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Clotrimazole/betamethasone diproprionate: a review of costs and complications in the treatment of common cutaneous fungal infections.

Pediatric dermatology (2002-02-28)
H L Greenberg, Tor A Shwayder, Nella Bieszk, David P Fivenson
ABSTRACT

The use of antifungal/corticosteroid combinations as topical therapy for dermatophytoses has been criticized as being less effective, more expensive, and the cause of more adverse cutaneous reactions than antifungal monotherapy. The combination of clotrimazole and betamethasone diproprionate (Lotrisone) is a mix of an azole antifungal and a high-potency corticosteroid, and is one of the most widely prescribed of these combinations. Our objective was to describe the beneficial and deleterious effects of Lotrisone in the treatment of common cutaneous fungal infections and its relative cost-effectiveness. We did a literature review documenting clinical trial data and adverse reactions to Lotrisone and collected a cost analysis of topical antifungal prescribing data over a 2-month period from a large midwestern staff-model health maintenance organization (HMO). Lotrisone is approved by the U.S. Food and Drug Administration (FDA) for the treatment of tinea pedis, tinea cruris, and tinea corporis in adults and children more than 12 years of age. Treatment is limited to 2 weeks in the groin area and 4 weeks on the feet. The most concerning adverse effects of Lotrisone were reported in children and included treatment failure, striae distensae, hirsuitism, and growth retardation. This combination was also reported to have decreased efficacy in clearing candidal and Trichophyton infections as compared to single-agent antifungals. Lotrisone was considerably more expensive than clotrimazole alone and was found to account for more than 50% of topical antifungal expenditures as prescribed by primary care physicians, but only 7% of topical antifungals prescribed by dermatologists. We found that Lotrisone was shown to have the potential to induce many steroid-related side effects and to be less cost effective than antifungal monotherapy. This combination should be used judiciously in the treatment of cutaneous fungal infections and may not be appropriate for use in children.

MATERIALS
Product Number
Brand
Product Description

Supelco
Clotrimazole, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Clotrimazole
Supelco
Betamethasone, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Betamethasone, ≥98%
Betamethasone, European Pharmacopoeia (EP) Reference Standard
USP
Clotrimazole, United States Pharmacopeia (USP) Reference Standard
Clotrimazole for peak identification, European Pharmacopoeia (EP) Reference Standard
Supelco
Betamethasone, VETRANAL®, analytical standard
Clotrimazole, European Pharmacopoeia (EP) Reference Standard
Supelco
Clotrimazole, VETRANAL®, analytical standard
Sigma-Aldrich
Betamethasone, meets USP testing specifications