Dronedarone

Dronedarone

What is Dronedarone?

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

Dronedarone side effects

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Dronedarone can cause serious side effects. Call your doctor immediately if you have:

• dry cough, shortness of breath;

• little or no urination;

• fast or pounding heartbeat, fluttering in the chest, shortness of breath, and sudden dizziness (as if you might faint);

• Heart problems – swelling, rapid weight gain, shortness of breath;

• Liver problems - loss of appetite, stomach pain (top right), fatigue, itching, dark urine, jaundice (yellowing of the skin or eyes); or

• low levels of magnesium or potassium - dizziness, numbness or tingling, irregular heartbeat, fluttering in the chest, increased thirst or need to urinate, muscle cramps or feeling weak.

Common dronedarone side effects may include:

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

• feeling weak or tired; or

• 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

Dronedarone can double your risk of death if you have certain heart conditions.Call your doctor immediately if you have an irregular pulse, chest tightness, wheezing, cough with foamy mucus, swelling or rapid weight gain, or difficulty breathing (especially at night).

Tell your doctor about any other medicines you start or stop. Many medicines can interact, and some medicines should not be used together.

Dronedarone can also cause liver problems. Call your doctor if you experience symptoms such as vomiting, loss of appetite, pain in the upper right side of your abdomen, dark urine, and yellowing of your skin or eyes.

Before you take this medicine

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

• severe liver disease;

• a serious heart condition such as “sick sinus syndrome,” “AV block” (unless you have a pacemaker), or a very slow heartbeat that has caused fainting;

• if you are pregnant or breastfeeding; or

• if you have taken a medicine called amiodarone and then had lung or liver problems.

Dronedarone can double your risk of death if you have certain heart conditions.You should not use dronedarone if:

• you have severe heart failure;

• You have recently been hospitalized for worsening heart failure symptoms (shortness of breath, chest tightness, difficulty breathing at night, swelling, rapid weight gain); or

• You have “permanent” atrial fibrillation that cannot be brought back to a normal rhythm (this will be determined by your doctor).

Many medications can interact and have dangerous effects. Some medications should not be used with dronedarone. Your doctor may change your treatment plan if you also use:

• other heart rhythm medications;

• cyclosporine;

• ritonavir or another antiviral medicine;

• an antibiotic such as clarithromycin or telithromycin;

• an antidepressant such as amitriptyline, clomipramine, doxepin, imipramine, nefazodone and others;

• antifungals such as itraconazole, ketoconazole or voriconazole; or

• Antipsychotics such as chlorpromazine, fluphenazine, promethazine, thioridazine and others.

Tell your doctor if you have other heart problems.

Dronedarone can harm an unborn baby.Use effective contraception to prevent pregnancy and tell your doctor if you become pregnant.

You should not breastfeed while using dronedarone.

How should I take dronedarone?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

Dronedarone is usually taken with morning and evening meals.

Your heart function may need to be checked every three months to see if you continue to need dronedarone. Do not stop taking dronedarone without your doctor's advice.

Check your pulse often and call your doctor if you notice an irregular rhythm.

Store at room temperature, away from heat and moisture.

Dronedarone dosage information

Usual adult dose for atrial fibrillation:

400 mg orally twice daily 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 (e.g. age over 70 years, hypertension). , diabetes, previous cerebrovascular accident, left atrial diameter 50 mm or more or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or are cardioverted.

Usual dose for adults for atrial flutter:

400 mg orally twice daily 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 (e.g. age over 70 years, hypertension). , diabetes, previous cerebrovascular accident, left atrial diameter 50 mm or more or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or are cardioverted.

What happens if I miss a dose?

Skip the missed dose and take the next dose at the regular time. Do not use two doses at the same time.

What happens if I overdose?

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

What should I avoid while taking dronedarone?

Grapefruit can interact with dronedarone and cause side effects. Avoid consuming grapefruit while taking dronedarone.

What other drugs affect dronedarone?

Dronedarone can cause serious heart problems.Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria or HIV.

Tell your doctor about all medications you are currently taking. Many medications can affect dronedarone, particularly:

• digoxin;

• St. John's wort;

• a blood thinner (warfarin, Coumadin, Jantoven);

• a diuretic or “water pill”;

• medicines for treating tuberculosis;

• medicines to prevent organ transplant rejection;

• seizure medications; or

• “Statin” cholesterol drugs (Lipitor, Zocor, Vytorin and others).

This list is not exhaustive and many other medications can affect dronedarone. This includes prescription and over-the-counter medications, vitamins and herbal products. Not all possible drug interactions are listed here.

More information

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