Lacosamide 100mg Tablets
It is used to treat seizures.
Drug Class
Antiepileptic Drug (AED)
Pharmacologic Class
Functionalized amino acid; Selective enhancer of slow inactivation of voltage-gated sodium channels
Pregnancy Category
Category C
FDA Approved
Oct 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lacosamide is a medication used to treat seizures in people with epilepsy. It works by affecting certain electrical signals in the brain to help prevent seizures. It can be used alone or with other seizure medications.
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 to feel better. It's crucial to complete the full course of treatment as prescribed.
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 accidental ingestion or misuse.
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 way to dispose of your medication. You may also want to explore local drug take-back programs in your area.
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 to feel better. It's crucial to complete the full course of treatment as prescribed.
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 accidental ingestion or misuse.
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 way to dispose of your medication. You may also want to explore local drug take-back programs in your area.
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
- Take lacosamide exactly as prescribed by your doctor. Do not stop taking it suddenly, as this can cause seizures to worsen or occur more frequently.
- Avoid alcohol and other CNS depressants, as they 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.
- Maintain regular follow-up appointments with your doctor to monitor your condition and medication effectiveness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 50 mg twice daily (BID), titrated weekly by 100 mg/day increments to a target dose of 200-400 mg/day (100-200 mg BID). Max 600 mg/day for adjunctive therapy, 400 mg/day for monotherapy.
Dose Range:
100 - 600 mg
Condition-Specific Dosing:
monotherapy:
Initial 50 mg BID, titrate weekly by 100 mg/day to 200-400 mg/day. Max 400 mg/day.
adjunctive_therapy:
Initial 50 mg BID, titrate weekly by 100 mg/day to 200-400 mg/day. Max 600 mg/day.
iv_loading_dose:
200 mg single IV dose, followed by 100 mg BID oral or IV starting approximately 12 hours later.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 4 years and older:
- <30 kg: Initial 1 mg/kg BID, titrate weekly by 2 mg/kg/day to 6-12 mg/kg/day (3-6 mg/kg BID). Max 12 mg/kg/day.
- 30 to <50 kg: Initial 50 mg BID, titrate weekly by 100 mg/day to 200-300 mg/day (100-150 mg BID). Max 300 mg/day.
Adolescent:
For patients âĨ50 kg: Adult dosing (initial 50 mg BID, titrate weekly by 100 mg/day to 200-400 mg/day. Max 400 mg/day for monotherapy, 600 mg/day for adjunctive therapy).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >50 mL/min).
Moderate:
No adjustment needed (CrCl 30-50 mL/min).
Severe:
Maximum recommended dose is 300 mg/day (CrCl â¤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:
No adjustment needed (Child-Pugh A).
Moderate:
Maximum recommended dose is 300 mg/day (Child-Pugh B). Titrate with caution.
Severe:
Not studied. Use with caution and consider lower maximum doses (Child-Pugh C).
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 (VGSCs), thereby stabilizing hyperexcitable neuronal membranes and inhibiting repetitive neuronal firing. It does not affect fast inactivation of VGSCs. Additionally, lacosamide binds to the collapsin response mediator protein 2 (CRMP-2), a phosphoprotein expressed in the nervous system involved in neuronal differentiation and axonal guidance, though the contribution of this binding to its anticonvulsant effect is unclear.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5 to 4 hours (oral)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
Approximately 0.67 L/kg
ProteinBinding:
<15%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 13 hours
Clearance:
Approximately 1.9 L/hr
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 40% (of dose excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Not acutely defined for seizure control; steady-state concentrations are reached in approximately 3 days with twice-daily dosing.
PeakEffect:
Not acutely defined for seizure control.
DurationOfAction:
Related to half-life; maintained with twice-daily dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects 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 occurred 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 urinate
+ 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 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 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 occurred 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 urinate
+ 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 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:
- Severe dizziness or fainting spells
- Double vision or blurred vision that is severe or persistent
- Problems with coordination or balance (ataxia)
- New or worsening depression, anxiety, or irritability
- Thoughts of harming yourself or others
- Unusual changes in behavior or mood
- Rash, fever, swollen lymph nodes, or swelling of the face (signs of a severe hypersensitivity reaction)
- Palpitations, chest pain, or feeling lightheaded (signs of heart rhythm problems)
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 health conditions and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
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.
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 health conditions and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
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.
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 engaging in activities that require alertness, as it may affect your ability to perform these tasks safely. 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 you have with your doctor.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor. If you experience any changes in your seizure patterns or severity 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 complications and 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 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 engaging in activities that require alertness, as it may affect your ability to perform these tasks safely. 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 you have with your doctor.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor. If you experience any changes in your seizure patterns or severity 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 complications and 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 to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Nausea
- Vomiting
- Diplopia (double vision)
- Ataxia (loss of coordination)
- Seizures
- Coma
- Cardiac conduction abnormalities (e.g., PR interval prolongation, QRS widening, bradycardia, atrioventricular block, ventricular tachycardia, asystole)
- Rhabdomyolysis
What to Do:
Call 1-800-222-1222 (Poison Control) immediately. Seek emergency medical attention. Treatment is generally supportive, including gastric lavage, activated charcoal, and close monitoring of vital signs and cardiac function (ECG). Hemodialysis may be effective in removing lacosamide.
