[Pharmacokinetic, bacteriological and clinical studies in the pediatric field on clarithromycin]

Pharmacokinetic, bacteriological and clinical studies were carried out on clarithromycin (TE-031, A-56268) in the pediatric field and following results were obtained. 1. Peak concentrations of TE-031 in the serum occurred at 1-2 hours after administration of 10 mg/kg in granular form and at 2 hours after administration of 20 mg/kg in granular form. Half-lives of the drug in serum were 2.5-3.3 hours in cases of 10 mg/kg dosage and 5.5 hour in case of 20 mg/kg dosage. TE-031 tablets were administered in a dosage between 1.7 and 5.0 mg/kg and peak concentrations in the serum occurred at 0.5-2 hours. Half-lives were 2.0-4.3 hours. 2. Urinary recovery rates obtained upon administration of TE-031 granule during the first 6 hours after administration were 20.3-62.9%, while they were 11.6-42.4% with TE-031 tablets. 3. Antibacterial activity of TE-031 against Campylobacter jejuni was equal to that of erythromycin and slightly superior to those of josamycin, midecamycin acetate and rokitamycin. 4. Bacteriological efficacy rate of TE-031 on 8 species of bacteria isolated from various samples was 88.4% and clinical efficacy rate on 66 cases (upper/lower respiratory tract infections, mycoplasmal pneumonia, Campylobacter enteritis, et al.) was 100%. 5. TE-031 was administered in dosages of 6.8-42.3 mg/kg/day (mostly 20-30 mg/kg/day) 3 times a day and lengths of administration ranged from 4 to 15 days. 6. Side effects due to TE-031 were observed in 1 case each of transient symptom and abnormal clinical laboratory test value. According to the above results, TE-031 was recognized as a useful antibiotic for the treatment of infections in the pediatric field.