Levetiracetam 250mg Tablets
It is used to treat seizures.
Drug Class
Anticonvulsant; Antiepileptic Drug (AED)
Pharmacologic Class
Pyrrolidine derivative; Synaptic vesicle glycoprotein 2A (SV2A) ligand
Pregnancy Category
Category C
FDA Approved
Nov 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levetiracetam is a medication used to help control seizures in people with epilepsy. It works by affecting certain chemicals in the brain to reduce abnormal electrical activity that can cause seizures.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well. To establish a routine, take your medication at the same time every day. Swallow the tablet whole - do not chew or crush it. If needed, you can break the tablet in half, but be sure not to chew or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Protect it from heat and light to preserve its effectiveness. Keep all medications in a safe place, out of the reach of children and pets, to prevent accidental ingestion.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well. To establish a routine, take your medication at the same time every day. Swallow the tablet whole - do not chew or crush it. If needed, you can break the tablet in half, but be sure not to chew or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Protect it from heat and light to preserve its effectiveness. Keep all medications in a safe place, out of the reach of children and pets, to prevent accidental ingestion.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed, usually twice a day, with or without food. Do not stop taking it suddenly without talking to your doctor, as this can cause seizures to worsen.
- Avoid or limit alcohol consumption, as it can increase side effects like dizziness and drowsiness.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness, drowsiness, and coordination problems.
- Maintain good oral hygiene and regular dental check-ups.
- Carry identification stating you have epilepsy and are taking antiepileptic medication.
Available Forms & Alternatives
Available Strengths:
- Levetiracetam 100mg/ml Solution
- Levetiracetam 1000mg Tablets
- Levetiracetam 250mg Tablets
- Levetiracetam 750mg Tablets
- Levetiracetam 500mg Tablets
- Levetiracetam ER 500mg Tablets
- Levetiracetam ER 750mg Tablets
- Levetiracetam 500mg/5ml Inj, 5ml
- Levetiracetam ER 500mg Tablets
- Levetiracetam ER 750mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 500 mg twice daily. Titration: Increase by 500 mg twice daily every 2 weeks. Maintenance: 1000 mg to 3000 mg twice daily.
Dose Range:
1000 - 6000 mg
Condition-Specific Dosing:
Myoclonic Seizures:
Initial: 500 mg twice daily. Titration: Increase by 500 mg twice daily every 2 weeks. Maintenance: 500 mg to 1500 mg twice daily.
Primary Generalized Tonic-Clonic Seizures:
Initial: 500 mg twice daily. Titration: Increase by 500 mg twice daily every 2 weeks. Maintenance: 500 mg to 1500 mg twice daily.
Pediatric Dosing
Neonatal:
Not established (limited data, often used off-label with careful monitoring)
Infant:
Partial-onset seizures (âĨ1 month to <4 years): Initial 10 mg/kg twice daily. Titrate to 20-40 mg/kg/day in 2 divided doses.
Child:
Partial-onset seizures (4 to <16 years): Initial 10 mg/kg twice daily. Titrate to 20-60 mg/kg/day in 2 divided doses. Max 3000 mg/day.
Adolescent:
Partial-onset seizures (âĨ16 years): Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: 500-1500 mg twice daily.
Moderate:
CrCl 30-50 mL/min: 250-750 mg twice daily.
Severe:
CrCl <30 mL/min: 250-500 mg twice daily.
Dialysis:
250-500 mg once daily, with a 250-500 mg supplemental dose after dialysis.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
Consider lower initial dose (e.g., 250 mg twice daily) and monitor renal function, as severe hepatic impairment may reduce renal clearance.
Pharmacology
Mechanism of Action
The precise mechanism by which levetiracetam exerts its antiepileptic effect is unknown. It differs from other antiepileptic drugs. In vitro and in vivo studies suggest that levetiracetam inhibits burst firing without affecting normal neuronal excitability, and it partially inhibits N-type calcium currents. It binds to the synaptic vesicle glycoprotein 2A (SV2A) in the brain, which is thought to modulate neurotransmitter release (e.g., glutamate, GABA). This binding may contribute to its anticonvulsant effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
1 hour (oral solution), 1 hour (immediate-release tablets)
FoodEffect:
Food does not affect the extent of absorption, but it may slightly decrease the rate (Tmax delayed by 1.5 hours).
Distribution:
Vd:
0.5-0.7 L/kg
ProteinBinding:
<10%
CnssPenetration:
Yes
Elimination:
HalfLife:
6-8 hours (adults), 5-7 hours (children), 10-11 hours (elderly), 10-16 hours (renal impairment)
Clearance:
Primarily renal clearance of unchanged drug and its inactive metabolite.
