DESCRIPTION
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:
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2-mg and 6-mg tablets (blister packs) containing 2 mg and 6 mg tegaserod, respectively and the following inactive ingredients: crospovidone, glyceryl monostearate, hypromellose, lactose monohydrate, poloxamer 188, and polyethylene glycol 4000.
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6-mg tablets (bottles) containing 6 mg tegaserod and the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, and colloidal silicon dioxide.
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