Advanced Consumer Information

Cordarone

Generic Name: amiodarone (Intravenous route, Oral route)

a-mi-OH-da-rone

Oral routeTablet

Amiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.

Amiodarone hydrochloride has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 10 to 17% in some series of patients with ventricular arrhythmias given doses around 400 mg/day, and as abnormal diffusion capacity without symptoms in a much higher percentage of patients. Pulmonary toxicity has been fatal about 10% of the time. Liver injury is common with amiodarone hydrochloride, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases. Like other antiarrhythmics, amiodarone hydrochloride can exacerbate the arrhythmia, e.g., by making the arrhythmia less well tolerated or more difficult to reverse. This has occurred in 2 to 5% of patients in various series, and significant heart block or sinus bradycardia has been seen in 2 to 5%. All of these events should be manageable in the proper clinical setting in most cases. Although the frequency of such proarrhythmic events does not appear greater with amiodarone hydrochloride than with many other agents used in this population, the effects are prolonged when they occur.

Even in patients at high risk of arrhythmic death, in whom the toxicity of amiodarone hydrochloride is an acceptable risk, amiodarone hydrochloride poses major management problems that could be life-threatening in a population at risk of sudden death, so that every effort should be made to utilize alternative agents first.

The difficulty of using amiodarone hydrochloride effectively and safely itself poses a significant risk to patients. Patients with the indicated arrhythmias must be hospitalized while the loading dose of amiodarone hydrochloride is given, and a response generally requires at least one week, usually two or more. Because absorption and elimination are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment. In a retrospective survey of 192 patients with ventricular tachyarrhythmias, 84 required dose reduction and 18 required at least temporary discontinuation because of adverse effects, and several series have reported 15 to 20% overall frequencies of discontinuation due to adverse reactions. The time at which a previously controlled life-threatening arrhythmia will recur after discontinuation or dose adjustment is unpredictable, ranging from weeks to months. The patient is obviously at great risk during this time and may need prolonged hospitalization. Attempts to substitute other antiarrhythmic agents when amiodarone hydrochloride must be stopped will be made difficult by the gradually, but unpredictably, changing amiodarone body burden. A similar problem exists when amiodarone hydrochloride is not effective; it still poses the risk of an interaction with whatever subsequent treatment is tried .

Amiodarone has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis). Liver injury is common, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases. Amiodarone can exacerbate the arrhythmia, e.g., by making the arrhythmia less well tolerated or more difficult to reverse. Patients with the indicated arrhythmias must be hospitalized while the loading dose is given, and a response generally requires at least one week, usually two or more .

Commonly used brand name(s):

In the U.S.

Cordarone
Cordarone IV
Pacerone

Available Dosage Forms:

Tablet
Solution

Therapeutic Class: Antiarrhythmic, Group III

Chemical Class: Benzofuran

User Reviews & Ratings

As a treatment for...	Avg User Ratings [?]
Arrhythmia	Be the first to rate it 1 reviews
Ventricular Tachycardia	Be the first to rate it 0 reviews
Ventricular Fibrillation	Be the first to rate it 0 reviews

Compare with other drugs.

Uses For Cordarone

Amiodarone belongs to the group of medicines known as antiarrhythmics. It is used to correct life-threatening heartbeat problems called ventricular arrhythmias in adults when other treatments did not work or were not tolerated.

Amiodarone produces its helpful effects by slowing nerve impulses in the heart and acting directly on the heart tissues.

This medicine is available only with your doctor's prescription.

Before Using Cordarone

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

Amiodarone can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Geriatric

Elderly patients may be more likely to get thyroid problems with this medicine. Also, difficulty in walking and numbness, tingling, trembling, or weakness in hands or feet are more likely to occur in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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

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.

Bepridil
Cisapride
Dronedarone
Grepafloxacin
Indinavir
Levomethadyl
Mesoridazine
Nelfinavir
Pimozide
Ritonavir
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Tipranavir
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.

Acebutolol
Acecainide
Ajmaline
Alprenolol
Amiodarone
Amisulpride
Amitriptyline
Amlodipine
Amoxapine
Amprenavir
Aprindine
Arsenic Trioxide
Astemizole
Atazanavir
Atenolol
Azimilide
Azithromycin
Betaxolol
Bevantolol
Bisoprolol
Bretylium
Bucindolol
Carteolol
Carvedilol
Celiprolol
Chloral Hydrate
Chloroquine
Chlorpromazine
Ciprofloxacin
Clarithromycin
Darunavir
Delavirdine
Desipramine
Dibenzepin
Digoxin
Dilevalol
Diltiazem
Disopyramide
Dofetilide
Dolasetron
Doxepin
Droperidol
Eletriptan
Enflurane
Erythromycin
Esmolol
Etravirine
Felodipine
Fentanyl
Flecainide
Fluconazole
Flunarizine
Fluoxetine
Fosamprenavir
Foscarnet
Gallopamil
Gatifloxacin
Gemifloxacin
Halofantrine
Haloperidol
Halothane
Hydroquinidine
Ibutilide
Iloperidone
Imipramine
Iohexol
Isoflurane
Isradipine
Itraconazole
Ketoconazole
Labetalol
Lacidipine
Lapatinib
Lercanidipine
Levobunolol
Levofloxacin
Lidocaine
Lidoflazine
Lopinavir
Loratadine
Lorcainide
Lovastatin
Lumefantrine
Manidipine
Mefloquine
Mepindolol
Methadone
Metipranolol
Metoprolol
Metronidazole
Mibefradil
Moxifloxacin
Nadolol
Nebivolol
Nicardipine
Nifedipine
Nilvadipine
Nimodipine
Nisoldipine
Nitrendipine
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Ondansetron
Oxprenolol
Paliperidone
Penbutolol
Pentamidine
Perhexiline
Pindolol
Pirmenol
Prajmaline
Pranidipine
Prilocaine
Probucol
Procainamide
Propafenone
Propranolol
Quetiapine
Quinidine
Ranolazine
Rifampin
Risperidone
Sematilide
Sertindole
Simvastatin
Sirolimus
Sotalol
Spiramycin
St John's Wort
Sulfamethoxazole
Sultopride
Sunitinib
Tacrolimus
Talinolol
Tedisamil
Telithromycin
Tertatolol
Tetrabenazine
Timolol
Tizanidine
Trazodone
Trimethoprim
Trimipramine
Vardenafil
Vasopressin
Verapamil
Voriconazole
Warfarin
Zolmitriptan
Zotepine

