[Laboratory and clinical studies of rokitamycin in pediatric fields].
We have carried out laboratory and clinical studies on rokitamycin (RKM, TMS-19-Q). The results are summarized as follows. Serum and urinary concentrations of RKM were determined in 6 children with ages between 6 and 12 years given single oral doses of 5, 10 and 15 mg/kg. Mean serum concentrations peaked at 30 minutes after administration of 5, 10 and 15 mg/kg, and respective peak values were 0.30 microgram/ml, 0.79 microgram/ml and 1.32 micrograms/ml. Biological half-lives for 5, 10 and 15 mg/kg were 2.0 hours, 1.65 hours and 1.36 hours. The 6-hour urinary recovery ranged from 1.11% to 2.58% after administration of 5 mg/kg, and the mean 6-hour urinary recoveries were 1.35% after administration of 10 mg/kg and 2.28% after administration of 15 mg/kg. Therapeutic responses were recorded as excellent or good in 22 (73.3%) of the children, comprising 6 with tonsillitis, 2 with pharyngitis, 4 with bronchitis, 1 with bronchopneumonia, 1 with Mycoplasma pneumonia, 2 with whooping cough, 5 with streptococcal infections, 5 with Campylobacter enteritis, 3 with impetigo and 1 with SSSS. The microbiological effectiveness of RKM on identified pathogens comprising 4 strains of Staphylococcus aureus, 1 strain of Streptococcus pneumoniae, 6 strains of Streptococcus pyogenes, 4 strains of Haemophilus influenzae and 5 strains of Campylobacter spp. was not so satisfactory as evidenced by a eradication rate of 50.0%. No significant side effect due to the drug was observed in any cases. In conclusion, RKM was found to be efficacious and safe for the treatment of bacterial infections in children.
D000284:Administration, Oral; D001774:Blood Chemical Analysis; D001991:Bronchitis / Q000188:drug therapy; D002167:Campylobacter / Q000187:drug effects; D002648:Child; D004341:Drug Evaluation; D004352:Drug Resistance, Microbial; D004751:Enteritis / Q000188:drug therapy; D005260:Female; D006801:Humans; D007933:Leucomycins / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D008297:Male; D015644:Miocamycin / Q000031:analogs & derivatives*; D012141:Respiratory Tract Infections / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D013211:Staphylococcus aureus / Q000187:drug effects; D013290:Streptococcal Infections / Q000188:drug therapy; D013297:Streptococcus pyogenes / Q000187:drug effects; D014069:Tonsillitis / Q000188:drug therapy
D007933:Leucomycins; D015644:Miocamycin; C033383:rokitamycin