title: [Laboratory and clinical studies of clarithromycin in pediatric fields].
abstract: We have carried out laboratory and clinical studies on clarithromycin (TE-031, A-56268). The results are summarized as follows. Serum and urinary concentrations of TE-031 were determined in 5 children with ages between 6 and 11 years given single oral doses of 5, 6.7, 10 and 15 mg/kg. Serum concentrations peaked at 1 hour after administration of 5, 6.7 and 15 mg/kg, and respective peak values were 1.98 micrograms/ml, 2.21 micrograms/ml and 5.58 micrograms/ml. Biological half-lives for the drug at 5, 6.7 and 15 mg/kg dose were 2.99 hours, 2.08 hours and 2.09 hours, respectively. Mean serum concentrations peaked at 2 hours after administration of 10 mg/kg, and peak values were 3.91 +/- 1.64 micrograms/ml. Biological half-lives were 3.00 +/- 0.58 hours. The 6-hour urinary recovery rates ranged from 22.7% to 23.8% after administration of 10 mg/kg, and the 6-hour urinary recoveries were 30.1%, 20.5% and 39.1% after administration of 5 mg/kg, 6.7 mg/kg and 15 mg/kg, respectively. Therapeutic responses were recorded as excellent or good in 35(89.7%) of the children, comprising 5 with tonsillitis, 3 with pharyngitis, 7 with bronchitis, 5 with pneumonia, 15 with Mycoplasma pneumonia, 1 with whooping cough and 3 with Campylobacter enteritis. The microbiological effectiveness of TE-031 on identified pathogens comprising 2 strains of Streptococcus pneumoniae, 5 strains of Haemophilus influenzae, 2 strains of Haemophilus parainfluenzae, 5 strains of Mycoplasma pneumoniae and Campylobacter spp. was satisfactory as evidenced by an eradication rate of 82.4%. No significant side effect due to the drug was observed in any cases. In conclusion, TE-031 was found to be efficacious and safe for the treatment of bacterial infections in children.
authors.affiliation: Department of Pediatrics, Osaka Medical College.
authors.forename: T
authors.initials: T
authors.lastname: Nishimura
authors.forename: K
authors.initials: K
authors.lastname: Tabuki
authors.forename: S
authors.initials: S
authors.lastname: Aoki
authors.forename: M
authors.initials: M
authors.lastname: Takagi
mesh_terms: D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin; D004341:Drug Evaluation; D004760:Enterocolitis / Q000188:drug therapy* / Q000378:metabolism / Q000382:microbiology; D004917:Erythromycin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009504:Neutrophils / Q000378:metabolism; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000378:metabolism / Q000382:microbiology
chemical_list: D004917:Erythromycin; D017291:Clarithromycin