What is the most important information I should know about dronedarone?
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Dronedarone is used to treat intermittent or "temporary" heart rhythm disorders. In some people with "permanent" atrial fibrillation, dronedarone increased the risk of stroke, hospitalization due to heart failure, and death. Talk with your doctor about your individual risk. Do not stop taking this medication without first talking to your doctor. Stopping suddenly may make your condition worse.
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You should not use dronedarone if you are allergic to dronedarone, if you are pregnant or breast-feeding, or if you have severe liver disease, certain serious heart conditions, especially severe heart failure, "AV block" or sick sinus syndrome (unless you have a pacemaker), a history of slow heart beats that have caused you to faint, or if you were recently hospitalized for heart failure. |
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There are many other medicines that can cause serious medical problems if you take them together with dronedarone. You may need to stop taking certain drugs while you are taking dronedarone. Tell your doctor about all other medications you use. |
Also tell your doctor if you have kidney disease, liver disease, a history of heart failure, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or if you have a pacemaker or defibrillator implanted in your chest.
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Dronedarone can harm an unborn baby or cause birth defects. Do not use dronedarone if you are pregnant.
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You may need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.
Dronedarone is an antiarrhythmic medication that affects the rhythm of heartbeats.
Dronedarone helps keep the heart beating normally in people with life-threatening heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart) and risk factors such as diabetes, high blood pressure, a history of stroke, or being over 70 years old.
Dronedarone is used to treat certain heart rhythm disorders called atrial fibrillation or atrial flutter. Dronedarone is given to reduce the need for hospitalization due to these heart conditions.
Dronedarone may also be used for purposes not listed in this medication guide.
What happens if I miss a dose?
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Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. |
What should I avoid while taking dronedarone?
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Grapefruit and grapefruit juice may interact with dronedarone and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
What are the possible side effects of dronedarone?
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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. |
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Call your doctor at once if you have a serious side effect such as: |
- severe dizziness, fainting, fast or pounding heartbeats;
- slow heart rate, feeling like you might pass out;
- a new or a worsening irregular heartbeat pattern;
- feeling short of breath, even with mild exertion, swelling in your ankles or feet, rapid weight gain;
- wheezing, cough, chest pain, trouble breathing, coughing up mucus;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- breathing problems while lying down trying to sleep; or
- low electrolytes (confusion, jerky muscle movements, uneven heartbeats, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).
Less serious side effects may include:
- mild stomach pain, diarrhea, upset stomach;
- feeling weak or tired; or
- mild skin rash or redness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect dronedarone?
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Many drugs can interact with dronedarone and some should not be used at the same time. Below is only a partial list of these drugs. Tell your doctor if you are using:
- a blood thinner such as warfarin (Coumadin, Jantoven);
- cyclosporine (Gengraf, Neoral, Sandimmune);
- digoxin (digitalis, Lanoxin, Lanoxicaps);
- sirolimus (Rapamune) or tacrolimus (Prograf);
- St. John's wort;
- theophylline (Elixophyllin, Theo-24, Uniphyl);
- tuberculosis medications;
- a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others;
- cholesterol-lowering medicines such as cholestyramine (Prevalite, Questran), atorvastatin (Lipitor), simvastatin (Zocor), lovastatin (Mevacor), pravastatin (Pravachol), or fluvastatin (Lescol);
- heart or blood pressure medication such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others; or
- seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others.
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This list is not complete and there are many other drugs that can cause serious drug interactions with dronedarone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. |
Where can I get more information?
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Your pharmacist can provide more information about dronedarone.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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