LACTULOSE

Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains; 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 3.0 to 5.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C 12 H 22 O 11 . It has the following structural formula: The molecular weight is 342.3 g/mole. It is freely soluble in water, sparingly soluble in methanol, practically insoluble in toluene, insoluble in ether. Chemical Structure

For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily. The dose may be increased to 60 mL daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement. Note: Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water or milk.

Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.

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. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Results of preliminary studies in humans and rats suggest that nonabsorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose solution.

Store at controlled room temperature 15° to 30°C (59° to 86° F). Do not freeze. Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 30°C (86° F) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use. Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature. Dispense in original container or in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Rx only Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Revised: July 2025 5256388-0725-03