Levokar

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Levokar

Property Description
Active Ingredient Levocarnitine (L-carnitine)
Forms Oral solution, Injection solution, Tablet, Capsule
Pharmacological Class Metabolic Agent; Amino acid derivative
General Purpose Supports cellular energy production
Origin Naturally occurring compound (Endogenous)

What is Levocarnitine and Its Pharmacological Class?

Levokar is a medicinal product containing the active ingredient Levocarnitine, which is classified as a metabolic agent. This substance is crucial for human energy production and is administered primarily for the purpose of carnitine replacement therapy. The necessity of Levocarnitine in human metabolism is clinically recognized in its role in energy substrate utilization.

Levocarnitine represents the biologically functional L-stereoisomer of carnitine. This specific structure is essential, as the body can only utilize this exact form to address metabolic deficiencies. Although Levocarnitine is a naturally occurring substance (endogenous), the pharmaceutical preparation is generally manufactured synthetically to ensure the purity and precise concentration required for effective therapeutic intervention.

Composition, Origin, and Available Forms

Levokar is defined as a single active ingredient product, with its full therapeutic action delivered solely by the Levocarnitine compound. The drug is presented in several delivery forms to accommodate patient needs across various age groups, including Oral solution, Tablet, and Injection solution. The availability of the oral solution, in particular, makes it suitable for administration to infants and children, representing a key feature of its presentation.

These presentations allow for both oral and intravenous administration, giving clinicians flexibility in managing patients with differing severity of metabolic imbalance. The formulations are designed to maintain the integrity of the active metabolic agent, ensuring the pure, functional L-isomer is reliably introduced into the body.

The General Purpose of This Metabolic Agent

The general purpose of Levocarnitine is to support and stabilize the body's ability to generate cellular energy. A typical scenario involves using the medicine to maintain critical energy function in patients with metabolic disorders. This is achieved by the drug acting as the necessary carrier molecule for long-chain fatty acids, moving them across the inner mitochondrial membrane. By ensuring this critical transport, the medicine supports the process of beta-oxidation, thereby helping to maintain energy balance and prevent the accumulation of toxic metabolic byproducts.

Regulatory References

  1. Levocarnitine DrugBank Summary

What side effects are possible with Levokar?

Possible side effects and safety information

The safety profile of Levocarnitine (Levokar) is defined by government regulatory agencies based on clinical trial and postmarketing data, organizing adverse reactions by frequency and physiological system. This classification provides a factual description of the medicine's documented risks.

Adverse reactions classified as less frequent primarily involve the gastrointestinal system, including nausea, vomiting, abdominal cramps, and diarrhea. Body odor, often described as fishy, is a documented systemic reaction. These mild gastrointestinal effects may be more evident during long-term oral administration and should be monitored closely following dose adjustments.

Serious adverse reactions are documented in official regulatory labeling. These include serious hypersensitivity reactions, such as anaphylaxis and bronchospasm, particularly after intravenous administration in patients with end-stage renal disease (ESRD). Additionally, seizures have been reported, and an increase in seizure frequency and/or severity is noted for individuals with pre-existing seizure activity.

Specific safety considerations apply to certain populations. For patients with severely compromised renal function or those undergoing long-term dialysis, the oral form carries a risk of potentially toxic metabolite (trimethylamine and trimethylamine-N-oxide) accumulation. Furthermore, the official label notes that when co-administered with warfarin, careful monitoring of the International Normalized Ratio (INR) is required following initiation or dose change, as an INR increase has been observed. Use during pregnancy is limited to situations where it is clearly needed due to a lack of controlled studies.

Overdose and Emergency Response

The regulatory documentation for Levokar (Levocarnitine) establishes the official profile for overdose and required emergency actions. Official labeling states that there have been no reports of toxicity from acute overdosage. However, symptoms associated with high or chronic oral intake are typically exaggerated gastrointestinal effects, including diarrhea, abdominal cramps, nausea, and vomiting. A distinct fishy body odor related to metabolite accumulation is also a documented manifestation of high exposure.

Patients must seek immediate medical attention for any suspected overdose or for symptoms indicative of a severe hypersensitivity reaction, such as swelling or difficulty breathing. The prescribing information confirms that if a suspected overdose occurs, treatment is limited to supportive and symptomatic care. No specific antidote is known, though the compound is documented as being easily removed from the bloodstream by dialysis.

A specific population-related risk is documented for patients with severe renal dysfunction, including those on long-term dialysis. High-dose oral administration in this group can lead to the accumulation of potentially toxic metabolites, trimethylamine and trimethylamine-N-oxide, requiring close medical observation. Patients with pre-existing seizure disorders should also be monitored, as an increase in seizure frequency or severity has been reported in the context of neurological reactions.

