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Aclidinium Uses, Dosage, Side Effects & Warnings | DrugsAtlas

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DRUG NAME: Aclidinium

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) 400 mcg per actuation
Fixed Dose Combination DPI Aclidinium 400 mcg + Formoterol 12 mcg per actuation

INDICATIONS + DOSING ā€” FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

ā– Chronic Obstructive Pulmonary Disease (COPD) ā€” Maintenance Therapy
Parameter Recommendation
Starting dose 400 mcg via inhalation twice daily
Titration Not applicable
Usual maintenance dose 400 mcg twice daily (morning and evening), approximately 12 hours apart
Maximum dose 400 mcg twice daily
Clinical Notes:
  • Not suitable for acute bronchospasm relief or rescue therapy
  • Administered via breath-actuated GenuairĀ® DPI device only
  • Fixed daily regimen required; exceeding recommended dose for breakthrough symptoms is not advised
  • Clinical benefit assessment recommended at 4ā€“6 weeks

Secondary Indications ā€” Adults (Off-label, if any)

Indication Status Evidence Basis
Asthma
Not established ā€” OFF-LABEL
 Investigational only; no Indian guideline support
Other respiratory conditions No documented use Not applicable
Note: Off-label use not recommended in routine Indian clinical practice. Any investigational use requires specialist supervision.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable ā€” Aclidinium 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 Contraindicated
Safety Statement:
  • Safety and efficacy not established in patients below 18 years
  • Contraindicated in children and adolescents
  • No paediatric dosing data available

RENAL ADJUSTMENT

Renal Function Recommendation
Mild impairment (eGFR 60ā€“89 mL/min) No dose adjustment required
Moderate impairment (eGFR 30ā€“59 mL/min) No dose adjustment required
Severe impairment (eGFR <30 mL/min) Use with caution; monitor for anticholinergic adverse effects
Haemodialysis No specific data available; use with caution
Note: Due to predominantly inhalational route with low systemic absorption, renal adjustment is generally not required. Vigilance advised in severe impairment.

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 aclidinium bromide or any excipient in the formulation
  • Known severe hypersensitivity to atropine or atropine derivatives (due to structural similarity)
  • Acute bronchospasm episodes (not a rescue medication)

CAUTIONS

  • Narrow-angle glaucoma: Risk of precipitating acute angle-closure; avoid powder contact with eyes
  • Prostatic hyperplasia / Bladder neck obstruction: Increased risk of urinary retention
  • Paradoxical bronchospasm: Discontinue immediately if symptoms worsen post-inhalation
  • Cardiovascular disease: Exercise caution in patients with unstable ischaemic heart disease, significant arrhythmias, or recent myocardial infarction
  • Rescue therapy requirement: Always prescribe alongside a short-acting bronchodilator (SABA) for acute symptom relief

PREGNANCY

Parameter Information
Risk category Limited human data; no major teratogenic risk in animal studies
Overall safety Use only if potential benefit to mother outweighs fetal risk
Preferred alternatives Salbutamol (SABA); inhaled corticosteroids for asthma management during pregnancy
When may be used Only when COPD exacerbation risk to mother outweighs fetal risk; specialist input recommended
Monitoring Maternal respiratory status; fetal growth surveillance with prolonged use

LACTATION

Parameter Information
Compatibility Probably compatible ā€” low systemic absorption expected
Drug levels in milk Likely negligible due to local airway action
Preferred alternatives Tiotropium (more safety data available in breastfeeding mothers)
Infant monitoring Observe for anticholinergic effects: dry mouth, irritability, poor feeding, constipation

ELDERLY

Parameter Recommendation
Starting dose 400 mcg twice daily (same as adults)
Titration Not applicable
Slower titration needed No
Extra risks Urinary retention (prostatic hypertrophy prevalent); cognitive effects in frail elderly; falls risk if dizziness occurs
Monitoring Adherence assessment; inhaler technique reassessment; urinary symptoms; cognitive status
Note: Generally, well tolerated in elderly population. GenuairĀ® device is breath-actuated and may be suitable for patients with poor hand coordination. Additional time may be required for inhaler technique training.

