Lacosamide 150mg Tablets

Manufacturer ASCEND Active Ingredient Lacosamide Tablets(la KOE sa mide) Pronunciation la KOE sa mide
It is used to treat seizures.
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Drug Class
Antiepileptic drug (AED)
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Pharmacologic Class
Voltage-gated sodium channel modulator
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Pregnancy Category
Not available
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FDA Approved
Oct 2008
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DEA Schedule
Not Controlled

Overview

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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 often used along with other seizure medicines.
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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 and secure location where children and pets cannot access it, and consider using a locked box or area. 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist, who may be aware of 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.
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Lifestyle & Tips

  • Take exactly as prescribed, do not stop abruptly without consulting your doctor, as this can increase seizure frequency.
  • Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness, drowsiness, and vision problems.
  • Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
  • Avoid alcohol, as it can worsen side effects like dizziness and drowsiness.
  • Inform your doctor about all other medications you are taking, especially those that affect heart rhythm.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 50 mg twice daily (BID), titrated weekly by 100 mg/day (50 mg BID) to a target maintenance dose of 200-400 mg/day (100-200 mg BID). Max 600 mg/day.
Dose Range: 200 - 400 mg

Condition-Specific Dosing:

IV_Loading_Dose: 200 mg single dose, followed by 100 mg BID oral maintenance, or 300 mg single dose, followed by 150 mg BID oral maintenance. Max 400 mg/day IV.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 4 years to <17 years: Initial 1 mg/kg BID, titrated weekly by 2 mg/kg/day (1 mg/kg BID) to target 6-12 mg/kg/day (max 300 mg/day). For patients weighing β‰₯50 kg, adult dosing applies.
Adolescent: β‰₯17 years: Adult dosing applies.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 50 mL/min).
Moderate: No adjustment needed (CrCl 30-50 mL/min).
Severe: Reduce maximum dose by 25% (CrCl < 30 mL/min).
Dialysis: Supplement up to 50% of the daily dose immediately after hemodialysis. Reduce maximum dose by 25%.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: Reduce maximum dose by 25%.
Severe: Not studied; use with caution, consider further dose reduction.

Pharmacology

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Mechanism of Action

Lacosamide selectively enhances slow inactivation of voltage-gated sodium channels (VGSCs), which results in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. It does not affect fast inactivation of VGSCs. It also binds to the collapsin response mediator protein 2 (CRMP-2), a phosphoprotein involved in neuronal differentiation and axonal guidance, but the contribution of this binding to its anticonvulsant effect is not fully understood.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: 0.5-4 hours (oral)
FoodEffect: No clinically significant effect of food on absorption.

Distribution:

Vd: 0.67 L/kg
ProteinBinding: <15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 13 hours
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (urine)
Unchanged: Approximately 95% (unchanged drug and O-desmethyl metabolite)
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Pharmacodynamics

OnsetOfAction: Within hours (oral), immediate (IV)
PeakEffect: Within 1-4 hours (oral)
DurationOfAction: Approximately 12 hours (based on BID dosing)

Safety & Warnings

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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 medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Change in balance
Memory problems or loss
Severe dizziness or passing out
Abnormal heartbeat (fast, slow, or irregular)
Shakiness
Double vision
Shortness of breath
Chest pain
Burning, numbness, or tingling sensations that are not normal
Inability to control eye movements

Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. If you experience any new or worsening symptoms, such as:

Depression
Feeling nervous, restless, or irritable
Panic attacks
Mood or behavior changes

contact your doctor right away. If you have suicidal thoughts or actions, seek help 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, contact 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 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, contact your doctor or seek medical attention if they bother you or do not go away:

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting spells
  • Double vision or blurred vision
  • Unusual tiredness or weakness
  • Problems with coordination or balance (ataxia)
  • New or worsening depression, anxiety, or agitation
  • Thoughts of harming yourself
  • Rash, fever, swollen lymph nodes, or swelling of the face (signs of a severe allergic reaction like DRESS syndrome)
  • Chest pain or palpitations
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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 medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you have, as they may interact with this medication.

To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other drugs and health conditions.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in any activity that requires your full attention, make sure you understand how this medication affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and exercise caution when climbing stairs.

As directed by your doctor, undergo regular blood tests to monitor your condition. Discuss any concerns or questions you may have with your doctor.

Prior to consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.

If you experience any changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly.

Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will guide you on how to gradually taper off the dosage.

