INDICATIONS AND USAGE:
KRISTALOSE® (lactulose) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
IMPORTANT SAFETY INFORMATION:
KRISTALOSE® is contraindicated in patients who require a low-galactose diet and should be used with caution in diabetics. Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications, such as loss of fluids, hypokalemia, and hypernatremia. Nausea and vomiting have been reported.
Safety and effectiveness in pediatric patients have not been established.