国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
Golden State Medical Supply, Inc.
TOPICAL
PRESCRIPTION DRUG
Betamethasone dipropionate cream USP, 0.05% 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 USP, 0.05% 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 51407-273-15) and 45 gram (NDC 51407-273-45) tubes. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM GOLDEN STATE MEDICAL SUPPLY, 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, a alog 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-11β,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 USP, 0.05% contains: 0.64 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 28 37 7 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 阅读完整的文件