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Umeclidinium Uses, Dosage, Side Effects & Price | DrugsAtlas

Authoritative Clinical Reference

DRUG NAME: Umeclidinium

Therapeutic Class: Anti cholinergic (Long-Acting Muscarinic Antagonist (LAMA))

Subclass: Bronchodilator

Specialty: Pulmonology

Schedule (India): H

Route(s): Inhalation (Dry Powder Inhaler - DPI)

Formulations Available in India:


Formulation	Strength
Dry Powder Inhaler (DPI) - Monotherapy	62.5 mcg per actuation (Ellipta device)
Fixed Dose Combination DPI	Umeclidinium 62.5 mcg + Vilanterol 25 mcg per actuation

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

❖ Chronic Obstructive Pulmonary Disease (COPD) — Maintenance Bronchodilation


Parameter	Recommendation
Starting dose	62.5 mcg via inhalation once daily
Titration	Not applicable; fixed-dose regimen
Usual maintenance dose	62.5 mcg once daily
Maximum dose	62.5 mcg once daily (do not exceed)

Clinical Notes:

Administer at the same time each day for consistent effect
Not indicated for acute bronchospasm relief or rescue therapy
Delivered via Ellipta® dry powder inhaler device
Clinical benefit assessment recommended at 4–6 weeks

Secondary Indications — Adults (Off-label, if any)


Indication	Dose	Duration	Supervision	Evidence Basis
Severe persistent asthma (as add-on to ICS + LABA triple therapy)	62.5 mcg once daily	Ongoing	Specialist only — OFF-LABEL	International RCTs (TRIMARAN, TRIGGER); GINA guidelines support LAMA add-on in severe uncontrolled asthma; No CDSCO-approved asthma indication

Note: Not first-line for asthma; use only in specialist settings when ICS + LABA inadequate. Never use as asthma monotherapy.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable — Umeclidinium is not approved for paediatric use.

Secondary Indications — Paediatric (Off-label, if any)

Not applicable — No off-label paediatric indications documented in Indian or international sources.


Age Group	Recommendation
<18 years	Not recommended; safety and efficacy not established

Safety Statement:

Use in patients below 18 years is not recommended
No paediatric dosing data available in Indian or international sources
Any investigational use requires specialist supervision

RENAL ADJUSTMENT


Renal Function	Recommendation
Mild impairment (eGFR 60–89 mL/min)	No dose adjustment required
Moderate impairment (eGFR 30–59 mL/min)	No dose adjustment required
Severe impairment (eGFR <30 mL/min)	No dose adjustment required
Haemodialysis	No specific data; likely no adjustment needed due to low systemic absorption

Note: Minimal systemic absorption via inhalation route; no clinically significant renal accumulation expected.

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)	Limited data; use with caution under specialist supervision

CONTRAINDICATIONS

Hypersensitivity to umeclidinium or any component of the inhaler formulation
Severe hypersensitivity to milk proteins (lactose monohydrate excipient in Ellipta® device contains milk proteins)

CAUTIONS

Narrow-angle glaucoma: Risk of precipitating or worsening acute angle-closure; avoid direct eye exposure to inhaled powder
Prostatic hyperplasia / Bladder outlet obstruction: May worsen urinary retention; monitor urinary symptoms
Paradoxical bronchospasm: Discontinue immediately if worsening respiratory symptoms occur after inhalation
Cardiovascular disease: Use with caution in patients with unstable cardiac conditions, significant arrhythmias
Not for acute bronchospasm: Ensure patient has access to SABA rescue inhaler
Asthma patients: Never use as monotherapy in asthma; only as add-on to ICS-containing regimens

PREGNANCY


Parameter	Information
Risk category	Limited human data; animal studies do not indicate direct harmful effects on fetus
Overall safety	Use only if potential benefit to mother outweighs risk to fetus
Preferred alternatives	Tiotropium (more clinical experience in pregnancy); short-acting anticholinergics if needed acutely
When may be used	Only when COPD management essential and alternatives unsuitable; specialist input advised
Monitoring	Maternal respiratory status; standard antenatal surveillance

