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Generlac (Lactulose) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

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 in the diet of mice for 18 months in concentrations of 3% and 10% (V/W) did not produce any evidence of carcinogenicity.

In studies in mice, rats, and rabbits, doses of lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects on breeding, conception, or parturition.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in mice, rats, and rabbits at doses up to 2 or 4 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.

OVERDOSAGE

Signs and Symptoms

There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated.

Oral LD

The acute oral LD50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats.

Dialysis

Dialysis data are not available for lactulose. Its molecular similarity to sucrose, however, would suggest it should be dialyzable.

CONTRAINDICATIONS

Since Generlac Solution (Lactulose Solution, USP) contains galactose (not more than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.

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