Ibutilide Fumarate Solution for injection

What is this medicine?

IBUTILIDE is an antiarrhythmic agent. This medicine can help your heart beat regularly.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease

• low blood magnesium levels

• low blood potassium levels

• other heart problems

• an unusual or allergic reaction to ibutilide, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health-care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• amoxapine

• arsenic trioxide

• certain antibiotics like clarithromycin, erythromycin, gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, sparfloxacin, telithromycin, troleandomycin

• cisapride

• droperidol

• haloperidol

• hawthorn

• levomethadyl

• maprotiline

• medicines to control heart rhythm

• medicines to treat or prevent malaria like chloroquine or halofantrine

• methadone

• pentamidine

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• pimozide

• ranolazine

• sertindole

• tricyclic antidepressants

• vardenafil

• ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fast, irregular heartbeat

• palpitations

• slow heart rate

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• increased blood pressure

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.