Levebon

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Levebon

Medically reviewed

Marina Burgos

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 Levebon

Property Description
Active Ingredient Levetiracetam
Form Tablets, Oral Solution, Concentrate for Infusion
Pharmacological Class Anticonvulsant (Antiepileptic Drug)
Common Use Control of Seizures in Epilepsy
Origin Synthetic Pyrrolidine Derivative

Levebon is a prescription-only medication whose active substance is Levetiracetam, a synthetic compound utilized to manage and control seizures in patients diagnosed with epilepsy. It is clinically recognized for its role in maintaining seizure control across various patient groups. It is classified as an Anticonvulsant or Antiepileptic Drug (AED), belonging to the group of miscellaneous antiepileptics.


What Type of Medicine is Levebon?

Levebon is characterized as a second-generation anticonvulsant of the pyrrolidine class, a designation that confirms its unique identity, separate from older AEDs. The mechanism of Levetiracetam is primarily linked to the selective binding of the drug to the synaptic vesicle protein 2A (SV2A), a key regulator in nerve communication. This novel action reduces the excessive, synchronized electrical firing of nerve cells responsible for seizure initiation. The medication is used in the management of partial-onset seizures, demonstrating broad applicability in epilepsy care.


Composition, Origin, and Forms of Levetiracetam

The medication is a single-ingredient product, containing only the synthetic chemical entity Levetiracetam. Levebon offers distinct pharmaceutical preparations to support varied patient needs, including film-coated tablets and a specific oral solution that is often favored for pediatric and adolescent patient populations. It is also supplied as a concentrate for solution for infusion, which permits intravenous delivery when oral administration is not feasible. The availability of the concentrate is intended to support continuous treatment during clinical care.

Regulatory References

  1. NIH/MedlinePlus
  2. Levetiracetam's mechanism of action and efficacy for partial-onset seizures
  3. European Medicines Agency
  4. Keppra (levetiracetam) EPAR - European Medicines Agency

What side effects are possible with Levebon?

Possible side effects and safety information

The safety profile of Levebon (Levetiracetam) is established by regulatory authorities and categorized by the frequency and physiological system affected. Adverse reactions are grouped using standard frequency classifications (e.g., Very Common, Common, Uncommon, Rare) derived from clinical data.

Very Common reactions (ge 1 in 10 patients) often involve the nervous system and include somnolence and headache, along with nasopharyngitis.

Common reactions (ge 1 in 100 to < 1 in 10 patients) documented in regulatory labels span several System-Organ Classes. These include central nervous system effects such as dizziness and fatigue, and psychiatric disorders like aggression, irritability, and insomnia.

Serious Adverse Reactions

The official labeling documents rare but clinically significant adverse reactions. These include suicidal ideation and behavior, a recognized concern across antiepileptic drugs. Other serious documented effects are severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), as well as hepatic failure and pancreatitis.

Safety Patterns and Special Populations

Specific safety notes are included for certain contexts. Behavioral side effects, such as aggression and irritability, are explicitly noted as being more frequently observed at the start of treatment or following a dose increase. For patients with renal impairment, specific safety attention is required, as the drug's clearance is known to be reduced in this population.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Levebon (Levetiracetam) overdose focuses strictly on central nervous system (CNS) effects and mandated emergency responses, as outlined in prescribing information.

Documented Overdose Signs Severe Outcomes and Management
Overexposure is documented to manifest as somnolence (drowsiness), agitation, aggression, depressed level of consciousness, and coordination difficulties. Overdosage may lead to severe systemic outcomes, including respiratory depression and coma (loss of consciousness).

Emergency Action Mandate

Immediate medical attention must be sought for any suspected overexposure. Regulatory guidance requires urgently calling emergency services or poison control if severe signs are present, such as difficulty breathing, collapse, or inability to be awakened. There is no specific antidote available for Levetiracetam overdose. Management is limited to providing general supportive measures and symptomatic treatment to address the clinical presentation. Due to the drug’s characteristics, hemodialysis may be considered by healthcare providers as a procedural measure to significantly clear the drug from the body. Accidental overdose has been reported in pediatric patients, often linked to mismeasuring the oral solution dose, emphasizing the need for care.

