País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
BUTENAFINE HYDROCHLORIDE (UNII: R8XA2029ZI) (BUTENAFINE - UNII:91Y494NL0X)
Mylan Pharmaceuticals Inc.
BUTENAFINE HYDROCHLORIDE
BUTENAFINE HYDROCHLORIDE 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Mentax® (butenafine HCl) Cream, 1% is indicated for the topical treatment of the dermatologic infection, tinea (pityriasis) versicolor due to M. furfur (formerly P. orbiculare). Butenafine HCl cream was not studied in immunocompromised patients. (See DOSAGE AND ADMINISTRATION.) Mentax® (butenafine HCl) Cream, 1%, is contraindicated in individuals who have known or suspected sensitivity to Mentax® Cream, 1%, or any of its components.
Mentax® (butenafine HCl) Cream, 1%, is supplied in tubes in the following sizes: 15-gram tube (NDC 0378-6151-46) 30-gram tube (NDC 0378-6151-49) STORE BETWEEN 5° and 30°C (41° and 86°F). Keep this and all medications out of the reach of children. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 6/2018 029.8 MENTAX:R8
New Drug Application
MENTAX- BUTENAFINE HYDROCHLORIDE CREAM MYLAN PHARMACEUTICALS INC. ---------- DESCRIPTION Mentax Cream, 1%, contains the synthetic antifungal agent, butenafine hydrochloride. Butenafine is a member of the class of antifungal compounds known as benzylamines which are structurally related to the allylamines. Butenafine HCl is designated chemically as N-4-_tert_-butylbenzyl-N-methyl-1-naphthalenemethylamine hydrochloride. The compound has the molecular formula C H N•HCl, a molecular weight of 353.93, and the following structural formula: Butenafine HCl is a white, odorless, crystalline powder. It is freely soluble in methanol, ethanol, and chloroform, and slightly soluble in water. Each gram of Mentax Cream, 1%, contains 10 mg of butenafine HCl in a white cream base of purified water USP, propylene glycol dicaprylate, glycerin USP, cetyl alcohol NF, glyceryl monostearate SE, white petrolatum USP, stearic acid NF, polyoxyethylene (23) cetyl ether, benzyl alcohol NF, diethanolamine NF, and sodium benzoate NF. CLINICAL PHARMACOLOGY PHARMACOKINETICS In one study conducted in healthy subjects for 14 days, 6 grams of Mentax Cream, 1%, was applied once daily to the dorsal skin (3,000 cm ) of 7 subjects, and 20 grams of the cream was applied once daily to the arms, trunk and groin areas (10,000 cm ) of another 12 subjects. After 14 days of topical applications, the 6-gram dose group yielded a mean peak plasma butenafine HCl concentration, Cmax of 1.4 ± 0.8 ng/mL, occurring at a mean time to the peak plasma concentration, Tmax, of 15 ± 8 hours, and a mean area under the plasma concentration-time curve, AUC of 23.9 ± 11.3 ng-hr/mL. For the 20- gram dose group, the mean Cmax was 5.0 ± 2.0 ng/mL, occurring at a mean Tmax of 6 ± 6 hours, and the mean AUC was 87.8 ± 45.3 ng-hr/mL. A biphasic decline of plasma butenafine HCl concentrations was observed with the half-lives estimated to be 35 hours and > 150 hours, respectively. At 72 hours after the last dose application, the mean plasma concentrations decreased to 0.3 ± 0. Leia o documento completo