Levofloxacin (7 brand names, 4 dosage forms, 3 routes)
Available dosage forms: INJECTABLE, TABLET, SOLUTION, SOLUTION/DROPS.
Routes of administration: INJECTION, ORAL, OPHTHALMIC.
Brand Names
- IQUIX
- LEVAQUIN
- LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- LEVOFLOXACIN
- LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- LEVOFLOXACIN; DEXTROSE
- QUIXIN
Boxed Warning
• 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 to 5.15 )], reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: o Uncomplicated urinary tract infection [see Indications and Usage (1.12)] o Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage ( 1.13)] o Acute bacterial sinusitis [see Indications and Usage ( 1.14)] .
Contraindications
Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3)].
Adverse Reactions
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: • Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions (5.1)] • 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)] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5)] • Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions ( 5.6)] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.7)] • Hepatotoxicity [see Warnings and Precautions ( 5.8)] • Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9)] • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ( 5.10)] • Prolongation of the QT Interval [see Warnings and Precautions ( 5.11)] • Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.12)] • Blood Glucose Disturbances [see Warnings and Precautions ( 5.13)] • Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.14)] • Development of Drug Resistant Bacteria [see Warnings and Precautions ( 5.15)] Crystalluria and cylindruria have been reported with quinolones, including levofloxacin. Therefore, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of a highly concentrated urine [see Dosage and Administration ( 2.5)].
Mechanism of Action
Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology ( 12.4)].
Overdosage
In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis. Levofloxacin exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of levofloxacin: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 mg/kg orally (approximately 10 or 19 times MRHD in mice and rats, respectively) and 250 mg/kg IV produced significant mortality (estimated to be greater than or equal to 50%) in rodents.