BETAMETHASONE VALERATE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Rebel Distributors Corp.

INN (International Name):

Betamethasone Valerate

Sammensetning:

Betamethasone Valerate 1 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Betamethasone valerate cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Betamethasone valerate cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Produkt oppsummering:

Betamethasone Valerate Cream USP, 0.1% is supplied in 15 gram (NDC 21695-583-15) and 45 gram (NDC 21695-584-45) tubes. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM
REBEL DISTRIBUTORS CORP.
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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 a topical
corticosteroid, betamethasone valerate.
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and antipruritic agents.
Betamethasone valerate is chemically designated as Pregna-1,
4-diene-3, 20-dione, 9-fluoro-11, 21-
dihydroxy-16-methyl-17 [(1-oxopentyl) oxy], (11β, 16β)-.
MF:
C
H FO
MW: 476.58
Each gram of Betamethasone Valerate Cream USP, 0.1% contains: 1.2 mg
betamethasone valerate USP
(equivalent to 1.0 mg betamethasone) with mineral oil, white
petrolatum, ceteth-20, cetyl alcohol,
stearyl alcohol, propylene glycol, phosphoric acid, sodium phosphate
monobasic, sodium hydroxide,
purified water and 4-chloro-m-cresol as a preservative.
CLINICAL PHARMACOLOGY
Betamethasone valerate cream as a topical corticosteroid has
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.
Betamethasone valerate cream 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 dressings may be a
valuable therapeutic adjunct for treatment of resistant de