{"adverse_reactions":["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."],"clinical_pharmacology":["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, anti-pruritic and vasoconstrictive action."],"contraindications":["CONTRAINDICATIONS Hydrocortisone Acetate Suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components."],"description":["DESCRIPTION Each Hydrocortisone Acetate 25 mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is a pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17- dihydroxy (11β)- with the following structural formula: C 23 H 32 O 6 MW 404.50 County Line Pharmaceuticals Hydrocortisone Acetate Structural Formula"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual dosage: One suppository in the rectum 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."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Drug abuse and dependence have not been reported in patients treated with Hydrocortisone Acetate Suppositories."],"effective_time":"20150713","how_supplied":["HOW SUPPLIED Hydrocortisone Acetate Suppositories are white, torpedo shaped, with one end tapered. Package of 12 suppositories NDC 43199-021-12 and package of 24 suppositories NDC 43199-021-24. Store at 20 o -25 o C (68 o -77 o F). See USP controlled room temperature. Store away from heat. Protect from freezing. Rx Only. Distributed by: County Line Pharmaceuticals, LLC Brookfield, WI 53005 For Inquiries Call: 1-866-207-5636 PI-CLP021B 6/11"],"id":"c723d2db-3be9-4463-8795-31430555624c","indications_and_usage":["INDICATIONS AND USAGE 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 pruritis ani."],"information_for_patients":["INFORMATION FOR PATIENTS Staining of fabric may occur with use of the suppository. Precautionary measures are recommended."],"openfda":{},"overdosage":["OVERDOSAGE If signs and symptoms of systemic overdosage occur, discontinue use."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - CARTON NDC 43199-021-12 12 Suppositories For Rectal Administration Rx Only Hydrocortisone Acetate Suppositories 25 mg County Line Pharmaceuticals, LLC Hydrocortisone Acetate Suppositories 25 mg 12 Suppositories TAMPER EVIDENT: DO NOT USE IF FILM IS TORN OR BROKEN County Line Pharmaceuticals Hydrocortisone Acetate Carton Label","PRINCIPAL DISPLAY PANEL - DOSE PACK HYDROCORTISONE ACETATE 25 mg SUPPOSITORY Mfd for: County Line Pharmaceuticals, LLC Brookfield, WI 53005 County Line Pharmaceuticals Hydrocortisone Acetate Dose Pack Label"],"precautions":["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 a favorable response does not occur promptly, the hydrocortisone acetate should be discontinued until the infection has been adequately controlled. No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories."],"pregnancy":["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, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother."],"set_id":"1812341f-c17f-4024-801c-92f11954a58a","spl_product_data_elements":["HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE HYDROCORTISONE"],"spl_unclassified_section":["OPENING INSTRUCTIONS Avoid excessive handling of the suppository, it is designed to melt at body temperature. Detach one (1) suppository slowly from the strip of suppositories. Separate tabs at top opening and pull downward slowly. Continue pulling downward slowly to almost the full length of the suppository. Gently remove the suppository from the package. Insert suppository into the rectum, pointed end first, with gentle pressure."],"version":"3"}