BETAMETHASONE VALERATE cream

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Betamethasone Valerate (UNII: 9IFA5XM7R2) (Betamethasone - UNII:9842X06Q6M)

Disponível em:

Taro Pharmaceuticals U.S.A., Inc.

DCI (Denominação Comum Internacional):

Betamethasone Valerate

Composição:

Betamethasone 1 mg in 1 g

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

Betamethasone Valerate Cream USP, 0.1% is supplied in 15 gram (NDC 51672-1269-1) and 45 gram (NDC 51672-1269-6) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM
TARO PHARMACEUTICALS U.S.A., INC.
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BETAMETHASONE VALERATE
CREAM USP, 0.1%
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Betamethasone Valerate Cream USP, 0.1% contains betamethasone valerate
USP, a synthetic
adrenocorticosteroid for dermatologic use. Betamethasone, an analog of
prednisolone, has a high
degree of glucocorticoid activity and a slight degree of
mineralocorticoid activity.
Betamethasone valerate is a white to practically white odorless
crystalline powder practically insoluble
in water, freely soluble in acetone and chloroform, soluble in
alcohol, and slightly soluble in benzene
and ether. Chemically it is
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione
17-
valerate. The structural formula is:
Molecular Formula: C
H FO
Molecular Weight: 476.59
Each gram of Betamethasone Valerate Cream USP, 0.1% contains 1.2 mg
betamethasone valerate
(equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream
of ceteareth-15, cetyl alcohol,
mineral oil, polyethylene glycol 1000, propylene glycol, purified
water, stearyl alcohol, white
petrolatum, phosphoric acid and sodium hydroxide (for pH adjustment);
chlorocresol is present as a
preservative.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic 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