Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65), BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
Proficient Rx LP
CLOTRIMAZOLE
CLOTRIMAZOLE 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Clotrimazole and Betamethasone Dipropionate Cream is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum . Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of clotrimazole and betamethasone dipropionate cream for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis ) has not been established. Several cases of treatment failure of clotrimazole and betamethasone dipropionate cream in the treatment of infections caused by Microsporum canis have been reported Clotrimazole and betamethasone dipropionate cream is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or i
Clotrimazole and Betamethasone Dipropionate Cream USP is supplied as follows: 15 gram tube in a carton (NDC 63187-095-15) 45 gram tube in a carton (NDC 63187-095-45) Store at 25°C (77(F); excursions permitted to 15(-30(C (59(-86(F) [See USP Controlled Room Temperature]. Manufactured by Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA FORM NO. 0379 Rev. 9/08 VC3206 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320
Abbreviated New Drug Application
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE- CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM PROFICIENT RX LP ---------- CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM USP RX ONLY FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS. DESCRIPTION Clotrimazole and Betamethasone Dipropionate Cream USP contains a combination of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use. Chemically, clotrimazole is 1-(_o_-chloro-α,α-diphenylbenzyl) imidazole, with the empirical formula C H ClN , a molecular weight of 344.84, and the following structural formula: Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate has the chemical name 9-fluoro-11(,17,21-trihydroxy-16(- methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C H FO , a molecular weight of 504.59, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. 22 17 2 28 37 7 insoluble in water. Each gram of Clotrimazole and Betamethasone Dipropionate Cream contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic cream. INACTIVE INGREDIENTS Cetereath-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, stearyl alcohol and white petrolatum; benzyl alcohol as preservative. Clotrimazole and betamethasone dipropionate cream is smooth, uniform, and white to off-white in color. CLINICAL PHARMACOLOGY CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Clotrimazole and betamethasone dipropionate cream has been shown to be at least as effective as clotrimazole alone in a different cream vehicle. Use of corticosteroids in the treatment of fungal infection may lead to suppression of host inflammation leading to সম্পূর্ণ নথি পড়ুন