Pronunciation:

a-MEE-oh-da-rone

Brand Names:

• Cordarone
• Cordarone IV
• Pacerone

Dosage Forms:

• Tablet
• Solution

Warnings:

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 .

Classifications:

Therapeutic—

Antiarrhythmic, Group III

Chemical—

Benzofuran

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

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.

Other 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
• Grepafloxacin
• Indinavir
• Levomethadyl
• Mesoridazine
• Nelfinavir
• Pimozide
• Ranolazine
• Ritonavir
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tipranavir
• Ziprasidone

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

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:

• Heartbeat problems—Amiodarone may make these problems worse.

• Hepatitis, acute—Risk of adverse effects is increased.
• Liver disease—Effects of amiodarone may be increased because of slower removal from the body

• Lung problems—Unwanted effects of amiodarone on the lungs may be worse

• Thyroid problems—Risk of overactive or underactive thyroid is increased

Proper Use of This Medicine:

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 This Medicine:

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.

Side Effects of This Medicine:

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.