Ambroxol – 2-amino-3,5-dibromo-N-[trans-4-hydroxycyclohexyl]benzylamine, an over-the-counter product, is a mucoactive agent and has been used widely to treat both acute and chronic respiratory diseases since 1978. 

A new study published in Mutidisciplinary Respiratory Medicine aimed to provide an overview of the clinical evidence available on the use of ambroxol in children with acute and chronic respiratory diseases.

Data for this review were obtained from both published and unpublished clinical studies, and real-world evidence studies. 

The findings revealed that these studies—almost 1 300 pediatric patients—reported strong clinical outcomes following the use of ambroxol in pediatric patients. Moreover, efficacy findings were consistent irrespective of age, including for patients as young as one month of age. Most studies found ambroxol to be well tolerated in children. 

Thus, clinical evidence for ambroxol shows treatment effects that offer significant benefits to pediatric patients for its licensed use as a secretolytic therapy in acute and chronic bronchopulmonary disorders associated with abnormal mucus secretion and impaired mucus transport. The findings indicated indicate that ambroxol, for its intended over-the-counter indications, is both efficacious and well tolerated in children and that the favorable benefit/risk profile of ambroxol reported in adults extends to the pediatric population, starting from early infancy, with acute and chronic respiratory diseases.

Source: Mutidisciplinary Respiratory Medicine. 2020 Mar 3;15(1):511. doi: 10.4081/mrm.2020.511.