Lotrimin cream 1%

LOTRIMIN products contain clotrimazole, USP, a synthetic antifungal agent having the chemical name 1-( o -Chloro-(alpha),(alpha)-diphenylbenzyl)imidazole; the empirical formula, C 22 H 17 CIN 2 ; a molecular weight of 344.84; and the chemical structure:

Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether, and very soluble in polyethylene glycol 400, ethanol, and chloroform.

Each gram of LOTRIMIN Cream contains 10 mg clotrimazole, USP in a vanishing cream base of benzyl alcohol NF (1%), cetearyl alcohol 70/30 (10%), cetyl esters wax NF, octyldodecanol NF, polysorbate 60 NF, sorbitan monostearate NF, and purified water USP.

Each gram of LOTRIMIN Lotion contains 10 mg clotrimazole, USP dispersed in an emulsion vehicle composed of benzyl alcohol NF (1%), cetearyl alcohol 70/30 (3.7%), cetyl esters wax NF, octyldodecanol NF, polysorbate 60 NF, sodium phosphate dibasic anhydrous R, sodium phosphate monobasic monohydrate USP, sorbitan monostearate NF, and purified water USP.

Each mL of LOTRIMIN Topical Solution contains 10 mg clotrimazole, USP in a nonaqueous vehicle of PEG 400 NF.

Prescription LOTRIMIN (clotrimazole cream, lotion, and solution 1%) products are indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur.

These formulations are also available as the LOTRIMIN AF (clotrimazole cream, lotion, and solution 1%) line of nonprescription products which are 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.

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

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 no mutagenic effect.

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 embryotoxicity (possibly 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. Because many drugs are 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.

Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.

LOTRIMIN Cream 1% is supplied in 15, 30, and 45-g tubes (NDC 0085-0613-02, 05, 04, respectively); boxes of one.

Store between 2° and 30°C (36° and 86°F).

LOTRIMIN Lotion 1% is supplied in 30-mL bottles (NDC 0085-0707-02); boxes of one.

Store between 2° and 25°C (36° and 77°F).

Shake well before using.

LOTRIMIN Topical Solution 1% is supplied in 10-mL and 30-mL plastic bottles (NDC 0085-0182-02, 04, respectively); boxes of one.

Store between 2° and 30°C (36° and 86°F).

Schering Corporation

Kenilworth, NJ 07033 USA

Rev. 1/99            17981013

                         22592203T

Copyright © 1984, 1991, 1993, 1994, 1999, Schering Corporation. All rights reserved.