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Carnitine supplements (Levocarnitine): Drug information

Carnitine supplements (Levocarnitine): Drug information
(For additional information see "Carnitine supplements (Levocarnitine): Patient drug information" and see "Carnitine supplements (Levocarnitine): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Carnitor;
  • Carnitor SF;
  • G-levOCARNitine S/F [OTC]
Brand Names: Canada
  • Carnitor;
  • ODAN Levocarnitine
Pharmacologic Category
  • Dietary Supplement
Dosing: Adult
Carnitine deficiency

Carnitine deficiency:

Primary or secondary: Oral:

Oral solution: Initial: 1,000 mg/day in divided doses (every 3 to 4 hours throughout the day); titrate slowly as needed to 1,000 to 3,000 mg/day in divided doses based on tolerance and therapeutic response; higher doses may be needed in some patients (administer only with caution).

Tablet: 990 mg 2 to 3 times a day, depending on clinical response.

Secondary: IV: 50 mg/kg/day in divided doses (every 3 or 4 hours; no less than every 6 hours); subsequent doses in the range of 50 mg/kg/day or higher if clinically indicated (maximum reported dose: 300 mg/kg/day). In patients with severe metabolic crisis, a 50 mg/kg loading dose followed by an additional 50 mg/kg in divided doses over the next 24 hours may be required.

Carnitine deficiency in patients with ESRD requiring dialysis

Carnitine deficiency in patients with ESRD requiring dialysis: IV: 10 to 20 mg/kg (dry body weight) after each dialysis session; guide dosage adjustments by trough (predialysis) levocarnitine concentrations. Evaluate clinical response at 3-month intervals and titrate to the lowest effective dose; therapy should be discontinued if no improvement is seen after 9 to 12 months of therapy (Eknoyan 2003). Note: Current guidelines do not support the routine use of levocarnitine in dialysis patients (K/DOQI guidelines 2000); however, the National Kidney Foundation indicates levocarnitine therapy in patients with hyporesponsiveness to erythropoietin-based products, symptomatic intradialytic hypotension, NYHA functional class III-IV or ACC/AHA stage C-D heart failure or symptomatic cardiomyopathy, or muscle weakness and fatigability affecting quality of life which are unresponsive to standard medical therapy (Eknoyan 2003).

Dietary supplement

Dietary supplement (OTC use): Oral: Refer to individual product labeling.

Valproic acid toxicity, acute

Valproic acid toxicity, acute (off-label use): IV: Initial: 100 mg/kg as an IV bolus followed by 50 mg/kg (maximum: 3,000 mg) as an IV bolus or intermittent infusion (over 15 to 30 minutes) every 8 hours; continue until ammonia levels are decreasing and clinical improvement is evident; patients may require several days of therapy (Perrott 2010). Some experts recommend a higher maximum loading dose (eg, 100 mg/kg [maximum: 6,000 mg]) and smaller, more frequent maintenance doses (eg, 15 mg/kg every 4 to 6 hours) in symptomatic patients (EASL 2019; Howland 2019; Russell 2007).

Dosing: Kidney Impairment: Adult

Oral: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, safety and efficacy of oral carnitine have not been evaluated in patients with renal insufficiency. Chronic administration of high oral doses to patients with severely compromised renal function or ESRD patients on dialysis may result in accumulation of potentially toxic metabolites.

IV: There are no dosage adjustments provided in the manufacturer’s labeling; dosage adjustments should be determined by levocarnitine levels and clinical response. Note: Current guidelines do not support the routine use of levocarnitine in dialysis patients (K/DOQI guidelines 2000); however, the National Kidney Foundation indicates levocarnitine therapy in patients with hyporesponsiveness to erythropoietin-based products, symptomatic intradialytic hypotension, NYHA functional class III-IV or ACC/AHA stage C-D heart failure or symptomatic cardiomyopathy, or muscle weakness and fatigability affecting quality of life which are unresponsive to standard medical therapy (Eknoyan 2003).

