Ambroxol Dosing in Pediatric Patients
For children aged 2-12 years, the standard oral ambroxol dose is 30 mg daily (divided into 2-3 doses), while children under 2 years typically receive 15 mg daily in divided doses. 1
Age-Based Dosing Guidelines
Infants and Young Children (1 month to 2 years)
- 15 mg per day divided into 2-3 doses (typically 7.5 mg twice daily or 5 mg three times daily) 1
- Ambroxol has demonstrated consistent efficacy and tolerability in patients as young as 1 month old 1
- The favorable benefit-risk profile extends to early infancy for acute and chronic respiratory diseases with abnormal mucus secretion 1
Children (2-12 years)
- 30 mg per day divided into 2-3 doses (typically 15 mg twice daily or 10 mg three times daily) 1, 2
- In clinical studies of children aged 2-13 years with spastic bronchitis, 30 mg daily (administered as 2 sachets) for 10 days proved effective and well-tolerated 2
Adolescents (>12 years)
- Adult dosing typically applies: 60 mg per day divided into 2-3 doses initially, which may be reduced to 30 mg daily for maintenance 1
Clinical Evidence and Efficacy
Ambroxol demonstrates strong clinical outcomes across all pediatric age groups for its licensed indication as secretolytic therapy in acute and chronic bronchopulmonary disorders. 1
- Clinical studies representing nearly 1,300 pediatric patients show consistent efficacy findings irrespective of age 1
- In comparative studies, ambroxol achieved more rapid symptomatic improvement than acetylcysteine in children with asthmatiform bronchitis 2
- Treatment effects include improved sputum quantity and quality, reduced difficulty expectorating, and decreased cough, dyspnea, and bronchial bruits 2
Safety Profile
Ambroxol is well-tolerated in children across all age groups, with the majority of studies reporting favorable safety outcomes. 1
- The favorable benefit-risk profile documented in adults extends to the pediatric population starting from early infancy 1
- Minor adverse events may include gastrointestinal discomfort, but severe adverse events are rare 1
- Long-term use has been studied, with one registry reporting treatment periods up to 76 months in pediatric patients without severe adverse events 3
Formulation and Administration
- Ambroxol is available as an over-the-counter oral formulation, typically as syrup or sachets for pediatric use 1, 2
- The medication can be administered 2-3 times daily with or without food 1
- For acute respiratory conditions, treatment duration is typically 7-10 days 2
Important Clinical Considerations
Do not underdose based on weight alone in very young infants—the 15 mg daily dose for children under 2 years has been validated in clinical studies starting from 1 month of age. 1