What is the recommended dose of Doxofylline (Doxofylline) for pediatric patients?

Doxofylline Dosing in Pediatric Patients

For children over 6 years of age with asthma, doxofylline should be dosed at 6 mg/kg per dose twice daily (BID). 1

Evidence-Based Dosing Recommendation

• The established pediatric dose is 6 mg/kg per dose administered twice daily for children ≥6 years of age 1
• This dosing regimen has been shown to improve spirometric parameters in children with asthma compared to placebo 1
• Doxofylline produces stable serum concentrations, eliminating the need for routine plasma monitoring except in specific circumstances 1

Clinical Context and Positioning

• Doxofylline may be used as add-on therapy in step 3 and step 4 asthma management in children, similar to theophylline's role 1
• This methylxanthine derivative demonstrates similar efficacy to theophylline but with significantly fewer adverse effects in both animal studies and human adults 1
• The drug is particularly valuable in resource-restricted settings as one of the few oral bronchodilator options available 1

Safety Profile and Monitoring

• Plasma monitoring is only required in two specific situations: patients with hepatic insufficiency and those with documented intolerance to xanthine drugs 1
• Retrospective data indicate that 11% of patients experienced some side effects, but only 5% reported moderate side effects 1
• The improved safety profile compared to theophylline addresses the poor compliance and high drop-out rates associated with traditional methylxanthine therapy 1

Important Limitations

• Doxofylline is not recommended for children under 6 years of age due to lack of safety and efficacy data in this younger population 1
• While adult data is robust, there remains a paucity of controlled studies specifically in pediatric populations with asthma 1