Glycoair Breezhaler Overdosage

Information related to indacaterol/glycopyrronium: In a single dose study in healthy volunteers the 4-fold of the therapeutic dose of indacaterol/glycopyrronium (four dose steps of 110/50 microgram separated by one hour, each) was well tolerated with no relevant effects on heart rate, QTc-interval, serum potassium or blood glucose.
In COPD patients, doses of up to 600/100 microgram were inhaled over two weeks and there were no relevant effects on heart rate, QTc-interval, blood glucose or serum potassium. There was an increase in ventricular ectopies after 14 days of dosing with 300/100 and 600/100 microgram indacaterol/glycopyrronium, but low prevalence and small patient numbers (N=49 and N=51 for 600/100 microgram and 300/100 microgram indacaterol/glycopyrronium, respectively) did preclude accurate analysis. In a total of four patients non-sustained ventricular tachycardia was recorded with the longest episode recorded being 9 beats (4 seconds).
An overdose could lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalemia, and hyperglycemia or could induce anticholinergic effects, i.e. increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding. Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalized. Use of cardioselective beta blockers may be considered for treating beta2-adrenergic effects, but only under the supervision of a physician and with extreme caution since the use of beta-adrenergic blockers may provoke bronchospasm.
Information related to indacaterol: In COPD patients single doses of 3000 microgram were associated with a moderate increase in pulse rate, systolic blood pressure increase and QTc interval.
Information related to glycopyrronium: In COPD patients, repeated orally inhaled administration of glycopyrronium at total doses of 100 and 200 microgram once-daily for 28 days were well tolerated.
Acute intoxication by inadvertent oral ingestion of glycopyrronium capsules is unlikely due to the low oral bioavailability (about 5%).
Peak plasma levels and total systemic exposure following i.v. administration of 150 microgram glycopyrronium bromide (equivalent to 120 microgram glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total systemic exposure at steady-state achieved with the recommended dose (50 microgram once-daily) of glycopyrronium and were well tolerated.