Usual Adult Dose for Constipation

50 mg orally 2 times a day

Use: Treatment of irritable bowel syndrome with constipation (IBS-C)

Usual Adult Dose for Irritable Bowel Syndrome

50 mg orally 2 times a day

Use: Treatment of irritable bowel syndrome with constipation (IBS-C)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Patients less than 6 years of age
• Patients with known/suspected mechanical gastrointestinal obstruction

• This drug is contraindicated in patients less than 6 years of age.
• In nonclinical studies in young juvenile rats, administration of this drug caused deaths presumed to be due to dehydration.
• Avoid use of this drug in patients 6 years to less than 12 years of age.
• The safety and effectiveness of this drug have not been established in patients less than 18 years of age

Dialysis

Data not available

Other Comments

Administration advice:

• The morning dose of this drug should be taken immediately prior to breakfast/first meal of the day; the second dose should be taken immediately prior to dinner.
• If a dose is missed, the missed dose should be skipped, and the next dose should be taken at the regular time. Patients should not take 2 doses at the same time.

• Protect from moisture; store in a dry area, and keep the bottle tightly closed when not in use.
• Avoid subdividing or repackaging this drug.

• GASTROINTESTINAL: Signs/symptoms of severe diarrhea

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients should be told to protect this drug from moisture (e.g., storing in a dry area, keeping the desiccant in the bottle, covering the bottle when not in use).
• Patients should be instructed to report episodes of severe diarrhea to their healthcare provider.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.