Amiodarone affects the rhythm of your heartbeats. It is used to help keep the heart beating normally in people with life-threatening heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart).

Amiodarone is used to treat ventricular tachycardia or ventricular fibrillation.

Amiodarone is for use only in treating life-threatening heart rhythm disorders.

Amiodarone can cause dangerous side effects on your heart, liver, lungs, or vision.

You should not take this medicine if you are allergic to amiodarone or iodine, or if you have heart block, a history of slow heartbeats that have caused you to faint, or if your heart cannot pump blood properly.

Call your doctor or get medical help at once if you have: chest pain, fast or pounding heartbeats, trouble breathing, vision problems, upper stomach pain, vomiting, dark urine, jaundice (yellowing of the skin or eyes), or if you cough up blood.

Tell your doctor if you have signs of a thyroid problem, such as weight changes, extreme tiredness, dry skin, thinning hair, feeling too hot or too cold, irregular menstrual periods, or swelling in your neck (goiter).

Take amiodarone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You will receive your first few doses in a hospital setting, where your heart rhythm can be monitored.

If you have been taking another heart rhythm medicine, you may need to gradually stop taking it when you start using amiodarone. Follow your doctor's dosing instructions very carefully.

You may take the tablets with or without food, but take it the same way each time.

It may take up to 3 weeks before your heart rhythm improves. Keep using the medicine as directed even if you feel well.

Amiodarone can have long lasting effects on your body. You may need frequent medical tests while using this medicine and for several months after your last dose.

If you need surgery (including laser eye surgery), tell the surgeon ahead of time that you are using amiodarone.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Arrhythmias:

IV:
Initial dose: 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:
-Loading infusions: 150 mg over the first 10 minutes (15 mg/min), followed by 360 mg over the next 6 hours (1 mg/min)
-Maintenance infusion: 540 mg over the remaining 18 hours (0.5 mg/min)

Maintenance dose: After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min; may increase infusion rate to achieve effective arrhythmia suppression.
-Supplemental infusions: 150 mg over 10 minutes (15 mg/min) for breakthrough episodes of ventricular fibrillation (VF) or hemodynamically unstable ventricular tachycardia (VT)

Maximum dose: Initial infusion rate: 30 mg/min

Duration of therapy: Until ventricular arrhythmias stabilize (most patients require 48 to 96 hours); maintenance infusion of up to 0.5 mg/min can be continued for up to 3 weeks.

Comments: Mean daily doses greater than 2100 mg for the first 24 hours were associated with increased risk of hypotension.

Use: Initiation of treatment and prophylaxis of frequently recurring VF and hemodynamically unstable VT in patients refractory to other therapy.


ORAL:
Loading dose: 800 to 1600 mg orally per day for 1 to 3 weeks (occasionally longer) until adequate arrhythmia control is achieved or if side effects become prominent, then switch to adjustment dose
Adjustment dose: 600 to 800 mg orally per day for 1 month, then switch to maintenance dose
Maintenance dose: 400 mg orally per day

Comments:
-May be administered once a day; twice a day dosing is recommended for total daily doses of 1000 mg or more or in patients who experience gastrointestinal tolerance.
-Close monitoring is indicated during the loading phase and surrounding any dose adjustments.
-Maintenance dose should be determined according to antiarrhythmic effect as assessed by patient tolerance as well as symptoms, Holter recordings, and/or programmed electrical stimulation; some patients may require up to 600 mg/day while some can be controlled on lower doses.

Use: Treatment of life-threatening recurrent VF or life-threatening recurrent hemodynamically unstable VT in patients refractory to adequate doses of other antiarrhythmics or those intolerant of alternative agents.

You should not use amiodarone if you have:

• a serious heart condition called "AV block" (2nd or 3rd degree), unless you have a pacemaker;

• a history of slow heartbeats that have caused you to faint; or

• if your heart cannot pump blood properly.

Amiodarone can cause dangerous side effects on your heart, liver, lungs, or thyroid.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• asthma or another lung disorder;

• liver disease;

• a thyroid disorder;

• vision problems;

• high or low blood pressure;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• if you have a pacemaker or defibrillator implanted in your chest.

Taking amiodarone during pregnancy may harm an unborn baby, or cause thyroid problems or abnormal heartbeats in the baby after it is born. Amiodarone may also affect the child's growth or development (speech, movement, academic skills) later in life. Tell your doctor if you are pregnant or if you become pregnant.

You should not breast-feed while taking this medicine, and for several months after stopping. Amiodarone takes a long time to clear from your body. Talk to your doctor about the best way to feed your baby during this time.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amiodarone can be fatal.

Overdose symptoms may include weakness, slow heart rate, feeling light-headed, or loss of consciousness.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not drink grapefruit juice while you are taking this medication.

Avoid driving or hazardous activity until you know how amiodarone will affect you. Your reactions could be impaired.

Grapefruit may interact with amiodarone and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking an herbal supplement containing St. John's wort.

Amiodarone could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to amiodarone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Amiodarone takes a long time to completely clear from your body. You may continue to have side effects from this medicine after you stop using it.

Call your doctor at once if you have any of these side effects, even if they occur up to several months after you stop using this medicine:

• wheezing, cough, chest pain, cough with bloody mucus, fever;

• a new or a worsening irregular heartbeat pattern (fast, slow, or pounding heartbeats);

• a light-headed feeling, like you might pass out;

• blurred vision, seeing halos around lights (your eyes may be more sensitive to light);

• liver problems - nausea, vomiting, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);

• nerve problems - loss of coordination, muscle weakness, uncontrolled muscle movement, or a prickly feeling in your hands or lower legs;

• signs of overactive thyroid - weight loss, thinning hair, feeling hot, increased sweating, tremors, feeling nervous or irritable, irregular menstrual periods, swelling in your neck (goiter); or

• signs of underactive thyroid - weight gain, tiredness, depression, trouble concentrating, feeling cold.

Common amiodarone side effects may include:

• nausea, vomiting, loss of appetite; or

• constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Amiodarone takes a long time to completely clear from your body. Drug interactions are possible for up to several months after you stop using amiodarone. Talk to your doctor before taking any medication during this time. Keep track of how long it has been since your last dose of amiodarone.

Many drugs can interact with amiodarone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.