Levetiracetam 1000mg 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 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. It's important to take it regularly as prescribed to keep seizure activity under control.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, and take it 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 still do not chew or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Protect it from heat and light. Keep all medications in a safe location, out of the reach of children and pets.
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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, and take it 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 still do not chew or crush it.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Protect it from heat and light. Keep all medications in a safe location, out of the reach of children and pets.
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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take exactly as prescribed, do not stop abruptly without consulting your doctor, as this can increase seizure risk.
- Avoid alcohol, 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 or drowsiness.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
- Maintain good hydration.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
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:
1000 mg/day (500 mg twice daily) initially, increasing to 3000 mg/day (1500 mg twice daily)
Dose Range:
1000 - 3000 mg
Condition-Specific Dosing:
Myoclonic Seizures:
Initial: 1000 mg/day (500 mg twice daily), increase by 1000 mg/day every 2 weeks to 3000 mg/day.
Primary Generalized Tonic-Clonic Seizures:
Initial: 1000 mg/day (500 mg twice daily), increase by 1000 mg/day every 2 weeks to 3000 mg/day.
Partial-Onset Seizures:
Initial: 1000 mg/day (500 mg twice daily), increase by 1000 mg/day every 2 weeks to 3000 mg/day. Max 3000 mg/day.
Pediatric Dosing
Neonatal:
Not established (limited data, typically off-label use with careful monitoring)
Infant:
Not established for all indications (e.g., partial-onset seizures from 1 month to <4 years: Initial 20 mg/kg/day in 2 divided doses, increase by 20 mg/kg/day every 2 weeks to 50 mg/kg/day)
Child:
Partial-onset seizures (4 to <16 years): Initial 20 mg/kg/day in 2 divided doses, increase by 20 mg/kg/day every 2 weeks to 60 mg/kg/day. Max 3000 mg/day.
Adolescent:
Partial-onset seizures (âĨ16 years): Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-79 mL/min: 1000-2000 mg/day in 2 divided doses.
Moderate:
CrCl 30-49 mL/min: 500-1500 mg/day in 2 divided doses.
Severe:
CrCl <30 mL/min: 500-1000 mg/day in 2 divided doses.
Dialysis:
500-1000 mg/day in 2 divided doses. A supplemental dose of 250-500 mg is recommended after dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No dose adjustment needed, but caution is advised in severe hepatic impairment with concomitant renal impairment.
Pharmacology
Mechanism of Action
The precise mechanism of action of levetiracetam is unknown. However, it differs from that of other antiepileptic drugs. In vitro and in vivo studies suggest that levetiracetam inhibits burst firing without affecting normal neuronal excitability, suggesting involvement in neuronal hyper-synchronization. A proposed mechanism involves binding to the synaptic vesicle protein 2A (SV2A), which is thought to modulate neurotransmitter release (e.g., glutamate, GABA) and thus prevent excessive neuronal activity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
1 hour (oral solution), 1.3 hours (tablets)
FoodEffect:
Food does not affect the extent of absorption but slightly decreases Cmax and prolongs Tmax.
Distribution:
Vd:
0.5-0.7 L/kg
ProteinBinding:
<10%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 7 hours (adults), 5-6 hours (children), 10-16 hours (elderly, renal impairment)
Clearance:
Not available (primarily renal excretion)
ExcretionRoute:
Renal (glomerular filtration followed by active tubular reabsorption)
Unchanged:
Approximately 66% (unchanged drug in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours to days, depending on titration)
PeakEffect:
Achieved with steady-state concentrations, typically within 2-4 days of consistent dosing.
DurationOfAction:
Approximately 12 hours (due to twice-daily dosing regimen)
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 notice any of the following signs or symptoms, contact your doctor or seek medical attention immediately:
Allergic reactions, characterized by:
+ 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
Liver problems, indicated by:
+ 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 (especially in people with a history of suicidal thoughts or actions)
New or worsening symptoms, such as:
+ Depression
+ Feeling nervous, restless, or irritable
+ Panic attacks
+ Other changes in mood or behavior
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may also affect internal organs
+ Signs 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 include:
- Fever
- Chills
- Sore throat
- Unexplained bruising or bleeding
- Feeling very tired or weak
Angioedema, a severe reaction that can be life-threatening, characterized by:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, 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 any side effects, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
* Submit a report 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 signs or symptoms, contact your doctor or seek medical attention immediately:
Allergic reactions, characterized by:
+ 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
Liver problems, indicated by:
+ 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 (especially in people with a history of suicidal thoughts or actions)
New or worsening symptoms, such as:
+ Depression
+ Feeling nervous, restless, or irritable
+ Panic attacks
+ Other changes in mood or behavior
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may also affect internal organs
+ Signs 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 include:
- Fever
- Chills
- Sore throat
- Unexplained bruising or bleeding
- Feeling very tired or weak
Angioedema, a severe reaction that can be life-threatening, characterized by:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, 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 any side effects, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Suicidal thoughts or behavior (new or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, severe restlessness, mania)
- Severe skin rash (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Unusual bleeding or bruising
- Signs of infection (fever, chills, sore throat)
- Severe weakness or muscle pain
- Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
- Difficulty breathing or swallowing
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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and other medications.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and other medications.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before operating a vehicle or engaging in activities that require alertness, wait until you understand how this medication affects you. Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.
