PHARMACOKINETIC AND CLINICAL STUDIES OF FLOMOXEF IN THE PERINATAL PERIOD

Pharmacokinetic and clinical studies on flomoxef (FMOX) in the perinatal period were carried out and following results were obtained 1. The pharmacokinetic parameter T 1/2's of FMOX in maternal serum, umbilical cord serum and amniotic fluid in mothers after single intravenous injection of 1g (n=46) and 2g(n=34) were 1.11, 9.24, 9.24 hours and 2.54, 12.49, 12.49 hours, respectively. Cmax's and Tmax's ofumbilical cord serum and amniotic fluid were 12.71, 11.77 μg/ml and 0.57, 3.35 hours upon single dose of 1 g i. v., and 35.17, 12.37 μg/ml and 0.32, 3.42 hours upon single dose of 2g i. v., respectively. 2. Clinical usefulness were evaluated in 93 cases including were various infections in pregnancy and puerperal period. In pregnancy cases, clinical efficacy rate was 95.5% (21/22), and 100% in puerperal period. Bacteriological response rate was 84.6% (eradicated: 29, decreased: 4, unchanged: 2, replaced: 4 and unknown: 8 cases). No severe side effects nor clinical laboratory test results were observed in any cases. From above basic and clinical results, we conclude that FMOX is a useful and safe agent for various infections in pregnancy and puerperal period.