Levetrim

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Levetrim

Medically reviewed

Laura Arias

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 Levetrim

Property Description
Active Ingredient Levetiracetam (INN)
Form Tablet (Immediate and Extended-Release), Oral Solution, Intravenous Solution
Pharmacological Class Antiepileptic Drug (AED) / Central Nervous System (CNS) Agent
General Purpose To modulate and stabilize abnormal electrical activity in the brain
Origin Synthetic, Second-Generation Pyrrolidone Derivative

Levetrim: Identity, Classification, and Origin

Levetrim is a prescription-only pharmaceutical preparation containing the active ingredient, Levetiracetam, which is chemically defined as a synthetic S-enantiomer and a chiral pyrrolidone derivative. It is formally designated as a second-generation antiepileptic drug (AED), belonging to the broader class of central nervous system (CNS) agents. This distinction is a key characteristic of its profile, as it is structurally and mechanistically unrelated to older anticonvulsants like phenytoin or carbamazepine, a factor recognized for reducing the potential for complex drug interactions.

Composition and Available Forms

This medication is a single-ingredient product, focused exclusively on Levetiracetam. It is available in diverse pharmaceutical preparations, including immediate-release and extended-release tablets, an oral solution with an aqueous base, and an intravenous (IV) solution. The availability of both oral and intravenous options provides clinical flexibility, supporting continuous therapy via the oral route and acute treatment via the intravenous route.

General Purpose of this Anticonvulsant

The core purpose of this anticonvulsant is to modulate and stabilize abnormal electrical activity within the brain by suppressing neuronal overactivity. The drug helps the central nervous system maintain a more controlled and orderly electrical state. This stabilizing function is typically applied in situations where abnormal electrical signals are a primary concern, achieving the therapeutic role of limiting neuronal hyperexcitability.

Regulatory References

  1. Levetiracetam - StatPearls

What side effects are possible with Levetrim?

Possible Side Effects and Safety Information

The safety profile for Levetrim (Levetiracetam) is classified by regulatory authorities based on observed frequency, with most commonly reported events affecting the central nervous system (CNS) and psychiatric domains. The official labeling establishes specific categories of adverse reactions and essential safety constraints.


Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized based on the proportion of patients who experienced them in clinical trials or post-marketing surveillance:

  • Very Common (Affecting ge 1 in 10): Nasopharyngitis, Somnolence (Drowsiness), and Headache.
  • Common (Affecting ge 1 in 100 but < 1 in 10): Asthenia/Fatigue, Aggression, Irritability, Dizziness, Anorexia, Vomiting, Diarrhea, and Rash.
  • Rare (Affecting < 1 in 1,000): Severe systemic events.

Serious Adverse Reactions and Safety Considerations

Regulatory documents include warnings for rare but clinically significant adverse reactions. The official label notes the potential for Suicidal Behavior and Ideation associated with antiepileptic drugs. Additionally, rare, potentially life-threatening systemic reactions have been reported, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Population-Specific Safety: The medicine's primary elimination via the kidneys necessitates that a dose modification be considered for patients with documented renal impairment. Furthermore, specific behavioral symptoms, such as aggression and irritability, were reported with higher frequency in pediatric patients in clinical studies. Abrupt discontinuation of the medicine must be avoided, as this is associated with the potential for increased seizure frequency.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory information describes specific manifestations that may occur in cases of Levetrim overdose, requiring immediate medical attention. Overdose may present with documented signs such as somnolence (drowsiness), ataxia (lack of coordination), agitation, aggression, tremor, and nystagmus (involuntary eye movements). Gastrointestinal symptoms like nausea and diarrhea have also been officially documented.

When to Seek Urgent Medical Help

Immediate medical attention must be sought for any suspected acute overdose. Severe outcomes officially documented in regulatory information include coma, increased seizure activity, and certain Electrocardiogram (ECG) changes. Contact emergency medical services without delay if an overdose is suspected.

Documented Management and Procedures

Treatment is officially defined as symptomatic and supportive, as no specific antidote is known. Officially described supportive measures may include consideration of gastric lavage or the use of activated charcoal to limit systemic absorption. Hospital monitoring of neurological status and vital signs may be required. Regulatory documents confirm that Levetiracetam is dialyzable, with a significant portion removed during standard hemodialysis.

Therapeutic Uses of Levetrim

What Levetrim Treats: Main Uses and Benefits

Levetrim is commonly used as a management option in epilepsy, applied in conditions where symptoms interfere with daily functioning and involve recurrent seizure patterns. This medication is utilized across therapeutic domains where additional symptomatic support is needed for conditions associated with heightened neurological or muscular activity.

