Medically reviewed by Drugs.com. Last updated on May 22, 2019.
(kloe TRIM a zole)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Generic: 10 mg (70 ea, 140 ea)
Generic: 10 mg
- Antifungal Agent, Imidazole Derivative
- Antifungal Agent, Oral Nonabsorbed
Binds to phospholipids in the fungal cell membrane altering cell wall permeability resulting in loss of essential intracellular elements
Oral: Inhibitory concentrations remain in the saliva for up to 3 hours after dissolution of the troche
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.
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.
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).
Refer to adult dosing.
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]).
Oral: Allow troche to dissolve slowly in the mouth. Dissolution is complete in approximately 30 minutes.
Store at 20°C to 25°C (68°F to 77°F). Avoid freezing.
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. Monitor therapy
Dofetilide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Dofetilide. Monitor therapy
Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Monitor therapy
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. Consider therapy modification
Neratinib: Clotrimazole (Oral) may increase the serum concentration of Neratinib. Management: Avoid concomitant use of neratinib and clotrimazole if possible. If combined, monitor for increased neratinib effects/toxicities. Consider therapy modification
NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Monitor therapy
Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Avoid combination
Tacrolimus (Systemic): Clotrimazole (Oral) may increase the serum concentration of Tacrolimus (Systemic). Monitor therapy
>10%: Hepatic: Abnormal liver function tests
Frequency not defined:
Gastrointestinal: Nausea, vomiting
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.
• 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.
• Administration: Clotrimazole must be slowly dissolved in the mouth for maximum efficacy.
Consider KOH test or culture prior to treatment to confirm oropharyngeal candidiasis; periodic liver function tests during therapy.
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patients may experience itching, nausea, vomiting, or numbness or tingling in mouth. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: azole antifungals