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 66% of the dose is excreted unchanged in the urine.
Pharmacodynamics
OnsetOfAction:
Rapid (within hours to days, depending on titration)
PeakEffect:
Achieved at steady-state concentrations, typically within 2-3 days of consistent dosing.
DurationOfAction:
Approximately 12 hours (consistent with twice-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Hallucinations (seeing or hearing things that are not there)
Severe dizziness or fainting
Changes in balance
Difficulty walking
Suicidal thoughts or actions (see below for more information)
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
+ Signs may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Low blood cell counts, which can increase the risk of:
+ Infections
+ Bleeding problems
+ Anemia
+ Signs may include:
- Fever
- Chills
- Sore throat
- Unexplained bruising or bleeding
- Feeling very tired or weak
Angioedema, a severe reaction that can be life-threatening, with signs such as:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
Suicidal Thoughts or Actions
Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts or actions, especially in people who have had suicidal thoughts or actions in the past. If you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Changes in mood or behavior
Contact your doctor right away. If you have suicidal thoughts or actions, seek medical help immediately.
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Nose or throat irritation
Trouble sleeping
Headache
* Flu-like symptoms
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Hallucinations (seeing or hearing things that are not there)
Severe dizziness or fainting
Changes in balance
Difficulty walking
Suicidal thoughts or actions (see below for more information)
Severe skin reactions, such as:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
+ Signs may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Low blood cell counts, which can increase the risk of:
+ Infections
+ Bleeding problems
+ Anemia
+ Signs may include:
- Fever
- Chills
- Sore throat
- Unexplained bruising or bleeding
- Feeling very tired or weak
Angioedema, a severe reaction that can be life-threatening, with signs such as:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
Suicidal Thoughts or Actions
Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts or actions, especially in people who have had suicidal thoughts or actions in the past. If you experience any new or worsening symptoms, such as:
Depression
Feeling nervous, restless, or irritable
Panic attacks
Changes in mood or behavior
Contact your doctor right away. If you have suicidal thoughts or actions, seek medical help immediately.
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Nose or throat irritation
Trouble sleeping
Headache
* Flu-like symptoms
Reporting Side Effects
If you have questions about side effects or want to report a side effect, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening depression, anxiety, agitation, or irritability
- Thoughts about self-harm or suicide
- Unusual changes in mood or behavior
- Severe skin rash, blistering, or peeling (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Fever, swollen glands, or other signs of infection
- Unusual bleeding or bruising
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- Worsening of seizures or new types of seizures
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease or are undergoing dialysis.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease or are undergoing dialysis.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention. Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
As directed by your doctor, regularly undergo blood tests and other laboratory examinations to monitor your condition. If you experience any changes in the frequency or severity of seizures after starting this medication, promptly discuss these changes with your doctor.
Do not abruptly discontinue taking this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If it becomes necessary to stop taking this drug, your doctor will instruct you on how to gradually taper off the medication to minimize potential risks.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Similarly, when administering this drug to children, use it with caution, as they may have a higher risk of experiencing certain side effects. Note that not all formulations of this medication are suitable for all children, so it is crucial to consult with your doctor before giving this drug to a child.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as it is necessary to discuss the potential benefits and risks of this medication to both you and your baby. Be aware that the effectiveness of this drug in controlling seizures may decrease during pregnancy, and if you have any concerns or questions, consult with your doctor.
Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention. Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
As directed by your doctor, regularly undergo blood tests and other laboratory examinations to monitor your condition. If you experience any changes in the frequency or severity of seizures after starting this medication, promptly discuss these changes with your doctor.
Do not abruptly discontinue taking this medication without first consulting your doctor, as this may increase your risk of experiencing seizures. If it becomes necessary to stop taking this drug, your doctor will instruct you on how to gradually taper off the medication to minimize potential risks.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Similarly, when administering this drug to children, use it with caution, as they may have a higher risk of experiencing certain side effects. Note that not all formulations of this medication are suitable for all children, so it is crucial to consult with your doctor before giving this drug to a child.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as it is necessary to discuss the potential benefits and risks of this medication to both you and your baby. Be aware that the effectiveness of this drug in controlling seizures may decrease during pregnancy, and if you have any concerns or questions, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Somnolence (extreme drowsiness)
- Agitation
- Aggression
- Decreased level of consciousness
- Respiratory depression
- Coma
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. There is no specific antidote; treatment is supportive and may include gastric lavage or emesis. Hemodialysis can remove levetiracetam from the body.
