[Efficacy and safety of faropenem in pediatric patients with bacterial infectious diseases].

Abstract

The only oral penem antibiotic, faropenem (FRPM: Farom Dry Syrup for pediatrics), is one of the few antibiotics that exerts potent antibacterial activity against penicillin-resistant Streptococcus pneumoniae (PRSP), and the dosage and administration schedule has been established for children. We studied the efficacy and safety of the drug in 113 pediatric patients with mild-to-moderate bacterial infectious diseases: upper respiratory tract infection (pharyngitis or tonsillitis), acute bronchitis, otitis media and urinary tract infection (UTI). The patients were administered oral FRPM at the dose of 15-30 mg/kg/day three times a day for 3 to 8 days (or 5 to 14 days for group A streptococcal infection). The study drug was found to be clinically effective in 63/70 cases (90.0%) of upper respiratory tract infection, 6/7 cases of acute bronchitis, 16/17 cases (94.1%) of otitis media and 6/6 cases of UTI. FRPM was demonstrated to have very potent antibacterial activity against S. pneumoniae, with a high bacteriological eradication rate. No serious adverse drug reactions were observed. The only side effect was diarrhea in 12.5% of the patients (14/112 cases). There was little difference in the incidence of diarrhea between FRPM and other oral beta-lactam antibiotics. Compliance with FRPM was found to be very good in this study. These findings suggest that FRPM is as useful for the treatment of bacterial infectious diseases in children as oral penicillin and cephem antibiotics.