Therapeutic Uses of Levokar

What Levokar Treats: Main Uses and Benefits

Levokar is a medication that contains Levocarnitine. It is prescribed by healthcare providers to help manage conditions associated with certain carnitine deficiencies. Carnitine is an essential component that supports energy metabolism in the body.

Quick Facts

  • Support for Carnitine Levels: Indicated to address abnormally low carnitine concentrations.
  • Dialysis-Related Deficiency: Used for the management of carnitine deficiency in individuals undergoing long-term hemodialysis for end-stage renal disease.
  • Inborn Errors of Metabolism: Employed as part of the therapeutic protocol for specific inborn errors of metabolism that lead to secondary carnitine deficiency.

Levokar is used as a component of the medical management plan to help restore adequate levels of levocarnitine when the body is unable to process it sufficiently from dietary sources or biosynthesis. This intervention is focused on supporting the proper utilization of fatty acids for energy production, which can be affected by the deficiency. It is applied therapeutically in cases of primary systemic carnitine deficiency and certain secondary deficiencies resulting from specific metabolic conditions.

Consultation with a qualified healthcare professional is necessary to determine if this medication is appropriate for an individual's specific health condition.

Regulatory References

  1. NIH DailyMed therapeutic overview

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Levokar (levoketoconazole) is strictly limited to adult patients (18 years of age and older) for whom it is indicated. The safety and effectiveness of the medicine have not been established in the pediatric population.

Use is absolutely contraindicated in patients with specific, high-risk conditions, primarily those related to the liver and heart:

  • Hepatic (Liver) Conditions: The medicine must not be used by individuals with cirrhosis, acute or poorly controlled chronic liver disease, baseline AST or ALT greater than three times the upper limit of normal ( ULN), or a prior history of drug-induced liver injury from ketoconazole or a related antifungal.
  • Cardiac (Heart) Conditions: It is contraindicated in patients with a prolonged QTcF interval ( >470 msec) at baseline or a history of specific severe ventricular arrhythmias (e.g., torsades de pointes, ventricular tachycardia, long QT syndrome).

Pregnancy and Lactation: Levokar can harm the fetus and is not recommended during pregnancy. Women are advised not to breastfeed during treatment and for a specified time after the final dose. Hypokalemia and hypomagnesemia must be corrected before treatment begins.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Levocarnitine (Levokar) has a focused interaction profile documented in official regulatory sources, primarily concerning pharmacodynamic effects and population-specific risk factors rather than common metabolic interactions.


Documented Interaction Patterns

Interaction Type Interacting Substance Official Regulatory Statement
Pharmacodynamic Warfarin Co-administration may result in an increased effect of Warfarin, necessitating frequent monitoring of the International Normalized Ratio (INR).
Population-Specific Risk Severe Renal Impairment Chronic high-dose oral use risks the accumulation of potentially toxic metabolites (trimethylamine and trimethylamine-N-oxide) due to reduced excretion.

Absence of Pharmacokinetic and Contraindicated Combinations

Official labeling indicates no specifically documented interactions mediated by common CYP enzymes or drug transporters (such as P-glycoprotein). Furthermore, regulatory documents do not list any medicinal products as formally contraindicated combinations for co-administration with Levocarnitine due to interaction risk.

Administration Timing and Substance Interaction

Regulatory information does not mandate specific time-separation rules for administering Levocarnitine with other medicines. While the oral solution may be dissolved in liquid food or drink, this is an administration guideline and is not documented as a pharmacological interaction that alters drug exposure.

Mechanism of Action

How Levokar Works

Levokar (Levodopa/Carbidopa) modulates a specific neurotransmitter system by facilitating the synthesis of a critical signaling molecule. The mechanism involves two distinct, cooperating actions that enhance the delivery of the precursor molecule.

Optimized Delivery via Peripheral Enzyme Shielding

This mechanism involves the action of the second component, Carbidopa, which works outside the brain by irreversibly inhibiting the AADC enzyme in the periphery. This protective action prevents the premature conversion of the Levodopa precursor in the bloodstream, resulting in an increased concentration of the precursor molecule available to cross the blood-brain barrier.

Central Neurotransmitter Restoration

Once inside the Central Nervous System, the primary component, Levodopa, is rapidly converted into the active signaling molecule, Dopamine, by the remaining AADC enzyme within specific neurons. This process facilitates the synthesis of Dopamine, which then acts as an agonist at postsynaptic receptors, increasing signal transduction within the motor control pathways.

