [1], strong CYP2C9 inhibitors ---> SmPC of [1] of eMC
Phenytoin is mainly metabolized in the liver by the CYP2C9 and CYP2C19 enzymes. Inhibition of phenytoin metabolism may produce significant increases in plasma phenytoin concentrations and increase the risk of phenytoin toxicity.
Fosphenytoin [1], succinimides ---> SmPC of [1] of eMC
Succinimides may increase phenytoin serum levels
Fosphenytoin [1], sucralfate ---> SmPC of [1] of eMC
Sucralfate may decrease phenytoin serum levels
Fosphenytoin [1], sulphonamides ---> SmPC of [1] of eMC
Sulfonamides may increase phenytoin serum levels
Fosphenytoin [1], teniposide ---> SmPC of [1] of eMC
Blood levels and/or effects of antineoplastic agents may be altered by phenytoin
Fosphenytoin [1], tetracyclines ---> SmPC of [1] of eMC
Blood levels and/or effects of tetracyclines may be altered by phenytoin
Fosphenytoin [1], theophylline ---> SmPC of [1] of eMC
Theophylline may decrease phenytoin serum levels. Blood levels and/or effects of theophylline may be altered by phenytoin (CYP1A2 induction)
Fosphenytoin [1], ticlopidine ---> SmPC of [1] of eMC
CYP2C9/2C19 inhibition may increase plasma phenytoin concentrations
Fosphenytoin [1], tolbutamide ---> SmPC of [1] of eMC
CYP2C9/2C19 inhibition may increase plasma phenytoin concentrations. Phenytoin may increase serum glucose levels and therefore adjustment for insulin or oral antidiabetic agents
Fosphenytoin [1], verapamil ---> SmPC of [1] of eMC
Blood levels and/or effects of verapamil may be altered by phenytoin (CYP3A4 induction)
Fosphenytoin [1], viloxazine ---> SmPC of [1] of eMC
Viloxazine may increase phenytoin serum levels
Fosphenytoin [1], vitamin D ---> SmPC of [1] of eMC
Blood levels and/or effects of vitamin D may be altered by phenytoin
Fosphenytoin [1], voriconazole ---> SmPC of [1] of eMC
Phenytoin is mainly metabolized in the liver by the CYP2C9 and CYP2C19 enzymes. Inhibition of phenytoin metabolism may produce significant increases in plasma phenytoin concentrations and increase the risk of phenytoin toxicity.
Fosphenytoin [1], warfarin ---> SmPC of [1] of eMC
Blood levels and/or effects of anticoagulants (warfarin) may be altered by phenytoin
Fosphenytoin, fotemustine
Fotemustine decreases the gastrointestinal fosphenytoin absorption (risk of seizures). Fosphenytoin increases the fotemustine metabolism (minor effect)
Fosphenytoin, H2 antagonists ---> SmPC of [phenytoin] of eMC
H2-antagonists may increase phenytoin serum levels
Fosphenytoin, idarubicin
Decreased phenytoin absorption (worsening of seizures) and increased toxicity or loss of efficacy loss of idarubicin due to metabolic induction
Fosphenytoin, imatinib [2] ---> SmPC of [2] of EMA
Substances that are inducers of CYP3A4 activity may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure. Concomitant use of strong CYP3A4 inducers and imatinib should be avoided.
Fosphenytoin, methadone [2] ---> SmPC of [2] of eMC
The hepatic enzyme-inducing drugs may lower plasma methadone levels and produce symptoms of withdrawal in methadone dependent patients.
Fosphenytoin, ulipristal [2] ---> SmPC of [2] of EMA
Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended
Fosphenytoin, valproic acid [2] ---> SmPC of [2] of eMC
Antiepileptics with enzyme inducing effect decrease valproic acid plasma levels. Valproic acid decreases phenytoin total levels and increases phenytoin free form with possible overdosage symptoms
Fosphenytoin, vigabatrin [2] ---> SmPC of [2] of eMC
During controlled clinical studies, a gradual reduction of 16-33% in the plasma concentration of phenytoin has been observed.
Fosphenytoin, xipamide
Decreased diuretic effect
Glibenclamide, phenytoin ---> SmPC of [fosphenytoin] of eMC
CYP2C9 inhibition may increase plasma phenytoin concentrations
Insulin, phenytoin ---> SmPC of [fosphenytoin] of eMC
Phenytoin may increase serum glucose levels and therefore adjustment for insulin or oral antidiabetic agents may be necessary.
Oral antidiabetics, phenytoin ---> SmPC of [fosphenytoin] of eMC
Phenytoin may increase serum glucose levels and therefore adjustment for insulin or oral antidiabetic agents may be necessary.
Phenytoin, strong CYP2C19 inductors ---> SmPC of [fosphenytoin] of eMC
Phenytoin is mainly metabolized in the liver by the cytochrome P450 CYP2C9 and CYP2C19 enzymes. Phenytoin clearance, thus plasma levels, might be affected by inductors of these enzymes.
Phenytoin, strong CYP2C19 inhibitors ---> SmPC of [fosphenytoin] of eMC
Phenytoin is mainly metabolized in the liver by the CYP2C9 and CYP2C19 enzymes. Inhibition of phenytoin metabolism may produce significant increases in plasma phenytoin concentrations and increase the risk of phenytoin toxicity.
Phenytoin, strong CYP2C9 inductors ---> SmPC of [fosphenytoin] of eMC
Phenytoin is mainly metabolized in the liver by the cytochrome P450 CYP2C9 and CYP2C19 enzymes. Phenytoin clearance, thus plasma levels, might be affected by inductors of these enzymes.
Phenytoin, strong CYP2C9 inhibitors ---> SmPC of [fosphenytoin] of eMC
Phenytoin is mainly metabolized in the liver by the CYP2C9 and CYP2C19 enzymes. Inhibition of phenytoin metabolism may produce significant increases in plasma phenytoin concentrations and increase the risk of phenytoin toxicity.
Phenytoin, ticlopidine ---> SmPC of [fosphenytoin] of eMC
CYP2C9/2C19 inhibition may increase plasma phenytoin concentrations
Phenytoin, viloxazine ---> SmPC of [fosphenytoin] of eMC
Viloxazine may increase phenytoin serum levels
CONTRAINDICATIONS of Fosphenytoin
- Hypersensitivity to fosphenytoin sodium or the excipients of Pro-Epanutin, or to phenytoin or other hydantoins.
- Parenteral phenytoin affects ventricular automaticity. Pro-Epanutin is therefore, contra-indicated in patients with sinus bradycardia, sino-atrial block, second and third degree A-V block and Adams-Stokes syndrome.
- Acute intermittent porphyria.
http://www.medicines.org.uk/emc/
Fossil tree
Acetylsalicylic acid, fossil tree [2] ---> SmPC of [2] of eMC
Possible increase in risk of bleeding
Antiepileptics, fossil tree
Concomitant use of ginkgo and anticonvulsant agents may decrease the anticonvulsant efficacy
Breast-feeding, fossil tree
Strict indication
Diclofenac, fossil tree
Additive anticoagulant effects may increase bleed risk.
Dipyridamole, fossil tree
Additive anticoagulant effects may increase the bleed risk. Concomitant therapy should be avoided.
Efavirenz, fossil tree ---> SmPC of [efavirenz/emtricitabine/tenofovir disoproxil] of EMA
Concomitant use of Ginkgo biloba extracts with efavirenz is not recommended
Efavirenz/emtricitabine/tenofovir disoproxil [1], fossil tree ---> SmPC of [1] of EMA
Concomitant use of Ginkgo biloba extracts with efavirenz is not recommended
Ethosuximide, fossil tree
Concomitant use of ginkgo and anticonvulsant agents may decrease the anticonvulsant efficacy
Fossil tree, ibuprofen
Ginkgo biloba with NSAID may increase the risk of bleeding
Fossil tree, lomitapide [2] ---> SmPC 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.
Fossil tree, NSAID
Ginkgo biloba with NSAID may increase the risk of bleeding
Fossil tree, platelet aggregation inhibitors
Ginkgo may enhance the effect of platelet aggregation inhibitors
Fossil tree, pregnancy
Strict indication
Fossil tree, tolbutamide [2] ---> SmPC of [2] of eMC
Extracts of ginkgo biloba may decrease absorption of tolbutamide and thereby decrease its efficacy.
Fostamatinib (Tavlesse)
Ability to drive, fostamatinib [2] ---> SmPC of [2] of EMA
Fostamatinib is not expected to influence the ability to drive or to use machines. The patient should avoid driving cars or using machines if feeling dizzy.
Anticoagulants with narrow therapeutic index, fostamatinib [2] ---> SmPC of [2] of EMA
Since SYK-inhibition may have potential effects on platelet aggregation, anticoagulant activity (e.g. INR) where relevant should be monitored when anticoagulants with narrow therapeutic index such as warfarin, are co-administered with fostamatinib.
