Country: United States
Language: English
Source: NLM (National Library of Medicine)
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
APNAR PHARMA LP
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; and 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.
Boxes of 12 suppositories NDC 24689-102-01 Boxes of 12 suppositories NDC 24689-103-01
unapproved drug other
HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY APNAR PHARMA LP _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 DESCRIPTION Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene 3, 20- dione, 21- (acetyloxy)-11,17-dihydroxy-(11ß) with the following structural formula: Each rectal suppository contains hydrocortisone acetate, 25 mg in a specially blended hydrogenated vegetable oil base. 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 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; and 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. CARCINOGENESIS No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories. INFORMATION FOR PATIEN Read the complete document