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 18 mg/kg/day total daily dose. 1, 2
Age-Specific Recommendations
- Children ≥6 years: 6 mg/kg/dose administered twice daily 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 is based on extrapolation from adult data and limited pediatric studies, as doxofylline represents a newer methylxanthine derivative with a more favorable side effect profile compared to theophylline. 1
Key Advantages Over Theophylline
- No routine plasma monitoring required in most patients, as doxofylline produces stable serum concentrations 1
- Monitoring is only necessary in children with hepatic insufficiency or documented intolerance to xanthine drugs 1
- Significantly fewer side effects compared to theophylline, with retrospective data showing only 5% of patients experiencing moderate adverse effects 1
Clinical Efficacy Data
A recent 2024 pilot study in Mexican children demonstrated that doxofylline at 18 mg/kg/day combined with inhaled corticosteroids allowed for steroid-sparing effects while maintaining lung function and improving asthma control. 2 This supports its use as add-on therapy in step 3 and step 4 asthma management in children. 1
Important Caveats
- The evidence base in pediatric populations remains limited, with most data extrapolated from adult studies 1
- Doxofylline has a weaker adenosine receptor antagonist effect compared to theophylline (15-fold lower potency), which accounts for its reduced side effect profile 3
- Unlike theophylline, doxofylline does not significantly affect diuresis, locomotor activity, gastric acid secretion, or cardiovascular parameters at therapeutic doses 3