Indacaterol + Glycopyrronium bromide

Patient with narrow-angle glaucoma, urinary retention; CV disorders (e.g. CAD, acute or history of MI, cardiac arrhythmias, hypertension, unstable ischaemic heart disease, left ventricular failure), known or suspected prolongation of the QT interval, history of long QT syndrome; diabetes mellitus, hyperthyroidism, hypokalaemia, seizure disorders. Not indicated for treatment of asthma or acute episodes of bronchospasm. Not to be used concomitantly with drugs containing other long-acting adrenergic agonists or long-acting muscarinic antagonists. Severe renal and hepatic impairment. Pregnancy and lactation.

Significant: Immediate hypersensitivity reactions (e.g. angioedema, rash, urticaria), hypokalaemia, hyperglycaemia, elevated blood pressure and heart rate, changes in ECG.
Cardiac disorders: Chest pain.
Gastrointestinal disorders: Dyspepsia, dental caries.
General disorders and administration site conditions: Pyrexia.
Nervous system disorders: Dizziness, headache.
Renal and urinary disorders: Bladder obstruction, urinary retention, UTI.
Respiratory, thoracic and mediastinal disorders: URTI, nasopharyngitis, sinusitis, rhinitis, cough, oropharyngeal pain (including throat irritation).
Potentially Fatal: Paradoxical bronchospasm.

Obtain FEV₁, peak flow and/or other pulmonary function tests. Monitor serum potassium, serum glucose, blood pressure and heart rate. Assess for signs and symptoms of glaucoma, hypersensitivity reactions and urinary retention.

Symptoms: Indacaterol: Tachycardia, headache, nausea, vomiting, drowsiness, tremor, palpitations, ventricular arrhythmias, metabolic acidosis, hypokalaemia, hyperglycaemia. Glycopyrronium bromide: Increased IOP, obstipation or difficulties voiding. Mangement: Symptomatic and supportive treatment. May consider giving cardioselective β-blockers with extreme caution.

Indacaterol: Antagonised effect with β-adrenergic blockers. May potentiate adverse events with other sympathomimetics. Increased risk of hypokalaemia with methylxanthine derivatives, steroids or non-potassium sparing diuretics. May increase QT-prolonging effects with drugs known to prolong QT interval.

Description:
Mechanism of Action: Indacaterol + Glycopyrronium bromide provides additive efficacy as a result of their different mode of action targeting different receptors and pathways in achieving smooth muscle relaxation.
Indacaterol is a long-acting β₂-agonist that selectively acts on β₂-receptors with little effect on heart rate, resulting in relaxation of the bronchial smooth muscle.
Glycopyrronium bromide is a quaternary ammonium antimuscarinic agent. It competitively and reversibly inhibits the action of acetylcholine at the muscarinic receptor subtypes 1-3 in the bronchial smooth muscle, thus resulting in bronchodilation.
Synonym(s): Glycopyrronium bromide: Glycopyrrolate.
Onset: Indacaterol: 5 minutes.
Duration: Indacaterol: 24 hours.
Pharmacokinetics:
Absorption: Indacaterol: Bioavailability: 43-45%. Time to peak plasma concentration: Approx 15 minutes.
Glycopyrronium bromide: Bioavailability: Approx 40%. Time to peak plasma concentration: 5 minutes.
Distribution: Indacaterol: Plasma protein binding: Approx 95%.
Glycopyrronium bromide: Plasma protein binding: 38-41%.
Metabolism: Indacaterol: Metabolised in the liver by CYP3A4, CYP2D6 and CYP1A1; UGT1A1 also contributes to metabolism.
Glycopyrronium bromide: Minimal metabolism in the liver.
Excretion: Indacaterol: Via faeces (>90%; 54% as unchanged drug); urine (<2% as unchanged drug). Elimination half-life: 40-56 hours.
Glycopyrronium bromide: Via urine and bile. Elimination half-life: 33-53 hours.

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6918554, Indacaterol. https://pubchem.ncbi.nlm.nih.gov/compound/Indacaterol. Accessed June 27, 2025.

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 11693, Glycopyrrolate. https://pubchem.ncbi.nlm.nih.gov/compound/Glycopyrrolate. Accessed June 27, 2025.

Store below 25°C. Protect from moisture.

Antiasthmatic & COPD Preparations

R03AL04 - indacaterol and glycopyrronium bromide ; Belongs to the class of combination of adrenergics with anticholinergics, that may also include a corticosteroid. Used in the treatment of obstructive airway diseases.

Brayfield A, Cadart C (eds). Glycopyrronium Bromide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/05/2025.

Brayfield A, Cadart C (eds). Indacaterol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/05/2025.

Glycopyrronium Bromide [Glycopyrrolate] (Oral Inhalation). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 26/06/2025.

Indacaterol and Glycopyrronium Bromide [Glycopyrrolate]. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 07/05/2025.

Indacaterol. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 07/05/2025.

Joint Formulary Committee. Glycopyrronium with Indacaterol. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 25/06/2025.

Novartis New Zealand Limited. Ultibro Breezhaler 110/50 micrograms, Powder Filled Inhalation Capsule data sheet 20 August 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 07/05/2025.

Ultibro Breezhaler 110/50 mcg Inhalation Powder Hard Capsule (Novartis Corporation [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/05/2025.

Ultibro Breezhaler 85 micrograms/43 micrograms Inhalation Powder Hard Capsules (Novartis Pharmaceuticals UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 07/05/2025.