Multaq

DRUG DESCRIPTION

Dronedarone HC1 is a benzofuran derivative with the following chemical name: N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride.

Dronedarone HC1 is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol.

Its empirical formula is C31H44N2O5S, with a relative molecular mass of 593.2. Its structural formula is:

MULTAQ
  (dronedarone) Structural Formula Illustration

MULTAQ (dronedarone tablets) is provided as tablets for oral administration.

Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base).

The inactive ingredients are:

Core of the tablets- hypromellose, starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal silicon dioxide, magnesium stearate.

Coating/polishing of the tablets- hypromellose, polyethylene glycol 6000, titanium dioxide, carnauba wax.

What are the possible side effects of dronedarone (Multaq)?

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.

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,...

Read All Potential Side Effects and See Pictures of Multaq

What are the precautions when taking dronedarone tablets (Multaq)?

See also Warning section.

Before taking dronedarone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, certain types of irregular heartbeat (sick sinus syndrome, second- or third-degree atrioventricular block).

Dronedarone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical...

Read All Potential Precautions of Multaq


Multaq Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea or diarrhea may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: symptoms of liver disease (such as dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin).

Seek immediate medical attention if any of these rare but serious side effects occur: unusually fast/slow/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking dronedarone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, certain types of irregular heartbeat (sick sinus syndrome, second- or third-degree atrioventricular block).

Dronedarone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using dronedarone, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dronedarone safely.

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Multaq Patient Information Including Side Effects

Brand Names: Multaq

Generic Name: dronedarone (Pronunciation: droe NE da rone)

  • What is dronedarone (Multaq)?
  • What are the possible side effects of dronedarone (Multaq)?
  • What is the most important information I should know about dronedarone (Multaq)?
  • What should I discuss with my healthcare provider before taking dronedarone (Multaq)?
  • How should I take dronedarone (Multaq)?
  • What happens if I miss a dose (Multaq)?
  • What happens if I overdose (Multaq)?
  • What should I avoid while taking dronedarone (Multaq)?
  • What other drugs will affect dronedarone (Multaq)?
  • Where can I get more information?

What is dronedarone (Multaq)?

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 other purposes not listed in this medication guide.

What are the possible side effects of dronedarone (Multaq)?

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.

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 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 is the most important information I should know about dronedarone (Multaq)?

You should not use this medication 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 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 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 dronedarone if you are pregnant. Use effective birth control, and tell your doctor right away if you become pregnant during treatment.

To be sure this medication 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.

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