HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use LEVOFLOXACIN INJECTION safely and effectively. See full prescribing information for LEVOFLOXACIN INJECTION. LEVOFLOXACIN injection, solution for intravenous use Initial U.S. Approval: 1996 WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS |
| Type of Infection | Dose Every 24 hours | Duration (days) |
|---|---|---|
| Nosocomial Pneumonia (1.1) | 750 mg | 7–14 |
| Community Acquired Pneumonia (1.2) | 500 mg | 7–14 |
| Community Acquired Pneumonia (1.3) | 750 mg | 5 |
| Complicated Skin and Skin Structure Infections (SSSI) (1.4) | 750 mg | 7–14 |
| Uncomplicated SSSI (1.5) | 500 mg | 7–10 |
| Chronic Bacterial Prostatitis (1.6) | 500 mg | 28 |
| Inhalational Anthrax (Post-Exposure) (1.7) | ||
| Adults and Pediatric Patients >50 kg | 500 mg | 60 |
| Pediatric Patients <50 kg and ≥6 months of age | 8 mg/kg BID (not to exceed 250 mg/dose) | 60 |
| Plague (1.8) Adults and Pediatric Patients >50 kg | 500 mg | 10 to 14 |
| Pediatric Patients <50 kg and ≥6 months of age | 8 mg/kg BID (not to exceed 250 mg/dose) | 10 to 14 |
| Complicated Urinary Tract Infection (1.9) or Acute Pyelonephritis (1.11) | 750 mg | 5 |
| Complicated Urinary Tract Infection (1.10) or Acute Pyelonephritis (1.11) | 250 mg | 10 |
| Uncomplicated Urinary Tract Infection (1.12) | 250 mg | 3 |
| Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) | 500 mg | 7 |
| Acute Bacterial Sinusitis (1.14) | 750 mg | 5 |
| 500 mg | 10–14 |
DOSAGE FORMS AND STRENGTHSFormulation (3) Strength Injection: premix single-use flexible containers 250 mg in 50 mL
500 mg in 100 mL
750 mg in 150 mL
| Formulation (3) | Strength |
|---|---|
| Injection: premix single-use flexible containers | 250 mg in 50 mL 500 mg in 100 mL 750 mg in 150 mL |
WARNINGS AND PRECAUTIONS- Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (4, 5.7)
- Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses (5.6)
- Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur (5.8)
- Clostridium difficile-associated colitis: evaluate if diarrhea occurs (5.10)
- 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 (5.11, 8.5)
- Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (4, 5.7)
- Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses (5.6)
- Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur (5.8)
- Clostridium difficile-associated colitis: evaluate if diarrhea occurs (5.10)
- 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 (5.11, 8.5)
ADVERSE REACTIONSThe most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness (6.2).
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness (6.2).
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONSInteracting Drug Interaction Multivalent cation – containing products including antacids, metal cations or didanosine Absorption of levofloxacin is decreased when the tablet or oral solution formulation is taken within 2 hours of these products. Do not co-administer the intravenous formulation in the same IV line with a multivalent cation, e.g., magnesium (2.4, 7.1) Warfarin Effect may be enhanced. Monitor prothrombin time, INR, watch for bleeding (7.2) Antidiabetic agents Carefully monitor blood glucose (5.13, 7.3)
| Interacting Drug | Interaction |
|---|---|
| Multivalent cation – containing products including antacids, metal cations or didanosine | Absorption of levofloxacin is decreased when the tablet or oral solution formulation is taken within 2 hours of these products. Do not co-administer the intravenous formulation in the same IV line with a multivalent cation, e.g., magnesium (2.4, 7.1) |
| Warfarin | Effect may be enhanced. Monitor prothrombin time, INR, watch for bleeding (7.2) |
| Antidiabetic agents | Carefully monitor blood glucose (5.13, 7.3) |
USE IN SPECIFIC POPULATIONS- Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older (5.8, 8.5, 17). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use (5.2, 8.5, 17). May be more susceptible to prolongation of the QT interval. (5.11, 8.5, 17).
- 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 (5.12, 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) (1.7, 2.2, 8.4, 14.9) and plague (1.8, 2.2, 8.4, 14.10).
- Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older (5.8, 8.5, 17). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use (5.2, 8.5, 17). May be more susceptible to prolongation of the QT interval. (5.11, 8.5, 17).
- 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 (5.12, 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) (1.7, 2.2, 8.4, 14.9) and plague (1.8, 2.2, 8.4, 14.10).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 5/2019