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Patient Information Sheet
Amiodarone (marketed as Cordarone)
This is a
summary of the most important information about amiodarone. For
details, talk to your healthcare professional.
FDA ALERT
– [05/2005]: Lung and Liver Damage and Worsening Heart
Problems. Amiodarone should only be used to treat adults with life
threatening irregular heartbeats, called ventricular arrhythmias,
when other treatments have not worked or have not been tolerated.
Amiodarone may cause serious side effects, including lung damage,
liver damage, and worsened irregular heartbeat. These can lead to
death. Call your healthcare professional or get medical help right
away if you feel:
-
Shortness of breath;
wheezing; or any trouble breathing;
-
Cough; chest pain; or
spitting up blood
-
Nausea or vomiting;
passing dark-colored urine; unusually tired; have yellow skin; or
stomach pain
-
Changes in your heart
beat, such as a pounding heart; very rapid or very slow heart beat
-
Faintness or
light-headedness
This information
reflects FDA’s preliminary analysis of data concerning this drug.
FDA is considering, but has not reached a final conclusion about,
this information. FDA intends to update this sheet when
additional information or analyses become available.
What Is Amiodarone?
Amiodarone is a medicine used to
treat adults with life-threatening irregular heartbeats, called
ventricular arrhythmias. Because of its serious side effects, it is
used only when other treatments have not worked or are not
tolerated.
Who Should Not Take Amiodarone?
Do not take amiodarone if you have:
- A serious condition called heart
block that can make your heart beat too slow
- Very slow heart rate
- Slow heart rate with dizziness or
light-headedness
What
Are The Risks?
- Lung and Liver Damage and
Worsening Heart Problems: See FDA Alert above.
You may have other side effects
while taking amiodarone. Amiodarone stays in your body for months,
so these side effects may continue after treatment is stopped.
- Serious vision problems:
Tell your healthcare professional if your vision blurs, you see
halos, or your eyes become light sensitive.
- Muscle problems:
You may have numbness or “pins and needles” in your arms or legs,
muscle weakness, uncontrolled movements, poor coordination, and
difficulty walking.
- Thyroid problems:
Tell your healthcare professional if you have weight loss or gain,
restlessness, body weakness, become over sensitive to heat or
cold, hair thinning, sweating, menstrual changes, or neck swelling
(goiter).
- Skin problems:
Your skin may change to a blue-gray color or you may have
increased sensitivity to the sun. Avoid exposure to the sun or
sun lamps. Use sunblock or protective clothing when out in the
sun.
- Digestion changes:
You may have nausea, vomiting, constipation, and loss of appetite.
- Pregnancy:
Amiodarone can harm your unborn baby. You should not plan to
become pregnant while taking amiodarone and for some time after
you stop taking amiodarone.
- Breast-feeding:
Amiodarone passes into your milk and can harm your baby. You
should not breast-feed while taking amiodarone and for some time
after you stop taking amiodarone.
Are
There Any Interactions With Drugs Or Foods?
Amiodarone may interact with other
medicines, causing serious side effects. Tell your healthcare
professional about the other medicines you take or plan to take,
especially:
- Antibiotics called fluoroquinolones, azoles, and macrolide
antibiotics
- Digoxin (also called Lanoxin, a drug used to treat irregular
heartbeat or heart failure)
- Other drugs to control heartbeat, such as quinidine,
procainamide (also called Procan or Procanbid), disopyramide (also
called Norpace), and phenytoin (also called Dilantin).
- Warfarin (a drug used to treat blood clots)
- Simvastatin (also called Zocor, a drug used to treat high
cholesterol
- Drugs to treat high blood pressure, called beta blockers and
calcium channel blockers
Do not drink grapefruit juice while
you are being treated with amiodarone because it affects how the
stomach absorbs amiodarone. Drinking grapefruit juice while taking
amiodarone may cause an overdose.
How Do
I Take Amiodarone?
-
Treatment should be
started in a hospital so that your condition can be monitored.
-
Your healthcare
professional will tell you to take amiodarone with or without
meals.
-
Take amiodarone
tablets the same way each time. If you miss a dose, do not take a
double dose to make up for the missed dose. Continue with your
next scheduled dose.
Cordarone FDA Approved 1985
Patient Information Sheet Revised
05/2005
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov  Back
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Amiodarone
Date created: May 2005 |
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