Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
hydrocortisone (UNII: WI4X0X7BPJ) (hydrocortisone - UNII:WI4X0X7BPJ)
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
hydrocortisone
hydrocortisone 25 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, 2.5% Hydrocortisone Ointment USP, 2.5% a white cream is available as follows: a white ointment is available as follows: NDC 0168-0080-31 30 g tubes NDC 0168-0146-30 28.35 g (1 oz) tubes NDC 0168-0080-16 453.6 g (1 Lb) jars NDC 0168-0146-16 453.6 g (1 Lb) jars Store at controlled room temperature 15° to 30°C (59° to 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46165000A R06/15 #145
Abbreviated New Drug Application
HYDROCORTISONE- HYDROCORTISONE OINTMENT HYDROCORTISONE- HYDROCORTISONE CREAM E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5% FOR DERMATOLOGICAL USE ONLY NOT FOR OPHTHALMIC USE RX ONLY DESCRIPTION: The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone cream USP, 2.5% and hydrocortisone ointment USP, 2.5% contain hydrocortisone, USP. Hydrocortisone, USP is a white to practically white crystalline powder. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-, (11β)-. The structural formula of hydrocortisone is: Each gram of the 2.5% cream contains 25 mg of hydrocortisone, USP in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water. Each gram of the 2.5% ointment contains 25 mg of hydrocortisone, USP in a base of white petrolatum and mineral oil. 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 o Belgenin tamamını okuyun