the medicine Anucort-HC Suppository Generic Name: hydrocortisone acetate Dosage Form: rectal suppository Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. ANUCORT-HC TM Slideshow 10 Common Symptoms That Should Never Be Ignored Anucort-HC Suppository Description Hydrocortisone Acetate is a 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 a specially blended hydrogenated vegetable oil base. Anucort-HC Suppository - 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. 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. CONTRAINDICATIONS Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. 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 a 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. INFORMATION FOR PATIENTS Staining of fabric may occur with use of the suppository. Precautionary measures are recommended. 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. 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 G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . DRUG ABUSE AND DEPENDENCE Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories. Overdosage If signs and symptoms of systemic overdosage occur, discontinue use. Anucort-HC Suppository 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 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. HOW SUPPLIED Boxes of 12 suppositories NDC 0713-0503-12 Boxes of 24 suppositories NDC 0713-0503-24 Boxes of 100 suppositories NDC 0713-0503-01 STORAGE AND HANDLING Store at 20-25 C (68 -77 F) [See USP Controlled Room Temperature]. Store away from heat . Protect From Freezing. Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080 8-0503GW7 Rev. 11/13 PRINCIPAL DISPLAY PANEL NDC 0713-0503-24 G&W ANUCORT-HC TM Hydrocortisone Acetate Suppositories 25 mg Rx only For Rectal Administration 24 Adult Suppositories Each suppository contains: Hydrocortisone Acetate 25 mg in a specially blended hydrogenated vegetable oil base. FOR RECTAL ADMINISTRATION. DOSAGE AND ADMINISTRATION: Read package insert for complete information before use. DIRECTIONS FOR USE: 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 rectum with gentle pressure, pointed end first. Store at 20-25 C (68 -77 F) [See USP Controlled Room Temperature]. Store away from heat. Protect From Freezing. NOTE: Staining of fabric may occur with the use of the suppository. Precautionary measures are recommended. WARNING: Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. G&W Laboratories, Inc. South Plainfield, NJ 07080 Visit our website @ www.gwlabs.com ANUCORT-HC hydrocortisone acetate suppository Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0713-0503 Route of Administration RECTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone Acetate (Hydrocortisone) Hydrocortisone Acetate 25 mg Inactive Ingredients Ingredient Name Strength Hydrogenated Palm Kernel Oil Packaging # Item Code Package Description 1 NDC:0713-0503-12 12 SUPPOSITORY in 1 CARTON 2 NDC:0713-0503-24 24 SUPPOSITORY in 1 CARTON 3 NDC:0713-0503-01 100 SUPPOSITORY in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/15/1990 Labeler - G&W Laboratories, Inc. (001271188) Registrant - G&W Laboratories, Inc. (001271188) Establishment Name Address ID/FEI Operations G&W Laboratories, Inc. 001271188 MANUFACTURE(0713-0503) Revised: 01/2012 G&W Laboratories, Inc. Next Interactions Print this page Add to My Med List More about Anucort-HC (hydrocortisone topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 2 Reviews Add your own review/rating Drug class: topical steroids Consumer resources Anucort-HC cream, ointment, suppository Professional resources Hydrocortisone topical (AHFS Monograph) Hydrocortisone in Absorbase (FDA) Other brands: Proctozone HC , Westcort , Proctocort , Locoid , ... +18 more Related treatment guides Hemorrhoids Anal Itching Pruritus FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical steroids Related Drugs topical steroids fluticasone topical , triamcinolone topical , hydrocortisone topical , clobetasol topical Hemorrhoids lidocaine topical , hydrocortisone topical , phenylephrine topical , Anusol-HC , Proctosol-HC , Proctozone HC , Analpram-HC , More... Anal Itching lidocaine topical , hydrocortisone topical , phenylephrine topical , Anusol-HC , Proctosol-HC , Proctozone HC , Proctofoam , More... Pruritus hydroxyzine , lidocaine topical , hydrocortisone topical , diphenhydramine , Benadryl , doxepin topical , Vistaril , More... Anucort-HC Rating 2 User Reviews 3.5 /10 2 User Reviews 3.5 Rate it! to steer
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