Abstract
Pharmacokinetical, bacteriological and clinical studies on norfloxacin (NFLX), a quinolonecarboxylic acid antibacterial agent, were conducted in the pediatric field.
1. Serum concentrations and urinary excretion of NFLX after single dose of 2.2-5.6 mg/kg (mean 4.4±1.2 mg/kg) were determined in 13 children with ages between 6 and 11 years.
The mean peak serum concentration of the drug was 0.37 ±0.20 itg/ml at 2 hours after administration. The mean half-life of the drug in serum was 2.8 ±0.4 hours and the serum concentration at 8 hours was 0.11 ± 0.06 μg/ml.
The mean urinary concentration reached a maximum of 125.2 ± 166.2 μg/ml in pooled urine from 0to 2 hours and the mean urinary recovery rate in the first 8 hours after administration was 22.1±6.0%.
A dose-response relationship was observed between doses/body weight and peak serum concentrations.
2. The clinical efficacy, bacteriological efficacy and the safety of NFLX were evaluated in 65pediatric patients with ages between 2 years 10 months and 15 years 7 months with infections. In 62assessable cases (acute purulent tonsillitis 9 cases, acute pneumonia 3 cases, cronic rhinitis 1 case, urinary tract infections 15 cases, and acute colitis 34 cases), clinical efficacies were excellent in 48 cases, good in 13 casses. and fair in 1 case with an overall efficacy rate of 98.4%.
Staphylococcus aureus 1 strain, Staphylococcus epidermidis 1 strain, Escherichia coli 10 strains, Salmonella sp. 5 strains, Morganella morganii 1 strain, Pseudomonas aeruginosa 3 strains, Haemophilus parainfluenzae 1 strain and Campylobacter jejuni 12 strains were isolated from the patients as pathogens.Bacteriologically, all of these strains were eradicated except that 3 strains of C. jejuni only decreased.
With regard to side effects, dizziness and nausea were observed in 1 case each but they were slight and the continuation of the treatment was possible. No abnormal laboratory test data were observed.
From the above results, NFLX was considered to be a useful drug for the treatment of pediatric infections.
