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Aclidinium Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

Anticholinergic

DRUG NAME: Aclidinium

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

Subclass: Bronchodilator

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

Primary Indications (Approved / Standard in India)

❖ Chronic Obstructive Pulmonary Disease (COPD) — 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 Genuair® DPI device only
Fixed daily regimen required; exceeding recommended dose for breakthrough symptoms is not advised
Clinical benefit assessment recommended at 4–6 weeks

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

Indication	Status	Evidence Basis
Asthma	Not established — 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 — Aclidinium 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	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 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)	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 — 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. Genuair® 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 — 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 FEV₁/FVC <0.70)
Assess inhaler technique suitability for Genuair® device
Screen for narrow-angle glaucoma, prostatic hyperplasia, bladder dysfunction

After Initiation (2–4 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 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
Bretaris Genuair®	Aclidinium 400 mcg DPI	AstraZeneca / Menarini
Duaklir Genuair®	Aclidinium 400 mcg + Formoterol 12 mcg DPI	AstraZeneca / Menarini

PRICE RANGE (INR)

Product	Approximate Price (INR)
Aclidinium 400 mcg DPI (~60 actuations)	₹1,200 – ₹1,600
Aclidinium + Formoterol FDC (Duaklir)	₹1,800 – ₹2,300 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 Genuair® DPI — 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

VERSION

RxIndia v0.2 — 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)
Manufacturer’s Product Insert (India-registered Genuair® 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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