CEFOTAXIME

Fetal Risk Summary

Cefotaxime is a parenteral, semisynthetic cephalosporin antibiotic. Reproduction studies in mice and rats have found no evidence of impaired fertility or fetal harm at doses up to 20 times the human dose (1). Cephalosporins are usually considered safe to use during pregnancy.

During the 2nd trimester, the drug readily crosses the placenta (2). The half-life of cefotaxime in fetal serum and in amniotic fluid was 2.3 and 2.8 hours, respectively. Five women with chorioamnionitis and in labor received cefotaxime (dose not specified) (3). The maternal and cord blood concentrations were nearly equivalent at 8.90 and 8.60 µg/mL, respectively, but the placental tissue:maternal blood ratio was 0.2 (dose to delivery interval not specified).

Breast Feeding Summary

Cefotaxime is excreted into breast milk in low concentrations. Following a 1-g IV dose, mean peak milk levels of 0.33 µg/mL were measured at 2–3 hours (2,4). The half-life in milk ranged from 2.36 to 3.89 hours (mean 2.93 hours). The milk:plasma ratios at 1, 2, and 3 hours were 0.027, 0.09, and 0.16, respectively. Although these levels are low, three potential problems exist for the nursing infant: modification of bowel flora, direct effects on the infant, and interference with the interpretation of culture results if a fever workup is required. The American Academy of Pediatrics considers cefotaxime to be compatible with breast feeding (5).

References

1. Product information. Claforan. Hoechst Marion Roussel, 1997.
2. Kafetzis DA, Lazarides CV, Siafas CA, Georgakopoulos PA, Papadatos CJ. Transfer of cefotaxime in human milk and from mother to foetus. J Antimicrob Chemother 1980;6 (Suppl A):135–41.
3. Maberry MC, Trimmer KJ, Bawdon RE, Sobhi S, Dax JB, Gilstrap LC III. Antibiotic concentration in maternal blood, cord blood and placental tissue in women with chorioamnionitis. Gynecol Obstet Invest 1992;33:185–6.
4. Kafetzis DA, Siafas CA, Georgakopoulos PA, Papadatos CJ. Passage of cephalosporins and amoxicillin into the breast milk. Acta Paediatr Scand 1981;70:285–8.
5. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.