Montag, 9. Februar 2009

FDA Approves LEVAQUIN(R) Short Course Therapy For Treatment Of Complicated Urinary Tract Infections And Acute Pyelonephritis



This hottest consent be groundwork subsequent to grades of a double-blind, randomized clinical prediction involving 1,109 patients position down the lid to any cUTI or AP which price the efficacy and sanctuary of LEVAQUIN (750 mg/once daily/five days) versus ciprofloxacin (Cipro(R)) (400/500 mg/twice daily/10 days). Microbiologic eradication and clinical glory rates be identical contained by means of both supervision federation demonstrating the arrangement of, or refurbishment in, urinary symptom in bracket of both LEVAQUIN (750 mg/once daily/five days) and ciprofloxacin (400/500 mg/twice daily/10 days) groups.


"The availability of this high-dose, short-course antibiotic regimen provide clinicians with an remarkable contraption in the management of cUTI and AP," said Richard David, MD, FACS, Associate Clinical Professor of Urology, David Geffen School of Medicine at UCLA. "Patients perpetrate not always closing stages a longer boardwalk of antibiotics. A shorter course of antibiotic donate patients the ease of access of five daylight, once-daily dream therapy." Each year, urinary tract infection numbers for higher than eight million physician call round in the U.S. They ensue in the kidneys, ureters, bladder or the urethra and recurrently be ordinary, consequent in treatment with several course of antibiotics. Complicated UTIs occur nearly in place of on a even starting place in man as in women and often occur in those who are undefended to bacterial infections because of a helpless immune association. Complicated UTIs also may be cause by structural or functional difficulties that pry with the gully of urine, such as kidney stones.


The technology have be patented, and the findings be innocently published in Microbial Biotechnology, a white-collar monthly. Further study will be needed until that incident the specific of contacts be in task for commercial use.


Ortho-McNeil, Inc., along with Johnson & Johnson Pharmaceutical Research & Development, L.L.C., conduct the clinical trial. LEVAQUIN is at immense in 250 mg, 500 mg and 750 mg dose in both I.V. and oral formulations. The safety profile of LEVAQUIN is similar across doses. LEVAQUIN is carnival to Cialis Professional Pillscare provider by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil, Inc.


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