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Freebase Commons Common /common

  • Levofloxacin (Dr. Reddy's Laboratories), manufactured drug form of Levofloxacin, 750mg/tablet levofloxacin film coated tablet, NDC 55111-281

Freebase Commons Business /business

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 , may exacerbate muscle weakness in persons with myasthenia gravis. Avoid levofloxacin 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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  • 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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  • The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness (6.2). To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc. at 1-888-375-3784 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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  • Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older (5.5, 8.5, 17). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use (5.1, 8.5, 17). May be more susceptible to prolongation of the QT interval. (5.9, 8.5, 17). Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) seen in more levofloxacin-treated patients than in comparator. Shown to cause arthropathy and osteochondrosis in juvenile animals (5.10, 8.4, 13.2). Safety in pediatric patients treated for more than 14 days has not been studied. Risk-benefit appropriate only for the treatment of inhalational anthrax (post-exposure) (1.13, 2.2, 8.4, 14.9)
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  • 43684-0
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  • 34088-5
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  • 34090-1

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