We examined the blood plasma and the middle ear tissue concentration of faropenem sodium after a single oral administration to adult patients with chronic otitis media. Faropenem sodium hydrate 300 mg was orally administered to 15 subjects. After 1–2 hours, blood plasma and middle ear tissue were simultaneously collected to measure the concentrations of faropenem sodium. The measurements were obtained from all subjects, with the means ± standard deviations of 2409.2 ± 1350.8 ng/mL and 179.4 ± 129.1 ng/g, respectively. The transfer rate of faropenem sodium into the middle ear tissue was 7.90 ± 4.52%. Assessment of the correlation for concentrations of faropenem sodium in the plasma and middle ear tissue in each subject yielded the Pearson’s correlation coefficient of 0.776, showing a positive correlation. These results show that faropenem sodium have a pharmacokinetic profile of penetration into the middle ear tissue in proportion to its plasma concentrations. While 7 adverse events were observed in 6 subjects, all these events were considered to be unrelated to the study drug, and none of them presented any safety concern.
