Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 71205-976-12 Box of 24 suppositories, NDC 71205-976-24 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. PHARMACIST: This product is not an Orange Book rated product, therefore all prescriptions using this product shall be subject to state and federal statutes as applicable. This product has not been subjected to FDA therapeutic or other equivalency testing. There are no claims of bioequivalence or therapeutic equivalence. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information contained within the enclosed prescribing information.; PRINCIPAL DISPLAY PANEL - 12 Suppository Carton NDC 71205-976-12 Rx Only Hydrocortisone Acetate Suppositories 25 mg FOR RECTAL USE ONLY 12 Suppositories Unit Dose 71205-976-12
- HOW SUPPLIED Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 71205-976-12 Box of 24 suppositories, NDC 71205-976-24 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. PHARMACIST: This product is not an Orange Book rated product, therefore all prescriptions using this product shall be subject to state and federal statutes as applicable. This product has not been subjected to FDA therapeutic or other equivalency testing. There are no claims of bioequivalence or therapeutic equivalence. Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information contained within the enclosed prescribing information.
- PRINCIPAL DISPLAY PANEL - 12 Suppository Carton NDC 71205-976-12 Rx Only Hydrocortisone Acetate Suppositories 25 mg FOR RECTAL USE ONLY 12 Suppositories Unit Dose 71205-976-12
Overview
Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula: Each suppository for rectal administration contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable base. Chemical 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 and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository. Remove the suppository from the pocket. Avoid excessive handling of suppository which is designed to melt at body temperature. Insert one suppository rectally, 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 Westminster Pharmaceuticals, LLC at 1-844-221-7294.
Storage & Handling
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.
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