Be aware that this medication has been associated with abnormal heart rhythms, which can rarely lead to severe cardiac complications and 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 you will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Nausea
  • Vomiting
  • Diplopia (double vision)
  • Ataxia (lack of coordination)
  • Seizures
  • Cardiac conduction abnormalities (e.g., PR prolongation, AV block, bradycardia)
  • Coma

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Drugs that prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, class I antiarrhythmics): May increase risk of AV block. ECG monitoring recommended.
  • Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine): May increase lacosamide exposure (minor pathway, but potential for increased side effects).
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Moderate Interactions

  • Strong CYP2C19 inducers (e.g., rifampin, St. John's Wort): May decrease lacosamide exposure.

Monitoring

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Baseline Monitoring

ECG

Rationale: To assess baseline cardiac conduction, especially PR interval, before initiating treatment, particularly in patients with pre-existing cardiac conduction problems or those on other PR-prolonging medications.

Timing: Prior to initiation

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Routine Monitoring

Cardiac rhythm/ECG

Frequency: Periodically, or if symptoms of cardiac conduction abnormalities occur (e.g., palpitations, syncope). More frequent monitoring if co-administered with other PR-prolonging drugs.

Target: Normal sinus rhythm, PR interval within normal limits for age.

Action Threshold: Significant PR prolongation, AV block, or symptomatic bradycardia; consider dose reduction or discontinuation.

Suicidal ideation/behavior

Frequency: Ongoing, especially during initial therapy and dose changes.

Target: Absence of new or worsening suicidal thoughts or behaviors.

Action Threshold: Report any changes in mood, behavior, or thoughts of self-harm immediately.

Dizziness, ataxia, diplopia, nausea

Frequency: Ongoing, especially during titration.

Target: Tolerable side effect profile.

Action Threshold: Severe or persistent symptoms may require dose adjustment or slower titration.

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Symptom Monitoring

  • Dizziness
  • Headache
  • Nausea
  • Vomiting
  • Diplopia (double vision)
  • Blurred vision
  • Ataxia (lack of coordination)
  • Tremor
  • Fatigue
  • Somnolence (drowsiness)
  • Cardiac conduction abnormalities (palpitations, slow heart rate, fainting)
  • Suicidal thoughts or behavior
  • Mood changes
  • Aggression
  • Depression
  • Rash
  • Hypersensitivity reactions (e.g., DRESS syndrome)

Special Patient Groups

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Pregnancy

Lacosamide is generally considered for use in pregnancy only if the potential benefit justifies the potential risk to the fetus. There are risks associated with both untreated epilepsy and exposure to antiepileptic drugs during pregnancy. A pregnancy exposure registry is available.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of major congenital malformations, though data are limited and conflicting. Neural tube defects are a concern with some AEDs, but less clear with lacosamide.
Second Trimester: Continued exposure, potential for growth restriction or other developmental effects.
Third Trimester: Continued exposure, potential for withdrawal symptoms in neonate if discontinued abruptly.
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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.

Infant Risk: L3 (Moderate risk). Monitor breastfed infants for sedation, poor feeding, and adequate weight gain. The O-desmethyl metabolite is also present in milk.
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Pediatric Use

Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based for younger children. Safety and efficacy in patients younger than 4 years have not been established.

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Geriatric Use

No specific dose adjustment is required based on age alone. However, dose adjustments may be necessary due to age-related decreases in renal function. Elderly patients may be more susceptible to dose-related adverse events such as dizziness, ataxia, and fatigue.

Clinical Information

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Clinical Pearls

  • Titration is crucial: Slow titration helps minimize CNS side effects like dizziness, ataxia, and diplopia.
  • Cardiac monitoring: Be mindful of PR interval prolongation, especially in patients with pre-existing cardiac conduction issues or those on other PR-prolonging medications. ECG monitoring may be warranted.
  • Suicidal ideation: Like all AEDs, monitor for changes in mood or behavior, including suicidal thoughts.
  • IV formulation: An IV formulation is available for situations where oral administration is not feasible, allowing for rapid attainment of therapeutic levels.
  • Drug-Drug Interactions: While not extensively metabolized by CYP450, be aware of potential interactions with strong CYP2C19 inhibitors/inducers and drugs affecting cardiac conduction.
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Alternative Therapies

  • Levetiracetam
  • Carbamazepine
  • Oxcarbazepine
  • Lamotrigine
  • Topiramate
  • Phenytoin
  • Valproic acid
  • Zonisamide
  • Gabapentin
  • Pregabalin
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Cost & Coverage

Average Cost: Varies widely per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (generic often Tier 1 or 2)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to 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, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.