Description
Dronedarone is used to lower the chance of hospitalization for atrial fibrillation (heart rhythm problems) in patients who currently have a normal heart rhythm and have had certain types of atrial fibrillation (paroxysmal or persistent) in the past. Dronedarone belongs to the group of medicines known as antiarrhythmics. It works directly on the heart tissue and will slow the nerve impulses in the heart. This helps keep the heart rhythm normal.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of dronedarone in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dronedarone in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Bepridil
- Boceprevir
- Buprenorphine
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Cisapride
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Cobicistat
- Colchicine
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Cyclosporine
- Dabrafenib
- Darunavir
- Dasatinib
- Degarelix
- Delamanid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acalabrutinib
- Acebutolol
- Acecainide
- Adagrasib
- Afatinib
- Alfentanil
- Alprazolam
- Apalutamide
- Apixaban
- Aprepitant
- Asciminib
- Atenolol
- Avacopan
- Avapritinib
- Azathioprine
- Azimilide
- Belzutifan
- Benzhydrocodone
- Berotralstat
- Betaxolol
- Betrixaban
- Bisoprolol
- Bosentan
- Bosutinib
- Bretylium
- Brexpiprazole
- Brigatinib
- Budesonide
- Capivasertib
- Carbamazepine
- Cariprazine
- Carteolol
- Carvedilol
- Celiprolol
- Chloral Hydrate
- Cilostazol
- Cobimetinib
- Codeine
- Dabigatran Etexilate
- Daridorexant
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amlodipine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- AV block (type of abnormal heart rhythm), without pacemaker or
- Bradycardia (slow heartbeat) or
- Heart failure, recent or history of or
- Heart rhythm problems (eg, prolonged QT or PR interval) or
- Liver disease, severe or
- Lung disease caused by amiodarone (Cordarone®) or
- Permanent atrial fibrillation (type of abnormal heart rhythm) or
- Sick sinus syndrome (type of abnormal heart rhythm), without pacemaker—Should not be used in patients with these conditions.
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Lung disease (eg, interstitial lung disease)—Use with caution. May make these conditions worse.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Take this medicine with food.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For heart rhythm problems:
- Adults—400 milligrams (mg) 2 times a day taken in the morning and evening.
- Children—Use and dose must be determined by your doctor.
- For heart rhythm problems:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment and for 5 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use this medicine if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), ritonavir (Norvir®), medicine for depression (eg, nefazodone, Serzone®), medicine for heart rhythm problems (eg, amiodarone, disopyramide, dofetilide, flecainide, propafenone, quinidine, sotalol, Cardioquin®, Cordarone®, Norpace®, Tikosyn®), medicine for infections (eg, clarithromycin, erythromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Ery-tab®, Ketek®, Klaricid®, Nizoral®, Sporanox®, Vfend®), or a phenothiazine medicine (eg, chlorpromazine, prochlorperazine, promethazine, thioridazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, Trilafon®). Using these medicines together may cause serious side effects.
Check with your doctor right away if you have chest pain, swelling of your hands, ankles, or feet, trouble breathing, or weight gain. These may be symptoms of heart failure.
This medicine can cause changes in your heart rhythm, including QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have fast, pounding, or irregular heartbeats.
Check with your doctor right away if you have upper stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause lung problems (eg, interstitial lung disease, pneumonitis, and pulmonary fibrosis). Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.
Hypokalemia (low potassium in the blood) or hypomagnesemia (low magnesium in the blood) can occur with this medicine. Check with your doctor right away if you have decreased urine, drowsiness, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain, cramps, spasms or twitching, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, trembling, trouble breathing, or unusual tiredness or weakness.
This medicine may increase the risk for heart attack, stroke, or other serious side effects. Talk to your doctor about whether you should continue to take this medicine.
Do not stop taking this medicine without first checking with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Chest pain or discomfort
- lightheadedness, dizziness, or fainting
- slow or irregular heartbeat
- trouble breathing
- unusual tiredness
Incidence not known
- Chills
- cough
- dark urine
- fever
- general feeling of discomfort or illness
- loss of appetite
- nausea or vomiting
- stomach pain
- thickening of bronchial secretions
- unusual tiredness or weakness
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- lack or loss of strength
Less common
- Acid or sour stomach
- belching
- blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, or scaly skin
- heartburn
- indigestion
- itching skin
- rash
- redness or discoloration of the skin
- skin rash, encrusted, scaly, and oozing
- skin rash, hives, itching, or redness
- stomach discomfort, upset, or pain
- swelling
Rare
- Change in taste
- increased sensitivity of the skin to sunlight
- loss of taste
- severe sunburn
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20073151
