Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Nivagen Pharmaceuticals Inc.
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 Acetate 2.5% Pramoxine HCl 1% Cream 2.5% 1 oz tube (NDC 75834-197-01) Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].
unapproved drug other
HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE- PRAMOXINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM NIVAGEN PHARMACEUTICALS INC. _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- HYDROCORTISONE ACETATE 2.5% PRAMOXINE HCL 1% CREAM 2.5% DESCRIPTION HYDROCORTISONE ACETATE 2.5% PRAMOXINE HCL 1% CREAM 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, petrolatum, mineral oil, paraffin, microcrystalline wax, polyethylene wax, lanolin alcohol, isopropyl palmitate, polyoxyethylene 40 stearate, propylene glycol, potassium sorbate, sorbic acid, tea lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy) -11,17-dihydroxy-, (11-beta) - C H O ; mol. wt: 404.50 pramoxine hydrochloride 4-(3-(p-butoxyphenoxy) propyl) morpholine hydrochloride C H NO .HCl; mol. wt: 329.87 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 the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. 23 32 6 17 27 3 Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact. PHARMACOKINETICS The extent of percutaneous Lue koko asiakirja