PREGNANCY: For PICOPREP no clinical data on exposed pregnancy are available. Studies in animals have shown reproductive toxicity. As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of PICOPREP during pregnancy.
Fertility: Studies with PICOPREP in animals have shown no impairment of fertility or embryo-fetal toxicity. In studies with sodium picosulfate alone, embryofetal toxicity has been observed in rats and rabbits at very high doses. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
LACTATION: There is no experience with the use of PICOPREP in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with PICOPREP may be considered for females who are breastfeeding.