Label: HYDROCORTISONE ACETATE suppository

Rx only

Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula:

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 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.

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 Cameron Pharmaceuticals, LLC at 1-888-767-7913.

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 and carefully separate tabs at top opening and pull downward from the pointed end to expose the suppository. Remove the suppository from the pocket. Avoid excessive handling of suppository which is designed to melt at body temperature. Insert one suppository rectally, 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 factital proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.

Hydrocortisone acetate suppositories 30mg are off-white, smooth surfaced and bullet shaped with one pointed end.

Box of 12 suppositories, NDC 42494-342-12

This product is not an Orange Book rated product, therefore all prescriptions using this product shall be subject to state and federal statutes as applicable. This product has not been subjected to FDA therapeutic or other equivalency testing. There are no claims of bioequivalence or therapeutic equivalence. Each person recommending a prescription substitution using the product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information contained within the enclosed prescribing information.

Rx Only

Manufacturing for:
Cameron Pharmaceuticals, LLC
Louisville, KY 40245

Rev. 08/21

Hydrocortisone Acetate Suppositories 30mg

FOR RECTAL USE ONLY

12 Suppositories
Unit Dose

Rx Only

2000014-01

NDC 42494-342-12

CAMERON
PHARMACEUTICALS ™

Hydrocortisone Acetate
Suppositories

30 mg
FOR RECTAL USE ONLY

12 Suppositories
Unit Dose

Rx Only