[Experimental and clinical evaluation of latamoxef in newborn and premature infants]

Latamoxef (LMOX) was administered as a one-shot intravenous injection of 10 mg/kg or 20 mg/kg to 28 newborn and immature infants of 1 to 28 days of age. For 6 hours following the administration, the concentrations of the drug in the plasma and in the urine were monitored and the urinary recovery rate was determined. In addition, 17 patients, consisting of newborns, immature infants and suckling infants, aged 0 days to 2 months and diagnosed as having various bacterial infections, were also treated with LMOX; the mean daily dosage was 103 mg/kg, administered in 2 to 6 divided doses as one-shot intravenous injections for an average duration of 11 days. These patients were subjected to the analysis for the clinical efficacy and bacteriological efficacy of the therapy. Furthermore, with the inclusion of 35 drop-out cases, a total of 52 patients was investigated for the occurrence of side effects by the LMOX therapy. The findings of these studies are summarized below. The patients were divided into 5 groups on the basis of age: 3 days old or less, 4--7 days, 8--14 days, 15--21 days and 22--28 days. Only in the 8--14 day-old group administered LMOX at 20 mg/kg, the maximum mean plasma concentration of the drug occurred at the time of 15 minutes postadministration, although some individuals showed peaks at 5 minutes. In all of the other age groups, for both the 10 and 20 mg/kg dosages, the maximum plasma concentration of LMOX occurred 5 minutes postinjection. In each of the age groups, a dose response was seen between the 2 dosage levels. However, a comparison of each group and control infants in terms of the LMOX plasma concentration at 30 minutes after injection revealed that the concentrations in the patients in this study were low. In terms of the half-life of the drug at the 2 dosage levels, both the mean and individual values in each of the age groups were longer than the half-lives in control infants. This tendency was especially marked in the case of infants 7 days of age or less. The values for the AUC also tended to be larger in the younger patient groups. A good level of LMOX was detected in the urine during each of the 0--2, 2--4 and 4--6 hour periods following administration.(ABSTRACT TRUNCATED AT 400 WORDS)