What is the recommended dosage and use of Ambroxol (Bromhexine) cough syrup?

Ambroxol Cough Syrup Dosage and Usage Guidelines

For most patients with cough, ambroxol cough syrup is recommended at a dose of 120 mg per day for adults, which provides optimal efficacy for reducing cough symptoms and improving mucus clearance. 1

Adult Dosing

• Standard adult dosage is 120 mg daily, which has shown significant improvements in sputum volume, sputum viscosity, expectoration difficulty, and cough severity compared to placebo 1
• Lower doses (30 mg daily) have not demonstrated clear clinical effects in controlled studies 1
• For adult syrup formulations, follow the specific product labeling for concentration and volume recommendations 2
• Extended-release capsule formulations are available for once-daily dosing but may have slower onset of action compared to syrup formulations 2

Pediatric Dosing

• Pediatric syrup formulations are available and have demonstrated efficacy and safety in children as young as 1 month of age 3
• Dosing for children should be adjusted based on age and weight according to product-specific instructions 3
• Pediatric formulations have shown comparable or slightly better efficacy than adult formulations in symptom relief 2

Duration and Timing

• Typical treatment duration is approximately 10-14 days for acute conditions 4, 1
• Most patients report symptom improvement within 60 minutes of administration for immediate-release formulations 2
• Extended-release capsules have a slower onset of action but provide longer-lasting effects 2

Clinical Indications

• Ambroxol is indicated for secretolytic therapy in acute and chronic bronchopulmonary disorders associated with abnormal mucus secretion and impaired mucus transport 3
• Particularly effective for productive cough, congested airways, and cough with difficult expectoration 5
• May be used in both acute bronchitis and chronic respiratory conditions 3, 4

Efficacy

• Ambroxol works through multiple mechanisms including secretagogue, anti-inflammatory, anti-oxidant, anti-bacterial, anti-viral, immunomodulatory, and local anesthetic effects 2
• Most effective for improving chest pain while coughing (approximately 75% improvement) 2
• Moderately effective for reducing sputum production (approximately 40% improvement) 2
• 92% of patients rate the effectiveness as "very good" or "good" in real-world studies 5

Safety and Tolerability

• Generally well-tolerated with 97% of patients rating safety as "very good" or "good" 5
• Adverse events occur in approximately 2.5% of users, primarily affecting the gastrointestinal tract 5
• No serious adverse events have been reported in large cohort studies 5
• Safe for use in pediatric populations when used according to age-appropriate dosing 3

Available Formulations

• Multiple formulations are available including extended-release capsules, adult syrup, pediatric syrup, and soft pastilles 2
• Pastilles and pediatric syrup formulations demonstrate the fastest onset of symptom relief 2
• Extended-release capsules provide longer duration of effect but slower onset 2

Important Considerations

• Ambroxol is not recommended as a first-line treatment for non-productive cough; for dry cough, dextromethorphan at 60 mg may be more appropriate 6
• In patients with acute bronchitis, mucokinetic agents like ambroxol are not consistently recommended due to conflicting evidence on their effect on cough 7
• For cough due to upper respiratory infections, peripheral cough suppressants have limited efficacy and are not generally recommended 7
• For chronic bronchitis, central cough suppressants such as codeine and dextromethorphan are recommended for short-term symptomatic relief 7

Practical Approach to Using Ambroxol

• Assess whether the cough is productive or non-productive before recommending ambroxol 5
• For productive cough with difficult expectoration, ambroxol at 120 mg daily for adults is appropriate 1
• For children, use age-appropriate pediatric formulations 3
• Monitor for improvement within the first 60 minutes (immediate-release formulations) 2
• Continue treatment for 10-14 days for optimal results 4, 1
• If no improvement after 5-7 days, reassess the diagnosis and consider alternative treatments 7