Zelnorm (Tegaserod Maleate) - Indications and Dosage

INDICATIONS AND USAGE

IBS with Constipation

Zelnorm^® (tegaserod maleate) is indicated for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation.

      The safety and effectiveness of Zelnorm in men with IBS with constipation have not been established.

Chronic Idiopathic Constipation

Zelnorm^® (tegaserod maleate) is indicated for the treatment of patients less than 65 years of age with chronic idiopathic constipation. The effectiveness of Zelnorm in patients 65 years or older with chronic idiopathic constipation has not been established (see Geriatric Use).

      The efficacy of Zelnorm for the treatment of IBS with constipation or chronic idiopathic constipation has not been studied beyond 12 weeks.

DOSAGE AND ADMINISTRATION

IBS with Constipation : The recommended dosage of Zelnorm^® (tegaserod maleate) is 6 mg taken twice daily orally before meals for 4-6 weeks. For those women who respond to therapy at 4-6 weeks, an additional 4-6 week course can be considered.

Chronic   Idiopathic Constipation: The recommended dosage of Zelnorm is 6 mg taken twice daily orally before meals. Physicians and patients should periodically assess the need for continued therapy.

HOW SUPPLIED

Zelnorm^® (tegaserod maleate) is available as whitish to slightly yellowish, marbled, circular flat tablets with a bevelled edge containing 2 mg or 6 mg tegaserod as follows:

2 - mg Tablet - white round engraved with “NVR” and “DL”

Unit Dose (blister pack)

      Box of 60 (strips of 10)…………………………………………….NDC 0078-0355-80

6 - mg Tablet - white round engraved with “NVR” and “EH”

Unit Dose (blister pack)

      Box of 60 (strips of 10) ……………………………………………NDC 0078-0356-80

Bottle of 60………………………………………………………………...NDC 0078-0426-20

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

See USP Controlled Room Temperature. Protect from moisture.

T2004-53