Umeclidinium Uses, Dosage, Side Effects & Price | DrugsAtlas
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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 ā FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
ā Chronic Obstructive Pulmonary Disease (COPD) ā 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 ElliptaĀ® dry powder inhaler device
- Clinical benefit assessment recommended at 4ā6 weeks
Secondary Indications ā 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 ā 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 ā Umeclidinium is not approved for paediatric use.
Secondary Indications ā Paediatric (Off-label, if any)
Not applicable ā 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 60ā89 mL/min) | No dose adjustment required |
| Moderate impairment (eGFR 30ā59 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 ElliptaĀ® 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 ā 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. ElliptaĀ® device requires adequate inspiratory effort ā 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 FEVā/FVC <0.70)
- Assess inhaler technique suitability for ElliptaĀ® device
- Screen for narrow-angle glaucoma, prostatic hyperplasia, bladder dysfunction
- Baseline symptom assessment (CAT score or mMRC dyspnoea scale)
After Initiation (4ā6 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 6ā12 monthly intervals
- Annual review of glaucoma risk and urinary symptoms in at-risk patients
- Inhaler technique and adherence check every 3ā6 months
- Reassess continued need and COPD phenotype annually
BRANDS AVAILABLE IN INDIA
| Brand Name | Composition | Manufacturer |
|---|---|---|
| Incruse ElliptaĀ® | Umeclidinium 62.5 mcg DPI (monotherapy) | GlaxoSmithKline |
| Anoro ElliptaĀ® | Umeclidinium 62.5 mcg + Vilanterol 25 mcg DPI (FDC) | GlaxoSmithKline |
PRICE RANGE (INR)
| Product | Approximate Price (INR) |
|---|---|
| Incruse ElliptaĀ® (30 doses) | ā¹3,500 ā ā¹4,500 per inhaler |
| Anoro ElliptaĀ® (30 doses) | ā¹4,000 ā ā¹5,000 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: ElliptaĀ® 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) ā 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
TAGS
Umeclidinium; COPD; LAMA; anticholinergic; inhaled bronchodilator; maintenance therapy; Ellipta; once-daily; elderly-safe; respiratory; pulmonology
VERSION
RxIndia v0.2 ā 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 ElliptaĀ® 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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