Cordarone - Consumer Medicine Information
|Condition:||Arrhythmia, Supraventricular Tachycardia, Ventricular Tachycardia, Ventricular Fibrillation|
|Class:||Group III antiarrhythmics|
|Ingredients:||amiodarone hydrochloride, lactose, magnesium stearate, povidone, colloidal silicon dioxide, corn starch and FD&C Red dye No. 40 Lake|
(Amiodarone Hydrochloride Tablets)
About This Medication
What the Medication is Used For
- Treatment of certain abnormal heart rhythms (arrhythmias).
What it Does
- CORDARONE has been prescribed to you by your doctor to restore or maintain a normal heart rhythm.
When it Should not Be Used
- Do not use CORDARONE if you are allergic to it or to any of the components of its formulation (see full list of components below). Contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
- Do not use CORDARONE if you have hepatitis, thyroid problems, or pulmonary disease (certain lung problems).
What the Medicinal Ingredient Is
CORDARONE is available in tablets containing 200 mg amiodarone hydrochloride as the active ingredient.
What the Nonmedicinal Ingredients Are
The nonmedicinal ingredients in CORDARONE are: lactose, magnesium stearate, povidone, colloidal silicon dioxide, corn starch and FD&C Red dye No. 40 Lake.
What Dosage Forms it Comes In
CORDARONE (Amiodarone Hydrochloride Tablets) 200 mg is available as an oral tablet.
Warnings and Precautions
Serious Warnings and Precautions
- CORDARONE is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.
- Pulmonary fibrosis (permanent scarring of the lungs) can occur and can be fatal.
- Like other antiarrhythmics, CORDARONE can worsen or start an irregular heartbeat (arrhythmias).
- Liver injury is common with CORDARONE, but is usually mild, however it can be serious and even fatal in some cases.
BEFORE you use CORDARONE talk to your doctor if:
- you have hepatitis, thyroid problems or lung abnormalities,
- you are breast feeding, pregnant or planning on becoming pregnant,
- you anticipate undergoing any surgery,
- you have any allergies to this drug or its ingredients or components of the container
- you are taking any medications (see INTERACTIONS WITH THIS MEDICATION).
Precautions When Taking Cordarone
Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted:
- CORDARONE may cause a worsening of the existing arrhythmias or precipitate a new arrhythmia.
- Both hyper- and hypothyroidism (too much or too little thyroid hormone released into the blood by the thyroid gland) may occur during, or soon after treatment with CORDARONE.
- One of the most serious complications is pulmonary (lung) toxicity, characterized by scarring or inflammation of the lungs. Clinical symptoms include cough, progressive shortness of breath, accompanied by weight loss and weakness.
- CORDARONE induces photosensitization in about 10% of patients. Sunscreen preparations or protective clothing may afford some protection to individual patients experiencing photosensitization. Blue-grey discoloration of exposed skin has been reported during long-term treatment. With discontinuation of therapy, the pigmentation fades slowly over a period of up to several years. The risk may be increased in patients of fair complexion or those with excessive sun exposure, and may be related to cumulative dose and duration of therapy.
- Loss of vision or other visual disturbances such as visual halos or blurred vision.
- Symptoms of nerve damage (peripheral neuropathy) such as pain, burning, or numbness.
- Progressive skin rash, often with blisters or lesions, which may lead to severe skin reactions that are sometimes fatal.
Interactions With This Medication
You should ensure that your doctor and pharmacist know all the medicines you are taking, prescription, non-prescription or herbal.
Drugs that may interact with CORDARONE include:
Azoles, Cholestyramine, Beta blockers (e.g., propranolol), Calcium channel antagonists (e.g., verapamil), Cholesterol-lowering medications (e.g., simvastatin, atorvastatin), Cimetidine, Cyclosporine, Dabigatran Digitalis, Digoxin, Disopyramide, Fentanyl, Flecainide, Fluoroquinolones, Lidocaine, Macrolide Antibiotics, Phenytoin Procainamide, Protease inhibitors (e.g., indinavir) Quinidine, Warfarin
Grapefruit Juice and the herbal preparation St. John's Wort may also interact with CORDARONE.