Dosing: Hepatic Impairment: Adult

Oral, IV: There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Carnitine supplements (Levocarnitine): Pediatric drug information")

Carnitine deficiency, treatment

Carnitine deficiency, treatment: Infants, Children, and Adolescents: Note: Variability in genetic mutations and clinical presentations exist; dosage should be individualized based upon patient response and serum carnitine concentrations.

Primary deficiency: Oral: Initial: 50 mg/kg/day in divided doses; may titrate slowly as needed to 100 mg/kg/day in divided doses; some patients may require higher doses (eg, 400 mg/kg/day) (Longo 2006; Magoulas 2012); maximum daily dose: 3,000 mg/day

Dosing interval (product specific):

Oral solution: Divided doses at evenly spaced intervals with or during meals (every 3 to 4 hours)

Tablets: Divide daily dose into 2 to 3 doses

Secondary deficiency:

Oral: Initial: 50 mg/kg/day in divided doses; may titrate slowly as needed to 100 mg/kg/day in divided doses; some conditions may require higher daily doses (eg, 300 mg/kg/day); maximum daily dose: 3,000 mg/day (Kölker 2011; Sutton 2012)

Dosing interval (product specific):

Oral solution: Divided doses at evenly spaced intervals with or during meals (every 3 to 4 hours)

Tablets: Divide daily dose into 2 to 3 doses

IV: 50 mg/kg as a single dose; titrate based on patient response. In patients with severe metabolic crisis, a 50 mg/kg loading dose followed by an equivalent dose given over the next 24 hours divided every 3 to 6 hours, may be required; maximum daily dose: 300 mg/kg/day

ESRD patients on hemodialysis: Limited data available: Children and Adolescents: IV: 10 to 20 mg/kg dry body weight after each dialysis session; evaluate clinical response at 3-month intervals and titrate to the lowest effective dose. Therapy should be discontinued if no improvement after 9 to 12 months of therapy. Note: Current guidelines do not support the routine use of levocarnitine in dialysis patients (KDOQI Guidelines 2006; KDOQI Work Group 2009); however, the National Kidney Foundation indicates levocarnitine therapy in patients with hyporesponsiveness to erythropoietin-based products, symptomatic intradialytic hypotension, NYHA functional class III-IV or ACC/AHA stage C-D heart failure or symptomatic cardiomyopathy, or muscle weakness and fatigability affecting quality of life which are unresponsive to standard medical therapy (Eknoyan 2003).

Valproic acid toxicity, acute

Valproic acid toxicity, acute: Limited data available: Children and Adolescents: Dosing based on level of hepatic involvement and should be adjusted based on clinical response or serum level of valproic acid:

No hepatotoxicity: IV: 100 mg/kg/day divided every 6 hours until serum ammonia and valproic acid concentrations begin to decrease and clinical improvement is evident; maximum daily dose: 3,000 mg/day (Russell 2007)

Symptomatic hyperammonemia or hepatotoxicity: Reported dosing regimens variable: IV: Loading dose: 100 mg/kg, maximum loading dose: 6 g; followed by 50 mg/kg/dose (up to 3,000 mg/dose) every 8 hours or 15 mg/kg/dose every 4 hours; continue treatment until serum ammonia concentrations begin to decrease and clinical improvement is evident; patients may require several days of therapy (Perrott 2010; Russell 2007)

Cyclic vomiting syndrome, prevention

Cyclic vomiting syndrome, prevention: Limited data available: Children and Adolescents: Oral: 50 to 100 mg/kg/day in divided doses 2 to 3 times daily; maximum dose: 1,000 mg/dose (Li 2008)

Dosing: Kidney Impairment: Pediatric

Oral: There are no dosage adjustments provided in the manufacturer’s labeling; safety and efficacy of oral carnitine have not been evaluated in patients with renal insufficiency. Chronic administration of high oral doses to patients with severely compromised renal function or ESRD patients on dialysis may result in accumulation of potentially toxic metabolites.

IV: There are no dosage adjustments provided in the manufacturer’s labeling; dosage adjustments should be determined by levocarnitine levels and clinical response.

