Hydrocortisone Acetate

HYDROCORTISONE ACETATE- hydrocortisone acetate suppository
Brandywine Pharmaceuticals, Inc.

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.

​Rx only ​| Unit Dose

Disclaimer: All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

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:

Hydrocortisone Acetate
(click image for full-size original)

Each suppository for rectal administration contains hydrocortisone acetate, USP 30 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 those components.

PRECAUTIONS:

Do not use hydrocortisone acetate suppositories unless adequate proctologic examination has been 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.

CARCINOGENS:

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

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, folliculities, hypopigmentation, allergic contact dermatitis, secondary infection.

DRUG ABUSE AND DEPENDENCE:

Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

DOSAGE AND ADMINISTRATION:

For rectal administration. Detach one suppository from strip of suppositories. 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 30 mg are off-white, smooth surfaced, and bullet shaped with one pointed end.

Box of 12 suppositories, NDC 71321-603-12

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.

WARNING: 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 for Brandywine Pharmaceuticals, LLC

West Chester, PA 19382 Rev. 2/21

Principal Display Panel

NDC 71321 ​-603 ​-12 ​Rx Only

​Hydrocortisone

Acetate

Suppositories

30 mg

​UNIT DOSE

FOR RECTAL USE ONLY

​BRANDYWINE PHARMACEUTICALS, LLC

​12 SUPPOSITORIES

​Hydrocortisone Acetate

​Suppositories

​30 mg

​12 SUPPOSITORIES

Hydrocortisone Acetate Label
(click image for full-size original)

HYDROCORTISONE ACETATE
hydrocortisone acetate suppository
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71321-603
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 30 mg
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED PALM KERNEL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71321-603-12 12 SUPPOSITORY in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/26/2021
Labeler — Brandywine Pharmaceuticals, Inc. (080581956)
Registrant — Brandywine Pharmaceuticals, Inc. (080581956)

Revised: 12/2021 Brandywine Pharmaceuticals, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.