WARNING:
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
See full prescribing information for complete boxed warning.
- Fluoroquinolones, including LEVOFLOXACIN INJECTION in 5% dextrose, 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 INJECTION immediately and avoid use of fluoroquinolones, including LEVOFLOXACIN INJECTION in 5% dextrose, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)]
- Fluoroquinolones, including LEVOFLOXACIN INJECTION in 5% dextrose, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid LEVOFLOXACIN INJECTION in 5% dextrose in patients with a known history of myasthenia gravis [see Warnings and Precautions (5.5)].
- Because fluoroquinolones, including LEVOFLOXACIN INJECTION in 5% dextrose, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.14)], reserve LEVOFLOXACIN INJECTION in 5% dextrose 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)]