Levofloxacin (injection)

Levofloxacin (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Levofloxacin injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

Culture and susceptibility testing

• Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see MICROBIOLOGY (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.
• As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin.

• Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

Nosocomial Pneumonia

• Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended.

Community-Acquired Pneumonia: 7-14 day Treatment Regimen

• Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
• MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Community-Acquired Pneumonia: 5-day Treatment Regimen

• Levofloxacin is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae.

Acute Bacterial Sinusitis: 5-day and 10-14 day Treatment Regimens

• Levofloxacin is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see CLINICAL STUDIES (14.4)].

1.Acute Bacterial Exacerbation of Chronic Bronchitis Levofloxacin is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

1.6 Complicated Skin and Skin Structure Infections Levofloxacin is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see CLINICAL STUDIES (14.5)].

1.7 Uncomplicated Skin and Skin Structure Infections Levofloxacin is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.

1.8 Chronic Bacterial Prostatitis Levofloxacin is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see CLINICAL STUDIES (14.6)].

1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen Levofloxacin is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see CLINICAL STUDIES (14.7)].

1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen Levofloxacin is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see CLINICAL STUDIES (14.8)].

1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen Levofloxacin is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia[see CLINICAL STUDIES (14.7,14.8)].

1.12 Uncomplicated Urinary Tract Infections Levofloxacin is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

1.13 Inhalational Anthrax (Post-Exposure) Levofloxacin is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk [see DOSAGE AND ADMINISTRATION (2.1, 2.2) and CLINICAL STUDIES (14.9)].

1.14 Plague Levofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].

CLOSE 2 DOSAGE & ADMINISTRATION 2.1 Dosage in Adult Patients with Normal Renal Function The usual dose of levofloxacin injection

is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1. These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Levofloxacin (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levofloxacin (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Levofloxacin (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Levofloxacin (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levofloxacin (injection) in pediatric patients.

Contraindications

There is limited information regarding Levofloxacin (injection) Contraindications in the drug label.

Warnings

There is limited information regarding Levofloxacin (injection) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Levofloxacin (injection) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Levofloxacin (injection) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Levofloxacin (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Levofloxacin (injection) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Levofloxacin (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Levofloxacin (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Levofloxacin (injection) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Levofloxacin (injection) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Levofloxacin (injection) in geriatric settings.

Gender

There is no FDA guidance on the use of Levofloxacin (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Levofloxacin (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Levofloxacin (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Levofloxacin (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Levofloxacin (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Levofloxacin (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Levofloxacin (injection) Administration in the drug label.

Monitoring

There is limited information regarding Levofloxacin (injection) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Levofloxacin (injection) and IV administrations.

Overdosage

There is limited information regarding Levofloxacin (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Levofloxacin (injection) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Levofloxacin (injection) Mechanism of Action in the drug label.

Structure

There is limited information regarding Levofloxacin (injection) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Levofloxacin (injection) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Levofloxacin (injection) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Levofloxacin (injection) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Levofloxacin (injection) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Levofloxacin (injection) How Supplied in the drug label.

Storage

There is limited information regarding Levofloxacin (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Levofloxacin (injection) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Levofloxacin (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Levofloxacin (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Levofloxacin (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.