BETAMETHASONE DIPROPIONATE ointment

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 ointment 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 ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.

Product summary:

Betamethasone dipropionate ointment, USP 0. 05% is available in: Store between 15° to 30°C (59° to 86°F). Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. B 2/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT
ACTAVIS PHARMA, INC.
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BETAMETHASONE DIPROPIONATE OINTMENT , USP 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
FOR DERMATOLOGIC USE ONLY –
NOT FOR OPHTHALMIC USE
DESCRIPTION
Betamethasone dipropionate ointment contains betamethasone
dipropionate, USP, a
synthetic adrenocorticosteroid, for dermatologic use. Betamethasone,
an analog 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-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 ointment 0.05% contains: 0.64
mg
betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone)
in an ointment
base consisting of mineral oil and white petrolatum.
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-
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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 dipropionate,
a corticosteroid, has been shown to have topical (dermatologic) and
systemic
pharmacologic and metabolic effects characteristic of this class of
drugs.
PHARMACOKINETICS: The extent of percutaneous absorpti