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hydrocortisone acetate suppository
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Each Anusol-HC® 25-mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base. Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy (11ß)- with the following structural formula:
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 anti-inflammatory, anti-pruritic and vasoconstrictive action.
INDICATIONS AND USAGE
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 pruritis 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.
Information for Patients
Staining of fabric may occur with use of the suppository. Precautionary measures are recommended.
Pregnancy Category C
|1. Burning||4. Dryness||7. Allergic contact dermatitis|
|2. Itching||5. Folliculitis||8. Secondary infection|
|3. Irritation||6. Hypopigmentation|
Drug abuse and dependence has not been reported in patients treated with Anusol-HC® suppositories.
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.
Anusol-HC® 25-mg Suppositories are white, cylinder shaped, with one end tapered. Package of 12 suppositories (NDC 65649-411-12) and package of 24 suppositories (NDC 65649-411-24).
Store at 20°-25°C (68°-77°F). See USP Controlled Temperature. Store away from heat. Protect from freezing.
Prescribing Information as of March 2005.
Manufactured for: Salix Pharmaceuticals, Inc., Morrisville, NC 27560
Avoid excessive handling of the suppository. It is designed to melt at body temperature.
1. Separate plastic film at top opening and pull downward.
2. Continue pulling downward to almost the full length of the suppository.
3. Gently remove the suppository from the film pocket.
Rev. 3/05 3000263-C
PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Anusol-HC® 12 Suppositories Carton Label
Store at 20°-25°C (68°-77°F). See USP Controlled Temperature. Store away from heat. Protect from freezing
(Hydrocortisone Acetate in a
Hydrogenated Vegetable Oil Base)
25 mg 12 Suppositories
hydrocortisone acetate suppository
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|Unapproved drug other||06/01/2004|
|Labeler - Salix Pharmaceuticals, Inc (793108036)|
|Paddock Laboratories, Inc.||086116803||MANUFACTURE|
Revised: 02/2011 Salix Pharmaceuticals, Inc
Reproduced with permission of U.S. National Library of Medicine
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|Over-the-counter (OTC) Drugs|