BETAMETHASONE DIPROPIONATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

Actavis Pharma, Inc.

INN (International Name):

BETAMETHASONE DIPROPIONATE

Composition:

BETAMETHASONE 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. Betamethasone dipropionate cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Product summary:

Betamethasone Dipropionate Cream, USP, 0. 05% is available in: Store between 15° to 30°C (59° to 86°F). Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev.A 9/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
ACTAVIS PHARMA, INC.
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BETAMETHASONE DIPROPIONATE CREAM, USP 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
FOR DERMATOLOGIC USE ONLY –
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Betamethasone dipropionate cream contains betamethasone dipropionate,
USP, a synthetic
adrenocorticosteroid, for dermatologic use. Betamethasone, an analog
of prednisolone, has high
corticosteroid activity and slight mineral-ocorticoid activity.
Betamethasone dipropionate is the 17,21-
dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-Fluoro-11 β,
17,21-trihydroxy-16β-methylpregna-1,4-
diene-3,20-dione 17,21-dipropionate, with the empirical formula C
H FO , a molecular weight of
504.6, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless
crystalline powder, insoluble in
water.
Each gram of betamethasone dipropionate cream 0.05% contains: 0.64 mg
betamethasone dipropionate
USP (equivalent to 0.5 mg betamethasone) in a hydrophilic cream base
consisting of purified water,
mineral oil, white petrolatum, polyethylene glycol 1000 monocetyl
ether, cetostearyl alcohol,
monobasic sodium phosphate, propylene glycol, phosphoric acid and/or
sodium hydroxide for pH
adjustment and chlorocresol as a preservative.
CLINICAL PHARMACOLOGY
The corticosteroids are a class of compounds comprising steroid
hormones, secreted by the adrenal
cortex and their synthetic analogs. In pharmacologic doses
corticosteroids are used primarily for their
anti-inflammatory and/or immunosuppressive effects.
Topical corticosteroids, such as betamethasone dipropionate, are
effective in the treatment of
corticosteroid-responsive dermatoses primarily because of their
anti-inflammatory, antipruritic, and
vasoconstrictive actions. However, while the physiologic,
pharmacologic, and clinical effects of the
corticosteroids are well known, the exact mechanisms of their actions
in each disease are uncertain.
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Betamethasone dipropion