Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 20 December 2017

Indication(s)

INDICATIONS AND USAGE 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.

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Fluid Management

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Advisory information

contraindications
CONTRAINDICATIONS Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
Special warnings and precautions
PRECAUTIONS General Since lactulose solution contains galactose (less than 1.6 g/15 mL) and lactose (less than 1.2 g/15 mL) it should be used with caution in diabetics. Information for Patients In the event that an unusual diarrheal condition occurs, contact your physician. Laboratory Tests Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. Drug Interactions 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. Carcinogenesis, Mutagenesis, Impairment of Fertility There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility. There are no known animal data on long-term potential for mutagenicity. Administration of lactulose solution in the diet of mice for 18 months in concentrations of 3 and 10 percent (v/w) did not produce any evidence of carcinogenicity. In studies of mice, rats, and rabbits, doses of lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects in breeding, conception, or parturition. Pregnancy Teratogenic Effects Pregnancy category B. Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Adverse reactions
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. To report SUSPECTED ADVERSE EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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.
Pregnancy and lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.

Interactions

Drug Interactions 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.

More information

Category Value
Authorisation number ANDA090503
Agency product number 9U7D5QH5AE
Orphan designation No
Product NDC 45963-439
Date Last Revised 06-01-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 544452
Marketing authorisation holder Actavis Pharma, Inc.