Mediclarum
Medicine guide

Carnitor Sf

1 g/10mL · Solution

  • Prescription only
  • Carnitine Analog
Active substance
Levocarnitine
Made by
Leadiant Biosciences, Inc.

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 · 2024-11-04

What it is

Carnitine Analog

Used for
  • CARNITOR ® (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency.
The label’s usual adult dose

Adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response.

Full directions ↓
Warning

Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticarial, and facial edema have been reported with oral CARNITOR ® .

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
12other products contain Levocarnitine — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • CARNITOR ® (levocarnitine) 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.
  • 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.
  • CARNITOR ® (levocarnitine) is 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 · 2024-11-04 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Peak level after3.3 h
Half-life0.585 h
Mostly cleared after≈ 2.9 hfive half-lives — our arithmetic
How it leaves the body

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 · 2024-11-04

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.

  • CARNITOR ® (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.
  • CARNITOR ® (levocarnitine) Oral Solution and CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution.
  • 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 CARNITOR ® (levocarnitine) Oral Solution or CARNITOR ® SF (levocarnitine) Sugar-Free 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 CARNITOR ® (levocarnitine) Oral Solution or CARNITOR ® SF (levocarnitine) Sugar-Free 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.
  • CARNITOR ® (levocarnitine) Oral Solution or CARNITOR ® SF (levocarnitine) Sugar-Free 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticarial, and facial edema have been reported with oral CARNITOR ® .
  • 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 CARNITOR ® and instruct patients to seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.
  • General CARNITOR ® (levocarnitine) Oral Solution and CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution are for oral/internal use only.
  • Gastrointestinal reactions may result from a too rapid consumption of carnitine.
  • CARNITOR ® (levocarnitine) Oral Solution and CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution may be consumed alone, or dissolved in drinks or other liquid foods to reduce taste fatigue.
  • They should be consumed slowly and doses should be spaced evenly throughout the day to maximize tolerance.
  • 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 CARNITOR ® .
  • Nursing Mothers Levocarnitine supplementation in nursing mothers has not been specifically studied.
  • Pediatric Use See DOSAGE AND ADMINISTRATION .
  • General CARNITOR ® (levocarnitine) Oral Solution and CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution are for oral/internal use only.

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 CARNITOR ® .
  • 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.
  • Gastrointestinal adverse reactions with CARNITOR ® (levocarnitine) Oral Solution or CARNITOR ® SF (levocarnitine) Sugar-Free 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 CARNITOR ® (see WARNINGS ).

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

  • CARNITOR ® (levocarnitine) Tablets are supplied as 330 mg tablets embossed with "CARNITOR ST" in individual blisters, packaged in boxes of 90 (NDC 54482-144-07).
  • Store in original packaging: content hygroscopic.
  • Store at 20°C to 25°C (68°F to 77°F).
  • See USP Controlled Room Temperature.
  • CARNITOR ® (levocarnitine) Tablets are distributed by Leadiant Biosciences, Inc.
  • CARNITOR ® (levocarnitine) Oral Solution is supplied in 118 mL (4 FL.
  • OZ.) plastic containers (NDC 54482-145-08 and NDC 54482-145-09).
  • Store at 20°C to 25°C (68°F to 77°F).
  • See USP Controlled Room Temperature.
  • Avoid excessive heat and protect from freezing.
  • CARNITOR ® (levocarnitine) Oral Solution is distributed by Leadiant Biosciences, Inc.
  • CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution is supplied in 118 mL (4 FL.
  • OZ.) plastic containers (NDC 54482-148-01 and NDC 54482-148-02).
  • Store at 20°C to 25°C (68°F to 77°F).
  • See USP Controlled Room Temperature.
  • Avoid excessive heat and protect from freezing.
  • CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution is distributed by Leadiant Biosciences, Inc.
  • Rx only.

Quoted from the official label, section “How Supplied”.

How to store it

  • CARNITOR ® (levocarnitine) Tablets are supplied as 330 mg tablets embossed with "CARNITOR ST" in individual blisters, packaged in boxes of 90 (NDC 54482-144-07).
  • Store in original packaging: content hygroscopic.
  • Store at 20°C to 25°C (68°F to 77°F).
  • See USP Controlled Room Temperature.
  • CARNITOR ® (levocarnitine) Tablets are distributed by Leadiant Biosciences, Inc.
  • CARNITOR ® (levocarnitine) Oral Solution is supplied in 118 mL (4 FL.
  • OZ.) plastic containers (NDC 54482-145-08 and NDC 54482-145-09).
  • Store at 20°C to 25°C (68°F to 77°F).
  • See USP Controlled Room Temperature.
  • Avoid excessive heat and protect from freezing.
  • CARNITOR ® (levocarnitine) Oral Solution is distributed by Leadiant Biosciences, Inc.
  • CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution is supplied in 118 mL (4 FL.
  • OZ.) plastic containers (NDC 54482-148-01 and NDC 54482-148-02).
  • Store at 20°C to 25°C (68°F to 77°F).
  • See USP Controlled Room Temperature.
  • Avoid excessive heat and protect from freezing.
  • CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution is distributed by Leadiant Biosciences, Inc.
  • Rx only.

Quoted from the official label, section “Storage and Handling”.

What is in it

  • CARNITOR ® (levocarnitine) is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane.
  • The chemical name of levocarnitine is 3-carboxy-2( R )-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt.
  • Levocarnitine is a white crystalline, hygroscopic powder.
  • It is readily soluble in water, hot alcohol, and 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 CARNITOR ® (levocarnitine) Tablet contains 330 mg of levocarnitine and the inactive ingredients magnesium stearate, microcrystalline cellulose and povidone.
  • Each 118 mL container of CARNITOR ® (levocarnitine) Oral Solution contains 1 g of levocarnitine/10 mL.
  • Also contains: Artificial Cherry Flavor, D,L,-Malic Acid, Purified Water, Sucrose.
  • Methylparaben NF and Propylparaben NF are added as preservatives.
  • The pH is approximately 5.
  • Each 118 mL container of CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution contains 1 g of levocarnitine/10 mL.
  • Also contains:
  • Natural Cherry Flavor, D,L,-Malic Acid, Purified Water, Sodium Saccharin USP.
  • Methylparaben NF and Propylparaben NF are added as preservatives.
  • The pH is approximately 5.
  • Chemical Structure

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 (5)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Same active substance, strength and form in other countries

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Details

Made byLeadiant Biosciences, Inc.
Active substanceLevocarnitine
Strength1 g/10mL
FormSolution
RouteOral
Packs24 BOTTLE, PLASTIC in 1 CASE / 118 mL in 1 BOTTLE, PLASTIC
NDC54482-148

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).

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