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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:

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)

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

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

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

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

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

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)

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

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

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

ELDERLY

• Starting dose: Standard adult dose — no specific reduction required
• 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

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

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

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

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

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

Clinical Responsibility

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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