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:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Betamethasone Dipropionate

Composition:

Betamethasone Dipropionate 0.64 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 supplied in 15 gram (NDC 51672-1274-1) and 45 gram (NDC 51672-1274-6) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
TARO PHARMACEUTICALS U.S.A., 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 USP, 0.05% contains betamethasone
dipropionate, USP, a synthetic
adrenocorticosteroid, for dermatologic use. Betamethasone, an analog
of prednisolone, has a high
degree of glucocorticoid activity and a slight mineralocorticoid
activity.
Betamethasone dipropionate is the 17, 21-dipropionate ester of
betamethasone.
Betamethasone dipropionate is a white to creamy 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:
MOLECULAR FORMULA C
H FO MOLECULAR WEIG HT OF
504 .6
Each gram of Betamethasone Dipropionate Cream USP, 0.05% contains:
0.643 mg betamethasone
dipropionate USP (equivalent to 0.5 mg betamethasone), in a
hydrophilic emollient cream consisting of
cetomacrogol 1000, cetostearyl alcohol, mineral oil, propylene glycol,
purified water, sodium
phosphate monobasic, white petrolatum, chlorocresol as preservative,
and phosphoric acid and/or
sodium hydroxide for pH adjustment.
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
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corticosteroids are well known, the exact mechanisms of their actions
in each disease are uncertain.
Betamethasone dipropionate, a corticosteroid, has