Levocarnitine

Name: Levocarnitine

What is levocarnitine?

Levocarnitine is a naturally occurring substance that the body needs for energy.

Levocarnitine is used to treat carnitine deficiency.

Levocarnitine may also be used for purposes not listed in this medication guide.

How should I take levocarnitine?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

The liquid medicine can be taken alone or mixed with a beverage or soft food. Sip or eat the mixture slowly.

Levocarnitine should be taken at evenly spaced intervals every 3 or 4 hours. This medicine works best if you take it with a meal or within 30 minutes after a meal.

While using levocarnitine, you may need frequent blood tests.

Store at room temperature away from moisture and heat.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Levocarnitine dosing information

Usual Adult Dose for Carnitine Deficiency:

METABOLIC DISORDERS:
Primary or secondary carnitine deficiency:
Oral solution:
Initial dose: 1 gram orally daily in evenly spaced divided doses (every 3 to 4 hours)
Maintenance dose: 1 to 3 grams orally daily in evenly spaced divided doses (every 3 to 4 hours)

Oral tablets:
990 mg orally 1 to 3 times a day, depending on clinical response

Intravenous solution:
50 mg/kg as a slow 2 to 3 minute bolus or by infusion, once a day
-A loading dose may be given in severe metabolic crisis, followed by an equivalent dose every 3 to 4 hours (but not less often than every 6 hours) over the following 24 hours
-Subsequent daily doses should 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 PATIENTS ON HEMODIALYSIS
Intravenous solution:
Initial dose: 10 to 20 mg/kg as a slow 2 to 3 minute bolus injection into the venous return line after each dialysis session
-Consider therapy for pre-dialysis trough levels of plasma carnitine below normal (40 to 50 micromol/L).
-Dose adjustments should be guided by pre-dialysis levocarnitine trough levels.
-Downward dose adjustments may be made as early as the third or fourth week of treatment.

Comments:
-Increase dose slowly while assessing tolerance and therapeutic response.
-Periodically monitor blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.
-Administer higher doses with caution and only where clinical and biochemical considerations make it likely that higher doses will be beneficial.
-In some patients, particularly those presenting with cardiomyopathy, supplementation may rapidly alleviate signs and symptoms.
-Treatment should include supportive and other therapy as indicated by the patient's condition.

Uses:
-Primary systemic carnitine deficiency
-Acute and chronic treatment of inborn errors of metabolism resulting in secondary carnitine deficiency
-Prevention and treatment of carnitine deficiency in end stage renal disease patients undergoing dialysis (IV form only)

Usual Pediatric Dose for Carnitine Deficiency:

METABOLIC DISORDERS:
Oral solution or tablets:
Initial dose: 50 mg/kg/day orally in evenly divided doses
Maintenance dose: 50 to 100 mg/kg/day orally in evenly divided doses
Maximum dose: 3 grams per day

Intravenous solution:
50 mg/kg as a slow 2 to 3 minute bolus or by infusion, once a day
-A loading dose may be given in severe metabolic crisis, followed by an equivalent dose every 3 to 4 hours (but not less often than every 6 hours) over the following 24 hours
-Subsequent daily doses should 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 PATIENTS ON HEMODIALYSIS
Intravenous solution:
Initial dose: 10 to 20 mg/kg as a slow 2 to 3 minute bolus injection into the venous return line after each dialysis session
-Consider therapy for pre-dialysis trough levels of plasma carnitine below normal (40 to 50 micromol/L).
-Dose adjustments should be guided by pre-dialysis levocarnitine trough levels.
-Downward dose adjustments may be made as early as the third or fourth week of treatment.

Comments:
-Increase dose slowly while assessing tolerance and therapeutic response.
-Periodically monitor blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.
-Administer higher doses with caution and only where clinical and biochemical considerations make it likely that higher doses will be beneficial.
-In some patients, particularly those presenting with cardiomyopathy, supplementation may rapidly alleviate signs and symptoms.
-Treatment should include supportive and other therapy as indicated by the patient's condition.

Uses:
-Primary systemic carnitine deficiency
-Acute and chronic treatment of inborn errors of metabolism resulting in secondary carnitine deficiency
-Prevention and treatment of carnitine deficiency in end stage renal disease patients undergoing dialysis (IV form only)

For Healthcare Professionals

Applies to levocarnitine: injectable solution, oral capsule, oral solution, oral tablet

Gastrointestinal

Very common (10% or more): Diarrhea (35%), abdominal pain (21%), vomiting (21%), nausea (12%)
Common (1% to 10%): Constipation, dyspepsia, gastrointestinal disorder, melena
Very rare (less than 0.01%): Abdominal cramps[Ref]

Nervous system

Very common (10% or more): Headache (37%), dizziness (18%), paresthesia (12%)
Common (1% to 10%): Hypertonia, vertigo, taste perversion
Frequency not reported: Seizures (with or without pre-existing seizure activity), increase in seizure frequency and/or severity[Ref]

Metabolic

There are reports from clinical trials of significant hypertriglyceridemia associated with high doses of levocarnitine (3 g/day) given to uremic dialysis patients.[Ref]

Very common (10% or more): Hypercalcemia (15%), hypervolemia (12%)
Common (1% to 10%): Anorexia, hyperkalemia[Ref]

Other

Very common (10% or more): Pain (35%), flu syndrome (29%), chest pain (15%), accidental injury (12%), asthenia (12%), fever (12%)
Common (1% to 10%): Peripheral edema, weight decrease, weight increase
Very rare (less than 0.01%): Body odor, International Normalized Ratio (INR) increased[Ref]

Local

Very common (10% or more): Injection site reaction (38%)[Ref]

Musculoskeletal

Musculoskeletal side effects, in chronic hemodialysis patients, for levocarnitine in relation to placebo therapy have included asthenia (8% to 12% vs 8%) and leg cramps (4% to 8% vs 13%). Mild myasthenia has occurred in uremic patients receiving D,L-carnitine (but not levocarnitine).[Ref]

Hematologic

There have been reports from clinical trials of significant increases in platelet aggregation associated with high doses of levocarnitine (3 g/day) given to hemodialysis patients.[Ref]

Very common (10% or more): Anemia (12%)[Ref]

Renal

Common (1% to 10%): Kidney failure (chronic hemodialysis patients)[Ref]

Endocrine

Common (1% to 10%): Parathyroid disorder[Ref]

Respiratory

Very common (10% or more): Pharyngitis (27%), cough increase (18%), dyspnea (11%), rhinitis (11%)
Common (1% to 10%): Bronchitis, sinusitis[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash[Ref]

Ocular

Common (1% to 10%): Amblyopia, eye disorder[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Cardiovascular

Very common (10% or more): Hypertension (21%), hypotension (19%)
Common (1% to 10%): Atrial fibrillation, arrhythmia, cardiovascular disorder, electrocardiogram abnormal, palpitations, tachycardia, vascular disorder[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction[Ref]

Psychiatric

Common (1% to 10%): Depression, anxiety, drug dependence, insomnia[Ref]

Immunologic

Very common (10% or more): Infection (24%)[Ref]

Some side effects of levocarnitine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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