Usual Adult Dose for Atrial Fibrillation

Less than 60 kg: 0.01 mg/kg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.
60 kg or more: 1 mg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.

Comments:

• In the post-cardiac surgery study, one or two IV infusions of 0.5 mg (0.005 mg/kg per dose for patients weighing less than 60 kg) were effective in terminating atrial fibrillation or flutter.
• In patients weighing more than 60 kg, a single 2 mg infusion has also been effective in terminating atrial fibrillation or flutter.
• Discontinue infusion upon arrhythmia termination or if sustained or non-sustained ventricular tachycardia or marked QT or QTc prolongation occurs.
• Monitor ECG continuously for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if arrhythmic activity occurs.

Usual Adult Dose for Atrial Flutter

Less than 60 kg: 0.01 mg/kg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.
60 kg or more: 1 mg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.

Comments:

• In the post-cardiac surgery study, one or two IV infusions of 0.5 mg (0.005 mg/kg per dose for patients weighing less than 60 kg) were effective in terminating atrial fibrillation or flutter.
• In patients weighing more than 60 kg, a single 2 mg infusion has also been effective in terminating atrial fibrillation or flutter.
• Discontinue infusion upon arrhythmia termination or if sustained or non-sustained ventricular tachycardia or marked QT or QTc prolongation occurs.
• Monitor ECG continuously for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if arrhythmic activity occurs.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

US BOXED WARNINGS:

• LIFE-THREATENING ARRHYTHMIAS - APPROPRIATE TREATMENT ENVIRONMENT: This drug can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation. In registration studies, these arrhythmias, which require cardioversion, occurred in 1.7% of treated patients during, or within a number of hours of, use of this drug. These arrhythmias can be reversed if treated promptly. Administration and continuous ECG monitoring by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia, is essential. Patients with atrial fibrillation lasting longer than 2 to 3 days must be adequately anticoagulated, usually for at least 2 weeks.
• CHOICE OF PATIENTS: Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm and treatments to maintain sinus rhythm carry risks. Patients to be treated with this drug, therefore, should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks, and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia, must administer this drug.
• This drug may be administered undiluted or diluted in 50 mL of diluent.

Storage requirements: Admixtures of this drug with approved diluents remain stable for 24 hours at room temperature and 48 hours at refrigerated temperatures.

Reconstitution/preparation techniques: One 10 mL vial of this drug (0.1 mg/mL) may be added to a 50 mL infusion bag to form an admixture of approximately 0.017 mg/mL.

IV compatibility:

• Compatible diluents: 5% dextrose injection; 0.9% sodium chloride injection
• Compatible containers: Polyvinyl chloride plastic bags; Polyolefin bags

General:

• In a trial comparing ibutilide and sotalol, ibutilide 2 mg administered as a single infusion to patients greater than 60 kg was also effective in terminating atrial fibrillation or atrial flutter.
• In the post-cardiac surgery study, one or two 0.005 mg/kg IV infusions for patients weighing less than 60 kg was effective in terminating atrial fibrillation or atrial flutter.

Monitoring:

• Monitor ECG continuously for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if arrhythmic activity occurs.
• Patients with abnormal liver function should be monitored by telemetry for more than the 4-hour period generally recommended.