Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone acetate suppositories 25 mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 16571-676-21 Box of 24 suppositories, NDC 16571-676-42 Hydrocortisone acetate suppositories 30 mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 16571-164-21 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. Rx Only Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52030/52050 Revised: 02/2024; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rising ® NDC 16571-676-21 Hydrocortisone Acetate Suppositories 25 mg For Rectal Administration 12 Adult Suppositories Rx only Rising ® NDC 16571-164-21 Hydrocortisone Acetate Suppositories 30 mg For Rectal Administration 12 Adult Suppositories Rx only hydrocortisone-25mg-12ct hydrocortisone-30mg-12ct
- HOW SUPPLIED Hydrocortisone acetate suppositories 25 mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 16571-676-21 Box of 24 suppositories, NDC 16571-676-42 Hydrocortisone acetate suppositories 30 mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 16571-164-21 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. Rx Only Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52030/52050 Revised: 02/2024
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rising ® NDC 16571-676-21 Hydrocortisone Acetate Suppositories 25 mg For Rectal Administration 12 Adult Suppositories Rx only Rising ® NDC 16571-164-21 Hydrocortisone Acetate Suppositories 30 mg For Rectal Administration 12 Adult Suppositories Rx only hydrocortisone-25mg-12ct hydrocortisone-30mg-12ct
Overview
Each Hydrocortisone Acetate Suppository for rectal administration contains 25 mg hydrocortisone acetate, USP in a specially blended hydrogenated vegetable oil base. Each Hydrocortisone Acetate Suppository for rectal administration contains 30 mg hydrocortisone acetate, USP in a specially blended hydrogenated vegetable 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-, (11ß)- with an empirical formula of C H O and the following structural formula: hydrocortisone-struc
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
Usual dosage: One suppository in the rectum twice daily 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
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 SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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