Cordarone

DRUG DESCRIPTION

Cordarone (amiodarone HCl) is a member of a class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams' classification) effects, available for oral administration as pink, scored tablets containing 200 mg of amiodarone hydrochloride. The inactive ingredients present are colloidal silicon dioxide, lactose, magnesium stearate, povidone, starch, and FD&C Red 40. Cordarone is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5diiodophenyl ketone hydrochloride.

The structural formula is as follows:

Cordarone® (amiodarone HCl) Structural Formula Illustration

Amiodarone HCl is a white to cream-colored crystalline powder. It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight.

What are the possible side effects of amiodarone (Cordarone, Pacerone)?

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

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

  • a new or a worsening irregular heartbeat pattern;
  • fast, slow, or pounding heartbeats;
  • feeling like you might pass out;
  • wheezing, cough, chest pain, trouble breathing, coughing up...

Read All Potential Side Effects and See Pictures of Cordarone »

What are the precautions when taking amiodarone hcl tablets (Cordarone)?

Before taking amiodarone, tell your doctor or pharmacist if you are allergic to it; or to iodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung disease, thyroid problems.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when...

Read All Potential Precautions of Cordarone »


Cordarone Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, constipation, loss of appetite, shaking, or tiredness may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, loss of coordination, tingling/numbness of the hands or feet, uncontrolled movements, new or worsening symptoms of heart failure (such as ankle/leg swelling, increased tiredness, increased shortness of breath when lying down).

Seek immediate medical attention if any of these rare but serious side effects occur: faster/slower/more irregular heartbeat, severe dizziness, fainting.

Amiodarone may infrequently cause thyroid problems. Either low thyroid function or overactive thyroid function may occur. Tell your doctor immediately if you develop any symptoms of low or overactive thyroid, including cold or heat intolerance, unexplained weight loss/gain, thinning hair, unusual sweating, nervousness, irritability, restlessness, or lump/growth in the front of the neck (goiter).

This drug may cause your skin to be more sensitive to the sun. With long-term treatment, you may infrequently develop blue-gray color of the skin. This effect is not harmful and color may return to normal after the drug is stopped. Avoid prolonged sun exposure to help prevent this effect. (See also Precautions section.)

This drug may infrequently cause vision changes. Very rarely, cases of permanent blindness have been reported. Tell your doctor immediately if you develop any vision changes (such as seeing halos or blurred vision).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking amiodarone, tell your doctor or pharmacist if you are allergic to it; or to iodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung disease, thyroid problems.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Amiodarone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using amiodarone, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using amiodarone safely.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

Amiodarone passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug.


Cordarone Patient Information Including Side Effects

Brand Names: Cordarone, Pacerone

Generic Name: amiodarone (oral) (Pronunciation: A mi OH da rone)

  • What is amiodarone (Cordarone)?
  • What are the possible side effects of amiodarone (Cordarone)?
  • What is the most important information I should know about amiodarone (Cordarone)?
  • What should I discuss with my healthcare provider before taking amiodarone (Cordarone)?
  • How should I take amiodarone (Cordarone)?
  • What happens if I miss a dose (Cordarone)?
  • What happens if I overdose (Cordarone)?
  • What should I avoid while taking amiodarone (Cordarone)?
  • What other drugs will affect amiodarone (Cordarone)?
  • Where can I get more information?

What is amiodarone (Cordarone)?

Amiodarone is an antiarrhythmic medication that affects the rhythm of heartbeats.

Amiodarone 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 may also be used for other purposes not listed in this medication guide.

What are the possible side effects of amiodarone (Cordarone)?

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

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

  • a new or a worsening irregular heartbeat pattern;
  • fast, slow, or pounding heartbeats;
  • feeling like you might pass out;
  • wheezing, cough, chest pain, trouble breathing, coughing up blood;
  • blurred vision, vision loss, headache or pain behind your eyes, sometimes with vomiting;
  • feeling short of breath, even with mild exertion, swelling, rapid weight gain;
  • weight loss, thinning hair, feeling too hot or too cold, increased sweating, irregular menstrual periods, swelling in your neck (goiter);
  • numbness, burning, pain, or tingling in your hands or feet; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • feeling dizzy or tired;
  • nausea, vomiting, stomach pain, constipation, loss of appetite;
  • sleep problems (insomnia);
  • weakness, lack of coordination; or
  • warmth, tingling, or redness under your skin.

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.

What is the most important information I should know about amiodarone (Cordarone)?

Amiodarone is for use only in life-threatening situations. This medication has the potential to cause side effects that could be fatal, and you will receive your first few doses in a hospital setting.

Do not use this medication if you are allergic to amiodarone or iodine, or if you have certain heart conditions such as "AV block," or a history of slow heart beats.

Do not use amiodarone without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your thyroid and liver function may also need to be tested, and you may need eye exams and chest x-rays. Do not miss any scheduled appointments.

You may continue to have side effects from amiodarone after you stop taking it. It could take up to several months for the medicine to completely clear from your body.

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