Amiodarone Oral (patient information)

IMPORTANT WARNING

Amiodarone may cause lung disease that can be serious or life-threatening.Tell your doctor if you have or have ever had any type of lung disease. If you experience any of the following symptoms, call your doctor immediately: fever, shortness of breath, wheezing, cough, coughing up blood, and any other breathing problems.

Amiodarone also may cause liver disease. Tell your doctor if you have or have ever had liver disease. If your experience any of the following symptoms, call your doctor immediately: upset stomach, vomiting, dark colored urine, excessive tiredness, yellowing of the skin or eyes, itching, or pain in the upper right part of the stomach.

Amiodarone may cause your irregular heart rhythm (arrhythmia) to worsen or may cause you to develop new arrhythmias. Tell your doctor if you have ever been dizzy or lightheaded or have fainted because your heartbeat was too slow and if you have or have ever had low levels of potassium in your blood; heart or thyroid disease; or any problems with your heart rhythm other than the irregular heartbeat being treated. Tell your doctor and pharmacist if you are taking any of the following medications: antifungals such as fluconazole (Diflucan), ketoconazole (Nizoral), and itraconazole (Sporanox); azithromycin (Zithromax); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Covera, Isoptin, Verelan); cisapride (Propulsid); clarithromycin (Biaxin); diuretics ('water pills'); dofetilide (Tikosyn); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoroquinolone antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam); other medications for irregular heartbeat such as digoxin (Lanoxin), disopyramide (Norpace), flecainide (Tambocor), phenytoin (Dilantin), procainamide (Procanbid, Pronestyl), quinidine (Quinidex) and sotalol (Betapace); and thioridazine (Mellaril). If you have any of the following symptoms, call your doctor immediately: lightheadedness; fainting; fast, slow, or pounding heartbeat; or feeling that your heart has skipped a beat.

You will probably be hospitalized for one week or longer when you begin your treatment with amiodarone. Your doctor will monitor you carefully during this time and for as long as you continue to take amiodarone. Your doctor will probably start you on a high dose of amiodarone and gradually decrease your dose as the medication begins to work. Your doctor may decrease your dose during your treatment if you develop side effects. Follow your doctor's directions carefully.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests, such as blood tests, X-rays, and electrocardiograms (EKGs, tests that record the electrical activity of the heart) before and during your treatment to be sure that it is safe for you to take amiodarone and to check your body's response to the medication.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with amiodarone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions.You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/medwatch/SAFETY/2005/Cordarone_Med_Guide.pdf.

Talk to your doctor about the risks of taking amiodarone.

Why this medication is prescribed

Amiodarone is used to treat and prevent certain types of ventricular arrhythmias (abnormal heart rhythm). Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles.

How this medication should be used

Amiodarone comes as a tablet to take by mouth. It is usually taken once or twice a day. Your doctor will tell you to take amiodarone with or without food; be sure to take it the same way each time. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amiodarone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Amiodarone controls arrhythmias but does not cure them. Continue to take amiodarone even if you feel well. Do not stop taking amiodarone without talking to your doctor. If you suddenly stop taking amiodarone, your condition may get worse.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before taking amiodarone:

• tell your doctor and pharmacist if you are allergic to amiodarone, iodine, any other drugs, or corn.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING and any of the following: antidepressants ('mood elevators') such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), nefazodone (Serzone); anticoagulants ('blood thinners') such as warfarin (coumadin); cholesterol lowering medications such as atorvastatin (Lipitor), cholestyramine (Questran), lovastatin (Mevacor), simvastatin (Zocor); cimetidine (Tagamet); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dextromethorphan (a medication in many cough preparations); dexamethasone (Decadron); fentanyl (Actiq, Duragesic); HIV protease inhibitors such as indinavir (Crixivan), and ritonavir (Norvir); isoniazid (INH, Nydrazid); medications for diabetes; medications for pain; medications for seizures such as carbamazepine (Tegretol), ethosuximide (Zarontin), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin); metronidazole (Flagyl); methotrexate (Rheumatrex); oral contraceptives (birth control pills); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); troglitazone (Rezulin); troleandomycin (TAO); and zafirlukast (Accolate). Your doctor may have to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had problems with your blood pressure.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use a reliable method of birth control to prevent pregnancy while you are taking amiodarone. If you become pregnant while taking amiodarone, call your doctor immediately. You should not breastfeed while you are taking amiodarone. Talk to your doctor if you plan to become pregnant or breastfeed during the first several months after your treatment because amiordarone may remain in your body for some time after you stop taking it.
• if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking amiodarone.
• plan to avoid unnecessary or prolonged exposure to sunlight or sunlamps and to wear protective clothing, sunglasses, and sunscreen. Amiodarone may make your skin sensitive to sunlight. *Exposed skin may turn blue-gray and may not return to normal even after you stop using this medication.
• you should know that amiodarone may cause vision problems including permanent blindness. Be sure to have regular eye exams during your treatment and call your doctor if you have any changes with your eyes or notice any changes in your vision.
• you should know that amiodarone may remain in your body for several months after your stop taking it. You may continue to experience side effects of amiodarone during this time. Be sure to tell your health care provider who treats you or prescribes any medication for you during this time that you have recently stopped taking amiodarone.

Special dietary instructions

Do not drink grapefruit juice while taking this medication.

What to do if you forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

Minor Side Effects

Amiodarone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• vomiting
• constipation
• headache
• decreased sex drive
• difficulty falling asleep or staying asleep
• flushing
• dry eyes
• changes in ability to taste and smell
• changes in amount of saliva

Severe Side Effects

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• rash
• weight loss or gain
• restlessness
• intolerance to heat or cold
• thinning hair
• excessive sweating
• changes in menstrual cycle
• swelling in the front of the neck (goiter)
• decreased vision or changes in your ability to see such as blurred vision or seeing halos
• eyes are sensitive to light
• eye pain
• swelling of the hands, feet, ankles, or lower legs
• shaking hands that you can not control
• movements that you can not control
• poor coordination or trouble walking
• numbness or tingling in the hands, legs, and feet
• muscle weakness

Laboratory animals who were given amiodarone developed thyroid tumors. It is not known if amiodarone increases the risk of developing thyroid tumors in humans.

Talk to your doctor about the risk of taking amiodarone.

Amiodarone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Protect this medication from light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• slow heartbeat
• upset stomach
• blurred vision
• lightheadedness
• fainting

Other information

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Cordarone®
• Pacerone®