BCRP substrates, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of fostamatinib may increase concentrations of P-gp substrates (e.g. digoxin) and BCRP substrates (e.g. rosuvastatin).
Boceprevir, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Breast-feeding, fostamatinib [2] ---> SmPC of [2] of EMA
A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with fostamatinib and for at least one month after the last dose.
Clarithromycin, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Cobicistat, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Conivaptan, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Digoxin, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of digoxin (0.25 mg once daily) fostamatinib 100 mg administered twice daily increased digoxin AUC by 37% and Cmax by 70%.
Diltiazem, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Drugs primarily metabolised by CYP2C8, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of fostamatinib does not affect the exposure of CYP2C8 substrate drugs. No dose adjustment of CYP2C8 substrate drug is necessary.
Drugs primarily metabolised by CYP3A4, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of fostamatinib may increase systemic exposure of some CYP3A4 substrate medicinal products. Patients should be monitored for toxicities of CYP3A4 substrate medicinal products
Drugs primarily metabolised by UGT1A1, fostamatinib [2] ---> SmPC of [2] of EMA
Inhibition of UGT1A1 may result in increased unconjugated bilirubin in the absence of other LFT abnormalities. Patients should be monitored for toxicity for drugs that are metabolised extensively by UGT1A1.
Elvitegravir/ritonavir, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Ethinyl estradiol, fostamatinib [2] ---> SmPC of [2] of EMA
Concomitant use of a combined hormonal contraceptive containing 0.03 mg ethinylestradiol with fostamatinib 100 mg administered twice daily increased AUC by 28% and Cmax by 34%.
Fertility, fostamatinib [2] ---> SmPC of [2] of EMA
There are no data on the effect of fostamatinib on human fertility. Based on the finding of reduced pregnancy rates in animal studies, fostamatinib may affect female fertility (see section 5.3).
Foods, fostamatinib [2] ---> SmPC of [2] of EMA
The tablets should be taken twice daily, whole with or without food. In the event of gastric upset, tablets may be taken with food.
Fostamatinib [1], gastric pH increasing medication ---> SmPC of [1] of EMA
Coadministration of fostamatinib with 150 mg ranitidine, an H2-blocker that increases gastric pH did not have clinically relevant impact on R406 exposure.
Fostamatinib [1], grapefruit juice ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], hormonal contraceptives ---> SmPC of [1] of EMA
Concomitant use of a combined hormonal contraceptive containing 0.03 mg ethinylestradiol with fostamatinib 100 mg administered twice daily increased AUC by 28% and Cmax by 34%.
Fostamatinib [1], idelalisib ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], indinavir/ritonavir ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], itraconazol ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], ketoconazole ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], lopinavir/ritonavir ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], men ---> SmPC of [1] of EMA
Studies in animals have shown no adverse effect on male fertility. Given there is no evidence for mutagenic or clastogenic potential, there is no concern for male-mediated birth defects.
Fostamatinib [1], midazolam ---> SmPC of [1] of EMA
Concomitant use of midazolam (single dose 7.5 mg) with fostamatinib 100 mg administered twice daily increased midazolam AUC by 23% and Cmax by 9%.
Fostamatinib [1], nefazodone ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], nelfinavir ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
Concomitant use of fostamatinib may increase concentrations of P-gp substrates (e.g. digoxin) and BCRP substrates (e.g. rosuvastatin).
Fostamatinib [1], paracetamol ---> SmPC of [1] of EMA
The potential of PK DDI for co-administration with acetaminophen therefore remains undetermined.
Fostamatinib [1], pioglitazone ---> SmPC of [1] of EMA
Concomitant use of pioglitazone (single dose 30 mg) with fostamatinib 100 mg administered twice daily increased pioglitazone AUC by 18% and decreased Cmax by 17%.
Fostamatinib [1], posaconazole ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], pregnancy ---> SmPC of [1] of EMA
Based on findings from animal studies and its mechanism of action, fostamatinib can cause foetal harm when administered to a pregnant woman. Pregnant women should be advised about the potential risk to a foetus
Fostamatinib [1], pregnancy ---> SmPC of [1] of EMA
If a patient becomes pregnant while taking fostamatinib, therapy should be discontinued. Fostamatinib is contraindicated during pregnancy (see sections 4.3 and 5.3).
Fostamatinib [1], ranitidine ---> SmPC of [1] of EMA
Coadministration of fostamatinib with 150 mg ranitidine, an H2-blocker that increases gastric pH did not have clinically relevant impact on R406 exposure.
Fostamatinib [1], rifampicin ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inducers decreases exposure to R406, which may result in reduced efficacy. Therefore, concomitant use of fostamatinib with strong CYP3A4 inducers is not recommended.
Fostamatinib [1], rituximab ---> SmPC of [1] of EMA
Co-administration with JAK-inhibitor, TPO-RAs, rituximab and other immune-modulating agents has not been investigated.
Fostamatinib [1], rosuvastatin ---> SmPC of [1] of EMA
Concomitant use of rosuvastatin (single dose 20 mg) with fostamatinib 100 mg administered twice daily increased rosuvastatin AUC by 95% and Cmax by 88%.
Fostamatinib [1], saquinavir/ritonavir ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], simvastatine ---> SmPC of [1] of EMA
Concomitant use of simvastatin (single dose 40 mg) with fostamatinib 100 mg administered twice daily increased simvastatin AUC by 64% and Cmax by 113% and simvastatin acid AUC by 66% and Cmax by 83%.
Fostamatinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inducers decreases exposure to R406, which may result in reduced efficacy. Therefore, concomitant use of fostamatinib with strong CYP3A4 inducers is not recommended.
Fostamatinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
A two-fold reduction in dose frequency (i.e. from 150 mg twice daily to 150 mg once daily or 100 mg twice daily to 100 mg once daily) of fostamatinib in the presence of a strong CYP3A4 inhibitor is warranted.
Fostamatinib [1], telaprevir ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], tipranavir/ritonavir ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], troleandomycin ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], verapamil ---> SmPC of [1] of EMA
Concomitant use of verapamil, a moderate CYP3A4 inhibitor (80 mg three times daily for 4 days) with a single dose of 150 mg fostamatinib increased R406 (the major active metabolite) AUC by 39% and Cmax by 6%.
Fostamatinib [1], voriconazole ---> SmPC of [1] of EMA
Concomitant use of fostamatinib with strong CYP3A4 inhibitors increases exposure to R406 (the major active metabolite), which may increase the risk of adverse reactions.
Fostamatinib [1], warfarin ---> SmPC of [1] of EMA
Since SYK-inhibition may have potential effects on platelet aggregation, anticoagulant activity (e.g. INR) where relevant should be monitored when anticoagulants with narrow therapeutic index such as warfarin, are co-administered with fostamatinib.
Fostamatinib [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential must use effective contraception during treatment and at least one month after the last dose.
Fostamatinib, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA
Coadministration of fostamatinib with ritonavir may increase fostamatinib metabolite R406 exposure resulting in dose-related adverse events such as hepatotoxicity, neutropenia, hypertension or diarrhoea.
Fostamatinib, ritonavir [2] ---> SmPC of [2] of EMA
Co-administration of fostamatinib with ritonavir may increase fostamatinib metabolite R406 exposure resulting in dose-related adverse events such as hepatotoxicity, neutropenia, hypertension, or diarrhoea.
CONTRAINDICATIONS of Fostamatinib (Tavlesse)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy (see section 4.6).
https://www.ema.europa.eu/en/documents/product-information/tavlesse-epar-product-information_en.pdf 02/12/2024
Fostemsavir (Rukobia)
Ability to drive, fostemsavir [2] ---> SmPC of [2] of EMA
The clinical status of the patient and the adverse reaction profile of fostemsavir should be borne in mind when considering the patient's ability to drive or operate machinery.
Amiodarone, fostemsavir [2] ---> SmPC of [2] of EMA
Fostemsavir should be used with caution in patients with a history of QT interval prolongation, when co-administered with a medicine with a known risk of Torsade de Pointes
Atazanavir/ritonavir, fostemsavir [2] ---> SmPC of [2] of EMA
Atazanavir/ritonavir increased temsavir concentrations. No dose adjustment of either medicinal product is necessary.
Atorvastatin, fostemsavir [2] ---> SmPC of [2] of EMA
Based on these data, temsavir is expected to affect the pharmacokinetics of active substances that are substrates of OATP1B1/3 or BCRP (e.g. rosuvastatin, atorvastatin, simvastatin, pitavastatin and fluvastatin).
BCRP substrates, fostemsavir [2] ---> SmPC of [2] of EMA
Based on these data, temsavir is expected to affect the pharmacokinetics of active substances that are substrates of OATP1B1/3 or BCRP (e.g. rosuvastatin, atorvastatin, simvastatin, pitavastatin and fluvastatin).
Breast-feeding, fostemsavir [2] ---> SmPC of [2] of EMA
It is unknown whether fostemsavir/temsavir are excreted in human milk. Available toxicokinetic data in lactating rats have shown excretion of fostemsavir/temsavir in milk (see section 5.3).
