Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone Acetate Suppositories are easy to open, color coded and available in cartons of 12. 25 mg NDC 0574-7090-12 30 mg NDC 0574-7093-12 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.; PRINCIPAL DISPLAY PANEL - 25 mg Carton NDC 0574-7090-12 Rx Only Hydrocortisone Acetate Suppositories 25 mg UNIT DOSE FOR RECTAL USE ONLY 12 Suppositories The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. 25 mg suppository carton serialization-template.jpg; PRINCIPAL DISPLAY PANEL – 30mg Carton NDC 0574-7093-12 Rx Only Hydrocortisone Acetate Suppositories 30 mg UNIT DOSE FOR RECTAL USE ONLY 12 Suppositories The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. 30mg suppository carton serialization-template
- HOW SUPPLIED Hydrocortisone Acetate Suppositories are easy to open, color coded and available in cartons of 12. 25 mg NDC 0574-7090-12 30 mg NDC 0574-7093-12 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
- PRINCIPAL DISPLAY PANEL - 25 mg Carton NDC 0574-7090-12 Rx Only Hydrocortisone Acetate Suppositories 25 mg UNIT DOSE FOR RECTAL USE ONLY 12 Suppositories The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. 25 mg suppository carton serialization-template.jpg
- PRINCIPAL DISPLAY PANEL – 30mg Carton NDC 0574-7093-12 Rx Only Hydrocortisone Acetate Suppositories 30 mg UNIT DOSE FOR RECTAL USE ONLY 12 Suppositories The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. 30mg suppository carton serialization-template
Overview
Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate in a hydrogenated cocoglyceride 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 C 23 H 32 O 6 the following structural formula: 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 the 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 the response of the individual case.
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 Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.