What are the guidelines for using Levofloxacin (fluoroquinolone antibiotic) in pediatric patients?

Guidelines for Using Levofloxacin in Pediatric Patients

Levofloxacin should be restricted in pediatric patients to situations where there is no safe and effective alternative to treat an infection caused by multidrug-resistant bacteria or when no other effective oral agent is available. 1

Limited FDA-Approved Indications

• Levofloxacin is FDA-approved for pediatric use only in specific situations:
  • Inhalational anthrax (post-exposure) in children 6 months and older 2
  • Plague (including pneumonic and septicemic plague) in children 6 months and older 2
• Safety has not been established in children younger than 6 months of age 2

Safety Concerns

• Fluoroquinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals 2
• Clinical studies have shown a higher incidence of musculoskeletal disorders in levofloxacin-treated children compared to those treated with non-fluoroquinolone antibiotics:
  • 2.1% vs. 0.9% at 2 months after treatment (p=0.04) 3
  • 3.4% vs. 1.8% at 12 months after treatment (p=0.03) 3
• Most common musculoskeletal adverse events include arthralgia, abnormal joint/gait examination, and accidental injury 1
• These events are generally mild to moderate in severity and typically resolve without sequelae 1, 2

Appropriate Clinical Scenarios for Use

Levofloxacin may be considered in the following situations:

• Infections caused by multidrug-resistant pathogens with no safer alternatives 1, 4
• Specific clinical scenarios:
  • Selected respiratory infections including tuberculosis 4
  • Exacerbation of lung disease in cystic fibrosis 4
  • Central nervous system infections 4
  • Enteric infections 4
  • Febrile neutropenia in high-risk patients 1
  • Community-acquired pneumonia when standard therapies cannot be used 5
  • Complicated urinary tract infections when first-line agents are not appropriate 1
  • Post-exposure prophylaxis for anthrax (as a second-line agent) 1

Dosing Recommendations

• Children metabolize levofloxacin faster than adults, requiring age-specific dosing 6:
  • Children 6 months to <5 years: 10 mg/kg every 12 hours (not to exceed 250 mg per dose) 6
  • Children ≥5 years: 10 mg/kg once daily (not to exceed 500 mg per dose) 6
• For anthrax post-exposure prophylaxis (when indicated):
  • Children ≥6 months: 16 mg/kg/day divided every 12 hours; each dose should not exceed 250 mg 1
  • Adults: 500 mg every 24 hours 1

Special Considerations for Cancer and HSCT Patients

• For antibacterial prophylaxis in pediatric cancer patients and hematopoietic stem cell transplantation (HSCT) recipients:
  • Levofloxacin is the preferred agent if antibacterial prophylaxis is planned 1
  • Administration should be restricted to the expected period of severe neutropenia (absolute neutrophil count <500/μL) 1
  • Prophylaxis should be considered for children with acute myeloid leukemia or relapsed acute lymphoblastic leukemia receiving intensive chemotherapy 1
  • Prophylaxis is not routinely recommended for children undergoing autologous HSCT 1

Monitoring and Precautions

• Inform patients and families about potential short and long-term fluoroquinolone-related adverse effects prior to administration 1
• Monitor for musculoskeletal adverse events, particularly arthralgia, which is the most common musculoskeletal disorder 1, 3
• If used for prophylaxis, institutions should closely monitor resistance rates over time 1
• Avoid antacids and other medications containing divalent cations within 2 hours of levofloxacin administration as they markedly decrease absorption 7

Common Pitfalls and Caveats

• Overuse of fluoroquinolones can lead to increased bacterial resistance 1
• Using levofloxacin for common infections where other effective and safer alternatives exist should be avoided 1, 4
• The risk of musculoskeletal adverse events must be weighed against the benefit of treating serious infections 1
• Levofloxacin or pediatric-friendly levofloxacin dosage forms may not be available in all countries, affecting feasibility of administration in young children treated as outpatients 1
• If levofloxacin cannot be used, ciprofloxacin is an alternative, though it has reduced activity against gram-positive bacteria, including viridans group streptococci 1

By carefully weighing the risks and benefits and limiting use to appropriate clinical scenarios, levofloxacin can be a valuable antimicrobial agent for select pediatric patients with serious infections when alternatives are limited or contraindicated.