CEFTIBUTEN

Fetal Risk Summary

Ceftibuten is an oral, semisynthetic cephalosporin antibiotic. Reproduction studies in rats found no evidence of impaired fertility at doses up to approximately 43 times the human dose on a mg/m2 basis (1). No teratogenesis or fetal harm was found in studies with rats and rabbits at doses up to approximately 8.6 and 1.5 times, respectively, the human dose on a mg/m2 basis.

No reports describing the use of ceftibuten in human pregnancy have been located. Cephalosporins are usually considered safe to use during pregnancy (see other cephalosporins for published human experience).

Breast Feeding Summary

No reports describing the use of ceftibuten during human lactation have been located. Low concentrations of other cephalosporins are secreted into milk, however, and the presence of ceftibuten in milk should be expected. Three potential problems exist for the nursing infant exposed to ceftibuten in milk: modification of bowel flora, direct effects on the infant, and interference with the interpretation of culture results if a fever workup is required. Although not specifically listing ceftibuten, the American Academy of Pediatrics classifies other cephalosporin antibiotics as compatible with breast feeding (2).

References

1. Product information. Cedax. Schering Corporation, 1997.
2. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.