Label: HYDROCORTISONE ACETATE suppository

  • NDC Code(s): 70795-2412-1, 70795-2412-2
  • Packager: GRAXCELL PHARMACEUTICAL, LLC.
  • 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 December 21, 2021

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

  • Graxcell Pharmaceutical, llc. Disclaimer: This drug has not been found by FDA to be safe and effective, and this labelling has not been approved by FDA. Hydrocortisone acetae, 25mg. Rectal suppositories.

    hydro structural formula

    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

  • 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.

  • INDICATIONS & 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.

  • 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 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.

    Carcinogenic: No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.

  • 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

    Graxcell pharmaceutical, llc.

    1-888-266-8818 or

    FDA @ 1-800-FDA-1088 or

    www.fda.gov/medwatch

  • OVERDOSAGE

    If signs and symptoms of systemic overdosage occur, discontinue use.

  • DOSAGE & ADMINISTRATION

    suppo 2

    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 in six to eight weeks or less, according to the response of the individual case.

    Rx only.

    OPENING INSTRUCTIONS

    Avoid excessive handling of the suppository. It is designed to melt at body temperature.

    1. Separate plastic film at top opening and pull downward.

    2. Continue pulling downward to almost the full length of the suppository.

    3. Gently remove the suppsitory from the film pocket.

  • HOW SUPPLIED

    Hydrocortisone Acetate suppositories 25mg are white,cyclinder shaped, with one end tapered.

    Package of 12 NDC 70795-2412-1

    and

    Package of 24 NDC 70795-2412-2

  • STORAGE AND HANDLING

    Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Store away from heat. Protect from freezing.

    Manufactured for:

    Graxcell pharmaceutical, LLC.

    130 knickerbocker ave,Bohemia, NY 11716

    Manufactured by:

    Graxcell pharmaceutical, llc.

    136 OAk Drive,

    syosset, NY 11791

    1-888-266-8818.

  • DRUG ABUSE AND DEPENDENCE

    Drug abuse and dependece have not been reported in patients treated with Hydrocortisone acetate suppositories.

  • PRINCIPAL DISPLAY PANEL

    Hydrocortisone Acetate 24ct

    Hydrocortisone Acetate 12ct

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE ACETATE 
    hydrocortisone acetate suppository
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70795-2412
    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 COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    Product Characteristics
    Coloryellow (off-white) Score    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70795-2412-112 in 1 CARTON; Type 0: Not a Combination Product10/18/2017
    2NDC:70795-2412-224 in 1 CARTON; Type 0: Not a Combination Product10/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/18/2017
    Labeler - GRAXCELL PHARMACEUTICAL, LLC. (056556923)