Vilanterol Uses, Dosage, Side Effects & Warnings | DrugsAtlas
Authoritative Clinical Reference
DRUG NAME: Vilanterol
Therapeutic Class: Bronchodilator
Subclass: Long-Acting β2-Adrenergic Agonist (LABA)
Speciality: Pulmonology
Schedule (India): Schedule H
Route(s): Inhalation
Formulations Available in India:
• Vilanterol 25 mcg inhalation powder — available ONLY as fixed-dose combinations:
• Vilanterol 25 mcg inhalation powder — available ONLY as fixed-dose combinations:
- With Fluticasone furoate (ICS + LABA)
- With Umeclidinium (LAMA + LABA)
- With Umeclidinium + Fluticasone furoate (LAMA + LABA + ICS)
• Monotherapy formulations: NOT AVAILABLE in India
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Important: Vilanterol is not approved or marketed as monotherapy in India. All prescribing must be as fixed-dose combination inhalers.
Primary Indications (Approved / Standard in India)
1. Chronic Obstructive Pulmonary Disease (COPD) — Maintenance Treatment
| FDC Combination | Vilanterol Dose | Total FDC Dose | Dosing |
| Fluticasone furoate + Vilanterol | 25 mcg | FF 100 mcg + VI 25 mcg | 1 inhalation once daily |
| Umeclidinium + Vilanterol | 25 mcg | UMEC 62.5 mcg + VI 25 mcg | 1 inhalation once daily |
| Umeclidinium + Fluticasone furoate + Vilanterol | 25 mcg | UMEC 62.5 mcg + FF 100 mcg + VI 25 mcg | 1 inhalation once daily |
Dosing Pattern:
• Starting dose: 1 inhalation once daily (same as maintenance)
• Titration: Not applicable — fixed-dose combination
• Usual maintenance dose: 1 inhalation once daily
• Maximum dose: 1 inhalation once daily (do not exceed)
• Starting dose: 1 inhalation once daily (same as maintenance)
• Titration: Not applicable — fixed-dose combination
• Usual maintenance dose: 1 inhalation once daily
• Maximum dose: 1 inhalation once daily (do not exceed)
Clinical Notes:
- Administer at same time each day
- Not for acute bronchospasm relief — always co-prescribe SABA rescue inhaler
- Triple therapy (LAMA + LABA + ICS) reserved for patients with frequent exacerbations despite dual therapy
2. Asthma — Persistent Asthma (only with Fluticasone furoate)
| FDC Combination | Indication | Dosing |
| Fluticasone furoate 100 mcg + Vilanterol 25 mcg | Patients inadequately controlled on ICS alone | 1 inhalation once daily |
| Fluticasone furoate 200 mcg + Vilanterol 25 mcg | Patients requiring higher ICS dose | 1 inhalation once daily |
Dosing Pattern:
• Starting dose: FF 100 mcg + VI 25 mcg — 1 inhalation once daily
• Titration: Step up to FF 200 mcg + VI 25 mcg if inadequate control after 4 weeks
• Usual maintenance dose: 1 inhalation once daily
• Maximum dose: FF 200 mcg + VI 25 mcg once daily
• Starting dose: FF 100 mcg + VI 25 mcg — 1 inhalation once daily
• Titration: Step up to FF 200 mcg + VI 25 mcg if inadequate control after 4 weeks
• Usual maintenance dose: 1 inhalation once daily
• Maximum dose: FF 200 mcg + VI 25 mcg once daily
Clinical Notes:
- Indicated only when ICS monotherapy provides insufficient control
- LABA monotherapy (without ICS) is contraindicated in asthma
- Always co-prescribe SABA for acute symptom relief
Secondary Indications – Adults (Off-label)
Not applicable. No established off-label indications in Indian practice.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
Asthma — Paediatric (≥12 years)
Only Fluticasone furoate + Vilanterol combination is approved for paediatric use.
