Clotrimazole

Prescription

Brand names: Clotrimazole

Dosage Form

Tablet

Route

ORAL

Manufacturer

Hikma Pharmacuticals USA USA Inc.

About This Medication

DESCRIPTION Each Clotrimazole Troche (lozenge) USP contains 10 mg clotrimazole USP [1-(o-chloro-α,α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth. Structural Formula: C 22 H 17 ClN 2 The troche dosage form is a large, slowly dissolving tablet (lozenge) containing 10 mg of clotrimazole USP dispersed in croscarmellose sodium, dextrates, magnesium stearate, microcrystalline cellulose and povidone. chemical structure.jpg

Active Ingredients

Ingredient	Strength
Clotrimazole	-

Indications & Usage

INDICATIONS AND USAGE Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole is also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION .)

Dosage & Administration

DOSAGE AND ADMINISTRATION Clotrimazole is administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible. For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation, the recommended dose is one troche three times daily for the duration of chemotherapy or until steroids are reduced to maintenance levels.

Side Effects Overview

ADVERSE REACTIONS Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials (See PRECAUTIONS ). Nausea, vomiting, unpleasant mouth sensations and pruritus have also been reported with the use of the troche.

Warnings & Precautions

WARNING Clotrimazole is not indicated for the treatment of systemic mycoses including systemic candidiasis.

Contraindications

CONTRAINDICATIONS Clotrimazole is contraindicated in patients who are hypersensitive to any of its components.

Frequently Asked Questions

INDICATIONS AND USAGE Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole is also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product …

DOSAGE AND ADMINISTRATION Clotrimazole is administered only as a lozenge that must be slowly dissolved in the mouth. The recommended dose is one troche five times a day for fourteen consecutive days. Only limited data are available on the safety and effectiveness of the clotrimazole troche after prolonged administration; therefore, therapy should be limited to short term use, if possible. For prophylaxis to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid …

WARNING Clotrimazole is not indicated for the treatment of systemic mycoses including systemic candidiasis.

CONTRAINDICATIONS Clotrimazole is contraindicated in patients who are hypersensitive to any of its components.

Clotrimazole is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Clotrimazole drug label (National Library of Medicine)
• openFDA — Clotrimazole label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 309371 (NLM Normalized Drug Names)
• NDC Directory — Clotrimazole (FDA National Drug Code)

Medical Disclaimer

The information on this page is intended for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.

Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.

Data sources: DailyMed (NLM), openFDA, MFDS