Active Ingredient: Vernakalant
Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults:
For this indication, competent medicine agencies globally authorize below treatments:
3 - 3 mg per kg of body weight
From 3 To 3 mg per kg of body weight once every day
Vernakalant is dosed by patient body weight, with a maximum calculated dose based upon 113 kg.
The recommended initial infusion is 3 mg/kg to be infused over a 10-minute period with a maximum initial dose of 339 mg (84.7 ml of 4 mg/ml solution). If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 2 mg/kg may be administered (maximum second infusion of 226 mg (56.5 ml of 4 mg/ml solution)). Cumulative doses of greater than 5 mg/kg should not be administered within 24 hours.
There are no clinical data on repeat doses after the initial and second infusions. By 24 hours there appears to be insignificant levels of vernakalant.
The initial infusion is administered as a 3 mg/kg dose over 10 minutes. During this period, the patient should be carefully monitored for any signs or symptoms of a sudden decrease in blood pressure or heart rate. If such signs develop, with or without symptomatic hypotension or bradycardia, the infusion should be stopped immediately.
If conversion to sinus rhythm has not occurred, the patient’s vital signs and cardiac rhythm should be observed for an additional 15 minutes.
If conversion to sinus rhythm did not occur with the initial infusion or within the 15-minute observation period, a 2 mg/kg second infusion should be administered over 10 minutes.
If conversion to sinus rhythm occurs during either the initial or second infusion, that infusion should be continued to completion. If haemodynamically stable atrial flutter is observed after the initial infusion, the second infusion may be administered as patients may convert to sinus rhythm.
For patients above 113 kg, vernakalant has a fixed dose. The initial dose is 339 mg (84.7 ml of 4 mg/ml solution). If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 226 mg (56.5 ml of 4 mg/ml solution) may be administered. Cumulative doses above 565 mg have not been evaluated.
No dose adjustment necessary.
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