Drug Interactions
Monitoring
Baseline Monitoring
Renal function (serum creatinine, eGFR)
Rationale: Levetiracetam is primarily renally excreted; dose adjustment is required in renal impairment.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: Rare reports of hematologic abnormalities (e.g., neutropenia, leukopenia).
Timing: Prior to initiation, consider if patient has pre-existing hematologic issues.
Psychiatric history/mood assessment
Rationale: Risk of behavioral changes, aggression, agitation, and suicidal ideation.
Timing: Prior to initiation.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly, at each follow-up visit.
Target: Reduction or elimination of seizures.
Action Threshold: Increased seizure frequency or severity may indicate need for dose adjustment or alternative therapy.
Adverse effects (CNS, behavioral, dermatologic)
Frequency: Regularly, at each follow-up visit.
Target: Absence or tolerability of side effects.
Action Threshold: Intolerable side effects (e.g., severe somnolence, dizziness, aggression, agitation, suicidal ideation, rash) require dose adjustment or discontinuation.
Renal function (serum creatinine, eGFR)
Frequency: Periodically, especially in elderly patients or those with risk factors for renal impairment.
Target: Stable renal function.
Action Threshold: Deterioration in renal function requires dose adjustment.
Mood and behavior assessment
Frequency: Regularly, at each follow-up visit.
Target: Stable mood and behavior.
Action Threshold: New or worsening depression, suicidal thoughts, aggression, or agitation require immediate assessment and intervention.
Symptom Monitoring
- Seizure control (frequency, type, severity)
- Dizziness
- Somnolence/fatigue
- Weakness
- Irritability
- Aggression
- Anxiety
- Depression
- Suicidal thoughts or behavior
- Mood changes
- Coordination problems
- Skin rash or severe skin reactions (e.g., SJS, TEN)
- Unusual bleeding or bruising
- Signs of infection (fever, sore throat)
Special Patient Groups
Pregnancy
Levetiracetam is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Enrollment in a pregnancy registry (e.g., North American Antiepileptic Drug Pregnancy Registry) is recommended.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, though data are less clear than for some other AEDs. Discuss risks vs. benefits with physician.
Second Trimester:
Continued monitoring of maternal and fetal well-being. Therapeutic drug monitoring may be considered as clearance can increase during pregnancy.
Third Trimester:
Continued monitoring. Consider vitamin K supplementation for the mother in the last month of pregnancy to prevent neonatal bleeding, especially if other AEDs are also used.
Lactation
Levetiracetam is excreted into human breast milk. The decision to breastfeed should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of therapy to the mother. Monitor breastfed infants for sedation, irritability, poor feeding, and developmental milestones.
Infant Risk:
Risk L3 (Moderate Concern). Monitor for drowsiness, poor feeding, and developmental delays. Some infants may experience irritability or sedation.
Pediatric Use
Approved for partial-onset seizures in patients âĨ1 month of age, myoclonic seizures in patients âĨ12 years of age, and primary generalized tonic-clonic seizures in patients âĨ6 years of age. Dosing is weight-based for younger children. Behavioral side effects (e.g., aggression, irritability) may be more prominent in pediatric patients.
Geriatric Use
No specific dose adjustment is needed based on age alone, but dose should be adjusted for age-related decline in renal function. Elderly patients may be more susceptible to CNS side effects (e.g., dizziness, somnolence, gait disturbance) and should be monitored closely.
Clinical Information
Clinical Pearls
- Levetiracetam has a favorable pharmacokinetic profile with high bioavailability, linear kinetics, and minimal protein binding, leading to predictable dosing and few drug-drug interactions.
- It is primarily renally excreted, necessitating dose adjustments in patients with renal impairment.
- Common side effects include somnolence, dizziness, asthenia, and behavioral changes (e.g., irritability, aggression, anxiety, depression). Behavioral side effects can be dose-related and may require dose reduction or discontinuation.
- Patients should be counseled on the risk of suicidal ideation and behavior, and to report any mood or behavioral changes immediately.
- Unlike many other AEDs, levetiracetam does not require therapeutic drug monitoring for efficacy, but levels can be checked in specific situations (e.g., pregnancy, renal impairment, suspected non-adherence).
Alternative Therapies
- Lamotrigine
- Valproic acid
- Topiramate
- Carbamazepine
- Oxcarbazepine
- Phenytoin
- Gabapentin
- Pregabalin
- Lacosamide
- Zonisamide
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 500mg)
Generic Available:
Yes
Insurance Coverage:
Generic Levetiracetam is typically covered as a Tier 1 or Tier 2 medication by most insurance plans. Brand-name versions may require prior authorization or be placed on higher tiers.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.