Dosing: Hepatic Impairment: Pediatric

Oral, IV: There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral [preservative free]:

Generic: 250 mg

Solution, Intravenous:

Carnitor: 200 mg/mL (5 mL)

Solution, Oral:

Carnitor: 1 g/10 mL (118 mL) [contains methylparaben, propylparaben; cherry flavor]

Carnitor SF: 1 g/10 mL (118 mL) [sugar free; contains methylparaben, propylparaben, saccharin sodium; cherry flavor]

G-levOCARNitine S/F: 1 g/10 mL (474 mL) [sugar free; contains methylparaben, propylene glycol, propylparaben]

Generic: 1 g/10 mL (118 mL)

Tablet, Oral:

Carnitor: 330 mg

Generic: 250 mg [DSC], 330 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Carnitor: 200 mg/mL (5 mL)

Solution, Oral:

Carnitor: 10% (118 mL) [contains methylparaben, propylparaben]

Generic: 10% (118 mL)

Tablet, Oral:

Carnitor: 330 mg

Administration: Adult

Oral solution: Solution is for oral use only (not for parenteral use); may be consumed alone or dissolved in either a drink or liquid food, and should be consumed slowly. Space doses every 3 to 4 hours evenly throughout the day, preferably during or following meals, to maximize tolerance.

IV:

Carnitine deficiency: Administer as a bolus dose over 2 to 3 minutes or by infusion. Doses should be administered every 3 to 4 hours, but never less than every 6 hours (eg, 4 doses/day).

Hemodialysis patients: Administer as a bolus dose over 2 to 3 minutes into the venous return line after each dialysis session.

Administration: Pediatric

Oral: Oral solution: May be taken directly or diluted in either beverages or liquid food; consume slowly; doses should be spaced evenly throughout the day, preferably during or following meals (every 3 to 4 hours) to improve tolerance

Parenteral: Dependent upon use:

Carnitine deficiency: May be administered undiluted (200 mg/mL) as IV push over 2 to 3 minutes or further dilute and administered as IV infusion

ESRD on hemodialysis: May be administered undiluted (200 mg/mL) IV push over 2 to 3 minutes into the venous return line

Valproic acid toxicity: May be administered undiluted (200 mg/mL) IV push over 2 to 3 minutes or further dilute and administered IV infusion

Use: Labeled Indications

Carnitine deficiency in patients with end-stage renal disease requiring hemodialysis (injection only): Prevention and treatment of carnitine deficiency in patients with end-stage renal disease (ESRD) who are undergoing dialysis.

Dietary supplement (OTC only): As a levocarnitine dietary supplement.

Primary systemic carnitine deficiency (oral [Rx] only): Treatment of primary systemic carnitine deficiency.

Secondary carnitine deficiency (oral [Rx] and injection): Acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.

Use: Off-Label: Adult

Elevated ammonia levels, coma, and/or hepatic dysfunction due to valproic acid overdose/toxicity

Medication Safety Issues
Sound-alike/look-alike issues:

LevOCARNitine may be confused with levETIRAcetam, levocabastine

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequencies noted with hemodialysis patients.

>10%:

Cardiovascular: Hypertension (intravenous: 18% to 21%), chest pain (intravenous: 15%)

Central nervous system: Headache (intravenous: 37%), dizziness (intravenous: 15% to 18%), paresthesia (intravenous: 12%)

Endocrine & metabolic: Hypercalcemia (intravenous: 6% to 15%)

Gastrointestinal: Diarrhea (intravenous: 35%), abdominal pain (intravenous: 21%), vomiting (intravenous: 21%), nausea (intravenous: 12%)

Hematologic & oncologic: Anemia (intravenous: 5% to 12%)

Infection: Infection (intravenous: 24%)

Neuromuscular & skeletal: Weakness (intravenous: 9% to 12%)

Respiratory: Cough (intravenous: 18%), rhinitis (intravenous: 11%)

Miscellaneous: Accidental injury (intravenous: 12%), fever (intravenous: 6% to 12%)

1% to 10%:

Cardiovascular: Tachycardia (intravenous: 6% to 9%), palpitations (intravenous: 3% to 8%), vascular disease (intravenous: 6%), peripheral edema (intravenous: 5% to 6%), ECG abnormality (intravenous: 3% to 6%), atrial fibrillation (intravenous: 2% to 6%)

