{"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."],"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 vasconstrictive action."],"contraindications":["Hydrocortisone Acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components"],"description":["Granlues Pharma, LLC Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. HYDROCORTISONE ACETATE, 25 mg Rectal Suppositories DESCRIPTION: Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula: Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil base. Hydrocortisone-01"],"dosage_and_administration":["For rectal administration. Detach one suppository from strip of suppositories. Remove the wrapper. 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 a 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. suppositories"],"drug_abuse_and_dependence":["Drug abuse and dependece have not been reported in patients treated with Hydrocortisone acetate suppositories."],"effective_time":"20160819","how_supplied":["Hydrocortisone Acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 and 24 suppositories, NDC 70795-4302-01 and NDC 70795-4302-02."],"id":"c7a031c3-b034-4452-86b0-47f14e784039","indications_and_usage":["Hydrocortisone acetate suppositories are indicated for the 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 puritus ani."],"openfda":{},"overdosage":["If signs and symptoms of systemic overdosage occur, discontinue use."],"package_label_principal_display_panel":["Label"],"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 corticosteroid 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."],"set_id":"3a70f993-7d41-28d0-e054-00144ff88e88","spl_product_data_elements":["HYDROCORTISONE ACETATE HEMMOREX HYDROCORTISONE ACETATE HYDROCORTISONE"],"storage_and_handling":["Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Excursions permitted to 15º-30ºC (59º-86ºF). Store away from heat. Protect from freezing. Manufactured for: Granules Pharma, LLC Bohemia, NY 11716 631-319-1055"],"version":"16"}