Lacosamide 50mg Tablets
It is used to treat seizures.
Drug Class
Anticonvulsant; Antiepileptic Drug (AED)
Pharmacologic Class
Functionalized amino acid; Voltage-gated sodium channel modulator (selective enhancement of slow inactivation)
Pregnancy Category
Not assigned; risk summary available
FDA Approved
Oct 2008
DEA Schedule
Schedule V
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 seizure activity.
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 with your prescription and follow the instructions closely. You can take this medication with or without food, and it's essential to swallow the tablet whole with a glass of water or another drink. Do not chew, break, or crush the tablet.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. It's crucial to maintain your treatment regimen to achieve the best results.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep it out of reach of children and pets, and consider storing it in a locked box or secure area to prevent unauthorized access.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next 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 the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's essential to swallow the tablet whole with a glass of water or another drink. Do not chew, break, or crush the tablet.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. It's crucial to maintain your treatment regimen to achieve the best results.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep it out of reach of children and pets, and consider storing it in a locked box or secure area to prevent unauthorized access.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next 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 the missed one.
Lifestyle & Tips
- Do not stop taking lacosamide suddenly, as this can increase your risk of seizures. Always consult your doctor before making any changes to your dose.
- Avoid alcohol while taking this medication, as it can increase side effects like dizziness and drowsiness.
- Be cautious when driving or operating machinery until you know how lacosamide affects you, as it can cause dizziness, blurred vision, or coordination problems.
- Report any new or worsening mood changes, depression, or suicidal thoughts to your doctor immediately.
- Carry a medical alert card or wear medical identification stating that you have epilepsy and are taking lacosamide.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 50 mg twice daily (100 mg/day), titrate weekly by 100 mg/day to a target maintenance dose of 200-400 mg/day given in two divided doses.
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
rapidTitration:
Loading dose of 200 mg orally once, followed by 100 mg twice daily approximately 12 hours later. Maintenance dose of 200-400 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 4 years of age.
Child:
4 years to less than 17 years: Initial 1 mg/kg twice daily (2 mg/kg/day). Titrate weekly by 2 mg/kg/day. Maintenance dose varies by weight: 4 to <11 kg: 6-12 mg/kg/day; 11 to <31 kg: 4-8 mg/kg/day; 31 to <50 kg: 4-6 mg/kg/day; âĨ50 kg: 200-400 mg/day.
Adolescent:
17 years and older: Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed (CrCl > 50 mL/min).
Moderate:
No dose adjustment needed (CrCl 30-50 mL/min).
Severe:
Maximum recommended dose is 300 mg/day (CrCl ⤠30 mL/min).
Dialysis:
Maximum recommended dose is 300 mg/day. A supplemental dose of up to 50% of the daily dose should be considered after hemodialysis.
Hepatic Impairment:
Mild:
Maximum recommended dose is 300 mg/day.
Moderate:
Maximum recommended dose is 300 mg/day.
Severe:
Not studied; use with caution and monitor closely. Dose reduction may be necessary.
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 slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. It does not affect fast inactivation of voltage-gated sodium channels.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
1-4 hours
FoodEffect:
No clinically significant effect of food on absorption.
Distribution:
Vd:
0.67 L/kg
ProteinBinding:
<15%
CnssPenetration:
Yes
Elimination:
HalfLife:
13 hours
Clearance:
0.48 L/h/kg
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 95% of the dose is excreted in the urine, with approximately 40% as unchanged lacosamide and 30% as the O-desmethyl metabolite.
Pharmacodynamics
OnsetOfAction:
Within hours (after first dose or loading dose)
PeakEffect:
Achieved with steady-state concentrations (typically 2-3 days with BID dosing)
DurationOfAction:
Maintained with twice-daily dosing due to half-life
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
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 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
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
contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
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 immediately:
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 urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ 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 notice any of the following symptoms and they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Blurred vision
Diarrhea
Upset stomach
Vomiting
Dry mouth
* Excessive sweating
This is not an exhaustive list of 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 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
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
contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
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 immediately:
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 urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ 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 notice any of the following symptoms and they bother you or do not go away, contact your doctor:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Blurred vision
Diarrhea
Upset stomach
Vomiting
Dry mouth
* Excessive sweating
This is not an exhaustive list of 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:
- New or worsening depression, anxiety, or irritability
- Thoughts of harming yourself or others
- Unusual changes in mood or behavior
- Severe skin rash, fever, swollen lymph nodes, or facial swelling (signs of DRESS syndrome)
- Chest pain, palpitations, or fainting spells
- Severe dizziness or loss of coordination
- Double vision or blurred vision
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you are experiencing to ensure safe use of this medication.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you are experiencing to ensure safe use of this medication.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions.
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 performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise care when navigating stairs.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Discuss any concerns or questions you have with your doctor.
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. If you experience changes in the frequency or severity of seizures after initiating 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 provide guidance on gradually tapering 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 or questions, discuss them with your doctor.
