Levocarnitine

What is Levocarnitine?

• Levocarnitine (Carnitor) is a form of carnitine, which is a substance made in muscle and liver tissue and found in certain foods, such as meat, poultry, fish, and some dairy products.
• Carnitor is also a drug that is used to treat patients who do not make enough carnitine and is being studied as a way to prevent tissue damage caused by chemotherapy.
• Carnitine is a type of dietary supplement.
• Also called L-carnitine.

Carnitine

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Carnitine ball-and-stick

What are the uses of this medicine?

Levocarnitine (Carnitor) is used:

• For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.
• For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.

How does this medicine work?

• 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 secondary carnitine deficiency:

• Secondary carnitine deficiency can be a consequence of inborn errors of metabolism or iatrogenic factors such as hemodialysis.
• Carnitor ® may alleviate the metabolic abnormalities of patients with inborn errors that result in accumulation of toxic organic acids.

In End Stage Renal Disease (ESRD) patients:

• End Stage Renal Disease (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.
• Certain clinical conditions common in hemodialysis patients such as malaise, muscle weakness, cardiomyopathy and cardiac arrhythmias may be related to abnormal carnitine metabolism.
• Pharmacokinetic and clinical studies with Carnitor ® have shown that administration of levocarnitine to ESRD patients on hemodialysis results in increased plasma levocarnitine concentrations.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• warfarin

Is this medicine FDA approved?

• Levocarnitine was approved by the U.S. Food and Drug Administration as a new molecular entity under the brand name Carnitor on December 27, 1985.

How should this medicine be used?

Recommended dosage: Metabolic Disorders:

• The recommended dose is 50 mg/kg given as a slow 2-3 minute bolus injection or by infusion.
• The highest dose administered has been 300 mg/kg.
• It is recommended that a plasma carnitine concentration be obtained prior to beginning this parenteral therapy.
• Weekly and monthly monitoring is recommended as well.
• This monitoring should include blood chemistries, vital signs, plasma carnitine concentrations (the plasma free carnitine concentration should be between 35 and 60 µmol/L) and overall clinical condition.

ESRD Patients on Hemodialysis:

• The recommended starting dose is 10-20 mg/kg dry body weight as a slow 2-3 minute bolus injection into the venous return line after each dialysis session.

Administration:

• Carnitor Injection is administered intravenously.
• It should be administered every 3 hours or every 4 hours, and never less than every 6 hours either by infusion or by intravenous injection.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Carnitor (levocarnitine) Injection is a sterile aqueous solution containing 1 g of levocarnitine per 5 mL vial.

This medicine is available in fallowing brand namesː

• Carnitor

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea and vomiting
• body odor
• gastritis

Less frequent side effects may include:

• Abdominal pain
• Accidental injury
• Allergic reaction
• Asthenia
• Back pain
• Chest pain
• Fever
• Flu syndrome
• Headache
• Infection
• Injection site reaction
• Pain
• Arrhythmia
• Atrial fibrillation
• Cardiovascular disorder
• Electrocardiogram abnormal
• Hemorrhage
• Hypertension
• Hypotension
• Palpitations
• Tachycardia
• Vascular disorder
• Anorexia
• Constipation
• Diarrhea
• Dyspepsia
• Gastrointestinal disorder
• Melena
• Nausea
• Stomach atony
• Vomiting
• Parathyroid disorder
• Anemia
• Hypercalcemia
• Hyperkalemia
• Hypervolemia
• Peripheral edema
• Weight decrease
• Weight increase
• Myalgia
• Bronchitis
• Cough increase
• Dyspnea
• Pharyngitis
• Respiratory disorder
• Rhinitis
• Sinusitis
• Pruritus
• Rash
• Special Senses
• Amblyopia
• Eye disorder
• Taste perversion
• Urinary tract infect
• Kidney failure

What special precautions should I follow?

• Serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following Carnitor ® administration, mostly in patients with end stage renal disease who are undergoing dialysis. If a severe hypersensitivity reaction occurs, discontinue Carnitor ® treatment and initiate appropriate medical treatment.
• The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are normally excreted in the urine.
• Levocarnitine supplementation in nursing mothers has not been specifically studied. Consideration may be given to discontinuation of nursing or of levocarnitine treatment.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• diarrhea

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Levocarnitine is easily removed from plasma by dialysis.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• LEVOCARNITINE

Inactive ingredients:

• WATER
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

• Leadiant Biosciences

Distributed by:

• Leadiant Biosciences, Inc.
• Gaithersburg, MD

What should I know about storage and disposal of this medication?

• Store at controlled room temperature (25°C).
• Avoid excessive heat.
• Protect from freezing.
• Discard any unused portion as the formulation does not contain preservative.

• Dailymed label info on Levocarnitine
• FDA Levocarnitine

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