LACTATION


Parameter	Information
Compatibility	Probably compatible — low systemic absorption expected
Drug levels in milk	Unknown; likely very low due to minimal systemic exposure
Preferred alternatives	Tiotropium (more clinical experience during breastfeeding)
Infant monitoring	Observe for anticholinergic effects: dry mouth, poor feeding, irritability, constipation

ELDERLY


Parameter	Recommendation
Starting dose	62.5 mcg once daily (same as adults)
Titration	Not applicable
Slower titration needed	No
Extra risks	Urinary retention (prostatic hypertrophy common); increased glaucoma risk; blurred vision; falls if dizziness occurs
Monitoring	Inhaler technique assessment; urinary symptoms; intraocular pressure in at-risk patients; adherence checks

Note: No age-related dose adjustment required. Ellipta® device requires adequate inspiratory effort — assess technique in frail elderly.

MAJOR DRUG INTERACTIONS


Interacting Drug/Class	Interaction	Recommendation
Other LAMAs (tiotropium, glycopyrronium, aclidinium)	Additive anticholinergic effects; therapeutic duplication	Avoid co-administration
Ipratropium (short-acting anticholinergic)	Increased anticholinergic burden with regular concurrent use	Avoid regular concurrent use
Systemic anticholinergic agents (trihexyphenidyl, oxybutynin, tricyclic antidepressants at high doses)	Increased systemic anticholinergic toxicity (urinary retention, constipation, confusion)	Avoid combination or use with caution

MODERATE DRUG INTERACTIONS


Interacting Drug/Class	Interaction	Recommendation
LABAs (vilanterol, formoterol, salmeterol)	Complementary mechanism; no pharmacokinetic interaction	Safe to combine; available as FDC (umeclidinium + vilanterol)
Inhaled corticosteroids (ICS)	No significant interaction	Safe for concurrent use; part of triple therapy
Beta-blockers (non-selective)	Potential antagonism of bronchodilator effect	Prefer cardioselective beta-blockers in COPD patients
First-generation antihistamines (chlorpheniramine, promethazine)	Additive anticholinergic and sedative effects	Monitor for urinary retention, sedation; prefer second-generation agents
QT-prolonging drugs	Minimal QT risk with umeclidinium alone	Monitor ECG if multiple QT-prolonging agents co-prescribed

COMMON ADVERSE EFFECTS

Nasopharyngitis
Upper respiratory tract infection
Headache
Cough
Pharyngitis
Dry mouth
Constipation

SERIOUS ADVERSE EFFECTS


Adverse Effect	Clinical Action
Paradoxical bronchospasm	Discontinue immediately; administer SABA rescue; do not rechallenge
Urinary retention	Discontinue if severe; urology referral in patients with BPH
Hypersensitivity reactions (rash, angioedema, anaphylaxis)	Discontinue; emergency management; do not rechallenge
Acute angle-closure glaucoma (blurred vision, eye pain, halos)	Discontinue; urgent ophthalmology referral
New-onset or worsening cardiac arrhythmia	Evaluate; consider discontinuation if causally related

MONITORING REQUIREMENTS

Baseline:

Confirm COPD diagnosis with spirometry (post-bronchodilator FEV₁/FVC <0.70)
Assess inhaler technique suitability for Ellipta® device
Screen for narrow-angle glaucoma, prostatic hyperplasia, bladder dysfunction
Baseline symptom assessment (CAT score or mMRC dyspnoea scale)

After Initiation (4–6 weeks):

Reassess symptom control and bronchodilator response
Monitor for anticholinergic adverse effects (dry mouth, urinary symptoms, visual disturbance)
Verify correct inhaler technique

Long-term:

