Cordarone

Amiodarone is a prescription medication used to treat adults with life-threatening abnormal heart rhythm known medically as ventricular arrhythmia. It is used when other medications fail to work. Amiodarone belongs to a group of drugs called antiarrhythmic drugs. It affects the potassium level in the heart muscle which helps the heart resist irregular electrical signals.

This medication comes in tablet form and is taken once or twice daily.

This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of amiodarone include nausea, vomiting, and tiredness.

Cordarone is part of the drug class:

• Antiarrhythmics, class III

Oral/Injectable:

Amiodarone can cause serious side effects that can lead to death including:

• lung damage
• liver damage
• worse heartbeat problems
• thyroid problems

Call your doctor or get medical help right away if you have any symptoms such as the following:

• shortness of breath, wheezing, or any other trouble breathing; coughing, chest pain, or spitting up of blood
• nausea or vomiting; passing brown or dark-colored urine; feel more tired than usual; your skin and whites of your eyes get yellow; or have stomach pain
• heart pounding, skipping a beat, beating very fast or very slowly; feel light-headed or faint
• weakness, weight loss or weight gain, heat or cold intolerance, hair thinning, sweating, changes in your menses, swelling of your neck (goiter), nervousness, irritability, restlessness, decreased concentration, depression in the elderly, or tremor.

Because of these possible side effects, amiodarone should only be used in adults with life-threatening heartbeat problems called ventricular arrhythmias, for which other treatments did not work or were not tolerated.

Amiodarone can cause other serious side effects. See "Side Effects". If you get serious side effects during treatment with amiodarone you may need to stop amiodarone, have your dose changed, or get medical treatment. Talk with your doctor before you stop taking amiodarone.

You may still have side effects after stopping amiodarone because the medicine stays in your body months after treatment is stopped.

Tell all your healthcare providers that you take or took amiodarone. This information is very important for other medical treatments or surgeries you may have.

Do not take amiodarone if you:

• have certain heart conditions (heart block, very slow heart rate, or slow heart rate with dizziness or lightheadedness)
• have an allergy to amiodarone, iodine, or any of the other ingredients in amiodarone. 

Tell your doctor if you are pregnant or planning to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Amiodarone can harm your unborn baby. Amiodarone can stay in your body for months after treatment is stopped. Therefore, talk with your doctor before you plan to get pregnant.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of amiodarone is 800 to 1,600 mg/day for 1 to 3 weeks.

When adequate arrhythmia control is achieved, or if you have side effects, the amiodarone dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day.

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 amiodarone 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 amiodarone in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving amiodarone.

Breast Feeding

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.

Interactions with Medicines

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.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Colchicine
• Dronedarone
• Fingolimod
• Fluconazole
• Grepafloxacin
• Indinavir
• Ketoconazole
• Levomethadyl
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Ritonavir
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tipranavir
• Vernakalant
• Ziprasidone

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.

• Abiraterone
• Acecainide
• Afatinib
• Agalsidase Alfa
• Alfuzosin
• Amiodarone
• Amitriptyline
• Amlodipine
• Amprenavir
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Bedaquiline
• Betrixaban
• Bicalutamide
• Boceprevir
• Bretylium
• Buserelin
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Dasabuvir
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Deutetrabenazine
• Digoxin
• Diltiazem
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Ebastine
• Efavirenz
• Eliglustat
• Encainide
• Enflurane
• Eribulin
• Erythromycin
• Escitalopram
• Etravirine
• Famotidine
• Felbamate
• Felodipine
• Fentanyl
• Flecainide
• Flunarizine
• Fluoxetine
• Fluvoxamine
• Formoterol
• Fosamprenavir
• Foscarnet
• Fosphenytoin
• Galantamine
• Gallopamil
• Gatifloxacin
• Gemifloxacin
• Ginkgo Biloba
• Goldenseal
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indecainide
• Iohexol
• Isoflurane
• Isoniazid
• Isradipine
• Itraconazole
• Ivabradine
• Lacidipine
• Lapatinib
• Ledipasvir
• Lercanidipine
• Leuprolide
• Levofloxacin
• Lidocaine
• Lidoflazine
• Lopinavir
• Loratadine
• Lovastatin
• Lumefantrine
• Manidipine
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mexiletine
• Mibefradil
• Miconazole
• Mifepristone
• Mizolastine
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nefazodone
• Nicardipine
• Nifedipine
• Nilotinib
• Nilvadipine
• Nisoldipine
• Nitrendipine
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ombitasvir
• Ondansetron
• Ospemifene
• Oxycodone
• Paliperidone
• Panobinostat
• Papaverine
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perhexiline
• Perphenazine
• Pimavanserin
• Pipamperone
• Pitolisant
• Pixantrone
• Pranidipine
• Prilocaine
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranitidine
• Ranolazine
• Regorafenib
• Ribociclib
• Rifampin
• Risperidone
• Salmeterol
• Sematilide
• Sertindole
• Sevoflurane
• Simeprevir
• Simvastatin
• Sirolimus
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sofosbuvir
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• St John's Wort
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tedisamil
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Ticagrelor
• Tizanidine
• Tocainide
• Tolterodine
• Topotecan
• Toremifene
• Trazodone
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vasopressin
• Vemurafenib
• Venetoclax
• Venlafaxine
• Verapamil
• Vilanterol
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voriconazole
• Vorinostat
• Warfarin
• Zileuton
• Zolmitriptan
• Zotepine
• Zuclopenthixol

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.

