国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
HALCINONIDE (UNII: SI86V6QNEG) (HALCINONIDE - UNII:SI86V6QNEG)
Glasshouse Pharmaceuticals Limited Canada
TOPICAL
PRESCRIPTION DRUG
Halcinonide 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 preparations.
Halcinonide Cream USP, 0.1% is supplied as: NDC 71428-011-30 Tubes containing 30 g of cream NDC 71428-011-60 Tubes containing 60 g of cream Store at room temperature; avoid excessive heat (104° F).
Abbreviated New Drug Application
HALCINONIDE- HALCINONIDE CREAM GLASSHOUSE PHARMACEUTICALS LIMITED CANADA ---------- HALCINONIDE CREAM USP, 0.1% For Topical Use Only. Not for Ophthalmic, Oral or Intravaginal Use. DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti- inflammatory and antipruritic agents. The steroids in this class include halcinonide. Halcinonide is designated chemically as 21-Chloro-9-fluoro-11β,16α, 17- trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. Graphic formula: Each gram of Halcinonide Cream USP, 0.1% contains 1 mg halcinonide in a specially formulated cream base consisting of cetyl alcohol, dimethicone 350, mono and diglycerides, isopropyl palmitate, polysorbate 60, propylene glycol, purified water, and titanium dioxide. CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic 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 systemically administered corticosteroi 完全なドキュメントを読む