Central nervous system: Drug dependence (intravenous: 6%), vertigo (intravenous: 6%), depression (intravenous: 5% to 6%)

Dermatologic: Skin rash (intravenous: 5%)

Endocrine & metabolic: Weight loss (intravenous: 8%), parathyroid disorder (intravenous: 6%), weight gain (intravenous: 3% to 6%)

Gastrointestinal: Dysgeusia (intravenous: 2% to 9%), melena (intravenous: 6%), anorexia (intravenous: 5% to 6%), gastrointestinal disorder (intravenous: 3% to 6%)

Hematologic & oncologic: Hemorrhage (intravenous: 9%)

Hypersensitivity: Hypersensitivity reaction (intravenous: 6%)

Ophthalmic: Amblyopia (intravenous: 6%), eye disease (intravenous: 3% to 6%)

Renal: Renal failure (intravenous: 6%)

Respiratory: Bronchitis (intravenous: 3% to 5%)

Frequency not defined:

Gastrointestinal: Gastritis (intravenous)

Miscellaneous: Body odor

<1%, postmarketing, and/or case reports: Abdominal cramps, anaphylaxis, bronchospasm, facial edema, laryngeal edema, myasthenia (uremic patients), seizure, urticaria

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to levocarnitine or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Gastrointestinal effects: GI reactions may result from too rapid consumption of oral carnitine; consume oral solution slowly and space doses evenly throughout the day to maximize tolerance.

• Hypersensitivity reactions: Serious hypersensitivity reactions have been reported after oral (eg, rash, urticaria, facial edema) and intravenous (eg, anaphylaxis, laryngeal edema, and bronchospasm) administration. Reactions from IV use have typically occurred in patients with end stage renal disease on dialysis and may occur within minutes after use. Discontinue immediately and institute appropriate medical therapy if an acute reaction occurs; consider risks and benefits of reinitiating therapy, and monitor patient for recurrence of severe hypersensitivity reaction if therapy is reinstated.

Disease-related concerns:

• Carnitine deficiency: Risk factors include: Age (infants and young children are deficient in the enzyme that activates carnitine), chronic valproic acid administration, concomitant neurologic disorders, congenital metabolic disorders, hepatic cirrhosis, renal failure, critical care patients (burns, sepsis, trauma, organ failure), use of multiple antiseizure drugs and other drugs (chemotherapy agents, antinucleoside analogues) (Katiyar 2007).

• Renal impairment: Safety and efficacy of oral carnitine have not been evaluated in patients with renal insufficiency. Chronic administration of high oral doses to patients with severely compromised renal function or ESRD patients on dialysis may result in accumulation of potentially toxic metabolites.

• Seizure disorder: Use with caution in patients with seizure disorders or in those at risk of seizures; both new-onset seizure activity as well as an increased frequency and/or severity of seizures has been observed.

Warnings: Additional Pediatric Considerations

Routine prophylactic use of carnitine in children receiving valproic acid to avoid carnitine deficiency and hepatotoxicity is probably not indicated (Freeman, 1994).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Vitamin K Antagonists (eg, warfarin): LevOCARNitine may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Pregnancy Considerations

Teratogenic effects were not observed in animal studies. Carnitine is a naturally occurring substance in mammalian metabolism.

Breastfeeding Considerations

In breast-feeding women, use must be weighed against the potential exposure of the infant to increased carnitine intake. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.

Monitoring Parameters

Carnitine concentrations (initially, weekly, and monthly for IV therapy)

Metabolic disorders: Monitor blood chemistry, vital signs, and plasma carnitine levels (maintain between 35 to 60 μmol/L). In ESRD patients on dialysis: National Kidney Foundation guidelines recommend basing treatment on clinical signs and symptoms; evaluate response at 3-month intervals and discontinue if no clinical improvement noted within 9 to 12 months (Eknoyan 2003).

Valproic acid toxicity: Evaluate valproic acid concentrations (every 4 to 6 hours until a downward trend is observed), electrolytes, blood gases, mental status, hepatic function, serum ammonia concentration, serum lactate, and platelets.

