Clotrimazole

INDICATIONS AND USAGE Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton floccosum , and Microsporum canis.

DOSAGE AND ADMINISTRATION Gently massage sufficient clotrimazole cream into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritis, usually occurs within the first week of treatment with clotrimazole cream. If the patient shows no clinical improvement after four weeks of treatment with clotrimazole cream, the diagnosis should be reviewed.

WARNINGS Clotrimazole cream is not for ophthalmic use.

CONTRAINDICATIONS Clotrimazole cream is contraindicated in individuals sensitive to its components.

Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.

Usage in Pregnancy: Pregnancy Category B The disposition of 14 C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans. (See CLINICAL PHARMACOLOGY ) In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole. High oral doses of clotrimazole in rats and mice ranging from 50 to 120 mg/kg resulted in embroyotoxicity (possible secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning. However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively. Oral absorption in the rat amounts to approximately 90% of the administered dose. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.

Nursing Mothers It is not known whether this drug is excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.

ADVERSE REACTIONS The following adverse reactions have been reported in connection with the use of this product: erythema, stinging, blistering, peeling, edema, pruritis, urticaria, burning, and general irritation of the skin.