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Praziquantel Pregnancy and Breastfeeding Warnings

Praziquantel is also known as: Biltricide

Medically reviewed on Jun 15, 2018

Praziquantel Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm. 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Praziquantel should be used during pregnancy only if clearly needed; caution is recommended.

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

See references

Praziquantel Breastfeeding Warnings

Use of praziquantel is considered acceptable; breastfeeding should not be a contraindication to maternal treatment.

Excreted into human milk: Yes (small amounts)

Comments: The effects in the nursing infant are unknown; side effects not expected due to minute levels of drug in breast milk.

Human milk drug levels were about 25% of the levels in maternal serum. The mean excretion of praziquantel in milk, in 10 lactating women, was less than 0.1% of the dose.

Suggestions to reduce infant exposure include taking the single dose just before the infant's longest sleep period or feeding the infant stored human milk or formula for 24 to 36 hours after the single (or last) dose.

The manufacturer recommends women should not breastfeed on the day of praziquantel treatment and during the subsequent 72 hours.

See references

References for pregnancy information

  1. "Drugs for Parasitic Infections. 3rd ed." New Rochelle, NY: The Medical Letter, Inc. (2013):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Biltricide (praziquantel)." Bayer, West Haven, CT.

References for breastfeeding information

  1. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):
  2. "Product Information. Biltricide (praziquantel)." Bayer, West Haven, CT.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  5. Putter J, Held F "Quantitative studies on the occurrence of praziquantel in milk and plasma of lactating women." Eur J Drug Metab Pharmacokinet 4 (1979): 193-8

Further information

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

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