Lacosamide 200mg Tablets
It is used to treat seizures.
Drug Class
Anticonvulsant
Pharmacologic Class
Functionalized amino acid (selective sodium channel inactivator)
Pregnancy Category
Category C
FDA Approved
Oct 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lacosamide is a medication used to treat certain types of seizures (epilepsy). It works by calming overactive nerves in the brain that cause seizures. It's important to take it exactly as prescribed, usually twice a day, and not to stop taking it suddenly, as this can cause seizures to return or worsen.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. 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 this medication as directed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom. Keep it in a safe location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication by throwing it away, but do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist or look into local drug take-back programs.
Missing 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 use this medication correctly, follow your doctor's instructions and read all the information provided. 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 this medication as directed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom. Keep it in a safe location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication by throwing it away, but do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist or look into local drug take-back programs.
Missing 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
- Take the medication exactly as prescribed, at the same times each day, with or without food.
- Do not stop taking lacosamide suddenly, as this can increase the risk of seizures. Any dose changes should be made under medical supervision.
- Avoid or limit alcohol consumption, 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 symptoms of depression, suicidal thoughts, or unusual changes in mood or behavior to your doctor immediately.
- Inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 50 mg twice daily (100 mg/day), titrated weekly by 100 mg/day increments to a target maintenance dose of 100-200 mg twice daily (200-400 mg/day).
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
monotherapy:
Initial 50 mg twice daily (100 mg/day), titrated weekly by 100 mg/day increments to a target maintenance dose of 100-200 mg twice daily (200-400 mg/day).
adjunctive therapy:
Initial 50 mg twice daily (100 mg/day), titrated weekly by 100 mg/day increments to a target maintenance dose of 100-200 mg twice daily (200-400 mg/day).
loading_dose:
200 mg single oral or IV dose, followed by 50 mg twice daily approximately 12 hours later, then continue with maintenance titration.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (approved for âĨ4 years)
Child:
For partial-onset seizures in patients âĨ4 years: Initial 1 mg/kg twice daily (2 mg/kg/day), titrated weekly by 1 mg/kg/day increments to target maintenance dose. Max 6-12 mg/kg/day depending on weight (e.g., 300 mg/day for 30-50 kg, 400 mg/day for >50 kg).
Adolescent:
For partial-onset seizures in patients âĨ4 years: Initial 1 mg/kg twice daily (2 mg/kg/day), titrated weekly by 1 mg/kg/day increments to target maintenance dose. Max 6-12 mg/kg/day depending on weight (e.g., 300 mg/day for 30-50 kg, 400 mg/day for >50 kg). For adolescents >50 kg, adult dosing applies.
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 supplementary dose of up to 50% of the daily dose should be given immediately after hemodialysis.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
Maximum recommended dose is 300 mg/day. Dose titration should be performed with caution.
Severe:
Not studied. Generally avoid or use with extreme caution and lower maximum dose, monitoring closely for adverse effects.
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. It also binds to collapsin-response mediator protein 2 (CRMP-2), a phosphoprotein involved in neuronal differentiation and axonal outgrowth, though the exact contribution of this binding to its anticonvulsant effect is not fully understood.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
1 to 4 hours (oral)
FoodEffect:
Food does not affect the rate or extent of absorption.
Distribution:
Vd:
Approximately 0.67 L/kg
ProteinBinding:
Less than 15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 13 hours
Clearance:
Approximately 0.48 L/h/kg
ExcretionRoute:
Primarily renal
Unchanged:
Approximately 40% (in urine)
Pharmacodynamics
OnsetOfAction:
Within hours of administration (following initial dose or loading dose)
PeakEffect:
Achieved within days of reaching stable maintenance dose
DurationOfAction:
Approximately 12 hours (consistent with twice-daily dosing)
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor 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, 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
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
Drowsiness
Fatigue
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 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
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
Drowsiness
Fatigue
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 lightheadedness
- Double vision (diplopia) or blurred vision
- Problems with coordination or balance (ataxia)
- Nausea or vomiting that is severe or persistent
- Unusual tiredness or weakness
- New or worsening depression, anxiety, or irritability
- Thoughts of harming yourself or others
- Hallucinations (seeing or hearing things that are not real)
- Rash or severe skin reactions
- Swelling of the face, lips, or tongue
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain)
- Palpitations, slow heartbeat, or fainting spells
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 allergic reaction you experienced, including any symptoms that occurred.
