Drugs in Pregnancy and Lactation: Tenth Edition

LACTULOSE

Laxative

PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible

BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible

PREGNANCY 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).

FETAL RISK SUMMARY

No impairment of fertility or fetal harm has been observed in pregnant mice, rats, and rabbits at doses up to three or six 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.

BREASTFEEDING SUMMARY

No reports describing the use of lactulose during human lactation have been located.

References

1.Product information. Cephulac. Marion Merrell Dow, 1992.

2.Product information. Duphalac. Solvay Pharmaceuticals, 2000.



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