Country: United States
Language: English
Source: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.
BETAMETHASONE DIPROPIONATE
BETAMETHASONE .50 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE - BETAMETHASONE DIPROPIONATE GEL E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- 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 Read the complete document