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Levaquin (Levofloxacin)
Levaquin (generic name: Levofloxacin) is a Fluoroquinolone Antibacterial [EPC] Small molecule drug developed by Santen. It is currently FDA-approved (first approved 1996) for Acute Moraxella catarrhalis bronchitis, Acute bacterial bronchitis, Acute bacterial sinusitis.
Levaquin works by inhibiting bacterial DNA replication and transcription by binding to the enzyme DNA gyrase.
Levaquin (Levofloxacin) is a fluoroquinolone antibacterial drug originally developed by Janssen Pharmaceutica and currently owned by Santen. It targets the multidrug and toxin extrusion protein 1 and is a small molecule modality. Levaquin is FDA-approved for various bacterial infections, including respiratory and eye infections, and has been on the market since 1996. The drug has a high bioavailability of 98% and a half-life of 8.8 hours. Levaquin is off-patent, with 36 generic manufacturers available.
At a glance
| Generic name | Levofloxacin |
|---|---|
| Sponsor | Santen |
| Drug class | Fluoroquinolone Antibacterial [EPC] |
| Target | Multidrug and toxin extrusion protein 1 |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1996 |
Mechanism of action
Levofloxacin is member of the fluoroquinolone class of antibacterial agents see Microbiology 12.4) ].
Approved indications
- Acute Moraxella catarrhalis bronchitis
- Acute bacterial bronchitis
- Acute bacterial sinusitis
- Acute exacerbation of chronic bronchitis
- Acute maxillary sinusitis
- Anthrax
- Bacterial Corneal Ulcer Infection
- Bacterial conjunctivitis
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial pneumonia
- Bacterial urinary infection
- Chlamydial pneumonia
- Chronic Enterococcus faecalis Prostatitis
- Chronic Escherichia coli Prostatitis
- Chronic Staphylococcus epidermidis Prostatitis
- Complicated Skin and Skin Structure Enterococcus Faecalis Infection
- Complicated Skin and Skin Structure Infection
- Complicated Skin and Skin Structure Proteus Infection
- Complicated Skin and Skin Structure Staphylococcus Aureus Infection
- Complicated Skin and Skin Structure Streptococcus Pyogenes Infection
Boxed warnings
- BOXED WARNING SECTION WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( 5.1 )], including: o Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2 )] o Peripheral neuropathy [see Warnings and Precautions ( 5.3)] o Central nervous system effects [see Warnings and Precautions (5.4)] Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (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 [see Warnings and Precautions (5.1 to 5.15 )], reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: o Uncomplicated urinary tract infection [see Indications and Usage (1.12)] o Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage ( 1.13)] o Acute bacterial sinusitis [see Indications and Usage ( 1.14)] 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 to 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)
Common side effects
- Nausea
- Headache
- Diarrhea
- Insomnia
- Constipation
- Dizziness
Drug interactions
- High Risk QT Prolonging Agents
- algeldrate
- dronedarone
- magnesium oxide
- mesoridazine
- methylprednisolone
- prednisolone
- prednisone
- procainamide
- sotalol
- sucralfate
- thioridazine
Key clinical trials
- Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (PHASE2,PHASE3)
- Prevalence of Asymptomatic H Pylori Infection Among Patients Undergoing PCI and Impact of Its Eradication on Occurrence of GIT Symptoms and Bleeding" (PHASE3)
- Antibiotyping and Prevalence of Virulent Genotypes Among Helicobacter Pylori and Their Impact on Response to Therapy (NA)
- Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial (NA)
- Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis (PHASE1,PHASE2)
- Antibiotic Resistance of Helicobacter Pylori in Nanjing: A Cross-Sectional Study
- A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants (PHASE1,PHASE2)
- Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP (PHASE4)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Levaquin CI brief — competitive landscape report
- Levaquin updates RSS · CI watch RSS
- Santen portfolio CI
Frequently asked questions about Levaquin
What is Levaquin?
Levaquin (Levofloxacin) is a Fluoroquinolone Antibacterial [EPC] drug developed by Santen, indicated for Acute Moraxella catarrhalis bronchitis, Acute bacterial bronchitis, Acute bacterial sinusitis.
How does Levaquin work?
Levaquin works by inhibiting bacterial DNA replication and transcription by binding to the enzyme DNA gyrase.
What is Levaquin used for?
Levaquin is indicated for Acute Moraxella catarrhalis bronchitis, Acute bacterial bronchitis, Acute bacterial sinusitis, Acute exacerbation of chronic bronchitis, Acute maxillary sinusitis.
Who makes Levaquin?
Levaquin is developed and marketed by Santen (see full Santen pipeline at /company/pfizer).
What is the generic name of Levaquin?
Levofloxacin is the generic (nonproprietary) name of Levaquin.
What drug class is Levaquin in?
Levaquin belongs to the Fluoroquinolone Antibacterial [EPC] class. See all Fluoroquinolone Antibacterial [EPC] drugs at /class/fluoroquinolone-antibacterial-epc.
When was Levaquin approved?
Levaquin was first approved on 1996.
What development phase is Levaquin in?
Levaquin is FDA-approved (marketed).
What are the side effects of Levaquin?
Common side effects of Levaquin include Nausea, Headache, Diarrhea, Insomnia, Constipation, Dizziness.
What does Levaquin target?
Levaquin targets Multidrug and toxin extrusion protein 1 and is a Fluoroquinolone Antibacterial [EPC].
Related
- Drug class: All Fluoroquinolone Antibacterial [EPC] drugs
- Target: All drugs targeting Multidrug and toxin extrusion protein 1
- Manufacturer: Santen — full pipeline
- Indication: Drugs for Acute Moraxella catarrhalis bronchitis
- Indication: Drugs for Acute bacterial bronchitis
- Indication: Drugs for Acute bacterial sinusitis
- Compare: Levaquin vs similar drugs
- Pricing: Levaquin cost, discount & access