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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