Lactulose: uses, appearance and warnings

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.

Lactulose Solution is available as follows: 8 fl oz (237 mL) bottle NDC 83745-405-08 16 fl oz (473 mL) bottle NDC 83745-405-16 32 fl oz (946 mL) bottle NDC 83745-405-32 Lactulose Solution contains lactulose 667 mg/mL (10 g/15 mL). Store between 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 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be harmaceutically 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: APOZEAL PHARMACEUTICALS INC. 2091 Hartel St Levittown, PA 19057 Made in USA Revised 11/2024 logo

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

A theoretical hazard may exist for patients being treated with lactulose solution 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.

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 Apozeal Pharmaceuticals Inc. at tel: 1-833-688-7848 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Results of preliminary studies in humans and rats suggest that non-absorbable 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.