Cefotaxime Pregnancy and Breastfeeding Warnings

Brand names: Claforan

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Cefotaxime Pregnancy Warnings

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

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.

See references

Cefotaxime Breastfeeding Warnings

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.

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

See references

Further information

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