[Fundamental and clinical studies on cefixime in the pediatric field]

Fundamental and clinical studies on cefixime (CFIX), a new oral cephem antibiotic, were carried out in the pediatric field. The results were as follows: Serum concentrations and urinary recovery rates were determined after oral administration of CFIX at doses of 3 mg/kg and 6 mg/kg in 2 cases each (4 cases in total). The mean serum concentrations of CFIX were 0.52 and 0.58 micrograms/ml at 2 hours, 0.80 and 1.42 micrograms/ml at 4 hours, 0.73 and 1.36 micrograms/ml at 6 hours, 0.54 and 1.12 micrograms/ml at 8 hours, respectively. The mean peak serum concentration of CFIX was obtained at 4 hours after administration, with serum half-lives (T1/2) of 3.77 and 5.30 hours, respectively. The mean cumulative urinary recovery rates within 12 hours after administration of CFIX at doses of 3 mg/kg and 6 mg/kg were 8.4% and 6.8%, respectively. Antibacterial activities of CFIX against clinically isolated strains of S. pyogenes, S. pneumoniae. E. faecalis, S. aureus, E. coli, H. influenzae, H. parainfluenzae were compared with those of amoxicillin (AMPC), cefaclor (CCL), and cephalexin (CEX). It was observed that CFIX was a little less active than AMPC against S. pyogenes and S. pneumoniae, but CFIX was more active than CCL and CEX. CFIX was the most active against E. coli, H. influenzae and H. parainfluenzae. Twenty-one pediatric patients with bacterial infections (10, tonsillitis; 4, pharyngitis; and 7, urinary tract infections) were treated with CFIX at doses of 1.5-6.0 mg/kg in 2 or 3 times daily for 4-10 days. The efficacy rate was 95.2% clinically and 91.3% bacteriologically. No adverse reactions were observed. An abnormal laboratory finding (slight elevation of S-GOT and S-GPT) was observed in 1 case.