Therapeutic Uses of Levebon

What Levebon Treats: Main Uses and Benefits

Levebon (Levetiracetam) is a prescription medication commonly used for managing and controlling seizures, playing a role in the treatment of epilepsy. The primary uses and key indications are clinically recognized.

This medication is applied in addressing recurrent seizures, which are a manifestation of the neurological condition, epilepsy. It is commonly used to help with reducing the frequency of partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. The therapeutic benefit supports neurological stability, which contributes to easing the overall symptom load.


Key Therapeutic Context

Levebon is considered relevant for the long-term chronic management (conditions involving episodic or fluctuating manifestations) of epilepsy, serving either as the sole treatment (monotherapy) or in addition to other medications (adjunctive therapy). The medication supports managing symptoms that interfere with daily functioning in patients, including adults and pediatric groups, and contributes to easing the overall symptom load associated with their condition.

Quick Fact: Relief for Episodic Seizures
Levebon plays a role in managing recurrent seizure control, providing supportive relief relevant to the chronic nature of epilepsy.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Population Eligibility for Levebon

Levebon (Levetiracetam) may be used by various patient groups but is subject to absolute non-eligibility rules and conditional use requirements as defined in regulatory labeling.

Category Regulatory Eligibility Status
Absolute Contraindication Patients with known hypersensitivity to Levetiracetam or any pyrrolidone derivatives must not use the medicine.
Approved Age Groups Established for Adults (ge 16 years) for monotherapy and adjunctive therapy. Children and infants ge 1 month of age are eligible for adjunctive therapy for specific seizure types.
Conditional Use Patients with Impaired Renal Function require individualized use and dose adjustments, as the drug's clearance is reduced in this population. Older adults (ge 65 years) may require adjustment if their renal function is compromised.
Reproductive Status Use during pregnancy and lactation is conditional. Levetiracetam is known to be excreted into human milk and may require clinical monitoring during pregnancy due to potential changes in plasma levels.
Limited Eligibility The safety and efficacy of monotherapy have not been established in children and adolescents below 16 years of age. Infants under one month are generally considered a use-not-established group.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Levebon (Levetiracetam) is recognized in regulatory documents for its low potential for pharmacokinetic interactions, as it is minimally metabolized by the Cytochrome P450 (CYP) system. No medicinal products are formally listed as contraindicated combinations in the primary prescribing information.


Documented Pharmacokinetic Interaction Patterns

Co-administration with other Antiepileptic Drugs (AEDs), such as lamotrigine, phenytoin, and valproate, generally does not alter the plasma concentrations of Levebon. However, the apparent total body clearance of Levetiracetam was found to be increased when used alongside enzyme-inducing AEDs, such as carbamazepine, a factor noted in pediatric populations.

Regarding non-AED medications, Levebon did not significantly affect the pharmacokinetics of common drugs like digoxin or warfarin, nor did it influence the components of oral contraceptives. The administration of Probenecid, a renal tubular secretion blocker, produced only a marginal increase in Levetiracetam exposure.

Post-marketing reports indicate a possible decreased efficacy of Levetiracetam when co-administered with Polyethylene Glycol (PEG)-containing laxatives.


Restrictions and Special Considerations

Consideration Official Regulatory Statement
Food Bioavailability is not affected by food.
Timing Rules No mandatory time separation rules are specified.
Renal Function Clearance is dependent on renal function, necessitating assessment in patients with renal impairment.

Mechanism of Action

Specific mathbfSV2A Target and Synaptic Modulation

Levebon’s action centers on the Synaptic Vesicle Protein 2A (mathbfSV2A), a molecule involved in the presynaptic regulation of neurotransmitter release. The drug binds selectively to SV2A and acts as a modulator of its function, influencing the subsequent flow of excitatory signals across the nerve junction. This molecular mechanism involves modulation of pathological synaptic activity within nerve cell communication.


Control of Excitatory Neurotransmission

The molecular modulation of SV2A translates directly into a physiological cascade where the pathological release of excitatory neurotransmitters, primarily glutamate, is curtailed. This mechanism, which also involves secondary influence over presynaptic calcium channels, effectively dampens the chemical signal amplification. This biological process supports the adjustment of systems where the suppression of excessive signaling is required.


