Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
Versapharm Incorporated
TOPICAL
PRESCRIPTION DRUG
Betamethasone Dipropionate Lotion, USP 0.05% w/w is a medium-potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. Betamethasone Dipropionate Lotion, USP 0.05% w/w is contraindicated in those patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any of the components in these preparation.
Betamethasone Dipropionate Lotion, USP 0.05% w/w is supplied as follows: 60 mL bottles (NDC 61748-475-60) Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. Store in carton until contents are used. Marketed by: VersaPharm Inc. – An Akorn Company Lake Forest, IL 60045 Manufactured by: Hi-Tech Pharmacal Co. Inc. – An Akorn Company Amityville, NY 11701 BDL00N Rev. 02/2018
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE LOTION VERSAPHARM INCORPORATED ---------- BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% W/W (POTENCY EXPRESSED AS BETAMETHASONE) RX ONLY FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE DESCRIPTION Betamethasone Dipropionate Lotion, USP 0.05% w/w 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 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. The structural formula is: Molecular Formula: C H FO Molecular Weight: 504.60 Betamethasone dipropionate is a white to cream white odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Lotion, USP 0.05% w/w contains: 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of isopropyl alcohol, USP (40.0%) and purified water, USP; slightly thickened with carbomer 934P. Sodium hydroxide solution to adjust pH, if 28 37 7 required. 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 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 ef Belgenin tamamını okuyun