Levofloxacin in 5% Dextrose Injection, USP Boxed Warning

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:
o
Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
o
Peripheral neuropathy [see Warnings and Precautions (5.3)]
o
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)].

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Levofloxacin in 5% Dextrose Injection, USP Quick Finder

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Boxed Warning

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:
o
Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
o
Peripheral neuropathy [see Warnings and Precautions (5.3)]
o
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)].
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