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Polyethylene glycol 3350 Pregnancy and Breastfeeding Warnings

Polyethylene glycol 3350 is also known as: ClearLax, GaviLAX, GlycoLax, HealthyLax, MiraLax, PEG3350, Purelax, SunMark ClearLax

Polyethylene glycol 3350 Pregnancy Warnings

Animal studies have not been conducted. There are no controlled data in human pregnancy. Systemic exposure if negligible, so clinically significant exposure of the fetus is not expected. 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.

Use is not recommended unless clearly needed. AU TGA pregnancy category: B1 US FDA pregnancy category: Not assigned

See references

Polyethylene glycol 3350 Breastfeeding Warnings

This drug should be used only if clearly needed. Excreted into human milk: Unknown Excreted into animal milk: Unknown

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0

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