| Age | Combination | Dose | Frequency |
| ≥12 years | FF 100 mcg + VI 25 mcg | 1 inhalation | Once daily |
| ≥12 years (if higher dose needed) | FF 200 mcg + VI 25 mcg | 1 inhalation | Once daily |
Dosing Pattern:
• Starting dose: FF 100 mcg + VI 25 mcg — 1 inhalation once daily
• Titration: Step up to FF 200 mcg + VI 25 mcg if needed after specialist review
• Maximum dose: FF 200 mcg + VI 25 mcg once daily
• Starting dose: FF 100 mcg + VI 25 mcg — 1 inhalation once daily
• Titration: Step up to FF 200 mcg + VI 25 mcg if needed after specialist review
• Maximum dose: FF 200 mcg + VI 25 mcg once daily
Children below 12 years: NOT RECOMMENDED except under paediatric pulmonologist supervision
Safety Monitoring in Paediatrics:
• Monitor for paradoxical bronchospasm — discontinue immediately if occurs
• Assess for tremor, tachycardia, palpitations
• Ensure correct inhaler technique at every visit
• Minimum age: 12 years for standard use
• Monitor for paradoxical bronchospasm — discontinue immediately if occurs
• Assess for tremor, tachycardia, palpitations
• Ensure correct inhaler technique at every visit
• Minimum age: 12 years for standard use
Secondary Indications – Paediatrics (Off-label)
• COPD: Not applicable — COPD does not occur in paediatric population
• Other indications: No established paediatric off-label uses in India
• Other indications: No established paediatric off-label uses in India
RENAL ADJUSTMENT
No dose adjustment required in renal impairment, including severe renal dysfunction (eGFR <30 mL/min/1.73m²).
Rationale: Negligible systemic absorption via inhalation route; renal clearance not clinically relevant.
Haemodialysis: No supplemental dose required.
HEPATIC ADJUSTMENT
| Hepatic Function | Recommendation |
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | No dose adjustment required |
| Severe impairment (Child-Pugh C) | Use with caution; monitor for systemic adverse effects |
Notes:
• Limited data in severe hepatic impairment
• Systemic exposure may increase in severe hepatic dysfunction
• Monitor for tremor, tachycardia, hypokalaemia
• Limited data in severe hepatic impairment
• Systemic exposure may increase in severe hepatic dysfunction
• Monitor for tremor, tachycardia, hypokalaemia
CONTRAINDICATIONS
• Known hypersensitivity to vilanterol or any excipient in the formulation
• Primary treatment of acute bronchospasm or status asthmaticus
• LABA monotherapy in asthma (vilanterol without ICS component)
• Severe milk protein allergy (lactose carrier contains milk proteins)
• Primary treatment of acute bronchospasm or status asthmaticus
• LABA monotherapy in asthma (vilanterol without ICS component)
• Severe milk protein allergy (lactose carrier contains milk proteins)
CAUTIONS
• Cardiovascular disease: ischaemic heart disease, arrhythmias, uncontrolled hypertension
• Thyrotoxicosis
• Convulsive disorders
• Uncorrected hypokalaemia
• Diabetes mellitus (may cause transient hyperglycaemia)
• Patients at risk of QT prolongation
• Concurrent use of potassium-depleting agents
• History of paradoxical bronchospasm with beta-agonists
• Thyrotoxicosis
• Convulsive disorders
• Uncorrected hypokalaemia
• Diabetes mellitus (may cause transient hyperglycaemia)
• Patients at risk of QT prolongation
• Concurrent use of potassium-depleting agents
• History of paradoxical bronchospasm with beta-agonists
PREGNANCY
| Parameter | Recommendation |
| Overall safety | Limited human data; use only if benefit outweighs risk |
| Risk category | Not classified formally in India; treat as caution |
| Preferred alternatives | Budesonide + Formoterol (more safety data available) |
| When to consider | Asthma/COPD uncontrolled on preferred agents; specialist input advised |
| Monitoring | Fetal heart rate, uterine activity in third trimester |
Notes:
• Beta-agonists may inhibit uterine contractions near term
• Poorly controlled asthma poses greater risk to mother and fetus than medication
• Beta-agonists may inhibit uterine contractions near term
• Poorly controlled asthma poses greater risk to mother and fetus than medication
LACTATION
| Parameter | Information |
| Compatibility | Likely compatible with breastfeeding |
