Is Levofloxacin appropriate for a 15-year-old patient?

From the Guidelines

Levofloxacin is not the first choice for a 15-year-old patient, due to concerns about potential adverse effects and lack of FDA approval for use in children.

Considerations for Use

• According to the guidelines for antimicrobial treatment and prophylaxis of plague, for children aged ≥3 months to 17 years, moxifloxacin is recommended as an alternative antimicrobial rather than a first-line agent because of lack of FDA approval for use in children and higher reported rates of prolonged QTc interval compared with other fluoroquinolones 1.
• However, for a 15-year-old patient, the dosage of levofloxacin can be considered as 500–750 mg every 24 hrs IV or PO, for a body weight ≥50 kg, as per the recommendations for treatment of plague 1.
• It is essential to note that the use of fluoroquinolones, including levofloxacin, in children is generally avoided due to the potential risk of cartilage damage and other adverse effects, but in life-threatening infections such as plague, the benefits may outweigh the risks 1.

Alternative Options

• Moxifloxacin is an alternative option for children aged ≥3 months to 17 years, but it is not FDA approved for use in children and has higher reported rates of prolonged QTc interval compared with other fluoroquinolones 1.
• Other antibiotics, such as doxycycline, may be considered for use in children aged <8 years, despite concerns about tooth staining or enamel hypoplasia, due to a favorable risk-benefit ratio in life-threatening infections such as plague 1.

From the FDA Drug Label

Safety and effectiveness in pediatric patients below the age of six months have not been established. Adverse Events In clinical trials, 1534 children (6 months to 16 years of age) were treated with oral and intravenous levofloxacin Children 6 months to 5 years of age received levofloxacin 10 mg/kg twice a day and children greater than 5 years of age received 10 mg/kg once a day (maximum 500 mg per day) for approximately 10 days

Levofloxacin use in a 15-year-old patient is supported by the drug label, as the patient is within the age range (6 months to 16 years) that was treated with levofloxacin in clinical trials 2. However, it is essential to consider the potential risks, including musculoskeletal disorders, and carefully weigh the benefits and risks before making a decision.

• The drug label reports a higher incidence of musculoskeletal disorders in children treated with levofloxacin compared to non-fluoroquinolone-treated children.
• The majority of musculoskeletal disorders were mild or moderate and resolved without sequelae. It is crucial to consult the drug label and consider the individual patient's circumstances before making a decision about levofloxacin use in a 15-year-old patient.

From the Research

Patient Age Considerations

• The patient in question is 15 years old, and according to the study 3, levofloxacin pharmacokinetics in children were investigated in 5 age groups, including 12 to 16 years.
• The study 3 found that levofloxacin elimination is age-dependent, and children younger than 5 years of age clear levofloxacin nearly twice as fast as adults.
• However, for children aged 12 to 16 years, the study 3 does not provide specific clearance rates, but it does suggest that children > or = 5 years need a daily dose of 10 mg/kg.

Dosage and Administration

• The study 4 describes a case of a 15-year-old obese adolescent patient who received levofloxacin at 1000 mg IV every 24 hours, which was later adjusted to 1000 mg IV every 12 hours based on therapeutic drug monitoring.
• The adjusted regimen provided an appropriate AUC exposure and was associated with a successful clinical outcome in this patient 4.
• The study 5 mentions that a high-dose (750 mg) short-course (5 days) of once-daily levofloxacin is approved for use in the US in the treatment of community-acquired pneumonia, acute bacterial sinusitis, complicated urinary tract infections, and acute pyelonephritis.

Safety Considerations

• The study 6 investigated the efficacy and safety of levofloxacin in children with severe infections and found that adverse events occurring during the initiation of levofloxacin therapy in children are reported to be relatively common, but only a small percentage of them were possibly related to levofloxacin.
• The study 7 discusses the safety considerations of fluoroquinolones, including levofloxacin, in the elderly population, but does not provide specific information on the safety of levofloxacin in adolescents.
• However, the study 4 suggests that therapeutic drug monitoring of levofloxacin can help optimize the dosage regimen and minimize the risk of adverse effects in obese adolescent patients.