Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Preferred Pharmaceuticals, Inc.
HYDROCORTISONE ACETATE
HYDROCORTISONE ACETATE 25 mg
RECTAL
PRESCRIPTION DRUG
For use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani. Hydrocortisone acetate suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components. Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.
Hydrocortisone acetate suppositories are easy to open, color coded and available in cartons of: 12's NDC 68788-9662-1 Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from freezing.
unapproved drug other
HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY PREFERRED 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 SUPPOSITORIES 25 MG DESCRIPTION Each suppository for rectal administration contains 25 mg hydrocortisone acetate USP in a hydrogenated cocoglyceride base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with the following structural formula: CLINICAL PHARMACOLOGY In normal subjects, about 26 percent of hydrocortisone acetate is absorbed when the hydrocortisone acetate suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces. Topical steroids are primarily effective because of their anti-inflammatory, antipruritic and vasoconstrictive action. INDICATIONS AND USAGE For use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani. CONTRAINDICATIONS Hydrocortisone acetate suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components. PRECAUTIONS Do not use unless adequate proctologic examination is made. If irritation develops, the product should be discontinued and appropriate therapy instituted. In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories. PREGNANCY CATEGORY C In laboratory animals, topical steroids have been associated with Leggi il documento completo