Vimpat 200mg/20ml Inj, 20ml
It is used to treat seizures.
Drug Class
Anticonvulsant
Pharmacologic Class
Sodium channel blocker (selective enhancement of fast inactivation)
Pregnancy Category
Category C
FDA Approved
Oct 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lacosamide is a medication used to help control certain types of seizures (epilepsy). It works by affecting nerve signals in the brain to reduce the electrical activity that causes seizures. This injection form is used when you cannot take the medicine by mouth or need a rapid effect.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the dosage instructions provided by your healthcare team. This medication is administered intravenously over a specified period.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the appropriate storage method.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the appropriate storage method.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
Lifestyle & Tips
- Do not drive or operate machinery until you know how this medication affects you, as it can cause dizziness and vision problems.
- Avoid alcohol, as it can worsen side effects like dizziness and drowsiness.
- Do not stop taking this medication suddenly without consulting your doctor, as this can lead to increased seizure frequency.
- Maintain regular follow-up appointments with your doctor to monitor your condition and medication effectiveness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 100 mg IV twice daily (200 mg/day). May increase by 50 mg twice daily (100 mg/day) weekly. Maintenance: 200-400 mg/day (100-200 mg twice daily). Max: 400 mg/day.
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
Rapid Titration:
Initial: 200 mg IV single loading dose, followed by 100 mg IV twice daily approximately 12 hours later. Maintenance: 200-400 mg/day (100-200 mg twice daily).
Conversion from Oral:
IV dose is equivalent to oral dose (1:1 conversion).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4 years to less than 17 years: Initial: 1 mg/kg IV twice daily (2 mg/kg/day). May increase by 1 mg/kg twice daily (2 mg/kg/day) weekly. Maintenance: 3-6 mg/kg twice daily (6-12 mg/kg/day). Max: 300 mg/day (for patients weighing <50 kg) or 400 mg/day (for patients weighing âĨ50 kg). Rapid Titration: 7 mg/kg IV single loading dose (for patients weighing <50 kg) or 200 mg IV single loading dose (for patients weighing âĨ50 kg), followed by 1 mg/kg IV twice daily (for patients weighing <50 kg) or 100 mg IV twice daily (for patients weighing âĨ50 kg) approximately 12 hours later. Max: 300 mg/day (for patients weighing <50 kg) or 400 mg/day (for patients weighing âĨ50 kg).
Adolescent:
17 years and older: Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >50 mL/min).
Moderate:
No adjustment needed (CrCl 30-50 mL/min).
Severe:
Initial: 50 mg twice daily (100 mg/day). Max: 300 mg/day (CrCl <30 mL/min).
Dialysis:
Supplementation of up to 50% of the daily dose should be considered after hemodialysis. Max: 300 mg/day.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
Initial: 50 mg twice daily (100 mg/day). Max: 300 mg/day.
Severe:
Not studied; use with caution and consider further dose reduction.
Pharmacology
Mechanism of Action
Lacosamide's precise mechanism of action as an antiepileptic drug is not fully understood. In vitro electrophysiological studies have shown that lacosamide selectively enhances fast inactivation of voltage-gated sodium channels, which leads to stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. It also binds to the collapsin response mediator protein 2 (CRMP-2), a phosphoprotein expressed in the nervous system, though the functional consequence of this binding is unknown.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV to oral conversion is 1:1)
Tmax:
Not applicable for IV administration (peak concentration is immediate)
FoodEffect:
Not applicable for IV administration
Distribution:
Vd:
0.6 L/kg
ProteinBinding:
<15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 13 hours
Clearance:
Not available (primarily renal excretion)
ExcretionRoute:
Renal (approximately 95% of dose)
Unchanged:
Approximately 40% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of IV administration)
PeakEffect:
Immediately after infusion
DurationOfAction:
Approximately 12 hours (consistent with twice-daily dosing)
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, 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
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
Feeling nervous, restless, or irritable
Panic attacks
Changes in mood or behavior
call your doctor right away. If you have suicidal thoughts or actions, seek medical attention 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, call 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 pass urine
+ Changes in the amount of urine passed
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach 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 and they bother you or do not go away, call your doctor:
Dizziness
Sleepiness
Tiredness
Weakness
Headache
Blurred vision
Diarrhea
Upset stomach
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, call 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, 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
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
Feeling nervous, restless, or irritable
Panic attacks
Changes in mood or behavior
call your doctor right away. If you have suicidal thoughts or actions, seek medical attention 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, call 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 pass urine
+ Changes in the amount of urine passed
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach 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 and they bother you or do not go away, call your doctor:
Dizziness
Sleepiness
Tiredness
Weakness
Headache
Blurred vision
Diarrhea
Upset stomach
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, call 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:
- Severe dizziness or fainting spells
- Double vision or blurred vision that is severe or persistent
- Unusual heartbeats (palpitations, very fast or very slow heart rate)
- New or worsening depression, anxiety, or other mood changes
- Thoughts of self-harm or suicide
- Severe skin rash or allergic reaction (e.g., swelling of face/lips, difficulty breathing)
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting)
- Signs of DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms): fever, rash, swollen lymph nodes, swelling of face, and involvement of other organs like liver, kidney, heart, or blood.
