Label: HYDROCORTISONE ACETATE suppository

  • NDC Code(s): 0574-7090-12, 0574-7093-12
  • Packager: Paddock Laboratories, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 18, 2020

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  • DESCRIPTION

    Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate in a hydrogenated cocoglyceride base.

    Hydrocortisone acetate is a 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-, (11β)- with an empirical formula of C23H32O6the following structural formula:

    Chemical Structure
  • 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.

  • 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.

  • CONTRAINDICATIONS

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

  • 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.

    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, 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 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.

  • 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.

  • 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.

  • HOW SUPPLIED

    Hydrocortisone Acetate Suppositories are easy to open, color coded and available in cartons of 12.

    25 mg NDC 0574-7090-12

    30 mg NDC 0574-7093-12

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

  • SPL UNCLASSIFIED SECTION

    Rx Only

    Manufactured By
    Perrigo®
    Minneapolis, MN 55427
    2201371 1B400 RC J1 Rev 07-19 B

  • PRINCIPAL DISPLAY PANEL - 25 mg Carton

    Rx Only

    NDC 0574-7090-12

    Hydrocortisone Acetate Suppositories

    25 mg

    UNIT DOSE

    12 Suppositories

    FOR RECTAL USE ONLY

    hydro-acet-25mg

    The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

    serialization-template.jpg
  • PRINCIPAL DISPLAY PANEL – 30mg Carton

    Rx Only

    NDC 0574-7093-12

    Hydrocortisone Acetate Suppositories

    30 mg

    UNIT DOSE

    12 Suppositories

    FOR RECTAL USE ONLY

    hydro-acet-30mg

    The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

    serialization-template
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE ACETATE 
    hydrocortisone acetate suppository
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0574-7090
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0574-7090-1212 in 1 BOX07/01/1990
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other07/01/1990
    HYDROCORTISONE ACETATE 
    hydrocortisone acetate suppository
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0574-7093
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0574-7093-1212 in 1 BOX07/01/1990
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other07/01/1990
    Labeler - Paddock Laboratories, LLC (967694121)