ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. The following local adverse reactions have been reported with Hydrocortisone Acetate Suppositories: 1. Burning 5. Folliculitis 2. Itching 6. Hypopigmentation 3. Irritation 7. Allergic Contact Dermatitis 4. Dryness 8. Secondary InfectionTo 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 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.

DESCRIPTION SECTION.

DESCRIPTION. Each Hydrocortisone Acetate Suppository for rectal administration contains 30 mg hydrocortisone acetate, USP in specially blended hydrogenated vegetable oil 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 C23H32O6 and the 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 response.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Hydrocortisone Acetate Suppositories are easy to open and available in cartons of:12s NDC 0713-0493-12. Store at controlled room temperature 15 to 30 (59 to 86 F). Store away from heat. 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.

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, Hydrocortisone Acetate Suppositories 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 and Nursing Mothers. 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.It is not known whether this drug is excreted in human milk. Since 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 taking the drug, taking into account the importance of the drug to the mother.Until adequate studies in pregnant or lactating women have been conducted, this drug should be used during pregnancy or by nursing mothers only when clearly needed and when the potential benefits outweigh the potential risks to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

PREGNANCY SECTION.

Pregnancy Category and Nursing Mothers. 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.It is not known whether this drug is excreted in human milk. Since 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 taking the drug, taking into account the importance of the drug to the mother.Until adequate studies in pregnant or lactating women have been conducted, this drug should be used during pregnancy or by nursing mothers only when clearly needed and when the potential benefits outweigh the potential risks to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.