Company: Boehringer Ingelheim Ireland Ltd.
Legal category: Prescription. GMS. Sport prohibited.
Active ingredient: Olodaterol (hydrochloride) 2.5mcg per puff.
Description: Solution for inhalation.
Presentation: 30 dose unit, €27.00.
Indication: Maintenance bronchodilator treatment of chronic obstructive pulmonary disease.
Pharmacology: Olodaterol has a high affinity and high selectivity for the human beta2-adrenoceptor. Activation of beta2-adrenoceptors in the airways results in stimulation of intracellular adenyl cyclase, an enzyme that mediates the synthesis of cyclic-3’,5’ adenosine monophosphate (cAMP). Elevated levels of cAMP induce bronchodilation by relaxation of airway smooth muscle cells.
Dosage: Adult: 5mcg given as two puffs from Respimat inhaler once daily, at same time of day. Elderly: As per adults. Children: Under 18 years, no relevant use.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients.
Special precautions: Not for use in asthma or acute episodes of bronchospasm, i.e. as a rescue therapy. Discontinue immediately if paradoxical bronchospasm occurs. Caution: Cardiovascular disorders, especially ischaemic heart disease, severe cardiac decompensation, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, hypertension, aneurysm, convulsive disorders or thyrotoxicosis, QT interval prolongation, patients unusually responsive to sympathomimetic amines, myocardial infarction during the previous year, unstable or life-threatening cardiac arrhythmia, hospitalisation for heart failure during the previous year, paroxysmal tachycardia (>100 beats per minute). May need to discontinue if clinically significant cardiovascular effects occur. May occur: Significant hypokalaemia, plasma glucose increases. Severe hepatic impairment (no data), severe renal impairment (limited experience). Driving/using machines (dizziness). Pregnancy (avoid), lactation (assess risk/benefit).
Drug interactions: Avoid: Other drugs containing long-acting beta2-adrenergic agonists. Caution: Halongenated hydrocarbon anaesthetics, cardioselective beta-blockers. Other adrenergic agents, xanthine derivatives, steroids, non-potassium sparing diuretics, beta-adrenergic blockers, monoamine oxidase inhibitors, tricyclic antidepressants, drugs prolonging the QTc interval.
Adverse drug reactions: None common.
Full prescribing information and references available from Boehringer Ingelheim Ireland Ltd. Telephone (01) 2959620.