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Details for: AMIODARONE HYDROCHLORIDE FOR INJECTION

Company: SANDOZ CANADA INCORPORATED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02242325AMIODARONE HYDROCHLORIDE FOR INJECTIONAMIODARONE HYDROCHLORIDE50 MG / MLLIQUIDINTRAVENOUS
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Amiodarone (intravenous) - Assessing the potential risk of side effects in fetuses and newborns
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).
Precautions when taking Amiodarone Hydrochloride for Injection or Amiodarone Syringe
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

In case of drug overdose, contact a health care practitioner, 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 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.

Serious side effects, how often they happen and what to do about them
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
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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

Date modified: