Details for: CARNITOR
Company: LEADIANT BIOSCIENCES, INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02144336 | CARNITOR | LEVOCARNITINE | 100 MG / ML | SOLUTION | ORAL |
| 02144344 | CARNITOR | LEVOCARNITINE | 200 MG / ML | SOLUTION | INTRAVENOUS |
| 02144328 | CARNITOR | LEVOCARNITINE | 330 MG | TABLET | ORAL |
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
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 non-medicinal ingredients are
CARNITOR® Tablet: magnesium stearate, microcrystalline
cellulose and povidone
CARNITOR® Oral Solution: artificial Cherry Flavor, D,LMalic Acid, Purified Water, Sucrose Syrup. Methylparaben NF
and Propylparaben NF are added as preservatives.
CARNITOR® Injection: hydrochloric acid and/or sodium
hydroxide.
What dosage form 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)
Warnings and precautions
Serious Warnings and Precautions
BEFORE you use CARNITOR® talk to your doctor or pharmacist if you:
- have kidney disease
- have diabetes or are on a low-calorie diet as CARNITOR® contains sucrose
- are pregnant or could be pregnant
- are breastfeeding
- have a history of seizures
Interactions with this medication
Drugs that may interact with CARNITOR® include:
- anticoagulants(acenocoumarol and warfarin)
Proper use of this medication
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
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.
Usual Dose
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 and what to do about them
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.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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 | ✔ | ||
| 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.
How to store
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.
Reporting 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 www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada.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 www.canada.ca/en/health-canada/services/drugs-healthproducts/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.
More information
This leaflet is Part III of a three-part "Product Monograph" published when CARNITOR® was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about CARNITOR® . Contact your doctor or pharmacist if you have any questions about the drug.
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.
This leaflet was prepared by Leadiant Biosciences, Inc.
Last revised: April 23, 2019