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Drug information for
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AMIODARONE (Systemic)
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Some commonly used brand names are:
In the U.S.—
Cordarone
Cordarone I.V.
In Canada—
Cordarone
Cordarone Intravenous
pms-Amiodarone
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Category
Antiarrhythmic
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Description
Amiodarone (am-ee-OH-da-rone) 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,
in the following dosage forms:
Oral
Tablets (U.S. and Canada)
Parenteral
Injection (U.S. and Canada)
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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 amiodarone, the following
should be considered:
Allergies—Tell your doctor if you have ever had any
unusual or allergic reaction to amiodarone or iodine or any
of the other ingredients in the tablet. Also tell your health
care professional if you are allergic to any other substances,
such as foods, preservatives, or dyes.
Pregnancy—Amiodarone has been shown to cause thyroid
problems in babies whose mothers took amiodarone when pregnant
and there is concern that amiodarone could cause slow heartbeat
in the newborn. In addition, amiodarone can stay in your body
for months after you have stopped taking it. However, this
medicine may be needed in serious situations that threaten
the mother's life. Be sure you have discussed this with your
doctor before taking this medicine.
Breast-feeding—Amiodarone passes into the breast milk
and has been shown to cause unwanted effects. In addition,
amiodarone can stay in your body for months after you have
stopped taking it. It may be necessary for you to stop breast-feeding
during treatment. Be sure you have discussed the risks and
benefits of the medicine with your doctor.
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.
Other 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. Tell your health care professional
if you are taking any other prescription or nonprescription
(over-the-counter [OTC]) medicines, herbal supplements including
St. John's Wort, or vitamin supplements. When you are taking
amiodarone, it is especially important that your health care
professional know if you are taking any of the following:
Anticoagulants (blood thinners) or
Other heart medicine or
Phenytoin (e.g., Dilantin)—Effects may be increased
Azoles (e.g., fluconazole [Diflucan], miconazole injection
[Monistat IV], ketoconazole [Nizoral], itraconazole [Sporanox],
voriconazole [Vfend]) or
Fluoroquinolones (ciprofloxacin [e.g., Cipro], enoxacin [e.g.,
Penetrex], grepafloxacin [e.g., Raxar], levofloxacin [e.g.,
Levaquin], lomefloxacin [e.g., Maxaquin], norfloxacin [e.g.,
Noroxin], ofloxacin [e.g., Floxin], sparfloxacin [e.g., Zagam])
or
Macrolide antibiotics (azithromycin [e.g., Zithromax], clarithromycin
[e.g., Biazin], erythromycin [e.g., Ery-Tab])—Heart problems
can result when any of these medicines are given together
with amiodarone.
Fentanyl (e.g., Duragesic)—Using this medicine together
with amiodarone may cause low blood pressure, slowed heart
rate, and other heart problems.
Simvastatin (e.g., Zocor)—May cause adverse effects with
the nervous system and muscles
Other medical problems—The presence of other medical
problems may affect the use of amiodarone. 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
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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 amiodarone 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 amiodarone. If your dose is different, do
not change it unless your doctor tells you to do so:
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, do not
take the missed dose at all and do not double the next one.
Instead, go back to your regular dosing schedule. If you miss
two or more doses in a row, check with your doctor.
Storage—To store this medicine:
Keep out of the reach of children.
Store away from heat and direct light.
Do not store in the bathroom, near the kitchen sink, or in
other damp places. Heat or moisture may cause the medicine
to break down.
Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of
children.
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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.
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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. Also, some
side effects may not appear until several weeks or months,
or even years, after you start taking amiodarone.
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
Other 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. However, check with
your doctor if any of the following side effects continue
or are bothersome:
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, your body may need time
to adjust. The length of time this takes depends on the amount
of medicine you were using and how long you used it. During
this period of time check with your doctor if you notice any
of the following side effects:
Cough; fever (slight); painful breathing; shortness of breath
Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your
doctor.
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