CORVERT Injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to CORVERT. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration.

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.

 In a trial comparing ibutilide and sotalol (see CLINICAL PHARMACOLOGY: Clinical Studies), 2 mg ibutilide fumarate administored 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 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 EGG 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 CORVERT and subsequent monitoring of the patient.

Dilution

CORVERT Injection may be administered undiluted or diluted in 50 mL of diluent. CORVERT 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 CORVERT Injection (0.1 mg/ mL):

5% Dextrose Injection
0.9% Sodium Chloride Injection.

The following intravenous solution containers are compatible with admixtures of CORVERT 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° Cor 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.

CORVERT Injection (ibutilide fumarate injection) is supplied as an acetate-buffered isotonic solution at a concentration of 0.1 mg/mL that has been adjusted to approximately pH 4.6 in 10 mL clear glass, single-dose, flip-top vials.

Single-dose 10 mL vial, 1 mg/10 mL (0.1 mg/mL) NDC 0009-3794-01

Store at controlled room temperature 20° to 25° C( 68° to 77° F)[ see USP]. Store vial in carton until used.

Caution: Federal law prohibits dispensing without prescription.

Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation
Kalamazoo, Michigan 49001, USA
Revised July 2002

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