title: [Clinical studies on and pharmacokinetics of a new carbapenem antibiotic, biapenem (L-627), in the pediatric field].
abstract: Clinical and pharmacokinetic studies were performed on a new carbapenem antibiotic, biapenem (L-627), in children with acute infectious diseases and the results were as follows: 1) Clinical efficacies were evaluated on the intravenous-administration at daily doses of 17-37.5 mg/kg for 4-7 consecutive days in 12 children; 8 children with pneumonia, 2 with cervical lymphadenitis, 1 with pyelonephritis and 1 with suspected sepsis. The clinical efficacies were excellent in 6 patients, good in 5 and poor in 1, yielding an efficacy rate of 91.7%. No side effects or abnormalities of the clinical laboratory tests were observed in 16 children including 12 children evaluated for the efficacy. 2) L-627 was administered at a dose of 6 mg/kg or 12 mg/kg, using 30 minutes drip infusion, to 5 children. Maximum concentrations of L-627 in plasma were observed at the end of administration and the values varied from 21.0 to 38.4 micrograms/ml (mean: 31.7 +/- 9.3, n = 3) at 6 mg/kg and 39.0 and 58.8 micrograms/ml (mean: 48.9, n = 2) at 12 mg/kg. The half-lives in plasma (beta phase) were from 0.73 to 1.41 hours (0.98 +/- 0.38, n = 3) and 0.88 and 0.90 hours (0.89, n = 2), and the urinary recovery rates in the first 6 hours were between 61.5 and 69.9% (65.5 +/- 4.2, n = 3) and 64.7 and 81.1% (72.9, n = 2) at 6 mg/kg and 12 mg/kg, respectively. The results indicate that L-627 is effective and safe in children with acute infectious diseases and suggest the usefulness of L-627 in the pediatric field.
authors.affiliation: Department of Pediatrics, Hirosaki University School of Medicine.
authors.forename: Y
authors.initials: Y
authors.lastname: Kakizaki
authors.forename: M
authors.initials: M
authors.lastname: Yokoyama
authors.forename: N
authors.initials: N
authors.lastname: Tsushima
mesh_terms: D000293:Adolescent; D001424:Bacterial Infections / Q000188:drug therapy* / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D005260:Female; D006207:Half-Life; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D011014:Pneumonia / Q000188:drug therapy; D013845:Thienamycins / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use*
chemical_list: D013845:Thienamycins; C065257:biapenem