Lacosamide 10mg/ml Oral Solution
It is used to treat seizures.
Drug Class
Anticonvulsant
Pharmacologic Class
Functionalized amino acid
Pregnancy Category
Category C
FDA Approved
Oct 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lacosamide is a medicine used to treat certain types of seizures (partial-onset seizures) in people with epilepsy. It works by calming overactive nerve signals in the brain.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food.
If you are taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Do not use a household teaspoon or tablespoon, as this could lead to an incorrect dose.
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better.
If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider and flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms and areas prone to moisture.
Do not freeze your medication.
After opening, discard any unused medication after 6 months.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most out of your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food.
If you are taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Do not use a household teaspoon or tablespoon, as this could lead to an incorrect dose.
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better.
If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider and flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms and areas prone to moisture.
Do not freeze your medication.
After opening, discard any unused medication after 6 months.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed; do not stop taking it suddenly, as this can cause seizures to worsen.
- May cause dizziness, drowsiness, or problems with coordination, especially when starting the medication or increasing the dose. Avoid driving or operating machinery until you know how it affects you.
- Avoid or limit alcohol consumption, as it can increase side effects like dizziness and drowsiness.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
- Report any new or worsening heart symptoms like palpitations, slow heartbeat, or fainting.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 50 mg twice daily (BID), titrated weekly by 50 mg BID to a target maintenance dose of 100-200 mg BID (200-400 mg/day).
Dose Range:
200 - 400 mg
Condition-Specific Dosing:
partial-onset seizures:
Initial 50 mg BID, titrate weekly by 50 mg BID to target 100-200 mg BID. Max 400 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4 years to <17 years: Initial 1 mg/kg BID, titrated weekly by 1 mg/kg BID. Target maintenance dose 3-6 mg/kg BID. Max 300 mg/day for patients 30 to <50 kg; Max 400 mg/day for patients âĨ50 kg.
Adolescent:
âĨ17 years: 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:
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 administered immediately after hemodialysis.
Hepatic Impairment:
Mild:
Maximum recommended dose is 300 mg/day (Child-Pugh A).
Moderate:
Maximum recommended dose is 300 mg/day (Child-Pugh B).
Severe:
Not studied; use with caution and monitor closely (Child-Pugh C).
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.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5 to 4 hours
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 0.48 L/h/kg
ExcretionRoute:
Primarily renal (approximately 95% of dose excreted in urine)
Unchanged:
Approximately 40%
Pharmacodynamics
OnsetOfAction:
Within hours of first dose (based on rapid absorption and Tmax)
PeakEffect:
Steady-state concentrations are achieved in approximately 3 days with twice-daily dosing.
DurationOfAction:
Related to half-life, allowing for 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 or coordination
Memory problems or loss
Severe dizziness or fainting
Abnormal heartbeat, including fast, slow, or irregular rhythms
Shakiness or tremors
Double vision
Shortness of breath
Chest pain
Burning, numbness, or tingling sensations that are not normal
Inability to control eye movements
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:
Depression
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavioral changes
seek medical attention immediately. If you have suicidal thoughts or actions, call your doctor right away.
A rare but potentially life-threatening condition has been reported in people taking seizure medications like this one. Seek medical attention immediately if you experience:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people taking this medication 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, contact your doctor:
Dizziness, drowsiness, tiredness, or weakness
Headache
Blurred vision
Diarrhea, nausea, or vomiting
Dry mouth
Excessive sweating
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, 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 or coordination
Memory problems or loss
Severe dizziness or fainting
Abnormal heartbeat, including fast, slow, or irregular rhythms
Shakiness or tremors
Double vision
Shortness of breath
Chest pain
Burning, numbness, or tingling sensations that are not normal
Inability to control eye movements
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:
Depression
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavioral changes
seek medical attention immediately. If you have suicidal thoughts or actions, call your doctor right away.
A rare but potentially life-threatening condition has been reported in people taking seizure medications like this one. Seek medical attention immediately if you experience:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Most people taking this medication 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, contact your doctor:
Dizziness, drowsiness, tiredness, or weakness
Headache
Blurred vision
Diarrhea, nausea, or vomiting
Dry mouth
Excessive sweating
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening seizures
- Severe dizziness or loss of balance
- Double vision or blurred vision
- Severe nausea or vomiting
- Rash or hives (could indicate a severe allergic reaction)
- Swelling of the face, lips, or tongue
- Difficulty breathing or swallowing
- Unusual changes in mood or behavior (e.g., new or worsening depression, anxiety, agitation, hostility, suicidal thoughts)
- Chest pain, palpitations, 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, 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 in combination with your other medications and health issues.
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, 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 in combination with your other medications and health issues.
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 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 the risk of seizures. If you need to discontinue the medication, your doctor will provide guidance on how to gradually taper off the dosage.
