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Hydrocortisone Suppository

Pronunciation

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.

Granlues Pharma, LLC


Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

HYDROCORTISONE ACETATE, 25 mg

Rectal Suppositories

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:

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

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.

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.

Hydrocortisone Acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components

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.

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

Granules Pharma LLC

1-631-319-1055 or

FDA @ 1-800-FDA-1088 or

www.fda.gov/medwatch

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

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.

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

Package of 12 NDC 70795-2412-01

and

Package of 24 NDC 70795-2412-02

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

Manufactured for:
Granules Pharma, LLC
Bohemia, NY 11716

631-319-1055

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

HYDROCORTISONE ACETATE 
hydrocortisone acetate suppository
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70795-2412
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 100 mg
Product Characteristics
Color yellow ((off-white)) Score     
Shape BULLET Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:70795-2412-2 24 mg in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/12/2016
Labeler - GRANULES PHARMA LLC (056556923)
Revised: 09/2016
 
GRANULES PHARMA LLC



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