Antibiotic (Cephalosporin)
PREGNANCY RECOMMENDATION: Compatible
BREASTFEEDING RECOMMENDATION: Compatible
PREGNANCY SUMMARY
No detectable teratogenic risk with cephalosporin antibiotics was found in a large 2001 study (see Cephalexin).
FETAL RISK SUMMARY
No reports describing the use of cefditoren in human pregnancy have been located. Cefditoren pivosil is a prodrug that is hydrolyzed during absorption to the active drug, cefditoren. It is an oral, semisynthetic cephalosporin antibiotic similar to other agents in this class. Cefditoren probably crosses the placenta, similar to other cephalosporins.
Reproduction studies have been conducted with cefditoren pivosil in rats and rabbits. In pregnant rats and rabbits, doses up to about 24 and 4 times, respectively, the human dose of 200 mg twice daily based on BSA (HD) were not teratogenic. In addition, rat fertility and reproduction were not affected by the highest dose. However, in rabbits, the highest dose caused severe maternal toxicity resulting in fetal toxicity and abortions. In a postnatal study in rats, a dose 18 times the HD produced no adverse effects on postnatal survival, physical and behavioral development, learning abilities, and reproductive capability at sexual maturity (1).
BREASTFEEDING SUMMARY
No reports describing the use of cefditoren in human lactation have been located. Small amounts of antibiotic have been found in breast milk for all cephalosporins that have been studied, so the presence of cefditoren in milk should be expected. In most cases, the effects of this exposure will be insignificant. However, three potential problems exist for the nursing infant exposed to cefditoren 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. The American Academy of Pediatrics classifies other cephalosporins as compatible with breastfeeding (for example, see Cefadroxil and Cefazolin).
Reference
1.Product information. Spectracef. Purdue Pharmaceutical Products, 2004.