Language selection

Search

Details for: CARNITOR

Company: LEADIANT BIOSCIENCES, INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02144336CARNITORLEVOCARNITINE100 MG / MLSOLUTIONORAL
02144344CARNITORLEVOCARNITINE200 MG / MLSOLUTIONINTRAVENOUS
02144328CARNITORLEVOCARNITINE330 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

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

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.

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.

Serious side effects, how often they happen and what to do about them
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:

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

Date modified: