Doxofylline Dosing
The recommended dose of doxofylline for adults is 400 mg twice daily (800 mg total daily dose), administered orally. 1, 2, 3
Standard Dosing Regimen
Adults
- 400 mg twice daily (BID) is the established therapeutic dose for chronic obstructive pulmonary disease (COPD) and bronchial asthma 1, 2, 4, 3
- This dosing has been validated in multiple clinical trials comparing doxofylline to theophylline 2, 3
- The medication can be taken with or without food, as there are no specific dietary restrictions 5
Comparison to Theophylline
- Doxofylline 400 mg BID demonstrates equivalent efficacy to theophylline 300-400 mg daily in improving spirometric parameters 1, 2, 3
- Doxofylline has a superior safety profile with significantly fewer adverse effects (8 side effects with doxofylline vs 25 with theophylline in one study) 2
- Unlike theophylline, doxofylline does not require intensive therapeutic drug monitoring due to its wider safety margin 5
Key Clinical Advantages
Safety Profile
- Doxofylline produces fewer typical methylxanthine side effects including reduced CNS stimulation, minimal effects on gastric acid secretion, and less cardiovascular toxicity compared to theophylline 6
- The drug has approximately 10-15 times lower potency as an adenosine receptor antagonist, which accounts for its improved tolerability 6
- Drop-out rates due to adverse effects are significantly lower (5 patients with doxofylline vs 10 with theophylline) 3
Monitoring Requirements
- Serum levels of 7.5-8.5 mcg/mL are achieved with standard dosing, but routine monitoring is not required unlike theophylline 3
- No need for frequent blood level checks makes doxofylline more practical for outpatient management 5
Important Caveats
Note: The FDA label reference 7 appears to describe a different medication (likely a sleep aid with 3-6 mg dosing taken at bedtime), not doxofylline. This should be disregarded as it does not match the methylxanthine bronchodilator profile of doxofylline.
The evidence consistently supports 400 mg BID as the standard dose across multiple respiratory conditions, with demonstrated efficacy in improving FEV1, FVC, and PEFR while maintaining better tolerability than theophylline 1, 2, 4, 3.