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:

Each suppository for rectal administration contains hydrocortisone acetate, USP 25 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 the components.

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.

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

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

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.

Hydrocortisone acetate suppositories 25 mg are white to off-white, smooth surfaced and bullet shaped with one pointed end.

Box of 12 suppositories, NDC 16571-676-21

Box of 24 suppositories, NDC 16571-676-42

Rising®                                 NDC 16571-676-21



Hydrocortisone Acetate

Suppositories

25 mg



For Rectal Administration



12 Adult Suppositories        Rx only

Rising®                                 NDC 16571-676-42



Hydrocortisone Acetate

Suppositories

25 mg



For Rectal Administration



24 Adult Suppositories        Rx only