Buprenorphine/naloxone, fostemsavir [2] ---> SmPC of [2] of EMA
No dose adjustment of either medicinal product is necessary.
Carbamazepine, fostemsavir [2] ---> SmPC of [2] of EMA
Significant decreases in temsavir plasma concentrations may also occur when fostemsavir is co-administered with other strong CYP3A inducers, and may result in loss of virologic response
Clarithromycin, fostemsavir [2] ---> SmPC of [2] of EMA
Fostemsavir may be co-administered with strong CYP3A4, BCRP and/or P-gp inhibitors without dose adjustment based on the results of clinical drug interaction studies with cobicistat and ritonavir.
Cobicistat, fostemsavir [2] ---> SmPC of [2] of EMA
Temsavir (inhibition of CYP3A enzymes, P-gp and/or BCRP). Cobicistat increased temsavir plasma concentrations. No dose adjustment is necessary
Daclatasvir, fostemsavir [2] ---> SmPC of [2] of EMA
Although not studied, temsavir may increase plasma concentrations of other HCV DAAs. No dose adjustment is necessary.
Darunavir/cobicistat, fostemsavir [2] ---> SmPC of [2] of EMA
Temsavir (inhibition of CYP3A enzymes, P-gp and/or BCRP). Darunavir/cobicistat increased temsavir plasma concentrations. No dose adjustment is necessary.
Darunavir/ritonavir, fostemsavir [2] ---> SmPC of [2] of EMA
Darunavir/ritonavir increased temsavir plasma concentrations. No dose adjustment is necessary for any medicinal product when co-administered.
Disopyramide, fostemsavir [2] ---> SmPC of [2] of EMA
Fostemsavir should be used with caution in patients with a history of QT interval prolongation, when co-administered with a medicine with a known risk of Torsade de Pointes
Efavirenz, fostemsavir [2] ---> SmPC of [2] of EMA
Temsavir (induction of CYP3A enzymes). This interaction has not been studied. Efavirenz is expected to decrease temsavir plasma concentrations. No dose adjustment is necessary.
Elbasvir/grazoprevir, fostemsavir [2] ---> SmPC of [2] of EMA
Temsavir may increase grazoprevir plasma levels to a clinically relevant extent caused by OATP1B1/3 inhibition by temsavir. Co-administration is not recommended as increased grazoprevir concentrations may increase the risk of ALT elevations.
Enzalutamide, fostemsavir [2] ---> SmPC of [2] of EMA
Significant decreases in temsavir plasma concentrations may also occur when fostemsavir is co-administered with other strong CYP3A inducers, and may result in loss of virologic response
Etravirine, fostemsavir [2] ---> SmPC of [2] of EMA
Temsavir (induction of CYP3A enzymes). This interaction has not been studied. Nevirapine is expected to decrease temsavir plasma concentrations. No dose adjustment is necessary.
Famotidine, fostemsavir [2] ---> SmPC of [2] of EMA
No dose adjustment is necessary when combined with medicinal products that increase gastric pH.
Fertility, fostemsavir [2] ---> SmPC of [2] of EMA
There are no data on the effects of fostemsavir on human male or female fertility. Animal studies indicate no effects of fostemsavir on male or female fertility at clinically relevant doses (see section 5.3).
Foods, fostemsavir [2] ---> SmPC of [2] of EMA
Fostemsavir can be taken with or without food (see section 5.2). The prolonged-release tablet should be swallowed whole with water, and not chewed, crushed or split.
Fostemsavir [1], gastric pH increasing medication ---> SmPC of [1] of EMA
No dose adjustment is necessary when combined with medicinal products that increase gastric pH.
Fostemsavir [1], H2 antagonists ---> SmPC of [1] of EMA
No dose adjustment is necessary when combined with medicinal products that increase gastric pH.
Fostemsavir [1], HMG-CoA reductase inhibitors ---> SmPC of [1] of EMA
Although not studied, use the lowest possible starting dose of other statins that are substrates of OATP1B1/3 and/or BCRP with careful monitoring for HMG-CoA reductase inhibitor-associated adverse reactions.
Fostemsavir [1], ibutilide ---> SmPC of [1] of EMA
Fostemsavir should be used with caution in patients with a history of QT interval prolongation, when co-administered with a medicine with a known risk of Torsade de Pointes
Fostemsavir [1], itraconazol ---> SmPC of [1] of EMA
Fostemsavir may be co-administered with strong CYP3A4, BCRP and/or P-gp inhibitors without dose adjustment based on the results of clinical drug interaction studies with cobicistat and ritonavir.
Fostemsavir [1], ledipasvir ---> SmPC of [1] of EMA
Although not studied, temsavir may increase plasma concentrations of other HCV DAAs. No dose adjustment is necessary.
Fostemsavir [1], maraviroc ---> SmPC of [1] of EMA
No dose adjustment of either medicinal product is necessary.
Fostemsavir [1], methadone ---> SmPC of [1] of EMA
No dose adjustment of either medicinal product is necessary.
Fostemsavir [1], mitotane ---> SmPC of [1] of EMA
Significant decreases in temsavir plasma concentrations may also occur when fostemsavir is co-administered with other strong CYP3A inducers, and may result in loss of virologic response
Fostemsavir [1], nevirapine ---> SmPC of [1] of EMA
Temsavir (induction of CYP3A enzymes). This interaction has not been studied. Nevirapine is expected to decrease temsavir plasma concentrations. No dose adjustment is necessary.
Fostemsavir [1], OATP1B1 substrates ---> SmPC of [1] of EMA
Based on these data, temsavir is expected to affect the pharmacokinetics of active substances that are substrates of OATP1B1/3 or BCRP (e.g. rosuvastatin, atorvastatin, simvastatin, pitavastatin and fluvastatin).
Fostemsavir [1], OATP1B3 substrates ---> SmPC of [1] of EMA
Based on these data, temsavir is expected to affect the pharmacokinetics of active substances that are substrates of OATP1B1/3 or BCRP (e.g. rosuvastatin, atorvastatin, simvastatin, pitavastatin and fluvastatin).
Fostemsavir [1], oral contraceptives ---> SmPC of [1] of EMA
Doses of oestrogen-based therapies, including oral contraceptives, should not contain more than 30 痢 of ethinyl oestradiol per day in patients who are receiving fostemsavir.
Fostemsavir [1], phenytoin ---> SmPC of [1] of EMA
Significant decreases in temsavir plasma concentrations may also occur when fostemsavir is co-administered with other strong CYP3A inducers, and may result in loss of virologic response
Fostemsavir [1], pitavastatin ---> SmPC of [1] of EMA
Based on these data, temsavir is expected to affect the pharmacokinetics of active substances that are substrates of OATP1B1/3 or BCRP (e.g. rosuvastatin, atorvastatin, simvastatin, pitavastatin and fluvastatin).
Fostemsavir [1], posaconazole ---> SmPC of [1] of EMA
Fostemsavir may be co-administered with strong CYP3A4, BCRP and/or P-gp inhibitors without dose adjustment based on the results of clinical drug interaction studies with cobicistat and ritonavir.
Fostemsavir [1], pravastatine ---> SmPC of [1] of EMA
Although not studied, clinically relevant increases in plasma concentrations of pravastatin are not expected as it is not a substrate of BCRP. No dose adjustment is required.
Fostemsavir [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure, it is preferable to avoid the use of Rukobia during pregnancy.
Fostemsavir [1], procainamide ---> SmPC of [1] of EMA
Fostemsavir should be used with caution in patients with a history of QT interval prolongation, when co-administered with a medicine with a known risk of Torsade de Pointes
Fostemsavir [1], QT interval prolonging drugs ---> SmPC of [1] of EMA
Fostemsavir should be used with caution in patients with a history of QT interval prolongation, when co-administered with a medicine with a known risk of Torsade de Pointes
Fostemsavir [1], quinidine ---> SmPC of [1] of EMA
Fostemsavir should be used with caution in patients with a history of QT interval prolongation, when co-administered with a medicine with a known risk of Torsade de Pointes
Fostemsavir [1], raltegravir ---> SmPC of [1] of EMA
No dose adjustment of either medicinal product is necessary.
Fostemsavir [1], rifabutin ---> SmPC of [1] of EMA
Temsavir (induction of CYP3A enzymes). Rifabutin decreased temsavir plasma concentrations. No dose adjustment is necessary.
Fostemsavir [1], rifampicin ---> SmPC of [1] of EMA
Rifampicin co-administration may lead to loss of virologic response to fostemsavir due to significant decreases in temsavir plasma levels caused by strong CYP3A4 induction. Therefore, the concomitant use of fostemsavir and rifampicin is contraindicated.
Fostemsavir [1], ritonavir ---> SmPC of [1] of EMA
Temsavir (inhibition of CYP3A and P-gp). Ritonavir increased temsavir plasma concentrations. No dose adjustment of either medicinal product is necessary.
