Olodaterol

SOURCE: eMC UK SPC, productName 'Striverdi Respimat 2.5 microgram, solution for inhalation' (https://www.medicines.org.uk/emc/product/3255/smpc), §4.2. VERBATIM: 'Adults — The recommended dose is 5 microgram olodaterol given as two actuations (puffs) from the Respimat inhaler once daily, at the same time of the day. The recommended dose should not be exceeded.' Note the cartridge is labelled 2.5 micrograms per actuation and two actuations make the single 5 microgram dose — do not present this as 2.5 micrograms twice daily. ELDERLY: elderly patients can use Striverdi Respimat at the recommended dose. HEPATIC IMPAIRMENT: patients with mild and moderate hepatic impairment can use the recommended dose; there are no data in severe hepatic impairment. PAEDIATRIC: 'There is no relevant use of Striverdi Respimat in the paediatric population (under 18 years)' — hence paedDose is null. NOT FOR ASTHMA, NOT A RESCUE THERAPY (§4.4): 'Striverdi Respimat should not be used in asthma. The long-term efficacy and safety of olodaterol in asthma have not been studied.' As a once-daily maintenance bronchodilator it should not be used for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy. Paradoxical bronchospasm may occur and may be life-threatening — discontinue immediately and substitute alternative therapy. Administer with caution in cardiovascular disorders (especially ischaemic heart disease, severe cardiac decompensation, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, hypertension, aneurysm), convulsive disorders, thyrotoxicosis, known or suspected QT prolongation (e.g. QT >0.44 s) and in patients unusually responsive to sympathomimetic amines; experience is limited in patients with MI in the previous year, unstable or life-threatening arrhythmia, hospitalisation for heart failure in the previous year, or paroxysmal tachycardia >100 bpm. Beta2-agonists may produce significant hypokalaemia (potentiated by hypoxia and concomitant treatment in severe COPD) and inhalation of high doses may increase plasma glucose. Caution with planned operations using halogenated hydrocarbon anaesthetics due to increased susceptibility to adverse cardiac effects. DEVICE: the inhaler is for a single patient; the re-usable inhaler can be used with up to 6 cartridges and should not be used for more than one year after the first cartridge is inserted. Each prepared inhaler delivers 60 actuations (30 doses). If not used for more than 7 days, release one actuation towards the ground; if not used for more than 21 days, re-prime until a cloud is visible then repeat three more times. SECTION COVERAGE: §4.5 was not retrieved in this bundle, so no interactions list is given (§4.4 cross-refers to §4.5 for concomitant treatment potentiating hypokalaemia). §4.4 was truncated at the source-fetch limit.