WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
- Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1)], including:
- Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
- Peripheral neuropathy [see Warnings and Precautions (5.3)]
- Central nervous system effects [see Warnings and Precautions (5.4)]
Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)].
- Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Levofloxacin in patients with a known history of myasthenia gravis [see Warnings and Precautions (5.5)].
- Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1–5.15)], reserve levofloxacin for use in patients who have no alternative treatment options for the following indications:
- Uncomplicated urinary tract infection [see Indications and Usage (1.12)]
- Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.13)]
- Acute bacterial sinusitis [see Indications and Usage (1.14)].