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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 Mar 5, 2024.

Polyethylene glycol 3350 with electrolytes Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

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. There are no controlled data in human pregnancy. No clinical effects are anticipated during pregnancy, as systemic exposure is negligible.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

References for pregnancy information

  1. Product Information. Golytely (polyethylene glycol 3350 with electrolytes). Braintree.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.
  4. Product Information. MoviPrep (polyethylene glycol 3350 with electrolytes). Physicians Total Care. 2016.
  5. Product Information. NuLYTELY with Flavor Packs (polyethylene glycol 3350 with electrolytes). Braintree Laboratories. 2016.
  6. Product Information. TriLyte with Flavor Packs (polyethylene glycol 3350 with electrolytes). Alaven Pharmaceuticals. 2016.
  7. Product Information. Colyte with Flavor Packs (polyethylene glycol 3350 with electrolytes). Alaven Pharmaceuticals. 2016.

References for breastfeeding information

  1. Product Information. Golytely (polyethylene glycol 3350 with electrolytes). Braintree.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.
  4. Product Information. MoviPrep (polyethylene glycol 3350 with electrolytes). Physicians Total Care. 2016.
  5. Product Information. NuLYTELY with Flavor Packs (polyethylene glycol 3350 with electrolytes). Braintree Laboratories. 2016.
  6. Product Information. TriLyte with Flavor Packs (polyethylene glycol 3350 with electrolytes). Alaven Pharmaceuticals. 2016.
  7. Product Information. Colyte with Flavor Packs (polyethylene glycol 3350 with electrolytes). Alaven Pharmaceuticals. 2016.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.