BETAMETHASONE VALERATE cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

REMEDYREPACK INC.

INN (International Name):

BETAMETHASONE VALERATE

Sammensætning:

BETAMETHASONE 1 mg in 1 g

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 oversigt:

Betamethasone Valerate Cream USP, 0.1% NDC: 70518-0721-00 NDC: 70518-0721-01 PACKAGING: 15 g in 1 TUBE, TYPE 0 PACKAGING: 45 g in 1 TUBE, TYPE 0 Store at room temperature 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorisation status:

New Drug Application

Produktets egenskaber

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM
REMEDYREPACK INC.
----------
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, polyoxyl 20 cetostearyl 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 clinical efficacies of the t