HYDROCORTISONE ACETATE

Hydrocortisone acetate is a corticosteroid designed chemically as pregn-4-ene 3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy––(11 β) with the following structural formula: Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended hydrogenated vegetable oil base. structural formula

: 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; and other inflammatory conditions of anorectum and pruritus ani.

: For rectal administration. Detach one suppository from strip of suppositories. Remove the wrapper. 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. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjec ted to FDA therapeutic or other equivalency testin g. No representation is made as to generic status or bioequivalency . Each person recommending a prescription substitution using this product shall make such recommendation based on his/her professional knowledge and opinion, upon evaluating the active ingredients, inactive ingredients, excipients and chemical information provided herein.

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

The following local adverse reactions have been reported with corticosteroid suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection.

STORAGE: Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Excursions permitted to 15º-30ºC (59º-86ºF). Store away from heat. Protect from freezing.