[Clinical studies of cefixime in pediatric field].

Pharmacokinetic and clinical studies of cefixime (CFIX) in children were done and the following results were obtained. Serum and urinary concentrations of CFIX were determined in 6 children aged 5 to 14 years given single doses of 1.5 or 6.0 mg/kg. Mean serum concentrations peaked at 4 hours after the administration of either 1.5 or 6.0 mg/kg, and respective peak values were 0.71 and 4.46 micrograms/ml. Biological half-lives for the low and the high doses were 5.28 and 4.45 hours, respectively. The 12-hours urinary recovery ranged from 7.0 to 13.8% after administration of 1.5 mg/kg, and the 8-hours urinary recovery was 18.1% after administration of 6.0 mg/kg. Therapeutic responses were recorded as excellent or good in 43 (97.7%) of the children, comprising 13 with tonsillitis and 31 with scarlet fever. The microbiological effectiveness of CFIX on identified pathogens comprising 29 strains of S. pyogenes and 2 strains of S. aureus was satisfactory as evidence by a high eradication rate of 93.5%. No clinical side effects were observed. Abnormal laboratory findings were elevation of GOT and/or GPT in 4 patients and eosinophilia in 1 patient. In conclusion, CFIX was found to be efficacious and safe for the treatment of bacterial infections in children.