Dronedarone Generic Name:
Dronedarone (DROE-NE-da-rone)Brand Name:
Dronedarone should not be used in patients with severe (class IV) heart failure. It should also not be used in patients with mild to moderate (class II or III) heart failure who have recently had worsening symptoms that required hospitalization or special treatment. The risk of death may be increased in these patients.
Dronedarone is used for:
Decreasing the risk of going to the hospital for heart problems. It is intended for use in certain patients who have had an irregular heartbeat called atrial fibrillation (AF) or atrial flutter (AFL) within the past 6 months.
Dronedarone is an antiarrhythmic. Exactly how it works is not known.
Do NOT use Dronedarone if:
- you are allergic to any ingredient in Dronedarone
- you have severe (class IV) heart failure
- you have mild to moderate (class II or III) heart failure and have recently had worsening symptoms that required hospitalization or special treatment
- you have second- or third-degree heart block or sick sinus syndrome, unless you have a pacemaker
- you have a very slow heartbeat or certain other types of irregular heartbeat
- you have severe liver problems
- you are pregnant or breast-feeding
- you take an antiarrhythmic (eg, amiodarone, flecainide, sotalol), carbamazepine, certain azole antifungals (eg, itraconazole, ketoconazole, voriconazole), certain macrolide antibiotics (eg, erythromycin, clarithromycin), certain phenothiazines (eg, thioridazine), cyclosporine, nefazodone, phenobarbital, phenytoin, rifampin, ritonavir, St. John's wort, telithromycin, or a tricyclic antidepressant (eg, amitriptyline)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Dronedarone :
Some medical conditions may interact with Dronedarone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of high blood pressure, stroke, or diabetes
- if you have a history of other heart problems (eg, heart block, heart failure, QT prolongation), electrolyte problems (eg, low blood potassium or magnesium), liver problems, or kidney problems
- if you will be having surgery, or if you have an implanted pacemaker or defibrillator
Some MEDICINES MAY INTERACT with Dronedarone . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Antiarrhythmics (eg, amiodarone, flecainide, sotalol), arsenic, certain azole antifungals (eg, ketoconazole, itraconazole, voriconazole), certain H1 antagonists (eg, astemizole, terfenadine), cimetidine, cisapride, clarithromycin, cyclosporine, certain macrolide antibiotics (eg, clarithromycin), certain phenothiazines (eg, thioridazine), diuretics (eg, furosemide, hydrochlorothiazide), dofetilide, droperidol, HIV protease inhibitors (eg, ritonavir, erythromycin), nefazodone, phosphodiesterase type 5 (PDE5) inhibitors (eg, vardenafil), pimozide, quinolones (eg, levofloxacin), serotonin receptor antagonists (eg, dolasetron), streptogramins (eg, dalfopristin, quinupristin), telithromycin, trazodone, tricyclic antidepressants (eg, amitriptyline), or ziprasidone because side effects, such as heart rhythm problems, may occur
- Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, rifampin, or St. John's wort because they may decrease Dronedarone 's effectiveness
- Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), calcium channel blockers (eg, verapamil, diltiazem), digoxin, HMG-CoA reductase inhibitors (eg, simvastatin), sirolimus, or tacrolimus because the risk of their side effects may be increased by Dronedarone
Ask your health care provider if Dronedarone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Dronedarone :
- Dronedarone comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dronedarone refilled.
- Take Dronedarone by mouth with the morning and evening meals.
- Do not eat grapefruit or drink grapefruit juice while you take Dronedarone .
- Take Dronedarone on a regular schedule to get the most benefit from it.
- Continue to take Dronedarone even if you feel well.
- If you miss a dose of Dronedarone , skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once
Ask your health care provider any questions you may have about how to use Dronedarone .
Important safety information:
- Dronedarone may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Dronedarone . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Tell your doctor or dentist that you take Dronedarone before you receive any medical or dental care, emergency care, or surgery.
- Women who may become pregnant must use an effective form of birth control while they take Dronedarone . Check with your doctor if you have questions about effective birth control.
- Dronedarone may affect certain lab tests, including kidney function tests. Be sure your doctor and lab personnel know you are taking Dronedarone .
- Lab tests, including electrocardiogram (ECG) and blood electrolyte levels, may be performed while you use Dronedarone . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Dronedarone should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Dronedarone has been shown to cause harm to the fetus. Avoid becoming pregnant while you use it. If you think you may be pregnant, contact your doctor right away. It is not known if Dronedarone is found in breast milk. Do not breast-feed while taking Dronedarone .
Possible side effects of Dronedarone :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; nausea; stomach pain; tiredness; vomiting; weakness.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; slow heartbeat; symptoms of heart failure (eg, shortness of breath, swelling of the hands or feet, sudden unexplained weight gain, wheezing); trouble sleeping because of breathing problems; worsening of irregular heartbeat.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include fainting; severe dizziness; unusually slow pulse; weakness.Proper storage of Dronedarone :
Store Dronedarone at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dronedarone out of the reach of children and away from pets.
- If you have any questions about Dronedarone , please talk with your doctor, pharmacist, or other health care provider.
- Dronedarone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Dronedarone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Dronedarone Professional Patient Advice (Wolters Kluwer)
- dronedarone Advanced Consumer (Micromedex) - Includes Dosage Information
- Multaq Prescribing Information (FDA)
- Multaq Consumer Overview