Zelnorm Lawsuit
Zelnorm, a tegaserod maleate tablet, was approved in 2002 by the FDA and is used to treat constipated women with irritable bowel syndrome. In 2004 the approval was expanded to treat chronic constipation in both men and women younger than 65. The drug is no longer available in the U.S.
The hydrogen maleate salt contained in Zelnorm is tegaserod. tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. The drug’s empirical formula is C16H23N5O.C4H4O4 and the molecular weight is 417.47.
As the maleate salt in Zelnorm, Tegaserod is a white to off-white crystalline powder and is soluble slightly in ethanol and even less soluble in water. 1.385mg of tegaserod as the maleate salt is equivalent to 1 mg of tegaserod.
Zelnorm is available for oral use in the 2 mg and 6 mg tablets in blister packs containing 2 mg and 6 mg tegaserod and the following inactive ingredients:
· lactose monohydrate
· polyethylene glycol 4000
· Crospovidone
· glyceryl monostearate
· hypromellose
· poloxamer 188
Zelnorm is also available in 6mg tablets in prescription bottles containing 6mg tegaserod and the following inactive ingredients:
· lactose monohydrate
· colloidal silicon dioxide
· crospovidone
· glyceryl behenate
· hypromellose
Zelnorm is used to treat patients less than 65 years of age with chronic idiopathic constipation and for the treatment of women with IBS. Zelnorm’s effectiveness in patients older than 65 years has not yet been established and its efficiency for treatment of IBS with constipation or chronic idiopathic constipation has not yet been studied beyond 12 weeks.
The recommended dose of Zelnorm for patients with Chronic Idiopathic Constipation is 6mg taken orally before meals twice daily. The need for continued therapy should be assessed periodically by patients and their physicians.