What is the most important information I should know about Cordarone?

• In some cases, Cordarone has been associated with serious and even fatal side effects such as lung problems, liver problems, and new or worsening irregular heartbeats. Discuss with your doctor the risks and benefits associated with the use of Cordarone.
• Do not skip doses or change the dosing schedule without talking to your doctor. Missed or delayed doses could be harmful.
• Do not consume grapefruit or grapefruit juice during treatment with Cordarone. Cordarone can interact with grapefruit and grapefruit juice, and the interaction may have dangerous effects. You should discuss the use of grapefruit and grapefruit juice with your doctor.
• Use caution when driving, operating machinery, or performing other hazardous activities. Cordarone may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities.
• Avoid prolonged exposure to sunlight. Cordarone may cause the skin to turn a bluish-gray color. This reaction is worse with exposure to the sun. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

What is Cordarone?

• Cordarone is an antiarrhythmic medication. Cordarone affects the way that the heart beats.
• Cordarone is used to treat irregular heartbeats.
• Cordarone may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Cordarone?

• In some cases, Cordarone has been associated with serious and even fatal side effects such as lung problems, liver problems, and new or worsening irregular heartbeats. Discuss with your doctor the risks and benefits associated with the use of Cordarone.
• Before taking Cordarone, tell your doctor if you
  • have any other type of heart disease or heart problems;
  • have liver disease;
  • have vision problems (especially optic neuritis);
  • have thyroid problems; or
  • need to have surgery.
• You may not be able to take Cordarone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Cordarone is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Do not take Cordarone without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• Cordarone passes into breast milk. It is not known whether this medication will affect a nursing infant. Do not take Cordarone without first talking to your doctor if you are breast-feeding a baby.

How should I take Cordarone?

• Take Cordarone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Cordarone can be taken with or without food. However, it should always be taken the same way, either with or without food.
• Do not consume grapefruit or grapefruit juice during treatment with Cordarone. Cordarone can interact with grapefruit and grapefruit juice, and the interaction may have dangerous effects. You should discuss the use of grapefruit and grapefruit juice with your doctor.
• It is important to take Cordarone regularly to get the most benefit.
• Do not skip doses or change the dosing schedule without talking to your doctor. Missed or delayed doses could be harmful.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with Cordarone to monitor progress and side effects.
• Store Cordarone at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication. A double dose could be dangerous.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of an Cordarone overdose include tiredness, dizziness, confusion, a slow heart rate, yellowing of the skin or eyes, diarrhea, abdominal pain, and worsening irregular heartbeats.

What should I avoid while taking Cordarone?

• Do not consume grapefruit or grapefruit juice during treatment with Cordarone. Cordarone can interact with grapefruit and grapefruit juice, and the interaction may have dangerous effects. You should discuss the use of grapefruit and grapefruit juice with your doctor.
• Use caution when driving, operating machinery, or performing other hazardous activities. Cordarone may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities.
• Avoid prolonged exposure to sunlight. Cordarone may cause the skin to turn a bluish-gray color. This reaction is worse with exposure to the sun. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.
• Follow any other special instructions given by your doctor regarding food, beverages, or activities (e.g., driving).

What are the possible side effects of Cordarone?

• If you experience any of the following serious side effects, stop taking Cordarone and seek emergency medical attention:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • a new or a worsening irregular heartbeat pattern;
  • wheezing, coughing, chest pain, or chest discomfort;
  • yellowing of the skin or eyes;
  • changes in vision, blurred vision, or decreased vision;
  • cough or shortness of breath;
  • fainting;
  • tremor or involuntary movements; or
  • skin rash;
• Other, less serious side effects may also occur. Continue to take Cordarone and talk to your doctor if you experience
  • dizziness or tiredness;
  • upset stomach, vomiting, decreased appetite, or diarrhea;
  • changes in taste;
  • poor coordination;
  • numbness, or tingling; or
  • bluish-gray discoloration of the skin.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Cordarone?

• Before taking Cordarone, tell your doctor if you are taking any of the following medicines:
  • cimetidine (Tagamet);
  • cholestyramine (Questran);
  • cyclosporine (Sandimmune, Neoral);
  • dextromethorphan (a cough suppressant commonly used in prescription and over-the-counter cough medications);
  • digoxin (Lanoxin, Lanoxicaps);
  • fentanyl (Duragesic, Actiq);
  • lidocaine (Xylocaine, others);
  • methotrexate (Rheumatrex);
  • rifampin (Rifadin, Rimactane);
  • the herbal product St. John's wort;
  • simvastatin (Zocor);
  • theophylline (Theo-Bid, Theo-Dur, Theolair, Elixophyllin, Slo-Phyllin, others);
  • warfarin (Coumadin);
  • a protease inhibitor such as indinavir (Crixivan), lopinavir-ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Fortovase, Invirase);
  • phenytoin (Dilantin), ethotoin (Peganone), or mephenytoin (Mesantoin);
  • flecainide (Tambocor), procainamide (Pronestyl, Procan SR, Procanbid), quinidine (Cardioquin, Quinaglute, Quinora, Quinidex), disopyramide (Norpace), or other medicines used to treat irregular heartbeats;
  • a beta-blocker such as acebutolol (Sectral), atenolol (Tenormin), metoprolol (Lopressor), propranolol (Inderal), and others; or
  • a calcium channel blocker such as verapamil (Calan, Verelan, Isoptin), diltiazem (Cardizem, Dilacor XR), nifedipine (Procardia, Adalat), felodipine (Plendil), and others.
• You may not be able to take Cordarone, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Cordarone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.