Usual Adult Dose for Irritable Bowel Syndrome

Usual dose: 100 mg orally twice a day

Comments:

• Dose should be reduced to 75 mg orally twice a day for patients unable to tolerate usual dose.
• If severe constipation develops, this drug should be discontinued.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild to Moderate Hepatic Impairment (Child-Pugh A or B): 75 mg orally twice a day
Severe Hepatic Impairment (Child-Pugh C): Contraindicated

Dose Adjustments

For patients unable to tolerate the usual dose: Reduce dose to 75 mg orally twice a day

For patients receiving concomitant OATP1B1 inhibitors: Reduce dose to 75 mg orally twice a day

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally twice a day with food
• If a dose is missed, take the next dose at the regular time; do not take 2 doses at the same time.

• This drug should not be used in patients without a gallbladder or in patients with risks factors for acute pancreatitis
• This drug should be discontinued in patients who develop severe constipation.
• Loperamide may be used for the acute management of severe diarrhea, but it should be discontinued if constipation develops; patients should not take alosetron or loperamide on a chronic basis due to the potential for constipation.
• Patients should avoid concomitant use of medications that may cause constipation.

• Monitor for constipation.
• Monitor for signs and symptoms of sphincter of Oddi spasm (e.g., acute worsening of abdominal pain [acute epigastric or right upper quadrant biliary pain] that may radiate to the back or shoulder and associated with pancreatic enzyme or hepatic transaminase elevations, especially within first few weeks.

• Patients should be instructed to stop taking this drug and get emergency medical care if new or worsening stomach or abdominal pain develops, especially if pain is in the upper right side of stomach or abdomen and radiates to back or shoulder develops; nausea and vomiting may or may not be present.
• Patients should stop this drug and contact their health care professional if they experience severe constipation.
• Patients should avoid concomitant use of medications that may cause constipation.
• Patients should avoid chronic and acute excessive alcohol intake.
• This drug may cause somnolence and sedation in some people; patients should understand how this drug effects their ability to drive or perform hazardous activities before undertaking these tasks.

Frequently asked questions

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