• Abarelix
• Acebutolol
• Acenocoumarol
• Alprenolol
• Atenolol
• Atorvastatin
• Betaxolol
• Bevantolol
• Bisoprolol
• Bucindolol
• Carteolol
• Carvedilol
• Celiprolol
• Cholestyramine
• Clonazepam
• Cyclosporine
• Dicumarol
• Digitoxin
• Dilevalol
• Esmolol
• Labetalol
• Levobunolol
• Mepindolol
• Methotrexate
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nevirapine
• Oxprenolol
• Penbutolol
• Phenytoin
• Pindolol
• Propranolol
• Rifapentine
• Rosuvastatin
• Talinolol
• Tertatolol
• Theophylline
• Timolol

Interactions with Food/Tobacco/Alcohol

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 may cause an increased risk of certain side effects 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), with no pacemaker or
• Bradycardia (slow heartbeat) or
• Cardiogenic shock or
• Sick sinus syndrome (type of abnormal heart rhythm), with no pacemaker—Should not be used in patients with these conditions.

• Eye or vision problems or
• Heart disease (e.g., congestive heart failure) or
• Heart rhythm problems (e.g., QT prolongation) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hypotension (low blood pressure) or
• Lung disease or other breathing problems (e.g., interstitial pneumonitis) or
• Thyroid problems—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain amiodarone. It may not be specific to Cordarone. Please read with care.

You will receive your first dose of this medicine in a hospital. Your doctor will watch you closely after you take this medicine to make sure you do not have any serious side effects.

Take amiodarone exactly as directed by your doctor even though you may feel well. Do not take more medicine than your doctor ordered and do not miss any doses. It may take one or two weeks before your body responds to this medicine.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food, but take amiodarone the same way each time.

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 ventricular arrhythmias:
    • Adults—At first, 800 to 1600 milligrams (mg) per day taken in divided doses. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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.

• It is used to treat certain types of abnormal heartbeats.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to amiodarone, iodine, or any other part of Cordarone (amiodarone tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Heart block, shock caused by heart problems, or slow heartbeat.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Cordarone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Cordarone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Always take with food or always take on an empty stomach.
• If you take cholestyramine, talk with your pharmacist about how to take it with this medicine.
• To gain the most benefit, do not miss doses.
• Keep taking Cordarone (amiodarone tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Signs of thyroid problems like a change in weight without trying, feeling nervous and excitable, feeling restless, feeling very weak, hair thinning, low mood (depression), neck swelling, not able to focus, not able to handle heat or cold, period (menstrual) changes, shakiness, or sweating.
• Change in balance.
• Shakiness, trouble moving around, or stiffness.
• Blue or gray skin color.
• Coughing up blood.
• Chest pain or pressure.
• A burning, numbness, or tingling feeling that is not normal.
• Fast or slow heartbeat.
• A new or worse heartbeat that does not feel normal.
• Change in eyesight, eye pain, or very bad eye irritation.
• If bright lights bother your eyes.
• Not able to pass urine or change in how much urine is passed.
• Very bad dizziness or passing out.
• Trouble controlling body movements.
• Joint pain.
• Muscle pain or weakness.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Any unexplained bruising or bleeding.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Upset stomach or throwing up.
• Feeling tired or weak.
• Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to amiodarone: oral tablet

Other dosage forms:

• intravenous solution

Along with its needed effects, amiodarone (the active ingredient contained in Cordarone) 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 while taking amiodarone:

• Cough
• dizziness, lightheadedness, or fainting
• fever (slight)
• numbness or tingling in the fingers or toes
• painful breathing
• sensitivity of the skin to sunlight
• shortness of breath
• trembling or shaking of the hands
• trouble with walking
• unusual and uncontrolled movements of the body
• weakness of the arms or legs

• Blue-gray coloring of the skin on the face, neck, and arms
• blurred vision or blue-green halos seen around objects
• coldness
• dry eyes
• dry, puffy skin
• fast or irregular heartbeat
• nervousness
• pain and swelling in the scrotum
• sensitivity of the eyes to light
• sensitivity to heat
• slow heartbeat
• sweating
• swelling of the feet or lower legs
• trouble with sleeping
• unusual tiredness
• weight gain or loss

• Skin rash
• yellow eyes or skin

• Abdominal or stomach pain
• agitation
• back, leg, or stomach pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine
• bloody, black, or tarry stools
• blue lips, fingernails, or skin
• blurred or double vision
• chest pain
• chills
• clay-colored stools
• coma
• confusion
• confusion as to time, place, or person
• coughing or spitting up blood
• cracks in the skin
• dark urine
• decreased urine output
• depression
• diarrhea
• difficult or labored breathing
• difficult urination
• dry cough
• eye pain
• fast heartbeat
• fatigue
• general body swelling
• high fever
• holding false beliefs that cannot be change by fact
• hostility
• inability to have or keep an erection
• indigestion
• irregular, fast or slow, or shallow breathing
• irritability
• itching
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• loss in sexual ability, desire, drive, or performance
• loss of heat from the body
• lower back or side pain
• mood or mental change
• muscle cramps or spasms
• muscle pain or stiffness
• muscle twitching
• no breathing
• noisy breathing
• nosebleeds
• pain in the abdomen, groin, or scrotum
• pain or burning with urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• rash
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• scaly skin
• seeing, hearing, or feeling things that are not there
• seizures
• severe headache
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in mouth
• stupor
• swelling of the face, ankles, or hands
• swelling of the scrotum
• swollen or painful glands
• tightness in the chest
• troubled breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vomiting of blood
• wheezing

Some side effects of amiodarone 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:

• Constipation
• headache
• loss of appetite
• nausea and vomiting

• Bitter or metallic taste
• decrease in sexual interest
• decreased sexual ability in males
• dizziness
• flushing of the face