Tegaserod (Zelnorm) Indications and Dosage
- constipation
- irritable bowel syndrome
Tegaserod (Zelnorm) Indications and Dosage
For the treatment irritable bowel syndrome (IBS) in women whose predominant bowel symptom is constipation:
NOTE: Safe and effective use in men has not been established.
Oral dosage:
Adult and elderly females: 6 mg PO twice per day before meals for 4 - 6 weeks. If patient response is favorable at that time, an additional 4 to 6 week course can be considered.
Adolescents and children: No studies have been conducted.
For the treatment of chronic constipation:
NOTE: Chronic constipation is defined as constipation lasting for longer than 6 months with < 3 complete spontaneous bowel movements (CSBM) per week. The CSBM involved straining, incomplete evacuation and/or hard stools. Patients with chronic constipation do not have any form of IBS (diarrhea-predominant, constipation-predominant or mixed-type IBS) or loose stools at any time.
Oral dosage:
Adults < 65 years: 6 mg PO twice daily before meals. In two controlled clinical trials (n=2281; female = 91%), both tegaserod 2 mg PO twice daily and 6 mg PO twice daily regimens were superior to placebo at 4 weeks. CSBM increased 41% and 43% in the tegaserod 2 and 6 mg dose groups, respectively; the placebo group increased 25% (P<0.0001). However, at 12 weeks, the 2 mg dose was superior to placebo in only one of the studies. Symptoms related to chronic constipation, such as abdominal pain, bloating, straining and stool consistency and bowel habit satisfaction were improved in the tegaserod groups. Diarrhea (4 - 6% in active group vs. 2% placebo) and headache (8% in active group vs. 5% placebo) were the most commonly reported ADRs.
Adolescents and children: No studies have been conducted.
Maximum Dosage Limits:
- Adults: 12 mg/day PO.
- Elderly: 12 mg/day PO.
- Adolescents: Not recommended.
- Children: Not recommended.
Patients with hepatic impairment:
No dosage adjustment is required in patients with mild hepatic impairment; however caution should be used. According to the manufacturer, tegaserod has not been adequately studied in patients with moderate to severe hepatic impairment and therefore should not be used in this population.
Patients with renal impairment:
No dosage adjustment is required for mild-to-moderate renal impairment. The manufacturer does not recommend use in patients with severe renal impairment.
Intermittent hemodialysis:
Pharmacokinetic parameters were not altered in hemodialysis patients. However, the manufacturer does not recommend use in patients with severe renal impairment.
Continuous hemodialysis:
Pharmacokinetic parameters were not altered in hemodialysis patients. However, the manufacturer does not recommend use in patients with severe renal impairment.
†non-FDA approved indication
[ Last revised: 8/24/2005 5:00:00 PM ]
References
. Camilleri M. Review article: Tegaserod. Aliment Pharmacol Ther 2001;15:277 - 89.
. Zhou H, McLeod J, Alladina L et al. Pharmacokinetics of SDZ HTF 919 not altered in subjects with severe renal insufficiency requiring hemodialysis (abstract no. PIII - 108) Clin Pharmacol Ther 1999;65:203.
. Johansen JF, Tougas G, Chey WD, et al. Tegaserod (Zelnorm) provides rapid and sustained relief of constipation, abdominal bloating/distention, and abdominal discomfort/pain in patients with chronic constipation (abstract 105071). 34th Annual Digestive Disease Week, Orlando, Florida. May 2003.
. Wald A, Johansen J, Tougas G et al. Safety and tolerability of tegaserod in patients treated for chronic constipation; a 12-week, double-blind, placebo controlled multicentre study performed in the Americas (abstract 106380). 34th Annual Digestive Disease Week, Orlando, Florida. May 2003.
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