Fostemsavir [1], rosuvastatin ---> SmPC of [1] of EMA
Based on these data, temsavir is expected to affect the pharmacokinetics of active substances that are substrates of OATP1B1/3 or BCRP (e.g. rosuvastatin, atorvastatin, simvastatin, pitavastatin and fluvastatin).
Fostemsavir [1], simvastatine ---> SmPC of [1] of EMA
Based on these data, temsavir is expected to affect the pharmacokinetics of active substances that are substrates of OATP1B1/3 or BCRP (e.g. rosuvastatin, atorvastatin, simvastatin, pitavastatin and fluvastatin).
Fostemsavir [1], sofosbuvir ---> SmPC of [1] of EMA
Although not studied, temsavir may increase plasma concentrations of other HCV DAAs. No dose adjustment is necessary.
Fostemsavir [1], sotalol ---> SmPC of [1] of EMA
Fostemsavir should be used with caution in patients with a history of QT interval prolongation, when co-administered with a medicine with a known risk of Torsade de Pointes
Fostemsavir [1], St. John's wort ---> SmPC of [1] of EMA
Significant decreases in temsavir plasma concentrations may also occur when fostemsavir is co-administered with other strong CYP3A inducers, and may result in loss of virologic response
Fostemsavir [1], strong BCRP inhibitors ---> SmPC of [1] of EMA
Fostemsavir may be co-administered with strong CYP3A4, BCRP and/or P-gp inhibitors without dose adjustment based on the results of clinical drug interaction studies with cobicistat and ritonavir.
Fostemsavir [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Significant decreases in temsavir plasma concentrations may also occur when fostemsavir is co-administered with other strong CYP3A inducers, and may result in loss of virologic response
Fostemsavir [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Fostemsavir may be co-administered with strong CYP3A4, BCRP and/or P-gp inhibitors without dose adjustment based on the results of clinical drug interaction studies with cobicistat and ritonavir.
Fostemsavir [1], strong P-gp inhibitors ---> SmPC of [1] of EMA
Fostemsavir may be co-administered with strong CYP3A4, BCRP and/or P-gp inhibitors without dose adjustment based on the results of clinical drug interaction studies with cobicistat and ritonavir.
Fostemsavir [1], tenofovir alafenamide ---> SmPC of [1] of EMA
This interaction has not been studied. Temsavir is expected to increase tenofovir alafenamide plasma concentrations. The recommended dose of TAF is 10 mg when coadministered with fostemsavir.
Fostemsavir [1], tenofovir disoproxil ---> SmPC of [1] of EMA
No dose adjustment of either medicinal product is necessary.
Fostemsavir [1], torsades de pointes inducing drugs ---> SmPC of [1] of EMA
Fostemsavir should be used with caution in patients with a history of QT interval prolongation, when co-administered with a medicine with a known risk of Torsade de Pointes
Fostemsavir [1], velpatasvir ---> SmPC of [1] of EMA
Although not studied, temsavir may increase plasma concentrations of other HCV DAAs. No dose adjustment is necessary.
Fostemsavir [1], voriconazole ---> SmPC of [1] of EMA
Fostemsavir may be co-administered with strong CYP3A4, BCRP and/or P-gp inhibitors without dose adjustment based on the results of clinical drug interaction studies with cobicistat and ritonavir.
Fostemsavir [1], voxilaprevir ---> SmPC of [1] of EMA
Although not studied, temsavir may increase plasma concentrations of other HCV DAAs. No dose adjustment is necessary.
CONTRAINDICATIONS of Fostemsavir (Rukobia)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Co-administration with strong CYP3A inducers including, but not limited to: carbamazepine, phenytoin, mitotane, enzalutamide, rifampicin and St John's wort (see section 4.5
https://www.ema.europa.eu/en/documents/product-information/rukobia-epar-product-information_en.pdf 11/09/2025
Fotemustine
Ability to drive, fotemustine
Fotemustine may affect ability to drive and use machines
Anticoagulants, fotemustine
Patients treated with anticoagulant and antineoplastic agents should be monitored more frequently
Breast-feeding, fotemustine
Fotemustine is contraindicated in breastfeeding
Dacarbazine, fotemustine
The co-administration of dacarbazine and fotemustine may cause acute pulmonary toxicity (adult respiratory distress syndrome)
Fosphenytoin, fotemustine
Fotemustine decreases the gastrointestinal fosphenytoin absorption (risk of seizures). Fosphenytoin increases the fotemustine metabolism (minor effect)
Fotemustine, immunosuppressives
The co-administration of fotemustine mit immunosuppresive agents may cause an excessive immunosuppression with risk of lymphoproliferation
Fotemustine, phenytoin
Fotemustine decreases the gastrointestinal phenytoin absorption (risk of seizures). Phenytoin increases the fotemustine metabolism (minor effect)
Fotemustine, pregnancy
Fotemustine is contraindicated in pregnancy
Fotemustine, vaccinations with live organism vaccines
Risk of fatal generalized vaccine-induced disease. Concomitant use not recommended. The yellow fever vaccine is contra-indicated
Fotemustine, yellow fever vaccine
Risk of fatal generalized vaccine-induced disease. The co-administration is contraindicated
Fremanezumab (Ajovy)
Breast-feeding, fremanezumab [2] ---> SmPC of [2] of EMA
A risk to breast-fed infants cannot be excluded during the first days after birth. Afterwards, use of fremanezumab could be considered during breast-feeding only if clinically needed.
Fertility, fremanezumab [2] ---> SmPC of [2] of EMA
There are no fertility data in humans. Available non-clinical data do not suggest an effect on fertility (see section 5.3).
Fremanezumab [1], migraine ---> SmPC of [1] of EMA
Furthermore, concomitant use of acute migraine treatments (specifically analgesics, ergots, and triptans) and migraine preventive medicinal products during the clinical studies did not affect the pharmacokinetics of fremanezumab.
Fremanezumab [1], pharmacokinetics ---> SmPC of [1] of EMA
No pharmacokinetic drug interactions are expected based on the characteristics of fremanezumab.
Fremanezumab [1], pregnancy ---> SmPC of [1] of EMA
As a precautionary measure, it is preferable to avoid the use of AJOVY during pregnancy.
CONTRAINDICATIONS of Fremanezumab (Ajovy)
- 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/ajovy-epar-product-information_en.pdf 04/04/2025
Frovatriptan
Ability to drive, frovatriptan [2] ---> SmPC of [2] of eMC
Migraine or treatment with frovatriptan may cause somnolence.
Breast-feeding, frovatriptan [2] ---> SmPC of [2] of eMC
Although it is not known whether frovatriptan or its metabolites are excreted in human breast milk, the administration of frovatriptan to women who are breastfeeding is not recommended, unless is clearly needed.
Citalopram, frovatriptan [2] ---> SmPC of [2] of eMC
Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome. Strict adherence to the recommended dose is an essential factor to prevent this syndrome.
Ergot derivatives, frovatriptan [2] ---> SmPC of [2] of eMC
Risks of hypertension and coronary artery constriction due to additive vasospastic effects when used concomitantly for the same migraine attack. Effects can be additive. The co-administration is contraindicated
Ergotamine, frovatriptan [2] ---> SmPC of [2] of eMC
Risks of hypertension and coronary artery constriction due to additive vasospastic effects when used concomitantly for the same migraine attack. Effects can be additive. The co-administration is contraindicated
Fluoxetine, frovatriptan [2] ---> SmPC of [2] of eMC
Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome. Strict adherence to the recommended dose is an essential factor to prevent this syndrome.
Fluvoxamine, frovatriptan [2] ---> SmPC of [2] of eMC
Fluvoxamine is a potent inhibitor of cytochrome CYP1A2 and has been shown to increase the blood levels of frovatriptan by 27-49%.
Frovatriptan [1], IMAOs ---> SmPC of [1] of eMC
Frovatriptan is not a substrate for MAO-A, however a potential risk of serotonin syndrome or hypertension cannot be excluded. The co-administration is not recommended
Frovatriptan [1], methylergometrine ---> SmPC of [1] of eMC
Risks of hypertension, coronary artery constriction.
Frovatriptan [1], methysergide ---> SmPC of [1] of eMC
Risks of hypertension and coronary artery constriction due to additive vasospastic effects when used concomitantly for the same migraine attack. Effects can be additive. The co-administration is contraindicated
Frovatriptan [1], oral contraceptives ---> SmPC of [1] of eMC
In female subjects taking oral contraceptives, concentrations of frovatriptan were 30% higher than in females not taking oral contraceptives. No increased incidence in the adverse event profile was reported.
Frovatriptan [1], paroxetine ---> SmPC of [1] of eMC
Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome. Strict adherence to the recommended dose is an essential factor to prevent this syndrome.
Frovatriptan [1], pregnancy ---> SmPC of [1] of eMC
Frovatriptan should not be used during pregnancy unless clearly necessary.
Frovatriptan [1], sertraline ---> SmPC of [1] of eMC
Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome. Strict adherence to the recommended dose is an essential factor to prevent this syndrome.