Proper Use of This Medication
Usual Adult Dose
- It is very important that you take CORDARONE exactly as your doctor has instructed.
- Never increase or decrease the amount of CORDARONE you are taking unless your doctor tells you to.
- Loading Dose: normally 800 to 1600 mg/day for 1 to 3 weeks (occasionally longer). Maintenance Dose: normally 600 to 800 mg/day for one month and then 200 to 400 mg/day (occasionally 600 mg/day).
- CORDARONE may be taken as a single daily dose, or in patients with severe gastrointestinal intolerance, as a twice a day dose.
What to Do in Case of Overdose
Contact a health care practitioner, the nearest hospital emergency department or the regional Poison Control Centre immediately, even though you may not feel sick.
If you happen to miss a dose, do not try to make up for it by doubling up on the dose next time. Just take your next regularly scheduled dose and try not to miss any more.
Side Effects and What to Do About Them
- You may experience side effects with the use of CORDARONE.
North American experience with chronic oral CORDARONE therapy suggest that amiodaroneassociated adverse drug reactions are very common, having occurred in approximately 75% of patients taking 400 mg or more per day. The most serious adverse effects associated with the use of CORDARONE involve your lungs, irregularities of your heart beat and hepatitis. Symptoms that suggest side effects relating to lung inflammation or scarring include: progressive shortness of breath, cough, weakness and weight loss. Symptoms that may suggest an irregularity of heart beat include: fainting, dizziness, light-headedness, weakness and chest pain.
Your doctor should monitor your blood for liver function. The following symptoms may be signs of liver problems: prolonged nausea and vomiting, abdominal pain or discolouration of the skin.
Other symptoms causing discontinuations less often have included disturbances of vision, reactions of the skin to sunlight, blue skin discoloration, lifethreatening or even fatal skin reactions, eczema, hyperthyroidism and hypothyroidism. Hypotension (low blood pressure), while seen, is uncommon (less than 1%) during CORDARONE Tablets therapy.
Chronic (i.e., long-term) administration of CORDARONE Tablets in rare instances may lead to the development of nerve damage (peripheral neuropathy) that may resolve when CORDARONE is discontinued, but this resolution has been slow and incomplete (see Precautions when taking CORDARONE).
Should you experience any of these while taking CORDARONE, consult your doctor immediately.
Serious Side Effects how Often They Happen and What to Do About Them
|Symptom / effect||Talk with|
In all cases
drug and call
movements, lack of
coordination, abnormal gait,
|Blue skin discolouration||Т|
|Severe skin reactions (e.g.|
progressive skin rash with
blisters) or allergic reaction
(e.g. swelling of the lips, face,
tongue and throat, trouble
|Low blood pressure (fainting|
episodes, severe dizziness
|Shortness of breath, chest pain,|
irregular heart beat, racing
(excessive bruising, easy
bleeding (e.g., when brushing
|Visual disturbances (halos or|
blurred vision), visual
|Vomiting, abdominal pain,|
photosensitivity (skin becomes
sensitive to light)
|Paresthesias (sensation of|
tingling, burning, crawling of
the skin) and Peripheral motor
and sensory neuropathies (e.g.,
|Cognitive disturbances (e.g.,|
confusion, inability to
|Liver problems (e.g., yellowing|
skin or eyes, abdominal pain or
|Alopecia (loss of hair)||Т|
This is not a complete list of side effects. For any unexpected effects while taking CORDARONE, contact your doctor or pharmacist.
How to Store It
- Keep bottle tightly closed.
- Store at 15° to 30°C.
- Protect from light.
- Keep out of reach of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effect, please contact your health care professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor,
Pfizer Canada Inc.
17 300 Trans-Canada Highway
toll-free, at: 1-800-463-6001
or at or at http://www.pfizer.ca.