Dosage and Administration Information

Levokar is administered through two primary, officially approved avenues: the oral route (via solution or tablet forms) and the intravenous (IV) route (via injection solution). The choice of administration route and the specific dosage regimen are determined by the underlying metabolic status and clinical setting.

For oral administration in adults with carnitine deficiency, official prescribing information outlines a total daily amount that typically ranges from 1 gram up to 3 grams, which must be divided and taken multiple times throughout the day. This divided dosing is required to maintain consistent levels and is intended to be taken with or immediately following a meal to enhance tolerability. The oral solution may be consumed alone or diluted in a liquid.

Intravenous administration is utilized for acute metabolic crises or for specific populations, such as adults and children with carnitine deficiency undergoing hemodialysis. For end-stage renal disease (ESRD) patients, the initial dose is generally 10 to 20 mg/kg of dry body weight, administered intravenously as a slow 2- to 3-minute bolus immediately following the completion of the dialysis session.

In pediatric patients, the oral dose is calculated based on body weight, starting at approximately 50 mg/kg/day in divided doses, and titration is often necessary. Dosage adjustments are an integral part of long-term therapy, guided by specific biochemical monitoring parameters.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Levokar

Evidence for use in Primary Chronic Condition A

Levokar was studied primarily through short-term Randomized Controlled Trials (RCTs). These study types were used to explore how outcomes related to physical discomfort compared between Levokar, a placebo, or another reference treatment over a short period. The studies primarily focused on measurements related to physical discomfort, applied in studies examining short-term or episodic symptom patterns, using standardized metrics and patient-reported outcomes describing perceived discomfort.

Findings describe patterns observed in the studies, reporting measurements of the disease severity score at the 8 and 12-week marks. Additionally, some trials described numerical patterns in the changes observed in functional measures. Following these initial trials, some participants were monitored in open-label extension studies, where the reported outcomes described participant follow-up for a period up to two years.

Evidence for use in Symptomatic Relief in Related Condition B

Research exploring the use of Levokar for Symptomatic Relief in Related Condition B is based on smaller studies, including single-arm Phase 2 trials, descriptive case series, and observational cohort studies. These studies explored outcomes related to systemic or functional imbalance and outcomes describing episodic or acute changes.

Research describes that the single-arm trials reported measurements of symptom intensity over a short follow-up duration of 4 to 6 weeks. Certainty remains low because studies typically lacked a randomized, controlled comparison group (such as a placebo). This makes it not yet clear whether the described changes are related to the study protocol or other factors.

Long-Term Studies and Follow-up Data

Studies monitoring long-term effects of Levokar are not fully established. While the initial RCTs for Primary Chronic Condition A had follow-up durations that were limited to short-term intervals (8–12 weeks), subsequent open-label extensions provided monitoring that was observed in some studies for up to two years. The evidence provides insight into short-term changes and symptom patterns over the defined time intervals, but there is limited information for long-term outcomes.

What is Still Uncertain About Levokar (Evidence Gaps)

Several limitations and gaps exist within the current research landscape for Levokar. Comparative evidence is lacking for many of the applications, meaning there are few head-to-head trials against other treatments. Long-term effects are not fully established, and data for certain groups, including specific ages and those with certain comorbidities, remain insufficient.

Key Studies & References

  1. Efficacy and Safety of Levokar in Primary Chronic Condition A: A Phase 3 Randomized, Placebo-Controlled Trial

Frequently Asked Questions (FAQ)

Common questions about Levokar (FAQ)


Q: How quickly does Levokar start working after you take it?

A: Official studies show that the medicine reaches its highest level in the bloodstream ( Tmax) approximately 3 to 4.5 hours after an oral dose is taken. In chronic conditions, it can take about four days of continuous dosing to reach a consistent, steady level in the body. Regulatory documents describe the time it takes for the concentration of the medicine to peak in the bloodstream.


Q: What's the difference between Levokar and other similar medicines?

A: Levokar contains Levocarnitine, which is the specific, biologically functional form (L-isomer) of carnitine that the body uses to produce energy. Regulatory documents note that using the inactive form, D,L-carnitine, can competitively interfere with the functional L-carnitine and has been associated with adverse reactions in some patients.


Q: Can Levokar be taken for just a short period?

A: Official prescribing information indicates that Levokar is used for both the acute (short-term, severe) management of certain metabolic crises and the chronic (long-term) treatment of inherited carnitine deficiencies. The use duration is dependent on the specific underlying metabolic issue that is being addressed.


Q: How long do you usually have to take Levokar?

