Hydrocortisone Acetate

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.

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

Each suppository for rectal administration contains hydrocortisone acetate, USP 30 mg in a specially blended hydrogenated vegetable base.

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.

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.

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

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.

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

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.

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 have not been reported in patients treated with hydrocortisone acetate suppositories.

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.

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

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.

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

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