| Excretion in milk | Unknown; expected to be minimal due to low systemic absorption |
| Preferred alternatives | No specific alternative required if clinically indicated |
| Infant monitoring | Irritability, feeding difficulties, sleep disturbance |
Notes:
• Inhaled route results in minimal systemic drug levels
• Based on class data for ICS/LABA combinations
• Inhaled route results in minimal systemic drug levels
• Based on class data for ICS/LABA combinations
ELDERLY
• Starting dose: Standard adult dose — no specific reduction required
• Titration: Not applicable (fixed-dose combination)
• Special considerations:
• Titration: Not applicable (fixed-dose combination)
• Special considerations:
- Ensure adequate inhaler technique (assess grip strength, inspiratory flow)
- Consider dry powder inhaler suitability — requires sufficient inspiratory effort
- Monitor for cardiac effects: tachycardia, palpitations, arrhythmias
- Increased susceptibility to hypokalaemia if on diuretics
- Assess for tremor which may be more pronounced
• No upper age limit for use
MAJOR DRUG INTERACTIONS
| Interacting Drug | Effect | Recommendation |
| Non-selective beta-blockers (propranolol, carvedilol) | Antagonism of bronchodilator effect; may precipitate severe bronchospasm | Avoid combination; use cardioselective beta-blocker if essential |
| Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) | Increased vilanterol systemic exposure; increased cardiovascular adverse effects | Avoid prolonged concurrent use; if unavoidable, monitor closely |
| MAO inhibitors | Potentiation of cardiovascular effects (hypertension, tachycardia) | Avoid concurrent use or use within 14 days of stopping MAOI |
| Tricyclic antidepressants | Potentiation of cardiovascular effects | Use with caution; monitor ECG and cardiovascular status |
MODERATE DRUG INTERACTIONS
| Interacting Drug | Effect | Recommendation |
| Loop diuretics (furosemide) | Additive hypokalaemia risk | Monitor serum potassium |
| Thiazide diuretics | Additive hypokalaemia risk | Monitor serum potassium |
| Xanthine derivatives (theophylline) | Additive hypokalaemia; increased risk of arrhythmias | Monitor potassium; avoid high doses |
| Digoxin | Beta-agonists may decrease serum digoxin levels | Monitor digoxin levels if symptoms change |
| Other long-acting beta-agonists | Cumulative beta-agonist toxicity | Avoid concurrent LABA therapy |
| QT-prolonging drugs | Additive QT prolongation risk | ECG monitoring if combination essential |
| Corticosteroids (systemic) | Additive hypokalaemia | Monitor potassium during concurrent use |
COMMON ADVERSE EFFECTS
• Headache
• Nasopharyngitis
• Upper respiratory tract infection
• Oropharyngeal pain
• Cough
• Dysphonia (hoarseness)
• Tremor
• Palpitations
• Muscle cramps
• Arthralgia
• Nasopharyngitis
• Upper respiratory tract infection
• Oropharyngeal pain
• Cough
• Dysphonia (hoarseness)
• Tremor
• Palpitations
• Muscle cramps
• Arthralgia
SERIOUS ADVERSE EFFECTS
| Adverse Effect | Clinical Note |
| Paradoxical bronchospasm | Discontinue immediately; provide alternative bronchodilator therapy |
| QT prolongation / Arrhythmias | More likely with concurrent QT-prolonging drugs or hypokalaemia |
| Severe hypokalaemia | Risk increased with high doses, concurrent diuretics; may cause arrhythmias |
| Anaphylaxis / Angioedema | Rare; discontinue and avoid re-exposure |
| Pneumonia (with ICS-containing combinations) | Monitor for increased frequency in COPD patients |
| Adrenal suppression (with high-dose ICS combinations) | Relevant for long-term high-dose ICS component |
MONITORING REQUIREMENTS
Baseline:
• Spirometry (FEV₁, FVC) to confirm diagnosis and establish baseline
• Serum potassium if patient on diuretics or at hypokalaemia risk
• ECG if pre-existing cardiac disease or QT prolongation risk
• Blood glucose in diabetic patients
• Spirometry (FEV₁, FVC) to confirm diagnosis and establish baseline
• Serum potassium if patient on diuretics or at hypokalaemia risk
• ECG if pre-existing cardiac disease or QT prolongation risk
• Blood glucose in diabetic patients
After initiation / dose change:
• Symptom assessment at 4 weeks
• Inhaler technique verification
• Heart rate and blood pressure in elderly or cardiac patients
• Serum potassium if on concurrent hypokalaemia-inducing drugs
• Symptom assessment at 4 weeks
• Inhaler technique verification
• Heart rate and blood pressure in elderly or cardiac patients
• Serum potassium if on concurrent hypokalaemia-inducing drugs
Long-term:
• Annual spirometry to assess disease control and progression
• Periodic potassium monitoring if on chronic diuretic therapy
• Assessment of exacerbation frequency
• Review inhaler technique at every visit
• Bone density monitoring if on long-term high-dose ICS combination
• Annual spirometry to assess disease control and progression
• Periodic potassium monitoring if on chronic diuretic therapy
• Assessment of exacerbation frequency
• Review inhaler technique at every visit
• Bone density monitoring if on long-term high-dose ICS combination
BRANDS AVAILABLE IN INDIA
| Brand Name | Composition | Manufacturer |
| Relvar Ellipta | Fluticasone furoate 100/200 mcg + Vilanterol 25 mcg | GSK |
| Anoro Ellipta | Umeclidinium 62.5 mcg + Vilanterol 25 mcg | GSK |
| Trelegy Ellipta | Umeclidinium 62.5 mcg + Fluticasone furoate 100 mcg + Vilanterol 25 mcg | GSK |
Note: All formulations are dry powder inhalers (DPI) in Ellipta device
PRICE RANGE (INR)
| Formulation | Approximate Price (30-dose pack) |
| Fluticasone furoate + Vilanterol | ₹2,500 – ₹3,500 |
| Umeclidinium + Vilanterol | ₹2,800 – ₹3,600 |
| Triple combination (UMEC + FF + VI) | ₹3,200 – ₹3,900 |
• NLEM status: Not listed (neither monocomponent nor FDC)
• Availability: Predominantly private sector; limited government supply
• Availability: Predominantly private sector; limited government supply
CLINICAL PEARLS
• Vilanterol monotherapy is NOT permitted in India — always prescribe as fixed-dose combination inhaler
• Once-daily dosing offers adherence advantage over twice-daily LABAs (salmeterol, formoterol)
• Ellipta device requires adequate inspiratory flow (≥30 L/min) — assess before prescribing, especially in elderly
• Never discontinue ICS/LABA combination abruptly in asthma patients — risk of severe exacerbation
• Always co-prescribe SABA rescue inhaler (salbutamol) for all asthma patients
• Triple therapy (LAMA + LABA + ICS) is indicated only for COPD patients with frequent exacerbations despite dual therapy
• Verify inhaler technique at every clinical encounter — poor technique is commonest cause of treatment failure
• Once-daily dosing offers adherence advantage over twice-daily LABAs (salmeterol, formoterol)
• Ellipta device requires adequate inspiratory flow (≥30 L/min) — assess before prescribing, especially in elderly
• Never discontinue ICS/LABA combination abruptly in asthma patients — risk of severe exacerbation
• Always co-prescribe SABA rescue inhaler (salbutamol) for all asthma patients
• Triple therapy (LAMA + LABA + ICS) is indicated only for COPD patients with frequent exacerbations despite dual therapy
• Verify inhaler technique at every clinical encounter — poor technique is commonest cause of treatment failure
TAGS
vilanterol; LABA; COPD; asthma; Ellipta; fluticasone furoate; umeclidinium; bronchodilator; inhaled therapy; fixed-dose combination; once-daily inhaler
VERSION
RxIndia v1.0 — 28 Feb 2026
REFERENCES
• CDSCO drug approvals
• Indian Pharmacopoeia / National Formulary of India 2021
• NLEM 2022
• API Textbook of Medicine, 11th edition
• AIIMS Internal Medicine Inhaled Therapy Protocol for COPD and Asthma
• Summary of Product Characteristics — Relvar Ellipta, Anoro Ellipta (India)
• GINA 2023 Guidelines (supportive reference)
• GOLD 2023 COPD Guidelines (supportive reference)
• Indian Pharmacopoeia / National Formulary of India 2021
• NLEM 2022
• API Textbook of Medicine, 11th edition
• AIIMS Internal Medicine Inhaled Therapy Protocol for COPD and Asthma
• Summary of Product Characteristics — Relvar Ellipta, Anoro Ellipta (India)
• GINA 2023 Guidelines (supportive reference)
• GOLD 2023 COPD Guidelines (supportive reference)
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This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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