Evigrade

Levofloxacin

AEMPS

Third-generation fluoroquinolone

ATC code: J01MA12

Brand names: Tavanic, Levaquin, Levofloxacino Cinfa, Levofloxacino Normon

Updated · Methodology

Indications

A

Community-acquired pneumonia

Second line

Second-line for community-acquired pneumonia. Dose 500–750 mg once daily for 5–7 days. /ATS 2019 and SEPAR 2024 set high-dose amoxicillin or amoxicillin + macrolide as first-line outpatient CAP. Levofloxacin is used in penicillin allergy, severe disease with resistant pneumococcus risk, or comorbidities (COPD, diabetes).

ICD-10: J18.9 · ICD-11: CA40.Z

A

Urinary tract infection

Second line

Second-line for acute pyelonephritis per EAU 2024 and 2010. Dose 500–750 mg once daily for 5–7 days. Not used in uncomplicated cystitis in non-pregnant women – first-line is fosfomycin or nitrofurantoin ( 2019 restriction).

ICD-10: N39.0 · ICD-11: GC08

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Common cold

Not recommended

Levofloxacin is prescribed for bronchitis, upper respiratory infections and presumed pneumonia without radiographic confirmation. 2024 AWaRe and 2019 confine fluoroquinolones to serious infections. The 2018 PRAC and boxed warning curtailed routine use due to tendinopathy, peripheral neuropathy and aortic aneurysm risk. Use in viral infections is not indicated.

ICD-10: J00 · ICD-11: CA00

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

An L-isomer of ofloxacin with 2× higher activity. Inhibits bacterial topoisomerase II (DNA gyrase) and topoisomerase IV. Spectrum covers gram-negatives (E. coli, Klebsiella, Pseudomonas aeruginosa, Haemophilus influenzae), gram-positives (Streptococcus pneumoniae including penicillin-resistant, methicillin-susceptible Staphylococcus aureus), and atypical pathogens (Mycoplasma, Chlamydia, Legionella). in 2019 substantially restricted fluoroquinolone indications due to severe adverse effects.

Safety

Boxed warning

FDA boxed warning: tendinitis, tendon rupture, peripheral neuropathy, psychiatric disorders; myasthenia gravis exacerbation; raised aortic aneurysm and dissection risk. Use only when alternatives are unavailable.

Contraindications

  • Hypersensitivity to levofloxacin or fluoroquinolones
  • Age under 18 (rare exceptions – inhalation anthrax)
  • Pregnancy and lactation
  • Epilepsy
  • Prior tendinitis or tendon rupture with fluoroquinolones
  • Myasthenia gravis
  • QT prolongation
  • Prior aortic aneurysm, Marfan or Ehlers-Danlos syndromes

Serious adverse effects

  • Tendinitis and tendon rupture (Achilles, shoulder)
  • Peripheral neuropathy (potentially irreversible)
  • Aortic aneurysm and dissection
  • Psychiatric disorders (depression, psychosis, suicidal ideation)
  • Hypoglycemia and hyperglycemia
  • Hepatic failure
  • Severe cutaneous reactions
  • Pseudomembranous colitis
  • Anaphylaxis
  • Retinal detachment

Common adverse effects

  • Nausea and diarrhea
  • Headache
  • Dizziness
  • Insomnia
  • Candidiasis
  • QT prolongation

Pregnancy: can you take Levofloxacin?

Contraindicated. β-lactams, macrolides, or cephalosporins are preferred in pregnant patients with severe infection.

Breastfeeding: can you take Levofloxacin?

Contraindicated during lactation.

RID, infant dose via milk
8.2%
Maternal half-life
7 h
Peak milk concentration
8.2 mg/L

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Special situations

in 2019 restricted fluoroquinolones due to severe, potentially irreversible adverse effects: tendinitis and tendon rupture (especially Achilles, higher risk in older adults and with steroids), peripheral neuropathy, psychiatric disorders, aortic aneurysm and dissection, retinal detachment. Not prescribed for mild or moderate infections with alternatives. Not used in patients with prior aortic aneurysm, Marfan or Ehlers-Danlos syndromes. Antacids, iron, zinc, calcium, bismuth reduce absorption – separate by at least 4 hours.

Drug–drug interactions

2 pairs found. Sorted from critical to minor.

CriticalCitalopramSSRI (selective serotonin reuptake inhibitor)

Mechanism

Levofloxacin is a fluoroquinolone, and its SmPC devotes a section to caution in patients already taking QT-prolonging drugs. The citalopram SmPC lists ongoing treatment with any drug capable of prolonging the QT interval among its contraindications, with no exceptions.

Symptoms

QTc prolongation on ECG, palpitations, dizziness, syncope. The end point is polymorphic ventricular tachycardia of the torsade type progressing to ventricular fibrillation. The risk is higher with hypokalaemia, hypomagnesaemia, bradycardia, decompensated heart failure and in women.

Management

The pair sits in the citalopram SmPC contraindications, so the question is which drug stays, not how far to cut the dose. The fluoroquinolone label says caution, the SSRI label says contraindication, and the stricter document sets the severity. For a community infection the antibiotic is picked outside this group.

Pair details →Citalopram →

ModerateAtomoxetineCentrally acting sympathomimetics

Mechanism

Both can lengthen the QT interval and the effect adds up. The atomoxetine label asks for caution in patients with congenital or acquired long QT and with a family history. The levofloxacin label warns that fluoroquinolones should be used with caution where QT prolongation risk factors exist, and explicitly mentions concomitant use of QT-prolonging medicines.

Symptoms

Palpitations, dizziness, a feeling of impending faint or syncope. The serious long-QT arrhythmia, torsade de pointes, can present directly with loss of consciousness. Hypokalaemia and hypomagnesaemia, common with vomiting or diarrhoea, increase the risk.

Management

For a common infection, an antibiotic without QT effect avoids the problem; levofloxacin is reserved for when there is no alternative. If the pair is necessary, correct potassium and magnesium before starting and consider an ECG in patients with heart disease, a family history of sudden death or other QT-prolonging drugs.

Pair details →Atomoxetine →

Label mentions23 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Majorcorticosteroidesclass named in the label
    «Tendinitis y rotura de tendones: A la primera señal de tendinitis (por ejemplo, hinchazón dolorosa, inflamación), se debe interrumpir el tratamiento con levofloxacino y se debe considerar un…»

    AEMPS, section 4.4 · Open on CIMA

  • Moderateantacidsclass named in the label
    «Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins: While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of…»

    FDA, section 7 · Open on DailyMed

  • Moderateantiarrítmicosclass named in the label
    «Medicamentos con capacidad de prolongar el intervalo QT: Levofloxacino, así como otras fluoroquinolonas, se deben usar con precaución en pacientes que estén recibiendo otros medicamentos que…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantesclass named in the label
    «Antagonistas de la vitamina K: Se han notificado incrementos en las pruebas de coagulación (PT/INR) y/o sangrado que pueden ser graves, en pacientes tratados con levofloxacino en combinación con un…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantidepresivos tricíclicosclass named in the label
    «Medicamentos con capacidad de prolongar el intervalo QT: Levofloxacino, así como otras fluoroquinolonas, se deben usar con precaución en pacientes que estén recibiendo otros medicamentos que…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantidiabeticsclass named in the label
    «DRUG INTERACTIONS: Antidiabetic agents Carefully monitor blood glucose ( 5.13 , 7.3 )»

    FDA, section 7 · Open on DailyMed

  • Moderateantipsicóticosclass named in the label
    «Medicamentos con capacidad de prolongar el intervalo QT: Levofloxacino, así como otras fluoroquinolonas, se deben usar con precaución en pacientes que estén recibiendo otros medicamentos que…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatemacrólidosclass named in the label
    «Medicamentos con capacidad de prolongar el intervalo QT: Levofloxacino, así como otras fluoroquinolonas, se deben usar con precaución en pacientes que estén recibiendo otros medicamentos que…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateTheophylline
    «Pacientes con predisposición convulsiva: Las quinolonas pueden disminuir el umbral epiléptico y pueden desencadenar convulsiones. Levofloxacino está contraindicado en pacientes con antecedentes de…»

