Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
H.J. Harkins Company, Inc.
BETAMETHASONE DIPROPIONATE
BETAMETHASONE 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Betamethasone dipropionate cream, 0.05% (augmented) 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 cream, 0.05% (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
Betamethasone dipropionate cream, 0.05% (augmented) is supplied in 15 g (NDC 68462-290-17) and 50 g (NDC 68462-290-52); boxes of one.
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE - BETAMETHASONE DIPROPIONATE CREAM H.J. HARKINS COMPANY, INC. ---------- BETAMETHASONE DIPROPIONATE CREAM, 0.05% (AUGMENTED*) (POTENCY EXPRESSED AS BETAMETHASONE) *Vehicle augments the penetration of the steroid. FOR DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC USE DESCRIPTION Betamethasone dipropionate cream, 0.05% (augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of 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, 0.05% (augmented) contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in an emollient cream base of purified water USP; chlorocresol NF; propylene glycol USP; white petrolatum USP; white wax NF; cyclomethicone NF; sorbitol solution USP; glyceryl oleate/propylene glycol; ceteareth-30; carbomer homopolymer NF; and sodium hydroxide NF. 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. 28 37 7 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 corticosteroids are Lesen Sie das vollständige Dokument