multaq

Multaq (dronedarone) is an antiarrhythmic medication that affects the rhythm of heartbeats.

Multaq 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.

Multaq is used to treat certain heart rhythm disorders called atrial fibrillation or atrial flutter. Multaq is given to reduce the need for hospitalization due to these heart conditions.

Important information

Do not stop taking Multaq without first talking to your doctor. Stopping suddenly may make your condition worse.

You should not use Multaq if you were recently hospitalized for heart failure, or if you now have symptoms of heart failure (shortness of breath, swelling, rapid weight gain). You also should not use this medicine if you have a "permanent" heart rhythm disorder called atrial fibrillation. Multaq can double your risk of death if you have any of these heart conditions.

Multaq can harm an unborn baby or cause birth defects. Do not use dronedarone if you are pregnant.

You should not breast-feed while using this medicine.

You should not use Multaq if you have severe liver disease or certain serious heart conditions such as "AV block" or sick sinus syndrome (unless you have a pacemaker). You should not use Multaq if you have a history of very slow heart beats, or if you have ever used amiodarone and it caused you to have lung problems or liver problems.

There are many other medicines that can cause serious medical problems if you take them together with Multaq. You may need to stop taking certain drugs while you are taking Multaq. Tell your doctor about all other medicines you use.

Before taking this medicine

Multaq is used to treat intermittent or "temporary" heart rhythm disorders. In some people with "permanent" atrial fibrillation, Multaq increased the risk of stroke, hospitalization due to heart failure, and death. Multaq can double your risk of death if you have any of these heart conditions:

• if you were recently hospitalized for heart failure;

• if you now have symptoms of heart failure (shortness of breath, swelling, rapid weight gain); or

• you have a "permanent" atrial fibrillation that cannot be changed back to a normal rhythm.

You also should not use Multaq if you are allergic to dronedarone, 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;

• if you are pregnant or breast-feeding; or

• if you have ever used amiodarone and it caused you to have lung problems or liver problems.

Some medicines can cause unwanted or dangerous effects when used with Multaq. You may need to stop taking certain drugs while you are taking this medicine. Tell your doctor about all other medicines you use, especially:

• cyclosporine;

• ritonavir;

• antifungal medicine - ketoconazole, itraconazole, voriconazole;

• an antibiotic - clarithromycin, telithromycin;

• an antidepressant;

• medicine to treat a psychiatric disorder; or

• other heart rhythm medicines.

To make sure Multaq is safe for you, 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.

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not use Multaq if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether dronedarone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking Multaq.

How should I take Multaq?

Take Multaq exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Multaq works best if you take it with your morning and evening meals.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG) every 3 months. This will help your doctor determine how long to treat you with Multaq. Your liver and kidney function may also need to be checked.

Use Multaq regularly even if you feel fine or have no symptoms. Get your prescription refilled before you run out of medicine completely.

You should not stop using Multaq suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from heat and moisture.

Multaq dosing information

Usual Adult Dose for Atrial Fibrillation:

400 mg orally 2 times a day with a meal

Use: To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age greater than 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or more, or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be cardioverted.

Usual Adult Dose for Atrial Flutter:

400 mg orally 2 times a day with a meal

Use: To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age greater than 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or more, or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be cardioverted.

What happens if I miss a dose?

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Multaq?

Grapefruit and grapefruit juice may interact with dronedarone and lead to unwanted side effects. Avoid the use of grapefruit products while taking Multaq.

Multaq side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Multaq: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• chest pain, wheezing, trouble breathing, dry cough, or coughing up mucus;

• breathing problems while lying down trying to sleep;

• severe dizziness, fainting, fast or pounding heartbeats;

• slow heart rate, feeling like you might pass out;

• a new or a worsening irregular heartbeat pattern;

• signs of a kidney problem - little or no urinating, painful or difficult urination, blood in your urine, swelling in your feet or ankles, feeling tired; or

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Multaq side effects may include:

• stomach pain, indigestion, nausea, vomiting, diarrhea;

• feeling weak or tired; or

• skin rash, itching, 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.

See also: Side effects (in more detail)

What other drugs will affect Multaq?

Many drugs can interact with dronedarone nd 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:

• cyclosporine (Gengraf, Neoral, Sandimmune);

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

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

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

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

• medicine 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 medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig);

• narcotic medication such as methadone (Methadose, Diskets, Dolophine); or

• seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others.

This list is not complete and there are many other medicines that can cause serious drug interactions with Multaq. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.