Spirometry at 6–12 monthly intervals
Annual review of glaucoma risk and urinary symptoms in at-risk patients
Inhaler technique and adherence check every 3–6 months
Reassess continued need and COPD phenotype annually

BRANDS AVAILABLE IN INDIA


Brand Name	Composition	Manufacturer
Incruse Ellipta®	Umeclidinium 62.5 mcg DPI (monotherapy)	GlaxoSmithKline
Anoro Ellipta®	Umeclidinium 62.5 mcg + Vilanterol 25 mcg DPI (FDC)	GlaxoSmithKline

PRICE RANGE (INR)


Product	Approximate Price (INR)
Incruse Ellipta® (30 doses)	₹3,500 – ₹4,500 per inhaler
Anoro Ellipta® (30 doses)	₹4,000 – ₹5,000 per inhaler

NLEM Status: Not included in current NLEM

Note: Prices may vary by region and pharmacy. Available through select distribution channels; limited government supply.

CLINICAL PEARLS

Once-daily advantage: Umeclidinium offers once-daily dosing compared to twice-daily aclidinium; may improve adherence in appropriate patients
Device-specific training: Ellipta® device requires adequate inspiratory flow; assess technique particularly in elderly or patients with severe airflow limitation
No LAMA stacking: Never combine with another LAMA (tiotropium, glycopyrronium, aclidinium) — risk of anticholinergic toxicity without additional bronchodilation
SABA for rescue: Always ensure patient has access to short-acting bronchodilator (salbutamol) for acute symptom relief
Triple therapy option: Umeclidinium + vilanterol (Anoro) provides LAMA + LABA; can add ICS separately for triple therapy in symptomatic COPD with exacerbation history
Urinary and ocular vigilance: Regularly assess urinary symptoms and ocular status in elderly male patients and those with glaucoma risk factors

VERSION

RxIndia v0.2 — 03 Feb 2026

REFERENCES

CDSCO (Product approval and labelling information)
Indian Pharmacopoeia
AIIMS Formulary
API Textbook of Medicine
GOLD 2023 Report (referenced for COPD classification only)
Goodman & Gilman's The Pharmacological Basis of Therapeutics
Manufacturer's Product Insert (India-registered Ellipta® devices)
GINA 2023 (referenced for off-label asthma context only)

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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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Umeclidinium Uses, Dosage, Side Effects & Price | DrugsAtlas

DRUG NAME: Umeclidinium

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Secondary Indications — Adults (Off-label, if any)

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Secondary Indications — Paediatric (Off-label, if any)

RENAL ADJUSTMENT

HEPATIC ADJUSTMENT

CONTRAINDICATIONS

CAUTIONS

PREGNANCY

LACTATION

ELDERLY

MAJOR DRUG INTERACTIONS

MODERATE DRUG INTERACTIONS

COMMON ADVERSE EFFECTS

SERIOUS ADVERSE EFFECTS

MONITORING REQUIREMENTS

BRANDS AVAILABLE IN INDIA

PRICE RANGE (INR)

CLINICAL PEARLS

TAGS

VERSION

REFERENCES

Clinical Responsibility

Is this information helpful?

RxIndia

Umeclidinium Uses, Dosage, Side Effects & Price | DrugsAtlas

DRUG NAME: Umeclidinium

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Secondary Indications — Adults (Off-label, if any)

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Secondary Indications — Paediatric (Off-label, if any)

RENAL ADJUSTMENT

HEPATIC ADJUSTMENT

CONTRAINDICATIONS

CAUTIONS

PREGNANCY

LACTATION

ELDERLY

MAJOR DRUG INTERACTIONS

MODERATE DRUG INTERACTIONS

COMMON ADVERSE EFFECTS

SERIOUS ADVERSE EFFECTS

MONITORING REQUIREMENTS

BRANDS AVAILABLE IN INDIA

PRICE RANGE (INR)

CLINICAL PEARLS

TAGS

VERSION

REFERENCES

Clinical Responsibility

Is this information helpful?