Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Actavis Pharma, Inc.
HYDROCORTISONE
HYDROCORTISONE 10 mg in 1 g
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.
Hydrocortisone Cream USP, 1% 1 oz (28. 4 g) tube NDC 0472-0321-26 Store at controlled room temperature 15° to 30°C (59° to 86°F). Avoid freezing. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 7/2020
Abbreviated New Drug Application
HYDROCORTISONE- HYDROCORTISONE CREAM ACTAVIS PHARMA, INC. ---------- HYDROCORTISONE CREAM USP, 1% TOPICAL CORTICOSTEROID RX ONLY DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone, USP is included in this class of synthetic corticosteroid. Chemically, hydrocortisone, USP is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11ß)- its molecular formula is C H O ; its molecular weight is 362.46; its Chemical Abstract Service (CAS) registry number is 50-23-7; and its structural formula is: Each gram of Hydrocortisone Cream USP, 1% provides 10 mg of hydrocortisone, USP in a non- staining water washable cream base consisting of stearyl alcohol, glyceryl monostearate, polyoxyl 40 stearate, isopropyl palmitate, paraffin, sorbitan monostearate, glycerin, lactic acid, potassium sorbate and purified water. 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. 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. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION). 21 30 5 Once absorbed through the Baca dokumen lengkap