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

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: 50090-1647 NDC: 50090-1647-0 15 g in a TUBE / 1 in a CARTON

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%
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.
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37
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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 s