Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)
REMEDYREPACK INC.
TOPICAL
PRESCRIPTION DRUG
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Betamethasone Valerate Cream USP, 0.1% is supplied in 15 gram (NDC 51672-1269-1) and 45 gram (NDC 51672-1269-6) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM REMEDYREPACK INC. ---------- BETAMETHASONE VALERATE CREAM USP, 0.1% RX ONLY FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION Betamethasone Valerate Cream USP, 0.1% contains betamethasone valerate 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 valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17- valerate. The structural formula is: Molecular Formula: C H FO Molecular Weight: 476.59 Each gram of Betamethasone Valerate Cream USP, 0.1% contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of ceteareth-15, cetyl alcohol, mineral oil, polyethylene glycol 1000, propylene glycol, purified water, stearyl alcohol, white petrolatum, phosphoric acid and sodium hydroxide (for pH adjustment); chlorocresol is present as a preservative. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. PHARMACOKINETICS The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammati Baca dokumen lengkap