What are the guidelines for fluoroquinolone (e.g. ciprofloxacin, levofloxacin) use in a 15-year-old pediatric patient?

From the Guidelines

Fluoroquinolones should generally be avoided in pediatric patients, including 15-year-olds, unless the benefits clearly outweigh the risks. These antibiotics are not first-line therapy for most pediatric infections due to concerns about potential adverse effects on developing cartilage and tendons. However, in specific situations where other antibiotics are ineffective or contraindicated, fluoroquinolones may be used under careful supervision. For a 15-year-old, if deemed necessary, ciprofloxacin may be dosed at 20-30 mg/kg/day divided twice daily (maximum 1.5 g/day) or levofloxacin at 8-10 mg/kg once daily (maximum 750 mg/day) 1. Treatment duration depends on the infection being treated, typically 7-14 days. Patients and parents should be warned about potential side effects including tendon pain, joint discomfort, and gastrointestinal symptoms. Any tendon pain should prompt immediate medication discontinuation and medical evaluation. The concern with fluoroquinolones stems from their inhibition of DNA gyrase and topoisomerase IV, which can affect cartilage development and tendon integrity. While the risk of permanent cartilage damage appears lower than initially feared, caution is still warranted, especially in growing adolescents.

Key Considerations

• Fluoroquinolones are not first-line therapy for most pediatric infections
• Use of fluoroquinolones in pediatric patients should be restricted to situations where there is no safe and effective alternative to treat an infection caused by multidrug-resistant bacteria or to provide oral therapy when parenteral therapy is not feasible and no other effective oral agent is available 1
• Patients and parents should be warned about potential side effects including tendon pain, joint discomfort, and gastrointestinal symptoms
• Any tendon pain should prompt immediate medication discontinuation and medical evaluation

Dosage and Administration

• Ciprofloxacin: 20-30 mg/kg/day divided twice daily (maximum 1.5 g/day)
• Levofloxacin: 8-10 mg/kg once daily (maximum 750 mg/day)
• Treatment duration: typically 7-14 days

Monitoring and Precautions

• Monitor patients for signs of tendonitis or tendon rupture
• Warn patients and parents about potential side effects including tendon pain, joint discomfort, and gastrointestinal symptoms
• Any tendon pain should prompt immediate medication discontinuation and medical evaluation

From the FDA Drug Label

8.4 Pediatric Use Quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species. Inhalational Anthrax (Post-Exposure) Levofloxacin is indicated in pediatric patients 6 months of age and older, for inhalational anthrax (post-exposure). The risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate. The safety of levofloxacin in pediatric patients treated for more than 14 days has not been studied

• Fluoroquinolone use in a 15-year-old pediatric patient: The FDA drug label for levofloxacin indicates that it is approved for use in pediatric patients 6 months of age and older for certain conditions, including inhalational anthrax (post-exposure) and plague. However, the label also notes that quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals, and the safety of levofloxacin in pediatric patients treated for more than 14 days has not been studied. For ciprofloxacin, the label states that it should be used in pediatric patients (less than 18 years of age) only for infections listed in the INDICATIONS AND USAGE section, and that an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. Given this information, caution should be exercised when considering fluoroquinolone use in a 15-year-old pediatric patient, and the potential benefits and risks should be carefully weighed 2, 3.

From the Research

Guidelines for Fluoroquinolone Use in Pediatric Patients

The use of fluoroquinolones in pediatric patients is limited due to concerns about potential musculoskeletal adverse events 4. However, recent studies have shown that the risk of musculoskeletal complications in children may not be significantly increased with fluoroquinolone treatment 5.

Indications for Fluoroquinolone Use

According to the U.S. Food and Drug Administration, indications for fluoroquinolone use in patients younger than 18 years include:

• Treatment of complicated urinary tract infections
• Postexposure treatment for inhalation anthrax 4 Other potential uses for fluoroquinolones in pediatric patients include:
• Treatment of multidrug-resistant infections that have not responded to standard antibiotic therapy in immunocompromised patients 4
• Treatment of selected respiratory infections, including tuberculosis, exacerbation of lung disease in cystic fibrosis, central nervous system infections, enteric infections, febrile neutropenia, and serious infections attributable to FQ-susceptible pathogen(s) in children with life-threatening allergies to alternative agents 6

Safety Considerations

While fluoroquinolones may be associated with a risk of musculoskeletal adverse events in pediatric patients, this risk may be marginal 6. A meta-analysis found no statistical difference between fluoroquinolone and non-fluoroquinolone groups in terms of musculoskeletal adverse events in children 5. However, another study found a slightly increased risk of musculoskeletal adverse events after fluoroquinolone treatment in pediatric patients, particularly in males, older patients, and some fluoroquinolone users 7.

Key Points to Consider

• Fluoroquinolone use in pediatric patients should be limited to selected indications and used with caution due to potential musculoskeletal adverse events 4, 6
• The choice of fluoroquinolone and its dosage should be carefully considered, taking into account the specific disease being treated and the patient's individual characteristics 6
• Pediatricians should be aware of the indications and adverse effects of fluoroquinolones and monitor patients closely for potential musculoskeletal adverse events 4