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Levofloxacin film-coated tablet
Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription in susceptible bacteria.
Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription in susceptible bacteria. Used for Bacterial infections including community-acquired pneumonia, Acute bacterial sinusitis, Acute bacterial exacerbation of chronic bronchitis.
At a glance
| Generic name | Levofloxacin film-coated tablet |
|---|---|
| Also known as | Leflodal film-coated tablet |
| Sponsor | Mackay Memorial Hospital |
| Drug class | Fluoroquinolone antibiotic |
| Target | DNA gyrase; Topoisomerase IV |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
As a fluoroquinolone antibiotic, levofloxacin works by binding to and inhibiting DNA gyrase (in gram-negative bacteria) and topoisomerase IV (in gram-positive bacteria), enzymes essential for bacterial DNA replication and repair. This leads to accumulation of DNA breaks, cell death, and bactericidal activity against a broad spectrum of aerobic gram-positive and gram-negative bacteria.
Approved indications
- Bacterial infections including community-acquired pneumonia
- Acute bacterial sinusitis
- Acute bacterial exacerbation of chronic bronchitis
- Uncomplicated skin and skin structure infections
- Complicated urinary tract infections
- Acute pyelonephritis
Common side effects
- Nausea
- Diarrhea
- Headache
- Insomnia
- Tendinitis/tendon rupture
- QT prolongation
- Photosensitivity
Key clinical trials
- Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection
- Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia (PHASE3)
- Intraluminal Mono-antibiotic Therapy for Helicobacter Pylori Infection - A Comparison of Levofloxacin Powder and Levofloxacin Solution (PHASE4)
- Non Interventional Study of Levofloxacin in Chronic Prostatitis
- Efficacy and Safety of Basic Triple Therapy Including Ilaprazole on the First Line Eradication Treatment of H.Pylori
- A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control (PHASE3)
- "Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients". (PHASE3)
- A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Levofloxacin film-coated tablet CI brief — competitive landscape report
- Levofloxacin film-coated tablet updates RSS · CI watch RSS
- Mackay Memorial Hospital portfolio CI