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Each Anusol-HC 25-mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated cocoglyceride base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-,(11(beta)) with the following structural formula:
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In normal subjects, about 26 percent 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 antiinflammatory, antipruritic and vasoconstrictive action.
For use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani.
Anusol-HC suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.
Do not use 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, the corticosteroid 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.
Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.
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. Anusol-HC 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 Anusol-HC 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 corticosteroid suppositories:
Drug abuse and dependence have not been reported in patients treated with Anusol-HC suppositories.
If signs and symptoms of systemic overdosage occur discontinue use.
Usual dosage: One suppository in the rectum morning and night for two weeks in nonspecific proctitis. In more severe cases, one suppository three times daily; or two suppositories twice daily. In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.
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Avoid excessive handling of the suppository. It is designed to melt at body temperature.
Anusol-HC 25-mg Suppositories are off-white, smooth surfaced, rod shaped with one rounded end. Package of 12 suppositories NDC 61570-172-61 and package of 24 suppositories NDC 61570-172-62.
Revised September 1993
Rx only
Distributed by: Monarch Pharmaceuticals, Inc.
Bristol, TN 37620
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