Broad-Spectrum Management of Recurrent Seizure Patterns

This approach is relevant for easing symptoms and is commonly used for multiple seizure categories, including symptom groups associated with both localized (focal-onset) and widespread (generalized) manifestations, such as myoclonic and primary generalized tonic-clonic seizures. Used as a supportive management option, it provides support that helps ease the overall symptom burden and may assist with managing the frequency and severity of these episodes.


Utility in Acute Scenarios and Across the Lifespan

Levetrim is relevant in clinical settings that involve acute or unstable symptom patterns, such as when short-term symptomatic assistance in stabilization is needed. Its therapeutic use extends to all major age groups—from infants 1 month of age and older to older adults—assisting in managing seizure symptoms across different life stages and supporting improved day-to-day comfort.


Quick Fact: Relief for Involuntary Motor Episodes The medication plays a role in managing symptoms related to sudden, uncontrolled movements, specifically the myoclonic jerks and convulsions associated with generalized seizure types.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Levetrim’s eligibility is strictly defined by regulatory bodies based on patient age, known sensitivities, and organ function status.

Populations Who Cannot Use Levetrim

Use is contraindicated (absolutely prohibited) for patients with a known hypersensitivity to the active ingredient, Levetiracetam, to any other pyrrolidone derivatives, or to any of the inactive ingredients in the formulation.

Age-Related Eligibility and Limitations

Official approval for Levetrim varies by the patient's age and the specific condition being addressed:

  • Infants ge 1 Month of Age: Approved for adjunctive treatment of partial-onset seizures.
  • Children lt 12 Years: Use for myoclonic seizures is not established due to insufficient data.
  • Adolescents lt 16 Years: Monotherapy use for partial-onset seizures is not established.
  • Older Adults ge 65 Years: Eligibility is conditional; a dose adjustment is formally recommended if they have compromised renal function.

Conditional Use Requirements

Eligibility is restricted for populations whose physiological status affects how the medicine is cleared from the body:

  • Renal Impairment: Patients with any degree of reduced kidney function are considered conditionally eligible. Their use is restricted to a regimen that includes an individualized dose adjustment, as the drug is primarily eliminated by the kidneys.
  • Severe Hepatic Impairment: Eligibility may require a dose reduction if the patient also has coexisting impaired renal clearance.

Reproductive Status

Use during pregnancy is a population that requires close monitoring, as the regulatory label notes the drug may cause fetal harm based on animal data. Levetiracetam is excreted into human milk, restricting eligibility during lactation and requiring clinical assessment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents establish that Levetrim (Levetiracetam) has a low potential for complex pharmacokinetic drug-drug interactions, primarily due to its minimal involvement with the hepatic cytochrome P450 enzyme system and low plasma protein binding. The majority of documented interaction patterns are classified as either pharmacodynamic or related to clearance modification, with no specific co-administered substance formally listed as a contraindication based on an interaction risk in primary regulatory labels.


Documented Interaction Patterns

Interaction Type Official Regulatory Statement
Pharmacodynamic Co-administration with Central Nervous System (CNS) depressants, including alcohol, may cause an additive increase in CNS-related effects such as somnolence and fatigue.
Pharmacokinetic Co-use with enzyme-inducing antiepileptic drugs (e.g., Carbamazepine) is documented to increase the total body clearance of Levetrim, resulting in reduced systemic exposure.
Non-Interacting Substances Co-administration with common substances like oral contraceptives (Ethinyl Estradiol/Levonorgestrel), Digoxin, or Warfarin is documented to not significantly affect their concentrations or activity.
Food Interaction Administration of the tablet with or without food does not affect the extent of bioavailability.

Population-Specific Clearance Note

Levetrim is primarily eliminated by the kidneys. Its systemic clearance is officially recognized as reduced in patients with renal impairment, which is a critical exposure consideration for this population.

Mechanism of Action

How Levetrim Works: Modulating Neural Signaling

Levetrim exerts its targeted effect on key regulatory systems by primarily acting on the presynaptic mechanisms of chemical transmission within the central nervous system. Its core mechanism involves modulating dysregulated physiological processes, influencing activity patterns within targeted neuronal pathways.

Primary Mechanism: Targeting SV2A

Levetrim acts on a defined biological target by selectively binding to Synaptic Vesicle Glycoprotein 2A (SV2A), a protein located on presynaptic vesicles. This interaction is used to initiate or suppress specific signaling events, adjusting the dynamics of neurotransmitter release from nerve terminals.

Pathway Effect: Regulating Neurotransmitter Release

Binding to SV2A modifies early molecular steps that influence systemic physiological outcomes. This activity modulates the release of excitatory neurotransmitters into the synapse, which is relevant in systems associated with heightened pathway activation. This action results in the reduction of neurotransmitter release concentration.

Physiological Consequence: Modulating Neural Circuits

This targeted pathway interference modulates the frequency of excitatory transmission within the central pathways. This action results in restricted influence of excitatory mediators, producing an alteration in the synaptic activity profile.

