CARNITOR PRODUCT MONOGRAPH - SALBI Flashcards
What is CARNITOR (levocarnitine) Injection indicated for:
- Treatment of primary systemic carnitine deficiency; 2. Acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency, and 3. Prevention and treatment of carnitine deficiency in patients with end stage renal disease (ESRD) who are undergoing dialysis
Are there any interaction with foods, herbs and drugs?
Interactions with food, herb or drugs have not been established
How soon / When can ESRD patients on HD start on CARNITOR IV?
It is recommended that therapy begin after being on hemodialysis for a period of six months. Note: the patient population most likely to experience significant clinical benefit are those who are severely depleted of whole body carnitine stores and this tends to be those who have been on maintainence HD the longest and other risk factors
What is the composition and dosage of CARNITOR IV?
Intravenous Injection 1 g / 5 mL (200 mg / mL) Hydrochloric acid, sodium hydroxide
What is the recommended dose for CARNITOR IV for ESRD patients?
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.
*Post-dialysis levocarnitine plasma levels approach physiological levels after approximately two months of therapy at 20 mg/kg. After two months of therapy and based on clinical assessment of symptoms, the dose may be adjusted to 5 mg/kg after each dialysis session (maintenance dosing)
How is CARNITOR IV administered?
CARNITOR Injection is administered intravenously. It can be given directly as bolus injection (often referred to as “IV push”) over a 2-3 minute period or it can be given as an infusion (admixed into an IV bag containing Sodium Chloride 0.9% or Lactated Ringer’s).
What is the compatibility/stability of CARNITOR INJECTION when it is mixed into a parenteral solution (for example as part of a TPN prescription).
CARNITOR Injection is compatible and stable when 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 polyvinyl chloride (PVC) plastic bags.
What is the dosage, form and packaging of CARNITOR?
CARNITOR (levocarnitine) Injection is a sterile aqueous solution containing 200 milligrams of levocarnitine per mL. It is available in 5 mL single dose vials, packaged 5 vials per carton. For intravenous use only. Each 5 mL vial contains 1 g of levocarnitine. The pH is adjusted to 6.0 to 6.5 with hydrochloric acid and/or sodium hydroxide.
How to manage a missed dose of CARNITOR?
If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.
What does CARNITOR do?
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.
What is the mechanism of action of CARNITOR?
CARNITOR (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids are utilized as an energy substrate in all tissues except the brain. In skeletal and cardiac muscle, fatty acids are the main substrate for energy production. In addition, CARNITOR can promote the excretion of excess organic or fatty acids in patients with defects in fatty acid metabolism and/or specific organic acidopathies that bioaccumulate Acyl-coenzyme A (acyl-CoA) esters within the mitochondria. In this manner, CARNITOR® may alleviate the metabolic abnormalities of patients with inborn errors that result in accumulation of toxic organic acids.
What are the major side effects of Carnitor?
Side effects include: -vomiting, nausea, upset stomach, diarrhea, abdominal cramps -abnormal taste -body odour (“fishy” smell) -headache
How should Carnitor IV be stored?
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. CARNITOR IV contains no preservatives: levocarnitine will support microbial growth.
What does the CARNITOR product monograph say about how ESRD patients on maintenance hemodialysis become carnitine deficient?
ESRD patients on maintenance hemodialysis may have low plasma carnitine concentrations and an increased ratio of acylcarnitine/carnitine because of reduced intake of meat and dairy products, reduced renal synthesis and dialytic losses.
What does the CARNITOR product monograph say are the clinical conditions commonly seen in HD patients that might be related to abnormal carnitine metabolism?
Certain clinical conditions common in hemodialysis patients such as malaise, muscle weakness, cardiomyopathy and cardiac arrhythmias may be related to abnormal carnitine metabolism.
