国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
GRAXCELL PHARMACEUTICAL, LLC.
RECTAL
PRESCRIPTION DRUG
Hydrocortisone acetate suppositories are indicated for the use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and puritus 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 dependece have not been reported in patients treated with Hydrocortisone acetate suppositories.
Hydrocortisone Acetate suppositories 25mg are white,cyclinder shaped, with one end tapered. Package of 12 NDC 70795-2412-1 and Package of 24 NDC 70795-2412-2
unapproved drug other
HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY GRAXCELL PHARMACEUTICAL, 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 SUPPOSITORY 25MG, 70795-2412 GRAXCELL PHARMACEUTICAL, LLC. DISCLAIMER: THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELLING HAS NOT BEEN APPROVED BY FDA. HYDROCORTISONE ACETAE, 25MG. RECTAL SUPPOSITORIES. Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene-3, 20- dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula: Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil base In normal subjects, about 26% of hydrocortisone acetate is absorbed when the 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 vasconstrictive action. Hydrocortisone acetate suppositories are indicated for the use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and puritus ani. Hydrocortisone Acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components 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. Carcinogenic: No long-term studies in animals have b 阅读完整的文件