Abstract
In pharmacokinetic and clinical studies of once daily 500 mg levofloxacin (LVFX) in adults with acute otitis media or acute rhinosinusitis, we assessed disease severity and LVFX efficacy using scoring based on local findings and clinical symptoms.
The LVFX tissue concentration of 2.25 to 5.83 hours after single 500 mg administration was 6.010±2.477 μg/g (mean±SD) in the maxillary sinus mucosa, with a tissue/plasma concentration ratio of 1.51±0.43. The clinical efficacy (test of cure) was 100% (13/13) in acute otitis media and acutely exacerbated chronic otitis media, 85.1% (63/74) in acute rhinosinusitis, and 90.9% (10/11) in acutely exacerbated chronic rhinosinusitis. Bacteriological eradication was 94.9% (37/39) in acute rhinosinusitis and 100% in acute otitis media (4/4) and acutely exacerbated chronic rhinosinusitis (3/3). Adverse reactions, all mild to moderate, occurred in 33.6% (38/113). Side effects, but no serious or clinically significant event, occurred in 22.1% (25/113).
In conclusion, LVFX once daily 500 mg p.o. entered well into maxillary sinus tissue and appears useful in treating otitis media and rhinosinusitis. Data confirmed that scoring was very useful in deciding appropriate otitis media and rhinosinusitis treatment.
