البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Rebel Distributors Corp
HYDROCORTISONE ACETATE
HYDROCORTISONE ACETATE 30 mg
RECTAL
PRESCRIPTION DRUG
For use in inflamed hemorrhoids, postirradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani. Hydrocortisone Acetate Suppositories are contraindicated in those patients having a history of hypersensitivity to any of the components. Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.
Box of 12 suppositories - NDC 21695-731-12 Rx only. Store at 20°–25°C (68°–77°F). See USP Controlled Room Temperature. Store away from heat. Protect from freezing. For Inquiries call: 1-866-207-5636 Distributed by: County Line Pharmaceuticals, LLC Brookfield, WI 53005 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
unapproved drug other
HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY REBEL DISTRIBUTORS CORP _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 PROCTOCORT Hydrocortisone Acetate Rectal Suppositories, 25 mg DESCRIPTION Each Hydrocortisone Acetate 25 mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is a pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula: CLINICAL PHARMACOLOGY 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 vasoconstrictive action. ® INDICATIONS AND USAGE For use in inflamed hemorrhoids, postirradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani. CONTRAINDICATIONS Hydrocortisone Acetate Suppositories are contraindicated in those patients having 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 hydrocortisone acetate should be discontinued until the infection has been adequately controlled. CARCINOGENESIS: No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories. PREGNANCY CATEGORY C: In laboratory animals, topical stero اقرأ الوثيقة كاملة