Patient Medication Information: uses, side effects, how to take - Amiodarone Hydrochloride for Injection (Pfizer Canada)
ABOUT THIS MEDICATION
What the medication is used for:
- 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 medicinal ingredient is:
Amiodarone hydrochloride.
What the nonmedicinal ingredients are:
Benzyl alcohol, polysorbate 80 and water for injection.
What dosage forms it comes in:
Amiodarone Hydrochloride for Injection, 50 mg/mL is available as a sterile solution for intravenous infusion.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
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BEFORE you use Amiodarone, 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 below).
Precautions when Amiodarone Hydrochloride for Injection is administered
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 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 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 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 amiodarone 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 |
| Sofosbuvir (alone or in combination with other antiviral drugs to treat Hepatitis C such as daclatasvir, simeprevir, ledipasvir) | |
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.
Usual Adult Dose:
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.
Overdose:
What to do in case of overdose
| If you think you have taken too much Amiodarone Hydrochloride for Injection, contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
You may experience side effects with the use of Amiodarone Hydrochloride for Injection.
Local injection site reaction including swelling, pain, redness, infection and pigmentation changes may be occur with Amiodarone Hydrochloride for Injection.
North American experience with chronic oral amiodarone hydrochloride therapy suggests that amiodarone associated 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 amiodarone hydrochloride 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 discoloration of the skin.
Other symptoms causing discontinuations less often have included disturbances of vision, reactions of the skin to sunlight, blue skin discoloration, life-threatening or even fatal skin reactions, eczema, hyperthyroidism and hypothyroidism. Hypotension (low blood pressure), is the most common adverse event seen with Intravenous Amiodarone therapy.
Should you experience any of these when Amiodarone Hydrochloride for Injection is administered, 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 in all cases | Immediately call your doctor or pharmacist | ||
| Tremor/abnormal involuntary movements, lack of coordination, abnormal gait, dizziness | √ | |||
| Blue skin discoloration | √ | |||
| 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) | √ | |||
| Paresthesias (sensation of tingling, burning, crawling of the skin) and 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) | √ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / Effect | Talk with your doctor or pharmacist in all cases | Immediately call your doctor or pharmacist |
|---|---|---|
| Alopecia (loss of hair) | √ |
This is not a complete list of side effects. For any unexpected effects when Amiodarone Hydrochloride for Injection is administered, contact your doctor or pharmacist.
HOW TO STORE IT
- Store at controlled room temperature, 15°C to 30°C.
- Protect from light and excessive heat.
- Use carton to protect contents from light until use.
- Keep out of reach and sight of children.
- Single-use. Discard unused portion.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
MORE INFORMATION
This document, plus the full product monograph prepared for health professionals, can be obtained by contacting the sponsor, Pfizer Canada Inc. at 1-800-463-6001
Pfizer Canada Inc.
Kirkland, Québec
H9J 2M5