Dosage and Administration Information

Official Administration Guidelines

Levetrim is administered following standard protocols for its two primary routes: oral and intravenous (IV). The oral route accommodates immediate-release (IR) and extended-release (XR) tablets, as well as an oral solution. The IV formulation is reserved for temporary use when oral administration is not feasible.


Administration Scope

Instruction Detail
Route of administration Oral and Intravenous (IV).
Dosing schedule The typical adult starting dose is 1000 mg total per day. The dose is usually increased every two weeks, up to a maximum recommended total daily dose of 3000 mg.
Frequency and Timing IR and IV forms are generally administered twice daily; the XR tablet is administered once daily. Intake is permissible with or without food.
Special Handling Extended-release tablets must be swallowed whole and must not be crushed or chewed. The IV concentrate must be diluted and infused slowly over 15 minutes.

Population-Based Use

Dosing requires individualization for patients with renal impairment, with adjustments based on calculated Creatinine Clearance. Pediatric dosing relies on specific weight-based calculations. Furthermore, a supplemental dose is required following hemodialysis sessions.

Connection to the overall use protocol: These instructions define a standardized protocol that structures treatment initiation, maintenance, and cessation. The protocol mandates two-week intervals for dose changes (titration) and requires strict adherence to form-specific rules, such as not crushing the XR tablet and diluting the IV solution, ensuring the drug is used within its designated parameters.

Recent Clinical Evidence

Levetrim: Recent Clinical Evidence

The research evidence for Levetrim (Levetiracetam) primarily comes from clinical studies designed to evaluate the patterns observed in subjects who received the medicine for conditions characterized by fluctuating or episodic manifestations of seizures. This overview summarizes the evidence base, focusing on the types of research conducted and the recognized limitations.


Evidence for use in Focal-Onset Seizures

The evaluation for focal-onset seizures is supported by a large number of controlled trials. Randomized Controlled Trials (RCTs) were the main study type used, comparing the medicine against placebo or other active treatments. Studies primarily examined metrics related to seizure frequency and the proportion of participants who met the study's threshold for response criteria (e.g., a 50% decrease). The initial research was heavily concentrated on the research context of the medicine's use as an add-on treatment. Evidence for its use as a single medication (monotherapy) remains an area where follow-up durations were limited.

Evidence for use in Generalized Seizure Patterns

Research was studied for use in generalized seizure types, specifically Myoclonic Seizures and Primary Generalized Tonic-Clonic Seizures (PGTCS). For both, evidence stems from short-term RCTs that monitored outcomes describing episodic or acute changes, such as seizure frequency. One recognized gap is the limited enrollment of subjects in the younger pediatric age groups (≤ 12 years) for PGTCS. Research was also evaluated in acute settings for Status Epilepticus (SE), where studies monitored the time needed to achieve seizure cessation.

Research in Special Populations and Uncertainty

Research was observed in various age groups, including neonates with acute seizures, using active comparator trials. Findings were mixed across these specialized studies, and analysis described high statistical variability, meaning that the consistency of the evidence base remains low for some studies. For many indications, long-term effects are not fully established, and the impact of the medicine over a period of many years is still being tracked and studied. Data for certain groups, such as very young children for some seizure types, remain insufficient compared to adult populations.

Key Studies & References

  1. Comparison of Efficacy and Safety of Phenobarbital and Levetiracetam in the Treatment of Neonatal Seizures: A Systematic Review and Meta-Analysis
  2. NG217: Epilepsies in children, young people and adults: evidence reviews for antiseizure monotherapy in the treatment of GTC and focal onset seizures (NICE Guideline Document)
  3. Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy (NCT00150735 - Long-term monotherapy trial details)

Frequently Asked Questions (FAQ)

Common questions about Levetrim (FAQ)


Q: How quickly should I expect Levetrim to start working?

Official data indicates that the immediate-release form of Levetrim is rapidly absorbed, reaching its highest concentration in the bloodstream within approximately one hour. While the drug is active in the body quickly, the time it takes to observe the desired clinical effect on the treated condition can vary between individuals.

Q: Has Levetrim been approved by major regulatory bodies?

Yes, Levetrim (Levetiracetam) is a prescription medicine that has been approved by major regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for use in treating specific types of seizures.

Q: How long does Levetrim typically stay in your system after the last dose?

Official pharmacokinetic data shows that the elimination half-life of Levetrim in healthy adults is around 7 hours. The medication is primarily removed from the body by the kidneys, meaning the clearance rate may be slowed in people who have kidney impairment.

Q: Is Levetrim available over-the-counter or is it prescription-only?

Levetrim (Levetiracetam) is designated as a prescription-only drug. It cannot be purchased over-the-counter and requires a valid prescription.

