Zelnorm

Zelnorm Information

Brand Name: Zelnorm

Generic Name: Tegaserod Maleate

Zelnorm is a medicine for the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation (not enough or hard bowel movements) as their main bowel problem. Women with this medical condition suffer from abdominal (stomach) pain or discomfort, bloating, and constipation. Zelnorm does not work for all women that use it. Zelnorm has not been shown to work in men with IBS.

Zelnorm increases the movement of stools (bowel movement) through the bowels. Zelnorm does not cure IBS. For those who are helped, Zelnorm reduces pain and discomfort in the abdominal area, bloating, and constipation. If you stop taking Zelnorm, your IBS symptoms may return within 1 or 2 weeks.

Zelnorm Indications

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 have not been established.

Zelnorm Ingredients and Composition

How Does Zelnorm Work?

Mechanism of Action

Clinical investigations have shown that both motor and sensory functions of the gut appear to be altered in patients suffering from irritable bowel syndrome (IBS). Both the enteric nervous system, which acts to integrate and process information in the gut, and 5-hydroxytryptamine (5-HT, serotonin) are thought to represent key elements in the etiology of IBS. Approximately 95% of serotonin is found throughout the gastrointestinal tract, primarily stored in enterochromaffin cells but also in enteric nerves acting as a neurotransmitter. Serotonin has been shown to be involved in regulating motility, visceral sensitivity and intestinal secretion. Investigations suggest an important role of serotonin Type-4 (5-HT4) receptors in the maintenance of gastrointestinal functions in humans.

Tegaserod, as usd in Zelnorm, 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. It has moderate affinity for 5-HT1 receptors. Tegaserod, by acting as an agonist at neuronal 5-HT4 receptors, triggers the release of further neurotransmitters such as calcitonin gene-related peptide from sensory neurons. The activation of 5-HT4 receptors in the gastrointestinal tract stimulates the peristaltic reflex and intestinal secretion, as well as inhibits visceral sensitivity. In vivo studies showed that tegaserod enhanced basal motor activity and normalized impaired motility throughout the gastrointestinal tract. In addition, studies demonstrated that tegaserod moderated visceral sensitivity during colorectal distension in animals.

How To Take Zelnorm and Zelnorm Dosage and Administration

The recommended Zelnorm dosage of is 6 mg taken twice daily orally before meals for 4 to 6 weeks. For those patients who respond to therapy at 4-6 weeks, an additional 4-6 week course can be considered.

If you suspect a Zelnorm Overdose

There have been no reports of human Zelnorm overdosage (tegaserod maleate). Single oral doses of 120 mg of tegaserod were administered to 3 healthy volunteers in one study. All 3 subjects developed diarrhea and headache. Two of these subjects also reported intermittent abdominal pain, and 1 developed orthostatic hypotension. In 28 healthy subjects exposed to Zelnorm doses of tegaserod of 90 to 180 mg/d for several days, adverse events were diarrhea (100%), headache (57%), abdominal pain (18%), flatulence (18%), nausea (7%) and vomiting (7%).

Based on the large distribution volume and high protein binding of tegaserod it is unlikely that tegaserod could be removed by dialysis. In cases of Zelnorm overdosage treat symptomatically and institute supportive measures as appropriate.

Zelnorm Pill Identification / ID and Appearance

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)

6 mg Tablet - white round engraved with "NVR" and "EH" Unit Dose (blister pack) Box of 60 (strips of 10)

Zelnorm Side Effects

Zelnorm Precautions and Contraindications

Zelnorm (tegaserod maleate) should not be initiated in patients who are currently experiencing or frequently experience diarrhea. Zelnorm should be discontinued immediately in patients with new or sudden worsening of abdominal pain.

Contraindications to Zelnorm

Zelnorm (tegaserod maleate) is contraindicated in those patients with:

• severe renal impairment
• moderate or severe hepatic impairment
• a history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
• a known hypersensitivity to the drug or any of its excipients

Zelnorm Clinical Trials and Studies

Additional Patient Information for Zelnorm

Patients should take Zelnorm before a meal.

Patients should also be aware of the possible occurrence of diarrhea during therapy. The majority of the Zelnorm patients reporting diarrhea had a single episode. In most cases, diarrhea occurred within the first week of treatment. Typically, diarrhea resolved with continued therapy. Patients should consult their physician if they experience severe diarrhea, or if the diarrhea is accompanied by severe cramping, abdominal pain, or dizziness. Patients should not initiate therapy with Zelnorm if they are currently experiencing or frequently experience diarrhea. Patients should consult their physician if they experience new or worsening abdominal pain.

Storing Zelnorm

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

Information about the Manufacturer of Zelnorm

Zelnorm Manufactured by: Novartis Pharma Stein AG

Zelnorm Distributed in the USA by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 Novartis,