HYDROCORTISONE ACETATE- hydrocortisone acetate suppository 
Major Pharmaceuticals

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.

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Hydrocortisone Acetate Suppositories, 25 mg
For Rectal Administration
Rx only

DESCRIPTION

Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural formula:

structure

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

CLINICAL PHARMACOLOGY

In normal subjects, about 26% 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, 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, 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 of 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 an adverse event, please contact Rising Pharma Holdings, Inc. at 1-844-874-7464, 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

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

Hydrocortisone acetate suppositories 25 mg are white to off-white, smooth surfaced and bullet shaped with one pointed end.
Carton of 12 suppositories, NDC 0904-7340-12

Carton of 24 suppositories, NDC 0904-7340-24

STORAGE

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes.

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.

Rx Only


Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

Distributed By:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268 USA



52030
Rev.01/21

Package/Label Display Panel

Hydrocortisone Acetate Suppositories

25 mg

12 Adult Suppositories

pre-printed box

HYDROCORTISONE ACETATE 
hydrocortisone acetate suppository
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0904-7340
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
ColorWHITEScore    
ShapeBULLETSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7340-1212 in 1 CARTON; Type 0: Not a Combination Product04/05/2024
2NDC:0904-7340-2424 in 1 CARTON; Type 0: Not a Combination Product04/05/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/05/2024
Labeler - Major Pharmaceuticals (191427277)

Revised: 4/2024
Document Id: 1281a82d-df00-4421-9c0d-951f8f9a9422
Set id: 1281a82d-df00-4421-9c0d-951f8f9a9422
Version: 1
Effective Time: 20240405
 
Major Pharmaceuticals