Sign Out
No data from clinical studies are available regarding overdose of TRELEGY ELLIPTA.
An overdose of TRELEGY ELLIPTA may produce signs, symptoms or adverse effects associated with the individual components' pharmacological actions as described as follows.
In the event of drug overdose, discontinue TRELEGY ELLIPTA and initiate appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm.
Cardiac monitoring including electrocardiogram monitoring is recommended in cases of overdosage.
Fluticasone Furoate: Chronic overdosage (use at excessive doses for prolonged periods) may result in signs/symptoms of hypercorticism (see Endocrine and Metabolism under Precautions).
The potential for acute toxic corticosteroid effects following overdosage with TRELEGY ELLIPTA is low. Because of low systemic bioavailability (15.2%) and an absence of acute drug related systemic findings in clinical trials, overdosage of fluticasone furoate is unlikely to require any treatment other than observation.
Single- and repeat-dose trials of fluticasone furoate at doses of 50 to 4,000 mcg have shown fluticasone furoate to be well tolerated. Decreases in mean serum cortisol were observed at dosages of 500 mcg or higher given once daily for 14 days.
Umeclidinium: An overdose of umeclidinium will likely produce signs and symptoms consistent with the known inhaled muscarinic antagonist adverse effects (e.g., dry mouth, visual accommodation disturbances and tachycardia). However, there were no systemic anticholinergic adverse effects following a once-daily inhaled dose of up to 1,000 mcg umeclidinium (16 times the maximum recommended daily dose) for 14 days in subjects with COPD.
Vilanterol: The expected signs and symptoms with overdosage of vilanterol are those typical of excessive beta-adrenergic stimulation (e.g., angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, QTc prolongation, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis). As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of vilanterol.
