Zelnorm (Tegaserod Maleate) Drug Information: Overdosage and Contraindications

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May 27, 2012

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What is irritable bowel syndrome (IBS)?

Irritable bowel syndrome (IBS) is one of the most common ailments of the bowel (intestines) and affects an estimated 15% of people in the US. The term, irritable bowel, is not a particularly accurate one since it implies that the bowel is responding irritably to normal stimuli, and this may or may not be the case. The several terms used for IBS, including spastic colon, spastic colitis, and mucous colitis, attest to the difficulty of getting a descriptive handle on the ailment. Moreover, each of the other names is itself as problematic as the term IBS.

IBS is best described as a functional disease. The concept of functional disease is particularly useful when discussing diseases of the gastrointestinal tract. The concept applies to the muscular organs of the gastrointestinal tract; the esophagus, stomach, small intestine, gallbladder, and colon. What is meant by the term, functional, is that either th...

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Please Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

OVERDOSE

There have been no reports of human overdosage with Zelnorm^® (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 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 overdosage treat symptomatically and institute supportive measures as appropriate.

CONTRAINDICATIONS

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

Last reviewed on RxList: 12/27/2004
This monograph has been modified to include the generic and brand name in many instances.