BETAMETHASONE DIPROPIONATE- betamethasone dipropionate ointment

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Preferred Pharmaceuticals Inc.

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

Betamethasone Dipropionate Ointment USP, 0.05% is supplied as follows: 45 g tubes NDC 68788-6947-4 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 I255J R07/12 #74 Relabeled By: Preferred Pharmaceuticals Inc.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT
PREFERRED PHARMACEUTICALS INC.
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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
(monohydrate); chlorocresol is present as a preservative. Sodium
hydroxide or phosphoric acid
solution to adjust pH, if required.
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. Sodium hydroxide solution to adjust pH, if required.
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 efficac