Schedule H

Inhalation

• Dry powder inhaler (DPI): 75 mcg capsule for inhalation

• DPI combination FDCs:

• Indacaterol + Glycopyrronium (85 mcg + 43 mcg)

• Indacaterol + Mometasone (150 mcg + 160 mcg)

• Indacaterol + Tiotropium

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

▶ Chronic Obstructive Pulmonary Disease (COPD) — Maintenance Treatment

Parameter Recommendation

Starting dose 75 mcg once daily via DPI

Titration Not required; fixed once-daily dosing

Usual maintenance dose 75 mcg once daily

Maximum dose 75 mcg once daily (monotherapy)

Key Clinical Notes:

• Indicated for long-term maintenance bronchodilation in COPD

• Not to be used for acute bronchospasm or rescue therapy

• Administer at the same time each day for optimal effect

• Review inhaler technique at each visit

▶ Asthma — Maintenance Treatment (ONLY as Fixed-Dose Combination with ICS)

Parameter Recommendation

Starting dose Indacaterol 150 mcg + Mometasone 160 mcg DPI once daily

Titration Not applicable

Usual maintenance dose Same as starting dose

Maximum dose Indacaterol 150 mcg + Mometasone 160 mcg once daily

Key Clinical Notes:

• Monotherapy with indacaterol is contraindicated in asthma

• Must always be co-administered with inhaled corticosteroid (ICS)

• Specialist prescription only

• Step-down to ICS alone if asthma control is achieved and maintained

Secondary Indications — Adults (Off-label)

Not applicable — no well-established off-label uses documented in Indian practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

⛔ Indacaterol monotherapy is NOT approved for children or adolescents in India.

Secondary Indications — Paediatrics (Off-label)

Indication Age Group Dose Duration Notes

Asthma (as part of FDC with ICS) — OFF-LABEL ≥12 years Indacaterol 150 mcg + Mometasone 160 mcg DPI once daily Long-term maintenance Specialist only

Evidence Basis: Supported by international RCTs; FDCs approved in adolescents in select countries.

⚠️ Not recommended below 12 years except under specialist guidance with documented clinical rationale.

• Known hypersensitivity to indacaterol or any excipient in formulation

• Severe milk protein allergy (lactose carrier derived from milk)

• Monotherapy in asthma (without ICS) — associated with increased asthma-related mortality

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

• Cardiovascular disease: ischaemic heart disease, arrhythmias, uncontrolled hypertension

• Hyperthyroidism or thyrotoxicosis

• Seizure disorders

• Uncontrolled diabetes mellitus — may cause transient hyperglycaemia; monitor blood glucose

• Hypokalaemia (uncorrected) — β2-agonists may worsen potassium depletion

• Concurrent use with other LABAs — avoid duplication

• Risk of paradoxical bronchospasm — discontinue if occurs

Aspect Details

Safety Limited human data; animal studies show no major teratogenicity at therapeutic doses

Recommendation Use only if potential benefit outweighs risk; avoid in first trimester unless clearly indicated

Preferred alternatives Salbutamol (SABA) for acute relief; Budesonide for maintenance (more safety data)

Monitoring Fetal growth surveillance; uteroplacental blood flow assessment if prolonged use

Aspect Details

Compatibility Likely compatible with breastfeeding

Drug transfer to milk Expected to be low due to minimal systemic absorption via inhalation

Infant effects No significant adverse effects expected

Monitoring Observe infant for feeding behaviour, irritability, and weight gain with prolonged maternal use

Aspect Recommendation

Starting dose 75 mcg once daily (same as younger adults)

Titration Not required

Special considerations Assess cardiac comorbidities before initiation

Cautions Polypharmacy risk; FDCs with multiple bronchodilators may increase cardiovascular adverse effects

Monitoring ECG at baseline if cardiac history; monitor for tremor, palpitations

Interacting Drug Mechanism / Effect Management

Non-selective beta-blockers (propranolol, carvedilol) Antagonism of bronchodilator effect; risk of bronchospasm Avoid combination; use cardioselective beta-blockers if essential

MAO inhibitors Enhanced cardiovascular effects (tachycardia, hypertension) Avoid co-administration

Tricyclic antidepressants Potentiation of cardiovascular effects Avoid combination or use with extreme caution

QT-prolonging drugs (haloperidol, ondansetron, macrolides) Additive QT prolongation risk ECG monitoring; avoid if possible

Interacting Drug Mechanism / Effect Management

Loop diuretics (furosemide) Increased risk of hypokalaemia Monitor serum potassium

Thiazide diuretics Increased risk of hypokalaemia Monitor serum potassium

Systemic corticosteroids Additive hypokalaemia risk Monitor serum potassium

Other LABAs (formoterol, salmeterol) Duplication of β2-agonist class Avoid concurrent use

Xanthine derivatives (theophylline) Additive effects on heart rate, hypokalaemia Monitor closely

• Cough (post-inhalation, transient)

• Nasopharyngitis

• Headache

• Upper respiratory tract infection

• Myalgia

• Dizziness

• Oropharyngeal pain

Adverse Effect Clinical Action

Paradoxical bronchospasm Discontinue immediately; treat with SABA; do not rechallenge

QT prolongation / arrhythmias ECG monitoring; discontinue if significant

Severe hypokalaemia Monitor potassium; correct electrolyte imbalance

Anaphylaxis / angioedema Discontinue; emergency management

Asthma-related death Risk with LABA monotherapy in asthma — never use without ICS

2–4 weeks after initiation Symptom control assessment; inhaler technique review

Periodic (every 3–6 months) Exacerbation frequency; symptom scores; adherence check

Annual Spirometry; comprehensive review of inhaler technique and device acceptability

Brand Name Composition Manufacturer

Onbrez Breezhaler Indacaterol 75 mcg Novartis

Arcapta Indacaterol 75 mcg —

NLEM Status Not included

Government Supply Available in select public sector COPD programmes under state health initiatives

Not a rescue inhaler — never dispense for acute bronchospasm relief; always ensure patient has SABA available

• LABA monotherapy is contraindicated in asthma — always combine with ICS to prevent asthma-related mortality

• Once-daily dosing advantage — improves adherence compared to twice-daily LABAs (formoterol, salmeterol)

• Inhaler technique is critical — the Breezhaler device requires adequate inspiratory flow; assess patient capability

• Step-up strategy in COPD — escalate to LABA+LAMA or LABA+LAMA+ICS FDC as per GOLD/India-adapted guidelines

• Check for beta-blocker use — if essential for cardiac indication, prefer cardioselective agents (bisoprolol, metoprolol)

Indacaterol; LABA; COPD; asthma; bronchodilator; inhaled therapy; once-daily dosing; Breezhaler; respiratory; pulmonology; not for rescue; ICS combination; India brands; NLEM-excluded

RxIndia v1.0 — 12 Apr 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• NPPA Drug Price List

• AIIMS Clinical Guidelines for COPD Management

• API Textbook of Medicine, 11th Edition

• GOLD 2023 Report (India-adapted modules)

• IAP Asthma Guidelines (paediatric context)

• Novartis India prescribing information (Onbrez, Ultibro)