Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene 3,
20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11B) with the following structural formula:
Each rectal suppository contains hydrocortisone acetate, USP 25 mg in a specially blended
hydrogenated vegetable oil base.
CLINICAL PHARMACOLOGY: In normal subjects, about 26% of hydrocortisone acetate is absorbed
when the 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 antiinflammatory, 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; and 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 the components.
Directions: 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 packet. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with 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.
Warnings: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.
INFORMATION FOR PATIENTS: Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.
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 to 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, folliculitis, 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.
OVERDOSAGE: If signs and symptoms of systemic overdosage occur, discontinue use.
