Diarrhea tegaserod

Tegaserod maleate (Zelnorm) is a partial serotonin (5-HT4) receptor agonist that causes an increase in peristaltic activity and intestinal secretion and moderation of visceral sensitivity. It increases the frequency of bowel movements and reduces abdominal discomfort, bloating, and straining. It is indicated for the treatment of patients younger than 65 years of age who experience chronic idiopathic constipation. The most common adverse effects include headache, abdominal pain, diarrhea, and nausea. 

Tegaserod maleate (Zelnorm) stimulates 5-HT4 receptors in the GI tract, thereby increasing intestinal secretion, peristalsis, and small bowel transit. It also reduces sensitivity related to abdominal distention. It has been shown to be more effective than placebo in improving global IBS symptoms and altered bowel habits in constipation-predominant IBS.21 Diarrhea is a possible adverse effect. 

Ischemic colitis has been observed in some patients taking tegaserod. The drug should be discontinued promptly if rectal bleeding, bloody diarrhea, or worsening abdominal pain occurs. 

Diarrhea Do not initiate tegaserod in patients who are currently experiencing or frequently experience diarrhea. Discontinue tegaserod immediately in patients with new or sudden worsening of abdominal pain. In most cases, diarrhea occurred within the first week of treatment. Typically, diarrhea resolved with continued therapy. Patients should consult their health care provider if they experience severe diarrhea or if the diarrhea is accompanied by severe cramping, abdominal pain, or dizziness. Discontinue tegaserod immediately in patients who develop severe diarrhea, hypotension, or syncope. 

Elderly Patients 65 years of age and older who received tegaserod for chronic idiopathic constipation experienced a higher incidence of diarrhea and discontinuations because of diarrhea than patients younger than 65 years of age. Pregnancy Category B. Use during pregnancy only if clearly needed. 

Ischemic colitis Ischemic colitis and other forms of intestinal ischemia have been reported in patients receiving tegaserod during marketed use of the drug. Discontinue tegaserod immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. 

Tegaserod appears to be an extremely safe agent. Diarrhea occurs in 9% of patients within the first few days of treatment, but resolves in the majority of patients. Less than 2% of patients discontinue the drug because of diarrhea. Although it is stated that the drug does not cross the blood-brain barrier (and does not affect central serotonin receptors), headache may occur. 

The newer serotonin receptor agonists and antagonists tegaserod and alosetron act on Gl-specific serotonin receptors to treat constipation-predominant and diarrhea-predominant IBS, respectively. However, both drugs are currently only indicated for women. Efficacy and safety in men has not been established because the initial manufacturer s sponsored clinical trials contained insufficient numbers of men with IBS to provide the necessary statistical power to prove efficacy and safety. Ongoing studies should determine if these drugs are indicated in men. 

HT4 agonists such as tegaserod. Although they also may blunt visceral sensation, a direct effect on spinal afferents has not been fully established. Alosetron was the first agent in this class specifically approved for the treatment of diarrhea-predominant IBS in women. 

Diarrhea and headache are the most common side effects of tegaserod, occurring in -10% of patients. Tegaserod does not appear to have any clinically relevant drug-drug interactions. No dosage adjustment is required in elderly patients or those with mild-to-moderate hepatic or renal impairment, but tegaserod should not be used in patients with severe hepatic or renal impairment. 

Observational studies In two identical open studies (El, E2) of oral tegaserod (6 mg bd over 1 year) in 780 women with dysmotility-like functional dyspepsia, who had previously completed two 6-week, randomized, placebo-controlled trials with tegaserod at the same dosage, tegaserod was effective against dyspeptic symptoms. Most adverse events were reported within the first 6 months, and the most common included diarrhea, headache, nausea, abdominal pain, vomiting, and constipation. One patient developed severe bradycardia. 

Placebo-controlled studies The efficacy of tegaserod 6 mg bd for 6 weeks in 2667 women with dysmotility-like functional dyspepsia has been evaluated in two randomized, double-blind, placebo-controlled trials [22 "]. There were some improvements in symptom severity and quality of life in those who took tegaserod, although the clinical implication of these improvements is uncertain. Diarrhea, requiring drug withdrawal, was more common with tegaserod than with placebo. 

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