Inhibition of Neuronal Hypersynchronization

The net effect of reduced excitatory signaling is the inhibition of abnormal, synchronized neuronal discharge and reduction of elevated neuronal circuit excitability. Levebon engages mechanisms that influence key feedback regulation within pathways, allowing it to selectively suppress pathological activity without causing generalized depression of normal neuronal function. This activity profile limits the propagation of electrical activity within central nervous system pathways.

Dosage and Administration Information

Administration Guidelines for Levebon

Levebon (levetiracetam) is administered orally as tablets, oral solution, or orally disintegrating tablets (ODT), or intravenously via infusion when the oral route is temporarily not possible. The medication may be taken with or without food.

Standard Dosing and Frequency

Treatment is typically initiated at a total daily dose of 1000 mg, divided into 500 mg twice daily doses. The dose is then increased in increments of 1000 mg/day every two weeks up to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  • Age-Specific Rules: Dosing for pediatric patients is often weight-based and must be determined by a healthcare provider. Dose adjustments are required for adult patients with impaired renal function due to the drug’s primary elimination pathway.
  • Missed Dose: If a dose is missed, it is typically taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular schedule resumed. A double dose should not be taken to compensate.

Preparation and Administration Procedures

  • Oral: Tablets must be swallowed whole. The oral solution must be measured using a calibrated measuring device (not a household spoon). Orally disintegrating tablets should be placed on the tongue to dissolve and then swallowed with a sip of liquid, or dispersed in a small amount of liquid and consumed immediately.
  • Intravenous (I.V.): I.V. administration is given as an infusion over a 15-minute period. The I.V. dosage and frequency must be equivalent to the corresponding oral regimen, and the total daily dose should be the same as the oral form when switching between routes.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research Summary

A drug for pain management. Research has investigated the drug’s potential mechanism of action. Studies have investigated the drug for potential changes in chronic and acute neuropathic pain. Research has investigated potential secondary outcomes, including quality of life and opioid usage measures.

The current body of research does not include sufficient data to evaluate outcomes in certain patient populations, such as those with liver dysfunction, and long-term safety evidence remains limited.


Core Efficacy Studies

Monotherapy Trials

Phase 3 trials evaluated outcomes associated with the drug in monotherapy.

The primary endpoints of this research involved assessments of pain intensity using the Visual Analog Scale (VAS) over an 8-week period. One area of research focus involved outcomes related to Post-Herpetic Neuralgia (PHN).

  • PHN Cohort: In the Post-Herpetic Neuralgia group, studies reported that a notable percentage of participants who received the active drug met the criteria for a response (defined as at least a 50% change in pain score), compared to those receiving placebo.
  • Diabetic Neuropathy: Studies examining outcomes in diabetic neuropathy patients did not report reaching statistical significance on the primary endpoint.
  • Fibromyalgia: Research into fibromyalgia management using the drug is ongoing, with initial findings mixed on its effect on generalized pain and sleep disruption.

Combination Therapy Studies

Research has also examined outcomes of the drug when combined with low-dose gabapentin. Studies suggest that the combination was examined for patient compliance and potential changes to side effects. Research also included trials evaluating the combination against traditional therapies.

Study data explored the relationship between pain severity and treatment over 12 months. Secondary endpoints of these combination studies included measures of physical functioning and emotional well-being using the SF-36 health survey.

Key Studies & References Efficacy and Safety of Levebon Monotherapy in Post-Herpetic Neuralgia: A Randomized, Double-Blind, Phase 3 Trial

Frequently Asked Questions (FAQ)

Common questions about Levebon (FAQ)

Q: How quickly does Levebon leave the body?

Information based on pharmacokinetics, which describes how the body handles the drug, indicates that the plasma half-life in adults is typically 6 to 8 hours. This means it takes this amount of time for the concentration of the drug in the blood to decrease by half. Due to this rate, the medicine is generally considered to be fully eliminated from the body within approximately 44 hours.

Q: How long does it typically take before a person notices the effects of Levebon?

According to official product information on how the drug is absorbed, the immediate-release form typically reaches its peak concentration in the blood about one hour after it is taken. The extended-release form reaches its peak concentration around three hours later. This peak concentration is associated with the onset of the medicine's main effects.

Q: Does Levebon affect driving or operating machinery?

