Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Anusol-HC ® 25 mg Suppositories are white, cylinder shaped, with one end tapered. NDC 65649-411-12 25 mg 12 suppositories NDC 65649-411-24 25 mg 24 suppositories Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. PROTECT FROM FREEZING. Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Anusol-HC is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2024 Salix Pharmaceuticals, Inc. or its affiliates OPENING INSTRUCTIONS Avoid excessive handling of the suppository. It is designed to melt at body temperature. 1. Separate plastic film at top opening and pull downward. 2. Continue pulling downward to almost the full length of the suppository. 3. Gently remove the suppository from the film pocket. Rev. 07/2024 9520702 Opening Instructions; PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Carton NDC 65649-411-12 Rx only Anusol-HC ® (Hydrocortisone Acetate in a Hydrogenated Vegetable Oil Base) 25 mg For rectal use only. Not for oral use. 12 Suppositories carton
- HOW SUPPLIED Anusol-HC ® 25 mg Suppositories are white, cylinder shaped, with one end tapered. NDC 65649-411-12 25 mg 12 suppositories NDC 65649-411-24 25 mg 24 suppositories Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. PROTECT FROM FREEZING. Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Anusol-HC is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2024 Salix Pharmaceuticals, Inc. or its affiliates OPENING INSTRUCTIONS Avoid excessive handling of the suppository. It is designed to melt at body temperature. 1. Separate plastic film at top opening and pull downward. 2. Continue pulling downward to almost the full length of the suppository. 3. Gently remove the suppository from the film pocket. Rev. 07/2024 9520702 Opening Instructions
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Carton NDC 65649-411-12 Rx only Anusol-HC ® (Hydrocortisone Acetate in a Hydrogenated Vegetable Oil Base) 25 mg For rectal use only. Not for oral use. 12 Suppositories carton
Overview
Each Anusol-HC ® 25 mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy (11β)- with the following structural formula: Structural Formula
Indications & Usage
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 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.
Warnings & Precautions
No warnings available yet.
Contraindications
CONTRAINDICATION Anusol-HC ® 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. 1. Burning 2. Itching 3. Irritation 4. Dryness 5. Folliculitis 6. Hypopigmentation 7. Allergic contact dermatitis 8. Secondary infection To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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