BETAMETHASONE VALERATE- betamethasone valerate cream

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)

제공처:

Preferred Pharmaceuticals, Inc.

INN (국제 이름):

BETAMETHASONE VALERATE

구성:

BETAMETHASONE VALERATE 1.2 mg in 1 g

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

제품 요약:

Betamethasone Valerate Cream USP, 0. 1% is supplied in: 15 g (0. 53 oz) tubes - 68788-0597-1 45 g (1. 59 oz) tubes - 68788-0597-4 Manufactured by Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA FORM NO. 0370/0371 VC2795 Rev. 2/06 Repackaged by Preferred Pharmaceuticals, Inc.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM
PREFERRED PHARMACEUTICALS, INC.
----------
BETAMETHASONE VALERATE CREAM, USP 0.1%
BETAMETHASONE VALERATE OINTMENT, USP 0.1%
DESCRIPTION
Betamethasone Valerate Cream and Betamethasone Valerate Ointment
contain Betamethasone Valerate
USP
(9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione
17-valerate); its
empirical formula is C
H FO ; its molecular weight is 476.59 (CAS Registry Number 2152-44-5);
its structural formula is:
Each gram of the 0.1% cream contains 1.2 mg betamethasone valerate
(equivalent to 1.0 mg
betamethasone) in a hydrophilic cream base consisting of purified
water, mineral oil, white petrolatum,
polyethylene glycol 1000 monocetyl ether, cetostearyl alcohol,
monobasic sodium phosphate,
phosphoric acid or sodium hydroxide and 4-chloro-m-cresol as a
preservative. Each gram of the 0.1%
ointment contains 1.2 mg betamethasone valerate (equivalent to 1.0 mg
betamethasone) in an ointment
base consisting of mineral oil, white petrolatum and hydrogenated
lanolin.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions. The
mechanism of anti-inflammatory activity of the topical corticosteroids
is unclear. Various laboratory
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
efficacies of the topical corticosteroids. There is some evidence to
suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic
efficacy in man.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors
including the vehicle, the integrity of the epidermal barrier, and the
use of occlusive dressings. Topical
corticosteroids can be absorbed from normal intact skin. Inflammation
and/or other disease processes in
the skin increase percutaneous absorption. Occlusive dressings
substantially increase the percutaneous
absorption of topical corticosteroids. Thus, occlusive dressin