Levetiracetam 100mg/ml Solution
It is used to treat seizures.
Drug Class
Anticonvulsant; Antiepileptic Drug (AED)
Pharmacologic Class
Pyrrolidine derivative; Synaptic Vesicle Glycoprotein 2A (SV2A) ligand
Pregnancy Category
Not available
FDA Approved
Nov 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levetiracetam is a medicine used to treat certain types of seizures (epilepsy). It works by affecting certain chemicals in the brain to help control seizure activity. It is often used along with other seizure medicines.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Take your medication at the same time every day to establish a routine.
If you are taking a liquid form of this medication, measure your dose carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.
Do not use a household teaspoon or tablespoon to measure your dose, as this can lead to taking too much medication.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light.
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 of your medication:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and continue with 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 ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Take your medication at the same time every day to establish a routine.
If you are taking a liquid form of this medication, measure your dose carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.
Do not use a household teaspoon or tablespoon to measure your dose, as this can lead to taking too much medication.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light.
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 of your medication:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and continue with 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 exactly as prescribed, usually twice a day, with or without food.
- Do not stop taking this medicine suddenly, as it can cause seizures to worsen or occur more frequently. Always talk to your doctor before stopping.
- Avoid driving or operating machinery until you know how this medicine 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.
- Limit or avoid alcohol consumption, as it can increase side effects like drowsiness and dizziness.
- Maintain good oral hygiene, as some seizure medications can affect gum health.
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 (BID), titrate by 500 mg BID increments every 2 weeks.
Dose Range:
1000 - 3000 mg
Condition-Specific Dosing:
partialOnsetSeizures:
Initial 500 mg BID, max 1500 mg BID.
myoclonicSeizures:
Initial 500 mg BID, max 1500 mg BID.
primaryGeneralizedTonicClonicSeizures:
Initial 500 mg BID, max 1500 mg BID.
Pediatric Dosing
Neonatal:
Not established (limited data, often off-label use with careful monitoring)
Infant:
1 month to <6 months: Initial 7 mg/kg BID, max 21 mg/kg BID. (Oral solution)
Child:
6 months to <4 years: Initial 10 mg/kg BID, max 30 mg/kg BID. (Oral solution)
4 years to <16 years: Initial 10 mg/kg BID, max 30 mg/kg BID. (Oral solution or tablets)
Adolescent:
16 years and older: Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: 500-1000 mg BID
Moderate:
CrCl 30-50 mL/min: 250-750 mg BID
Severe:
CrCl <30 mL/min: 250-500 mg BID
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 if CrCl <70 mL/min (e.g., 500 mg once daily initially), as severe hepatic impairment may reduce non-renal clearance.
Pharmacology
Mechanism of Action
The precise mechanism of action of levetiracetam is unknown. It differs from other antiepileptic drugs. It binds to the synaptic vesicle protein 2A (SV2A), a ubiquitous integral membrane protein of synaptic vesicles, 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:
95-100%
Tmax:
Approximately 1 hour (oral solution/tablet)
FoodEffect:
Food does not affect the extent of absorption, but may slightly delay the rate.
Distribution:
Vd:
Approximately 0.5-0.7 L/kg
ProteinBinding:
<10%
CnssPenetration:
Yes
Elimination:
HalfLife:
Adults: 7 Âą 1 hours; Children: 5-7 hours; Renal impairment: Prolonged (up to 25 hours in severe impairment)
Clearance:
Renal clearance is approximately 0.6 mL/min/kg
ExcretionRoute:
Renal (primarily unchanged drug and inactive metabolite)
Unchanged:
Approximately 66% of the dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid (within hours to days of reaching therapeutic levels)
PeakEffect:
Achieved within 1-2 weeks of titration to target dose.
DurationOfAction:
Maintained with twice-daily dosing due to half-life.
Confidence:
Medium
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 when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 immediate medical attention.
Other Side Effects
Most people do not experience severe side effects, and many have no side effects or only minor ones. 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, contact your doctor or call 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 when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 immediate medical attention.
Other Side Effects
Most people do not experience severe side effects, and many have no side effects or only minor ones. 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, contact your doctor or call 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:
- Severe skin rash or blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Unusual bruising or bleeding, signs of infection (fever, sore throat) - may indicate blood dyscrasias
- Swelling of the face, lips, tongue, or throat (angioedema)
- Difficulty breathing or swallowing
- New or worsening depression, anxiety, agitation, aggression, or suicidal thoughts
- Significant increase in seizure frequency or severity
- Severe dizziness or loss of coordination
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 allergic reaction you experienced, including any symptoms that occurred.