Regularly undergo blood tests and other laboratory examinations as directed by your doctor. If you experience changes in the frequency or severity of seizures after starting this medication, discuss these changes with your doctor.
Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. Similarly, when administering this medication to children, use 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 consult your doctor before giving it to a child.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to both you and your baby. Be aware that this medication may be less effective in controlling seizures during pregnancy. If you have concerns, consult your doctor to address any questions you may have.
Regularly undergo blood tests and other laboratory examinations as directed by your doctor. If you experience changes in the frequency or severity of seizures after starting this medication, discuss these changes with your doctor.
Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dosage.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. Similarly, when administering this medication to children, use 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 consult your doctor before giving it to a child.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to both you and your baby. Be aware that this medication may be less effective in controlling seizures during pregnancy. If you have concerns, consult your doctor to address any questions you may have.
Overdose Information
Overdose Symptoms:
- Somnolence
- Agitation
- Aggression
- Depressed level of consciousness
- Respiratory depression
- Coma
What to Do:
Seek immediate medical attention or call 911. There is no specific antidote. Treatment is supportive and may include gastric lavage, emesis, or hemodialysis (which can remove up to 50% of the drug). Call 1-800-222-1222 for Poison Control.
Drug Interactions
Moderate Interactions
- Methotrexate (may decrease methotrexate clearance, leading to increased methotrexate levels and toxicity; monitor methotrexate levels and adjust dose as needed)
- Orlistat (may reduce absorption of levetiracetam; separate administration by at least 2 hours)
Monitoring
Baseline Monitoring
Renal function (serum creatinine, eGFR)
Rationale: Levetiracetam is primarily renally excreted, and dose adjustments are necessary 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, and periodically if clinically indicated.
Routine Monitoring
Clinical response (seizure frequency and severity)
Frequency: Regularly, at each follow-up visit.
Target: Reduction or elimination of seizures.
Action Threshold: Increased seizure frequency or lack of efficacy may warrant dose adjustment or alternative therapy.
Adverse effects (e.g., somnolence, dizziness, behavioral changes, psychiatric symptoms)
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 (serum creatinine, eGFR)
Frequency: Periodically, especially in elderly patients or those with pre-existing renal impairment.
Target: Within normal limits or stable for patient's baseline.
Action Threshold: Significant decline in renal function necessitates levetiracetam dose adjustment.
Symptom Monitoring
- Changes in mood or behavior (e.g., aggression, agitation, depression, anxiety)
- Thoughts of self-harm or suicide
- Unusual tiredness or weakness
- Dizziness or unsteadiness
- Difficulty concentrating or memory problems
- New or worsening skin rash
- Signs of infection (fever, sore throat)
- Unexplained bruising or bleeding
Special Patient Groups
Pregnancy
Levetiracetam is generally considered one of the safer antiepileptic drugs during pregnancy, but it is still classified as Category C. Data from pregnancy registries suggest a lower risk of major congenital malformations compared to some other AEDs. However, no drug is completely risk-free, and the decision to use levetiracetam during pregnancy should be made after careful consideration of the benefits of seizure control versus potential risks to the fetus.
Trimester-Specific Risks:
First Trimester:
Small increased risk of major congenital malformations (e.g., cardiovascular, cleft palate) compared to general population, but lower than many other AEDs. Folic acid supplementation is recommended.
Second Trimester:
Generally considered safe, continued monitoring of drug levels (if clinically indicated) and fetal development.
Third Trimester:
Generally considered safe, continued monitoring. Neonatal withdrawal symptoms are rare but possible.
Lactation
Levetiracetam is excreted into breast milk. The amount transferred to the infant is relatively low, and adverse effects in breastfed infants are generally mild (e.g., sedation, irritability). It is considered compatible with breastfeeding by many experts, but monitoring the infant for drowsiness or poor feeding is recommended.
Infant Risk:
Low to moderate risk. Monitor for sedation, irritability, poor feeding, or developmental milestones. Consider therapeutic drug monitoring in the infant if concerns arise.
Pediatric Use
Dosing is weight-based and age-dependent. Children may metabolize levetiracetam faster than adults, leading to shorter half-lives. Behavioral changes (e.g., aggression, irritability) may be more prominent in pediatric patients, especially younger children. Close monitoring for these effects is crucial.
Geriatric Use
Dose adjustments are often necessary in elderly patients due to age-related decline in renal function. Start with lower doses and titrate slowly. Elderly patients may also be more susceptible to central nervous system side effects like dizziness and somnolence.
Clinical Information
Clinical Pearls
- Levetiracetam has a favorable drug interaction profile compared to many other AEDs, as it is not significantly metabolized by CYP450 enzymes.
- Abrupt discontinuation can increase seizure frequency; always taper off slowly under medical supervision.
- Patients should be counseled on potential psychiatric and behavioral side effects, including suicidal ideation, and instructed to report them immediately.
- Oral solution is available for patients who have difficulty swallowing tablets.
- Extended-release (XR) formulation is available for once-daily dosing, which may improve adherence.
Alternative Therapies
- Lamotrigine
- Valproic Acid
- Carbamazepine
- Oxcarbazepine
- Topiramate
- Phenytoin
- Gabapentin
- Pregabalin
- Zonisamide
- Lacosamide
Cost & Coverage
Average Cost:
$15 - $100+ per 30 tablets (generic 1000mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, 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. 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, we encourage you to discuss them 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 seeking help, be prepared to provide details about the overdose, including the amount taken and the time it occurred.