CLOTRIMAZOLE- clotrimazole_cream

Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur In vitro Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis Candida Candida albicans in vitro Trichophyton Microsporum Epidermophyton Candida in vivo in vitro Candida albicans Strains of fungi having a natural resistance to clotrimazole are rare. Only a single isolate of Candida guilliermondi No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans Trichophyton mentagrophytes C. albicans, C. krusei, C. pseudotropicalis C. albicans C. albicans C. albicans In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. Both these events began rapidly and extensively after addition of the drug. Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites. Following topical and vaginal administration, however, clotrimazole appears to be minimally absorbed. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm 3 3 3 Following intravaginal administration of 100 mg 14 14

Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans 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, Microsporum canis

Gently massage sufficient Clotrimazole Cream USP, 1% into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritus, 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.

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

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

Usage in Pregnancy
The disposition of 14 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 their first trimester of pregnancy. Studies in pregnant rats with intravaginal High oral not Because animal reproductive 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.
Pediatric Use
Safety and effectiveness in children have been established for clotrimazole when used as indicated and in the recommended dosage.

Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans

WARNINGS
Clotrimazole cream USP is not for ophthalmic use.
Carcinogenesis,Mutagenesis, Impairment of Fertility
An 18-month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect. In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes during the metaphase. Prior to testing, the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight. The results of this study showed that clotrimazole had not mutagenic effect.
OVERDOSAGE
Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.

Sun Pharmaceutical Industries, Inc.

CLOTRIMAZOLE- clotrimazole_cream Product manual source documgent