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. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change 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, any of 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 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. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change 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.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution 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 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 it is necessary 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, in rare cases, lead to severe cardiac problems and even death. If you have any questions or concerns, 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, as it is crucial to weigh the benefits and risks of this medication for both you and your baby.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution 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 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 it is necessary 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, in rare cases, lead to severe cardiac problems and even death. If you have any questions or concerns, 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, as it is crucial to weigh the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Nausea
- Vomiting
- Diplopia
- Ataxia
- Seizures
- Coma
- Cardiac conduction abnormalities (e.g., PR prolongation, AV block)
- Bradycardia
- Hypotension
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is 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, pregabalin, rufinamide): May increase risk of AV block or bradycardia. Use with caution.
- Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine): May increase lacosamide exposure, though this is generally not clinically significant due to minor CYP metabolism.
- Strong CYP2C19 inducers (e.g., rifampin, St. John's Wort): May decrease lacosamide exposure, though generally not clinically significant.
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess for baseline cardiac conduction abnormalities, especially in patients with pre-existing cardiac conditions or those on other PR-prolonging medications.
Timing: Prior to initiation, if clinically indicated (e.g., cardiac history, concomitant medications).
Renal function (CrCl)
Rationale: To guide initial dosing and dose adjustments in patients with renal impairment.
Timing: Prior to initiation.
Hepatic function (LFTs)
Rationale: To guide initial dosing and dose adjustments in patients with hepatic impairment.
Timing: Prior to initiation.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly throughout treatment
Target: Reduction in seizure activity
Action Threshold: Increased seizure frequency or lack of efficacy may warrant dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, nausea, diplopia, ataxia, fatigue)
Frequency: Regularly, especially during titration and dose changes
Target: Minimization of side effects
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Cardiac rhythm (ECG)
Frequency: If symptoms of arrhythmia develop (e.g., palpitations, syncope) or in patients with pre-existing cardiac conduction issues.
Target: Normal sinus rhythm, PR interval within normal limits
Action Threshold: Significant PR prolongation, AV block, or other arrhythmias may require dose reduction or discontinuation.
Mood and behavior changes (e.g., suicidal ideation)
Frequency: Regularly, especially during initial therapy and dose changes
Target: Stable mood, absence of suicidal thoughts
Action Threshold: Emergence or worsening of depression, suicidal thoughts, or unusual behavior requires immediate evaluation.
Symptom Monitoring
- Dizziness
- Nausea
- Vomiting
- Diplopia (double vision)
- Ataxia (impaired coordination)
- Fatigue
- Headache
- Tremor
- Blurred vision
- Suicidal thoughts or behavior
- Palpitations
- Syncope (fainting)
- Bradycardia
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Lacosamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy exposure registries are available.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, though human data are limited. Animal studies show developmental toxicity.
Second Trimester:
Not specifically studied, but continued exposure carries potential risks.
Third Trimester:
Not specifically studied, but continued exposure carries potential risks. Neonatal withdrawal symptoms are not typically associated with lacosamide.
Lactation
Lacosamide is excreted into human milk. The decision to discontinue breastfeeding 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). Potential for infant drowsiness, poor feeding, or other adverse effects. Monitor infant closely.
Pediatric Use
Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based for children and adolescents. 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, but dose adjustments may be necessary for age-related decreases in renal function. Elderly patients may be more susceptible to adverse effects such as dizziness, ataxia, and falls.
Clinical Information
Clinical Pearls
- Lacosamide is generally well-tolerated when titrated slowly. Rapid titration increases the risk of dizziness, nausea, and diplopia.
- It has a low potential for drug-drug interactions compared to many other AEDs due to its primary non-CYP metabolism.
- While generally not requiring routine ECG monitoring, caution is advised in patients with pre-existing cardiac conduction problems or those on other PR-prolonging medications.
- Can be used as monotherapy or adjunctive therapy for partial-onset seizures.
- Available in oral tablets, oral solution, and intravenous (IV) formulation, allowing for flexibility in administration, including IV loading doses.
Alternative Therapies
- Levetiracetam (Keppra)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Lamotrigine (Lamictal)
- Phenytoin (Dilantin)
- Topiramate (Topamax)
- Zonisamide (Zonegran)
- Gabapentin (Neurontin)
- Pregabalin (Lyrica)
Cost & Coverage
Average Cost:
Varies, typically $300-$600 per 30 tablets (200mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for generic), Tier 3 or 4 (for brand) depending on insurance plan formulary.
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, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.