Polyethylene glycol 3350 with electrolytes Pregnancy and Breastfeeding Warnings

Brand names: Clenz-Lyte, Co-Lav, Colonic Lavage Solution, Colyte, GaviLyte-C, GaviLyte-G, GaviLyte-H, GaviLyte-N, Go-Evac, GoLYTELY, MoviPrep, NuLYTELY, PEG-3350 with Electolytes, Plenvu, Suclear, Suflave, TriLyte

Medically reviewed by Drugs.com. Last updated on Jun 12, 2024.

Polyethylene glycol 3350 with electrolytes Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies have shown indirect reproductive toxicity, including reduction in fetal and placental weight, reduced fetal viability, increased limb and paw hyperflexion, and abortions at maternally toxic doses; there was no indication of teratogenicity. No clinical effects are anticipated during pregnancy, as systemic exposure is negligible. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Polyethylene glycol 3350 with electrolytes Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-No effects on the infant are expected since systemic exposure to the breastfeeding woman is negligible.

See references

Further information

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