BETAMETHASONE DIPROPIONATE - betamethasone dipropionate gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.

INN (International Name):

BETAMETHASONE DIPROPIONATE

Composition:

BETAMETHASONE .50 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone dipropionate gel (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dose should not exceed 50 g per week because of potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. This product is not recommended for use in pediatric patients under 12 years of age. Betamethasone dipropionate gel (augmented) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Betamethasone Dipropionate Gel, 0.05% (augmented) is supplied as follows: Store between 2° and 25°C (36° and 77°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 I2266C R11/11 #194

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE - BETAMETHASONE DIPROPIONATE GEL
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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BETAMETHASONE DIPROPIONATE GEL, 0.05%
(AUGMENTED*)
(POTENCY EXPRESSED AS BETAMETHASONE)
* VEHICLE AUGMENTS THE PENETRATION OF THE STEROID.
FOR DERMATOLOGICAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Betamethasone dipropionate gel (augmented) contains betamethasone
dipropionate, USP, a syn-thetic
fluorinated corticosteroid for topical dermatologic use. Betamethasone
dipropionate is included in a
class of compounds consisting primarily of synthetic corticosteroids
for use topically as anti-
inflammatory and anti-pruritic agents.
Chemically, betamethasone dipropionate is
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-
diene-3,20-dione 17,21-dipropionate, with the molecular 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 gel (augmented) contains: 0.64
mg betamethasone
dipropionate, USP (equivalent to 0.5 mg betamethasone), in an
augmented gel base of purified water,
propylene glycol, carbomer 940, and sodium hydroxide.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, betamethasone dipropionate has
anti-inflammatory, anti-pruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation, such as
prostaglandins and leukotrienes, by inhibiting
the release of their common pre-cursor, arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors i