levofloxacin
Regulatory sources consulted
Approved indications
- Pneumonia, pyelonephritis and complicated urinary infections, prostatitis, skin infections, sinusitis, and bronchitis exacerbation when other options are unsuitable.
Contraindications
Absolute
- Hypersensitivity to levofloxacin or other quinolones; epilepsy; history of quinolone-related tendon disorder; growing age; pregnancy; breastfeeding.
Clinical warnings
- It may cause tendinitis or tendon rupture, peripheral neuropathy, and disabling or potentially irreversible central nervous system effects; discontinue immediately at the first symptoms. — CIMA/AEMPS, ficha técnica 75614
- It may exacerbate myasthenia gravis and cause respiratory weakness; avoid in patients with a known history. — CIMA/AEMPS, ficha técnica 75614
- Major warning · It has been associated with aortic aneurysm or dissection; avoid in high-risk patients unless no alternatives exist and seek emergency care for sudden chest, abdominal, or back pain. — CIMA/AEMPS, ficha técnica 75614
- Major warning · It may disturb blood glucose, including severe hypoglycemia; monitor glucose in people with diabetes and discontinue with a significant disturbance. — CIMA/AEMPS, ficha técnica 75614
- Major warning · Clostridioides difficile-associated diarrhea and colitis may occur during or after treatment; assess significant diarrhea and discontinue if confirmed. — CIMA/AEMPS, ficha técnica 75614
- Major warning · It may prolong QT; avoid with prolonged QT, uncorrected hypokalemia, significant bradycardia, or QT-prolonging drugs. — CIMA/AEMPS, ficha técnica 75614
Drug interactions
- HighAntacids and supplements containing multivalent cations
Mechanism: Aluminum, magnesium, calcium, iron, and zinc form chelates and markedly reduce oral absorption.
Recommendation: Separate doses according to the product-specific interval.
CIMA/AEMPS, ficha técnica 75614
- HighWarfarin and coumarin anticoagulants
Mechanism: It may increase anticoagulant effect and INR.
Recommendation: Monitor INR and signs of bleeding during and after treatment.
CIMA/AEMPS, ficha técnica 75614
- HighSystemic corticosteroids
Mechanism: They increase the risk of tendinitis and tendon rupture.
Recommendation: Avoid the combination when possible, especially in older or transplant patients.
CIMA/AEMPS, ficha técnica 75614
Adverse events
Common (≥1%)
Nausea, diarrhea, headache, and dizziness
Rare but serious
Tendon rupture, persistent peripheral neuropathy, severe neuropsychiatric reaction, anaphylaxis, and aortic dissection
Pregnancy and lactation
It is contraindicated during pregnancy and breastfeeding according to the CIMA product.
Recent literature (PubMed)
Helicobacter pylori is a prevalent, global infectious disease that causes dyspepsia, peptic ulcer disease, and gastric cancer. The American College of Gastroenterology commissioned this clinical practice guideline (CPG) to inform the evidence-based management of patients with H. pylori infection in North America. This CPG used Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology to systematically analyze 11 Population, Intervention, Comparison, and Outcome questions and generate recommendations. Where evidence was insufficient or the topic did not lend itself to GRADE, expert consensus was used to create 6 key concepts. For treatment-naive patients with H. pylori infection, bismuth quadruple therapy (BQT) for 14 days is the preferred regimen when antibiotic susceptibility is unknown. Rifabutin triple therapy or potassium-competitive acid blocker dual therapy for 14 days is a suitable empiric alternative in patients without penicillin allergy. In treatment-experienced patients with persistent H. pylori infection, "optimized" BQT for 14 days is preferred for those who have not been treated with optimized BQT previously and for whom antibiotic susceptibility is unknown. In patients previously treated with optimized BQT, rifabutin triple therapy for 14 days is a suitable empiric alternative. Salvage regimens containing clarithromycin or levofloxacin should only be used if antibiotic susceptibility is confirmed. The CPG also addresses who to test, the need for universal post-treatment test-of-cure, and the current evidence regarding antibiotic susceptibility testing and its role in guiding the choice of initial and salvage treatment. The CPG concludes with a discussion of proposed research priorities to address knowledge gaps and inform future management recommendations in patients with H. pylori infection from North America.
Prostatitis is defined as infection, inflammation, or pain of the prostate gland and affects approximately 9.3% of men in their lifetime. Acute bacterial prostatitis consists of a urinary tract infection (UTI) that includes infection of the prostate, typically associated with fever or chills and caused by gram-negative bacteria, such as Escherichia coli, Klebsiella, or Pseudomonas, in 80% to 97% of cases. First-line therapy for acute prostatitis is broad-spectrum intravenous or oral antibiotics, such as intravenous piperacillin-tazobactam, ceftriaxone, or oral ciprofloxacin, which has a 92% to 97% success rate when prescribed for 2 to 4 weeks for people with febrile UTI and acute prostatitis. Chronic bacterial prostatitis is defined as a persistent bacterial infection of the prostate, typically presenting as recurrent UTIs from the same strain. Up to 74% of chronic bacterial prostatitis diagnoses are due to gram-negative organisms, such as E coli. First-line therapy for chronic bacterial prostatitis is a minimum 4-week course of levofloxacin or ciprofloxacin. Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) presents as pelvic pain or discomfort for at least 3 months and is associated with urinary symptoms, such as urinary frequency. CP/CPPS is diagnosed when evaluation, including history and physical examination, urine culture, and postvoid residual measurement, does not identify other causes for the symptoms, such as infection, cancer, urinary obstruction, or urinary retention. The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) measures symptom severity (scale of 0-43), with a 6-point change considered clinically meaningful. First-line oral therapy for CP/CPPS with urinary symptoms is α-blockers (eg, tamsulosin, alfuzosin; ΔNIH-CPSI score difference vs placebo = -10.8 to -4.8). Other oral therapies are associated with modest changes in NIH-CPSI score compared with placebo, including anti-inflammatory drugs (eg, ibuprofen; ΔNIH-
Legionellosis is the infection caused by bacteria of the genus Legionella, including a non-pneumonic influenza-like syndrome, and Legionnaires' disease is a more serious illness characterized by pneumonia. Legionellosis is becoming increasingly important as a public health problem throughout the world; although it is an underreported disease, studies have consistently documented a high incidence. In addition, health costs associated with the disease are high. Diagnosis of Legionnaires' disease is based mainly on the detection of Legionella pneumophila serogroup 1 antigen in urine. However, there have been advances in detection tests for patients with legionellosis. New methodologies show greater sensitivity and specificity, detect more species and serogroups of Legionella spp., and have the potential for use in epidemiological studies. Testing for Legionella spp. is recommended at hospital admission for severe community-acquired pneumonia, and antibiotics directed against Legionella spp. should be included early as empirical therapy. Inadequate or delayed antibiotic treatment in Legionella pneumonia has been associated with a worse prognosis. Either a fluoroquinolone (levofloxacin or moxifloxacin) or a macrolide (azithromycin preferred) is the recommended first-line therapy for Legionnaires' disease; however, little information is available regarding adverse events or complications, or about the duration of antibiotic therapy and its association with clinical outcomes. Most published studies evaluating antibiotic treatment for Legionnaires' disease are observational and consequently susceptible to bias and confounding. Well-designed studies are needed to assess the usefulness of diagnostic tests regarding clinical outcomes, as well as randomized trials comparing fluoroquinolones and macrolides or combination therapy that evaluate outcomes and adverse events.
For decades, poor treatment options and low-quality evidence plagued care for patients with rifampin-resistant tuberculosis. The advent of new drugs to treat tuberculosis and enhanced funding now permit randomized, controlled trials of shortened-duration, all-oral treatments for rifampin-resistant tuberculosis. We conducted a phase 3, multinational, open-label, randomized, controlled noninferiority trial to compare standard therapy for treatment of fluoroquinolone-susceptible, rifampin-resistant tuberculosis with five 9-month oral regimens that included various combinations of bedaquiline (B), delamanid (D), linezolid (L), levofloxacin (Lfx) or moxifloxacin (M), clofazimine (C), and pyrazinamide (Z). Participants were randomly assigned (with the use of Bayesian response-adaptive randomization) to receive one of five combinations or standard therapy. The primary end point was a favorable outcome at week 73, defined by two negative sputum culture results or favorable bacteriologic, clinical, and radiologic evolution. The noninferiority margin was -12 percentage points. Among the 754 participants who underwent randomization, 699 were included in the modified intention-to-treat analysis, and 562 in the per-protocol analysis. In the modified intention-to-treat analysis, 80.7% of the patients in the standard-therapy group had favorable outcomes. The risk difference between standard therapy and each of the four new regimens that were found to be noninferior in the modified intention-to-treat population was as follows: BCLLfxZ, 9.8 percentage points (95% confidence interval [CI], 0.9 to 18.7); BLMZ, 8.3 percentage points (95% CI, -0.8 to 17.4); BDLLfxZ, 4.6 percentage points (95% CI, -4.9 to 14.1); and DCMZ, 2.5 percentage points (95% CI, -7.5 to 12.5). Differences were similar in the per-protocol population, with the exception of DCMZ, which was not noninferior in that population. The proportion of participants with grade 3 or higher adverse events was similar across the r
Mycoplasma pneumoniae (MP) is an important cause of community-acquired pneumonia in children and young adolescents. Despite macrolide antibiotics effectiveness as a first-line therapy, persistence of fever and/or clinical deterioration sometimes may complicate treatment and may even lead to severe systemic disease. To date, there is no consensus on alternative treatment options, optimal dosage, and duration for treating severe, progressive, and systemic MP pneumonia after macrolide treatment failure. Macrolide-resistant MP pneumonia and refractory MP pneumonia are the two major complex conditions that are clinically encountered. Currently, the vast majority of MP isolates are resistant to macrolides in East Asia, especially China, whereas in Europe and North America, whereas in Europe and North America prevalence is substantially lower than in Asia, varying across countries. The severity of pneumonia and extrapulmonary presentations may reflect the intensity of the host's immune reaction or the dissemination of bacterial infection. Children infected with macrolide-resistant MP strains who receive macrolide treatment experience persistent fever with extended antibiotic therapy and minimal decrease in MP-DNA load. Alternative second-line agents such as tetracyclines (doxycycline or minocycline) and fluoroquinolones (ciprofloxacin or levofloxacin) may lead to clinical improvement after macrolide treatment failure in children. Refractory MP pneumonia reflects a deterioration of clinical and radiological findings due to excessive immune response against the infection. Immunomodulators such as corticosteroids and intravenous immunoglobulin (IVIG) have shown promising results in treatment of refractory MP pneumonia, particularly when combined with appropriate antimicrobials. Corticosteroid-resistant hyperinflammatory MP pneumonia represents a persistent or recrudescent fever despite corticosteroid therapy with intravenous methylprednisolone at standard dosage. This report