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 liver disease, as this may affect your ability to take this medication.
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 conditions.
Remember, do not start, stop, or change the dose 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 liver disease, as this may affect your ability to take this medication.
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 conditions.
Remember, do not start, stop, or change the dose 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 any activity that requires your full attention, wait until you understand how this medication affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when navigating stairs.
As directed by your doctor, undergo regular blood tests and discuss the results with them. Prior to consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
If you experience changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly. Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of seizures. If it is necessary to stop taking this medication, your doctor will instruct you 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 complications and death. If you have concerns, discuss them with your doctor. Additionally, 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 they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when navigating stairs.
As directed by your doctor, undergo regular blood tests and discuss the results with them. Prior to consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
If you experience changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly. Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of seizures. If it is necessary to stop taking this medication, your doctor will instruct you 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 complications and death. If you have concerns, discuss them with your doctor. Additionally, 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 they 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
- Seizures
- Coma
- Cardiac conduction abnormalities (e.g., PR prolongation, QRS widening, bradycardia, AV block, atrial fibrillation/flutter)
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is supportive and may include gastric lavage, activated charcoal, and monitoring of vital signs and ECG.
Drug Interactions
Moderate Interactions
- Drugs that prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, antiarrhythmics)
- Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) - may increase lacosamide exposure
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - minor effect on lacosamide exposure
- Strong CYP2C19 inducers (e.g., rifampin, St. John's Wort) - may decrease lacosamide exposure
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess baseline cardiac conduction, especially in patients with pre-existing cardiac conduction problems or those taking other medications that prolong the PR interval.
Timing: Prior to initiation of treatment
Routine Monitoring
ECG
Frequency: After titration to maintenance dose, or if patient develops cardiac symptoms (e.g., palpitations, bradycardia, syncope).
Target: Normal PR interval (typically <200 ms in adults)
Action Threshold: Significant PR prolongation, new onset of atrial fibrillation/flutter, or other conduction abnormalities; consider dose reduction or discontinuation.
Renal function (CrCl)
Frequency: Periodically, especially in patients with known or suspected renal impairment.
Target: Not applicable
Action Threshold: Dose adjustment needed for CrCl <30 mL/min.
Hepatic function (LFTs)
Frequency: Periodically, especially in patients with known or suspected hepatic impairment.
Target: Not applicable
Action Threshold: Dose adjustment needed for moderate hepatic impairment; caution in severe impairment.
Symptom Monitoring
- Dizziness
- Nausea
- Diplopia (double vision)
- Headache
- Fatigue
- Ataxia (impaired coordination)
- Blurred vision
- Tremor
- Cardiac symptoms (palpitations, slow heart rate, fainting)
- Mood changes (depression, aggression, suicidal ideation)
- Rash
Special Patient Groups
Pregnancy
Lacosamide is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy registry is available (North American Antiepileptic Drug Pregnancy Registry: 1-888-233-2334).
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, though data are limited and conflicting. Animal studies show developmental toxicity.
Second Trimester:
Not specifically studied, but continued exposure may carry risks.
Third Trimester:
Not specifically studied, but continued exposure may carry risks. Consider potential for withdrawal symptoms in neonate if mother is on high doses.
Lactation
Lacosamide is excreted into human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother. Monitor breastfed infants for sedation, poor feeding, and developmental milestones.
Infant Risk:
L3 (Moderately Safe - limited controlled studies show no adverse effects, or risk is minimal). Potential for infant exposure and adverse effects (e.g., drowsiness, feeding difficulties) exists, especially in neonates or infants with impaired renal function.
Pediatric Use
Approved for partial-onset seizures in patients 4 years and older, and for primary generalized tonic-clonic seizures in patients 4 years and older. Dosing is weight-based for younger children. Safety and efficacy in patients younger than 4 years have not been established.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have decreased renal function, which may necessitate dose adjustment. They may also be more susceptible to cardiac conduction abnormalities and dizziness.
Clinical Information
Clinical Pearls
- IV lacosamide can be administered as a 30-60 minute infusion. Do not administer as a rapid IV push.
- The IV formulation is an alternative for patients when oral administration is temporarily not feasible. The conversion from IV to oral is 1:1.
- Rapid titration with a loading dose can be used for quicker seizure control, but may increase the risk of adverse events like dizziness and ataxia.
- Monitor for cardiac conduction abnormalities, especially in patients with pre-existing cardiac issues or those on other PR-prolonging drugs. ECG monitoring is recommended.
- Patients should be advised about the risk of dizziness, ataxia, and diplopia, especially during initiation and titration.
- Lacosamide has a low potential for drug-drug interactions compared to some other AEDs, but caution is still warranted with PR-prolonging agents.
Alternative Therapies
- Levetiracetam (Keppra)
- Phenytoin (Dilantin)
- Fosphenytoin (Cerebyx)
- Valproic Acid (Depakote)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
- Gabapentin (Neurontin)
- Pregabalin (Lyrica)
Cost & Coverage
Average Cost:
Not available per 200mg/20ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs for safe disposal. This medication is accompanied by a Medication Guide, which provides important information about its use. Read this guide carefully and review it again whenever your prescription is refilled. 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 contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.