Q: Does Levetrim have a generic version available?

Yes, the active ingredient in Levetrim, Levetiracetam, is available in generic versions, as indicated in its regulatory labeling.

Q: Are there different strengths or formulations of Levetrim?

Yes, Levetrim is available in several forms, including immediate-release tablets, extended-release tablets, an oral solution, and an intravenous (IV) solution. Each formulation is offered in various official strengths.

Q: Why do doctors prescribe Levetrim for different conditions?

Regulatory agencies have approved Levetrim for the treatment of several distinct types of seizures, including partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. This approval is based on clinical evidence for managing these specific conditions.


Q: Does Levetrim interact with common pain relievers like ibuprofen?

Official regulatory labeling for Levetrim does not list a specific pharmacokinetic interaction with non-prescription pain relievers such as ibuprofen. Levetrim is generally noted for having a low potential for complex drug-drug interactions compared to some other antiepileptic drugs.

Q: Does Levetrim interfere with birth control pills?

Regulatory studies indicate that taking Levetrim alongside common oral contraceptives (such as those containing Ethinyl Estradiol and Levonorgestrel) does not appear to significantly affect the concentration or activity of the birth control medication.

Q: What are the contraindications for Levetrim?

Official labeling states that Levetrim is absolutely contraindicated (prohibited) if a person has a known severe allergy or hypersensitivity to the active ingredient, Levetiracetam, or to any of the other ingredients in the product. Consulting the full official information is important for a complete list of warnings and restrictions.

Q: Can children be prescribed Levetrim, and is the formulation different?

Yes, Levetrim is approved for children as young as one month for certain uses. The product is offered in an oral solution, which is the preferred formulation for administration to infants and children under the age of 6 years.

Q: Is Levetrim safe to take during pregnancy (general question)?

Official information states that Levetrim may cause fetal harm based on animal data. Therefore, the decision for use during pregnancy involves careful clinical assessment and monitoring, as the drug should be used only if the potential benefit justifies the potential risk.

Q: Do older adults react differently to Levetrim compared to younger people?

Official information indicates that a dose adjustment should be considered for older adults (age 65 and over) if they have compromised renal function (reduced kidney clearance), as the drug is mainly eliminated by the kidneys. The adjustment addresses differences in drug clearance in this population.


Q: Can Levetrim affect the results of blood tests?

Levetrim is associated with rare reports of hematologic abnormalities (changes in blood cell counts) and liver enzyme abnormalities. These changes may be detectable through routine laboratory blood tests and are listed in the official product information.

Q: Are there any warning signs for a serious reaction to Levetrim?

The product label highlights rare but serious reactions, such as severe skin reactions (like Stevens-Johnson Syndrome or DRESS). If a person experiences new or worsening symptoms, such as rash, fever, or swollen lymph nodes, the official guidance is to seek immediate evaluation from a healthcare provider.

Q: Can Levetrim affect your mood or cause anxiety?

Yes, official drug labeling includes warnings that behavioral abnormalities, including anxiety, irritability, and aggression, have been reported. Patients should be monitored by their healthcare provider for any significant psychiatric signs or changes in mood while taking the medication.

Q: Is it safe to drive while taking Levetrim?

Due to the risk of somnolence (drowsiness) and fatigue, the official label cautions that individuals should refrain from driving or operating machinery until they understand how the medication affects them. This is because these side effects can impair the ability to perform skilled tasks.

Q: Are there any reports of Levetrim causing dizziness?

Yes, dizziness is listed as a common adverse reaction in clinical trial data. This means it was reported more frequently by individuals taking the drug compared to those taking a placebo.

Q: Do you have to stop taking Levetrim gradually, or can you stop all at once?

Official warnings indicate that the dose of Levetrim should be gradually reduced over time. Abruptly stopping the medication is discouraged because it can increase the risk of withdrawal seizures (a worsening in the frequency or severity of seizures).

How should Levetrim be stored and disposed of?

How to Store and Dispose of Levetrim?

The official storage and disposal guidelines for Levetrim (Levetiracetam) ensure product stability and safety, based on government regulatory documentation.

Storage/Handling Requirement Official Constraint
Temperature Store at controlled room temperature (20 C to 25 C), with permissible excursions up to 30 C.
Protection Keep the medication in its original container, tightly closed, and away from excess heat, light, and moisture.
Child Safety Mandatory to keep out of the sight and reach of children (containers require child-resistant closures).
IV Solution Stability The diluted intravenous solution has a limited stability period (e.g., 24 hours when refrigerated) and must be used immediately or stored accordingly.

Any unused portion of the single-dose IV vial must be discarded. Expired or unused oral product must not be disposed of in wastewater or household trash but should be discarded via an approved special waste collection point, following all local and national regulations.

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

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