BETAMETHASONE VALERATE cream BETAMETHASONE VALERATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

BETAMETHASONE VALERATE

Composition:

BETAMETHASONE VALERATE 1.2 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Betamethasone Valerate Cream USP, 0. 1% is supplied in: 15 g (0. 53 oz) tubes NDC 0472-0370-15 45 g (1. 59 oz) tubes NDC 0472-0370-45 Betamethasone Valerate Ointment USP, 0. 1% is supplied in: 15 g (0. 53 oz) tubes NDC 0472-0371-15 45 g (1. 59 oz) tubes NDC 0472-0371-45 Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised –  November 2016 I600-5531/34 GW7148

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM
BETAMETHASONE VALERATE- BETAMETHASONE VALERATE OINTMENT
ACTAVIS PHARMA, INC.
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BETAMETHASONE VALERATE CREAM USP, 0.1%
BETAMETHASONE VALERATE OINTMENT USP, 0.1%
FOR EXTERNAL USE ONLY – NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Betamethasone Valerate Cream, USP and Betamethasone Valerate Ointment,
USP contain betamethasone
valerate, USP
(9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione
17-valerate); its
molecular 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,
USP (equivalent to 1.0 mg
betamethasone) in a hydrophilic cream base consisting of purified
water, mineral oil, white petrolatum,
polyethylene glycol 1,000 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, USP (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 absorptio