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| |  FDA Approves Avelox (Moxifloxacin HCl) For Community Acquired Pneumonia Due To Penicillin-Resistant Streptococcus Pneumoniae WEST HAVEN, CT -- March 4, 2003 -- The United States Food and Drug Administration (FDA) has approved a supplemental new drug application for Avelox® (moxifloxacin HCl) Tablets/I.V. as a treatment for community-acquired pneumonia (CAP) due to penicillin-resistant Streptococcus pneumoniae (PRSP). "Avelox, a highly active agent in the fluoroquinolone class, is now an important option in treating penicillin-resistant S. pneumoniae," said Dr. Shurjeel Choudhri, Director, Senior Clinical Research Physician, Bayer Pharmaceuticals Corporation. "A key principal of proper antibiotic use is choosing an agent with excellent activity which may help reduce the development of resistance and maintain efficacy. Avelox has been shown in clinical studies to demonstrate high activity in vitro and excellent clinical success against S. pneumoniae -- important because this organism's resistance is a worldwide public health concern." Data provided to the FDA showed that Avelox therapy was effective in each of the 21 cases of pneumonia caused by penicillin-resistant Streptococcus pneumoniae. The clinical and bacteriological efficacy of Avelox in the treatment of Streptococcus pneumoniae was evaluated in nine clinical studies, which totaled 244 Avelox treated patients with CAP due to S. pneumoniae. About 25 to 35 percent of S. pneumoniae isolates in the United States are currently resistant or intermediately resistant to penicillin, according to the IDSA.(1) The National Institutes of Health (NIH) estimate there are approximately four million cases of community-acquired pneumonia in the United States each year,(2) and according to the Centers for Disease Control and Prevention (CDC) Streptococcus pneumoniae infections cause up to 135,000 hospitalizations.(3) About Avelox(R) Avelox(R) (moxifloxacin HCl) Tablets and I.V. are indicated for acute bacterial exacerbation of chronic bronchitis (ABECB), acute bacterial sinusitis, community-acquired pneumonia (CAP), and uncomplicated skin and skin structure infections (uSSSI), caused by susceptible strains of indicated organisms.(4) Avelox is a prescription medication that is generally well-tolerated. The most common side effects, which are usually mild, include nausea, diarrhea, and dizziness. You should be careful about driving or operating machinery until you are sure Avelox is not causing dizziness. You should not take Avelox if you have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as ciprofloxacin or levofloxacin. You should avoid taking Avelox if you have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol. If you are pregnant or planning to become pregnant while taking Avelox, talk to your healthcare provider before taking this medication. Avelox is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. Avelox is not recommended for children under the age of 18 years. Many antacids and multivitamins may interfere with the absorption of Avelox and may prevent it from working properly. You should take Avelox either 4 hours before or 8 hours after taking these products. Be sure to inform your healthcare provider of any medical conditions you have and all prescription and non-prescription medications or supplements you are taking. If you have any concerns about your medication or side effects, please contact your healthcare provider. He or she has been provided with complete prescribing information for Avelox. For Avelox prescribing information and indicated organisms, log on to http://www.AveloxUSA.com or call Bayer Clinical Communications at 800-288-8371. About Bayer Pharmaceuticals Corporation Bayer HealthCare includes the global activities of Bayer AG in the fields of Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare. Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease. (1) Bartlett J, Dowell S, Mandell L, File T, Musher D, and Fine M. Guidelines from the Infectious Disease Society of America: practice guidelines for the management of community-acquired pneumonia in adults. Clinical Infectious Disease 2000;31:347-82
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