Patient Medication Information: uses, side effects, how to take - Amiodarone Hydrochloride for Injection (Sandoz Canada)
Serious warnings and precautions
Amiodarone Hydrochloride for Injection can cause serious and potentially life-threatening side effects, including serious issues with the:
Because of these risks:
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What Amiodarone Hydrochloride for Injection is used for:
Amiodarone Hydrochloride for Injection is used in adults to treat certain life-threatening abnormal heart rhythms (arrhythmias).
How Amiodarone Hydrochloride for Injection works:
Amiodarone Hydrochloride for Injection belongs to a group of medicines known as antiarrhythmic agents. It works by blocking certain channels in the heart. This helps to restore or maintain a normal heart rhythm.
The ingredients in Amiodarone Hydrochloride for Injection are:
Medicinal ingredient(s): amiodarone hydrochloride.
Non-medicinal ingredients: benzyl alcohol, polysorbate-80, hydrochloric acid and/or sodium hydroxide, and water for injection.
Amiodarone Hydrochloride for Injection comes in the following dosage form(s):
Solution: 50 mg/mL of amiodarone hydrochloride.
Do not use Amiodarone Hydrochloride for Injection if:
- you are allergic to amiodarone hydrochloride or any of the other ingredients in Amiodarone Hydrochloride for Injection.
- you are experiencing cardiogenic shock (heart is not able to pump enough blood to the organs of the body).
you have any of the following heart problems:
- severe sinus-node dysfunction that causes bradycardia (heart’s natural pacemaker does not work properly, causing a low heart rate);
- second- or third-degree atrioventricular block (problem with the electrical signals in the heart, causing a delay or complete block in the heart's rhythm);
- episodes of bradycardia causing syncope (low heart rate episodes, causing fainting), unless a pacemaker is used to regulate the heart rate.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Amiodarone Hydrochloride for Injection. Talk about any health conditions or problems you may have, including if you:
- have or have had any other heart problems.
- are planning to get a heart transplant or are waiting to get a heart transplant.
- have an implanted defibrillator or pacemaker for your heart.
- have previously received electrical defibrillations (electrical shock that helps the heart return to a normal rhythm).
- have liver problems (e.g., hepatitis).
- have bowel problems (e.g., severe diarrhea or diarrhea for long period of time).
- are low in potassium (hypokalemia) or low in magnesium (hypomagnesemia).
- have or have had any thyroid problems.
- are elderly.
are breast-feeding or plan to breast-feed. Amiodarone Hydrochloride for Injection can pass into the breast milk.
- are pregnant or plan to become pregnant. If you become pregnant while taking Amiodarone Hydrochloride for Injection, tell your healthcare professional right away to discuss the risks for you and your baby.
Other warnings you should know about:
Testing and check-ups: Your healthcare professional will monitor and assess your health before, during, and after your treatment with Amiodarone Hydrochloride for Injection. This includes monitoring the following:
- your heart (e.g., heart rhythm, heartbeats, and its electrical system);
- your thyroid gland;
- your liver;
- your electrolyte levels (e.g., potassium, magnesium, etc.);
- your breathing and lungs; and
- your eye vision.
- Pediatrics: Amiodarone Hydrochloride for Injection contains benzyl alcohol. Serious side effects (e.g., gasping syndrome) including death have happened in newborns or infants who have received benzyl alcohol intravenously (through the veins).
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Amiodarone Hydrochloride for Injection:
- beta-blockers, medicines used to lower blood pressure (e.g., propranolol).
- cyclosporine, a medicine used to help prevent organ rejection.
- medicines used to treat depression (e.g., trazodone and St. John’s Wort).
- anticoagulants, medicines used to thin the blood or prevent blood clots (e.g., warfarin, clopidogrel, and dabigatran).
- digoxin and digitalis, medicines used to treat certain heart problems.
- medicines used to lower high cholesterol (e.g., cholestyramine, simvastatin and atorvastatin).
- antivirals, medicines used to treat Hepatitis C (e.g., sofosbuvir, daclatasvir, simeprevir, and ledipasvir).
- antiarrhythmics, medicines used to treat irregular heartbeat (e.g., procainamide, quinidine, disopyramide, and flecainide).
- protease inhibitors, medicines used to treat HIV infection (e.g., indinavir).
- phenytoin, a medicine used to prevent seizures.
- calcium channel blockers, medicines used to lower blood pressure (e.g., verapamil and diltiazem).
- cimetidine, a medicine used to treat ulcers.
- Fentanyl, a medicine used to treat pain.
- antibiotics, medicines used to treat bacterial infections (e.g., fluoroquinolones and rifampin).
