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ibutilide (Corvert)

 

Classes: Antidysrhythmics, III

Dosing and uses of Corvert (ibutilide)

 

Adult dosage forms and strengths

injectable solution

  • 0.1mg/mL

 

Atrial Fibrillation/Flutter

<60 kg: 0.01 mg/kg (0.1 mL/kg) IV infusion repeat after 10 minutes PRn

>60 kg: 1 mg (one vial) IV infusion, repeat after 10 minutes PRn

 

Renal Impairment

Dose adjustment not necessary

 

Hepatic Impairment

Dose adjustment not necessary

 

Pediatric dosage forms and strengths

Safety & efficacy not established

 

Corvert (ibutilide) adverse (side) effects

1-10%

Headache (4%)

Bradycardia (2%)

HTN (2%)

Hypotension (2%)

Palpitations (2%)

QTc interval prolongation (<2%)

Nausea (>2%)

 

< 1%

Heart failure

Erythematous bollous lesions

Nodal arrythmia

Renal failure

Ventricular tachycardia

Syncope

Heart block

Torsades de pointes

Potentially lethal arrhythmias: sustained polymorphic V-Tach (Torsades de Pointes), AV block

 

Warnings

Black box warnings

May cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation

Studies show arrhythmias requiring cardioversion occurred in 1.7% of treated patients during or within a number of hours of using ibutilide fumarate; these arrhythmias can be reversed if treated promptly

Administer in with continuous ECG monitoring & by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia

Patients with atrial fibrillation >2-3 days' duration must be adequately anticoagulated, generally for at least 2 wk

Carefully select patients: Patients with chronic atrial fibrillation have a strong tendency to revert after conversion to sinus rhythm and treatment to maintain sinus rhythms carry risks

 

Contraindications

Prolongs QT interval: concurrent QT-prolonging drugs or congenital long QT patients; QTc >440 msec

 

Cautions

Administer in a setting of continuous ECG monitoring and by personnel trained in treating arrhythmias such as polymorphic ventricular tachycardia

ANTICIPATE ARRHYTHMIAS, have all materials at hand to handle potential lethal arrhythmias for at least 4-6 hr

A-Fib >2-3 days duration requires anticoagulation prior to therapy

Hypokalemia, hypomagnesemia other electrolyte distrubances must be corrected prior and throughout therapy

Caution in bradycardia, CHF, electrolyte abnormalities, history of polymorphic VT after antiarrhythmic therapy, liver disease, proarrhythmic events, recent MI

Monitor for heart block

Drugs that prolong the QT interval and other class I or class III antiarrhythmic agents should not be given concurrently with ibutilide (or within 4 hours after infusion), other antiarrhythmics should be withheld prior to conversion with ibutilide (eg, 5 half-lives)

 

Pregnancy and lactation

Pregnancy category: C

Lactation: enters breast milk; contraindicated

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Corvert (ibutilide)

Mechanism of action

Prolongs action potential duration and increase both atrial and ventricular refractoriness (class III effects)

Markedly prolongs action potential and repolarization

 

Pharmacokinetics

Half-Life: 2-12 hr

Onset: 90 min following infusion

Duration: 24 hr

Protein Bound: 40%

Vd: 11 L/kg

Metabolism: Liver via oxidation

Metabolites: Hydroxy derivative (active)

Excretion: Urine (82%); feces (20%)

 

Administration

IV Compatibilities

Solution: D5W, Ns

 

IV Preparation

Dilute in 50 mL NS or D5W to make 0.017 mg/mL solution

 

IV Administration

IV infusion over 10 min diluted or undiluted

 

Storage

May store diluted soln for 24 hr at room temperature OR 48 hr at 2-8°C (36-46°F)