[Pharmacokinetic and clinical studies of cefotiam in neonates and premature infants].

Cefotiam (CTM) was given to 25 mature and premature infants, ranging in age from 0 to 24 days, who have various nearly-healed bacterial infections. CTM was administered at the dose of 10 mg/kg by intravenous injections or by 1-hour intravenous drip infusions, or at the dose of 20 mg/kg by intravenous injections. Only a small number of subjects being examined, they were divided by their aged day into 3 groups; 0-3 days old, 4-7 days old and 8-24 days old. We compared the time courses of changes in serum and urine levels of CTM in these groups. The clinical study was done with 8 male and 4 female infants ranging in age from 3 days to 4 months. One had septicemia, 4 had bronchopneumonia, 3 had urinary tract infection, 1 had colitis, 2 had abscess, and 1 had maxillary sinusitis. Changes in serum and urinary levels of CTM Changes in serum levels after 10 mg/kg intravenous injection. Peak serum CTM levels of all 3 groups were achieved at 30 minutes after administration; the levels were between 11.7 and 23.6 micrograms/ml; and differences were not significant. Serum levels then gradually decreased in all the groups to 0.5-7.0 micrograms/ml at 6 hours after administration. Half-lives of serum CTM levels tended to be shorter in older infants; means were 2.7, 2.2 and 1.3 hours for the 0-3 day-old, the 4-7 day-old and the 8-24 day-old respectively. Changes in serum levels of CTM after 10 mg/kg 1-hour intravenous drip infusion. The 0-3 day-old and the 4-7 day-old had peak serum CTM levels, ranging from 16.3 to 35.8 micrograms/ml, at the end of drip infusion. Half-lives of serum CTM levels tended to be shorter in older infants, with 3.2 hours for the 0-3 day-old and 2.0 hours for the 4-7 day-old groups. Changes in serum levels after 20 mg/kg intravenous injection. The 0-3 day-old and the 4-7 day-old had peak serum levels, ranging from 30.6 to 42.1 micrograms/ml, at 30 minutes after administration, then serum levels of CTM in either group showed a gradual decrease to 2.5-11.4 micrograms/ml at 6 hours after injection.(ABSTRACT TRUNCATED AT 400 WORDS)