BETAMETHASONE DIPROPIONATE cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Golden State Medical Supply, Inc.

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Betamethasone dipropionate cream USP, 0.05% 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 USP, 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Produkt oversigt:

Betamethasone Dipropionate Cream USP, 0.05% is supplied in 15 gram (NDC 51407-273-15) and 45 gram (NDC 51407-273-45) tubes. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
GOLDEN STATE MEDICAL SUPPLY, 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, a alog of
prednisolone, has high corticosteroid activity and slight
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 USP, 0.05% contains:
0.64 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
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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.
Betamethasone dipro