Amiodarone - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||Arrhythmia, Atrial Fibrillation, Atrial Flutter, Chagas disease (Trypanosomiasis), Ventricular Tachycardia, Ventricular Fibrillation, WPW Syndrome (Wolff-Parkinson-White Syndrome)|
|Ingredients:||Amiodarone Hydrochloride, Benzyl Alcohol as preservative, Polysorbate 80 and Water for Injection|
About This Medication
What the Medication is Used For
Amiodarone Hydrochloride for Injection is used for the treatment of certain abnormal heart rhythms (arrhythmias).
What it Does
Amiodarone Hydrochloride for Injection 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 Amiodarone Hydrochloride for Injection 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 Amiodarone Hydrochloride for Injection if you have hepatitis, thyroid problems, or pulmonary disease (certain lung problems)
What the Medical Ingredient Is
What the Non-medicinal Ingredients Are
Benzyl Alcohol as preservative, Polysorbate 80 and Water for Injection
What Dosage Forms it Comes In
Solution for Injection
Vial stoppers do not contain latex.
Warning and Precautions
Serious Warnings and Precautions
- Amiodarone Hydrochloride for Injection 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, Amiodarone Hydrochloride for Injection can worsen or start an irregular heartbeat (arrhythmias).
- Liver injury is common with amiodarone, but is usually mild, however it can be serious and even fatal in some cases.
Before using Amiodarone Hydrochloride for Injection, talk to your doctor or pharmacist 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 anticipate undergoing any surgery
- You are taking any medications (see INTERACTIONS WITH THIS MEDICATION).
Precautions when taking Amiodarone Hydrochloride for Injection
Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted:
- Amiodarone Hydrochloride for Injection may cause a worsening of the existing arrhythmia 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 Amiodarone Hydrochloride for Injection.
- 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.
- Amiodarone Hydrochloride for Injection induces photosensitization in about 10% of patients. Sunscreen preparations or protective clothing may afford some protection to individual patients experiencing photosensitization. Blue-grey discolouration 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.
There have been reports of fatal “gasping syndrome” in babies less than one month old after receiving intravenous solutions containing the preservative benzyl alcohol.
Intravenous amiodarone has been found to leach out plasticizers (DEHP) from intravenous tubing which may adversely affect male reproductive tract development in the fetus, infant, and toddler if the exposure is several times higher than in adults.
Interaction 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 Amiodarone Hydrochloride for Injection include:
Other antiarrhythmic drugs
Beta blockers (e.g., propranolol),
Calcium channel antagonists (e.g., verapamil),
Cholesterol-lowering medications (e.g.,
Protease inhibitors (e.g., indinavir)
Grapefruit juice and the herbal preparation St. John’s Wort may also interact with Amiodarone Hydrochloride for Injection.
Proper Use of This Medication
Amiodarone Hydrochloride for Injection Will be Administered by a Healthcare Professional.
The recommended starting dose of Amiodarone Hydrochloride for Injection is about 1000 mg over the first 24 hours of therapy. Your physician will begin the infusion with a high dose (15 mg/min) and will then reduce the dosage (1 mg/min) over the next 6 hours. After that, the dose will be further reduced (0.5 mg/min) and may be maintained, as needed, for no more than a few weeks (2 to 3 weeks). Your physician will monitor your condition and adjust your dosage as necessary. Once your heartbeat has returned to normal, your physician may switch you to an oral version of this drug.
|In case of drug 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.|
Side Effects and What to Do About Them
You may experience side effects with the use of Amiodarone Hydrochloride for Injection.
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 discoloration of the skin.
Other symptoms causing discontinuation less often have included disturbances of vision, reactions of the skin to sunlight, blue skin discolouration, life-threatening or even fatal skin reactions, eczema, hyperthyroidism and hypothyroidism.
Should you experience any of these while taking Amiodarone Hydrochloride for Injection, consult your doctor immediately.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|In all cases|
|Tremor/abnormal involuntary movements, lack of coordination, abnormal gait, dizziness||✓|
|Blue skin discolouration||✓|
|Severe skin reactions (e.g., progressive skin rash with blisters) or allergic reaction (e.g., swelling of the lips, face, tongue and throat, trouble breathing)||✓|
|Low blood pressure (fainting episodes, severe dizziness)||✓|
|shortness of breath, chest pain, irregular heartbeat, racing heart,||✓|
|Bleeding abnormalities (excessive bruising, easy bleeding, (e.g., when brushing teeth)||✓|
|Visual disturbances (halos or blurred vision), visual impairment||✓|
|Vomiting, abdominal pain, diarrhea||✓|
|Solar dermatitis/ photosensitivity (skin becomes sensitive to light)||✓|
|Parathesias (sensation of tingling, burning, crawling of the skin)||✓|
|Peripheral motor and sensory neuropathies (e.g., muscular weakness)||✓|
|Cognitive disturbances (e.g., confusion, inability to concentrate)||✓|
|Liver problems (e.g., yellowing skin or eyes, abdominal pain or vomiting)||✓|
|Alopecia (loss of hair)||✓|
This is not a complete list of side effects. For any unexpected effects while taking Amiodarone Hydrochloride for Injection, contact your doctor or pharmacist.
How to Store It
Store between 15 °C and 25 °C and protect from light and excessive heat. Use carton to protect contents from light until use.
The 3 mL and 9 mL fill sizes are multiple-dose vials. Discard unused portion 28 days after initial puncture.
Keep out of reach and sight of children.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
NOTE:Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at 1-877-821-7724.