BETAMETHASONE VALERATE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

STAT RX USA LLC

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Produkt oppsummering:

Store at controlled room temperature 15° - 30°C (59° - 86°F). E. FOUGERA and CO. A division of Nycomed US Inc. Melville, NY 11747 I240D R12/07 #57

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BETAMETHASONE VALERATE - BETAMETHASONE VALERATE CREAM
STAT RX USA LLC
----------
RX ONLY
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION
Betamethasone Valerate Cream, Ointment and Lotion contain
betamethasone valerate USP, a synthetic
adrenocortico-steroid 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:
Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate
(equivalent to 1 mg
betamethasone) in a soft, white, hydrophilic cream of purified water,
mineral oil, white petrolatum,
polyethylene glycol 1000 monocetyl ether, cetostearyl alcohol,
monobasic sodium phosphate and
phosphoric acid or sodium hydroxide; chlorocresol is present as a
preservative.
Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate
(equivalent to 1 mg
betamethasone) in an ointment base of white petrolatum and mineral
oil.
Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate
(equivalent to 1 mg
betamethasone) in a vehicle of isopropyl alcohol and water slightly
thickened with carbomer 934P.
Phosphoric acid or sodium hydroxide is used to adjust pH.
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