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  • Levofloxacin (Wockhardt), manufactured drug form of Levofloxacin, 750mg/tablet levofloxacin tablet, NDC 55648-547

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Freebase Commons Medicine /medicine

Section name Section URI Prominent warning Highlight text Subject manufactured drug Section LOINC code
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  • WARNING: Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [ See Warnings and Precautions (5.1) ]. Fluoroquinolones, including levofloxacin tablets, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid levofloxacin tablets in patients with a known history of myasthenia gravis [ See Warnings and Precautions (5.2) ].
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  • 34066-1
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  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
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  • 49489-8
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  • Warnings and Precautions Exacerbation of myasthenia gravis (5.2)                                                                     01/2011
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  • 43683-2
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  • Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3) Acute bacterial sinusitis (1.4) Acute bacterial exacerbation of chronic bronchitis (1.5) Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7) Chronic bacterial prostatitis (1.8) Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12) Acute pyelonephritis (1.11) Inhalational anthrax, post-exposure (1.13). Not tested in humans for post-exposure prevention of inhalational anthrax; plasma concentrations are likely to predict efficacy  (14.9)
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  • 34067-9
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  • Dosage in patients with normal renal function (2.1) Adjust dose for creatinine clearance < 50 mL/min (2.3, 8.6, 12.3)
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  • 34068-7
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  • 43678-2
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  • Known hypersensitivity to levofloxacin or other quinolones (4, 5.3)
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  • 34070-3
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  • Risk of tendinitis and tendon rupture is increased. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants. Discontinue if pain or inflammation in a tendon occurs (5.1, 8.5) May exacerbate muscle weakness in persons with myasthenia gravis. Avoid use in patients with a known history of myasthenia gravis (5.2). Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (4, 5.3) Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses (5.4) Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur (5.5) Central nervous system effects, including convulsions, anxiety, confusion, depression, and insomnia may occur after the first dose. Use with caution in patients with known or suspected disorders that may predispose them to seizures or lower the seizure threshold (5.6) Clostridium difficile -associated colitis: evaluate if diarrhea occurs (5.7) Peripheral neuropathy: discontinue if symptoms occur in order to prevent irreversibility (5.8) Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval (5.9, 8.5)
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  • 43685-7
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  • The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness (6.2). To report SUSPECTED ADVERSE REACTIONS, contact Wockhardt USA LLC., at 1-800-346-6854 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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  • 34084-4
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  • 34073-7

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