Adult Dosing

Conversion of atrial fibrillation or atrial flutter

• <60 kg (132 lb): 0.01 mg/kg IV infusion over 10 minutes
• 60 kg (132 lb): 1 mg IV infusion over 10 minutes

Note:

• If no response is achieved within 10 minutes after the end of the initial infusion, repeat the dose of equal strength 10 minutes after completion of the first infusion
• Observe patients with continuous ECG monitoring for at least 4 hrs following infusion or until QTc has returned to baseline

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Rapid conversion of recent onset atrial fibrillation or atrial flutter to sinus rhythm

• Hypersensitivity to any of the ingredients of the product
• History of polymorphic ventricular tachycardia

• Therapy may cause fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, in association with or without QT prolongation (torsades de pointes). These arrhythmias can be reversed if treated promptly
• Administer the drug with continuous ECG monitoring by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic VT. Patients with atrial fibrillation of duration >2-3 days must be adequately anticoagulated for at least 2 wks
• Patients with chronic atrial fibrillation have a tendency to revert after conversion to sinus rhythm; treatments to maintain sinus rhythm carry risks. Hence, patients to be treated with ibutilide should be carefully selected such that the expected benefits of maintaining sinus rhythm outweigh the immediate risks of ibutilide, and the risks of maintenance therapy, and are likely to offer an advantage compared with alternative management

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; use with caution

• Ibutilide may cause or worsen ventricular arrhythmias, particularly sustained polymorphic VT, in association with or without QT prolongation (torsades de pointes) [US Black Box Warning]
• Therapy is not recommended in patients with a history of polymorphic VT such as torsades de pointes
• During registration trials, many initial episodes of polymorphic VT occurred within 40 mins after the start of the first ibutilide infusion; however, certain instances of recurrent polymorphic VT occurred about 3 hrs after the initial infusion
• Administer the drug with continuous ECG monitoring by personnel skilled in identification and treatment of acute ventricular arrhythmias, particularly polymorphic VT. Patients with atrial fibrillation of duration >2-3 days must be adequately anticoagulated for at least 2 wks [US Black Box Warning]
• Well trained personnel with proper equipment including cardiac monitoring equipment, intracardiac pacing facilities, a cardioverter/defibrillator, and medication for treatment of sustained VT, including polymorphic VT, must be available during and after administration of ibutilide
• Hypokalemia and hypomagnesemia should be corrected before therapy initiation to reduce the potential for proarrhythmia
• Do not administer class Ia antiarrhythmic drugs (Vaughan Williams Classification) and other class III drugs concurrently with ibutilide injection or within 4 hrs post-infusion because of their potential to prolong refractoriness
• Co-administration of ibutilide injection with drugs that prolong the QT interval may increase the potential for proarrhythmia

Cautions: Use cautiously in

• Hepatic impairment
• QT prolongation
• Heart failure
• Bradycardia
• Known or suspected digoxin levels above the usual therapeutic range
• Elderly patients

Pregnancy Category:C

Breastfeeding: Safety unknown. Manufacturer advises not to breastfeed an infant if the patient is receiving ibutilide.

• CV: Sustained polymorphic VT, torsades de pointes, ventricular extrasystoles, nonsustained monomorphic VT, nonsustained polymorphic VT, hypotension/postural hypotension, bundle branch block, AV block, hypertension, QT prolongation, palpitation, tachycardia/sinus tachycardia/supraventricular tachycardia, nodal arrhythmia, extrasystoles, bradycardia/sinus bradycardia
• GI: Nausea
• CNS: Headache

• Class III anti-arrhythmic agent; prolongs action potential duration and increases both atrial and ventricular refractoriness; delays repolarization by activation of a slow, inward current (predominantly sodium), rather than by blocking outward potassium currents
• Produces mild slowing of the sinus rate and atrioventricular conduction, and dose-related prolongation of the QT interval, which is thought to be associated with its antiarrhythmic activity. Produces no clinically significant effect on QRS duration
• Produces no clinically significant effects on cardiac output, mean pulmonary arterial pressure, or pulmonary capillary wedge pressure
• Metabolized in liver
• Excretion: Urine 82% (7% unchanged); feces 19%
• Half-life: 6 hrs (range 2-12 hrs)

US Trade Name(s)

• Corvert

US Availability

ibutilide (generic)

• INJ: 0.1 mg/mL

Corvert

• INJ: 0.1 mg/mL (10 mL vial)

Canadian Trade Name(s)

• Corvert

Canadian Availability

Corvert

• INJ: 0.1 mg/mL (10 mL vial)

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Cardiovascular

Antiarrhythmic Agents

Group III Antiarrhythmics