Patient Medication Information: uses, side effects, how to take - Carnitor
What the medication is used for:
CARNITOR® 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:
CARNITOR® 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 CARNITOR® 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:
CARNITOR® Tablet: magnesium stearate, microcrystalline cellulose and povidone
CARNITOR® Oral Solution: artificial Cherry Flavor, D,L- Malic Acid, Purified Water, Sucrose Syrup. Methylparaben NF and Propylparaben NF are added as preservatives.
CARNITOR® Injection: hydrochloric acid and/or sodium hydroxide.
What dosage forms it comes in:
CARNITOR® Tablets 330 mg
CARNITOR® Oral Solution 1 g / 10 mL (100 mg / mL)
CARNITOR® Injection 1 g / 5 mL (200 mg / mL)
BEFORE you use CARNITOR® talk to your doctor or pharmacist
Usual dose: CARNITOR® Tablets
Adult
The recommended oral dosage is 990 mg (3 tablets) 2 or 3 times a day.
Pediatrics (<18 years of age)
The recommended oral dosage for infants and children is between 50 and 100 mg / kg / day in divided doses, with a maximum of 3 g / day. Dosage should begin at 50 mg / kg / day.
CARNITOR® Oral Solution
CARNITOR® Oral Solution may be taken alone or dissolved in a drink or other liquid food. Doses should be spaced evenly throughout the day (every three or four hours) preferably during or following meals and should be consumed slowly in order to limit side effects.
Adults
The recommended oral dosage is 1 to 3 g / day for a 50 kg person, which is equivalent to 10 to 30 mL / day of CARNITOR® Oral Solution. Dosage should start at 1 g / day (10 mL / day), and be increased slowly.
Pediatrics (<18 years of age)
The recommended oral dosage for infants and children is 50 to 100 mg / kg / day which is equivalent to 0.5 mL / kg / day CARNITOR® Oral Solution. Dosage should start at
50 mg / kg / day, and be increased slowly to a maximum of
3 g / day (30 mL / day).
CARNITOR® Injection
CARNITOR® Injection is administered intravenously. Metabolic Disorders
INTERACTIONS WITH THIS MEDICATION
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
PROPER USE OF THIS MEDICATION
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.
CARNITOR® 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.
CARNITOR® 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
If any of these affects you severely, tell your doctor or pharmacist.
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
| 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 get immediat 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 | AllergicReaction/ Anaphylaxis: difficulty swallowing or breathing, hives, swelling of the face, lips, tongue or throat, rash | ✓ | ||||
| Seizure | ✓ | |||||
| Rare | Low Blood Sugar | ✓ | ||||
| Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | ✓ | |||||
| 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 get immediate medical help | ||||
| Only if severe | In all cases | |||||
| Very Rare | Injection Site Reaction: redness, swelling, tenderness | ✓ | ||||
Signs of dermatitis exfoliative: rash, rednesss, 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 CARNITOR®, contact your doctor or pharmacist.
CARNITOR® Tablets should be stored at room temperature (15-30°C). Avoid excessive high temperatures or heat such as in hot weather and direct contact from the sun. Protect from freezing. Once the foil package has been opened and the tablets are not used, they must be disposed of.
CARNITOR® Oral Solution 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. Store upright.
CARNITOR® 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.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Leadiant Biosciences, Inc. at: 1-800-447-0169.
Last revised: April 23, 2019
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REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program Health Canada
Postal Locator 1908C
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.