Bromhexine (Bisolvon) Syrup Should NOT Be Used in a 7-Month-Old Infant
The European Respiratory Society explicitly recommends against routine use of bromhexine in children and adolescents with bronchiectasis (conditional recommendation, very low quality of evidence), and this applies to the entire pediatric age range including infants as young as 7 months. 1, 2
Why This Recommendation Applies to Your 7-Month-Old
Lack of Pediatric Evidence and Safety Concerns
No pediatric studies exist – All available evidence for bromhexine comes exclusively from adult-based randomized controlled trials, with zero pediatric-specific studies identified in systematic reviews. 1, 2
Increased adverse events – Studies demonstrate higher rates of adverse effects with bromhexine compared to placebo (OR 2.93,95% CI 0.12-73.97), though the wide confidence interval reflects limited data. 3, 2
Guideline panels express concern – The European Respiratory Society panel specifically noted that most clinicians would be "very concerned" about using bromhexine due to potential adverse effects in the pediatric population. 2
Practical Limitations at This Age
Infants cannot cooperate with expectoration – At 7 months of age, children lack the developmental ability to cough effectively or expectorate mucus, making the theoretical benefit of a mucolytic agent questionable from a practical standpoint. 2
The mechanism requires active participation – Bromhexine works by thinning mucus to improve expectoration, but this requires the child to be able to cough productively, which is not feasible in infants. 3, 4
What Should Be Used Instead
Airway Clearance Techniques Are Strongly Recommended
Non-pharmacologic approaches are preferred – The European Respiratory Society strongly recommends individualized airway clearance techniques taught by pediatric-trained chest physiotherapists for children with bronchiectasis, using age-appropriate and developmentally suitable methods. 1, 2
These avoid medication risks – Physical therapy approaches provide proven benefit while completely avoiding the adverse effect profile of mucolytic medications. 2
For Specific Respiratory Conditions
If the infant has thick mucus from infection – Focus on hydration, humidified air, and gentle nasal suctioning rather than systemic mucolytics. 2
If considering any medication – Consult a pediatric pulmonologist or pediatrician for age-appropriate alternatives, as the evidence base for mucoactive agents in infants is extremely limited. 1, 2
Critical Caveats
Very low quality evidence means substantial uncertainty exists about both efficacy and safety in children, making the risk-benefit ratio unfavorable. 1, 2
The balance of evidence favors not using bromhexine based on patient/parent values, substantial adverse effects, and lack of proven efficacy. 2
Alternative formulations don't change the recommendation – Even if a liquid syrup formulation exists, the fundamental concern is the drug itself, not the delivery method, in this age group. 2