Levocarnitine
330 mg · Tablet
- Prescription only
- Carnitine Analog
- Active substance
- Levocarnitine
- Made by
- Rising Pharma Holdings, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2024-08-19
Carnitine Analog
- Levocarnitine tablets are indicated in the treatment of primary systemic carnitine deficiency.
Adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response.
Full directions ↓Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticaria, and facial edema have been reported with oral levocarnitine.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Levocarnitine tablets are 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.
- Associated symptoms included hypotonia, muscle weakness and failure to thrive.
- A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY ).
- In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms.
- Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.
- Levocarnitine tablets are also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
From the official label · 2024-08-19 · DailyMed
How it works
From this product’s own US prescribing label.
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.
Following a single i.v. administration, approximately 76% of the levocarnitine dose was excreted in the urine during the 0-24h interval.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-08-19
Do not take it if
None known.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Levocarnitine tablets.
- Adults:
- The recommended oral dosage for
- adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response.
- Infants and children:
- The recommended oral dosage for infants and children is between 50 and 100 mg/kg/day in divided doses, with a maximum of 3 g/day.
- Dosage should begin at 50 mg/kg/day.
- The exact dosage will depend on clinical response.
- Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- 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 tablets and instruct patients to seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.
- General 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.
- Drug Interactions Reports of INR increase with the use of warfarin have been observed.
- Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenicity tests performed in Salmonella typhimurium, Saccharomyces cerevisiae, and Schizosaccharomyces pombe indicate that levocarnitine is not mutagenic.
- No long-term animal studies have been performed to evaluate the carcinogenic potential of levocarnitine.
- 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.
- Nursing Mothers Levocarnitine supplementation in nursing mothers has not been specifically studied.
- Pediatric Use See DOSAGE AND ADMINISTRATION .
- General 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.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- 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.
- Levocarnitine supplementation in nursing mothers has not been specifically studied.
- Studies in dairy cows indicate that the concentration of levocarnitine in milk is increased following exogenous administration of levocarnitine.
- In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother.
- Consideration may be given to discontinuation of nursing or of levocarnitine treatment.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
Reports of INR increase with the use of warfarin have been observed. It is recommended that INR levels be monitored in patients on warfarin therapy after the initiation of treatment with levocarnitine or after dose adjustments.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- 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.
Quoted from the official label, section “Overdosage”.
Use in children
See DOSAGE AND ADMINISTRATION .
Quoted from the official label, section “Pediatric Use”.
Side effects
- 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.
- 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 ).
- To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Levocarnitine tablets, USP are supplied as white, round compressed tablets debossed “ Cor ” over “ 160 ” on one side and other side is plain.
- They are supplied as follows:
- Blister pack of 10 tablets, packaged in boxes of 90 tablets (NDC 16571-762-09) Store in original packaging:
- content hygroscopic.
- Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature].
- KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Quoted from the official label, section “How Supplied”.
What is in it
- Levocarnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane.
- The chemical name of levocarnitine is (R)-3-carboxy-2-hydroxy-N,N,N-trimethy-1-propanaminium hydroxide, inner salt.
- Levocarnitine is a white, crystalline powder or colourless crystals.
- It is freely soluble in water, soluble in warm alcohol, practically insoluble in acetone.
- The specific rotation of levocarnitine is between -29° and -32°.
- Its chemical structure is: Empirical Formula: C 7 H 15 NO 3 Molecular Weight:
- 161.20 Each levocarnitine tablet, USP intended for oral administration contains 330 mg of levocarnitine.
- In addition, it also contains the following inactive ingredients:
- magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. levocarnitine-struc
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (3)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 3 of 3
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Netherlands2 matching products
Details
| Made by | Rising Pharma Holdings, Inc. |
|---|---|
| Active substance | Levocarnitine |
| Strength | 330 mg |
| Form | Tablet |
| Route | Oral |
| Packs | 9 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK |
| NDC | 16571-762 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
10 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Solution4 products
1 g/10mL4
- Injection, Solution3 products
1 g/5mL2
1 g/5mL · 2 companies
- 200 mg/mL
- Tablet2 products
330 mg2
330 mg · 2 companies
- ANI Pharmaceuticals, Inc.
- Rising Pharma Holdings, Inc. · this page
- Injection1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.