Summary of Use during Lactation

Cefditoren is no longer marketed in the United States. Because of the low levels of cefditoren in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. Occasionally disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, have been reported with cephalosporins, but these effects have not been adequately evaluated. Cefditoren is acceptable in nursing mothers.

Drug Levels

Maternal Levels. Twelve lactating women were given cefditoren 200 mg before a meal. Complete milk samples were collected with a breast pump 1 hour before administration and at 1, 2, 3, 4, 6, 8, and 12 hours after the dose. The average peak milk level was 11.3 mcg/L, at an average of 4.87 hours after the dose and the half-life in milk was 2.42 hours. The average milk concentration was 5.65 mcg/L, which resulted in a relative infant dose (RID) of 0.0073% of the weight-adjusted dosage.[1] However, the actual milk volumes were low at an average of 405 mL/day and the infant weights averaged 8.8 kg, resulting in a daily infant milk intake of only 45 mL/kg. Using the standard daily milk volume of 150 mL/kg, the RID would be 0.025%. Furthermore, the trough concentration at 12 hours after the dose averaged 5.94 mcg/L, which is similar to the average milk level. Therefore, the peak and average milk levels and the RID are likely to be about double these values at steady-state, but still low (RID~0.05%).

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Ceftibuten

References

1.

Chen Z, Feng S, Cai L, et al. Pharmacokinetic study of cefditoren pivoxil in breast milk and blood of lactating women. Biopharm Drug Dispos 2025;46:147–54. [PubMed: 40794466]

Substance Name

Cefditoren

CAS Registry Number

104145-95-1

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Infective Agents

Antibacterial Agents

Cephalosporins