Indacaterol + Glycopyrronium


Concise Prescribing Info
Indications/Uses
Maintenance therapy in COPD.
Dosage/Direction for Use
Adult : Inhalation Each inhalation cap contains indacaterol (mcg)/glycopyrrolate (mcg) 27.5 /15.6: 1 cap bid via inhaler device. Each inhalation cap contains indacaterol (mcg) and glycopyrrolate (mcg) 85/54: 1 cap once daily via inhaler device.
Dosage Details
Inhalation/Respiratory
Maintenance therapy in chronic obstructive pulmonary disease
Adult: Available preparations:
Indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg per inhalation cap
1 cap bid via inhaler device.

Indacaterol 85 mcg and glycopyrrolate 54 mcg per inhalation cap
1 cap once daily via inhaler device.
Contraindications
Monotherapy for the treatment of asthma, acute bronchospasm, acute episodes of COPD.
Special Precautions
Patient with arrhythmia, coronary insufficiency, hypertension, CHF, diabetes mellitus, hyperthyroidism, thyrotoxicosis, hypokalaemia, narrow angle glaucoma, prostatic hyperplasia/bladder neck obstruction, urinary retention, seizure disorder. Severe hepatic or renal impairment, ESRD. Pregnancy and lactation.
Adverse Reactions
Significant: CNS depression, hypersensitivity reactions (e.g. angioedema, urticaria), hypertension, increased heart rate, ECG changes, hyperglycaemia, diabetes mellitus and ketoacidosis exacerbation, thyroid stimulation, hypokalaemia, narrow-angle glaucoma, urinary retention.
Cardiac disorders: Ischaemic heart disease, atrial fibrillation, tachycardia, palpitations.
Gastrointestinal disorders: Dyspepsia, dental carries, gastroenteritis, dry mouth.
General disorders and administration site conditions: Pyrexia, chest pain, fatigue, peripheral oedema.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain, muscle spasm, myalgia, back pain.
Nervous system disorders: Headache, dizziness, paraesthesia.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Cough, nasopharyngitis, upper respiratory infection, sinusitis, rhinitis.
Skin and subcutaneous tissue disorders: Pruritus, rash.
Potentially Fatal: Asthma-related deaths, rarely, paradoxical bronchospasm.
Patient Counseling Information
This drug may cause drowsiness, dizziness, and/or blurred vision, if affected, do not drive or operate machinery.
MonitoringParameters
Obtain FEV1, FVC, and/or other pulmonary function tests, serum K, blood glucose. Monitor heart rate, blood pressure and signs of CNS stimulation.
Drug Interactions
Indacaterol: May potentiate hypokalaemic effect with xanthine derivatives, steroids, diuretics. May potentiate CV effects with MAOIs, TCA, QTc-prolonging agents. May cause sever bronchospasm with β-blockers.
Glycopyrronium: Increased adverse effects with other anticholinergic drugs.
Action
Description: Indacaterol is a long acting beta2- agonist that acts locally in the lungs and relaxes bronchial smooth muscle.
Glycopyrronium is a long acting muscarinic receptor antagonist. It causes bronchodilatation by inhibiting the acetylcholine at muscarinic receptor subtypes 1-3 in bronchial smooth muscles.
Onset: Within 5 minutes.
Pharmacokinetics:
Absorption: Indacaterol: Absolute bioavailability: 43-45%. Time to peak plasma concentration: Approx 15 minutes.
Glycopyrronium: Poorly absorbed from the gastrointestinal tract. Bioavailability: Approx 10-25%. Time to peak plasma concentration: Approx 5 minutes.
Distribution: Indacaterol: Plasma protein binding: Approx 95%.
Glycopyrronium: Crosses blood-brain barrier (poorly). Volume of distribution: 83 L. Plasma protein binding: 38-41%.
Metabolism: Indacaterol: Metabolised by CYP3A4 isoenzyme and via glucuronidation by uridine diphosphate-glucuronosyltransferase (UGT) 1A1.
Excretion: Indacaterol: Via faeces (54% as unchanged drug, 23% as metabolites); urine. Elimination half-life: 40-56 hours.
Glycopyrronium: Via faeces; urine (23% as parent drug). Terminal elimination half-life: 33-57 hours.
Chemical Structure

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Storage
Store between 15-25°C. Protect from light and moisture.
ATC Classification
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.
Disclaimer: This information is independently developed by MIMS based on Indacaterol + Glycopyrronium from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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