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For Healthcare ProfessionalsLEVAQUIN is a broad-spectrum, concentration-dependent, quinolone antibiotic used in adults as a lung, sinus, skin, and genitourinary tract infection treatment when such infections are caused by bacteria. LEVAQUIN kills many of the types of bacteria that can infect the lungs, sinuses, skin, and urinary tract and has been shown in a large number of clinical trials to be safe and effective for the treatment of many bacterial infections. The following sections have been developed to help you as a healthcare professional understand more about LEVAQUIN and how it can help meet your needs with your patients.
Convenient, Once-a-day dosing
IMPORTANT SAFETY INFORMATION FOR LEVAQUIN The most common adverse drug reactions (≥3%) in US clinical trials were nausea, headache, diarrhea, insomnia, constipation, and dizziness. Safety and efficacy in pregnant women and nursing mothers have not been established. Levofloxacin is not indicated for pediatric patients (<18 years of age). Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin or other quinolone antibacterials. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylactic reactions and some of unknown etiology, have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions may include effects on the liver, including hepatitis, jaundice, and acute hepatic necrosis or failure, and hematologic effects, including agranulocytosis, thrombocytopenia, and other hematologic abnormalities. These reactions may occur following the first dose or multiple doses. Discontinue levofloxacin at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity. Severe hepatotoxicity (including acute hepatitis and fatal events) not associated with hypersensitivity has also been reported. Discontinue immediately if signs and symptoms of hepatitis develop. Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin, during and after therapy. This risk is increased in patients over 65 years old, and is further increased with concomitant corticosteroid therapy. Discontinue in patients experiencing pain, inflammation, or tendon rupture. Central nervous system effects, including convulsions, confusion, anxiety, depression, and insomnia, may occur after the first dose. As with other quinolones, levofloxacin should be used with caution in patients with known or suspected central nervous system disorders that may predispose them to seizures or lower the seizure threshold. Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including levofloxacin. If diarrhea occurs, evaluate for CDAD and treat appropriately. Rare cases of peripheral neuropathy have been reported in patients receiving quinolones, including levofloxacin. Discontinue if symptoms of neuropathy occur to prevent the development of an irreversible condition. Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. Levofloxacin should be avoided in patients with known risk factors such as prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents. Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx®* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should not be taken within 2 hours before or after levofloxacin administration. For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship, please see full US Prescribing Information. *Videx is a registered trademark of Bristol-Myers Squibb Company.
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