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 to discuss the potential benefits and risks to both you and your baby.
When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise care when navigating stairs.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Discuss any concerns or questions you have with your doctor.
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. If you experience changes in the frequency or severity of seizures after initiating 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 provide guidance on gradually tapering 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 or questions, discuss them with your doctor.
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 to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Nausea
- Vomiting
- Diplopia (double vision)
- Ataxia (lack of coordination)
- Seizures
- Coma
- Cardiac arrest
- PR interval prolongation
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and may include gastric lavage, activated charcoal, and monitoring of vital signs and ECG.
Drug Interactions
Major Interactions
- Drugs that prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, other AEDs like carbamazepine, lamotrigine, phenytoin) - potential for additive cardiac effects.
- Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) - may increase lacosamide exposure, though generally not clinically significant enough to warrant dose adjustment unless renal impairment is also present.
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess baseline cardiac conduction, especially in patients with pre-existing cardiac conditions or those on other PR-prolonging medications.
Timing: Prior to initiation, if clinically indicated.
Renal function (CrCl)
Rationale: To guide initial dosing and subsequent adjustments in patients with renal impairment.
Timing: Prior to initiation.
Hepatic function (LFTs)
Rationale: To guide initial dosing and subsequent adjustments in patients with hepatic impairment.
Timing: Prior to initiation.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly throughout treatment
Target: Reduction in seizure frequency, improved seizure control
Action Threshold: Increased seizure frequency or lack of efficacy may indicate need for dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, nausea, diplopia, ataxia)
Frequency: Regularly, especially during titration and dose changes
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Symptoms of suicidal ideation or behavior
Frequency: Regularly, especially during initial weeks of treatment and with dose changes
Target: Absence of new or worsening suicidal thoughts/behavior
Action Threshold: Report any changes in mood, behavior, or thoughts immediately.
Signs/symptoms of hypersensitivity reaction (DRESS syndrome)
Frequency: Regularly, especially during initial weeks to months of treatment
Target: Absence of rash, fever, lymphadenopathy, facial swelling, eosinophilia, or organ dysfunction
Action Threshold: Discontinue immediately if DRESS is suspected.
ECG
Frequency: As clinically indicated (e.g., new cardiac symptoms, changes in concomitant medications, or if PR prolongation is a concern)
Target: Normal PR interval or stable PR interval within acceptable limits
Action Threshold: Significant PR prolongation or new arrhythmias may require dose adjustment or discontinuation.
Symptom Monitoring
- Dizziness
- Nausea
- Vomiting
- Diplopia (double vision)
- Blurred vision
- Ataxia (lack of coordination)
- Tremor
- Fatigue
- Suicidal thoughts or behavior
- Rash
- Fever
- Lymphadenopathy (swollen lymph nodes)
- Facial swelling
- Eosinophilia
- Organ dysfunction (e.g., hepatitis, nephritis)
Special Patient Groups
Pregnancy
Lacosamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data from pregnancy registries suggest a potential for increased risk of major congenital malformations (e.g., cardiac defects, cleft lip/palate) compared to the general population, but the absolute risk is low and may be lower than some other AEDs. Enrollment in the North American Antiepileptic Drug (NAAED) Pregnancy Registry is encouraged.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations.
Second Trimester:
Continued monitoring for fetal development.
Third Trimester:
No specific increased risks identified beyond general AED considerations; monitor for neonatal withdrawal if discontinued late in pregnancy.
Lactation
Lacosamide is excreted into human breast milk. The amount of lacosamide transferred to the infant is low. Monitor breastfed infants for sedation, poor feeding, and developmental milestones. Weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
Low to moderate risk (L3)
Pediatric Use
Approved for use in patients 4 years of age and older. Dosing is weight-based and requires careful titration. Safety and efficacy in pediatric patients younger than 4 years have not been established.
Geriatric Use
Increased incidence of adverse events (e.g., dizziness, ataxia, falls) in elderly patients. Dose adjustments may be necessary based on renal function, which commonly declines with age. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Lacosamide is a Schedule V controlled substance due to a low potential for abuse, including euphoria.
- Titrate the dose slowly to minimize CNS-related side effects such as dizziness, nausea, and diplopia.
- Caution is advised when co-administering with other drugs known to prolong the PR interval (e.g., beta-blockers, calcium channel blockers, digoxin) or in patients with pre-existing cardiac conduction problems.
- Patients should be monitored for signs and symptoms of DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) syndrome, a potentially life-threatening hypersensitivity reaction.
- Oral and intravenous formulations are bioequivalent, allowing for seamless transition between routes.
Alternative Therapies
- Levetiracetam (Keppra)
- Lamotrigine (Lamictal)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Phenytoin (Dilantin)
- Valproic Acid (Depakote)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
Cost & Coverage
Average Cost:
$100 - $300 per 30 tablets (50mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic); Tier 3 or Tier 4 (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 for patients. Please 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. 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 amount, and the time it occurred.