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:

H.J. Harkins Company, 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, 0.05% (augmented) is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. Betamethasone dipropionate cream, 0.05% (augmented) 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, 0.05% (augmented) is supplied in 15 g (NDC 68462-290-17) and 50 g (NDC 68462-290-52); boxes of one.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE - BETAMETHASONE DIPROPIONATE CREAM
H.J. HARKINS COMPANY, INC.
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BETAMETHASONE DIPROPIONATE CREAM, 0.05% (AUGMENTED*)
(POTENCY EXPRESSED AS BETAMETHASONE)
*Vehicle augments the penetration of the steroid.
FOR DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC USE
DESCRIPTION
Betamethasone dipropionate cream, 0.05% (augmented) contains
betamethasone dipropionate, USP, a
synthetic adrenocorticosteroid, for dermatologic use in an emollient
base. Betamethasone, an analog of
prednisolone, has a high degree of corticosteroid activity and a
slight degree of mineralocorticoid
activity. Betamethasone dipropionate is the 17, 21-dipropionate ester
of betamethasone.
Chemically, betamethasone dipropionate is
9-fluoro-11β,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% (augmented)
contains: 0.643 mg betamethasone
dipropionate USP (equivalent to 0.5 mg betamethasone) in an emollient
cream base of purified water
USP; chlorocresol NF; propylene glycol USP; white petrolatum USP;
white wax NF; cyclomethicone
NF; sorbitol solution USP; glyceryl oleate/propylene glycol;
ceteareth-30; carbomer homopolymer NF;
and sodium hydroxide NF.
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.
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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