Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Box of 12 suppositories - 30 mg - NDC 65649-511-12 Box of 24 suppositories - 30 mg - NDC 65649-511-24 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 Proctocort is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2024 Salix Pharmaceuticals, Inc. or its affiliates Rev. 07/2024 9521401; PACKAGE LABEL PRINCIPAL DISPLAY PANEL - PROCTOCORT ® 30 mg Carton Label NDC 65649-511-12 Rx only PROCTOCORT ® Hydrocortisone Acetate Rectal Suppositories For rectal use only. Not for oral use. 30 mg 12 Suppositories carton
- HOW SUPPLIED Box of 12 suppositories - 30 mg - NDC 65649-511-12 Box of 24 suppositories - 30 mg - NDC 65649-511-24 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 Proctocort is a trademark of Salix Pharmaceuticals, Inc. or its affiliates. © 2024 Salix Pharmaceuticals, Inc. or its affiliates Rev. 07/2024 9521401
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL - PROCTOCORT ® 30 mg Carton Label NDC 65649-511-12 Rx only PROCTOCORT ® Hydrocortisone Acetate Rectal Suppositories For rectal use only. Not for oral use. 30 mg 12 Suppositories carton
Overview
Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula: Each rectal suppository contains hydrocortisone acetate, USP 30 mg in a specially blended hydrogenated vegetable oil base. Proctocort Structural Formula
Indications & Usage
Proctocort ® Suppositories are indicated for use in inflamed hemorrhoids, postirradiation (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. Remove the foil wrapper. 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
Proctocort ® 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 Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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