Maximum Daily Dose of Vilanterol
The maximum recommended daily dose of vilanterol is 25 mcg once daily, regardless of the combination product used. 1
Dosing by Indication
COPD
- Standard dose: Vilanterol 25 mcg once daily (as part of BREO ELLIPTA 100/25 mcg)
- Maximum: 25 mcg once daily
- This is the only approved strength for COPD 1
Asthma
Adults (≥18 years):
- Vilanterol 25 mcg once daily (combined with either fluticasone furoate 100 mcg or 200 mcg)
- Maximum: 25 mcg once daily, even when using the higher ICS dose (BREO ELLIPTA 200/25 mcg) 1
Adolescents (12-17 years):
- Vilanterol 25 mcg once daily (as BREO ELLIPTA 100/25 mcg only)
- Maximum: 25 mcg once daily 1
Children (5-11 years):
- Vilanterol 25 mcg once daily (as BREO ELLIPTA 50/25 mcg)
- Maximum: 25 mcg once daily 1
Critical Safety Points
Do not exceed one inhalation per 24-hour period. More frequent administration or higher doses increase the risk of adverse cardiovascular effects, including tachycardia, tremor, and potential QTc prolongation 1. The vilanterol component remains constant at 25 mcg across all approved formulations—only the inhaled corticosteroid dose varies.
Important Caveats
- No dose adjustment for age alone in elderly patients 1
- No renal dose adjustment specified in labeling, though caution is warranted 1
- Strong CYP3A4 inhibitors (e.g., ketoconazole) increase vilanterol exposure; use with caution but do not adjust dose 1
- Vilanterol should be used at the same time every day to maintain consistent 24-hour bronchodilation 1
The 25 mcg once-daily dosing was established through dose-ranging studies demonstrating that this dose provides clinically meaningful improvements in lung function (≥130 mL increase in trough FEV1) with an acceptable safety profile similar to placebo 2.