Indacaterol Uses, Dosage, Side Effects & Benefits | DrugsAtlas

Authoritative Clinical Reference

DRUG NAME: Indacaterol

Therapeutic Class: Bronchodilator

Subclass: Long-acting beta-2 adrenergic agonist (LABA)

Speciality: Pulmonology

Schedule (India): Schedule H

Route(s): Inhalation (dry powder)

Formulations Available in India:
• Indacaterol maleate dry powder inhalation capsules: 150 mcg per capsule
• Indacaterol maleate dry powder inhalation capsules: 110 mcg per capsule (as component in FDCs)
• Administered via specific dry powder inhaler device (Breezhaler)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

COPD (Chronic Obstructive Pulmonary Disease) — Moderate to Severe, Maintenance Therapy

Parameter	Recommendation
Starting dose	150 mcg inhaled once daily via dry powder inhaler
Titration	Not required
Usual maintenance dose	150 mcg once daily
Maximum dose	300 mcg once daily (rarely required; specialist discretion only)

Key Clinical Notes:
• Onset of bronchodilation within 5 minutes; duration ≥24 hours
• Not indicated for acute symptom relief — must be used as regular maintenance therapy
• Can be combined with LAMA or ICS as part of fixed-dose combinations
• Ensure correct inhaler technique with Breezhaler device

Secondary Indications – Adults Only (Off-label):

Indication	Persistent Asthma (with inhaled corticosteroid) — OFF-LABEL
Dose	110–150 mcg once daily + regular ICS
Duration	Chronic maintenance
Specialist input	Required
Evidence basis	International RCTs; Indian asthma guidelines prefer established LABA+ICS FDCs (formoterol/salmeterol)

Indication	Symptomatic dyspnoea in Interstitial Lung Disease — OFF-LABEL
Dose	150 mcg once daily
Duration	As needed for symptom control
Specialist input	Required (Pulmonology)
Evidence basis	Limited observational studies; not standard of care

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India):

Not recommended below 18 years — safety and efficacy not established in paediatric population.

Secondary Indications – Paediatric Doses (Off-label):

Not applicable.

Not recommended below 18 years except under specialist supervision.

If LABA therapy required in adolescents, prefer established agents (formoterol, salmeterol) as part of ICS+LABA fixed-dose combinations under pulmonology guidance.

RENAL ADJUSTMENT

No dose adjustment required in any degree of renal impairment, including end-stage renal disease.

Minimal systemic absorption limits renal exposure.

HEPATIC ADJUSTMENT

Child-Pugh Class	Recommendation
A (Mild)	No dose adjustment required
B (Moderate)	No dose adjustment required
C (Severe)	Use with caution — limited pharmacokinetic data; specialist discretion advised

CONTRAINDICATIONS

• Known hypersensitivity to indacaterol maleate or any excipient (including lactose)

• Monotherapy in asthma without concurrent inhaled corticosteroid (LABA monotherapy increases risk of asthma-related death)

• Acute bronchospasm or status asthmaticus (not a rescue medication)

CAUTIONS

• Cardiovascular disease — arrhythmias, coronary artery disease, uncontrolled hypertension (monitor heart rate and blood pressure)

• Seizure disorders — may lower seizure threshold

• Hyperthyroidism

• Diabetes mellitus — may cause transient hyperglycaemia

• Hypokalaemia — risk increased with concurrent diuretics or corticosteroids

• History of paradoxical bronchospasm with inhaled medications

• Concurrent use with other beta-agonists may increase adverse effects

• Prolonged QTc interval or concurrent QT-prolonging medications

PREGNANCY

Parameter	Recommendation
Safety category	Limited human data; minimal systemic absorption expected
Preferred alternatives	ICS + formoterol or ICS + salmeterol combinations (more established safety data in pregnancy)
When to use	Only when benefits clearly outweigh potential fetal risks
Monitoring	Maternal heart rate; fetal growth assessment

LACTATION

Parameter	Recommendation
Compatibility	Likely compatible due to minimal systemic absorption
Preferred alternatives	ICS + formoterol or ICS + salmeterol combinations (established lactation safety)
Drug levels in milk	Expected to be low
Infant monitoring	Feeding behaviour, irritability, tremor (rare)

