[Fundamental and clinical studies on cefixime (5% granules) in the pediatric field]

Fundamental and clinical studies were carried out on cefixime (CFIX) 5% granules, and the results are summarized below. Antimicrobial activity Antimicrobial activities of CFIX, cefaclor, cefroxadine, cephalexin and amoxicillin (AMPC) were studied against clinical isolates. CFIX showed greater activities than all the other antibiotics against E. coli, K. pneumoniae, H. influenzae, P. mirabilis, E. cloacae and S. marcescens, but it was slightly less active than AMPC against S. pyogenes. Absorption and excretion Serum concentrations and urinary excretions of CFIX were determined following single or repeated oral administration. In 8 patients given single dose of CFIX 1.5 or 3.0 mg/kg, mean serum concentrations were 1.27 and 1.09 micrograms/ml at 2 hours, 1.27 and 1.35 micrograms/ml at 4 hours, 0.85 and 1.10 micrograms/ml at 6 hours, 0.17 and 0.24 micrograms/ml 12 hours after administration, respectively. Mean serum half-lives were 2.54 hours for the dose of 1.5 mg/kg and 2.60 hours for 3.0 mg/kg. Urinary recovery rates in the 12-hours urine varied 6.7 to 33.6%, with an average of 13.5%. In 3 patients given a repeated dose of CFIX 3.0 or 5.6 mg/kg b.i.d., the serum concentrations were 0.23-1.01 micrograms/ml at 0 hour, 1.91-2.80 micrograms/ml at 2-4 hours and 1.13-2.07 micrograms/ml at 6-8 hours after administration. Clinical study The CFIX was given orally by mainly b.i.d. at a daily dose of 4.4-11.6 mg/kg for 4-15 days to a total of 33 patients consisting of 3 patients with pneumonia, 3 with bronchitis, 9 with tonsillitis, 15 with UTI, one each with scarlet fever, lymphadenitis and colitis. Clinical responses were excellent in 24 patients, good in 8 and fair in 1, with an effectiveness rate of 97.0%. All of the 21 bacterial isolates examined were eradicated after CFIX treatments including 3 beta-lactamase producing strains. No side effects of abnormal laboratory findings were observed in these patients.