Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Cameron Pharmaceuticals, LLC
HYDROCORTISONE ACETATE
HYDROCORTISONE ACETATE 30 mg
RECTAL
PRESCRIPTION DRUG
Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani. Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.
Hydrocortisone acetate suppositories 30 mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 42494-302-12
unapproved drug other
HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY CAMERON PHARMACEUTICALS, LLC _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, 30 MG FOR RECTAL ADMINISTRATION RX ONLY DESCRIPTION Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21- (acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural formula: Each suppository for rectal administration contains hydrocortisone acetate, USP 30 mg in a specially blended hydrogenated vegetable base. CLINICAL PHARMACOLOGY: In normal subjects, about 26% 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, anti-pruritic and vasoconstrictive action. INDICATIONS AND USAGE: Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani. CONTRAINDICATIONS: Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. PRECAUTIONS: Do not use hydrocortisone acetate suppositories 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, hydrocortisone acetate should be discontinued until the infection has been adequately controlled. CARCINOGENES IS : No long-term studies in animals have been performed Leggi il documento completo