Overview
Levofloxacin is a fluoroquinolone antibiotic and the optical S-(-) isomer of racemic ofloxacin. It reportedly carries 8 to 128-fold more activity against both gram-negative and gram-positive bacteria compared to R-(+)-ofloxacin and remains stereochemically stable following administration (i.e. it does not invert to the inactive isomer). Levofloxacin, along with other quinolones such as gatifloxacin and moxifloxacin, is a member of the third generation of fluoroquinolones, colloquially referred to as the "respiratory quinolones" due to improved activity against gram-positive bacteria commonly implicated in respiratory infections. Levofloxacin was first approved by the FDA in 1996, and was approved in Canada and several South American countries soon after.
Indication
In oral and intravenous formulations, levofloxacin is indicated in adults for the treatment of various infections caused by susceptible bacteria, including infections of the upper respiratory tract, lower respiratory tract, skin, skin structures, urinary tract, and prostate. The oral formulation is also indicated in both adults and children 6 months of age and older for the post-exposure management of inhalational anthrax caused by Bacillus anthracis and for the treatment and/or prophylaxis of plague caused by Yersinia pestis. In its ophthalmic formulation, levofloxacin is indicated for the treatment of bacterial conjunctivitis caused by susceptible organisms. An inhalational solution available in Canada is indicated for the management of cystic fibrosis patients aged 18 years or older with chronic pulmonary Pseudomonas aeruginosa infections.
Associated Conditions
- Abscesses caused by susceptible bacteria
- Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible bacteria
- Acute Pyelonephritis caused by Infection Due to Escherichia Coli
- Bacterial Conjunctivitis caused by susceptible bacteria
- Cellulitis caused by susceptible bacteria
- Community Acquired Pneumonia (CAP) caused by susceptible bacteria
- Furuncle caused by susceptible bacteria
- Impetigo caused by susceptible bacteria
- Inhalational Anthrax
- Nosocomial Pneumonia caused by Pseudomonas Infections
- Nosocomial Pneumonia caused by susceptible bacteria
- Plague caused by Yersinia pestis
- Pyoderma caused by susceptible bacteria
- Wound Infections caused by susceptible bacteria
- Acute bacterial sinusitis caused by susceptible bacteria
- Chronic Bacterial prostatitis caused by susceptible bacteria
- Chronic Pseudomonas Infections
- Complicated Urinary Tract Infection caused by susceptible bacteria
- Complicated skin and skin-structure infections caused by susceptible bacteria
- Uncomplicated Urinary Tract Infection caused by susceptible bacteria
- Uncomplicated skin and skin-structure infections caused by susceptible bacteria
Research Report
An Expert Monograph on Levofloxacin (DB01137)
Section 1: Introduction and Drug Classification
1.1 Overview and Clinical Significance
Levofloxacin is a potent, synthetic, broad-spectrum antibacterial agent belonging to the fluoroquinolone drug class.[1] It represents a significant milestone in antibiotic development, being the pure, pharmacologically active S-(-)-enantiomer of the racemic compound ofloxacin.[1] The isolation of this single isomer was a deliberate act of rational drug design aimed at optimizing therapeutic efficacy. The resulting molecule, levofloxacin, exhibits substantially greater antibacterial potency than its counterpart, the R-(+)-isomer, with reports indicating an 8- to 128-fold increase in activity against a range of both Gram-negative and Gram-positive bacteria.[1] A critical feature contributing to its clinical utility is its stereochemical stability; following administration, levofloxacin does not invert to the less active R-(+)-enantiomer, ensuring consistent and predictable bactericidal effects.[1]
1.2 Classification as a "Respiratory Quinolone"
Levofloxacin is categorized as a third-generation fluoroquinolone, often grouped with agents like gatifloxacin and moxifloxacin.[1] This generation is colloquially referred to as the "respiratory quinolones".[1] This designation arose from their enhanced
in vitro activity against key pathogens implicated in respiratory tract infections, most notably Streptococcus pneumoniae. The improved coverage against this and other Gram-positive organisms addressed a significant limitation of earlier-generation fluoroquinolones, such as ciprofloxacin, thereby expanding their therapeutic role in conditions like community-acquired pneumonia.[3]
1.3 The Efficacy-Safety Dichotomy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/17 | Not Applicable | Not yet recruiting | Wuhan Pulmonary Hospital | ||
2025/06/27 | Not Applicable | Not yet recruiting | Rehman Medical Institute - RMI | ||
2025/06/15 | Phase 4 | Not yet recruiting | Rehman Medical Institute - RMI | ||
2025/04/08 | Not Applicable | Not yet recruiting | Amina Aslam | ||
2025/03/05 | Phase 2 | Not yet recruiting | Copenhagen Respiratory Research | ||
2025/01/28 | Phase 2 | Recruiting | Hayder Adnan Fawzi | ||
