CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Clotrimazole and Betamethasone Dipropionate Cream USP contains a combination of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use. Chemically, clotrimazole is 1-( o -chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C 22 H 17 ClN 2 , a molecular weight of 344 . 84, and the following structural formula: Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate has the chemical name 9-fluoro-11(,17,21-trihydroxy-16(-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504 . 59, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Clotrimazole and Betamethasone Dipropionate Cream contains 10 mg clotrimazole and 0 . 643 mg betamethasone dipropionate (equivalent to 0 . 5 mg betamethasone), in a hydrophilic cream. INACTIVE INGREDIENTS Cetereath-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol and white petrolatum; benzyl alcohol as preservative. Clotrimazole and betamethasone dipropionate cream is smooth, uniform, and white to off-white in color. T:\Maryland\Published\Semi-Solids\Clotrimazole and Betamethasone Dipropionate Cream USP Rev.4-08\formula1.jpg T:\Maryland\Published\Semi-Solids\Clotrimazole and Betamethasone Dipropionate Cream USP Rev.4-08\formula2.jpg

Clotrimazole and Betamethasone Dipropionate Cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum . Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis ) has not been established. Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported

Gently massage sufficient clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day, in the morning and evening. Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea corporis or tinea cruris shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Clotrimazole and betamethasone dipropionate cream should not be used longer than 4 weeks in the treatment of tinea pedis and amounts greater than 45 g per week of clotrimazole and betamethasone dipropionate cream should not be used. If a patient with tinea pedis shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Clotrimazole and betamethasone dipropionate cream should not be used with occlusive dressings.

Clotrimazole and betamethasone dipropionate cream is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in these preparations.

Adverse reactions reported for clotrimazole and betamethasone dipropionate cream in clinical trials were paresthesia in 1 . 9% of patients, and rash, edema, and secondary infection, each in less than 1% of patients. The following local adverse reactions have been reported with topical corticosteroids and may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), and sensitization (local reactions upon repeated application of product). In the pediatric population, reported adverse events for clotrimazole and betamethasone dipropionate cream include growth retardation, benign intracranial hypertension, Cushing’s syndrome (HPA axis suppression), and local cutaneous reactions, including skin atrophy. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Adverse reactions reported with the use of clotrimazole are as follows: erythema, stinging, blistering, peeling, edema, pruritus, urticaria and general irritation of the skin.