Overdose : מינון יתר

4.9   Overdose

There is limited information on overdosing with Spiolto Respimat. Spiolto Respimat has been studied up to 5 microgram / 10 microgram (tiotropium/olodaterol) in COPD patients and up to 10 microgram / 40 microgram (tiotropium/olodaterol) in healthy subjects; no clinically relevant effects were observed.
An overdose could lead to exaggerated anti-muscarinic effects of tiotropium and/or exaggerated β2 agonists effects of olodaterol.

Symptoms
Overdose of anticholinergic tiotropium
High doses of tiotropium may lead to anticholinergic signs and symptoms.

However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 microgram tiotropium bromide in healthy volunteers. Additionally, no relevant adverse events, beyond dry mouth/throat and dry nasal mucosa were observed following 14-day dosing of up to 40 microgram tiotropium inhalation solution in healthy volunteers with the exception of pronounced reduction in salivary flow from day 7 onwards.

Overdose of ß2-agonist olodaterol

Spiolto Respimat                                        Approved prescribing information Inhalation solution                                     May 2019
An overdose of olodaterol is likely to lead to exaggerated effects typical of beta 2-adrenergic agonists, e.g. myocardial ischaemia, hypertension or hypotension, tachycardia, arrhythmias, palpitation, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis.

Treatment of overdose
Treatment with Spiolto Respimat should be discontinued. Supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Use of cardioselective beta-blockers may be considered, but only subject to extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm.