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Generic Zelnorm Tegaserod 2/6mg

Side effects like feeling of warmth, itching skin, redness of the face, neck, and arms and occasionally, upper chest, swollen face, full feeling, excess air or gas in stomach or intestines, migraine, nausea are common but not fatal. Indigestion, vomiting is rare side effects but found. Also don't ignore side effects like backache, and leg pain. Tegaserod is a 5-HT4 receptor partial agonist that binds with high affinity at human 5-HT4 receptors, whereas it has no appreciable affinity for 5-HT3 or dopamine receptors.

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Zelnorm Precautions

Three multicenter, double blind, placebo-controlled studies evaluated Zelnorm in 2,470 women with irritable bowel syndrome (IBS) symptoms, namely abdominal pain, bloating and constipation. Two studies were fixed dose studies and the third was a dose-titration study. In all three studies Zelnorm was administered for 12 weeks and efficacy was evaluated based on patients' ratings of their relief of symptoms and the intensity of symptoms. In most cases, diarrhea occurred within the first week of treatment.

Zelnorm Usage Guidelines

Zelnorm has been approved by the FDA for the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation as their main symptom. Other problems associated with IBS include abdominal pain and bloating. Ischemic colitis and other forms of intestinal ischemia have been reported in patients receiving Zelnorm during marketed use of the drug In some cases, hospitalization was required. Tegaserod is a partial agonist that binds with high affinity at human 5-HT4 receptors, whereas it has no appreciable affinity for 5-HT3 or dopamine receptors. It has moderate affinity for 5-HT1 receptors. There was no evidence of carcinogenicity at a lower dose of 200 mg/kg/day (approximately 24 to 35 times the human exposure at 6 mg b.i.d. based on plasma AUC 0-24 hr) or 60 mg/kg/day (approximately 3 to 4 times the human exposure at 6 mg b.i.d. based on plasma AUC 0-24 hr).

Zelnorm Side Effects

Patients should also be aware of the possible occurrence of diarrhea during therapy. Diarrhea can be a pharmacologic response to Zelnorm. The majority of the Zelnorm patients reporting diarrhea had a single episode. Tegaserod was not carcinogenic in rats given oral dietary doses up to 180 mg/kg/day (approximately 93 to 111 times the human exposure at 6 mg b.i.d. based on plasma AUC 0-24 hr) for 110 to 124 weeks. In mice, dietary administration of tegaserod for 104 weeks produced mucosal hyperplasia and adenocarcinoma of small intestine at 600 mg/kg/day (approximately 83 to 110 times the human exposure at 6 mg b.i.d. based on plasma AUC 0-24 hr).

Mechanism Of Action

However, in vivo, no clinically relevant drug-drug interactions have been observed with dextromethorphan (CYP2D6 prototype substrate), and theophylline (CYP1A2 prototype substrate). There was no effect on the pharmacokinetics of digoxin, oral contraceptives, and warfarin. The main human metabolite of tegaserod hydrogen maleate, 5-methoxyindole-3-carboxylic acid glucuronide, did not inhibit the activity of any of the above cytochrome P450 isoenzymes in in vitro tests.

Zelnorm Adverse Reactions

An increase in abdominal surgeries was observed on Zelnorm (9/2,965; 0.3%) vs. placebo (3/1,740; 0.2%) in the Phase 3 IBS clinical studies. The following list of adverse events includes those from Phase 3 clinical studies (6 mg b.i.d. or 2 mg b.i.d.) which were reported more frequently (greater than 0.2%) in patients on Zelnorm than placebo; or which were considered by the investigator to be possibly related to Zelnorm and reported more frequently (greater than 0.1%) on Zelnorm than placebo; or which lead to discontinuation more frequently (greater than /=0.1% and in more than 1 patient) on Zelnorm than placebo. The list also contains those serious adverse events from all clinical trials in patients treated with either 6 mg b.i.d. or 2 mg b.i.d.