Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 25mg (12 count) NDC 10135-0751-12 25mg (24 count) NDC 10135-0751-24 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. Protect from freezing. Manufactured for/ Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 07/22 ID; PRINCIPAL DISPLAY PANEL - 25 mg Suppository Carton NDC 10135-0751-12 Rx Only Hydrocortisone Acetate Suppositories 25 mg FOR RECTAL USE ONLY 12 Suppositories 12-count; PRINCIPAL DISPLAY PANEL - 25 mg Suppository Carton NDC 10135-0751-24 Rx Only Hydrocortisone Acetate Suppositories 25 mg FOR RECTAL USE ONLY 24 Suppositories 24-count
- HOW SUPPLIED 25mg (12 count) NDC 10135-0751-12 25mg (24 count) NDC 10135-0751-24 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. Protect from freezing. Manufactured for/ Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 07/22 ID
- PRINCIPAL DISPLAY PANEL - 25 mg Suppository Carton NDC 10135-0751-12 Rx Only Hydrocortisone Acetate Suppositories 25 mg FOR RECTAL USE ONLY 12 Suppositories 12-count
- PRINCIPAL DISPLAY PANEL - 25 mg Suppository Carton NDC 10135-0751-24 Rx Only Hydrocortisone Acetate Suppositories 25 mg FOR RECTAL USE ONLY 24 Suppositories 24-count
Overview
Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate USP in a hydrogenated palm kernel 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 C23 H32O6 and the following structural formula: struct
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
For rectal administration: Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis.ln 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. Detach and hold one suppository upright(point upward). Separate tabs at top opening and pull downward to almost the full length of the suppository. Carefully remove the suppository, avoiding excessive handling, which is designed to melt at body temperature. Insert suppository into the rectum, pointed end first, with gentle pressure.
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 Hydrocortisone Acetate Suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, and secondary infection. To report SUSPECTED ADVERSE REACTIONS, contact Marlex Pharmaceuticals at 1-888-582-1953 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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