Serious consequences of diarrhea, including hypovolemia, hypotension, and syncope have been reported in the clinical studies and during marketed use of Zelnorm® (tegaserod maleate) In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop severe diarrhea, hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea (see ADVERSE REACTIONS).
There is currently no manufacturer warning information available for this drug.
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.
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.
Zelnorm® (tegaserod maleate) tablets contain tegaserod as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5O•C4H4O4. The molecular weight is 417.47 and the structural formula is
Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each 1.385 mg of tegaserod as the maleate is equivalent to 1 mg of tegaserod. Zelnorm is available for oral use in the following tablet formulations:
