DRONEDARONE

(droe NE da rone) Brand: Multaq

What is the most significant information I must know about dronedarone?

• Dronedarone is used to treat intermittent or "temporary" heart rhythm disorders. In some people with "permanent" atrial fibrillation, dronedarone heighten the risk of stroke, hospitalization due to heart failure, and death. Conversation with your doctor about your individual risk. Do not stop taking this medicine without first talking to your doctor. Stopping suddenly may create your condition worse.

• You must not use dronedarone if you are allergic to dronedarone, if you are pregnant or breast-feeding, or if you have severe liver malady, determined 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.

• There are much another medicines that can reason serious medical problems if you take them together with dronedarone. You may need to stop taking determined drugs while you are taking dronedarone. Speak your doctor about all another medications you use.

• Also speak your doctor if you have kidney malady, liver malady, 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.

• Dronedarone can harm an unborn child or reason birth defects. Do not use dronedarone if you are pregnant.

• You may need regular medical trials to be certain this medicine is not causing deleterious effects. Visit your doctor regularly.

What is dronedarone?

• Dronedarone is an antiarrhythmic medicine that affects the rhythm of heartbeats.

• Dronedarone helps hold the heart beating normally in people with life-threatening heart rhythm disorders of the atrium (the upper chambers of the heart that let blood to flow into the heart) and risk factors such as diabetes, tall blood pressure, a history of stroke, or being over 70 years old.

• Dronedarone is used to treat determined 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 medicine guide.

What must I discuss with my healthcare provider till taking dronedarone?

• You must not use this medicine if you are allergic to dronedarone, or if you have:

· severe liver disease;

· determined 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;

· if you were hospitalized with severe heart failure within the past 30 days; or

· if you are pregnant or breast-feeding.

· heart rhythm medication;

· an antibiotic or antifungal medication;

· an antidepressant;

· medication to treat HIV or AIDS;

· medication to treat or prevent malaria;

· medication to treat a psychiatric disorder;

· migraine headache medication;

· narcotic pain medicine;

· medication to prevent or treat nausea and vomiting; or

· medication used to prevent organ transplant rejection.

• To create certain you can safely take dronedarone, speak your doctor if you have any of these another conditions:

· 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.

• FDA pregnancy category X. This medicine can harm an unborn child or reason birth defects. Do not use dronedarone if you are pregnant. Speak your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.

• It is not known whether dronedarone passes into breast milk or if it could harm a nursing child. You must not breast-feed while taking dronedarone.

How must I take dronedarone?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

• Dronedarone works excellent if you take it with your morning and evening meals.

• Use dronedarone regularly even if you feel beautiful or have no symptoms. Get your prescription refilled till you run out of medication completely.

• To be certain this medicine is not causing deleterious effects, your heart function will need to be checked each 3 months using an electrocardiograph or ECG (sometimes called an EKG). An ECG measures electrical activity of the heart. This will help your doctor determine how long to treat you with dronedarone. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

• Do not stop taking this medicine without first talking to your doctor.

• Store at room temperature away from heat and moisture.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking dronedarone?

• Grapefruit and grapefruit juice may interact with dronedarone and lead to potentially dangerous effects. Discuss the use of grapefruit commodity with your doctor.

What are the possible side effects of dronedarone?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have a serious side effect such as:

· severe dizziness, fainting, quick or pounding heartbeats;

· slow heart course, 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 foots, 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, heighten urination, leg discomfort, muscle weakness or limp feeling).

• Smaller serious side effects may include:

· mild stomach pain, diarrhea, upset stomach;

· feeling weak or weary; 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect dronedarone?

• Many drugs can interact with dronedarone and some must not be used at the same time. Below is only a partial list of these drugs. Speak your doctor if you are using:

· cyclosporine (Gengraf, Neoral, Sandimmune);

· dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

· medicine for treating tuberculosis;

· cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

· St. John's wort;

· theophylline (Elixophyllin, Theo-24, Uniphyl);

· an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);

· antifungal medicine such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), posaconazole (Noxafil), or voriconazole (Vfend);

· an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), or nefazodone;

· anti-malaria medications such as chloroquine (Aralen) or mefloquine (Lariam);

· a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

· 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 medicine such as amlodipine (Norvasc), digoxin (digitalis, Lanoxin, Lanoxicaps), diltiazem (Cardizem, Dilacor, Tiazac), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

· heart rhythm medication such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), ibutilide (Corvert), nicardipine (Cardene), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);

· medication to prevent blood clots, such as warfarin (Coumadin, Jantoven) or dabigatran (Pradaxa);

· medication to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);

· medication to treat HIV, AIDS, or hepatitis C;

· medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);

· migraine headache medication such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig);

· narcotic medicine such as methadone (Methadose, Diskets, Dolophine); or

· seizure medicine such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others.

• This list is not complete and there are much another drugs that can reason serious drug interactions with dronedarone. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor. Hold a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about dronedarone.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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