Drug-labels.com

Amiodarone Hydrochloride Injection (Mylan Pharmaceuticals, PM 00038314): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Pre Market
Strength:
50 mg
Active ingredient:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Amiodarone Hydrochloride Injection (Mylan Pharmaceuticals, PM 00038314)

ABOUT THIS MEDICATION

What the medication is used for:

Treatment of certain abnormal heart rhythms (arrhythmias).

What it does:

Amiodarone Hydrochloride 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 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 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 Injection 50 mg/mL is available in ampoules.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

  • Amiodarone Hydrochloride 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 Injection can worsen or start an irregular heartbeat (arrhythmias).
  • Liver injury is common with Amiodarone Hydrochloride
  • Injection, but is usually mild, however it can be serious and even fatal in some cases.

BEFORE you use Amiodarone Hydrochloride 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 are taking any medications (see INTERACTIONS WITH THIS MEDICATION).

Precautions when taking Amiodarone Hydrochloride Injection:

Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted:

  • Amiodarone Hydrochloride 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 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 Injection 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 Injection 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, Sofosbuvir (alone or in combination with other antiviral drugs to treat Hepatitis C such as daclatasvir, simeprevir, ledipasvir), Warfarin.

Grapefruit Juice and the herbal preparation St. John’s Wort may also interact with Amiodarone Hydrochloride Injection.

PROPER USE OF THIS MEDICATION

Amiodarone Hydrochloride Injection will be administered by a healthcare professional.

Usual dose:

The recommended starting dose of Amiodarone Hydrochloride 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

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 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 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 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

In all cases

Stop taking drug and seek immediate emergency medical attention
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✓
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 seek immediate emergency medical attention
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 Injection, contact your doctor or pharmacist.

TORE IT

HOW TO STORE IT

Amiodarone Hydrochloride Injection, 50 mg/mL: Store between 15 and 30°C. Protect from light and excessive heat. Single use ampoules. Discard unused portion.

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 (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 1908C Ottawa, ON

      K1A 0K9

      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.

MOR

MORE INFORMATION

E INFORMATION

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Etobicoke, Ontario M8Z 2S6

Last Revised: March 1, 2017

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-800-575-1379

www.mylan.ca

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02387700

Revision date stated in the text: March 1, 2017

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Amiodarone Hydrochloride Injection (Mylan Pharmaceuticals, PM 00038314)

Rx or OTC
Prescription (Rx)?
DIN 02387700
Schedule(s) PRESCRIPTION
Active ingredient(s) Amiodarone hydrochloride 50 MG
Dosage form(s) Solution
Route(s) of administration Intravenous
Drug class (WHO ATC)
  1. C Cardiovascular system drugs
    1. C01 Cardiac therapy drugs
      1. C01B Antiarrhythmics, class I and III
        1. C01BD Antiarrhythmics, class III
          1. C01BD01 Amiodarone
Company MYLAN PHARMACEUTICALS ULC
Current status Cancelled Pre Market
Current status date February 24, 2022

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.