Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
Betamethasone Dipropionate (UNII: 826Y60901U) (Betamethasone - UNII:9842X06Q6M)
Taro Pharmaceuticals U.S.A., Inc.
Betamethasone Dipropionate
Betamethasone Dipropionate 0.64 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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.
Betamethasone Dipropionate Cream USP, 0.05% is supplied in 15 gram (NDC 51672-1274-1) and 45 gram (NDC 51672-1274-6) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM TARO PHARMACEUTICALS U.S.A., INC. ---------- 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, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is: MOLECULAR FORMULA C H FO MOLECULAR WEIG HT OF 504 .6 Each gram of Betamethasone Dipropionate Cream USP, 0.05% contains: 0.643 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 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 28 37 7 corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has Lees het volledige document