To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

RECENT MAJOR CHANGES

Warnings and Precautions

• Exacerbation of myasthenia gravis (5.2)01/2011

INDICATIONS AND USAGE

LEVAQUIN® is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4).

• Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3)
• Acute bacterial sinusitis (1.4)
• Acute bacterial exacerbation of chronic bronchitis (1.5)
• Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7)
• Chronic bacterial prostatitis (1.8)
• Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12)
• Acute pyelonephritis (1.11)
• Inhalational anthrax, post-exposure (1.13). Not tested in humans for post-exposure prevention of inhalational anthrax; plasma concentrations are likely to predict efficacy (14.9)

DOSAGE AND ADMINISTRATION

• Dosage in patients with normal renal function (2.1)

• Adjust dose for creatinine clearance < 50 mL/min (2.3, 8.6, 12.3)
• IV Injection, Single-Use or Premix: Slow IV infusion only, over 60 or 90 minutes depending on dose. Avoid rapid or bolus IV (2.5)
• Dilute single-use vials to 5 mg/mL prior to IV infusion (2.6)
• Do not mix with other medications in vial or IV line (2.6)

DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS

Known hypersensitivity to LEVAQUIN® or other quinolones (4, 5.3)

WARNINGS AND PRECAUTIONS

• Risk of tendinitis and tendon rupture is increased. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants. Discontinue if pain or inflammation in a tendon occurs (5.1, 8.5)
• May exacerbate muscle weakness in persons with myasthenia gravis. Avoid use in patients with a known history of myasthenia gravis (5.2).
• Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (4,5.3)
• Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses (5.4)
• Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur (5.5)
• Central nervous system effects, including convulsions, anxiety, confusion, depression, and insomnia may occur after the first dose. Use with caution in patients with known or suspected disorders that may predispose them to seizures or lower the seizure threshold (5.6)
• Clostridium difficile-associated colitis: eva luate if diarrhea occurs (5.7)
• Peripheral neuropathy: discontinue if symptoms occur in order to prevent irreversibility (5.8)
• Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval (5.9, 8.5)

ADVERSE REACTIONS

The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness (6.2).

To report SUSPECTED ADVERSE REACTIONS, contact Ortho-McNeil-Janssen Scientific Affairs Customer Communications Center at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

• Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older (5.5, 8.5, 17). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use (5.1, 8.5, 17). May be more susceptible to prolongation of the QT interval. (5.9, 8.5, 17).
• Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) seen in more LEVAQUIN®-treated patients than in comparator. Shown to cause arthropathy and osteochondrosis in juvenile animals (5.10, 8.4, 13.2). Safety in pediatric patients treated for more than 14 days has not been studied. Risk-benefit appropriate only for the treatment of inhalational anthrax (post-exposure) (1.13, 2.2, 8.4, 14.9)