Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
HYDROCORTISONE BUTYRATE (UNII: 05RMF7YPWN) (HYDROCORTISONE BUTYRATE - UNII:05RMF7YPWN)
Rebel Distributors Corp
TOPICAL
PRESCRIPTION DRUG
Hydrocortisone butyrate cream USP, 0.1% is 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 Butyrate Cream, USP, 0.1% is supplied in tubes containing: 15 g NDC 21695-971-15
New Drug Application
HYDROCORTISONE BUTYRATE- HYDROCORTISONE BUTYRATE CREAM REBEL DISTRIBUTORS CORP ---------- HYDROCORTISONE BUTYRATE CREAM, USP, 0.1% FOR DERMATOLOGICAL USE ONLY DESCRIPTION Hydrocortisone Butyrate Cream USP, 0.1% contains the topical corticosteroid hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: pregn-4-ene-3,20-dione, 11,21 - dihydroxy-17-[(1-oxobutyl)oxy]-, (11β-); the molecular formula: C H O ; the molecular weight: 432.54; and the CAS registry number: 13609-67-1. Its structural formula is: Each gram of hydrocortisone butyrate cream USP, 0.1% contains 1.0 mg of hydrocortisone butyrate in a hydrophilic base consisting of cetostearyl alcohol, ceteth-20, mineral oil, white petrolatum, citric acid, sodium citrate, propylparaben and butylparaben (preservatives) 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.) Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to Belgenin tamamını okuyun