WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVISFluoroquinolones, including Ciprofloxacin Injection (in 5%Dextrose Injection), 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 Ciprofloxacin Injection (in 5% Dextrose Injection) immediately and avoid the use of fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)].
Fluoroquinolones, including Ciprofloxacin Injection (in 5%Dextrose Injection), may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Ciprofloxacin Injection in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5)].
Because fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)], reserve Ciprofloxacin Injection (in 5% Dextrose Injection) for use in patients who have no alternative treatment options for the following indications:
- Acute exacerbation of chronic bronchitis [see Indications and Usage (1.9)]
- Acute Sinusitis [see Indications and Usage (1.11)]