Company: GlaxoSmithKline.
Legal category: Prescription. GMS. Sport prohibited.
Active ingredients: Umeclidinium/vilanterol (as trifenatate) 55/22mcg per delivered dose.
Description: Inhalation powder.
Presentation: 30 dose unit, €39.95.
Indication: Maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease.
Pharmacology: Umeclidinium/vilanterol is a combination inhaled long-acting muscarinic receptor antagonist/long-acting beta2-adrenergic agonist. Both compounds act locally on airways to produce bronchodilation by separate mechanisms. Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors on airway smooth muscle. Vilanterol stimulates intracellular adenylate cyclase which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Dosage: Adult: One inhalation of 55/22mcg once daily (maximum), at same time of day. Elderly: As per adults. Children: Under 18 years, no relevant use.
Contraindications: Hypersensitivity to the active substances or to any of the excipients.
Special precautions: Not for use in asthma or acute episodes of bronchospasm. Discontinue immediately if paradoxical bronchospasm occurs. Re-evaluate treatment regimen if COPD deteriorates. Caution: Severe hepatic impairment, severe cardiovascular disease, urinary retention, narrow-angle glaucoma, convulsive disorders, thyrotoxicosis, patients unusually responsive to beta2-adrenergic agonists. May occur: Significant hypokalaemia, transient hyperglycemia. Diabetes (closely monitor plasma glucose upon initiation). Contains lactose. Pregnancy, lactation (assess risk/benefit).
Drug interactions: Not recommended: Other long-acting muscarinic antagonists, other long-acting beta2-adrenergic agonists. Avoid: Beta-adrenergic blockers (unless clearly necessary). Caution: Drugs which may cause hypokalaemia (methylxanthine derivatives, steroids, or non-potassium-sparing diuretics), strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin).
Adverse drug reactions: Urinary tract infection, sinusitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, constipation, dry mouth.
Full prescribing information and references available from GlaxoSmithKline. Telephone: (01) 4955000. Fax: (01) 4955105.
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