Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
hydrocortisone acetate (UNII: 3X7931PO74) (hydrocortisone - UNII:WI4X0X7BPJ)
Schwarz Pharma
hydrocortisone acetate
AEROSOL, FOAM
90 mg in 900 mg
RECTAL
PRESCRIPTION DRUG
Cortifoam® is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas. Cortifoam® is contraindicated in patients who are hypersensitive to any components of this product. Local contraindications to the use of intrarectal steroids include obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulas and sinus tracts.
Cortifoam® is supplied in an aerosol container with a special rectal applicator. Each applicator delivers approximately 900 mg of foam containing approximately 80 mg of hydrocortisone as 90 mg of hydrocortisone acetate. When used correctly, the aerosol container will deliver a minimum of 14 applications. NDC 0091-0695-2 15 g Store at controlled room temperature, 20°-25°C (68°-77°F). DO NOT REFRIGERATE. Rx Only
CORTIFOAM- HYDROCORTISONE ACETATE AEROSOL, FOAM SCHWARZ PHARMA ---------- CORTIFOAM® (HYDROCORTISONE ACETATE RECTAL AEROSOL) 10% RECTAL FOAM DES CRIPTION Cortifoam® (hydrocortisone acetate rectal aerosol) 10% Rectal Foam contains hydrocortisone acetate 10% in a base containing propylene glycol, emulsifying wax, polyoxyethylene-10-stearyl ether, cetyl alcohol, methylparaben, propylparaben, trolamine, purified water and inert propellants: isobutane and propane. Each application delivers approximately 900 mg of foam containing 80 mg of hydrocortisone (90 mg of hydrocortisone acetate). The molecular weight of hydrocortisone acetate is 404.50. It is designated chemically as pregn-4-ene- 3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-,(11β)-. The empirical formula is C H O and the structural formula is: Hydrocortisone acetate, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is insoluble in water (1 mg/100 mL) and slightly soluble in alcohol and chloroform. CLINICAL PHARMACOLOGY Cortifoam® provides effective topical administration of an anti-inflammatory corticosteroid as adjunctive therapy of ulcerative proctitis. Direct observations of methylene blue-containing foam have shown staining about 10 centimeters into the rectum. INDICATIONS AND USAGE Cortifoam® is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas. CONTRAINDICATIONS Cortifoam® is contraindicated in patients who are hypersensitive to any components of this product. Local contraindications to the use of intrarectal steroids include obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulas and sinus tracts. 23 32 6 WARNINGS GENERAL Do not insert any part of the aerosol container directly into the anus. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above Leggi il documento completo