Source: FDA, National Drug Code (US) Revision Year: 2020
ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C).
Limitations of Use:
The recommended dosage of ZELNORM in adult women less than 65 years of age is 6 mg taken twice daily orally at least 30 minutes before meals [see Clinical Pharmacology (12.3)]. Discontinue ZELNORM in patients who have not had adequate control of symptoms after 4 to 6 weeks of treatment.
Single oral doses of 120 mg (20 times the recommended dose) of ZELNORM were administered to three healthy subjects in one study. All three subjects developed diarrhea and headache. Two of these subjects also reported intermittent abdominal pain and one developed orthostatic hypotension. In 28 healthy subjects exposed to 90 to 180 mg per day of ZELNORM (7.5 to 15 times the recommended daily dosage) for several days, adverse reactions 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.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
See USP Controlled Room Temperature. Protect from moisture.
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