Patient Medication Information: uses, side effects, how to take - Amiodarone Omega
What dosage forms it comes in:
Amiodarone Omega 50 mg/mL, is available in amber glass vials.
What the medication is used for:
Treatment of certain abnormal heart rhythms (arrhythmias).
What it does:
Amiodarone Omega 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 Omega 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 Omega if you have
hepatitis, thyroid problems, or pulmonary disease (certain lung problems).
What the medicinal ingredient is:
Amiodarone hydrochloride
What the nonmedicinal ingredients are:
Amiodarone Omega in vials: benzyl alcohol, polysorbate-80, sodium hydroxide and/or hydrochloric acid and water for injection.
BEFORE you use Amiodarone Omega 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
Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted:
- Amiodarone Omega 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 Omega.
One of the most serious complications is pulmonary
(lung) toxicity, characterized by scarring or inflammation of the lungs. Clinical symptoms include ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- Amiodarone Omega 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 Omega can worsen or start an irregular heartbeat (arrhythmias).
- Liver injury is common with Amiodarone Omega, but is usually mild, however it can be serious and even fatal in some cases.
cough, progressive shortness of breath, accompanied by weight loss and weakness.
Amiodarone Omega 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.
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 Omega 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 Omega.
Amiodarone Hydrochloride for Injection will be administered by a healthcare professional.
Usual 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
You may experience side effects with the use of Amiodarone Hydrochloride for 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 Omega, consult your doctor immediately.
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
PROPER USE OF THIS MEDICATION
INTERACTIONS WITH THIS MEDICATION
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
| In all cases | ||
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) | ✓ | |
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Omega Laboratories Limited, at:
1-800-363-0584
Or by written request at: 11 177 Hamon
Montreal, Quebec
Canada, H3M3E4
This is not a complete list of side effects. For any unexpected effects while taking Amiodarone Hydrochloride for Injection, contact your doctor or pharmacist.
Or by visiting the manufacturer’s website:
www.omegalaboratory.com
Last revised: June 4, 2018
Amiodarone Omega, 50 mg/mL: Store between 15 and 25°C. Protect from light and excessive heat.
Use carton to protect contents from light until use.
Keep out of reach of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction
Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
HOW TO STORE IT
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or |
| 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) | ✓ | |