Pronunciation: droe NE da rone
400 mg, oval, white, imprinted with LOGO, 4142
What is the most important information I should know about dronedarone?
Dronedarone can double your risk of death if you have certain heart conditions. Call your doctor at once if you have an irregular pulse, chest tightness, wheezing, a cough with foamy mucus, swelling or rapid weight gain, or trouble breathing (especially at night).
Tell your doctor about all other medicines you start or stop using. Many drugs can interact, and some drugs should not be used together.
Dronedarone can also cause liver problems. Call your doctor if you have symptoms such as vomiting, loss of appetite, right-sided upper stomach pain, dark urine, and yellowing of your skin or eyes.
What is dronedarone?
Dronedarone is a heart rhythm medicine that helps lower your risk of needing to be hospitalized for a heart rhythm disorder called atrial fibrillation. Dronedarone is for adults who have had this disorder in the past, but now have normal heart rhythm.
Dronedarone may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking dronedarone?
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 very slow heartbeats that have caused you to faint;
- if you are pregnant or breastfeeding; or
- if you used a medicine called amiodarone and then had lung problems or liver problems.
Dronedarone can double your risk of death if you have certain heart conditions. You should not use this medicine if:
- you have severe heart failure;
- you were recently hospitalized for worsening heart failure symptoms (shortness of breath, chest tightness, night-time breathing problems, swelling, rapid weight gain); or
- you have a "permanent" atrial fibrillation that cannot be changed back to a normal rhythm (this will be determined by your doctor).
Many drugs can interact and cause dangerous effects. Some drugs should not be used together with dronedarone. Your doctor may change your treatment plan if you also use:
- other heart rhythm medicines;
- ritonavir or other antiviral medicine;
- an antibiotic such as clarithromycin or telithromycin;
- an antidepressant such as amitriptyline, clomipramine, doxepin, imipramine, nefazodone, and others;
- antifungal medicine such as itraconazole, ketoconazole, or voriconazole; or
- antipsychotic medicine such as chlorpromazine, fluphenazine, promethazine, thioridazine, and others.
Tell your doctor if you have other heart problems.
Dronedarone may harm an unborn baby. Use effective birth control 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 directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Dronedarone is usually taken with morning and evening meals.
Your heart function may need to be checked every 3 months to help determine if you still 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.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
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 dronedarone?
Grapefruit may interact with dronedarone and cause side effects. Avoid consuming grapefruit while taking dronedarone.
What are the possible side effects of dronedarone?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- dry cough, shortness of breath;
- little or no urination;
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
- heart problems --swelling, rapid weight gain, feeling short of breath;
- liver problems --loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or
- low magnesium or potassium levels --dizziness, numbness or tingling, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle cramps or limp feeling.
Common 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.
What other drugs will affect dronedarone?
Dronedarone can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.
Tell your doctor about all your current medicines. Many drugs can affect dronedarone, especially:
- St. John's wort;
- a blood thinner (warfarin, Coumadin, Jantoven);
- a diuretic or "water pill";
- medicines to treat tuberculosis;
- medicine to prevent organ transplant rejection;
- seizure medicine; or
- "statin" cholesterol medication (Lipitor, Zocor, Vytorin, and others).
This list is not complete and many other drugs may affect dronedarone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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