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Levofloxacin Solution for Oral use(levofloxacin)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Levofloxacin Oral Solution safely and effectively. See full prescribing information for Levofloxacin Oral Solution.
Levofloxacin Solution for Oral use
Initial U.S. Approval: 1996
WARNING:
See full prescribing information for complete boxed warning.
Fluoroquinolones, including Levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [see Warnings and Precautions (5.1)].
Fluoroquinolones, including Levofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Levofloxacin in patients with a known history of myasthenia gravis [see Warnings and Precautions (5.2)].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Levofloxacin and other antibacterial drugs, Levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
RECENT MAJOR CHANGES
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Warnings and Precautions |
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Peripheral Neuropathy (5.8)
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09/2013 |
INDICATIONS AND USAGE
Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4).
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Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3)
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Acute bacterial sinusitis (1.4)
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Acute bacterial exacerbation of chronic bronchitis (1.5)
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Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7)
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Chronic bacterial prostatitis (1.8)
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Urinary tract infections: complicated (1.9, 1.10) and uncomplicated (1.12)
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Acute pyelonephritis (1.11)
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Inhalational anthrax, post-exposure (1.13)
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Plague (1.14)
DOSAGE AND ADMINISTRATION
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Dosage in patients with normal renal function (2.1)
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Type of Infection |
Dose Every 24 hours |
Duration (days) |
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Nosocomial Pneumonia (1.1) |
750 mg |
7–14 |
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Community Acquired Pneumonia (1.2) |
500 mg |
7–14 |
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Community Acquired Pneumonia (1.3) |
750 mg |
5 |
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Acute Bacterial Sinusitis (1.4) |
750 mg |
5 |
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500 mg |
10–14 |
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Acute Bacterial Exacerbation of Chronic Bronchitis (1.5) |
500 mg |
7 |
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Complicated Skin and Skin Structure Infections (SSSI) (1.6) |
750 mg |
7–14 |
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Uncomplicated SSSI (1.7) |
500 mg |
7–10 |
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Chronic Bacterial Prostatitis (1.8) |
500 mg |
28 |
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Complicated Urinary Tract Infection (1.9) or Acute Pyelonephritis (1.11) |
750 mg |
5 |
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Complicated Urinary Tract Infection (1.10) or Acute Pyelonephritis (1.11) |
250 mg |
10 |
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Uncomplicated Urinary Tract Infection (1.12) |
250 mg |
3 |
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Inhalational Anthrax (Post-Exposure) (1.13) |
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Adults and Pediatric Patients > 50 kg |
500 mg |
60 |
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Pediatric Patients < 50 kg and ≥ 6 months of age |
8 mg/kg BID (not to exceed 250 mg/dose) |
60 |
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Plague (1.14) |
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Adults and Pediatric Patients > 50 kg |
500 mg |
10 to 14 |
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Pediatric Patients < 50 kg and ≥ 6 months of age |
8 mg/kg BID (not to exceed 250 mg/dose) |
10 to 14 |
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Adjust dose for creatinine clearance < 50 mL/min (2.3, 8.6, 12.3)
DOSAGE FORMS AND STRENGTHS
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Formulation (3) |
Strength |
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Oral Solution |
25 mg/mL
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CONTRAINDICATIONS
Known hypersensitivity to Levofloxacin or other quinolones (4, 5.3)
WARNINGS AND PRECAUTIONS
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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)
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May exacerbate muscle weakness in persons with myasthenia gravis. Avoid use in patients with a known history of myasthenia gravis (5.2)
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Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (4, 5.3)
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Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses (5.4)
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Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur (5.5)
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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. Increased intracranial pressure (pseudotumor cerebri) has been reported (5.6)
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Clostridium difficile-associated colitis: eva luate if diarrhea occurs (5.7)
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Peripheral neuropathy: discontinue immediately if symptoms occur in order to prevent irreversibility (5.8)
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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 1-800-667-8570 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Interacting Drug |
Interaction |
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Multivalent cation-containing products including antacids, metal cations or didanosine |
Absorption of levofloxacin is decreased when the oral solution formulation is taken within 2 hours of these products (2.4, 7.1) |
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Warfarin |
Effect may be enhanced. Monitor prothrombin time, INR, watch for bleeding (7.2) |
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Antidiabetic agents |
Carefully monitor blood glucose (5.11, 7.3) |
USE IN SPECIFIC POPULATIONS
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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).
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Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) seen in more Levofloxacin-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) and plague (1.14, 2.2, 8.4, 14.10)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 6/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
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