SPL UNCLASSIFIED SECTION.

Carcinogenesis No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

STORAGE AND HANDLING SECTION.

Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from freezing.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. The following local adverse reactions have been reported with corticosteroid suppositories: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, and secondary infection.To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. In normal subjects, about 26 percent of hydrocortisone acetate is absorbed when the hydrocortisone acetate 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, antipruritic and vasoconstrictive action.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Hydrocortisone Acetate Suppositories are contraindicated in those patients with history of hypersensitivity to any of the components.

DESCRIPTION SECTION.

DESCRIPTION. Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate in hydrogenated cocoglyceride base. Hydrocortisone acetate is 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-, (11)- with an empirical formula of C23H32O6the following structural formula:. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND 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.

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. Hydrocortisone Acetate Suppositories are easy to open, color coded and available in cartons of 12.25 mgNDC 0574-7090-1230 mgNDC 0574-7093-12. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from freezing.

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, other inflammatory conditions of the anorectum, and pruritus ani.

OVERDOSAGE SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 25 mg Carton. Rx OnlyNDC 0574-7090-12Hydrocortisone Acetate Suppositories25 mgUNIT DOSE12 SuppositoriesFOR RECTAL USE ONLYThe following image is placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.. hydro-acet-25mg. serialization-template.jpg.

PRECAUTIONS SECTION.

PRECAUTIONS. Do not use 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, the corticosteroid 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 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. 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.

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. 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.