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AMIRONE (CORDARONE) INDICATIONS

Amirone is used for treating life-threatening recurrent heart rhythm disturbances in patients who cannot tolerate or do not respond well to other medicines. Amirone is an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm. It is usually used in situations in which the abnormal heart rhythms, if not treated, could cause death.

AMIRONE (CORDARONE) INSTRUCTIONS

Use Amirone as directed by your doctor.

  • Take Amirone by mouth. It is best taken with food. However, it is more important to take it consistently with regard to meals. If you take it with food, try to always take it with food to improve absorption of Amirone. If you prefer to take it on an empty stomach, then always try to take it on an empty stomach.
  • Do not eat grapefruit or drink grapefruit juice while you take Amirone.
  • Amirone works best when there is a constant level of the medicine in your body. Take Amirone on a regular schedule around the clock, unless your doctor tells you otherwise. Take it at the same time each day.
  • If you miss a dose of Amirone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Amirone.

AMIRONE (CORDARONE) STORAGE

Store Amirone at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amirone out of the reach of children and away from pets.

AMIRONE (CORDARONE) MORE INFO:

Active Ingredient:Amiodarone HCl.

Do NOT use Amirone if:

  • you are allergic to any ingredient in Amirone, including iodine
  • you have complete, second degree, third degree, or severe sinoatrial heart block; an abnormally slow heartbeat; or shock due to serious heart problems; or if you have had fainting due to slow heartbeat (except if you have a pacemaker)
  • you are taking cisapride, dofetilide, an H1

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Amirone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, lung disease, heart problems, low blood pressure, thyroid problems, electrolyte problems (eg, low blood potassium or magnesium), eye problems, or sinoatrial heart block
  • if you will be having surgery, or if you have an implanted pacemaker or defibrillator
  • if you take medicine for diabetes (eg, glyburide).

Some medicines may interact with Amirone. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Antiarrhythmics (eg, flecainide), arsenic, azole antifungals (eg, ketoconazole), cimetidine, cisapride, diuretics (eg, furosemide, hydrochlorothiazide), dofetilide, droperidol, H1
  • Narcotic pain relievers (eg, fentanyl) because low blood pressure, slow heartbeat, and other heart problems may occur
  • Cholestyramine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Amirone's effectiveness
  • Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased or the risk of their side effects may be increased by Amirone
  • Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), calcium channel blockers (eg, verapamil, diltiazem), cyclosporine, dextromethorphan, digoxin, HMG-CoA reductase inhibitors (eg, simvastatin), lidocaine, or methotrexate because the risk of their side effects may be increased by Amirone
  • Clopidogrel because its effectiveness may be decreased by Amirone.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amirone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

  • Amirone may cause dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Amirone with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Severe and sometimes fatal lung or other breathing problems have been reported with Amirone. Contact your doctor right away if you develop shortness of breath, chest pain, wheezing, fever, or cough, or if you begin coughing up blood.
  • Long-term exposure to Amirone may cause blue-gray discoloration of the skin, particularly of the face and hands. This effect is not harmful and usually reverses, sometimes incompletely, after the medicine is stopped. Avoiding prolonged exposure to the sun may help to prevent this effect.
  • Limit alcoholic beverages while taking Amirone.
  • It may take several days to weeks for Amirone to work. A response may not be seen for up to 3 weeks after the medicine is started.
  • Amirone stays in your body for weeks or months, even after you are no longer taking it. Therefore, caution is advised not only during treatment, but for several months after treatment with Amirone has stopped if you are taking any interacting medicines.
  • Amirone may cause skin reactions similar to serious sunburn or sensitivity to sunlight. Avoid the sun, sunlamps, or tanning booths until you know how you react to Amirone. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Tell your doctor or dentist that you take Amirone before you receive any medical or dental care, emergency care, or surgery (including eye surgery to correct vision problems).
  • Your doctor may want you to check your pulse rate every day while you take Amirone. Learn how to monitor your pulse.
  • Carry an ID card at all times that says you take Amirone.
  • Lab tests, including electrocardiogram (ECG), chest x-rays, lung tests, liver tests, thyroid tests, and eye exams, may be performed while you use Amirone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Amirone should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.
  • Pregnancy and breast-feeding: Amirone has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amirone while you are pregnant. Amirone is found in breast milk. Do not breastfeed while taking Amirone.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Abnormal skin sensations (loss of sensation; tingling; numbness; prickling); bitter taste in mouth; blue-green discoloring of skin (especially hands or feet); constipation; decreased sexual interest; dizziness; dry eyes; flushing of the face; general body discomfort; headache; involuntary muscle movements; loss of appetite; nausea; poor coordination; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; chills; coldness; cough; coughing up blood; dark urine; decreased urination; easy bruising or bleeding; enlarged thyroid gland; eye discomfort; fatigue; fever; irregular pulse; loss of coordination; menstrual changes; muscle pain, tenderness, or weakness (especially with fever or unusual tiredness); nervousness; persistent sore throat; severe dizziness; severe stomach pain; shortness of breath; skin reaction similar to serious sunburn; slow heartbeat; sluggishness; sweating; tingling or numbness of hands or feet; uncontrolled shaking or tremor; unexplained weight change; vision changes (seeing halos, blurred vision, loss of vision); wheezing; worsening of irregular heartbeat; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.



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