Ibutilide Fumarate 1 mg/10mL
Ibutilide Fumarate · INJECTION, SOLUTION · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Ibutilide Fumarate is a injection, solution containing ibutilide fumarate at 1 mg/10mL, taken intravenous. Manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..
Key Facts
- Brand Name
- Ibutilide Fumarate
- Generic Name
- Ibutilide Fumarate
- NDC Code (Product)
23155-326- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Strength
- 1 mg/10mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA204146
- Marketing Start
- 04/01/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ibutilide fumarate injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to ibutilide fumarate. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration. LIFE-THREATENING ARRHYTHMIAS—APPROPRIATE TREATMENT ENVIRONMENT Ibutilide fumarate can cause potentially fatal arrhythmias, particularly sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes), but sometimes without documented QT prolongation. In registration studies, these arrhythmias, which require cardioversion, occurred in 1.7% of treated patients during, or within a number of hours of, use of Ibutilide fumarate. These arrhythmias can be reversed if treated promptly (see WARNINGS, Proarrhythmia ). It is essential that Ibutilide fumarate be administered in a setting of continuous ECG monitoring and by personnel trained in identification and treatment of acute ventricular arrhythmias, particularly polymorphic ventricular tachycardia. Patients with a…
Dosage & Administration
DOSAGE AND ADMINISTRATION The recommended dose based on controlled trials (see CLINICAL STUDIES ) is outlined in the Table below. Ibutilide infusion should be stopped as soon as the presenting arrhythmia is terminated or in the event of sustained or nonsustained ventricular tachycardia, or marked prolongation of QT or QTc. Recommended Dose of Ibutilide Fumarate Injection Patient Weight Initial Infusion (over 10 minutes) Second Infusion 60 kg (132 lb) or more One vial (1 mg ibutilide fumarate) If the arrhythmia does not terminate within 10 minutes after the end of the initial infusion, a second 10-minute infusion of equal strength may be administered 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 terminat…
Warnings
WARNINGS Proarrhythmia Like other antiarrhythmic agents, ibutilide fumarate injection can induce or worsen ventricular arrhythmias in some patients. This may have potentially fatal consequences. Torsades de pointes, a polymorphic ventricular tachycardia that develops in the setting of a prolonged QT interval, may occur because of the effect ibutilide fumarate has on cardiac repolarization, but ibutilide fumarate can also cause polymorphic VT in the absence of excessive prolongation of the QT interval. In general, with drugs that prolong the QT interval, the risk of torsades de pointes is thought to increase progressively as the QT interval is prolonged and may be worsened with bradycardia, a varying heart rate, and hypokalemia. In clinical trials conducted in patients with atrial fibrillation and atrial flutter, those with QTc intervals greater than 440 msec were not usually allowed to participate, and serum potassium had to be above 4 mEq/L. Although change in QTc was dose dependent for ibutilide, there was no clear relationship between risk of serious proarrhythmia and dose in clinical studies, possibly due to the small number of events. In clinical trials of intravenous ibutilid…
Contraindications
CONTRAINDICATIONS Ibutilide fumarate injection is contraindicated in patients who have previously demonstrated hypersensitivity to ibutilide fumarate or any of the other product components.
Drug Interactions
Drug Interactions No specific pharmacokinetic or other formal drug interaction studies were conducted. Digoxin Supraventricular arrhythmias may mask the cardiotoxicity associated with excessive digoxin levels. Therefore, it is advisable to be particularly cautious in patients whose plasma digoxin levels are above or suspected to be above the usual therapeutic range. Co-administration of digoxin did not have effects on either the safety or efficacy of ibutilide in the clinical trials. Calcium channel blocking agents Co-administration of calcium channel blockers did not have any effect on either the safety or efficacy of ibutilide in the clinical trials. Beta-adrenergic blocking agents Co-administration of beta-adrenergic blocking agents did not have any effect on either the safety or efficacy of ibutilide in the clinical trials.
Adverse Reactions
ADVERSE REACTIONS Ibutilide fumarate injection was generally well tolerated in clinical trials. Of the 586 patients with atrial fibrillation or atrial flutter who received ibutilide fumarate in phase II/III studies, 149 (25%) reported medical events related to the cardiovascular system, including sustained polymorphic ventricular tachycardia (1.7%) and nonsustained polymorphic ventricular tachycardia (2.7%). Other clinically important adverse events with an uncertain relationship to ibutilide fumarate include the following (0.2% represents one patient): sustained monomorphic ventricular tachycardia (0.2%), nonsustained monomorphic ventricular tachycardia (4.9%), AV block (1.5%), bundle branch block (1.9%), ventricular extrasystoles (5.1%), supraventricular extrasystoles (0.9%), hypotension/postural hypotension (2%), bradycardia/sinus bradycardia (1.2%), nodal arrhythmia (0.7%), congestive heart failure (0.5%), tachycardia/sinus tachycardia/supraventricular tachycardia (2.7%), idioventricular rhythm (0.2%), syncope (0.3%), and renal failure (0.3%). The incidence of these events, except for syncope, was greater in the group treated with ibutilide fumarate than in the placebo group. A…
Frequently Asked Questions
What is Ibutilide Fumarate used for?
Ibutilide Fumarate contains Ibutilide Fumarate. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Ibutilide Fumarate a controlled substance?
Ibutilide Fumarate is not classified as a controlled substance by the DEA.
What is the generic name for Ibutilide Fumarate?
The generic name for Ibutilide Fumarate is Ibutilide Fumarate. There are 1 other brand versions of Ibutilide Fumarate.
What is the NDC code for Ibutilide Fumarate 1 mg/10mL?
The NDC (National Drug Code) for Ibutilide Fumarate 1 mg/10mL is 23155-326, listed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..