Indacaterol/ Glycopyrronium

Registered South African indications:

• Chronic obstructive pulmonary disease

Contraindications

• Hypersensitivity to the active ingredients or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment 
• Severe hepatic impairment 
• Asthma
• Acute bronchospasm
• Narrow-angle glaucoma
• Urinary retention
• Cardiovascular disorders 
• Known or suspected QT prolongation
• Arrhythmia
• Diabetes mellitus
• Seizure disorders
• Thyrotoxicosis
• Unusual responsiveness to beta agonist
• Hypokalaemia
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption 
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: cps

Chronic obstructive pulmonary disease

Indacaterol/ Glycopyrronium
110μg/ 50μg

• Inhaled (cps): 1 cap, dly

Not established for use in children below 18 years

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution; not recommended

Renal impairment

• Severe: Caution; dose adjustment recommended 

Hepatic impairment

• Severe: Caution; no information available

Elderly

• No dose adjustment recommended

Central Nervous System Disorders

• Insomnia
• Dizziness
• Headache
• Paraesthesia

Cardiovascular Disorders

• Ischaemic heart disease
• Atrial fibrillation
• Tachycardia
• Palpitations

Respiratory Disorders

• Cough
• Oropharyngeal pain including throat irritation
• Paradoxical bronchospasm
• Dysphonia
• Epistaxis

Gastrointestinal Disorders

• Dyspepsia
• Dental caries
• Gastroenteritis
• Dry mouth

Genitourinary Disorders

• Bladder obstruction and urinary retention

Endocrine and Metabolic Disorders

• Hyperglycaemia and diabetes mellitus

Musculoskeletal Disorders

• Musculoskeletal pain
• Muscle spasm
• Myalgia
• Pain in extremity

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash

Immune, Blood and Lymphatic System Disorders

• Upper respiratory tract infection
• Nasopharyngitis
• Urinary tract infection
• Sinusitis
• Rhinitis
• Hypersensitivity
• Angioedema

Sensory Disorders

• Glaucoma

Others

• Pyrexia
• Chest pain
• Oedema peripheral
• Fatigue

• Beta blockers
• Anticholinergics
• Sympathomimetic agents
• Methylxanthine derivatives
• Steroids
• Non-potassium-sparing diuretics
• CYP3A4 inhibitors
• P-glycoprotein inhibitors

• Pulmonary function test
• Serum potassium
• Blood glucose
• Heart rate

Indacaterol
Indacaterol is a long-acting beta-adrenergic agonist. It stimulates intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle. When inhaled, indacaterol acts locally in the lung as a bronchodilator.

Glycopyrronium
Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic). Parasympathetic nerves are the major bronchoconstrictive neural pathway in airways, and cholinergic tone is the key reversible component of airflow obstruction in COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.

COMBINATION PREPARATIONS

Indacaterol/ Glycopyrronium

Capsules, lung admin 110μg/ 50μg

• Ultibro Breezhaler (Novartis)