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)