Levetiracetam ER 750mg Tablets
It is used to treat seizures.
Drug Class
Anticonvulsant
Pharmacologic Class
Pyrrolidine derivative
Pregnancy Category
Category C
FDA Approved
Sep 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levetiracetam ER is an extended-release medication used to help control certain types of seizures (epilepsy). It works by affecting certain chemicals in the brain to reduce seizure activity. The extended-release form means you take it once a day.
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.
Take your medication with or without food, as directed by your doctor.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Take your medication at the same time every day to establish a routine.
Swallow the tablets whole; do not chew or crush them.
Special Instructions for Extended-Release Tablets (Elepsia XR)
Each extended-release tablet has two distinct layers: a blue layer and a white to off-white layer. If your tablet does not have both layers, do not take it. Instead, contact your pharmacist.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light to preserve its effectiveness.
Keep all medications in a safe and secure 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.
If it is 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 a missed dose.
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.
Take your medication with or without food, as directed by your doctor.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Take your medication at the same time every day to establish a routine.
Swallow the tablets whole; do not chew or crush them.
Special Instructions for Extended-Release Tablets (Elepsia XR)
Each extended-release tablet has two distinct layers: a blue layer and a white to off-white layer. If your tablet does not have both layers, do not take it. Instead, contact your pharmacist.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light to preserve its effectiveness.
Keep all medications in a safe and secure 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.
If it is 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 a missed dose.
Lifestyle & Tips
- Take the medication exactly as prescribed, at the same time each day.
- Do not crush, chew, or break the extended-release tablets; swallow them whole.
- Do not stop taking this medication suddenly, as it can increase your risk of seizures. Any dose changes should be made under the guidance of your doctor.
- Avoid alcohol or other CNS depressants, as they can increase side effects like dizziness and drowsiness.
- Be aware of potential changes in mood or behavior, including depression or suicidal thoughts, and report them to your doctor immediately.
- Carry identification indicating 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: 1000 mg once daily. Increase by 1000 mg/day every 2 weeks to a maximum of 3000 mg once daily.
Dose Range:
1000 - 3000 mg
Condition-Specific Dosing:
partial-onset seizures:
Initial: 1000 mg once daily. Increase by 1000 mg/day every 2 weeks to a maximum of 3000 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Levetiracetam ER is not recommended for pediatric patients under 16 years of age)
Adolescent:
For adolescents 16 years and older: Initial: 1000 mg once daily. Increase by 1000 mg/day every 2 weeks to a maximum of 3000 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: No dose adjustment needed.
Moderate:
CrCl 30-50 mL/min: Initial 500 mg once daily, max 1500 mg once daily.
Severe:
CrCl <30 mL/min: Initial 500 mg once daily, max 1000 mg once daily.
Dialysis:
ESRD patients on dialysis: Initial 500 mg once daily, max 1000 mg once daily. A 250 mg to 500 mg supplemental dose is recommended after dialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
No specific dose adjustment recommended for severe hepatic impairment, but consider renal function as hepatic impairment may reduce non-renal clearance of levetiracetam.
Pharmacology
Mechanism of Action
The precise mechanism of action for levetiracetam is unknown, but it differs from other antiepileptic drugs. It is thought to exert its antiepileptic effects through binding to the synaptic vesicle protein 2A (SV2A) in the brain, which is involved in neurotransmitter release. This binding is hypothesized to modulate synaptic transmission and inhibit hypersynchronized burst firing.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
Approximately 4 hours (for ER formulation)
FoodEffect:
Food does not affect the extent of absorption of levetiracetam ER, but it may slightly decrease the rate of absorption.
Distribution:
Vd:
Approximately 0.5-0.7 L/kg
ProteinBinding:
<10%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 7 hours (adults), prolonged in renal impairment.
Clearance:
Approximately 0.96 mL/min/kg
ExcretionRoute:
Renal (primarily unchanged drug and inactive metabolite)
Unchanged:
Approximately 66% (unchanged drug)
Pharmacodynamics
OnsetOfAction:
Within days of reaching therapeutic levels (titration period)
PeakEffect:
Not directly applicable as it's a chronic medication for seizure control; peak plasma concentration reached at Tmax.
