Table 6 lists adverse reactions that have been identified during post-approval use of levofloxacin. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
|System/Organ Class||Adverse Reaction|
|Blood and Lymphatic System Disorders|| |
|Immune System Disorders|| |
hypersensitivity reactions, sometimes fatal including: anaphylactic/anaphylactoid reactions
serum sickness[see Warnings and Precautions (5.3, 5.4)]
|Psychiatric Disorders|| |
isolated reports of suicide attempt and suicidal ideation[see Warnings and Precautions (5.6)]
|Nervous System Disorders|| |
exacerbation of myasthenia gravis [see Warnings and Precautions (5.2)]
peripheral neuropathy [see Warnings and Precautions (5.8)]
isolated reports of encephalopathy
abnormal electroencephalogram (EEG)
pseudotumor cerebri [see Warnings and Precautions (5.6)]
|Eye Disorders|| |
vision disturbance, including diplopia
visual acuity reduced
|Ear and Labyrinth Disorders|| |
|Cardiac Disorders|| |
isolated reports of Torsades de pointes
electrocardiogram QT prolonged
|Respiratory, Thoracic and Mediastinal Disorders||isolated reports of allergic pneumonitis [see Warnings and Precautions (5.4)]|
|Hepatobiliary Disorders|| |
hepatic failure (including fatal cases)
jaundice[see Warnings and Precautions (5.4, 5.5)]
|Skin and Subcutaneous Tissue Disorders|| |
bullous eruptions to include:
toxic epidermal necrolysis
photosensitivity/phototoxicity reaction [see Warnings and Precautions (5.12)]
|Musculoskeletal and Connective Tissue Disorders|| |
tendon rupture [see Warnings and Precautions (5.1)]
muscle injury, including rupture
|Renal and Urinary Disorders||interstitial nephritis [see Warnings and Precautions (5.4)]|
|General Disorders and Administration Site Conditions|| |
prothrombin time prolonged
international normalized ratio prolonged
While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of levofloxacin tablets with antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. Tablets with antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine may substantially interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. These agents should be taken at least 2 hours before or 2 hours after oral levofloxacin tablet administration.
No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for R- and S-warfarin was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of warfarin on levofloxacin absorption and disposition was observed. However, there have been reports during the post-marketing experience in patients that levofloxacin enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and levofloxacin use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR) or other suitable anticoagulation tests should be closely monitored if levofloxacin is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding [see Adverse Reactions (6.3) and Patient Counseling Information (17.4)].
Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are coadministered [see Warnings and Precautions (5.11), Adverse Reactions (6.2) and Patient Counseling Information (17.4)].
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