Details for: AMIODARONE HYDROCHLORIDE FOR INJECTION
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02242325 | AMIODARONE HYDROCHLORIDE FOR INJECTION | AMIODARONE HYDROCHLORIDE | 50 MG / ML | LIQUID | INTRAVENOUS |
Summary Reports
Summary Safety Review - PRADAXA (dabigatran) and MULTAQ (dronedarone) or CORDARONE (amiodarone) - Drug-Drug Interaction
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Treatment of certain abnormal heart rhythms (arrhythmias).
What it does
Amiodarone Hydrochloride for Injection or Amiodarone Syringe 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 or Amiodarone Syringe 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 or Amiodarone Syringe if you have hepatitis, thyroid problems, or pulmonary disease (certain lung problems).
What the medicinal ingredient is
Amiodarone hydrochloride
What the non-medicinal ingredients are
Amiodarone Hydrochloride for Injection in vials: benzyl
alcohol, polysorbate-80, sodium hydroxide and/or hydrochloric
acid and water for injection.
Amiodarone Syringe in pre-filled syringes: benzyl alcohol,
polysorbate-80 and water for injection.
What dosage form it comes in
Amiodarone Hydrochloride for Injection, 50 mg/mL, is
available in amber glass vials.
Amiodarone Syringe, 150 mg/ 3 mL, is available as pre-filled
polymer syringes.
Warnings and precautions
Serious Warnings and Precautions
- Amiodarone Hydrochloride for Injection or Amiodarone Syringe 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 or Amiodarone Syringe can worsen or start an irregular heartbeat (arrhythmias).
- Liver injury is common with Amiodarone Hydrochloride for Injection or Amiodarone Syringe, but is usually mild, however it can be serious and even fatal in some cases.
BEFORE you use Amiodarone Hydrochloride for Injection or Amiodarone Syringe 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 are taking any medications (see INTERACTIONS WITH THIS MEDICATION).
Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted:
- Amiodarone Hydrochloride for Injection or Amiodarone Syringe 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 or Amiodarone Syringe.
- 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 or Amiodarone Syringe 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 Hydrochloride
for Injection or Amiodarone Syringe include:
Azoles, Beta-blockers (e.g., propranolol), Calcium channel
antagonists (e.g., verapamil), Cholesterol-lowering medications
(e.g., simvastatin, atorvastatin), Cholestyramine, 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 Amiodarone Hydrochloride
for Injection or Amiodarone Syringe.
Proper use of this medication
Amiodarone Hydrochloride for Injection or Amiodarone Syringe will be administered by a healthcare professional.
Usual Dose
The recommended starting dose of Amiodarone Hydrochloride for Injection or Amiodarone Syringe 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
Side effects and what to do about them
You may experience side effects with the use of Amiodarone
Hydrochloride for Injection or Amiodarone Syringe.
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, life-threatening or even fatal
skin reactions, eczema, hyperthyroidism and hypothyroidism.
Should you experience any of these while taking
Amiodarone Hydrochloride for Injection or Amiodarone
Syringe, consult your doctor immediately.
| Symptom / effect | Talk with your doctor or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|
| 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) | ✔ | |
| Paresthesias (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 or Amiodarone Syringe, contact your doctor or pharmacist.
How to store
Amiodarone Hydrochloride for Injection, 50 mg/mL: Store
between 15 and 30°C. Protect from light and excessive heat.
Single use vials. Discard unused portion.
Amiodarone Syringe, 150 mg/ 3 mL: Store between 15 and
30°C. Protect from light and excessive heat.
Keep out of reach 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;
- 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 0701E
Ottawa, ON
K1A 0K9
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 found by contacting the sponsor,
Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145 Jules-Léger
Boucherville QC
J4B 7K8
Or by e-mail at:
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc.
Last revised: December 6, 2016