Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)
Padagis Israel Pharmaceuticals Ltd
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 Dipropionate Ointment USP, 0.05% is supplied as follows: 15 g tubes NDC 45802-505-14 45 g tubes NDC 45802-505-84 Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. Made in Israel Manufactured By Padagis Yeruham, Israel Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 08-21 65M00 RC J1
Abbreviated New Drug Application
BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- 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 a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4- diene-3,20-dione 17,21- dipropionate. The structural formula is: Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic 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 (See DOSAGE AND ADMINISTRATION). 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. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (See DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled t Lesen Sie das vollständige Dokument