Frovatriptan [1], SSRI ---> SmPC of [1] of eMC
Selective serotonin-reuptake inhibitors mit frovatriptan: Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome. Strict adherence to the recommended dose is an essential factor to prevent this syndrome.
Frovatriptan [1], St. John's wort ---> SmPC of [1] of eMC
As with other triptans the risk of the occurrence of serotonin syndrome may be increased.
Frovatriptan [1], triptans ---> SmPC of [1] of eMC
Risks of hypertension and coronary artery constriction due to additive vasospastic effects when used concomitantly for the same migraine attack. Effects can be additive. The co-administration is contraindicated
CONTRAINDICATIONS of Frovatriptan
- hypersensitivity to frovatriptan or to any of the excipients.
- patients with a history of myocardial infarction, ischaemic heart disease, coronary vasospasm (e.g. Prinzmetal's angina), peripheral vascular disease, patients
presenting with symptoms or signs compatible with ischaemic heart disease.
- Moderately severe or severe hypertension, uncontrolled mild hypertension.
- previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA).
- severe hepatic impairment (Child-Pugh C).
- Concomitant administration of frovatriptan with ergotamine or ergotamine derivatives (including methysergide) or other 5-hydroxytryptamine (5-HT1) receptor agonists.
http://www.medicines.org.uk/emc/
Fruquintinib (Fruzaqla)
Ability to drive, fruquintinib [2] ---> SmPC of [2] of EMA
Fruquintinib has minor influence on the ability to drive and use machines. Fatigue may occur following administration of fruquintinib (see section 4.8).
BCRP substrates, fruquintinib [2] ---> SmPC of [2] of EMA
No dose adjustment is recommended for BCRP substrates during concomitant use with fruquintinib.
Breast-feeding, fruquintinib [2] ---> SmPC of [2] of EMA
A risk to the breast-feeding newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment and for 2 weeks after the last dose.
CYP3A4 inhibitors, fruquintinib [2] ---> SmPC of [2] of EMA
No dose adjustment of fruquintinib is needed during concomitant use with CYP3A inhibitors.
Dabigatran etexilate, fruquintinib [2] ---> SmPC of [2] of EMA
Co-administration of a single dose of dabigatran etexilate 150 mg (a P-gp substrate) with a single dose of fruquintinib 5 mg decreased AUC of dabigatran by 9%.
Fertility, fruquintinib [2] ---> SmPC of [2] of EMA
There are no data on the effects of fruquintinib on human fertility. Results from animal studies indicate that fruquintinib may impair male and female fertility (see section 5.3).
Fruquintinib [1], gastric pH increasing medication ---> SmPC of [1] of EMA
No dose adjustment of fruquintinib is needed during concomitant use with gastric acid lowering agents.
Fruquintinib [1], itraconazol ---> SmPC of [1] of EMA
No dose adjustment of fruquintinib is needed during concomitant use with CYP3A inhibitors.
Fruquintinib [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA
The concomitant use of fruquintinib with strong and moderate CYP3A inducers should be avoided.
Fruquintinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
No dose adjustment is recommended for P-gp substrates during concomitant use with fruquintinib.
Fruquintinib [1], pregnancy ---> SmPC of [1] of EMA
FRUZAQLA should not be used during pregnancy unless the clinical condition of the woman requires treatment with fruquintinib.
Fruquintinib [1], pregnancy ---> SmPC of [1] of EMA
If fruquintinib is used during pregnancy or if the patient becomes pregnant while on treatment, the patient must be informed of the potential hazard to the foetus.
Fruquintinib [1], rabeprazole ---> SmPC of [1] of EMA
Co-administration of fruquintinib with rabeprazole (a proton pump inhibitor) 40 mg once daily did not result in clinically meaningful changes in the AUC of fruquintinib.
Fruquintinib [1], rifampicin ---> SmPC of [1] of EMA
Co-administration of fruquintinib with rifampicin (a strong CYP3A inducer) 600 mg once daily decreased fruquintinib AUCinf by 65% and decreased Cmax by 12%.
Fruquintinib [1], rosuvastatin ---> SmPC of [1] of EMA
Co-administration of a single 10 mg dose of rosuvastatin (a BCRP substrate) with a single 5 mg dose of fruquintinib decreased AUC of rosuvastatin by 19%.
Fruquintinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
The concomitant use of fruquintinib with strong and moderate CYP3A inducers should be avoided.
Fruquintinib [1], women of childbearing potential ---> SmPC of [1] of EMA
Women of childbearing potential should be advised to use highly effective contraception during treatment and for at least 2 weeks following the last dose of fruquintinib.
CONTRAINDICATIONS of Fruquintinib (Fruzaqla)
- Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
https://www.ema.europa.eu/en/documents/product-information/fruzaqla-epar-product-information_en.pdf 10/07/2024
Fulvestrant (Faslodex)
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.
Ability to drive, fulvestrant [2] ---> SmPC of [2] of EMA
Since asthenia has been reported very commonly with Faslodex, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
Anticoagulants, fulvestrant [2] ---> SmPC of [2] of EMA
Due to the intramuscular route of administration, fulvestrant should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.
Breast-feeding, fulvestrant [2] ---> SmPC of [2] of EMA
Considering the potential for serious adverse reactions due to fulvestrant in breast-fed infants, use during lactation is contraindicated
Fertility, fulvestrant [2] ---> SmPC of [2] of EMA
The effects of Faslodex on fertility in humans has not been studied.
Fulvestrant [1], ketoconazole ---> SmPC of [1] of EMA
Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Fulvestrant [1], pregnancy ---> SmPC of [1] of EMA
Faslodex is contraindicated in pregnancy (see section 4.3). Studies in animals have shown reproductive toxicity including an increased incidence of foetal abnormalities and deaths (see section 5.3).
Fulvestrant [1], pregnancy ---> SmPC of [1] of EMA
If pregnancy occurs while taking Faslodex, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.
Fulvestrant [1], rifampicin ---> SmPC of [1] of EMA
Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Fulvestrant [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Dose adjustment is not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.
Fulvestrant [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Dose adjustment is not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.
Fulvestrant [1], women of childbearing potential ---> SmPC of [1] of EMA
Patients of childbearing potential should use effective contraception during treatment with Faslodex and for 2 years after the last dose.
Fulvestrant, palbociclib [2] ---> SmPC of [2] of EMA
Data from a clinical study in patients with breast cancer showed that there was no clinically relevant drug interaction between palbociclib and fulvestrant when the two medicinal products were coadministered.
Fulvestrant, ribociclib [2] ---> SmPC of [2] of EMA
Data from a clinical study in patients with breast cancer indicated no clinically relevant effects of fulvestrant on ribociclib exposure following co-administration of these medicinal products.
CONTRAINDICATIONS of Fulvestrant (Faslodex)
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Pregnancy and lactation
- Severe hepatic impairment
https://www.ema.europa.eu/en/documents/product-information/faslodex-epar-product-information_en.pdf 21/03/2024
Other trade names: Fulvestrant Mylan,
Furosemide
Ability to drive, furosemide [2] ---> SmPC of [2] of eMC
Reduced mental alertness may impair ability to drive or operate dangerous machinery.
ACE inhibitors, furosemide [2] ---> SmPC of [2] of eMC
A marked fall in blood pressure and deterioration in renal function
Acemetacine, furosemide
Furosemide accelerates the elimination of acemetacine
Acetylsalicylic acid, furosemide [2] ---> SmPC of [2] of eMC
NSAID may reduce the diuretic effects of furosemide.
ACTH, furosemide [2] ---> SmPC of [2] of eMC
The co-administration may increase the risk of hypokalaemia.
Adrenaline, furosemide
The co-administration may weaken the effect of pressor amine
AIIRA, furosemide [2] ---> SmPC of [2] of eMC
A marked fall in blood pressure and deterioration in renal function
Ajmaline, furosemide
Not to mix. Formation of flocculent precipitate
Alcohol, furosemide
The co-administration may enhance the hypotensive effect
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/amlodipine [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/hydrochlorothiazide, furosemide ---> SmPC 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%
Amikacine [1], furosemide ---> SmPC 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.
Amiloride/hydrochlorothiazide, furosemide
The co-administration of amiloride/hydrochlorothiazide and kaliuretic diuretics (e. g. furosemide) may increase the potassium loss
Aminoglutethimide, furosemide
The co-administration may increase the risk of hyponatraemia
Aminoglycoside antibiotics, furosemide [2] ---> SmPC of [2] of eMC
Increased risk of ototoxicity and nephrotoxicity with aminoglycosides. Concomitant use should be avoided
Aminophylline, furosemide
There is an increased risk of hypokalaemia when theophylline derivatives are given with diuretics
Amiodarone, furosemide
Caution should be exercised over combined therapy with drugs which may also cause hypokalaemia and/or hypomagnesaemia
Antidiabetics, furosemide [2] ---> SmPC of [2] of eMC
Furosemide may attenuate the effects of the anti-diabetic drug
Antihypertensives, furosemide [2] ---> SmPC of [2] of eMC
The co-administration may enhance the hypotensive effect
Ataluren [1], furosemide ---> SmPC 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
Atenolol/chlortalidone, furosemide
Increased loss of potassium and/or magnesium.