MAJOR DRUG INTERACTIONS

Interacting Drug/Class Interaction Recommendation
Other LAMAs (tiotropium, glycopyrronium, umeclidinium) Additive anticholinergic effects; mechanism duplication Avoid co-administration
Ipratropium (short-acting anticholinergic) Increased anticholinergic burden with regular concurrent use Avoid regular concurrent use; occasional rescue acceptable

MODERATE DRUG INTERACTIONS

Interacting Drug/Class Interaction Recommendation
Tricyclic antidepressants (amitriptyline, imipramine) Additive anticholinergic effects ā€” urinary retention, dry mouth, constipation Use with caution; monitor for symptoms
Antipsychotics (chlorpromazine, olanzapine) Additive anticholinergic effects Monitor for urinary retention, cognitive impairment
First-generation antihistamines (chlorpheniramine, diphenhydramine) Additive sedation and anticholinergic burden Monitor closely; prefer second-generation antihistamines
Inhaled corticosteroids (ICS) No pharmacokinetic interaction Safe for concurrent use; part of triple therapy
LABAs (formoterol, salmeterol) No interaction; complementary mechanism Safe to combine; available as FDC

COMMON ADVERSE EFFECTS

  • Headache
  • Nasopharyngitis
  • Cough (post-inhalation)
  • Dry mouth (xerostomia)
  • Sinusitis
  • Diarrhoea

SERIOUS ADVERSE EFFECTS

Adverse Effect Clinical Action
Paradoxical bronchospasm Discontinue immediately; administer SABA rescue; do not rechallenge
Hypersensitivity reactions (anaphylaxis, angioedema, urticaria) Discontinue; initiate emergency management; do not rechallenge
Acute angle-closure glaucoma Discontinue; urgent ophthalmology referral required
Urinary retention Discontinue if severe; urology referral if obstructive symptoms worsen

MONITORING REQUIREMENTS

Baseline:
  • Confirm COPD diagnosis with spirometry (post-bronchodilator FEVā‚/FVC <0.70)
  • Assess inhaler technique suitability for GenuairĀ® device
  • Screen for narrow-angle glaucoma, prostatic hyperplasia, bladder dysfunction
After Initiation (2ā€“4 weeks):
  • Monitor for anticholinergic adverse effects (dry mouth, urinary symptoms, visual disturbance)
  • Assess bronchodilator response and symptom improvement
  • CAT score or mMRC dyspnoea assessment
Long-term:
  • Spirometry at 6ā€“12 monthly intervals
  • Annual review of glaucoma risk and urinary symptoms in at-risk patients
  • Inhaler technique and adherence check every 3ā€“6 months
  • Reassess continued need and COPD phenotype annually

BRANDS AVAILABLE IN INDIA

Brand Name Composition Manufacturer
Bretaris GenuairĀ® Aclidinium 400 mcg DPI AstraZeneca / Menarini
Duaklir GenuairĀ® Aclidinium 400 mcg + Formoterol 12 mcg DPI AstraZeneca / Menarini

PRICE RANGE (INR)

Product Approximate Price (INR)
Aclidinium 400 mcg DPI (~60 actuations) ā‚¹1,200 ā€“ ā‚¹1,600
Aclidinium + Formoterol FDC (Duaklir) ā‚¹1,800 ā€“ ā‚¹2,300 per inhaler
NLEM Status: Not included in current NLEM
Note: Prices may vary by region and pharmacy. Government supply availability is limited.

CLINICAL PEARLS

  • Device-specific training essential: Aclidinium requires GenuairĀ® DPI ā€” patient education on correct inhalation technique is mandatory before initiation
  • Twice-daily regimen: Unlike tiotropium (once daily), aclidinium requires twice-daily dosing; may suit patients preferring a morning-evening routine
  • Faster bronchodilation onset: Quicker onset compared to tiotropium; may benefit symptomatic patients seeking faster relief
  • Triple therapy option: Can be combined with LABA + ICS as part of triple therapy for moderate-to-severe COPD (GOLD Group E patients)
  • Lower xerostomia incidence: Some comparative data suggest lower dry mouth incidence than tiotropium; consider switching if patient intolerant to tiotropium
  • Not for asthma: Avoid use in asthma outside specialist investigational settings; no established role in Indian asthma management guidelines

TAGS

Aclidinium; COPD; LAMA; anticholinergic; inhaled bronchodilator; maintenance therapy; Genuair; elderly-safe; respiratory; not for asthma; 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 Guidelines (referenced for COPD classification only, not primary dosing)
  • National TB-Elimination COPD Module (MoHFW)
  • Manufacturerā€™s Product Insert (India-registered GenuairĀ® DPI)
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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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