Adult: For rapid conversion of recent-onset cases into sinus rhythm: As ibutilide fumarate: <60 kg: 0.01 mg/kg; ≥60 kg: 1 mg. Dose to be given via infusion over 10 minutes. If arrhythmia persists within 10 minutes after completion of initial infusion, may administer a second 10-minute infusion of similar dose. Discontinue infusion as soon as arrhythmia is terminated, or if ventricular tachycardia (sustained or nonsustained) or marked QT/QTc prolongation occurs. Elderly: Initiate at the lower end of dosing range.
May be given undiluted or diluted. Diluted infusion: Prior to administration, add 10 mL (1 vial) of ibutilide to 50 mL of 0.9% NaCl or 5% dextrose inj to make a final concentration of approx 0.017 mg/mL.
Concomitant use with class Ia (e.g. disopyramide, quinidine, procainamide) and other class III (e.g. amiodarone, sotalol) antiarrhythmic drugs or within 4 hours postinfusion of ibutilide.
Patient with chronic atrial fibrillation. Correct electrolyte imbalance (particularly hypomagnesaemia and hypokalaemia) before administration and during therapy. Patient taking digoxin, particularly when plasma digoxin levels are confirmed or suspected to be above the usual therapeutic range. Not recommended in patients who previously had polymorphic ventricular tachycardia (e.g. torsades de pointes). Elderly. Pregnancy and lactation.
Significant: Reversible or complete heart block; nonsustained ventricular tachycardia (monomorphic or polymorphic). Cardiac disorders: Supraventricular tachycardia, atrioventricular block, ventricular extrasystoles, bundle branch block, bradycardia, tachycardia, palpitations. Gastrointestinal disorders: Nausea. Nervous system disorders: Headache. Vascular disorders: Hypotension, hypertension. Potentially Fatal: Arrhythmias, especially sustained polymorphic ventricular tachycardia, usually with QT prolongation or torsades de pointes but occasionally without documented QT interval prolongation.
Monitor patient with continuous ECG for at least 4 hours after infusion or until QTc returned to baseline; electrolytes.
May increase the risk of proarrhythmia with other agents known to prolong QT interval (e.g. TCAs, phenothiazines, tetracyclic antidepressants, H1-receptor antagonist antihistamines). Potentially Fatal: May cause additive prolongation of refractoriness with class Ia antiarrhythmic drugs (e.g. quinidine, procainamide, disopyramide) and other class III antiarrhythmics (e.g. amiodarone, sotalol).
Description: Ibutilide is a methanesulfonanilide derivative class III antiarrhythmic agent. It prolongs the myocardial action potential duration and enhances the atrial and ventricular refractoriness predominantly by activating slow inward Na current (INa-s). Onset: Conversion to sinus rhythm: ≤90 minutes following the start of infusion. Pharmacokinetics: Distribution: Widely distributed in the body (after IV infusion). Plasma protein-binding: Approx 40%. Metabolism: Extensively metabolised in the liver via oxidation into several metabolites. Excretion: Mainly via urine (approx 82%, approx 7% as unchanged drug); faeces (approx 19%). Elimination half-life: Approx 6 hours (range: 2-12 hours).
Store between 20-25°C. Diluted infusions are stable for 24 hours between 15-30°C and for 48 hours between 2-8°C.
C01BD05 - ibutilide ; Belongs to class III antiarrhythmics.
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