AMIODARONE

Do NOT use Amiodarone if:

• you are allergic to any ingredient in Amiodarone, 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 antagonist (eg, astemizole, loratadine, terfenadine), an HIV protease inhibitor (eg, ritonavir), a phosphodiesterase type 5 inhibitor (eg, vardenafil), or a streptogramin (eg, dalfopristin, quinupristin)

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

Before using Amiodarone:

Some medical conditions may interact with Amiodarone. 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 Amiodarone. 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 antagonists (eg, astemizole, loratadine, terfenadine), HIV protease inhibitors (eg, ritonavir), ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, thioridazine), phosphodiesterase type 5 inhibitors (eg, vardenafil), pimozide, quinolones (eg, ciprofloxacin), serotonin receptor antagonists (eg, dolasetron), streptogramins (eg, dalfopristin, quinupristin), trazodone, or ziprasidone because side effects, such as heart rhythm problems or seizures, may occur
• 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 Amiodarone’s effectiveness
• Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased or the risk of their side effects may be increased by Amiodarone
• 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 Amiodarone
• Clopidogrel because its effectiveness may be decreased by Amiodarone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amiodarone 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.

How to use Amiodarone:

Use Amiodarone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Amiodarone comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Amiodarone refilled.
• Take Amiodarone 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 Amiodarone. 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 Amiodarone.
• Amiodarone works best when there is a constant level of the medicine in your body. Take Amiodarone 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 Amiodarone, 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 Amiodarone.

Important safety information:

• Amiodarone may cause dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Amiodarone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Severe and sometimes fatal lung or other breathing problems have been reported with Amiodarone. 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 Amiodarone 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 Amiodarone.
• It may take several days to weeks for Amiodarone to work. A response may not be seen for up to 3 weeks after the medicine is started.
• Amiodarone 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 Amiodarone has stopped if you are taking any interacting medicines.
• Amiodarone 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 Amiodarone. 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 Amiodarone 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 Amiodarone. Learn how to monitor your pulse.
• Carry an ID card at all times that says you take Amiodarone.
• Lab tests, including electrocardiogram (ECG), chest x-rays, lung tests, liver tests, thyroid tests, and eye exams, may be performed while you use Amiodarone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Amiodarone should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Amiodarone 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 Amiodarone while you are pregnant. Amiodarone is found in breast milk. Do not breast-feed while taking Amiodarone.

Possible side effects of Amiodarone:

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. Call your doctor for medical advice about side effects.

If OVERDOSE is suspected:

Contact your local Poison Control or emergency room immediately. Symptoms may include fainting; severe dizziness; unusually slow pulse; weakness.

 

Proper storage of Amiodarone:

Store Amiodarone 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 Amiodarone out of the reach of children and away from pets.

General information:

• If you have any questions about Amiodarone, please talk with your doctor, pharmacist, or other health care provider.
• Amiodarone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Amiodarone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.