Ibutilide is an anti-arrhythmic heart medication that corrects certain conditions of irregular heart rhythm.

Ibutilide is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Ibutilide is used in people with atrial fibrillation or atrial flutter.

Ibutilide may also be used for purposes not listed in this medication guide.

Ibutilide can cause life-threatening irregular heart rhythms. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG) so that any further problems can be treated quickly.

Ibutilide is injected into a vein through an IV. A healthcare provider will give you this injection.

Ibutilide can cause life-threatening irregular heart rhythms. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG) so that any further problems can be treated quickly. Cardiac emergency equipment will also be kept nearby in case it is needed to treat you.

Heart monitoring may continue for several hours after you have stopped receiving ibutilide.

Usual Adult Dose for Atrial Fibrillation:

Less than 60 kg: 0.01 mg/kg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.
60 kg or more: 1 mg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.

Comments:
-In the post-cardiac surgery study, one or two IV infusions of 0.5 mg (0.005 mg/kg per dose for patients weighing less than 60 kg) were effective in terminating atrial fibrillation or flutter.
-In patients weighing more than 60 kg, a single 2 mg infusion has also been effective in terminating atrial fibrillation or flutter.
-Discontinue infusion upon arrhythmia termination or if sustained or non-sustained ventricular tachycardia or marked QT or QTc prolongation occurs.
-Monitor ECG continuously for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if arrhythmic activity occurs.

Usual Adult Dose for Atrial Flutter:

Less than 60 kg: 0.01 mg/kg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.
60 kg or more: 1 mg IV over 10 minutes; if arrhythmia persists 10 minutes after the end of the first infusion, repeat once.

Comments:
-In the post-cardiac surgery study, one or two IV infusions of 0.5 mg (0.005 mg/kg per dose for patients weighing less than 60 kg) were effective in terminating atrial fibrillation or flutter.
-In patients weighing more than 60 kg, a single 2 mg infusion has also been effective in terminating atrial fibrillation or flutter.
-Discontinue infusion upon arrhythmia termination or if sustained or non-sustained ventricular tachycardia or marked QT or QTc prolongation occurs.
-Monitor ECG continuously for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if arrhythmic activity occurs.

You should not receive this medication if you are allergic to ibutilide.

If possible, tell your doctor if you have taken a heart rhythm medication within the past 4 hours before receiving ibutilide.

To make sure ibutilide is safe for you, tell your doctor if you have congestive heart failure.

FDA pregnancy category C. It is not known whether ibutilide will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether ibutilide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers about your health conditions, or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows you have received ibutilide.

Because you will receive ibutilide in a clinical setting, you are not likely to miss a dose.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have:

• headache with chest pain and severe dizziness;

• shortness of breath; or

• a light-headed feeling, like you might pass out.

Common side effects of ibutilide may include:

• mild headache; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor if you have taken a heart rhythm medication within the past 4 hours. This includes:

• amiodarone;

• disopyramide;

• dofetilide;

• dronedarone;

• procainamide;

• quinidine; or

• sotalol.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ibutilide, especially:

• citalopram, fingolimod, lumefantrine, mifepristone, saquinavir; or

• an antibiotic--azithromycin, clarithromycin, erythromycin; cancer medicine--arsenic trioxide, degarelix, nilotinib, toremifene, vandetanib, vemurafenib; medicine to treat mental illness--iloperidone, pimozide, thioridazine, ziprasidone.

This list is not complete. Other drugs may interact with ibutilide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.