Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: 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 mL
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 Lotion USP, 2.5% is supplied in a 59 mL (2 Fl Oz) bottle. Shake well before using. Store at controlled room temperature 15°- 30°C (59°- 86°F). Keep out of the reach of children. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2288C/IF2288C R10/15 #278
Abbreviated New Drug Application
HYDROCORTISONE- HYDROCORTISONE LOTION E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- HYDROCORTISONE LOTION USP, 2.5% RX ONLY FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES DESCRIPTION: Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone in a vehicle consisting of carbomer 980, propylene glycol, polysorbate 40, propylene glycol stearate, cholesterol and related sterols, isopropyl myristate, sorbitan palmitate, cetyl alcohol, triethanolamine, sorbic acid, simethicone, and purified water. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)- and is represented by the following structural formula: Hydrocortisone has the molecular formula C H O and a molecular weight of 362.47. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. 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 21 30 5 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 the percutaneous absorption of topical corticosteroids. 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 ADMI Baca dokumen lengkap