Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
betamethasone dipropionate (UNII: 826Y60901U) (betamethasone dipropionate - UNII:826Y60901U)
Physicians Total Care, Inc.
betamethasone dipropionate
betamethasone dipropionate 0.64 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Betamethasone dipropionate lotion (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. The total dose should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Betamethasone dipropionate lotion (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.
Betamethasone Dipropionate Lotion USP 0.05% (Augmented) is supplied as follows: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)[see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 I2267A R1/08 #105 Relabeling (Additional barcode label) by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE AUGMENTED- BETAMETHASONE DIPROPIONATE LOTION PHYSICIANS TOTAL CARE, INC. ---------- BETAMETHASONE DIPROPIONATE LOTION USP 0.05% (AUGMENTED*) (POTENCY EXPRESSED AS BETAMETHASONE) * VEHICLE AUGMENTS THE PENETRATION OF THE STEROID. FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE RX ONLY DESCRIPTION Betamethasone Dipropionate Lotion USP 0.05% (Augmented) 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-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: It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. Each gram of Betamethasone Dipropionate Lotion USP 0.05% (Augmented) contains 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in an augmented lotion base of purified water; isopropyl alcohol (30%); hydroxypropyl cellulose; propylene glycol; monobasic sodium phosphate and phosphoric acid used to adjust the pH. 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 28 3 Lees het volledige document