The safety and pharmacokinetics of cefotaxime in the treatment of neonates.

Seventeen neonates with clinical signs of infection who would otherwise have received gentamicin with penicillin were treated with cefotaxime (50 mg/kg bd) for a period of 5 days. One hundred eleven bacteriological cultures were collected and those from 6/17 neonates yielded pathogenic or potentially pathogenic bacteria. Biochemical investigations undertaken before, during, and after the treatment revealed no adverse effects on renal or hepatic function associated with cefotaxime therapy. In addition to manual methods, a computer program was used to determine six pharmacokinetic variables. The mean peak serum level was 87.4 +/- 36.2 mg/liter, the mean trough level 8.0 +/- 6.9 mg/liter and the serum half life 3.1 +/- 0.8 hours. All the neonates showed clinical improvement following cefotaxime treatment with no adverse clinical signs and were discharged well from hospital. It is concluded that cefotaxime may be safely used in neonates and is a suitable alternative to gentamicin and penicillin for primary treatment in units that do not have a persistent and serious problem with infections due to Pseudomonas aeruginosa.