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news.The FDA has approved the use of the five-day, once-daily regimen of Ortho-McNeil's Levaquin 750mg iv and oral, for the treatment of complicated urinary tract infections and acute pyelonephritis.
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This latest approval is based on results of a double-blind, randomized clinical trial involving 1,109 patients with either complicated urinary tract infections (cUTI) or acute pyelonephritis (AP) which assessed the efficacy and safety of Levaquin (750mg/once daily/five days) versus ciprofloxacin (400/500mg/twice daily/10 days).
Microbiologic eradication and clinical success rates were similar in both treatment groups demonstrating the resolution of, or improvement in, urinary symptoms for both Levaquin (750mg/once daily/five days) and ciprofloxacin (400/500mg/twice daily/10 days) groups.
Richard David Associate clinical professor of urology, David Geffen School of Medicine at UCLA, said: “The availability of this high-dose, short-course antibiotic regimen provides clinicians with an important tool in the management of (cUTI) and (AP). Patients do not always finish a longer course of antibiotics. A shorter course of antibiotic offers patients the convenience of five day, once-daily therapy.”