title: [Basic and clinical studies on use of clarithromycin granules in pediatrics].
abstract: Studies were conducted on in vivo pharmacokinetics of clarithromycin (TE-031, A-56268) in children and also on the efficacy and the safety of this macrolide antibiotic in the treatment of bacterial infections in children. The results obtained are summarized as follows: 1. TE-031 granules were orally administered to 5 children in a dosage of 5 mg/kg before meal. Maximum drug concentrations (range: 0.29-2.0 micrograms/ml) in the serum occurred during a period from 30 minutes to 1 hour after administration, but there were clear differences in blood concentrations among the individuals. 2. TE-031 granules were orally administered in a average dosage of 20 mg/kg/day to a total of 17 patients, consisting of 14 children with respiratory tract infections and 3 children with intestinal infections. The clinical efficacy evaluation resulted in 10 excellent cases, 6 good cases and 1 fair case, for an efficacy rate of 94.1%. 3. Studies on the bacterial efficacy were carried out for 10 cases. The TE-031 bacteriological efficacy evaluation showed elimination in 7 cases, a decreased bacterial count in 2 cases, and no change in 1 case. The elimination rate was, thus, 70.0%. Elimination rates according to different species of bacteria were 66.7% (2 of 3 strains) for Staphylococcus aureus, 100% for both Streptococcus pneumoniae (3 of 3) and Streptococcus pyogenes (1 of 1), and 42.9% (3 of 7) for Haemophilus influenzae. 4. There were no symptoms which were attributable to side effects of the TE-031 therapy. The only laboratory test abnormality detected was eosinophilia in 1 patient.
authors.affiliation: Department of Pediatrics, School of Medicine, Ehime University.
authors.forename: M
authors.initials: M
authors.lastname: Hayashi
authors.forename: K
authors.initials: K
authors.lastname: Kida
authors.forename: H
authors.initials: H
authors.lastname: Matsuda
authors.forename: M
authors.initials: M
authors.lastname: Murase
mesh_terms: D000367:Age Factors; D001419:Bacteria / Q000187:drug effects / Q000302:isolation & purification; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin; D004304:Dosage Forms; D004341:Drug Evaluation; D004352:Drug Resistance, Microbial; D004760:Enterocolitis / Q000188:drug therapy* / Q000378:metabolism / Q000382:microbiology; D004917:Erythromycin / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000378:metabolism / Q000382:microbiology
chemical_list: D004304:Dosage Forms; D004917:Erythromycin; D017291:Clarithromycin