Pharmacokinetic and clinical studies on flomoxef (FMOX) in the perinatal period in obstetrics and gynecology were performed and the results obtained are summarized as follows:
1. Concentrations of FMOX in maternal serum, umbilical cord serum and amniotic fluid were determined after intravenous injection of 1 g. The maternal serum concentration was 41.9μg/ml at 16 minutes after administration, and gradually decreased thereafter to 1.36μg/ml at 5 hours 19 minutes.
The concentration of FMOX in umbilical cord serum was 17.5μg/ml at 16 minutes after administration, then gradually decreased thereafter, was slightly higher than that in maternal serum after approx. 3 hours and was 2.88μg/ml at 5 hours 19 minutes.
The amniotic fluid concentration was 0.31μg/ml at 16 minutes after administration, increased to 7.85-15.8μg/ml at approx. 3 hours, and gradually decreased while maintaining relatively high levels.
2. One or two grams of FMOX were given by intravenous drip infusion twice daily to 17 patients with perinatal infections for 5 to 7 days. Clinical efficacies were evaluated as excellent in 7 cases and good in 10, suggesting that FMOX was effective in all cases.
No subjective side effects were observed in any of the 17 patients. As to abnormal laboratory findings, a minor degree of elevation of GPT was observed in 1 patient and that of GOT·GPT in 1. No other abnormal changes in laboratory examinations were observed.
Considering the above results, we conclude that FMOX is a useful antibiotic in perinatal infections.
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