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Generic Name: Amiodarone Tablets (a-MEE-oh-duh-rone)
Brand Name: Examples include Cordarone and Pacerone
Pacerone should only be used in patients with life-threatening irregular heartbeat. Worsening of irregular heartbeat, life-threatening lung disease, and serious liver problems may occur with use of Pacerone . Alternative medicines should be tried before Pacerone is used. Initial use of Pacerone requires close monitoring and dose selection may be difficult. It is very common to require a dosage decrease or discontinuation of treatment. The recurrence of the irregular heartbeat after discontinuation or dosage adjustment is unpredictable and hospitalization may be required.
Pacerone is used for:
Treating life-threatening recurrent heart rhythm disturbances in patients who cannot tolerate or do not respond well to other
medicines. It may also be used for other conditions as determined by your doctor.
Pacerone 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.
Do NOT use Pacerone if:
- you are allergic to any ingredient in Pacerone , 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 inhibitors (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 Pacerone :
Some medical conditions may interact with Pacerone . 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
- if you take medicine for diabetes (eg, glyburide)
Some MEDICINES MAY INTERACT with Pacerone . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Cholestyramine, hydantoins (eg, phenytoin), rifampin, or St. John"s wort because they may decrease Pacerone "s effectiveness
- 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
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
- 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 their actions and side effects may be increased by Pacerone
- Thyroid hormones (eg, levothyroxine) because their effectiveness
may be decreased or their risk of side effects may be increased by Pacerone
- Clopidogrel because its effectiveness may be decreased by Pacerone
This may not be a complete list of all interactions that may occur. Ask your health care provider if Pacerone 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 Pacerone :
Use Pacerone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Pacerone comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Pacerone refilled.
- Pacerone 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 this
medicine. If you prefer to take it on an empty stomach, then always try to take it on an empty stomach.
- Avoid eating grapefruit or drinking grapefruit juice while taking Pacerone .
- Pacerone works best when there is a constant level of the medicine in your body. Take Pacerone on a regular schedule around the clock, unless otherwise directed by your doctor. Take Pacerone at the same time each day.
- If you miss a dose of Pacerone , 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 Pacerone .
Important safety information:
- Pacerone may cause dizziness, lightheadedness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you
react to Pacerone . Using Pacerone alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Long-term exposure to Pacerone 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 Pacerone .
- It may take several days to weeks for Pacerone to work. A response may not be seen for up to 3 weeks after the medicine is started.
- Pacerone 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 Pacerone has stopped if you are taking any interacting medicines.
- Pacerone may cause skin reactions similar to serious sunburn or sensitivity to sunlight. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Pacerone . Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
- Before you have any medical or dental treatments, emergency care, or surgery (including eye surgery to correct vision problems), tell the doctor or dentist that you are using Pacerone .
- Your doctor may want you to check your pulse rate every day while you take Pacerone . Learn how to monitor your pulse.
- Carry an identification card at all times that says you are taking Pacerone .
- LAB TESTS, including electrocardiogram (ECG), chest x-rays, lung tests, liver tests, thyroid tests, and eye exams, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
- Use Pacerone with
extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Pacerone has been shown to cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Pacerone during pregnancy. Pacerone is excreted in breast milk. Do not breast-feed while taking Pacerone .
Possible side effects of Pacerone :
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:
Seek medical attention right away if any of these SEVERE side effects occur:
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
Severe allergic reactions (rash; hives; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include fainting; severe dizziness;
unusually slow pulse; weakness.
Proper storage of Pacerone :
Store Pacerone 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 Pacerone out of the reach of children and away from pets.
- If you have any questions about Pacerone , please talk with your doctor, pharmacist, or other health care provider.
- Pacerone 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.
This information is a summary only. It does not contain all information about Pacerone . 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.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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