Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Acetate Suppositories are easy to open, color coded and available in cartons of 12. 30 mg NDC 63629-2531-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504; Hydrocortisone Acetate 30 mg Suppos #12 Label
- HOW SUPPLIED Hydrocortisone Acetate Suppositories are easy to open, color coded and available in cartons of 12. 30 mg NDC 63629-2531-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
- Hydrocortisone Acetate 30 mg Suppos #12 Label
Overview
Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate in a hydrogenated cocoglyceride 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 the following 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, other inflammatory conditions of the anorectum, and pruritus ani.
Dosage & Administration
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 the response of the individual case.
Warnings & Precautions
No warnings available yet.
Contraindications
Hydrocortisone Acetate Suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.
Adverse Reactions
The following local adverse reactions have been reported with corticosteroid suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, and secondary infection. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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