2024/12/19 | Phase 4 | ENROLLING_BY_INVITATION | |||
2024/11/12 | Phase 3 | Completed | Federico II University | ||
2024/10/21 | Not Applicable | Not yet recruiting | |||
2024/10/21 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | 65841-693 | ORAL | 750 mg in 1 1 | 10/4/2023 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-337 | ORAL | 750 mg in 1 1 | 9/14/2020 | |
| Camber Pharmaceuticals, Inc. | 31722-723 | ORAL | 750 mg in 1 1 | 1/20/2024 | |
| Macleods Pharmaceuticals Limited | 33342-531 | ORAL | 250 mg in 1 1 | 1/6/2023 | |
| Redpharm Drug | 67296-2126 | ORAL | 500 mg in 1 1 | 6/10/2025 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0077 | ORAL | 750 mg in 1 1 | 11/10/2022 | |
| Aidarex Pharmaceuticals LLC | 33261-793 | ORAL | 500 mg in 1 1 | 1/8/2014 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0286 | ORAL | 25 mg in 1 mL | 11/30/2018 | |
| AuroMedics Pharma LLC | 55150-156 | INTRAVENOUS | 500 mg in 20 mL | 11/10/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-4726 | ORAL | 250 mg in 1 1 | 2/17/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/25/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AVATAC FILM COATED TABLET 500 MG | SIN15341P | TABLET, FILM COATED | 500mg | 10/13/2017 | |
| LEVOFLOXACIN MEVON FILM-COATED TABLET 500 MG | SIN16099P | TABLET, FILM COATED | 500 mg | 2/4/2021 | |
| CRAVIT OPHTHALMIC SOLUTION 0.5% w/v | SIN11826P | SOLUTION | 0.5% w/v | 2/28/2002 | |
| VOLEQUIN INFUSION 5MG/ML | SIN15605P | INFUSION, SOLUTION | 5mg/ml | 1/3/2019 | |
| LUFI-500 TABLET 500mg | SIN14808P | TABLET, FILM COATED | 500mg | 7/15/2015 | |
| CRAVIT TABLET 250 mg | SIN11633P | TABLET, FILM COATED | 250 mg | 8/16/2001 | |
| CRAVIT I.V. For Infusion 5mg/ml | SIN11883P | INJECTION | 5mg/ml | 4/22/2002 | |
| LEFLOXCIN FILM-COATED TABLET 500 mg | SIN15180P | TABLET, FILM COATED | 500mg | 2/27/2017 | |
| LEVORES SOLUTION FOR INFUSION 5MG/ML | SIN16966P | INFUSION, SOLUTION | 5mg/ml | 3/4/2024 | |
| CRAVIT OPHTHALMIC SOLUTION 1.5% w/v | SIN15047P | SOLUTION, STERILE | 15mg/ml | 7/18/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LEVOFLOXACIN HEC PHARM TABLETS 500MG | N/A | N/A | N/A | 7/28/2017 | |
| VICK-LEVOXA TAB 250MG | N/A | N/A | N/A | 3/15/2008 | |
| LEVOFLOXACIN KABI SOLUTION FOR INFUSION 500MG/100ML | N/A | N/A | N/A | 2/28/2017 | |
| VOFLOX TABLETS 500MG | N/A | N/A | N/A | 6/18/2024 | |
| CRAVIT TAB 250MG | N/A | N/A | N/A | 10/14/2003 | |
| LEVOFLOXACIN TABLETS 250MG | N/A | N/A | N/A | 8/25/2014 | |
| CRAVIT IV SOLUTION FOR INFUSION 5MG/ML | N/A | N/A | N/A | 8/23/1999 | |
| LEVOFLOXACIN SOLUTION FOR INFUSION 500MG/100ML | N/A | N/A | N/A | 6/19/2025 | |
| VLOFINOX SOLUTION FOR INFUSION 500MG/100ML | N/A | N/A | N/A | 2/6/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| LEVOFLOXACIN IN 5% DEXTROSE INJECTION | 02314932 | Solution - Intravenous | 5 MG / ML | 12/23/2011 | |
| NTP-LEVOFLOXACIN | teva canada limited | 02358654 | Tablet - Oral | 250 MG | N/A |
| NTP-LEVOFLOXACIN | teva canada limited | 02358662 | Tablet - Oral | 500 MG | N/A |
| LEVAQUIN 25MG/ML | 02236840 | Solution - Intravenous | 25 MG / ML | 1/29/1998 | |
| LEVOFLOXACIN IN 5% DEXTROSE INJECTION | Sterimax Inc | 02460122 | Solution - Intravenous | 5 MG / ML | N/A |
| AVA-LEVOFLOXACIN | avanstra inc | 02361027 | Tablet - Oral | 250 MG | 9/15/2011 |
| LEVAQUIN | 02236841 | Tablet - Oral | 250 MG | 11/28/1997 | |
| LEVOFLOXACIN IN 5% DEXTROSE INJECTION | hikma canada limited | 02537079 | Solution - Intravenous | 5 MG / ML | 10/23/2023 |
| NTP-LEVOFLOXACIN | teva canada limited | 02358670 | Tablet - Oral | 750 MG | N/A |
| LEVAQUIN 750MG | 02246804 | Tablet - Oral | 750 MG | 1/30/2004 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LEVOFLOXACINO STADA 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 69455 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVOFLOXACINO NORMON 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 69697 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ASEY 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Especialidades Farmaceuticas Centrum S.A. | 70906 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVOFLOXACINO ACCORDPHARMA 5mg/ml SOLUCION PARA PERFUSION | 69723 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| WORONOL 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Avanzia Pharmaceutical Spain S.L. | 74242 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LEVOFLOXACINO PENSA 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Towa Pharmaceutical S.A. | 69567 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVOFLOXACINO ARISTO 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 76008 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LEVOFLOXACINO AUROBINDO 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Aurobindo S.L.U. | 74832 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LEVOFLOXACINO ALTER 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Alter S.A. | 76349 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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