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Cefotaxime Pregnancy and Breastfeeding Warnings

Cefotaxime is also known as: Claforan

Medically reviewed on April 5, 2017

Cefotaxime Pregnancy Warnings

Animal models have failed to reveal evidence of embryotoxicity or teratogenicity. Compared to pups not exposed to this drug, pups exposed to 0.8 times the recommended human dose (in body surface area) during pregnancy and throughout lactation were lighter in weight at birth and were smaller during the first 21 days of nursing. 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.

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

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

See references

Cefotaxime Breastfeeding Warnings

Peak concentrations of 0.25 to 0.52 mcg/mL were measured 2 to 3 hours after IV administration.

Use is generally considered acceptable; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Yes

Comment: Maternal doses of cephalosporins have resulted in reports of neonatal diarrhea and thrush.

See references

References for pregnancy information

  1. "Product Information. Claforan (cefotaxime)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. 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 -]):
  4. "Product Information. Claforan (cefotaxime)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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