ered 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 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 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 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°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
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 0009-3794-22
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Store vial in carton until used.
SPL UNCLASSIFIED SECTION
Rx only
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
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NOVAPLUS is a registered trademark of Vizient, Inc.
LAB-0385-2.0
August 2016
PRINCIPAL DISPLAY PANEL - 10 ML VIAL LABEL
NDC 0009-3794-22
Rx ONLY
Corvert®
Ibutilide Fumarate Inj.
10 mL Single Dose Vial
For IV Use Only
1 mg per
10 mL
(0.1 mg per mL)
Distributed by Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
N+ and NOVAPLUS are registered
trademarks of Vizient, Inc.
NOVAPLUS®
PRINCIPAL DISPLAY PANEL - 10 mL Vial Label
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