pharmacopeia
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/api/v1/drug/levocarnitine

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Biological Macromolecular Activity.

Indications

Sourced from openFDA
  • Levocarnitine oral solution is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy.

Contraindications

Sourced from openFDA
  • None known.contraindicated

Dosage & administration

Sourced from openFDA

For oral use only. Not for parenteral use. Adults: The recommended dosage of levocarnitine is 1 to 3 g/day for a 50 kg subject, which is equivalent to 10 to 30 mL/day of levocarnitine oral solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 1 g/day (10 mL/day), and be increased slowly while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition. Infants and children: The recommended dosage of levocarnitine is 50 to 100 mg/kg/day which is equivalent to 0.5 mL/kg/day levocarnitine oral solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 50 mg/kg/day, and be increased slowly to a maximum of 3 g/day (30 mL/day) while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition. Levocarnitine oral solution may be consumed alone or dissolved in 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 maximize tolerance.

Warnings & precautions

Sourced from openFDA

Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticaria, and facial edema have been reported with oral levocarnitine. Other serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following intravenous levocarnitine administration, mostly in patients with end-stage renal disease undergoing dialysis. Discontinue use of levocarnitine and instruct patients to seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.

Adverse reactions

Sourced from openFDA

The following adverse reactions associated with the use of oral formulations of levocarnitine were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliability, or to establish a causal relationship to drug exposure. Gastrointestinal Reactions : Various mild gastrointestinal complaints have been reported during the long-term administration of oral L- or D,L-carnitine; these include transient nausea and vomiting, abdominal cramps, and diarrhea. Gastrointestinal adverse reactions with levocarnitine oral solution dissolved in liquids might be avoided by a slow consumption of the solution or by a greater dilution. Decreasing the dosage often diminishes or eliminates drug-related patient body odor or gastrointestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration and after any dosage increases. Musculoskeletal Reactions : Mild myasthenia has been described only in uremic patients receiving D,L-carnitine. Neurologic Reactions : Seizures have been reported to occur in patients with or without pre-existing seizure activity receiving either oral or intravenous levocarnitine. In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported. Hypersensitivity Reactions : Rash, urticaria, and facial edema have been reported with oral levocarnitine (see WARNINGS ).

Use in specific populations

Sourced from openFDA

Pregnancy Reproductive studies have been performed in rats and rabbits at doses up to 3.8 times the human dose on the basis of surface area and have revealed no evidence of impaired fertility or harm to the fetus due to levocarnitine. 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.

Pharmacokinetics

Sourced from openFDA
Metabolism
In a relative bioavailability study in 15 healthy adult male volunteers, levocarnitine tablets were found to be bio-equivalent to levocarnitine oral solution. Following 4 days of dosing with 6 tablets of levocarnitine 330 mg b.i.d.

Overdosage

Sourced from openFDA

There have been no reports of toxicity from levocarnitine overdosage. Levocarnitine is easily removed from plasma by dialysis. The intravenous LD 50 of levocarnitine in rats is 5.4 g/kg and the oral LD 50 of levocarnitine in mice is 19.2 g/kg. Large doses of levocarnitine may cause diarrhea.

Approval history

Sourced from openFDA
  • Dec 27, 1985NDANDA018948Leadiant Biosci Inc
  • Apr 10, 1986NDANDA019257Leadiant Biosci Inc
  • Dec 16, 1992NDANDA020182Leadiant Biosci Inc
  • Mar 29, 2001ANDAANDA075567Hikma
  • Jun 22, 2001ANDAANDA075861Am Regent
  • Aug 10, 2004ANDAANDA076851Rising
  • Sep 20, 2004ANDAANDA076858Rising
  • Aug 14, 2019ANDAANDA211676Novitium Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,516 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Seizure37511%
  2. 2Off Label Use2747.8%
  3. 3Vomiting2216.3%
  4. 4Diarrhoea2005.7%
  5. 5Drug Ineffective1905.4%
  6. 6Fatigue1775.0%
  7. 7Pneumonia1775.0%
  8. 8Pyrexia1674.7%
  9. 9Product Dose Omission Issue1313.7%
  10. 10Nausea1293.7%
  11. 11Death1173.3%
  12. 12Decreased Appetite1123.2%
  13. 13Somnolence1123.2%
  14. 14Dyspnoea1043.0%
  15. 15Headache862.4%

Literature

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Recent PubMed references pinned to Levocarnitine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 305 ClinicalTrials.gov registrations naming Levocarnitine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Levocarnitine work?
Mechanism-of-action class: Biological Macromolecular Activity.
What is Levocarnitine used for?
According to FDA labeling, Levocarnitine carries indications including: Levocarnitine oral solution is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Levocarnitine?
Levocarnitine is classified as Amino acids and derivatives, Carnitine Analog, Biological Macromolecular Activity, Cellular Activity Alteration.
What are the brand names for Levocarnitine?
Levocarnitine is marketed under brand names including Carni Q-Gel Forte, Carnitor.
What are the contraindications for Levocarnitine?
Levocarnitine labeling lists contraindications including: None known.. Always consult the full prescribing information and a clinician.
Note. Data for levocarnitine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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