    AEMPS, section 4.4 · Open on CIMA

  • ModerateWarfarin
    «Antagonistas de la vitamina K: Se han notificado incrementos en las pruebas de coagulación (PT/INR) y/o sangrado que pueden ser graves, en pacientes tratados con levofloxacino en combinación con un…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateWarfarin
    «DRUG INTERACTIONS: Warfarin Effect may be enhanced. Monitor prothrombin time, INR and watch for bleeding ( 7.2 )»

    FDA, section 7 · Open on DailyMed

  • AINEclass named in the label
    «Teofilina, fenbufeno o medicamentos antiinflamatorios no esteroideos similares: No se hallaron interacciones farmacocinéticas entre levofloxacino y teofilina en ningún ensayo clínico. Sin embargo, se…»

    AEMPS, section 4.5 · Open on CIMA

  • antiácidosclass named in the label
    «Sales de hierro, sales de zinc, antiácidos que contienen magnesio o aluminio, didanosina»

    AEMPS, section 4.5 · Open on CIMA

  • «Ciclosporina: La vida media de ciclosporina se incrementó en un 33%, cuando se administró conjuntamente con levofloxacino.»

    AEMPS, section 4.5 · Open on CIMA

  • «Otra información relevante: Estudios de farmacología clínica han demostrado que la farmacocinética de levofloxacino no se vió afectada en ningún grado clínicamente relevante cuando se administraba…»

    AEMPS, section 4.5 · Open on CIMA

  • «Digoxin: No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers…»

    FDA, section 7 · Open on DailyMed

  • «Otra información relevante: Estudios de farmacología clínica han demostrado que la farmacocinética de levofloxacino no se vió afectada en ningún grado clínicamente relevante cuando se administraba…»

    AEMPS, section 4.5 · Open on CIMA

  • «Theophylline: No significant effect of levofloxacin on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers…»

    FDA, section 7 · Open on DailyMed

From other drugs’ labels

  • CriticalHydroxyzine
    «La administración conjunta de hidroxizina con fármacos que se sabe que prolongan el intervalo QT y/o inducen Torsade de Pointes, como por ej. antiarrítmicos clase IA (ej. quinidina, disopiramida) y…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAzithromycin
    «Medicamentos asociados con prolongación del intervalo QT: Azitromicina se debe usar con precaución en pacientes que reciben medicamentos que se sabe que prolongan el intervalo QT (ver sección 4.4)…»

    AEMPS, section 4.5 · Open on CIMA

  • «Está contraindicado el uso concomitante de las siguientes sustancias: ciertos antibióticos (p. ej., eritromicina, levofloxacino, moxifloxacino, espiramicina)»

    AEMPS, section 4.5 · Open on CIMA

  • «Ciertos antibióticos (p. ej., claritromicina, eritromicina, levofloxacino, moxifloxacino)»

    AEMPS, section 4.5 · Open on CIMA

  • «Efectos cardiovasculares: Determinados antibióticos (p. ej., azitromicina, claritromicina, eritromicina, levofloxacino, moxifloxacino, telitromicina).»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Levofloxacin used for?

Levofloxacin is evaluated for the following indications with varying evidence strength: Community-acquired pneumonia (evidence tier A), Urinary tract infection (evidence tier A), COPD exacerbation (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Levofloxacin?

Common side effects of Levofloxacin (≥ 1 in 100): Nausea and diarrhea, Headache, Dizziness, Insomnia, Candidiasis, QT prolongation. See the Safety section for uncommon and serious reactions.

Is Levofloxacin safe during pregnancy?

Contraindicated. β-lactams, macrolides, or cephalosporins are preferred in pregnant patients with severe infection.

Is Levofloxacin compatible with breastfeeding?

Contraindicated during lactation.

Who should not take Levofloxacin?

Levofloxacin is contraindicated in: Hypersensitivity to levofloxacin or fluoroquinolones; Age under 18 (rare exceptions – inhalation anthrax); Pregnancy and lactation; Epilepsy; Prior tendinitis or tendon rupture with fluoroquinolones. Full list in the Safety section.

Does Levofloxacin carry an FDA boxed warning?

FDA boxed warning: tendinitis, tendon rupture, peripheral neuropathy, psychiatric disorders; myasthenia gravis exacerbation; raised aortic aneurysm and dissection risk. Use only when alternatives are unavailable.

Official sources

Direct links to regulator labels. Open in a new tab.

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