Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Boxes of 12 suppositories NDC 0713-0503-12 Boxes of 24 suppositories NDC 0713-0503-24 Boxes of 100 suppositories NDC 0713-0503-01; PRINCIPAL DISPLAY PANEL NDC 0713-0503-12 ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 12 Adult Suppositories Cosette Pharmaceuticals, Inc. NDC 0713-0503-24 ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 24 Adult Suppositories Cosette Pharmaceuticals, Inc. NDC 0713-0503-01 ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 100 Adult Suppositories Cosette Pharmaceuticals, Inc. carton-12 carton-24 carton-100
- HOW SUPPLIED Boxes of 12 suppositories NDC 0713-0503-12 Boxes of 24 suppositories NDC 0713-0503-24 Boxes of 100 suppositories NDC 0713-0503-01
- PRINCIPAL DISPLAY PANEL NDC 0713-0503-12 ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 12 Adult Suppositories Cosette Pharmaceuticals, Inc. NDC 0713-0503-24 ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 24 Adult Suppositories Cosette Pharmaceuticals, Inc. NDC 0713-0503-01 ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 100 Adult Suppositories Cosette Pharmaceuticals, Inc. carton-12 carton-24 carton-100
Overview
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, USP 25 mg in a specially blended hydrogenated vegetable oil base. structural formula
Indications & 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.
Dosage & Administration
For rectal administration. Detach one suppository from strip of suppositories. Hold suppository upright. Separate tabs at top opening and pull downward from the pointed end. Continue pulling downward to almost the full length of the suppository. Carefully remove the suppository from the pocket. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with gentle pressure, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.
Warnings & Precautions
No warnings available yet.
Contraindications
Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components.
Adverse Reactions
The following local adverse reactions have been reported with hydrocortisone acetate suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Storage & Handling
STORAGE AND HANDLING Store at 20-25°C (68°-77°F) [See USP Controlled Room Temperature]. Store away from heat. Protect From Freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0503CPLNC1 Iss. 12/2019 VC 7388
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