Doxofylline Dosing in Children
For children over 6 years of age with asthma, the recommended dose of doxofylline is 6 mg/kg per dose twice daily (BID), which translates to approximately 12-18 mg/kg/day in divided doses. 1, 2
Age-Specific Recommendations
- Children ≥6 years: 6 mg/kg/dose twice daily is the established pediatric dosing regimen 1
- Children <6 years: Doxofylline is not recommended due to lack of safety and efficacy data in this age group 1
Clinical Context and Evidence
The dosing recommendation comes from retrospective pediatric data and recent clinical trials demonstrating efficacy in children with asthma:
- A 2024 Mexican study used 18 mg/kg/day (divided doses) in children aged 6-16 years as a steroid-sparing agent, showing maintained lung function and improved asthma control 2
- The 6 mg/kg/dose BID regimen produces stable serum concentrations without requiring routine plasma monitoring in healthy children 1
Monitoring Requirements
Plasma monitoring is only required in specific circumstances:
- Children with hepatic insufficiency 1
- Patients with documented intolerance to xanthine drugs 1
- Unlike theophylline, routine therapeutic drug monitoring is not necessary due to doxofylline's stable pharmacokinetic profile 1
Safety Profile Advantages
Doxofylline demonstrates significantly fewer adverse effects compared to theophylline:
- Only 5% of pediatric patients reported moderate side effects in retrospective data 1
- Animal and human studies show reduced CNS stimulation, minimal effects on gastric acid secretion, and less cardiovascular toxicity compared to aminophylline 3
- The drug has approximately 10-15 times lower adenosine receptor antagonism than theophylline, accounting for its improved tolerability 3
Clinical Application
Doxofylline may be used as add-on therapy in Step 3 and Step 4 asthma management in children over 6 years, extrapolating from adult data and limited pediatric studies 1, 2. It can serve as an alternative to theophylline when oral bronchodilator therapy is needed, particularly in resource-limited settings 1.