Atracurium [1], furosemide ---> SmPC 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
Azathioprine, furosemide
Furosemide decreases the metabolism of azathioprine
Beclometasone [1], furosemide ---> SmPC of [1] of eMC
Diuretic effect antagonised (sodium retention) and increased risk of hypokalaemia.
Beta2-adrenergic agonists, furosemide
The co-administration may increase the risk of hypokalaemia. Use with caution
Bezafibrate, furosemide
Bezafibrate may enhance the furosemide effect due to displacement from its plasma protein binding
Bile-acid sequestrants, furosemide
Decreased absorption of furosemide. Administer 2 to 3 hours apart
Bleomycin, furosemide
Incompatibility
Breast-feeding, furosemide [2] ---> SmPC of [2] of eMC
Furosemide may inhibit lactation or may pass into the breast milk, it should therefore be used with caution in nursing mothers.
Carbamazepine [1], furosemide ---> SmPC of [1] of eMC
Concomitant medication with carbamazepine and furosemide may lead to symptomatic hyponatraemia.
Carbenoxolone, furosemide [2] ---> SmPC of [2] of eMC
The co-administration may increase the risk of hypokalaemia.
Cefixime, furosemide
A treatment with high doses of cephalosporins in patients receiving diuretics may cause renal function impairment
Cefotaxime, furosemide [2] ---> SmPC of [2] of eMC
The combination of cefotaxime with nephrotoxic drugs may potentiate the nephrotoxicity. Monitoring of renal function is recommended
Cefpodoxime, furosemide
Increased risk of renal insufficiency
Ceftazidime, furosemide
Increased risk of renal insufficiency
Cefuroxime, furosemide
A treatment with high doses of cephalosporins should be done with caution in patients receiving potent diuretics, because renal function impairment cannot be excluded
Cephalosporins, furosemide ---> SmPC of [ceftazidime/avibactam] of EMA
Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function
Chloral hydrate, furosemide [2] ---> SmPC of [2] of eMC
Chloral hydrate followed by intravenous furosemide may result in sweating, hot flushes and variable blood pressure including hypertension due to a hypermetabolic state caused by displacement of thyroid hormone from its bound state.
Cholestyramine, furosemide
Decreased absorption of furosemide. Administer 2 to 3 hours apart
Cisatracurium [1], furosemide ---> SmPC of [1] of eMC
Diuretics increase the magnitude and/or duration of action of non-depolarising neuromuscular blocking agents
Cisplatin, furosemide
The co-administration may intensify the nephrotoxic, ototoxic and cytotoxic effects. Strict indication
Class IA antiarrhythmic agents, furosemide
Electrolyte imbalance may enhance the toxicity of antiarrhythmic agent. Monitoring of serum potassium and ECG is recommended
Class III antiarrhythmic agents, furosemide
Electrolyte imbalance may enhance the toxicity of antiarrhythmic agent. Monitoring of serum potassium and ECG is recommended
Colchicine, furosemide
The co-administration may decrease the effect of colchicine and/or increase its toxicity
Colesevelam, furosemide
Colesevelam may decrease the absorption of furosemide.
Colestipol [1], furosemide ---> SmPC of [1] of eMC
Colestipol may delay or reduce the absorption of furosemide
Corticosteroids, furosemide [2] ---> SmPC of [2] of eMC
Diuretic effect anatgonised (sodium retention) and increased risk of hypokalaemia.
Curare-type muscle relaxants, furosemide [2] ---> SmPC of [2] of eMC
The effects of curare may be enhanced by furosemide.
Cyclosporine, furosemide
The co-administration is associated with increased risk of gouty arthritis.
Dasabuvir with ombitasvir/paritaprevir/ritonavir, furosemide ---> SmPC of [dasabuvir] of EMA
Possibly increased furosemide plasma concentrations due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir. Monitor patients for clinical effects; a decrease in furosemide dose of up to 50% may be required.
Digital glycosides, furosemide [2] ---> SmPC of [2] of eMC
Furosemide induced hypokalaemia/hypomagnaesemia and electrolyte disturbances (including magnesium) increase the risk of cardiac toxicity.
Diuretics, furosemide [2] ---> SmPC of [2] of eMC
A marked fall in blood pressure and deterioration in renal function
Dopamine, furosemide
Dopamine may increase the effect of diuretic agents.
Electrolyte imbalance, furosemide [2] ---> SmPC of [2] of eMC
Hypokalaemia and electrolyte disturbances (including magnesium) increases the risk of cardiac toxicity.
Enalapril/hydrochlorothiazide [1], furosemide ---> SmPC of [1] of eMC
Hydrochlorothiazide may increase the loss of potassium and/or magnesium.
Encorafenib [1], furosemide ---> SmPC of [1] of EMA
Agents that are substrates of renal transporters OAT1, OAT3, OCT2 (such as furosemide, penicillin) may have increased exposure and should be therefore co-administered with caution.
Ephedrine, furosemide
Furosemide and other diuretics may decrease the pressor response of ephedrine
Epinephrine, furosemide
The co-administration may weaken the effect of pressor amine
Fenofibrate, furosemide
The co-administration may increase the plasma levels of fibrate and furosemide
Fibrates, furosemide
The co-administration may increase the plasma levels of fibrate and furosemide
Foods, furosemide
Take with food to reduce irritation.
Fosphenytoin [1], furosemide ---> SmPC of [1] of eMC
Blood levels and/or effects of furosemide may be altered by phenytoin
Furosemide [1], glucocorticoids ---> SmPC of [1] of eMC
The co-administration may increase the risk of hypokalaemia.
Furosemide [1], glycyrrhiza ---> SmPC of [1] of eMC
The co-administration may increase the risk of hypokalaemia.
Furosemide [1], laxatives ---> SmPC of [1] of eMC
The co-administration may increase the risk of hypokalaemia.
Furosemide [1], lithium ---> SmPC of [1] of eMC
Furosemide reduces lithium excretion with increased plasma lithium concentrations (risk of toxicity). Avoid concomitant administration unless plasma levels are monitored.
Furosemide [1], NSAID ---> SmPC of [1] of eMC
NSAID may reduce the diuretic effects of furosemide.
Furosemide [1], pregnancy ---> SmPC of [1] of eMC
The drug should not be used in pregnant women unless the benefits to the patient outweigh the possible risk to the foetus which includes persistence of patent ductus arteriosus
Furosemide [1], probenecide ---> SmPC of [1] of eMC
Probenecid reduced renal clearance of furosemide and decreased diuretic effect.
Furosemide [1], QT interval prolonging drugs ---> SmPC of [1] of eMC
Cardiac toxicity may be increased by furosemide-induced hypokalaemia and/or hypomagnesaemia.
Furosemide [1], salicylates ---> SmPC of [1] of eMC
Salicylate may attenuate the action of furosemide and the salicylate effects (also the toxic) may be increased by furosemide.
Furosemide [1], sucralfate ---> SmPC of [1] of eMC
Sucralfate decreases the absorption of furosemide. Must not be taken within 2 hours of each other
Furosemide, general anesthetics
The co-administration may enhance the hypotensive effect
Furosemide, hydantoins
The hydantoin decreases the effect of furosemide
Furosemide, ibutilide
Electrolyte imbalance may enhance the toxicity of antiarrhythmic agent. Monitoring of serum potassium and ECG is recommended
Furosemide, immunosuppressives
The co-administration may increase the nephrotoxicity risk. Concomitant use should be avoided
Furosemide, indapamide [2] ---> SmPC of [2] of eMC
The co-administration of indapamide with diuretics which may cause hypokalaemia is not recommended.
Furosemide, indometacin
Furosemide may accelerate the elimination of indometacin
Furosemide, iodinated contrast media
The co-administration may increase the nephrotoxicity risk. Concomitant use should be avoided
Furosemide, leflunomide [2] ---> SmPC of [2] of EMA
A771726 is an inhibitor of OAT3 in vivo .Therefore, when co-administered leflunomide with substrates of OAT3 caution is recommended.
Furosemide, mesalazine
Possible attenuation of the diuretic effect
Furosemide, metformin
Furosemide may increase the plasma levels of metformin and metformin may decrease the plasma levels of furosemide
Furosemide, methotrexate
Drugs which, like furosemide, undergo renal tubular secretion may reduce the effect of furosemide. Furosemide may also decrease renal elimination of these drugs.
Furosemide, methoxsalen
The co-administration of methoxsalen with photosensitizing agents should be done with caution
Furosemide, metolazone
The co-administration may potentiate significantly the effect of metolazone and cause severe electrolyte imbalances
Furosemide, milrinone [2] ---> SmPC of [2] of eMC
Furosemide should not be administered in intravenous lines containing milrinone lactate in order to avoid precipitation.
