Vimpat 10mg/ml Sol (glass Btl)
It is used to treat seizures.
Drug Class
Antiepileptic drug (AED)
Pharmacologic Class
Functionalized amino acid
Pregnancy Category
Not available
FDA Approved
May 2009
DEA Schedule
Schedule V
Overview
What is this medicine?
Lacosamide is a medication used to treat certain types of seizures (partial-onset seizures) in people with epilepsy. It works by affecting nerve signals in the brain to help control seizures.
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.
If you are taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Do not use a household teaspoon or tablespoon, as this could result in taking too much medication.
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better.
Special Instructions for Feeding Tubes
If you have a feeding tube, you can still use this medication. Follow the instructions provided by your doctor or healthcare provider. After administering the medication through the feeding tube, be sure to flush the tube.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms and areas prone to moisture.
Do not freeze your medication.
* After opening, discard any unused portion after 6 months.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, 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 one.
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.
If you are taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Do not use a household teaspoon or tablespoon, as this could result in taking too much medication.
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better.
Special Instructions for Feeding Tubes
If you have a feeding tube, you can still use this medication. Follow the instructions provided by your doctor or healthcare provider. After administering the medication through the feeding tube, be sure to flush the tube.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms and areas prone to moisture.
Do not freeze your medication.
* After opening, discard any unused portion after 6 months.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, 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 one.
Lifestyle & Tips
- Take exactly as prescribed, do not stop suddenly without consulting your doctor, as this can increase seizure risk.
- May cause dizziness, drowsiness, or problems with coordination. Avoid driving or operating machinery until you know how this medication affects you.
- Avoid alcohol, as it can worsen side effects like dizziness and drowsiness.
- Report any new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior to your doctor immediately.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 50 mg twice daily (100 mg/day). May increase by 50 mg twice daily weekly to a target maintenance dose of 100-200 mg twice daily (200-400 mg/day). Max: 400 mg/day.
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
rapid_titration:
Initial: 200 mg single loading dose, followed by 100 mg twice daily starting approximately 12 hours later. Subsequent dose adjustments should be made by 50 mg twice daily weekly.
monotherapy:
Initial: 50 mg twice daily (100 mg/day). May increase by 50 mg twice daily weekly to a target maintenance dose of 150-200 mg twice daily (300-400 mg/day). Max: 400 mg/day.
Pediatric Dosing
Neonatal:
Not established (Safety and effectiveness in pediatric patients less than 4 years of age have not been established).
Infant:
Not established (Safety and effectiveness in pediatric patients less than 4 years of age have not been established).
Child:
4 years to <50 kg: Initial: 1 mg/kg twice daily (2 mg/kg/day). Increase by 1 mg/kg twice daily weekly to a target maintenance dose of 3-6 mg/kg twice daily (6-12 mg/kg/day). Max: 12 mg/kg/day (not to exceed 400 mg/day).
4 years to <50 kg (rapid titration): Initial: 7 mg/kg single loading dose, followed by 3.5 mg/kg twice daily starting approximately 12 hours later. Subsequent dose adjustments should be made by 1.75 mg/kg twice daily weekly. Max: 12 mg/kg/day (not to exceed 400 mg/day).
Adolescent:
≥50 kg: Adult dosing applies (Initial: 50 mg twice daily; Maintenance: 100-200 mg twice daily).
≥50 kg (rapid titration): Adult dosing applies (Initial: 200 mg single loading dose, followed by 100 mg twice daily).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >50 mL/min).
Moderate:
No adjustment needed (CrCl >30 to ≤50 mL/min).
Severe:
Reduce maximum dose by 25% (CrCl ≤30 mL/min). Max: 300 mg/day. Titrate with caution.
Dialysis:
Reduce maximum dose by 25% (Max: 300 mg/day). A supplementary dose of up to 50% of the daily dose should be administered immediately after hemodialysis.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
Reduce maximum dose by 25% (Max: 300 mg/day). Titrate with caution.
Severe:
Not recommended (limited data, potential for increased exposure).
Pharmacology
Mechanism of Action
Lacosamide is a functionalized amino acid that selectively enhances slow inactivation of voltage-gated sodium channels (VGSCs), thereby stabilizing hyperexcitable neuronal membranes and inhibiting repetitive neuronal firing. It does not affect fast inactivation of VGSCs. The precise mechanism by which lacosamide exerts its antiepileptic effect in humans is not fully understood.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5 to 4 hours (oral solution may be slightly faster than tablets)
FoodEffect:
Minimal effect on rate and extent of absorption. Can be taken with or without food.
