Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)
Novitium Pharma LLC
TOPICAL
PRESCRIPTION DRUG
Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product 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 fluoccosum, and Microsporum canis . Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Clotrimazole Topical Solution, USP 1% is supplied as follows: NDC 70954-036-20 in 30 mL one bottle in a carton Store at 2° to 30°C (36° to 86°F). Manufactured by: Novitium Pharma LLC 70 Lake Drive East Windsor, New Jersey 08520 LB-4008-01 Revised:12/18
Abbreviated New Drug Application
CLOTRIMAZOLE - CLOTRIMAZOLE TOPICAL SOLUTION NOVITIUM PHARMA LLC ---------- CLOTRIMAZOLE TOPICAL SOLUTION, USP 1% FOR TOPICAL USE ONLY NOT FOR OPTHALMIC USE. THIS PRODUCT IS ALSO AVAILABLE WITHOUT PRESCRIPTION. RX ONLY DESCRIPTION Clotrimazole Topical Solution, USP 1% contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the following structural formula: Molecular Formula C H CIN Molecular Weight 344.85 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 mL of Clotrimazole Topical Solution, USP 1% contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400. 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. _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_. 22 17 2 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 to clotrimazole. No single Soma hati kamili