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Pharmacologic Category
Antifungal Agent, Imidazole Derivative; Antifungal Agent, Oral Nonabsorbed
Dosing: Adult
Oropharyngeal candidiasis (prophylaxis): Oral: 10 mg dissolved slowly 3 times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.
Oropharyngeal candidiasis (treatment): Oral: 10 mg dissolved slowly 5 times daily for 14 consecutive days. Note: When used for initial treatment in patients with HIV-1, duration of therapy is 7 to 14 days (DHHS [adult] 2014; DHHS [pediatric] 2013).
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Pediatric
Candidiasis, oropharyngeal; treatment: Children ≥3 years and Adolescents: Oral: 10 mg troche dissolved slowly 5 times daily for 14 consecutive days. Note: When used for initial treatment in patients with HIV, duration of therapy is 7 to 14 days (HHS [OI adult 2016]; HHS [OI pediatric 2016]).
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling.
Use: Labeled Indications
Oropharyngeal candidiasis (treatment): Local treatment of oropharyngeal candidiasis.
Oropharyngeal candidiasis (prophylaxis): To reduce the incidence of oropharyngeal candidiasis in immunocompromised patients undergoing chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation.
* See Uses in AHFS Essentials for additional information.
Clinical Practice Guidelines
Opportunistic Infections:
DHHS, Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV-Exposed and HIV-Infected Children, November 2013
DHHS, Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, October 2014 [Note: Information contained within this monograph is pending revision based on these more recent guidelines]
Administration: Oral
Allow troche to dissolve slowly in the mouth. Dissolution is complete in approximately 30 minutes.
Administration: Pediatric
Oral: Allow lozenge (troche) to slowly dissolve in mouth. Dissolution is complete in approximately 30 minutes.
Storage/Stability
Store at 20°C to 25°C (68°F to 77°F). Avoid freezing.
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat or prevent fungal infections in the mouth.
Frequently reported side effects of this drug
• Itching
• Nausea
• Vomiting
• Numbness or tingling in mouth
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Medication Safety Issues
Sound-alike/look-alike issues:
International issues:
Contraindications
Hypersensitivity to clotrimazole or any component of the formulation
Documentation of allergenic cross-reactivity for antifungals is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity can not be ruled out with certainty.
Warnings/Precautions
Concerns related to adverse effects:
• Hepatic effects: Abnormal LFTs have been reported, including abnormal aspartate aminotransferase (AST). Elevations are usually minimal. Monitor LFTs periodically, especially in patients with preexisting hepatic impairment.
Disease-related concerns:
• Hepatic impairment: Use with caution; abnormal LFTs have been reported. Elevations are usually minimal. Monitor LFTs periodically.
• Systemic fungal infection: Clotrimazole should not be used for treatment of systemic fungal infection.
Concurrent drug therapy related concerns:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Other warnings/precautions:
• Administration: Clotrimazole must be slowly dissolved in the mouth for maximum efficacy.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
Localized fungal infections frequently follow broad-spectrum antimicrobial therapy. Specifically, oral and vaginal infections due to Candida.
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed in animal reproduction studies.
Breast-Feeding Considerations
It is not known if clotrimazole is excreted in breast milk following oral (troche) administration (data not located); however, systemic absorption is low (Sawyer 1975).
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
>10%: Hepatic: Abnormal liver function tests
Frequency not defined:
Dermatologic: Pruritus
Gastrointestinal: Nausea, vomiting
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects
Inhibits CYP3A4 (weak)
Drug Interactions Open Interactions
ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Risk C: Monitor therapy
Dofetilide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Dofetilide. Risk C: Monitor therapy
Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Risk C: Monitor therapy
Lemborexant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Risk D: Consider therapy modification
Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Risk D: Consider therapy modification
NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Risk C: Monitor therapy
Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination
Tacrolimus (Systemic): Clotrimazole (Oral) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Triazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Triazolam. Management: Consider triazolam dose reduction in patients receiving concomitant weak CYP3A4 inhibitors. Risk D: Consider therapy modification
Ubrogepant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (if needed) of ubrogepant should be limited to 50 mg. Risk D: Consider therapy modification
Monitoring Parameters
Consider KOH test or culture prior to treatment to confirm oropharyngeal candidiasis; periodic liver function tests during therapy.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Lozenge, Mouth/Throat:
Generic: 10 mg (70 ea, 140 ea)
Troche, Mouth/Throat:
Generic: 10 mg
Anatomic Therapeutic Chemical (ATC) Classification
- A01AB18
- G01AF02
Generic Available (US)
Yes
Pricing: US
Troche (Clotrimazole Mouth/Throat)
10 mg (per each): $3.22 - $3.44
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Mechanism of Action
Binds to phospholipids in the fungal cell membrane altering cell wall permeability resulting in loss of essential intracellular elements
Pharmacodynamics/Kinetics
Distribution: Oral: Inhibitory concentrations remain in the saliva for up to 3 hours after dissolution of the troche
Dental Use
Treatment of susceptible fungal infections, including oropharyngeal candidiasis; limited data suggest that clotrimazole troches may be effective for prophylaxis against oropharyngeal candidiasis in neutropenic patients
* See Uses in AHFS Essentials for additional information.
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Dental Usual Dosing
Oropharyngeal candidiasis: Children >3 years and Adults: Oral:
Prophylaxis: 10 mg troche dissolved 3 times/day for the duration of chemotherapy or until steroids are reduced to maintenance levels
Treatment: 10 mg troche dissolved slowly 5 times/day for 14 consecutive days
Index Terms
Mycelex
FDA Approval Date
June 17, 1983
References
Clotrimazole troche [prescribing information]. Columbus, OH: Roxane Laboratories; August 2014.
Clotrimazole lozenge [prescribing information]. Minneapolis, MN: Perrigo; March 2012.
Clotrimazole Troche lozenges (clotrimazole oral) [prescribing information]. Eatontown, NJ: West-Ward Pharmaceuticals Corp; April 2016.
DHHS Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Department of Health and Human Services. November 2013. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/oi_guidelines_pediatrics.pdf.
DHHS Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. October 2014. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf. Accessed November 12, 2014
Duhm B, Medenwald H, Puetter J, et al. The pharmacokinetics of clotrimazole 14C. Postgrad Med J. 1974;50(Suppl 1):13-16.[PubMed 4467160]
Sawyer PR, Brogden RN, Piner RM, et al. Clotrimazole: a review of its antifungal activity and therapeutic efficacy. Drugs. 1975; 9:424-447.[PubMed 1097234]
Brand Names: International
Aflorix (AR)
Last Updated 3/20/20
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