Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
HYDROCORTISONE BUTYRATE (UNII: 05RMF7YPWN) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Bausch Health US, LLC
HYDROCORTISONE BUTYRATE
HYDROCORTISONE BUTYRATE 1 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Locoid (hydrocortisone butyrate) Solution, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of seborrheic dermatitis. None.
Locoid® (hydrocortisone butyrate) Solution, 0.1% is supplied in polyethylene bottles containing: 60 mL (NDC 16781-391-60)
New Drug Application
LOCOID- HYDROCORTISONE BUTYRATE SOLUTION BAUSCH HEALTH US, LLC ---------- LOCOID (HYDROCORTISONE BUTYRATE) SOLUTION, 0.1% FOR TOPICAL USE ONLY DESCRIPTION Locoid (hydrocortisone butyrate) Solution, 0.1% contains the topical corticosteroid, hydrocortisone butyrate, a nonfluorinated hydrocortisone ester. It has the chemical name: 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the molecular formula: C H O ; the molecular weight: 432.54; and the CAS registry number: 13609-67-1. Its structural formula is: Each mL of Locoid Solution contains 1 mg of hydrocortisone butyrate in a vehicle consisting of anhydrous citric acid, glycerin, isopropyl alcohol (50% v/v), povidone, purified water, and sodium citrate. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic, and vasoconstrictive actions. The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of 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 ® ® 25 36 6 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. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the read_full_document