Drug Interactions
Major Interactions
- Drugs that prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, antiarrhythmics like Class I antiarrhythmics, tricyclic antidepressants): Concomitant use may lead to additive PR interval prolongation. ECG monitoring is recommended if used together, especially in patients with underlying cardiac conditions or on high doses of lacosamide.
Moderate Interactions
- Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine): May increase lacosamide plasma concentrations by 20-30%, but generally not considered clinically significant enough to warrant dose adjustment.
- Strong CYP2C19 inducers (e.g., rifampin, St. John's Wort): May decrease lacosamide plasma concentrations, potentially reducing efficacy. Monitor for decreased seizure control.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess baseline cardiac conduction, especially PR interval, given lacosamide's potential to prolong PR interval. Recommended for patients with underlying cardiac conditions (e.g., conduction abnormalities, severe cardiac disease) or those on concomitant medications known to prolong PR interval.
Timing: Prior to initiation of therapy.
Renal and Hepatic Function Tests
Rationale: To establish baseline function and guide dose adjustments in patients with impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical monitoring for adverse effects
Frequency: Regularly, especially during titration and dose changes.
Target: N/A
Action Threshold: Report dizziness, ataxia, diplopia, nausea, vomiting, fatigue, suicidal thoughts, or signs of cardiac conduction abnormalities (e.g., palpitations, syncope).
ECG (if indicated)
Frequency: As clinically indicated, especially if symptoms of cardiac conduction abnormalities develop or if concomitant PR-prolonging medications are initiated/adjusted.
Target: Normal PR interval (typically <200 ms in adults)
Action Threshold: Significant PR prolongation or development of cardiac arrhythmias may warrant dose reduction or discontinuation.
Symptom Monitoring
- Dizziness
- Headache
- Nausea
- Vomiting
- Diplopia (double vision)
- Blurred vision
- Ataxia (impaired coordination)
- Fatigue
- Tremor
- Nystagmus
- Suicidal thoughts or behavior (class effect for AEDs)
- Signs of cardiac conduction abnormalities (e.g., palpitations, syncope, bradycardia)
- Hypersensitivity reactions (e.g., rash, fever, lymphadenopathy, eosinophilia)
Special Patient Groups
Pregnancy
Lacosamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal data, lacosamide may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. A pregnancy registry is available for women exposed to antiepileptic drugs during pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations based on animal data, though human data are limited and do not suggest a consistent pattern of increased risk.
Second Trimester:
Not specifically studied, but continued exposure carries potential risks.
Third Trimester:
Not specifically studied, but continued exposure carries potential risks. Consider monitoring for withdrawal symptoms in the neonate if exposure continues until delivery.
Lactation
Lacosamide is excreted into human milk. The effect on the breastfed infant is unknown. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk to infant is unknown. Monitor breastfed infants for sedation, poor feeding, and developmental milestones. L3 (moderately safe) is often assigned, but caution is advised due to limited data.
Pediatric Use
Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based for younger and lighter children. Safety and efficacy in patients younger than 4 years have not been established. Adverse effects are generally similar to adults, but specific monitoring for growth and development may be considered.
Geriatric Use
No specific dose adjustment is required based on age alone, but dose adjustments may be necessary due to age-related decreases in renal function. Elderly patients may be more susceptible to dose-related adverse effects such as dizziness, ataxia, and falls. Start with lower doses and titrate slowly, monitoring closely for adverse effects.
Clinical Information
Clinical Pearls
- Lacosamide has a unique mechanism of action among AEDs, selectively enhancing slow inactivation of voltage-gated sodium channels.
- Titration is crucial to minimize CNS-related adverse effects like dizziness, nausea, and diplopia.
- It has a relatively low potential for pharmacokinetic drug interactions with other AEDs, making it a good option for polytherapy.
- Monitor ECG, especially PR interval, in patients with pre-existing cardiac conduction problems or those taking other medications that prolong the PR interval.
- IV formulation is available for situations where oral administration is not feasible, with a direct conversion from oral to IV dosing.
- Patients should be warned about the potential for suicidal thoughts or behavior, a class effect of all AEDs.
Alternative Therapies
- Levetiracetam
- Carbamazepine
- Oxcarbazepine
- Phenytoin
- Lamotrigine
- Topiramate
- Zonisamide
- Gabapentin
- Pregabalin
Cost & Coverage
Average Cost:
Varies widely (e.g., $300-$1000+) per 30 tablets (100mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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.