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news.The FDA has approved a new shorter and more aggressive treatment schedule for Ortho-McNeil's acute bacterial sinusitis treatment, Levaquin. The drug can now be prescribed to be taken once a day over five days in a 750mg dose, having been previously only approved to be taken once a day over ten days in a 500mg dose.
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Sinusitis is one of the most common conditions seen by primary care physicians, and according to the National Ambulatory Medical Care Survey, is the fifth most common condition for which an antibiotic is prescribed. Each year in the US there are an estimated 20 million cases of acute bacterial sinusitis.
“This new dosing regimen for sinusitis falls in line with the American Academy of Family Physicians and World Health Organization antibiotic recommendations which call for more aggressive, shorter courses of therapy that could also help reduce bacterial resistance,” said Dr Michael Poole, Georgia Ear and Sinus Institute, Georgia. “Physicians now have another effective dosing option that provides patients with favorable symptom improvement and increased dosing convenience.”
The approval was based on a multi-center clinical study that evaluated 780 adult outpatients diagnosed with acute bacterial sinusitis. The primary outcome measured in this study was the complete or partial resolution of the signs and symptoms of acute bacterial sinusitis to the degree that no further antibiotic treatment was necessary.