ADVERSE REACTIONS SECTION.

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 Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. In normal subjects, about 26% of hydrocortisone acetate is absorbed when the suppository is applied to the rectum. Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces. Topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasoconstrictive action.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS Hydrocortisone acetate suppositories are contraindicated in those patients having history of hypersensitivity to hydrocortisone acetate or any of the components.

DESCRIPTION SECTION.

DESCRIPTION. Hydrocortisone Acetate is corticosteroid designated chemically as pregn-4-ene 3, 20-dione,21-(acetyloxy)-11, 17-dihydroxy-(11ss) with the following structural formula: Each rectal suppository contains hydrocortisone acetate, USP 25 mg in specially blended hydrogenated vegetable oil base.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND 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 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.

DRUG ABUSE AND DEPENDENCE SECTION.

DRUG ABUSE AND DEPENDENCE Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

HOW SUPPLIED SECTION.

HOW SUPPLIED Boxes of 12 suppositories NDC 0713-0503-12Boxes of 24 suppositories NDC 0713-0503-24Boxes of 100 suppositories NDC 0713-0503-01.

INDICATIONS & USAGE SECTION.

INDICATIONS AND 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; and other inflammatory conditions of anorectum and pruritus ani.

INFORMATION FOR PATIENTS SECTION.

INFORMATION FOR PATIENTS. Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.

OVERDOSAGE SECTION.

OVERDOSAGE. If signs and symptoms of systemic overdosage occur, discontinue use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 0713-0503-12ANUCORT-HCTM Hydrocortisone Acetate Suppositories25 mgRx onlyFor Rectal Administration12 Adult SuppositoriesCosette Pharmaceuticals, Inc.NDC 0713-0503-24ANUCORT-HCTM Hydrocortisone Acetate Suppositories25 mgRx onlyFor Rectal Administration24 Adult SuppositoriesCosette Pharmaceuticals, Inc.NDC 0713-0503-01ANUCORT-HCTM Hydrocortisone Acetate Suppositories25 mgRx onlyFor Rectal Administration100 Adult SuppositoriesCosette Pharmaceuticals, Inc.HYDROCORTISONE ACETATE 25mgManufactured by:Cosette Pharmaceuticals, Inc.111 Coolidge Street,South Plainfield,NJ 07080. carton-12. carton-24. carton-100. pack.

PRECAUTIONS SECTION.

PRECAUTIONS Do not use hydrocortisone acetate suppositories unless adequate proctologic examination is made. If irritation develops, the product should be discontinued and appropriate therapy instituted. In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted. If favorable response does not occur promptly, hydrocortisone acetate should be discontinued until the infection has been adequately controlled. Carcinogenesis: No long term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

PREGNANCY SECTION.

PREGNANCY CATEGORY C. In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels. There are no adequate and well controlled studies in pregnant women. Hydrocortisone acetate suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. It is not known whether this drug is excreted in human milk and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocortisone acetate suppositories, decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

STORAGE AND HANDLING SECTION.

STORAGE AND HANDLING. Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. Store away from heat. Protect From Freezing. Manufactured by: Cosette Pharmaceuticals, Inc.111 Coolidge Street,South Plainfield, NJ 07080 8-0503CP1 Iss. 09/2019.