Levofloxacin in 5% Dextrose Injection, USP Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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

See full prescribing information for complete boxed warning.

Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1), including:

o
Tendinitis and tendon rupture (5.2)
o
Peripheral neuropathy (5.3)
o
Central nervous system effects (5.4)

Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions (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 (5.1–5.15), reserve levofloxacin for use in patients who have no alternative treatment options for the following indications:

o
Uncomplicated urinary tract infection (1.12)
o
Acute bacterial exacerbation of chronic bronchitis (1.13)
o
Acute bacterial sinusitis (1.14)

RECENT MAJOR CHANGES

Warnings and Precautions, Hypersensitivity Reactions (5.7)

7/2024

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).

•
Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3)
•
Skin and Skin Structure Infections: Complicated (1.4) and Uncomplicated (1.5)
•
Chronic bacterial prostatitis (1.6)
•
Inhalational Anthrax, Post-Exposure (1.7)
•
Plague (1.8)
•
Urinary Tract Infections: Complicated (1.9, 1.10) and Uncomplicated (1.12)
•
Acute Pyelonephritis (1.11)
•
Acute Bacterial Exacerbation of Chronic Bronchitis (1.13)
•
Acute Bacterial Sinusitis (1.14)

Usage

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 (1.15).

DOSAGE AND ADMINISTRATION

•
Dosage in patients with normal renal function (2.1)
Type of Infection Dose Every 24 hoursDuration
(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

•
Adjust dose for creatinine clearance <50 mL/min (2.3, 8.6, 12.3)
•
IV Injection Premix: Slow IV infusion only, over 60 or 90 minutes depending on dose. Avoid rapid or bolus IV (2.5)
•
Do not mix with other medications in IV line (2.6)

DOSAGE FORMS AND STRENGTHS

Formulation (3) Strength

Injection: premix single-use flexible containers

250 mg in 50 mL
500 mg in 100 mL
750 mg in 150 mL

CONTRAINDICATIONS

Known hypersensitivity to levofloxacin or other quinolones (4, 5.7)

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)

ADVERSE REACTIONS

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 INTERACTIONS

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).

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 7/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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

See full prescribing information for complete boxed warning.

Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1), including:

o
Tendinitis and tendon rupture (5.2)
o
Peripheral neuropathy (5.3)
o
Central nervous system effects (5.4)

Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions (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 (5.1–5.15), reserve levofloxacin for use in patients who have no alternative treatment options for the following indications:

o
Uncomplicated urinary tract infection (1.12)
o
Acute bacterial exacerbation of chronic bronchitis (1.13)
o
Acute bacterial sinusitis (1.14)

RECENT MAJOR CHANGES

Warnings and Precautions, Hypersensitivity Reactions (5.7)

7/2024

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).

•
Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3)
•
Skin and Skin Structure Infections: Complicated (1.4) and Uncomplicated (1.5)
•
Chronic bacterial prostatitis (1.6)
•
Inhalational Anthrax, Post-Exposure (1.7)
•
Plague (1.8)
•
Urinary Tract Infections: Complicated (1.9, 1.10) and Uncomplicated (1.12)
•
Acute Pyelonephritis (1.11)
•
Acute Bacterial Exacerbation of Chronic Bronchitis (1.13)
•
Acute Bacterial Sinusitis (1.14)

Usage

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 (1.15).

DOSAGE AND ADMINISTRATION

•
Dosage in patients with normal renal function (2.1)
Type of Infection Dose Every 24 hoursDuration
(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

•
Adjust dose for creatinine clearance <50 mL/min (2.3, 8.6, 12.3)
•
IV Injection Premix: Slow IV infusion only, over 60 or 90 minutes depending on dose. Avoid rapid or bolus IV (2.5)
•
Do not mix with other medications in IV line (2.6)

DOSAGE FORMS AND STRENGTHS

Formulation (3) Strength

Injection: premix single-use flexible containers

250 mg in 50 mL
500 mg in 100 mL
750 mg in 150 mL

CONTRAINDICATIONS

Known hypersensitivity to levofloxacin or other quinolones (4, 5.7)

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)

ADVERSE REACTIONS

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 INTERACTIONS

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).

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 7/2024
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