butenafine Hydrochloride

Butenafine cream is indicated for the topical treatment of the following superficial dermatophytosis: Interdigital tinea pedis (athlete's foot); Tinea corporis (ringworm); Tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans.

Butenafine is a synthetic antifungal agent that is structurally and pharmacologically related to allylamine antifungals. The exact mechanism of action has not been established, but it is suggested that butenafine's antifungal activity is exerted through the alteration of cellular membranes, which results in increased membrane permeability, and growth inhibition.

Butenafine is mainly active against dermatophytes and has superior fungicidal activity against this group of fungi when compared to that of terbinafine, naftifine, tolnaftate, clotrimazole, and bifonazole. It is also active against Candida albicans and this activity is superior to that of terbinafine and naftifine. Butenafine also generates low MICs for Cryptococcus neoformans and Aspergillus spp. as well.

In the treatment of interdigital tinea pedis, Butenafine should be applied twice daily for 7 days or once daily for 4 weeks. Patients with tinea corporis or tinea cruris should apply Butenafine once daily for two weeks. Sufficient Butenafine cream should be applied to cover affected areas and immediately surrounding skin of patients with interdigital tinea pedis, tinea corporis and tinea cruris.

Potential drug interactions between butenafine HCl cream and other drugs have not been evaluated.

Butenafine Hydrochloride is contraindicated in individuals who have known or suspected sensitivity to this cream or any of its components.

Rarely local mild burning or irritation may be experienced. Hypersensitivity reactions may occur.

Pregnancy Category C. As no adequate and well-controlled studies have been conducted, this drug should be used during pregnancy only if clearly needed. It is not known if butenafine HCl is excreted in human milk. Caution should be exercised in prescribing butenafine HCl to a nursing woman.

Butenafine cream is not for ophthalmic, oral, or intravaginal use. This is for external use only. If irritation or sensitivity develops with the use of Butenafine cream, treatment should be discontinued and appropriate therapy instituted.

Overdosage of butenafine HCl in humans has not been reported to date.

Topical Antifungal preparations

Safety and efficacy in pediatric patients below the age of 12 years have not been studied.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.