Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)
NuCare Pharmaceuticals,Inc.
TOPICAL
PRESCRIPTION DRUG
Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . Clotrimazole is also available as a nonprescription item which is 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 . Clotrimazole cream USP is contraindicated in individuals sensitive to its components.
Clotrimazole Cream USP, 1% is supplied in 15 g ( NDC 68071-2315-5) Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CLOTRIMAZOLE- CLOTRIMAZOLE CREAM NUCARE PHARMACEUTICALS,INC. ---------- CLOTRIMAZOLE CREAM USP, 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. RX ONLY DESCRIPTION Clotrimazole Cream USP, 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C H ClN ; a molecular weight of 344.84; and the structural formula: 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 clotrimazole cream USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative. CLINICAL PHARMACOLOGY Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and _Malassezia furfur_. The primary action of clotrimazole is against dividing and growing organisms. 22 17 2 _In vitro_, clotrimazole exhibits fungistatic and fungicidal activity against isolates of _Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,_ _Microsporum canis_ and _Candida_ species including _Candida albicans_. In general, the _in_ _vitro_ activity of clotrimazole corresponds to that of tolnaftate and griseofulvin against the mycelia of dermatophytes ( _Trichophyton_, _Microsporum_, and _Epidermophyton_), and to that of the polyenes (amphotericin B and nystatin) against budding fungi ( _Candida_). Using an _in vivo_ (mouse) and an _in vitro_ (mouse kidney homogenate) testing system, clotrimazole and miconazole were equally effective in preventing the growth of the pseudomycelia and mycelia of _Candida albicans_. Strains of fungi having a natural resistance to clotrimazole are rare. Only a single isolate of _Candida guilliermondi_ has been reported to ha Preberite celoten dokument