BETAMETHASONE DIPROPIONATE cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

betamethasone dipropionate (UNII: 826Y60901U) (betamethasone - UNII:9842X06Q6M)

Tillgänglig från:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International namn):

betamethasone dipropionate

Sammansättning:

betamethasone 0.5 mg in 1 g

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska 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.

Produktsammanfattning:

Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. E. FOUGERA & CO. A division of fougera PHARMACETICALS INC. Melville, New York 11747 I255I R10/11 #74

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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BETAMETHASONE DIPROPIONATE CREAM USP, 0.05%
BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%
BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
For Dermatologic Use Only
Not for Ophthalmic Use
DESCRIPTION
Betamethasone Dipropionate Cream, Ointment and Lotion contain
betamethasone dipropionate 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 dipropionate is a white to cream white odorless
crystalline powder insoluble in water.
Chemically, it is
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione
17,21-
dipropionate. The structural formula is:
Each gram of the 0.05% Cream contains 0.64 mg betamethasone
dipropionate (equivalent to 0.5 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 0.05% Ointment contains 0.64 mg betamethasone
dipropionate (equivalent to 0.5 mg
betamethasone) in an ointment base of mineral oil and white
petrolatum.
Each gram of the 0.05% Lotion contains 0.64 mg betamethasone
dipropionate (equivalent to 0.5 mg
betamethasone) in a vehicle of isopropyl alcohol and purified 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 to