BETAMETHASONE VALERATE ointment

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 1 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: 50090-0165 NDC: 50090-0165-0 15 g in a TUBE

Autorisasjon status:

New Drug Application

Preparatomtale

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE OINTMENT
A-S MEDICATION SOLUTIONS
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BETAMETHASONE VALERATE CREAM USP, 0.1%
BETAMETHASONE VALERATE OINTMENT USP, 0.1%
BETAMETHASONE VALERATE LOTION USP, 0.1%
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Betamethasone Valerate Cream, Ointment and Lotion contain
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:
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 (to adjust pH, if required);
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.
Sodium hydroxide is used to adjust pH.
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
clinica