Levetiracetam 500mg Tablets
It is used to treat seizures.
Drug Class
Anticonvulsant; Antiepileptic Drug (AED)
Pharmacologic Class
Pyrrolidine derivative
Pregnancy Category
Category C
FDA Approved
Nov 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levetiracetam is a medication used to treat certain types of seizures (epilepsy). It works by affecting nerve activity in the brain to help prevent seizures. It's important to take it regularly as prescribed, even if you feel well, to keep your seizures under control.
How to Use This Medicine
Taking Your Medication Correctly
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. However, if needed, you can break the tablet in half, but be sure not to chew or crush it.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Protect your medication from heat and light. Keep all medications in a secure 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. However, if needed, you can break the tablet in half, but be sure not to chew or crush it.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Protect your medication from heat and light. Keep all medications in a secure 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 exactly as prescribed, do not stop abruptly without consulting your doctor, as this can increase seizure risk.
- Do not drive or operate machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Avoid alcohol, as it can increase side effects like drowsiness and dizziness.
- Report any new or worsening mood changes, depression, or suicidal thoughts to your doctor immediately.
- Maintain good oral hygiene, as some AEDs can affect gum health (though less common with levetiracetam).
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. Increase by 500 mg twice daily every 2 weeks to a maximum of 1500 mg twice daily.
Dose Range:
1000 - 3000 mg
Condition-Specific Dosing:
Myoclonic Seizures:
Initial: 500 mg twice daily. Increase by 500 mg twice daily every 2 weeks to a maximum of 1500 mg twice daily.
Primary Generalized Tonic-Clonic Seizures:
Initial: 500 mg twice daily. Increase by 500 mg twice daily every 2 weeks to a maximum of 1500 mg twice daily.
Partial-Onset Seizures:
Initial: 500 mg twice daily. Increase by 500 mg twice daily every 2 weeks to a maximum of 1500 mg twice daily.
Pediatric Dosing
Neonatal:
Not established (limited data, often off-label use with careful titration)
Infant:
Not established for all indications (e.g., partial-onset seizures from 1 month to <4 years: Initial 10 mg/kg twice daily, max 25 mg/kg twice daily)
Child:
Partial-onset seizures (4 to <16 years): Initial 10 mg/kg twice daily, max 30 mg/kg twice daily. Myoclonic/PGTC seizures (12 to <16 years): Initial 500 mg twice daily, max 1500 mg twice daily.
Adolescent:
Partial-onset seizures (âĨ16 years): Same as adult dosing. Myoclonic/PGTC seizures (âĨ12 years): Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-79 mL/min: 500-1500 mg twice daily
Moderate:
CrCl 30-49 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 dose reduction by 50% for initial dose if CrCl <70 mL/min, then monitor renal function and adjust accordingly.
Pharmacology
Mechanism of Action
The precise mechanism by which levetiracetam exerts its antiepileptic effect is unknown. It does not act via known mechanisms of other antiepileptic drugs. In vitro and in vivo studies suggest that levetiracetam inhibits burst firing without affecting normal neuronal excitability. It binds selectively to the synaptic vesicle protein 2A (SV2A) in the brain, which is thought to modulate neurotransmitter release. It also inhibits N-type calcium currents and reverses the reduction in GABA- and glycine-gated currents induced by zinc and beta-carbolines.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
1 hour (oral solution), 1.3 hours (tablet)
FoodEffect:
Food does not affect the extent of absorption, but it may slightly decrease the rate of absorption (Tmax delayed by 1.5 hours).
Distribution:
Vd:
0.5-0.7 L/kg
ProteinBinding:
<10%
CnssPenetration:
Yes
Elimination:
HalfLife:
7 Âą 1 hours (adults); 5-7 hours (children); 10-11 hours (elderly)
Clearance:
0.96 mL/min/kg (adults)
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
66%
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 (due to twice-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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, including:
+ 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 including:
+ 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 experience 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 or https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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, including:
+ 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 including:
+ 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 experience 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 or https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening depression, anxiety, or other mood changes
- Thoughts of self-harm or suicide
- Unusual changes in behavior or aggression
- Severe skin rash or blistering
- Fever, sore throat, or other signs of infection
- Unusual bleeding or bruising
- Severe fatigue or weakness
- Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
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 in combination 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 in combination 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 or worsening of seizures after starting this medication, promptly discuss this with your doctor.