DurationOfAction:
24 hours (due to extended-release formulation)
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 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 passing out
Change in balance
Trouble 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 of severe skin reactions 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 of low blood cell counts 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 symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Feeling dizzy, sleepy, tired, or weak
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
Visit the FDA's MedWatch website 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 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 passing out
Change in balance
Trouble 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 of severe skin reactions 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 of low blood cell counts 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 symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Feeling dizzy, sleepy, tired, or weak
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
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Worsening depression or new mood problems
- Thoughts of harming yourself
- Unusual changes in behavior or mood (e.g., agitation, aggression, panic attacks)
- New or worsening seizures
- Severe rash or skin reactions
- Unexplained fever, sore throat, or easy bruising/bleeding (signs of blood problems)
- Severe weakness or muscle pain
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. Before operating a vehicle or engaging in activities that require alertness, wait until you understand how this drug affects you. Consult your doctor before consuming alcohol, marijuana, or other forms of cannabis, as well as 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 drug, your doctor will instruct you on how to gradually taper off the medication.
You may notice what appears to be a tablet in your stool, but this is a normal occurrence and not a cause for concern. If you have any questions or concerns, consult your doctor.
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 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, and consult your doctor if you have any questions or concerns.
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 drug, your doctor will instruct you on how to gradually taper off the medication.
You may notice what appears to be a tablet in your stool, but this is a normal occurrence and not a cause for concern. If you have any questions or concerns, consult your doctor.
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 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, and consult your doctor if you have any questions or concerns.
Overdose Information
Overdose Symptoms:
- Somnolence
- Agitation
- Aggression
- Decreased level of consciousness
- Respiratory depression
- Coma
What to Do:
Call 1-800-222-1222 (Poison Control). Seek immediate medical attention. There is no specific antidote. Treatment is supportive and may include gastric lavage or emesis. Hemodialysis can remove levetiracetam.
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
Routine Monitoring
Clinical response (seizure frequency and severity)
Frequency: Regularly throughout therapy
Target: Optimal seizure control with minimal side effects
Action Threshold: Increased seizure frequency or uncontrolled seizures may indicate need for dose adjustment or alternative therapy.
Adverse effects (e.g., somnolence, dizziness, behavioral changes, psychiatric symptoms)
Frequency: Regularly, especially during titration and dose changes
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Mood and behavior changes (e.g., depression, agitation, suicidal ideation)
Frequency: Regularly, especially during initial therapy and dose changes
Target: Stable mood and behavior
Action Threshold: New or worsening psychiatric symptoms require immediate evaluation and intervention.
Symptom Monitoring
- Drowsiness
- Dizziness
- Fatigue
- Irritability
- Aggression
- Depression
- Anxiety
- Suicidal thoughts or behavior
- Changes in seizure pattern
- Rash or severe skin reactions
- 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. 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. Pregnancy registries are available to monitor outcomes.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, though data are somewhat conflicting and generally lower than for older AEDs. Encourage enrollment in pregnancy registries.
Second Trimester:
Not specifically studied for unique risks in this trimester, but continued exposure.
Third Trimester:
Not specifically studied for unique risks in this trimester, but continued exposure. Potential for withdrawal symptoms in neonate if discontinued abruptly before delivery.
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 sedation, irritability, and poor feeding.
Infant Risk:
L3 - Moderate risk. Monitor infant for drowsiness, poor feeding, and developmental milestones.
Pediatric Use
Levetiracetam ER is not recommended for pediatric patients under 16 years of age due to lack of data. Immediate-release levetiracetam is approved for younger pediatric populations.
Geriatric Use
No specific dose adjustment is needed based on age alone, but dose should be adjusted for age-related decline in renal function. Start at the lower end of the dosing range and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Levetiracetam ER is a once-daily formulation, which can improve patient adherence compared to immediate-release formulations.
- Unlike many other AEDs, levetiracetam has a favorable drug interaction profile due to its minimal metabolism by CYP450 enzymes and low protein binding.
- Patients should be counseled on potential psychiatric side effects, including irritability, aggression, depression, and suicidal ideation, and instructed to report these immediately.
- Abrupt discontinuation can lead to increased seizure frequency or status epilepticus; doses should be tapered gradually.
- Renal function must be assessed before initiating therapy and monitored periodically, as dose adjustments are critical in renal impairment.
Alternative Therapies
- Immediate-release Levetiracetam
- Other antiepileptic drugs for partial-onset seizures (e.g., Lamotrigine, Carbamazepine, Oxcarbazepine, Phenytoin, Valproate, Topiramate, Zonisamide, Lacosamide, Perampanel, Brivaracetam)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$300+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
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 detailed information, including the name of the medication, the amount taken, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
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 detailed information, including the name of the medication, the amount taken, and the time it occurred.