BETAMETHASONE DIPROPIONATE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

A-S Medication Solutions

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Product: 50090-1839 NDC: 50090-1839-0 45 g in a TUBE / 1 in a CARTON

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
A-S MEDICATION SOLUTIONS
----------
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
28
37
7
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.
Betamethasone dipro