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An Observational Study on the Pharmacokinetics of Levofloxacin in Lactating Atypical Pneumonia Patients

Shang J, Pang L, Long J, Liu Y, Lu Y

Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine, 2025

24 participants · 1 citation

Abstract

Importance: Atypical pneumonia in postpartum women may alter drug pharmacokinetics (PK) through cytokine-mediated changes in vascular permeability, yet the breast milk disposition of levofloxacin in this population remains uncharacterized. Objective: This observational study aimed to compare levofloxacin PK in lactating atypical pneumonia patients ( n = 10) receiving 400 mg once daily for 3 days with historical healthy controls and to assess infant exposure risks. Methods: Breast milk samples from subjects 6–10 were collected at predetermined time points (0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours) following the last dose of 3 days. Subjects 1–5 had random daytime sampling. The concentration of levofloxacin in breast milk was measured using a validated high-performance liquid chromatography method with ultraviolet detection (correlation coefficient: 0.9997; limit of detection: 0.15 μg/mL; recovery: 91.36–102.28%; RSD <5%). PK parameters were derived using noncompartmental analysis in Phoenix WinNonlin (version 8.35). Results: Key milk PK parameters included C max of subjects 1–5 was 15.74 ± 6.55 μg/mL, and in subjects 6–10 was 14.55 ± 2.56 μg/mL. The elimination half-life (t 1/2β ) in subjects 1–5 was 7.46 ± 3.39 hours and in subjects 6–10 was 4.57 ± 1.14 hours. The AUC 0−24 in subjects 1–5 was 84.31 ± 22.60 mg·h/L and in subjects 6–10 was 63.99 ± 11.78 mg·h/L. Conclusions: Based on a 150 mL/kg/day milk intake, the estimated infant daily exposure in subjects 1–5 and 6–10 was…

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