Ambroxol Dosing Recommendations
The standard dose of ambroxol for adults is 30 mg three times daily (90 mg/day total), while children should receive weight-based dosing of approximately 1.2-1.6 mg/kg/day divided into 2-3 doses.
Adult Dosing
For acute and chronic respiratory conditions in adults, ambroxol 30 mg three times daily is the established therapeutic dose. 1, 2
- The extended-release formulation allows for once-daily dosing of 75 mg, which provides equivalent 24-hour exposure to immediate-release formulations given twice daily 1
- Higher doses (250-500 mg twice daily) have been studied and are well-tolerated, though these are primarily used for investigational purposes rather than routine respiratory therapy 3
- For sore throat relief, lozenges containing 20-30 mg ambroxol provide local anesthetic effects, with up to 6 lozenges daily (maximum 180 mg/day) demonstrating superior pain relief compared to placebo 4
Pediatric Dosing
Children from 1 month to 12 years should receive ambroxol at approximately 1.2-1.6 mg/kg/day, typically divided into 2-3 doses throughout the day. 2
- Clinical evidence supports efficacy and safety in pediatric patients as young as 1 month of age 2
- The favorable benefit-risk profile observed in adults extends to the pediatric population across all age groups 2
- For critically ill children with ARDS, investigational high-dose protocols have used 40 mg/kg/day divided into four doses, though this is not standard practice and requires further study 5
Formulation Considerations
- Immediate-release tablets (30 mg) are typically dosed 2-3 times daily 1
- Extended-release capsules (75 mg) provide once-daily dosing convenience with similar pharmacokinetic profiles 1
- Effervescent tablets (60 mg) can be split and given twice daily 1
- Lozenges (20-30 mg) are specifically formulated for local anesthetic effects in sore throat and should not exceed 6 lozenges daily 4
Clinical Pearls and Caveats
- Ambroxol reaches steady-state plasma concentrations after 2-3 days of regular dosing 3
- The medication is well-tolerated across all age groups with minimal adverse events reported in clinical trials 2, 3, 4
- Extended-release formulations achieve peak concentrations (tmax) at approximately 6 hours, compared to 1-2 hours for immediate-release forms 1
- Avoid using investigational high-dose protocols (>40 mg/kg/day in children or >500 mg twice daily in adults) outside of research settings, as standard doses provide adequate therapeutic benefit with established safety profiles 2, 5