Furosemide, mivacurium [2] ---> SmPC of [2] of eMC
As all non-depolarising neuromuscular blocking agents, the magnitude and/or duration of non-depolarising neuromuscular block may be increased and infusion requirements may be reduced as a result of interaction with diuretics
Furosemide, muscle relaxants (non-depolarizing) ---> SmPC 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, naproxen
NSAID may reduce the diuretic effects of furosemide.
Furosemide, naproxen/esomeprazole [2] ---> SmPC of [2] of eMC
Clinical studies, as well as postmarketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis
Furosemide, nebivolol [2] ---> SmPC of [2] of eMC
Co-administration of furosemide did not affect the pharmacokinetics of nebivolol.
Furosemide, nephrotoxic substances
The co-administration may increase the nephrotoxicity risk. Concomitant use should be avoided
Furosemide, nicotine [2] ---> SmPC of [2] of eMC
Smoking may lead to reduced diuretic response to furosemide
Furosemide, nimodipine
The co-administration of nimodipine with potential nephrotoxic agents may impairment the renal function
Furosemide, noradrenaline
The co-administration may weaken the effect of pressor amine
Furosemide, norepinephrine
The co-administration may weaken the effect of pressor amine
Furosemide, ofloxacin [2] ---> SmPC of [2] of eMC
With high doses of quinolones, impairment of excretion and an increase in serum levels may occur when co-administered with other drugs that undergo renal tubular secretion
Furosemide, olaparib [2] ---> SmPC of [2] of EMA
Olaparib is an inhibitor of BCRP. It cannot be excluded that olaparib may increase the exposure to substrates of BCRP
Furosemide, olsalazine
The natriuretic effect of furosemide may be decreased
Furosemide, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC of [2] of EMA
Possibly increased furosemide plasma concentrations due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir. Monitor patients for clinical effects; a decrease in furosemide dose of up to 50% may be required.
Furosemide, oral anticoagulants
Furosemide enhances the effect of oral anticoagulant agent
Furosemide, ototoxic agents
Increased risk of ototoxicity with other ototoxic agents. The combination should be avoided
Furosemide, penicillin G
The co-administration may increase the risk of hypokalaemia.
Furosemide, pentamidine
The co-administration may increase the nephrotoxicity risk. Concomitant use should be avoided
Furosemide, peripheral antiadrenergic agent
Furosemide may enhance the effect of peripheral antiadrenergic agent
Furosemide, phenobarbital
The co-administration may weaken the effect of furosemide
Furosemide, phenytoin
Phenytoin may decrease the plasma concentrations of furosemide
Furosemide, platinum compounds
The co-administration may increase the nephrotoxicity risk. Concomitant use should be avoided
Furosemide, polymyxin
The co-administration may increase the nephrotoxicity risk. Concomitant use should be avoided
Furosemide, prednisolone
The co-administration may increase the risk of hypokalaemia.
Furosemide, quinolones ---> SmPC of [ofloxacin] of eMC
With high doses of quinolones, impairment of excretion and an increase in serum levels may occur when co-administered with other drugs that undergo renal tubular secretion
Furosemide, risperidone [2] ---> SmPC of [2] of eMC
Co-administration is not recommended. Higher incidence of mortality in elderly patients with dementia
Furosemide, rofecoxib
Rofecoxib may reduce the diuretic effects of furosemide.
Furosemide, sacubitril/valsartan [2] ---> SmPC of [2] of EMA
Co-administration of Entresto and furosemide had no effect on the pharmacokinetics of Entresto but reduced Cmax and AUC of furosemide by 50% and 28%, respectively.
Furosemide, sodium zirconium cyclosilicate [2] ---> SmPC 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.
Furosemide, sucroferric oxyhydroxide [2] ---> SmPC of [2] of EMA
Drug-drug interaction studies have been conducted in healthy subjects with losartan, furosemide, digoxin, warfarin, and omeprazole. Co-administration of Velphoro did not affect the bioavailability of these products as measured by the AUC.
Furosemide, sympathomimetics
The co-administration may weaken the effect of pressor amine
Furosemide, tafamidis [2] ---> SmPC of [2] of EMA
Tafamidis inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters
Furosemide, tamsulosin [2] ---> SmPC of [2] of eMC
Concomitant furosemide lowers plasma concentrations of tamsulosin but, as the concentration of tamsulosin remains within the normal range, posology need not be altered.
Furosemide, teicoplanin [2] ---> SmPC 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.
Furosemide, telmisartan [2] ---> SmPC of [2] of EMA
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.
Furosemide, teriflunomide [2] ---> SmPC of [2] of EMA
When teriflunomide (OAT3 inhibitor) is coadministered with substrates of OAT3 caution is recommended.
Furosemide, theophylline [2] ---> SmPC of [2] of eMC
Furosemide may potentiate the effects of theophylline.
Furosemide, thiamine
In long-term administration with furosemide, there can be a thiamine deficiency due to renal elimination
Furosemide, thiazides
Synergic diuretic effect
Furosemide, thyroid hormones
Increased plasma levels of thyroid hormone
Furosemide, tobramycin [2] ---> SmPC of [2] of EMA
Concomitant use of tobramycin with diuretic compounds is not recommended. Such compounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Furosemide, treprostinil
Decreased treprostinil clearance
Furosemide, tubular secretion
Drugs which, like furosemide, undergo renal tubular secretion may reduce the effect of furosemide. Furosemide may also decrease renal elimination of these drugs.
Furosemide, vitamin B1
In long-term administration with furosemide, there can be a thiamine deficiency due to renal elimination
Furosemide, warfarin
The co-administration may enhance the anticoagulant effect
Furosemide, xipamide
Increased risk of hypokaliemia (additive effect)
CONTRAINDICATIONS of Furosemide
Furosemide is contraindicated in the following circumstances
- Hypersensitivity to furosemide, any of its excipients, sulphonamides, sulphonamide derivatives/amiloride
- Anuria and impaired renal function (creatinine clearance below 30 mL/min per 1.73 m² body surface area) and renal failure resulting from poisoning by nephrotoxic and/or
hepatotoxic agents
- Electrolyte disturbances (severe hyponatraemia: severe hypokalaemia, hypovolaemia), dehydration and/or hypotension
- Concomitant potassium supplements or potassium sparing diuretics
- Pre-coma/coma associated with hepatic cirrhosis or encephalopathy
- Addison's disease
- Digitalis intoxication
- Breast-feeding women
http://www.medicines.org.uk/emc/
Fusafungine
Breast-feeding, fusafungine
A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy should be made
Fusafungine, pregnancy
Caution should be exercised when prescribing to pregnant women.
Fusidic acid
Atorvastatin [1], fusidic acid ---> SmPC 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
Breast-feeding, fusidic acid [2] ---> SmPC of [2] of eMC
No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/sodium fusidate to the breast-feeding woman is negligible.
Coumarin anticoagulants, fusidic acid
The co-administration with fusidate systemically may increase the plasma concentration of the anticoagulant.
Cyclosporine, fusidic acid
Co-administration with fusidic acid systemically may cause increased plasma concentration of ciclosporin
Dasabuvir with ombitasvir/paritaprevir/ritonavir, fusidic acid ---> SmPC 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
Drugs metabolised by CYP3A4, fusidic acid
The co-administration may results in a mutual inhibition of their metabolisms. The use of fusidic acid systemically should be avoided with CYP-3A4 biotransformed drugs.
Drugs primarily metabolised by CYP3A4, fusidic acid
The co-administration may results in a mutual inhibition of their metabolisms. The use of fusidic acid systemically should be avoided with CYP-3A4 biotransformed drugs.
Ezetimibe/simvastatine [1], fusidic acid ---> SmPC of [1] of eMC
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins.
Fenofibrate/pravastatine [1], fusidic acid ---> SmPC of [1] of EMA
The co-administration may cause increased plasma levels of pravastatine and fusidic acid and is contra-indicated. The risk of myopathy and rhabdomyolysis may increase
Fenofibrate/simvastatin [1], fusidic acid ---> SmPC of [1] of EMA
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins. Co-administration of this combination may cause increased plasma concentrations of both agents.
Foods, fusidic acid
Take with food to reduce irritation.
Fusidic acid [1], pregnancy ---> SmPC of [1] of eMC
No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible. Topical form can be used during pregnancy.
Fusidic acid [1], statins ---> SmPC of [1] of eMC
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic Fucidin® with statins. Co-administration of this combination may cause increased plasma concentrations of both agents.
Fusidic acid, indinavir/ritonavir ---> SmPC of [indinavir] of EMA
Indinavir/ritonavir should not be administered with fusidic acid
Fusidic acid, latex
Decreased breaking strength
Fusidic acid, levomethadone
The enzymatic induction may decrease the plasma levels of levomethadone and abstinence syndrome may occur
Fusidic acid, lopinavir/ritonavir [2] ---> SmPC 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.
Fusidic acid, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC 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
Fusidic acid, oral anticoagulants
The co-administration with fusidate systemically may increase the plasma concentration of the anticoagulant.
