Monograph Details
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Gastrointestinal Tract
> Colorectal disorders
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ZELNORM |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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5-HT4 receptor agonist. |
| Generic Name |
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Tegaserod (as maleate) 2mg, 6mg; tabs. |
| Indications |
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Short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. |
| Children |
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<18 years: not recommended. |
| Adults |
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Take on empty stomach before meals. ≥18 years: 6 mg twice daily for 4–6 weeks; responders may repeat for an additional 4–6 weeks. Reevaluate periodically; efficacy not established beyond 12 weeks. |
| Contraindications |
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Diarrhea (acute or chronic). Ischemic colitis. Severe renal impairment. Moderate to severe hepatic impairment. History of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, abdominal adhesions. |
| Precautions |
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Do not start in patients with diarrhea or in those who frequently have diarrhea. Discontinue immediately if new or worsening abdominal pain occurs. Follow-up if severe abdominal cramps/pain or dizziness accompanies diarrhea, or if severe diarrhea occurs. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Adverse Reactions |
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Diarrhea (usually occurs within 1st week, then resolves), headache, arthropathy, ischemic colitis; rare: abdominal surgery (esp. gallbladder). |
| Extra Text |
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Note: Zelnorm is only available through a treatment IND by calling (866) 248-1348 or (888) 669-6682. |
| How Supplied |
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Tabs—60 |
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