at usual clinical doses. Medical events (e.g., proarrhythmia, AV block) that occur after the overdosage should be treated with measures appropriate for that condition.
DOSAGE AND ADMINISTRATION
The recommended dose based on controlled trials (see CLINICAL PHARMACOLOGY: CLINICAL STUDIES) is outlined in the Table below. Ibutilide infusion should be stopped as soon as the presenting arrhythmia is terminated or in the event of sustained or nonsustained ventricular tachycardia, or marked prolongation of QT or QTc.
Recommended Dose of Ibutilide Fumarate Injection
Patient Weight Initial Infusion
(over 10 minutes) Second Infusion
60 kg (132 lb)
or more
One vial
(1 mg ibutilide fumarate)
If the arrhythmia does not terminate within 10 minutes after the end of the initial infusion, a second 10-minute infusion of equal strength may be administered 10 minutes after completion of the first infusion.
Less than 60 kg
(132 lb)
0.1 mL/kg
(0.01 mg/kg ibutilide fumarate)
In a trial comparing ibutilide and sotalol (see CLINICAL PHARMACOLOGY: CLINICAL STUDIES), 2 mg ibutilide fumarate administered as a single infusion to patients weighing more than 60 kg was also effective in terminating atrial fibrillation or atrial flutter.
In the post-cardiac surgery study (see CLINICAL PHARMACOLOGY: CLINICAL STUDIES), one or two intravenous infusions of 0.5 mg (0.005 mg/kg per dose for patients weighing less than 60 kg) was effective in terminating atrial fibrillation or atrial flutter.
Patients should be observed with continuous ECG monitoring for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if any arrhythmic activity is noted. Skilled personnel and proper equipment (see WARNINGS, PROARRHYTHMIA), such as a cardioverter/defibrillator, and medication for treatment of sustained ventricular tachycardia, including polymorphic ventricular tachycardia, must be available during administration of ibutilide fumarate injection and subsequent monitoring of the patient.
Dilution
Ibutilide fumarate injection may be administered undiluted or diluted in 50 mL of diluent. Ibutilide fumarate injection may be added to 0.9% Sodium Chloride injection or 5% Dextrose injection before infusion. The contents of one 10 mL vial (0.1 mg/mL) may be added to a 50 mL infusion bag to form an admixture of approximately 0.017 mg/mL ibutilide fumarate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Compatibility and Stability
The following diluents are compatible with ibutilide fumarate injection (0.1 mg/mL):
5% Dextrose injection
0.9% Sodium Chloride injection.
The following intravenous solution containers are compatible with admixtures of ibutilide fumarate injection (0.1 mg/mL):
polyvinyl chloride plastic bags
polyolefin bags.
Admixtures of the product, with approved diluents, are chemically and physically stable for 24 hours at room temperature (15° to 30°C or 59° to 86°F) and for 48 hours at refrigerated temperatures (2° to 8°C or 36° to 46°F). Strict adherence to the use of aseptic technique during the preparation of the admixture is recommended in order to maintain sterility.
HOW SUPPLIED
Ibutilide Fumarate Injection is supplied as an acetate-buffered isotonic solution at a conce |
