Pharmacokinetic Study of Cefditoren Pivoxil in Breast Milk and Blood of Lactating Women

Abstract

To provide a theoretical basis for the rational use of cefditoren pivoxil in lactating women by conducting a pharmacokinetic study of cefditoren in the blood and milk of these women. Twelve participants meeting the inclusion criteria took cefditoren pivoxil tablets 200 mg after a meal, and the breast milk was collected over certain time periods with their volumes recorded. Blood samples were also collected at certain time points for pharmacokinetic analysis. Conduct a statistical analysis on the drug concentrations in breast milk and plasma and their correlation. Assessing the risk of taking cefditoren pivoxil during lactation using the milk-to-plasma ratio (M/P) and the relative infant dose (RID). Adverse events were monitored throughout the study period. Twelve lactating women participated in the study, providing a total of 84 breast milk samples. The correlation coefficient between cefditoren in breast milk and cefditoren in maternal plasma is 0.748 and is significant at the 0.01 level, with an M/P ratio of 0.008, and a RID of 0.0073%. Cefditoren is minimally distributed in human breast milk. There is a significant positive correlation between maternal blood drug levels and milk drug levels. Based on the M/P ratio and RID, it is inferred that the infant’s exposure is low, that is, the absolute dose of cefditoren transmitted to the infant through breastfeeding is low and is unlikely to cause any significant adverse effects. The results of this study will provide information for the use of cefditoren pivoxil in lactating women.