INDICATIONS AND USAGE 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.

WARNINGS A theoretical hazard may exist for patients being treated with lactulose who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy.

Accumulation of H 2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction.

Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution.

Insufflation of CO 2 as an additional safeguard may be pursued but is considered to be a redundant measure.

ADVERSE REACTIONS Precise frequency data are not available.

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.