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Pralidoxime Pregnancy and Breastfeeding Warnings

Pralidoxime is also known as: Protopam Chloride

Medically reviewed on Dec 15, 2017

Pralidoxime Pregnancy Warnings

Animal studies have not been conducted. There are no controlled data in human pregnancy. The molecular weight is low enough that this drug could cross the placenta. Two case reports of use in pregnancy for organophosphate poisoning resulted in healthy newborns.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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: Exempt
US FDA pregnancy category: Not assigned

See references

Pralidoxime Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The molecular weight of this drug is low enough that it could be excreted in breast milk.
-Consider delaying breastfeeding for at least 6 to 7 hours (about 5 half-lives) after a dose of this drug has been given.

See references

References for pregnancy information

  1. "Product Information. Protopam Chloride (pralidoxime)." Baxter Healthcare Corporation, Deerfield, IL.
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  3. 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]):

References for breastfeeding information

  1. "Product Information. Protopam Chloride (pralidoxime)." Baxter Healthcare Corporation, Deerfield, IL.
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

Further information

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

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