BETAMETHASONE VALERATE- betamethasone valerate cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

A-S Medication Solutions

INN (International Name):

BETAMETHASONE VALERATE

Sammensetning:

BETAMETHASONE VALERATE 1.2 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Product: 50090-0237 NDC: 50090-0237-0 15 g in a TUBE

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM
A-S MEDICATION SOLUTIONS
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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 absorption.
Occlusive dressings substantially
increase the pe