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 you 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 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 allergic reaction you experienced, including any symptoms that occurred.
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 you 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 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.
Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require alertness. 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 changes in your seizures or if they worsen after starting this medication, discuss this with your doctor promptly.
Do not abruptly discontinue taking this medication without first consulting your doctor, as this may increase your risk of experiencing 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 alertness. 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 changes in your seizures or if they worsen after starting this medication, discuss this with your doctor promptly.
Do not abruptly discontinue taking this medication without first consulting your doctor, as this may increase your risk of experiencing 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
- Decreased level of consciousness
- Respiratory depression
- Coma
What to Do:
Call 911 or Poison Control (1-800-222-1222) immediately. 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
Moderate Interactions
- Methotrexate (may decrease methotrexate clearance, leading to increased methotrexate levels and toxicity)
- Oral contraceptives (no significant interaction, but monitor)
- Digoxin (no significant interaction, but monitor)
Monitoring
Baseline Monitoring
Renal function (serum creatinine, CrCl)
Rationale: Levetiracetam is primarily renally eliminated; 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, then periodically if clinically indicated.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly at follow-up visits
Target: Reduction or elimination of seizures
Action Threshold: Increased seizure frequency or breakthrough seizures may indicate need for dose adjustment or alternative therapy.
Behavioral/mood changes (e.g., aggression, agitation, depression, suicidal ideation)
Frequency: Regularly at follow-up visits, especially during initial titration and dose changes.
Target: Absence of significant adverse psychiatric effects.
Action Threshold: New or worsening psychiatric symptoms require immediate evaluation and potential dose adjustment or discontinuation.
Renal function (serum creatinine, CrCl)
Frequency: Periodically, especially in elderly patients or those with pre-existing renal impairment.
Target: Stable renal function.
Action Threshold: Significant decline in renal function requires dose adjustment.
Symptom Monitoring
- Dizziness
- Somnolence/fatigue
- Asthenia
- Irritability
- Aggression
- Anxiety
- Depression
- Suicidal thoughts or behavior
- Coordination difficulties (ataxia, gait disturbance)
- Changes in appetite or weight
- Skin rash
Special Patient Groups
Pregnancy
Levetiracetam is excreted in 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.
Trimester-Specific Risks:
First Trimester:
Data from pregnancy registries suggest no increased risk of major congenital malformations compared to the general population, but some studies suggest a small increased risk, particularly with polytherapy. Risk vs. benefit must be carefully weighed.
Second Trimester:
Continued monitoring of maternal seizure control and fetal development.
Third Trimester:
Continued monitoring. No specific risks identified for this trimester beyond general AED considerations.
Lactation
Levetiracetam is excreted into human breast milk. Monitor breastfed infants for sedation, irritability, and poor feeding. The American Academy of Pediatrics considers levetiracetam compatible with breastfeeding.
Infant Risk:
Low to moderate risk. Monitor for drowsiness, poor feeding, and developmental milestones.
Pediatric Use
Dosing is weight-based and age-dependent. Younger children (especially infants) have faster clearance and may require higher mg/kg doses. Behavioral side effects (e.g., irritability, aggression) may be more prominent in pediatric patients.
Geriatric Use
Start with lower doses and titrate slowly due to potential age-related decline in renal function. Monitor renal function closely. Increased risk of falls due to dizziness/somnolence.
Clinical Information
Clinical Pearls
- Levetiracetam has a favorable drug interaction profile due to minimal hepatic metabolism via CYP450 enzymes.
- Behavioral and psychiatric side effects (e.g., irritability, aggression, depression, anxiety, psychosis) are common, especially during initial titration or at higher doses. Patients and caregivers should be counseled to report these promptly.
- Renal dose adjustment is crucial, as levetiracetam is primarily renally eliminated.
- Do not discontinue abruptly due to risk of increased seizure frequency or status epilepticus.
- Available in multiple formulations (tablet, oral solution, extended-release tablet, IV), offering flexibility in administration.
Alternative Therapies
- Lamotrigine
- Valproic Acid
- Carbamazepine
- Oxcarbazepine
- Topiramate
- Zonisamide
- Lacosamide
- Phenytoin
Cost & Coverage
Average Cost:
Varies widely, e.g., $20-$100+ per 473 mL bottle of 100 mg/mL solution
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
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 quantity, and the time it occurred.