HYDROCORTISONE ACETATE

Each Hydrocortisone Acetate Suppository for rectal administration contains 30 mg hydrocortisone acetate, USP in a specially blended hydrogenated vegetable oil base. Hydrocortisone acetate is a corticosteroid. The molecular weight of hydrocortisone acetate is 404.50. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11β)- with an empirical formula of C 23 H 32 O 6 and the following structural formula: Chemical Structure

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 the anorectum, and pruritus ani.

Usual dosage: One suppository in the rectum twice daily morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.

Hydrocortisone Acetate Suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.

The following local adverse reactions have been reported with Hydrocortisone Acetate Suppositories: 1. Burning 5. Folliculitis 2. Itching 6. Hypopigmentation 3. Irritation 7. Allergic Contact Dermatitis 4. Dryness 8. 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 .

Store at controlled room temperature 15° to 30° C (59° to 86° F). Store away from heat. Protect from freezing.