Temafloxacin: a safe antibiotic for the elderly, patients with comorbidities, and other special populations.

During the Phase I, II, and III clinical development program, temafloxacin has demonstrated an excellent safety profile, with reported overall rates of adverse events comparable to quinolone and nonquinolone reference agents. This favorable safety record was consistently observed when special populations, suspected to be at higher risk for drug-related adverse events, were evaluated. For instance, the rates of all adverse events as well as most adverse events by organ system were similar between elderly (greater than or equal to 66 years) and younger temafloxacin recipients. Temafloxacin does not significantly alter the pharmacokinetic/pharmacodynamic effects of numerous drugs often used in the elderly (for example, warfarin, theophylline, caffeine, and cimetidine). Based on an evaluation of adverse events among elderly patients with varying degrees of renal impairment, dosage adjustment of temafloxacin is necessary only for elderly patients with severe renal impairment. Temafloxacin appears to be comparably safe to other quinolones and nonquinolones for the treatment of infections among diabetics and patients with chronic lung disease. Because of its lack of interaction with theophylline clearance, temafloxacin may be preferred to selected other quinolones for the latter population.