Levofloxacin approved for treatment of pneumonia.The United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved Levaquin(r) (levofloxacin tablets/injection; Ortho-McNeil Pharmaceutical, Inc.) for the treatment of penicillin-resistant Streptococcus pneumoniae in community-acquired pneumonia (CAP) This new indication makes Levaquin the first prescription antimicrobial agent specifically indicated for CAP caused by this resistant bacterium, giving physicians an additional option when penicillin-resistant pneumococcal pneumonia is present or suspected. Levaquin is also indicated for the treatment of mild, moderate, and severe CAP caused by other pathogens, acute maxillary max·il·lar·y adj. Of or relating to a jaw or jawbone, especially the upper one. n. A maxillar; a jawbone. maxillary (mak´siler´ē), adj sinusitis sinusitis Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise. and acute bacterial exacerbation of chronic bronchitis, in addition to mild to moderate uncomplicated skin and skin structure infections, complicated urinary tract infections, acute pyelonephritis, and uncomplicated urinary tract infections. Data provided to the FDA demonstrated that Levaquin was effective in each of 15 cases of pneumonia caused by penicillin-resistant S pneumoniae (pooled data), including six with bacteremia bacteremia: see septicemia. bacteremia Presence of bacteria in the blood. Short-term bacteremia follows dental or surgical procedures, especially if local infection or very high-risk surgery releases bacteria from isolated sites. . Levaquin is well tolerated. The most common drug-related adverse events for the drug in U.S. clinical trials were nausea (1.3%) and diarrhea (1.1%). There was a low incidence of dizziness (0.4 %) and insomnia (0.3 %). The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. Levofloxacin is contraindicated in persons with a history of hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to levofloxacin, quinolone antimicrobial agents, or any other components of this product. Full Prescribing Information is available upon request. |
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