Bacteriological, pharmacokinetic and clinical studies on Banantab (cefpodoxime proxetil, CPDX-PR), a new oral cephalosporin derivative, were conducted in 235 patients with otorhinolaryngological infections.
1) A dose of 100mg of CPDX-PR was administered after meals twice daily for 3-16 days. The clinical efficacy rate was 93.3% in acute otitis media (15 cases), 80.4% in acute exacerbation of chronic otitis media (46 cases), 84.2% in acute sinusitis (19 cases), 70.5% in acute exacerbation of chronic sinusitis (44 cases), 81.5% in acute tonsillitis (27 cases), 71.4% in acute exacerbation of chronic tonsillitis (7 cases), 87.0% in acute pharyngolaryngitis (54 cases), 58.3% in acute exacerbation of chronic pharyngolaryngitis (12 cases), and 90.0% in acute otitis externa (10 cases).
2) In bacteriological studies, 134 strains of causative organisms were isolated from 117 patients. The bacteriological eradication rate was 84.3%.
3) As to adverse effects, abdominal pain and nausea were observed in one case each. Elevation of GOT and GPT was noted in one patient.
4) Drug concentrations in serum, palatine tonsil, and maxillary sinus mucosa were measured after oral administration of 200mg during fasting. Tissue concentrations of CPDX two hours after administration of the serum level were 27.0±12.8% (mean±S. D.) in palatine tonsils and 63.8±15.1% in maxillary sinus mucosa.
Our results show that CPDX-PR is useful in otorhinolaryngological infections.