[Pharmacokinetic and clinical studies of cefotiam during the perinatal period in pregnant women].

Pharmacokinetic and clinical studies of cefotiam (CTM) were carried out in pregnant women. The results obtained are summarized below. The concentration of CTM in amniotic fluid increased gradually up to 14.7 micrograms/ml at 4.5 hours after administration and gradually declined thereafter. This amniotic fluid concentration was sufficiently higher than reported MIC90's of CTM against E. coli strains. Passages of CTM to embryo, fetus and fetal appendages were minimal. The passage of CTM to milk was minimal. The CTM was used in the treatment of 6 pregnant patients with pyelonephritis and unknown fever and 1 with puerperal pyelonephritis. Clinical responses were positive in 85.7% (6/7). The CTM was used 7 patients with rupture of the membrane and 2 patients with operation for the purpose of prophylaxis and it was effective in 77.8% (7/9). Neither noteworthy adverse reactions nor abnormal laboratory data in our patients or neonates were observed throughout the studies.