Do not abruptly discontinue taking this medication without first consulting your doctor, as this may increase your risk of seizures. If it is 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. Not all formulations of this medication are suitable for all children, so it is crucial to consult with your doctor before giving it to a child.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby. Be aware that this drug may be less effective in controlling seizures during pregnancy, and if you have any concerns, 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 or worsening of seizures after starting this medication, promptly discuss this with your doctor.
Do not abruptly discontinue taking this medication without first consulting your doctor, as this may increase your risk of seizures. If it is 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. Not all formulations of this medication are suitable for all children, so it is crucial to consult with your doctor before giving it to a child.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby. Be aware that this drug may be less effective in controlling seizures during pregnancy, and if you have any concerns, consult with your doctor.
Overdose Information
Overdose Symptoms:
- Somnolence
- Agitation
- Aggression
- Depressed level of consciousness
- Respiratory depression
- Coma
What to Do:
Call 911 or your local emergency number immediately. For advice, call a poison control center at 1-800-222-1222. There is no specific antidote; treatment is supportive and may include gastric lavage or emesis. Hemodialysis can remove approximately 50% of levetiracetam from the body.
Drug Interactions
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Levetiracetam is primarily renally excreted, and dose adjustments are necessary in patients with impaired renal function.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: Rare reports of hematologic abnormalities (e.g., neutropenia, leukopenia, pancytopenia).
Timing: Prior to initiation, and periodically if clinically indicated or symptoms arise.
Psychiatric history/mood assessment
Rationale: Risk of behavioral abnormalities, including 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 activity or lack of efficacy may warrant dose adjustment or alternative therapy.
Adverse effects (e.g., somnolence, dizziness, behavioral changes)
Frequency: Regularly, at each follow-up visit
Target: Minimization of side effects
Action Threshold: Significant or intolerable side effects may require dose reduction or discontinuation.
Renal function (CrCl)
Frequency: Periodically, especially in elderly or those with pre-existing renal impairment
Target: Stable renal function
Action Threshold: Deterioration in renal function requires dose adjustment.
Symptom Monitoring
- Drowsiness
- Dizziness
- Fatigue
- Irritability
- Aggression
- Anxiety
- Depression
- Mood changes
- Suicidal thoughts or behavior
- Unusual bleeding or bruising
- Signs of infection (fever, sore throat)
- Severe skin rash
Special Patient Groups
Pregnancy
Levetiracetam is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Enrollment in the North American Antiepileptic Drug (NAAED) Pregnancy Registry is encouraged.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations compared to general population, but lower than some other AEDs. Data from registries suggest a relatively low risk.
Second Trimester:
Not available
Third Trimester:
Not available
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 treatment to the mother. Monitor breastfed infants for drowsiness, irritability, and poor feeding.
Infant Risk:
L3 (Moderately Safe - There are no controlled studies in breastfeeding women, but the risk of adverse effects to the infant is possible. Use should be considered only if the potential benefit justifies the potential risk to the infant.)
Pediatric Use
Dosing varies significantly by age and indication. Close monitoring for behavioral changes is crucial, as irritability and aggression can be more pronounced in children. Renal function should be monitored, especially in younger children.
Geriatric Use
Dose adjustment is recommended for elderly patients with impaired renal function. Start with a lower dose and titrate slowly. Monitor for increased somnolence, dizziness, and gait disturbances due to increased sensitivity to CNS effects.
Clinical Information
Clinical Pearls
- Levetiracetam has a favorable pharmacokinetic profile with minimal protein binding and no significant CYP450 interactions, making it a good choice for polytherapy.
- Behavioral side effects (irritability, aggression, mood changes) are common, especially during initial titration or at higher doses. Patients and caregivers should be counseled on these and encouraged to report them.
- Renal dose adjustment is critical, as the drug is primarily renally eliminated.
- Abrupt discontinuation can precipitate seizures; always taper slowly under medical supervision.
- Available in various formulations (tablet, oral solution, extended-release tablet, IV) offering flexibility in administration.
Alternative Therapies
- Lamotrigine
- Valproic Acid
- Carbamazepine
- Oxcarbazepine
- Topiramate
- Zonisamide
- Lacosamide
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets (generic 500mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its safe and effective use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its safe and effective use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.