- antifungals, medicines used to treat fungal infections (e.g., azoles).
- anesthetics, medicines used to prevent pain (e.g., lidocaine).
- antihistamines, medicines used to prevent and treat allergy symptoms (e.g., loratadine).
- dextromethorphan, a medicine used to relieve coughing.
- methotrexate, a medicine used to treat cancer and arthritis.
- stimulating laxative agents, medicines used to treat constipation.
How to take Amiodarone Hydrochloride for Injection:
Your healthcare professional will prepare and give you Amiodarone Hydrochloride for Injection in a hospital. You will receive Amiodarone Hydrochloride for Injection through your veins (i.e., “intravenously” or “IV”).
Usual dose:
Your healthcare professional will determine the right dose of Amiodarone Hydrochloride for Injection for you. This will depend on your age, health, if you take other medication, and how you react to Amiodarone Hydrochloride for Injection. Your healthcare professional may also adjust your dose to ensure that the lowest effective dose is prescribed.
Once your heartbeat has returned to normal, your healthcare professional may switch you to an oral version of amiodarone hydrochloride.
Overdose:
| If you think you, or a person you are caring for, have taken too much Amiodarone Hydrochloride for Injection, contact a healthcare professional, hospital emergency department, regional poison control centre, or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669), immediately, even if there are no symptoms. |
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Possible side effects from using Amiodarone Hydrochloride for Injection:
These are not all the possible side effects you may have when taking Amiodarone Hydrochloride for Injection. If you experience any side effects not listed here, tell your healthcare professional.
The side effects of Amiodarone Hydrochloride for Injection may include:
- feeling disoriented,
- erectile dysfunction,
- low sex drive,
- hallucinations,
- altered sense of smell.
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very Common | |||
| Eye problems: blurred vision, cloudy vision, visual halos, dry eyes, eye discomfort, gritty sensation in the eyes, pain in or around the eye, difficulty with colour vision, blind spots, or vision loss. | X | ||
| Common | |||
| Heart problems: fainting, dizziness, light-headedness, chest pain, shortness of breath, palpitations, racing heart, rapid or irregular heart beat, fatigue, loss of consciousness, weak pulse, or low blood pressure. | X | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, or fatigue (may occur when going from lying or sitting to standing up). | X | ||
| Kidney problems: fatigue, swelling in the legs, ankles, or feet, urinating more or less frequent, confusion, nausea, vomiting, shortness of breath, high blood pressure, low appetite, or chest pain. | X | ||
| Liver problems: abdominal discomfort and pain, feeling fullness, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, fatigue, nausea, or vomiting. | X | ||
| Lung problems: shortness of breath, shallow breathing, difficult breathing, cough, weakness, weight loss, fatigue, chest discomfort, wheezing, chest tightness, confusion, blue lips, or fever. | X | ||
| Thyroid problems: abnormal weight change, abnormally fast or slow heart rate, palpitations, increased sweating, tremors, fatigue, diarrhea, dry skin and hair, muscle weakness, constipation, enlarged thyroid, swelling at the base of the neck, difficulty swallowing, difficulty breathing, tightness in the throat, or cough. | X | ||
| Unknown | |||
| Allergic reactions: difficulty swallowing, difficulty breathing, | X | ||
| wheezing, drop in blood pressure, nausea, vomiting, hives, rash, or swelling of the face, lips, tongue, or throat. | |||
| Blood problems: easy bruising, unexplained bruising, prolonged bleeding, frequent nosebleeds, fatigue, pale skin, shortness of breath, dark urine, infections, weakness, fever, chills, weight loss, sore throat, or mouth ulcers. | X | ||
| Injection site reactions: swelling, irritation, redness, pain, infection, or peeling of the skin at the site of the injection. | X | ||
| Movement problems: tremor, abnormal involuntary movements, lack of coordination, change to the normal walking pattern, dizziness, tiredness, tingling, burning sensation, muscular weakness, or loss of sensation. | X | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heart beat, nausea, vomiting, or tenderness when touching the abdomen. | X | ||
| Severe skin reactions: increased sensitivity to sunlight, blue-grey coloured skin, rash, dry skin, itchiness, blisters, new spot on the skin, redness, blistering, peeling of the skin or inside of the lips, eyes, mouth, nasal passages or genitals, fever, chills, or body aches. | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Amiodarone Hydrochloride for Injection will be stored by your healthcare professional between 15°C and 30°C. Protected from light and excessive heat.
Keep out of reach and sight of children.
If you want more information about Amiodarone Hydrochloride for Injection:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.sandoz.ca), or by calling 1-800-361-3062.
Date of Authorization: 2025-05-13