Anusol HC

Salix Pharmaceuticals, Inc

FULL PRESCRIBING INFORMATION: CONTENTS*

• ANUSOL HC DESCRIPTION
• CLINICAL PHARMACOLOGY
• ANUSOL HC INDICATIONS AND USAGE
• CONTRAINDICATION
• PRECAUTIONS
• Information for Patients
• Pregnancy Category C
• ANUSOL HC ADVERSE REACTIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• ANUSOL HC DOSAGE AND ADMINISTRATION
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

Anusol-HC^®

25-mg Suppository

(Hydrocortisone Acetate)

ANUSOL HC DESCRIPTION

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:

CLINICAL PHARMACOLOGY

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.

ANUSOL HC 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.

CONTRAINDICATION

 Anusol-HC^® suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.

PRECAUTIONS

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

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.

ANUSOL HC ADVERSE REACTIONS

The following local adverse reactions have been reported with corticosteroid suppositories.

DRUG ABUSE AND DEPENDENCE

Drug abuse and dependence has not been reported in patients treated with Anusol-HC^® suppositories.

OVERDOSAGE

If signs and symptoms of systemic overdosage occur, discontinue use.

ANUSOL HC DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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.

Rx only.

Prescribing Information as of March 2005.

Manufactured for: Salix Pharmaceuticals, Inc., Morrisville, NC 27560

  OPENING INSTRUCTIONS

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.

                                                                                                                                                                 6415

                                                                                                                                                                 Rev. 3/05 3000263-C

PACKAGE LABEL PRINCIPAL DISPLAY PANEL -  Anusol-HC^® 12 Suppositories Carton Label

NDC  65649-411-12

Rx only

Store at 20°-25°C (68°-77°F). See USP Controlled Temperature. Store away from heat. Protect from freezing  

Anusol-HC^®   

(Hydrocortisone Acetate in a

Hydrogenated Vegetable Oil Base)

25 mg                                 12 Suppositories