ELDERLY

• Starting dose: 150 mcg once daily (same as younger adults)

• Titration: Not required

• No routine dose reduction necessary

• Additional monitoring: Cardiovascular effects (tachycardia, palpitations), tremor, electrolyte disturbances

• Assess for polypharmacy interactions; review concurrent medications

MAJOR DRUG INTERACTIONS

Interacting Drug	Mechanism / Effect	Recommendation
Non-selective beta-blockers (propranolol, carvedilol)	Antagonism of bronchodilatory effect	AVOID unless strongly indicated; use cardioselective beta-blockers if essential
MAO inhibitors	Enhanced beta-agonist cardiovascular effects	AVOID combination
Tricyclic antidepressants	Potentiation of cardiovascular effects	AVOID or use with extreme caution
QT-prolonging drugs (macrolides, fluoroquinolones, antipsychotics, ondansetron)	Additive QT prolongation risk	AVOID or monitor ECG closely

MODERATE DRUG INTERACTIONS

Interacting Drug	Effect	Management
Loop/thiazide diuretics	Increased risk of hypokalaemia	Monitor serum potassium
Systemic/high-dose inhaled corticosteroids	Exacerbation of hypokalaemia	Monitor serum potassium
Other sympathomimetics	Additive cardiovascular stimulation	Avoid duplicate beta-agonist therapy
Xanthine derivatives (theophylline)	Additive effects — tachycardia, tremor	Monitor clinically; consider theophylline dose adjustment
Antidiabetic agents	Transient hyperglycaemia may occur	Monitor blood glucose

COMMON ADVERSE EFFECTS

• Cough (particularly post-inhalation)

• Headache

• Nasopharyngitis

• Upper respiratory tract infection

• Tremor

• Palpitations

• Muscle spasms

SERIOUS ADVERSE EFFECTS

• Paradoxical bronchospasm — discontinue immediately; do not re-challenge

• Hypokalaemia with associated cardiac arrhythmias (rare)

• QT prolongation (dose-dependent)

• Severe hypersensitivity reactions including urticaria and angioedema (rare)

• Asthma-related death (associated with LABA monotherapy without ICS)

MONITORING REQUIREMENTS

Phase	Parameters
Baseline	Spirometry/PEFR; cardiovascular assessment (HR, BP); serum potassium (if high-risk); ECG (if cardiac risk factors)
After initiation/dose change	Reassess symptoms and spirometry within 2–4 weeks; monitor HR/BP in patients with cardiovascular disease
Long-term	Spirometry every 3–6 months; inhaler technique assessment; serum potassium in patients on diuretics or systemic corticosteroids; symptom and exacerbation monitoring

BRANDS AVAILABLE IN INDIA

Monotherapy:
• Onbrez Breezhaler (Indacaterol 150 mcg capsules)

Fixed-Dose Combinations (FDCs):
• Ultibro Breezhaler (Indacaterol 110 mcg + Glycopyrronium 50 mcg)
• Xoterna Breezhaler (Indacaterol + Glycopyrronium)

PRICE RANGE (INR)

• Indacaterol 150 mcg capsules: ₹30–₹50 per capsule

• FDC (Indacaterol + Glycopyrronium): ₹70–₹110 per capsule

• Not listed under NLEM; not under NPPA price control

• Prices vary across brands and regions

CLINICAL PEARLS

• Not suitable as monotherapy in asthma — always combine with inhaled corticosteroid to reduce mortality risk

• Once-daily dosing improves adherence compared to twice-daily LABAs in COPD maintenance

• Rapid onset (<5 minutes) but NOT a rescue bronchodilator — patients must have separate SABA for acute symptoms

• Consider LAMA+indacaterol once-daily FDC for COPD patients requiring dual bronchodilation

• Post-inhalation cough is common and usually transient — reassure patients to improve compliance

• Proper Breezhaler technique is critical — counsel on correct capsule piercing and inhalation; device education essential

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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