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Piperacillin Pregnancy and Breastfeeding Warnings

Brand names: Pipracil

Piperacillin Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk.

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

Animal studies have failed to reveal evidence of fetotoxicity or teratogenicity; this drug was shown to cross the placenta in rats. 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.

See references

Piperacillin Breastfeeding Warnings

Use is considered acceptable; caution is recommended.

Excreted into human milk: Yes (in small amounts)

Comments:
-Low levels in milk are not expected to cause harmful effects in the nursing infant.
-Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with penicillins, but such effects have not been adequately evaluated.

According to limited data, maternal doses up to 12 g produce low levels in breast milk.

This drug (4 g IV every 8 hours) was administered to 8 women for at least 3 days; milk levels were measured after 2 subsequent doses. In the 3 hours after each dose, milk levels ranged from 0.49 to 1.5 mg/L and 1.1 to 1.9 mg/L after the first and second dose, respectively; peak milk levels were reached 2 to 3 hours after dosing.

See references

References for pregnancy information

  1. (2001) "Product Information. Pipracil (piperacillin)." Lederle Laboratories
  2. Heikkila A, Erkkola R (1994) "Review of beta-lactam antibiotics in pregnancy - the need for adjustment of dosage schedules." Clin Pharmacokinet, 27, p. 49-62
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee (2007) Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf
  4. Cerner Multum, Inc. (2015) "Canadian Product Information."

References for breastfeeding information

  1. (2001) "Product Information. Pipracil (piperacillin)." Lederle Laboratories
  2. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  3. Cerner Multum, Inc. (2015) "Canadian Product Information."

Further information

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