Be aware that this medication has been associated with abnormal heart rhythms, which can rarely lead to severe cardiac problems and even death. If you have any questions or concerns, discuss them with your doctor.
If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products may contain phenylalanine.
Individuals 65 years or older should use this medication with caution, as they 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 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 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 the risk of seizures. If you need to discontinue the medication, your doctor will provide guidance on how to gradually taper off the dosage.
Be aware that this medication has been associated with abnormal heart rhythms, which can rarely lead to severe cardiac problems and even death. If you have any questions or concerns, discuss them with your doctor.
If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products may contain phenylalanine.
Individuals 65 years or older should use this medication with caution, as they 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 you and your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Nausea
- Vomiting
- Diplopia (double vision)
- Ataxia (lack of coordination)
- Seizures
- Coma
- Cardiac conduction abnormalities (e.g., PR interval prolongation, AV block, bradycardia)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and monitoring of vital signs and ECG.
Drug Interactions
Major Interactions
- Drugs known to prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, other antiepileptic drugs like carbamazepine, lamotrigine, phenytoin) - increased risk of AV block or bradycardia.
- Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine) - may increase lacosamide exposure (minor clinical significance).
Moderate Interactions
- Strong CYP2C19 inducers (e.g., rifampin, St. John's Wort) - may decrease lacosamide exposure (minor clinical significance).
- Alcohol - may increase CNS depressant effects.
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess baseline cardiac conduction, especially in patients with pre-existing cardiac conditions or those on concomitant medications that prolong PR interval.
Timing: Prior to initiation, if clinically indicated.
Renal function (CrCl)
Rationale: To guide dose adjustments in patients with renal impairment.
Timing: Prior to initiation.
Hepatic function (LFTs)
Rationale: To guide dose adjustments in patients with hepatic impairment.
Timing: Prior to initiation.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly, at each follow-up visit
Target: Reduction in seizure frequency, improved seizure control
Action Threshold: Increased seizure frequency, breakthrough seizures
Adverse effects (e.g., dizziness, nausea, diplopia, ataxia, fatigue)
Frequency: Regularly, at each follow-up visit, especially during titration
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects, requiring dose reduction or discontinuation
Symptoms of suicidal ideation or behavior, depression, or unusual mood/behavior changes
Frequency: Regularly, at each follow-up visit, and educate patients/caregivers to monitor
Target: Absence of new or worsening psychiatric symptoms
Action Threshold: Emergence or worsening of suicidal thoughts, depression, aggression, or hostility
Cardiac symptoms (e.g., palpitations, syncope, chest pain)
Frequency: If patient reports symptoms or has cardiac risk factors
Target: Normal cardiac rhythm and function
Action Threshold: New or worsening cardiac symptoms, significant PR prolongation on ECG (if monitored)
Symptom Monitoring
- Dizziness
- Nausea
- Vomiting
- Diplopia (double vision)
- Blurred vision
- Ataxia (lack of coordination)
- Fatigue
- Headache
- Suicidal thoughts or behavior
- Depression
- Aggression
- Hostility
- Rash
- Palpitations
- Syncope (fainting)
- Chest pain
Special Patient Groups
Pregnancy
Lacosamide is classified as 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. Patients should be enrolled in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
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 carries potential risks.
Third Trimester:
Not specifically studied, but continued exposure carries potential risks.
Lactation
Lacosamide is excreted into human breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother's clinical need for lacosamide, and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition. Monitor infants for sedation, poor feeding, or other adverse effects.
Infant Risk:
L3 (Moderately safe) - Monitor infant for drowsiness, poor feeding, or developmental milestones.
Pediatric Use
Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based for children 4 to <17 years. Safety and effectiveness in pediatric 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 due to age-related decreases in renal or hepatic function. Elderly patients may be more susceptible to adverse effects such as dizziness, ataxia, and falls.
Clinical Information
Clinical Pearls
- Titrate lacosamide slowly to minimize dose-dependent adverse effects such as dizziness, nausea, and diplopia.
- Lacosamide can prolong the PR interval; use with caution in patients with pre-existing cardiac conduction problems or those taking other medications that prolong the PR interval.
- The oral solution can be taken with or without food.
- Patients should be advised not to discontinue lacosamide abruptly due to the risk of increased seizure frequency or status epilepticus.
- Monitor for signs of suicidal ideation, as with all AEDs.
Alternative Therapies
- Levetiracetam (Keppra)
- Carbamazepine (Tegretol)
- Oxcarbazepine (Trileptal)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Valproate (Depakote)
- Phenytoin (Dilantin)
- Gabapentin (Neurontin)
- Pregabalin (Lyrica)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and dosage form/strength. Oral solution is generally more expensive than tablets. per 480 mL bottle (10 mg/mL)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for generic), Tier 3 or 4 (for brand)
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 is a valuable resource that provides important information about your treatment. 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 your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. 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 your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.