Distribution:
Vd:
Approximately 0.6 L/kg
ProteinBinding:
Less than 15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 13 hours
Clearance:
Approximately 0.48 L/h/kg
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 40% (unchanged drug in urine); approximately 30% as O-desmethyl metabolite.
Pharmacodynamics
OnsetOfAction:
Within hours of initial dose (based on pharmacokinetic profile and clinical effect)
PeakEffect:
Within 1-4 hours post-dose
DurationOfAction:
Approximately 12 hours (consistent with twice-daily dosing)
Safety & Warnings
BLACK BOX WARNING
Antiepileptic drugs (AEDs), including lacosamide, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Change in balance
Memory problems or loss
Severe dizziness or passing out
Abnormal heartbeat (fast, slow, or irregular)
Shakiness
Double vision
Shortness of breath
Chest pain
Burning, numbness, or tingling sensations that are not normal
Inability to control eye movements
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:
Depression
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavioral changes
contact your doctor right away. If you have suicidal thoughts or actions, seek medical help immediately.
A rare but potentially life-threatening condition has been reported in people taking seizure medications like this one. If you experience any of the following symptoms, contact your doctor right away:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people do not experience significant 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:
Dizziness, drowsiness, tiredness, or weakness
Headache
Blurred vision
Diarrhea, nausea, or vomiting
Dry mouth
Excessive sweating
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or 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 experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Change in balance
Memory problems or loss
Severe dizziness or passing out
Abnormal heartbeat (fast, slow, or irregular)
Shakiness
Double vision
Shortness of breath
Chest pain
Burning, numbness, or tingling sensations that are not normal
Inability to control eye movements
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:
Depression
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavioral changes
contact your doctor right away. If you have suicidal thoughts or actions, seek medical help immediately.
A rare but potentially life-threatening condition has been reported in people taking seizure medications like this one. If you experience any of the following symptoms, contact your doctor right away:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people do not experience significant 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:
Dizziness, drowsiness, tiredness, or weakness
Headache
Blurred vision
Diarrhea, nausea, or vomiting
Dry mouth
Excessive sweating
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening seizures or new types of seizures.
- Severe dizziness, lightheadedness, or fainting.
- Double vision or blurred vision.
- Severe skin rash, fever, swollen glands, or swelling of the face (signs of a serious allergic reaction or DRESS syndrome).
- Unusual bruising or bleeding.
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain).
- Any thoughts of harming yourself or others.
- New or worsening depression, anxiety, agitation, or panic attacks.
- Irregular heartbeat, palpitations, or chest 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 allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the safety and efficacy of the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins
* Any health problems you have or have had in the past
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
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 liver disease, as this may affect the safety and efficacy of the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins
* Any health problems you have or have had in the past
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious when driving or performing tasks that require your full attention, as it may affect your alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be careful when climbing stairs.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor. If you experience any changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly.
Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of seizures. If you need to discontinue the medication, your doctor will provide guidance on how to gradually taper off the dosage.
Be aware that this medication has been associated with abnormal heart rhythms, which can rarely lead to severe cardiac problems and even death. If you have any questions or concerns, discuss them with your doctor. Additionally, if you have phenylketonuria (PKU), consult with your doctor, as some formulations of this medication may contain phenylalanine.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
When starting this medication, be cautious when driving or performing tasks that require your full attention, as it may affect your alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be careful when climbing stairs.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor. If you experience any changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly.
Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of seizures. If you need to discontinue the medication, your doctor will provide guidance on how to gradually taper off the dosage.
Be aware that this medication has been associated with abnormal heart rhythms, which can rarely lead to severe cardiac problems and even death. If you have any questions or concerns, discuss them with your doctor. Additionally, if you have phenylketonuria (PKU), consult with your doctor, as some formulations of this medication may contain phenylalanine.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Nausea
- Vomiting
- Diplopia
- Ataxia
- Somnolence
- Seizures (including status epilepticus)
- Coma
- Cardiac conduction abnormalities (e.g., PR interval prolongation, QRS widening, bradycardia, AV block)
- Hypotension
- Cardiac arrest
What to Do:
Seek immediate medical attention or call 911. Contact a poison control center (1-800-222-1222). Management is supportive and may include gastric lavage, activated charcoal, and close monitoring of vital signs and cardiac function. Hemodialysis can remove lacosamide.
