Patient Medication Information: uses, side effects, how to take - Levocarnitine Injection (Sola Pharmaceuticals Canada)
What the medication is used for:
LEVOCARNITINE INJECTION is used to treat carnitine deficiency, a rare disorder in which body levels of carnitine, an amino acid, is less than what is needed for the normal function of the body.
What it does:
LEVOCARNITINE INJECTION is given to supplement the normal diet with carnitine to be able to process foods, especially fats and convert them to energy to work the muscles and organs in the body properly.
When it should not be used:
Do not use LEVOCARNITINE INJECTION if you are allergic to carnitine or any of the ingredients in the product (see below).
What the medicinal ingredient is:
Levocarnitine
What the nonmedicinal ingredients are:
Hydrochloric acid and water for injection.
What dosage forms it comes in:
Solution: 1 g / 5 mL (200 mg / mL)
BEFORE you use LEVOCARNITINE INJECTION talk to your doctor or pharmacist if you:
- have kidney disease
are pregnant or could be pregnant
- are breastfeeding
- have a history of seizures
Drugs that may interact with LEVOCARNITINE INJECTION include:
- anticoagulants (acenocoumarol and warfarin)
Usual dose:
LEVOCARNITINE INJECTION is administered intravenously.
Metabolic Disorders
The recommended dose is 50 mg / kg given as a slow 2-3 minute bolus injection or by infusion. Often the initial dose is given in patients with severe metabolic crisis, followed by an equivalent dose over the following 24 hours. It should be administered every 3 or 4 hours, and never less than every 6 hours either by infusion or by intravenous injection. All subsequent daily doses are recommended to be in the range of 50 mg / kg or as therapy may require. The highest dose administered has been 300 mg / kg.
End Stage Renal Disease (ESRD) Patients on Hemodialysis The recommended dose is 20 mg / kg dry body weight as a slow 2-3 minute bolus injection into the venous return line after each dialysis session. It is recommended that therapy begin after being on hemodialysis for a period of 6 months. After 2 months of therapy, the dose may be adjusted to 5 mg / kg after each dialysis session.
Pediatrics (<18 years of age)
No dosage adjustments are required in this patient population.
LEVOCARNITINE INJECTION can be mixed in parenteral solutions of Sodium Chloride 0.9% or Lactated Ringer’s in concentrations ranging from 250 mg / 500 mL (0.5 mg / mL) to 4000 mg / 500 mL (8.0 mg / mL) and stored at room temperature (25 °C) for up to 24 hours in PVC plastic bags.
LEVOCARNITINE INJECTION should be checked visually for any floating particles and changes in colour prior to administration. Do not use if there are particles or colour changes.
Overdose:
Missed Dose:
If a dose of this medication has been missed, it should be taken as soon as possible unless it is almost time for the next dose. In this case, skip the missed dose and go back to the regular dosing schedule. Do not take 2 doses together.
Side effects include:
- vomiting, nausea, upset stomach, diarrhea, abdominal cramps
- abnormal taste
- body odour (“fishy” smell)
- headache
WARNINGS AND PRECAUTIONS
PROPER USE OF THIS MEDICATION
If you think you, or a person you are caring for, have taken too much LEVOCARNITINE 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 signs or symptoms.
INTERACTIONS WITH THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
ABOUT THIS MEDICATION
If any of these affects you severely, tell your doctor or pharmacist.
Serious side effects and what to do about them
Symptom / effect
Talk to your healthcare professional
Stop taking drug and
get immedia te
medical help
Only if severe
In all cases
Common
High Blood Pressure: headache, dizziness, vision problems, shortness of breath
✓
Abnormal Heartbeat: palpitations
✓
Decreased Platelets: bleeding or bruising, fatigue and weakness
✓
Anemia: fatigue, loss of energy, weakness, shortness of breath
✓
Bronchitis: coughing and difficulty breathing
✓
Increased levels of calcium: increased thirst, frequent urination, nausea, vomiting, constipation, bone pain, confusion and fatigue
✓
Uncommon
Allergic Reaction/ Anaphylaxis: difficulty swallowing or breathing, hives, swelling of the face, lips, tongue or throat, rash
✓
Seizure
✓
Rare
Low Blood Sugar
✓
Serious side effects and what to do about them
Symptom / effect
Talk to your healthcare professional
Stop taking drug and get immedia te medical help
Only if severe
In all cases
Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine
✓
Very Rare
Injection Site Reaction: redness, swelling, tenderness
✓
Signs of dermatitis exfoliative:
rash, redness, widespread blistering or peeling of the skin and mucosa (mouth)
✓
This is not a complete list of side effects. For any unexpected effects while taking LEVOCARNITINE INJECTION, contact your doctor or pharmacist.
LEVOCARNITINE INJECTION should be stored at room temperature (15-30°C). Avoid high temperatures or heat such as in hot weather and direct contact from the sun. Protect from freezing. Once the package has been opened and the injection is not used up, it must be disposed of.
Keep out of reach and sight 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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Call 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.
HOW TO STORE IT
If you want more information about LEVOCARNITINE INJECTION:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Consumer 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); or by calling 905-857-3132.