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
Acenocoumarol
Aprindine
Cholestyramine
Clonazepam
Clopidogrel
Cyclosporine
Dicumarol
Digitoxin
Flecainide
Fosphenytoin
Methotrexate
Nevirapine
Phenytoin
Procainamide
Rifapentine
Rosuvastatin
Theophylline
Tolterodine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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

Proper Use of amiodarone

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.

Take amiodarone exactly as directed by your doctor even though you may feel well. Do not take more medicine than ordered and do not miss any doses.

Oral amiodarone should not be taken with grapefruit juice or other grapefruit products because these may increase the concentrations of amiodarone in the body.

Read the medication guide for amiodarone tablets before you begin taking them and each time you get a refill. There may be new information. This does not take the place of talking with your doctor about your treatment.

Your doctor will tell you to take amiodarone tablets with or without meals. Make sure you take amiodarone tablets 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 treatment of ventricular arrhythmias:
  - Adults—At first, 800 to 1600 milligrams (mg) per day taken in divided doses. Then, 600 to 800 mg per day for one month. Then, 400 mg per day.
  - Children—Dose is based on body weight and must be determined by your doctor. The dose for the first ten days is usually 10 mg per kilogram (4.55 mg per pound) of body weight per day. Then, the dose is decreased to 5 mg per kilogram (2.27 mg per pound) of body weight per day. After several weeks, the dose is then decreased to 2.5 mg per kilogram (1.14 mg per pound) of body weight per day.
For injection dosage form:
- For treatment of ventricular arrhythmias
  - Adults—At first, the dose is 150 mg injected into a vein for ten minutes, followed by a dose of 360 mg injected into a vein for six hours, followed by a dose of 540 mg injected into a vein for eighteen hours. After the first twenty-four hours of therapy, the dose is 720 mg injected into a vein every twenty-four hours; this dose may be continued for as long as three weeks.
  - Children—Use is not recommended.

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.

Precautions While Using Cordarone

It is important that your doctor check your progress at regular visits to make sure the medicine is working properly. This will allow for changes to be made in the amount of medicine you are taking, if necessary.

It is important that you have regular eye exams before and during treatment with this medicine.

Your doctor may want you to carry a medical identification card or bracelet stating that you are taking this medicine.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Amiodarone increases the sensitivity of your skin to sunlight; too much exposure could cause a serious sunburn. Your skin may continue to be sensitive to sunlight for several months after treatment with this medicine is stopped. A sunburn can occur even through window glass or thin cotton clothing. If you must go out in the sunlight, cover your skin and wear a wide-brimmed hat. A product applied to the skin to prevent sunburn should also be used. In case of a severe sunburn, check with your doctor.

After you have taken this medicine for a long time, it may cause a blue-gray color to appear on your skin, especially in areas exposed to the sun, such as your face, neck, and arms. This color will usually fade after treatment with amiodarone has ended, although it may take several months. However, check with your doctor if this effect occurs.

Check with your doctor if you notice any changes in your vision, such as a decrease in peripheral vision or in the clarity of the objects that you see, blurred vision, see halos, or your eyes become sensitive to light.

Cordarone 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:

More common

Cough
painful breathing
shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Dizziness, lightheadedness, or fainting
fever (slight)
numbness or tingling in fingers or toes
sensitivity of skin to sunlight
trembling or shaking of hands
trouble in walking
unusual and uncontrolled movements of the body
weakness of arms or legs

Less common

Blue-gray coloring of skin on 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 scrotum
sensitivity of eyes to light
sensitivity to heat
slow heartbeat
sweating
swelling of feet or lower legs
trouble in sleeping
unusual tiredness
weight gain or loss

Rare

Skin rash
yellow eyes or skin

Frequency not determined

Abdominal or stomach pain
agitation
back, leg, or stomach pains
bleeding gums
blistering, peeling, loosening of skin
bloating
blood in 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
hallucinations
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 face, eyelids, lips, tongue, throat, hands, legs, feet, 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 abdomen, groin, or scrotum
pain or burning with urination
pains in stomach, side, or abdomen, possibly radiating to the back
pale skin
pinpoint red spots on skin
rapid weight gain
rash
red irritated eyes
red skin lesions, often with a purple center
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 lips or in mouth; stupor
swelling of face, ankles, or hands
swelling of scrotum
swollen or painful glands
tightness in chest
troubled breathing
unpleasant breath odor
unusual bleeding or bruising
unusual excitement, nervousness, or restlessness
unusual tiredness or weakness
vomiting of blood
weakness
wheezing

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

Constipation
headache
loss of appetite
nausea and vomiting

Less common

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

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Cough
fever (slight)
painful breathing
shortness of breath

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.