Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone acetate suppositories 25 mg are white to off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 70752-169-02 Box of 24 suppositories, NDC 70752-169-23 STORAGE Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Rx Only Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52030 Rev.01/21; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70752-169-02 Hydrocortisone Acetate Suppositories 25 mg For Rectal Administration 12 Adult Suppositories Rx only NDC 70752-169-23 Hydrocortisone Acetate Suppositories 25 mg For Rectal Administration 24 Adult Suppositories Rx only 12Count 24
- HOW SUPPLIED Hydrocortisone acetate suppositories 25 mg are white to off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 70752-169-02 Box of 24 suppositories, NDC 70752-169-23 STORAGE Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Rx Only Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52030 Rev.01/21
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70752-169-02 Hydrocortisone Acetate Suppositories 25 mg For Rectal Administration 12 Adult Suppositories Rx only NDC 70752-169-23 Hydrocortisone Acetate Suppositories 25 mg For Rectal Administration 24 Adult Suppositories Rx only 12Count 24
Overview
Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural formula: Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base. structure
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 anorectum, and pruritus ani.
Dosage & Administration
For rectal administration. Detach one suppository from strip of suppositories. Hold suppository upright. Separate tabs at top opening and pull downward from the pointed end. Continue pulling downward to almost the full length of the suppository. Carefully remove the suppository from the pocket. 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
Hydrocortisone acetate 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 an adverse event, please contact Quagen Pharmaceuticals LLC. at 1-888-344-9603, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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