Country: United States
Language: English
Source: NLM (National Library of Medicine)
betamethasone dipropionate (UNII: 826Y60901U) (betamethasone - UNII:9842X06Q6M)
Warrick Pharmaceuticals Corporation
betamethasone dipropionate
OINTMENT
0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Augmented Betamethasone Dipropionate Ointment is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Augmented Betamethasone Dipropionate Ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
Augmented Betamethasone Dipropionate Ointment 0.05% is supplied in 15-g (NDC 59930-1575-1) and 50-g (NDC 59930-1575-3) tubes; boxes of one. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT WARRICK PHARMACEUTICALS CORPORATION ---------- AUGMENTED BETAMETHASONE DIPROPIONATE OINTMENT 0.05% (POTENCY EXPRESSED AS BETAMETHASONE) FOR DERMATOLOGIC USE ONLY– NOT FOR OPHTHALMIC USE PRODUCT INFORMATION DESCRIPTION Augmented Betamethasone Dipropionate Ointment contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. 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-methyl-pregna-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 Augmented Betamethasone Dipropionate Ointment 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in ACTIBASE , an optimized vehicle of propylene glycol; propylene glycol stearate (55% monoester); white wax; 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-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. * 28 37 7 ® Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic Read the complete document