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언어: 영어
출처: NLM (National Library of Medicine)
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)
Physicians Total Care, Inc.
CLOTRIMAZOLE
CLOTRIMAZOLE 10 mg in 1 g
TOPICAL
OTC DRUG
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. 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
Clotrimazole Cream USP, 1% is supplied in Store between 2°- 30°C (36°- 86°F). CAUTION: Federal law prohibits dispensing without prescription. Mfd. by: TARO Pharmaceuticals Inc., Bramalea, Ontario, Canada L6T 1C3 Revision Date: June, 1996 Relabeling of "Additional barcode" label by: Physicians Total Care, Inc., Tulsa, OK 74146
Abbreviated New Drug Application
CLOTRIMAZOLE - CLOTRIMAZOLE CREAM PHYSICIANS TOTAL CARE, INC. ---------- FOR EXTERNAL USE ONLY ACTIVE INGREDIENT 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 contains 10 mg clotrimazole. INACTIVE INGREDIENTS Each gram of Clotrimazole Cream is dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, 2-octyldodecanol, purified water, and benzyl alcohol (1%) as preservative. PURPOSE 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. _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 have primary resistance 전체 문서 읽기