[Fundamental and clinical studies on cefixime in pediatrics]

We have evaluated cefixime (CFIX) fine granules for pharmacokinetics and therapeutic effectiveness in children with infections. The results were summarized as follows. Pharmacokinetic parameters after the oral administration of single doses of 1.5 mg and 6.0 mg per kg body weight in a cross-over design in 1 child were as follows: The peak serum CFIX concentrations were 0.65 microgram/ml at 2 to 3 hours and 3.33 micrograms/ml at 4 hours for the low and the high doses, respectively; the respective biological half-lives were 2.4 hours and 2.5 hours, and urinary recovery was 10.3% at 8 hours and 5.2% at 12 hours, respectively. A clinical study was performed on 19 children with infections, including 7 with bronchitis; 3 each with tonsillitis, UTI, and cervical lymphadenitis; and 1 each with pharyngitis, retroauricular lymphadenitis, and enteritis. Doses ranging from 1.8 to 7.8 mg/kg body weight were given b.i.d. or t.i.d. The period of treatment ranged from 3 to 13 days. The therapeutic response was considered "excellent" in 15 and "good" in 4, with an effectiveness rate of 100%. No side effects were observed. The only abnormal laboratory findings was a slight elevation of GOT and GTP recorded in 1 child. It was concluded that CFIX was a promising drug for the treatment of bacterial infections in children.