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Hydrocortisone Suppository

Generic Name: hydrocortisone acetate
Dosage Form: rectal suppository

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.

Rectal Suppositories

Hydrocortisone Suppository 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:

C 23H32O6           MW 404.51

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

Hydrocortisone 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 for Hydrocortisone Suppository

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. 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 Bio-Pharm, Inc. at 1-800-912-9561 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.

Hydrocortisone 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 is Hydrocortisone Suppository Supplied

Boxes of 12 suppositories NDC 59741-301-12
Boxes of 24 suppositories NDC 59741-301-24
Boxes of 100 suppositories NDC 59741-301-01

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

Rx only

Manufactured for:
Bio-Pharm, Inc.
Levittown, PA 19057
Rev. 01/18

PRINCIPAL DISPLAY PANEL - 25 mg Suppository Carton

BIO-PHARM
NDC 59741-301-12

Hydrocortisone Acetate Suppositories

25 mg

Rx only

12 Adult Suppositories
For Rectal Administration

HYDROCORTISONE ACETATE 
hydrocortisone acetate suppository
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59741-301
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  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:59741-301-12 12 SUPPOSITORY in 1 CARTON
2 NDC:59741-301-24 24 SUPPOSITORY in 1 CARTON
3 NDC:59741-301-01 100 SUPPOSITORY in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/06/2001
Labeler - Bio-Pharm, Inc. (801652546)
Establishment
Name Address ID/FEI Operations
Bio-Pharm, Inc. 801652546 MANUFACTURE(59741-301), ANALYSIS(59741-301), PACK(59741-301), LABEL(59741-301)
Revised: 02/2018
 
Bio-Pharm, Inc.
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