LACTULOSE

Fetal Risk Summary

Lactulose is a synthetic disaccharide that is biodegraded only by bacteria in the colon to the low molecular weight acids, lactic acid, formic acid, and acetic acid. Small amounts of lactulose, about 3% of a dose, are absorbed following oral administration (1).

No impairment of fertility or fetal harm have been observed in pregnant mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose (2). No reports on the use of this product in human pregnancy or lactation have been located, but the risk to the fetus and the newborn appears to be negligible.

Breast Feeding Summary

No data are available.

References

1. Product information. Cephulac. Marion Merrell Dow, 1992.
2. Product information. Duphalac. Solvay Pharmaceuticals, 2000.