Betamethasone dipropionate and Clotrimazole

Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.

Clotrimazole is an azole antifungal. Betamethasone dipropionate is a corticosteroid. Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation, however, the precise mechanism of action for the treatment of tinea pedis, tinea cruris and tinea corporis is unknown.

Treatment of tinea corporis or tinea cruris: • Apply a thin film of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) into the affected skin areas twice a day for one week. • Do not use more than 45 grams per week. Do not use with occlusive dressings. • If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base), the diagnosis should be reviewed. • Do not use longer than 2 weeks. Treatment of tinea pedis: • Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) into the affected skin areas twice a day for two weeks. • Do not use more than 45 grams per week. Do not use with occlusive dressings.

None. • None.

• Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of the treatment. Risk factor(s) are: use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop. • Pediatric patients may be more susceptible to systemic toxicity. • The use of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) in the treatment of diaper dermatitis is not recommended. • Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist.

Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients.

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).