[Studies on plasma levels and clinical efficacy of rokitamycin in pediatrics]

Pharmacokinetic and clinical evaluations of rokitamycin (RKM, TMS-19-Q), a new macrolide antibiotic, were carried out. RKM was administered orally to 14 patients with congenital heart diseases before cardiocatheterization and angiography. Peak plasma levels of RKM were observed at 30 minutes after the administration at dosages of 5, 10, 15 mg/kg. Although the reason is not clear, there were great variations among plasma levels. Peak plasma levels of patients with relatively good absorption were high enough against bacteria such as beta-hemolytic Streptococcus, Mycoplasma pneumoniae and Chlamydia trachomatis. Clinical responses were evaluated in 5 children comprising 2 cases of mycoplasmal pneumonia, 2 cases of Chlamydia infection and 1 case of beta-hemolytic streptococcal tonsillitis. All of these cases had excellent or good responses without any side effect. Furthermore, no child refused to take RKM dry syrup.