Drug Interactions
Major Interactions
- Drugs that prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, carbamazepine): May increase risk of PR interval prolongation and cardiac adverse events. Use with caution, consider ECG monitoring.
- Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine): May increase lacosamide exposure, especially in patients who are poor metabolizers of CYP2C19. Monitor for increased adverse effects.
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To determine appropriate dosing, especially in severe impairment.
Timing: Prior to initiation.
Hepatic function (ALT, AST, bilirubin)
Rationale: To determine appropriate dosing, especially in moderate to severe impairment.
Timing: Prior to initiation.
ECG
Rationale: Consider for patients with pre-existing cardiac conditions (e.g., conduction abnormalities, severe cardiac disease) or those on concomitant medications known to prolong PR interval.
Timing: Prior to initiation.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly, at each follow-up visit.
Target: Reduction in seizure activity.
Action Threshold: Increased seizure frequency or lack of improvement may indicate need for dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, nausea, diplopia, ataxia, somnolence, suicidal ideation)
Frequency: Regularly, at each follow-up visit, especially during titration.
Target: Absence or tolerability of side effects.
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
ECG (if indicated)
Frequency: Periodically, especially if patient develops cardiac symptoms or is on other PR-prolonging drugs.
Target: Normal PR interval.
Action Threshold: Significant PR prolongation or cardiac arrhythmias may require dose adjustment or discontinuation.
Symptom Monitoring
- Dizziness
- Nausea
- Vomiting
- Diplopia (double vision)
- Blurred vision
- Ataxia (loss of coordination)
- Somnolence (drowsiness)
- Fatigue
- Tremor
- Suicidal thoughts or behavior
- Depression or mood changes
- Aggression or agitation
- Panic attacks
- Insomnia
- New or worsening anxiety
- Restlessness
- Irritability
- Other unusual changes in behavior or mood
- Signs of hypersensitivity reaction (e.g., rash, fever, lymphadenopathy, facial swelling)
- Cardiac symptoms (e.g., palpitations, slow heart rate, fainting)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of lacosamide in pregnant women. Based on animal data, lacosamide may cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients should be enrolled in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
Trimester-Specific Risks:
First Trimester:
Animal studies show developmental toxicity (e.g., increased embryofetal mortality, skeletal and visceral malformations) at clinically relevant exposures.
Second Trimester:
Risk of fetal harm continues throughout pregnancy.
Third Trimester:
Risk of fetal harm continues throughout pregnancy. Consider potential for withdrawal symptoms in neonate if exposed late in pregnancy.
Lactation
Lacosamide is excreted into human milk. There are no data on the effects of lacosamide on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition. Monitor breastfed infants for drowsiness, adequate weight gain, and developmental milestones.
Infant Risk:
L3 (Moderate risk - limited data, but potential for infant adverse effects such as drowsiness or poor feeding exists. Monitor infant closely.)
Pediatric Use
Safety and effectiveness in pediatric patients less than 4 years of age have not been established. Dosing for pediatric patients 4 years and older is weight-based. Monitor for behavioral changes and suicidal ideation, as with all AEDs.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment may be necessary for elderly patients with renal or hepatic impairment. Start at the lower end of the dosing range and titrate slowly due to potential for increased sensitivity to adverse effects (e.g., dizziness, ataxia, falls).
Clinical Information
Clinical Pearls
- Lacosamide has a low protein binding and minimal CYP450 interaction, making it a good option for patients on multiple medications.
- The oral solution is bioequivalent to the tablets and can be used interchangeably.
- Rapid titration with a loading dose can be used for quicker seizure control, but may increase the risk of acute adverse events like dizziness and ataxia.
- Monitor for PR interval prolongation, especially in patients with pre-existing cardiac conduction problems or on other medications that affect cardiac conduction.
- Patients should be advised to report any signs of suicidal ideation or unusual behavioral changes immediately.
- Lacosamide can cause dizziness and ataxia, particularly during initiation and dose escalation. Advise patients to be cautious with activities requiring mental alertness.
Alternative Therapies
- Levetiracetam (Keppra)
- Oxcarbazepine (Trileptal)
- Carbamazepine (Tegretol)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
- Phenytoin (Dilantin)
- Valproic Acid (Depakote)
Cost & Coverage
Average Cost:
$300 - $600 per 460 mL bottle (10 mg/mL)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand name), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.