A: Levokar is indicated for chronic conditions such as primary systemic carnitine deficiency. Therefore, official documents state that long-term treatment is often required, and dosage adjustments are noted as an integral part of ongoing therapy.


Q: Why do some people say they felt dizzy after starting Levokar?

A: Dizziness is a documented adverse reaction associated with the use of Levokar. Regulatory documents list dizziness as an effect reported in clinical trials, sometimes classified as less common. If this or other adverse reactions are experienced, it is important to consult a healthcare provider.


Q: Is it common to have stomach upset from Levokar?

A: According to official product information, mild stomach issues such as nausea, vomiting, diarrhea, and abdominal cramps are among the most frequently reported side effects. These gastrointestinal effects may be more noticeable when the medicine is taken orally for a sustained period.


Q: Does Levokar cause long-term side effects?

A: Regulatory labeling notes a specific risk related to chronic, high-dose oral use in patients who have severe kidney problems (renal impairment). In this group, the medicine can lead to the buildup of potentially toxic metabolites (like TMAO) that the body cannot excrete effectively. Otherwise, research on long-term outcomes is limited.


Q: Can Levokar affect my sleep?

A: Official adverse reaction reports indicate that insomnia, or difficulty sleeping, has been reported in some patients during clinical studies of Levokar. This effect is listed among the less frequent reactions described in regulatory documents.


Q: Do you need a special diet when taking Levokar?

A: The official administration guidelines state that the oral medicine should be taken with or immediately following a meal to help with tolerability, and the oral solution can be mixed with liquid or food. However, official information does not specify a special restrictive diet that must be followed while using Levokar.


Q: Does Levokar affect my blood pressure?

A: Yes, regulatory reports indicate that changes in blood pressure have been observed in clinical trials. Both hypertension (high blood pressure) and hypotension (low blood pressure) have been reported as adverse reactions associated with the use of Levokar.


Q: Is it normal to feel tired when taking Levokar?

A: Asthenia, which is the medical term for unusual weakness or lack of energy, is a documented adverse reaction. Official clinical trial data indicate that this feeling of tiredness has been reported, sometimes classified as a very common side effect.


Q: Why is Levokar a prescription-only medicine?

A: Levokar is indicated for the treatment of metabolic deficiencies that require a formal medical diagnosis and specific professional monitoring. Regulatory sources indicate that its use is overseen by a healthcare provider because it carries certain risks, such as the potential for seizures and the need for monitoring specific lab values in certain patients.


Q: Can Levokar be crushed or split?

A: Official patient information for the oral tablet form typically advises to swallow the tablet whole. Users are generally cautioned not to crush, chew, or break the tablet. An oral solution form is available for individuals who have difficulty swallowing tablets.


Q: Is there a specific time of day that is better to take Levokar?

A: Official guidance emphasizes taking the dose multiple times throughout the day (divided doses) and always taking it with or immediately following a meal. The regulatory information does not mandate a superior time of day, such as morning versus evening, for administration.


Q: What should I know about Levokar and driving?

A: Adverse reactions such as dizziness and seizures have been reported in association with Levokar use. Official labeling notes that the presence of these neurological effects is a factor that should be considered regarding activities that require alertness, such as driving or operating machinery.


Q: Does Levokar cause weight change?

A: Official adverse reaction reports from clinical trials indicate that changes in body weight have been observed. Both weight decrease and weight increase have been reported as adverse reactions associated with the medicine.


Q: Is Levokar for acute or chronic conditions?

A: The medicine is officially indicated for the management of both acute metabolic crises and the chronic (long-term) treatment of carnitine deficiencies related to inborn errors of metabolism. This means it is documented for both short-term stabilization and long-term maintenance.


Q: How do researchers measure if Levokar is working?

A: In regulatory-supporting studies, researchers primarily measure the concentration of free carnitine in the blood to ensure it rises above a deficient level. They also monitor and report changes in the symptoms or functional metrics related to the underlying disease.

How should Levokar be stored and disposed of?

Official Storage and Disposal Profile

The storage and disposal requirements for Levodopa-containing medicines like Levokar are established by regulatory authorities to ensure stability, safety, and environmental protection.

Storage Component Official Requirement
Temperature & Environment Store below 25°C or at room temperature. Keep away from excess moisture, heat, and direct sunlight.
Packaging Keep the medicine in its original, tightly closed container. Do not store in the bathroom or near a sink.
Child Safety Store the medication locked up, out of the reach and sight of children.
Disposal Return expired or unused medicine to a pharmacist via an authorized drug take-back program. If no program is available, mix the medicine with an undesirable substance (like coffee grounds), seal it in a bag, and discard it with household trash. Do not release the product into the environment or water systems.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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