Label: HYDROCORTISONE ACETATE suppository

  • NDC Code(s): 75834-147-06, 75834-147-12, 75834-147-24
  • Packager: Nivagen Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated September 23, 2021

If you are a consumer or patient please visit this version.

  • 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:

    Chemical Structure

    Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil base.

  • 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 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

    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 suppositoriesNDC 75834-147-12
    Boxes of 24 suppositoriesNDC 75834-147-24

    Rx only.

    STORAGE AND HANDLING

    Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Store away from heat. Protect From Freezing.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Nivagen Pharmaceuticals, Inc.
    Sacramento, CA 95827 USA
    Toll Free 1-877-977-0687

    Rev. 04/20

  • PRINCIPAL DISPLAY PANEL - 25 mg Suppository Blister Pack Carton

    NIVAGEN

    NDC 75834-147-24

    Hydrocortisone Acetate
    Suppositories 25 mg

    24 Adult Suppositories
    Rx only

    For Rectal Administration

    PRINCIPAL DISPLAY PANEL - 25 mg Suppository Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE ACETATE 
    hydrocortisone acetate suppository
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75834-147
    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)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75834-147-122 in 1 CARTON05/15/2020
    1NDC:75834-147-066 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:75834-147-244 in 1 CARTON05/15/2020
    2NDC:75834-147-066 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other05/15/2020
    Labeler - Nivagen Pharmaceuticals, Inc. (052032418)