MENTAX- butenafine hydrochloride cream

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

BUTENAFINE HYDROCHLORIDE (UNII: R8XA2029ZI) (BUTENAFINE - UNII:91Y494NL0X)

Dostępny od:

Mylan Pharmaceuticals Inc.

INN (International Nazwa):

BUTENAFINE HYDROCHLORIDE

Skład:

BUTENAFINE HYDROCHLORIDE 10 mg in 1 g

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

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

Status autoryzacji:

New Drug Application

Charakterystyka produktu

MENTAX- BUTENAFINE HYDROCHLORIDE CREAM
MYLAN PHARMACEUTICALS INC.
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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.