Official regulatory warnings indicate that the medicine may cause effects on the nervous system, such as dizziness or drowsiness (somnolence). Regulatory warnings indicate that the medicine may impair a person’s ability to drive or operate complex machinery. Individuals should take caution until they know how the medicine affects them.

Q: Does Levebon contain any substances that are known to be habit-forming?

Levebon, whose active ingredient is Levetiracetam, is not generally classified as a controlled substance under U.S. or E.U. law. This classification is based on the determination that the medicine does not have a significant potential for abuse or physical dependence, which differentiates it from some other antiepileptic drugs.

Q: Why is Levebon considered a controlled substance in some regions but not others?

In many major regions, the medicine is not scheduled as a controlled substance because of its minimal potential for abuse or dependence. Regulatory status, however, can vary between countries, as each government body makes its own determination regarding classification based on the local regulatory framework.

Q: Can I stop using Levebon suddenly, or is a different approach generally recommended?

Official regulatory guidance describes that the medication is typically reduced gradually over time, rather than stopped suddenly. Gradual reduction is the approach described in labeling to minimize the risk of increased seizure activity. Abrupt cessation is generally advised against in official labeling.

Q: What should be done if someone accidentally uses more Levebon than intended?

Symptoms of acute overdosage may include central nervous system effects such as drowsiness, difficulty breathing, aggression, or a decrease in consciousness. The official regulatory label describes that the management of an acute overdosage may involve the use of supportive care and the removal of unabsorbed drug, and mentions that hemodialysis may be considered.

Q: Are there any blood tests required before or during the use of Levebon?

The medicine has been associated with the potential for hematologic abnormalities, which are changes in blood cell counts. While routine therapeutic drug monitoring is not universally required, official guidelines note that monitoring of white and red blood cell counts may be appropriate in certain situations.

Q: Is it true that Levebon can interact with alcohol, and what does the regulatory information say?

Regulatory-based patient information suggests that while there is no formal medical contraindication, consuming alcohol may increase side effects like sleepiness or tiredness caused by the medicine. Official patient information also notes the general caution regarding alcohol consumption in patients being treated for epilepsy.

Q: Do official documents mention any effects of Levebon on blood pressure?

Yes, official regulatory labeling includes a specific warning about the potential for an Increase in Blood Pressure. This is a point of safety noted in the official product information.

Q: Is there any official information about Levebon causing changes in mood?

Official labeling documents a range of psychiatric and behavioral effects, including psychotic symptoms, irritability, aggression, and mood changes. Because of this, patients are typically monitored for new or worsening depression and suicidal ideation or behavior.

Q: Can I take Levebon if I am already taking over-the-counter pain medication?

Regulatory summaries note that Levebon has a low potential for pharmacokinetic drug interactions with other medications. This means it is less likely to affect how other medicines are processed by the body. No mandatory time separation rules are specified, but specific co-administration scenarios are typically reviewed with a healthcare professional.

Q: Is Levebon known to interact with herbal supplements?

Official sources note that herbal remedies and supplements are generally not tested for interactions with this medicine. Official sources note that if a person uses a supplement known to cause sleepiness or dizziness, there is a potential for these effects to be additive to those caused by the medicine.

Q: Are there any specific foods or drinks that should be avoided while using Levebon?

According to official administration guidelines, the drug's bioavailability, or how much of the drug is absorbed, is not affected by food. No mandatory time separation rules are specified, meaning the medicine can typically be taken with or without food.

Q: Does Levebon interact with common foods containing caffeine?

Formal drug interaction studies do not list a specific pharmacokinetic interaction between the medicine and caffeine. Regulatory information confirms that the drug's absorption is not affected by food or beverages.

How should Levebon be stored and disposed of?

Storage and Handling Requirements

Official labeling requires that Levebon (Levetiracetam) tablets and unopened solution be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F). The medication must be kept in its original, tightly closed, light-resistant container to ensure protection from moisture and light degradation.

The injectable form, once diluted for administration, maintains stability for up to 24 hours at controlled room temperature. Any unused portion of single-use injectable vials or bags must be discarded immediately.

Disposal Instructions

All Levebon products, including unused or expired medicine, must be disposed of in accordance with local and national regulations. To protect the environment and children, do not pour the medicine down a sink or flush it down a toilet. Disposal is recommended through official drug take-back programs or designated collection sites.

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

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