Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
Actavis Pharma, Inc.
BETAMETHASONE DIPROPIONATE
BETAMETHASONE 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Betamethasone dipropionate ointment 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 ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.
Betamethasone dipropionate ointment, USP 0. 05% is available in: Store between 15° to 30°C (59° to 86°F). Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. B 2/2023
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT ACTAVIS PHARMA, INC. ---------- BETAMETHASONE DIPROPIONATE OINTMENT , USP 0.05% (POTENCY EXPRESSED AS BETAMETHASONE) RX ONLY FOR DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC USE DESCRIPTION Betamethasone dipropionate ointment contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog 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-11 β, 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 ointment 0.05% contains: 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an ointment base consisting of mineral oil and white petrolatum. 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- 28 37 7 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 dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. PHARMACOKINETICS: The extent of percutaneous absorpti Lees het volledige document