Multaq

Generic Name: dronedarone (droe NE da role)

What is 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.

Multaq may also be used for other purposes not listed in this medication guide.

Important information about Multaq

You 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 were recently hospitalized for heart failure, or if you are pregnant or breast-feeding. 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 medications you use.

Also tell your doctor if you have 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.

This medication can harm an unborn baby or cause birth defects. Do not use Multaq if you are pregnant. Use effective birth control, and tell your doctor right away if you become pregnant during treatment.

To be sure Multaq is not causing harmful effects, your blood and heart rhythm may need to be tested on a regular basis. Do not miss any scheduled appointments.

Before taking Multaq

You should not use Multaq if you are allergic to dronedarone, or if you have:

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

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 medications you use, especially:

heart rhythm medication;

an antibiotic or antifungal medication;

an antidepressant;

medicine to treat HIV or AIDS;

medicine to treat or prevent malaria;

medicine to treat a psychiatric disorder;

migraine headache medication;

narcotic pain medicine;

medicine to prevent or treat nausea and vomiting; or

medicine used to prevent organ transplant rejection.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Multaq:

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. Multaq can harm an unborn baby or cause birth defects. Do not use this medicine if you are pregnant. Tell 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 baby. Do not use Multaq if you are breast-feeding a baby.

How should I take Multaq?

Take Multaq exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water. Multaq works best if you take it with your morning and evening meals.

It is important to use Multaq regularly to get the most benefit. Keep using this medication even if you feel fine or have no symptoms. Get your prescription refilled before you run out of medicine completely.

To be sure Multaq is not causing harmful effects, your blood and heart rhythm will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Store Multaq at room temperature away from heat and moisture.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include weakness, slow heart rate, feeling light-headed, or fainting.

What should I avoid while taking Multaq?

Grapefruit and grapefruit juice may interact with Multaq and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Multaq side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Multaq: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

slow heart rate, fast or pounding heartbeats, 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;

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 Multaq side effects may include:

nausea, vomiting, stomach pain, diarrhea, upset stomach;

feeling weak or tired; or

mild skin rash, redness, or itching

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 Multaq?

Many drugs can interact with Multaq 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);

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, 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.