Fusidic acid, penicillins
Fusidic acid may diminish the therapeutic effect of penicillins. The penicillin should be administered 2 hours before fusidic acid.
Fusidic acid, pitavastatin
The co-administration may cause increased plasma concentrations of both agents and is contra-indicated. The risk of myopathy including rhabdomyolysis may be increased.
Fusidic acid, pravastatine ---> SmPC of [fenofibrate/pravastatine] of EMA
The co-administration may cause increased plasma levels of pravastatine and fusidic acid and is contra-indicated. The risk of myopathy and rhabdomyolysis may increase
Fusidic acid, protease inhibitors
Co-administration of fusidic acid and HIV protease inhibitors increases the plasma concentrations of both agents which may result in hepatotoxicity.
Fusidic acid, ritonavir [2] ---> SmPC of [2] of EMA
Ritonavir co-administration is likely to result in increased plasma concentrations of both fusidic acid and ritonavir and is therefore contraindicated
Fusidic acid, rocuronium/sugammadex
Some displacement of rocuronium from the complex with sugammadex and recurrence of neuromuscular blockade can occur
Fusidic acid, rosuvastatin [2] ---> SmPC of [2] of eMC
Combination with rosuvastatin and fusidic acid is not recommended. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination
Fusidic acid, saquinavir/ritonavir ---> SmPC of [saquinavir] of EMA
Co-administration of fusidic acid and saquinavir/ritonavir can cause increased plasma concentration of both fusidic acid and saquinavir/ritonavir.
Fusidic acid, statins
As with other statins, muscle-related events, including rhabdomyolysis, have been reported in post-marketing experience with atorvastatin and fusidic acid given concurrently.
Fusidic acid, statins ---> SmPC of [ezetimibe/atorvastatin] 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.
Fusidic acid, sugammadex [2] ---> SmPC of [2] of EMA
For toremifene and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
CONTRAINDICATIONS of Fusidic acid
- Hypersensitivity to the active substance or to any of the excipients.
http://www.medicines.org.uk/emc/
Futibatinib (Lytgobi)
Ability to drive, futibatinib [2] ---> SmPC of [2] of EMA
Patients should be advised to be cautious when driving or operating machines in case they experience fatigue or visual disturbances during the treatment with Lytgobi (see section 4.4).
BCRP substrates, futibatinib [2] ---> SmPC of [2] of EMA
Co-administration of futibatinib with P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g, rosuvastatin) substrates may increase their exposure.
Breast-feeding, futibatinib [2] ---> SmPC of [2] of EMA
Breast-feeding should be discontinued during treatment with Lytgobi and for 1 week after the last dose.
Carbamazepine, futibatinib [2] ---> SmPC of [2] of EMA
Co-administration of futibatinib with strong or moderate CYP3A4/P-gp inducers, such as rifampicin, should be avoided. If this is not possible, gradually increasing the futibatinib dose based on careful monitoring of tolerability should be considered.
Clarithromycin, futibatinib [2] ---> SmPC of [2] of EMA
Co-administration of futibatinib with strong CYP3A4/P-gp inhibitors, such as itraconazole, should be avoided. If this is not possible, based on careful monitoring of tolerability, a futibatinib dose reduction to the next lower level should be considered.
Colchicine, futibatinib [2] ---> SmPC of [2] of EMA
Co-administration of futibatinib with P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g, rosuvastatin) substrates may increase their exposure.
Contraceptives, futibatinib [2] ---> SmPC of [2] of EMA
An effective method of contraception should be used in women of childbearing potential and in men with women partners of childbearing potential during treatment with Lytgobi and for 1 week following completion of therapy.
Contraceptives1, futibatinib [2] ---> SmPC of [2] of EMA
Since the effect of futibatinib on the metabolism and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception to avoid pregnancy.
Dabigatran, futibatinib [2] ---> SmPC of [2] of EMA
Co-administration of futibatinib with P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g, rosuvastatin) substrates may increase their exposure.
Digoxin, futibatinib [2] ---> SmPC of [2] of EMA
Co-administration of futibatinib with P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g, rosuvastatin) substrates may increase their exposure.
Drugs primarily metabolised by CYP1A2, futibatinib [2] ---> SmPC of [2] of EMA
Co-administration of futibatinib with CYP1A2 sensitive substrates (e.g, olanzapine, theophylline) may decrease their exposure and therefore may affect their activity.
Efavirenz, futibatinib [2] ---> SmPC of [2] of EMA
Co-administration of futibatinib with strong or moderate CYP3A4/P-gp inducers, such as rifampicin, should be avoided. If this is not possible, gradually increasing the futibatinib dose based on careful monitoring of tolerability should be considered.
Fertility, futibatinib [2] ---> SmPC of [2] of EMA
Based on the pharmacology of futibatinib, impairment of male and female fertility cannot be excluded.
Foods, futibatinib [2] ---> SmPC of [2] of EMA
Lytgobi is for oral use. The tablets should be taken with or without food at about the same time each day. The tablets should be swallowed whole to ensure that the full dose is administered.
Futibatinib [1], lansoprazole ---> SmPC of [1] of EMA
Co-administrations of a proton pump inhibitor (lansoprazole) did not result in a clinically important change in futibatinib exposure.
Futibatinib [1], midazolam ---> SmPC of [1] of EMA
Co-administrations of futibatinib had no clinically significant impact on midazolam exposure.
Futibatinib [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration of futibatinib with strong or moderate CYP3A4/P-gp inducers, such as rifampicin, should be avoided. If this is not possible, gradually increasing the futibatinib dose based on careful monitoring of tolerability should be considered.
Futibatinib [1], olanzapine ---> SmPC of [1] of EMA
Co-administration of futibatinib with CYP1A2 sensitive substrates (e.g, olanzapine, theophylline) may decrease their exposure and therefore may affect their activity.
Futibatinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA
Co-administration of futibatinib with P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g, rosuvastatin) substrates may increase their exposure.
Futibatinib [1], phenobarbital ---> SmPC of [1] of EMA
Co-administration of futibatinib with strong or moderate CYP3A4/P-gp inducers, such as rifampicin, should be avoided. If this is not possible, gradually increasing the futibatinib dose based on careful monitoring of tolerability should be considered.
Futibatinib [1], phenytoin ---> SmPC of [1] of EMA
Co-administration of futibatinib with strong or moderate CYP3A4/P-gp inducers, such as rifampicin, should be avoided. If this is not possible, gradually increasing the futibatinib dose based on careful monitoring of tolerability should be considered.
Futibatinib [1], pregnancy ---> SmPC of [1] of EMA
Lytgobi should not be used during pregnancy unless the potential benefit for the women justifies the potential risk to the foetus.
Futibatinib [1], rifampicin ---> SmPC of [1] of EMA
Co-administration of futibatinib with strong or moderate CYP3A4/P-gp inducers, such as rifampicin, should be avoided. If this is not possible, gradually increasing the futibatinib dose based on careful monitoring of tolerability should be considered.
Futibatinib [1], rosuvastatin ---> SmPC of [1] of EMA
Co-administration of futibatinib with P-gp (e.g., digoxin, dabigatran, colchicine) or BCRP (e.g, rosuvastatin) substrates may increase their exposure.
Futibatinib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA
Co-administration of futibatinib with strong or moderate CYP3A4/P-gp inducers, such as rifampicin, should be avoided. If this is not possible, gradually increasing the futibatinib dose based on careful monitoring of tolerability should be considered.
Futibatinib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA
Co-administration of futibatinib with strong CYP3A4/P-gp inhibitors, such as itraconazole, should be avoided. If this is not possible, based on careful monitoring of tolerability, a futibatinib dose reduction to the next lower level should be considered.
Futibatinib [1], strong P-gp inductors ---> SmPC of [1] of EMA
Co-administration of futibatinib with strong or moderate CYP3A4/P-gp inducers, such as rifampicin, should be avoided. If this is not possible, gradually increasing the futibatinib dose based on careful monitoring of tolerability should be considered.
Futibatinib [1], strong P-gp inhibitors ---> SmPC of [1] of EMA
Co-administration of futibatinib with strong CYP3A4/P-gp inhibitors, such as itraconazole, should be avoided. If this is not possible, based on careful monitoring of tolerability, a futibatinib dose reduction to the next lower level should be considered.
Futibatinib [1], theophylline ---> SmPC of [1] of EMA
Co-administration of futibatinib with CYP1A2 sensitive substrates (e.g, olanzapine, theophylline) may decrease their exposure and therefore may affect their activity.
Futibatinib, itraconazol
Co-administration of futibatinib with strong CYP3A4/P-gp inhibitors, such as itraconazole, should be avoided. If this is not possible, based on careful monitoring of tolerability, a futibatinib dose reduction to the next lower level should be considered.
CONTRAINDICATIONS of Futibatinib (Lytgobi)
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/lytgobi-epar-product-information_en.pdf 11/12/2024