Reference Range

Normal carnitine levels are 40 to 50 micromole/L; levels should be maintained on therapy between 35 to 60 micromole/L

Mechanism of Action

Carnitine is a naturally occurring metabolic compound which functions as a carrier molecule for long-chain fatty acids within the mitochondria, facilitating energy production. Carnitine deficiency is associated with accumulation of excess acyl CoA esters and disruption of intermediary metabolism.

In patients with valproic acid toxicity, the administration of exogenous carnitine shifts the metabolism of valproic acid toward beta-oxidation and away from omega-oxidation and potentially hepatotoxic metabolite production (Baddour 2018; Eyer 2005).

Pharmacokinetics

Protein binding: None

Metabolism: Hepatic; Major metabolites: Trimethylamine (TMA) and trimethylamine N-oxide (TMAO)

Bioavailability: Oral solution: 15.9% ± 4.9%; Tablet: 15.1% ± 5.3%

Half-life elimination: 17.4 hours

Time to peak: Oral: 3.3 hours

Excretion: Urine (76%, 4% to 8% as unchanged drug); feces (<1%)

Pricing: US

Solution (Acticarnitine SF Oral)

1 g/10 mL (per mL): $0.05

Solution (Carnitor Intravenous)

200 mg/mL (per mL): $8.83

Solution (Carnitor Oral)

1 g/10 mL (per mL): $0.37

Solution (Carnitor SF Oral)

1 g/10 mL (per mL): $0.45

Solution (levOCARNitine (Dietary) Oral)

1 g/10 mL (per mL): $0.03

Solution (levOCARNitine Oral)

1 g/10 mL (per mL): $0.39

Tablets (Carnitor Oral)

330 mg (per each): $1.32

Tablets (levOCARNitine (Dietary) Oral)

330 mg (per each): $0.34

Tablets (levOCARNitine L-Tartrate Oral)

330 mg (per each): $0.20

Tablets (levOCARNitine Oral)

330 mg (per each): $1.10

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Abedine (JP);
  • Actigeron (CL);
  • Agvantar (UA);
  • Albicar (AR);
  • Bio-Carnitine (BE, TH);
  • Biocarn (CH, DE);
  • Branigen (IT);
  • Cardimax (PH);
  • Cardispan (CR, DO, GT, HN, MX, NI, PA, SV);
  • Carnicin (VE);
  • Carnicle (IN);
  • Carnicor (ES, PH);
  • Carnil (GR, RO);
  • Carnin (KR);
  • Carniten (RU);
  • Carnitene (CH, HK, HR, NL, TW);
  • Carnitex (RU);
  • Carnitina (AR);
  • Carnitine (IL);
  • Carnitol (EG);
  • Carnitor (BD, GB, HK, IN);
  • Carnivit (GR, PL);
  • Carnivita (EG);
  • Carry FA (KR);
  • Cartan (CN);
  • Cartin (PH);
  • Cartine (BD, PH);
  • Chudex (PL);
  • Creavit (CL);
  • Disocor (PT);
  • Dongweili (CN);
  • Efe-Carn (CR, DO, GT, HN, NI, PA, SV);
  • Elcarnitol (CH);
  • Entomin (JP);
  • Fertilix (AR);
  • Fitmax L-Karnityna (PL);
  • Growart (GR);
  • Hardbody L-Karnityna (PL);
  • L-Cadul (KR);
  • L-Carn (KR);
  • L-Carnitin (AT, CZ, PL);
  • L-Cartin FF (JP);
  • L-Karnityna (PL);
  • Lecarna (MT);
  • Lencar (IN);
  • Levocar (BD);
  • Levocarnil (FR);
  • Levocarnitin (TW);
  • Levohistam (EG);
  • Lixi (VE);
  • Monocamin (JP);
  • Nefrocarnit (DE, EE, NL, TR);
  • Neurex (AR);
  • Neuroactil (AR);
  • Novacart (MX);
  • Ocarnix (BD);
  • Provicar (MX);
  • Rocarnin (VE);
  • Secabiol (ES);
  • Trian (TR);
  • Yu Li (CN)


For country code abbreviations (show table)
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