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Asthma: STRIVERDI RESPIMAT should not be used in asthma. The long-term effectiveness and safety of olodaterol in asthma have not been studied. Long-acting beta2-adrenergic agonists (LABA) may increase the risk of asthma-related hospitalisations and death.
Data from a large placebo-controlled study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including olodaterol, the active ingredient in STRIVERDI RESPIMAT.
Acute bronchospasm: STRIVERDI RESPIMAT is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Hypersensitivity: As with all medications, immediate hypersensitivity reactions may occur after administration of STRIVERDI RESPIMAT.
Deterioration of disease and acute episodes: STRIVERDI RESPIMAT should not be initiated in patients with acutely deteriorating COPD. In this case, the patient's COPD management plan should direct the patient to seek medical advice immediately, and a re-evaluation of the patient and the COPD treatment regimen should be undertaken. Increasing the daily dosage of STRIVERDI RESPIMAT beyond the recommended dose is not appropriate.
Paradoxical bronchospasm: As with other Inhaled medicines STRIVERDI RESPIMAT may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs STRIVERDI RESPIMAT should be discontinued immediately and alternative therapy substituted.
Systemic effects: Long acting beta2-adrenergic agonists should be administered with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy and hypertension; in patients with convulsive disorders or thyrotoxicosis, in patients with known or suspected prolongation of the QT interval; and in patients who are unusually responsive to sympathomimetic amines.
Patients with a history of myocardial infarction during the previous year, unstable or life-threatening cardiac arrhythmia, hospitalized for heart failure during the previous year or with a diagnosis of paroxysmal tachycardia (>100 beats per minute) were excluded from the clinical trials. Therefore the experience in these patient groups is limited. STRIVERDI RESPIMAT should be used with caution in these patient groups.
Cardiovascular effects: Like other beta2-adrenergic agonists, olodaterol may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In case such effects occur, treatment may need to be discontinued. In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave and ST segment depression, although the clinical significance of these observations is unknown.
Hypokalaemia: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see Interactions), which may increase the susceptibility to cardiac arrhythmias.
Hyperglycaemia: Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose.
STRIVERDI RESPIMAT should not be used in conjunction with any other medication containing long-acting beta2-adrenergic agonists.
Patients who have been taking inhaled, short acting beta2-adrenergic agonists on a regular basis (e.g. four times a day) should be instructed to use them only for symptomatic relief of acute respiratory symptoms.
Excipients: This medicine contains 0.0011 mg benzalkonium chloride in each actuation.
Benzalkonium chloride may cause wheezing and breathing difficulties. Patients with asthma are at an increased risk for these adverse events.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed.
However, patients should be advised that dizziness has been reported in clinical trials. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience dizziness, they should avoid potentially hazardous tasks such as driving or operating machinery.
