Vimpat 100mg Tablets

Manufacturer UCB 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
Selective enhancer of slow inactivation of voltage-gated sodium channels
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Pregnancy Category
Category C
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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 (partial-onset seizures) in people with epilepsy. It works by affecting how nerve signals are sent in the brain, which helps to reduce the number of seizures you have.
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How to Use This Medicine

Taking Your Medication

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 best to swallow the tablet whole with a glass of water or another drink. Do not chew, break, or crush the tablet.

It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the medication and minimize the risk of any potential side effects.

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 you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or look into 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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, do not stop suddenly without consulting your doctor, as this can increase seizure risk.
  • May cause dizziness, drowsiness, or problems with coordination; avoid driving or operating machinery until you know how it affects you.
  • Avoid alcohol, as it can worsen side effects like dizziness and drowsiness.
  • Report any new or worsening symptoms of depression, suicidal thoughts, or unusual changes in mood or behavior to your doctor immediately.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 50 mg orally twice daily (100 mg/day). Titrate weekly by 50 mg twice daily (100 mg/day) increments. Maintenance: 100-200 mg orally twice daily (200-400 mg/day). Max: 400 mg/day.
Dose Range: 100 - 400 mg

Condition-Specific Dosing:

rapid_titration: Initial: 200 mg single oral loading dose, followed by 100 mg twice daily starting approximately 12 hours later. Maintenance: 100-200 mg orally twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Oral solution/tablet: 1 month to <4 years: Initial 1 mg/kg twice daily, titrate weekly by 1 mg/kg/day increments. Maintenance 3-6 mg/kg/day. Max 12 mg/kg/day (not to exceed 400 mg/day). 4 years to <17 years: Initial 1 mg/kg twice daily, titrate weekly by 1 mg/kg/day increments. Maintenance 4-8 mg/kg/day. Max 12 mg/kg/day (not to exceed 400 mg/day).
Adolescent: 17 years and older: Same as adult dosing.
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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: Max recommended dose 300 mg/day (CrCl <30 mL/min). Titrate with caution.
Dialysis: Max recommended dose 300 mg/day. A supplemental dose of up to 50% of the daily dose should be administered immediately after hemodialysis.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: Max recommended dose 300 mg/day. Titrate with caution.
Severe: Not studied; use with caution, consider lower doses and close monitoring.

Pharmacology

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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, thereby stabilizing hyperexcitable neuronal membranes and inhibiting repetitive neuronal firing. It does not affect fast inactivation of sodium channels.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 100%
Tmax: 1-4 hours
FoodEffect: Food does not affect the rate or extent of absorption.

Distribution:

Vd: 0.6 L/kg
ProteinBinding: <15%
CnssPenetration: Yes

Elimination:

HalfLife: 13 hours
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (approximately 95% of dose)
Unchanged: Approximately 40%
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Pharmacodynamics

OnsetOfAction: Within hours (after loading dose) to days (with titration)
PeakEffect: Achieved at steady-state (typically 3 days with twice-daily dosing)
DurationOfAction: Approximately 12 hours (consistent with twice-daily dosing)

Safety & Warnings

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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 fainting
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
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavioral changes

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 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 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, or weakness
Headache
Blurred vision
Diarrhea, nausea, or vomiting
Dry mouth
Excessive sweating

This is not an exhaustive list of 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.
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Seek Immediate Medical Attention If You Experience:

  • New or worsening suicidal thoughts or behavior
  • Severe skin rash or allergic reaction (e.g., fever, swollen glands, facial swelling, rash, yellowing of skin/eyes)
  • Dizziness, unsteadiness, or problems with coordination that are severe or persistent
  • Double vision or blurred vision
  • Signs of heart problems (e.g., slow or irregular heartbeat, fainting, chest pain, shortness of breath)
  • Unexplained muscle pain, tenderness, or weakness (rare, but can indicate rhabdomyolysis)
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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, health conditions, and concerns with your doctor. This includes:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* 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 medications 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.

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 you have 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 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 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.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage, activated charcoal, and monitoring of vital signs and ECG.

Drug Interactions

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Major Interactions

  • Drugs that prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, class I antiarrhythmics) - increased risk of AV block or bradycardia.
  • Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) - may increase lacosamide exposure (minor effect).
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Moderate Interactions

  • Other CNS depressants (e.g., alcohol, opioids, benzodiazepines) - additive CNS depression (dizziness, ataxia, somnolence).
  • Carbamazepine, Phenytoin (enzyme inducers) - may slightly decrease lacosamide exposure, but generally not clinically significant.

Monitoring

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Baseline Monitoring

ECG

Rationale: To assess baseline cardiac conduction, especially in patients with pre-existing cardiac conditions or on other PR-prolonging medications.

Timing: Prior to initiation, if clinically indicated.

Renal function (CrCl)

Rationale: Lacosamide is primarily renally excreted; dose adjustment may be needed in severe impairment.

Timing: Prior to initiation.

Hepatic function (LFTs)

Rationale: Dose adjustment may be needed in moderate to severe hepatic impairment.

Timing: Prior to initiation.

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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 or lack of efficacy may warrant dose adjustment or alternative therapy.

Adverse effects (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 may require dose reduction or discontinuation.

Mood and behavior changes (suicidal ideation)

Frequency: Regularly, at each follow-up visit.

Target: Stable mood, absence of suicidal thoughts.

Action Threshold: Emergence or worsening of depression, suicidal thoughts, or unusual behavior requires immediate evaluation.

ECG (PR interval)

Frequency: Periodically, if patient develops cardiac symptoms, or is on other PR-prolonging drugs, or has underlying cardiac conduction abnormalities.

Target: Normal PR interval for age.

Action Threshold: Significant PR prolongation or development of AV block requires cardiology consultation and potential dose adjustment or discontinuation.

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Symptom Monitoring

  • Dizziness
  • Nausea
  • Vomiting
  • Diplopia (double vision)
  • Blurred vision
  • Ataxia (lack of coordination)
  • Fatigue
  • Somnolence (sleepiness)
  • Headache
  • Tremor
  • Rash
  • Pruritus (itching)
  • Suicidal thoughts or behavior
  • Signs of hypersensitivity reaction (e.g., fever, rash, lymphadenopathy, facial swelling, eosinophilia)

Special Patient Groups

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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 for specific AEDs. Animal studies showed developmental toxicity.
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 neonates if exposed throughout pregnancy.
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Lactation

Lacosamide is excreted into human 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, and weight gain.

Infant Risk: L3 (Moderately Safe - limited controlled studies show no increase in adverse effects; non-life-threatening adverse effects possible; risk of adverse effects is possible but small).
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Pediatric Use

Approved for partial-onset seizures in patients 1 month of age and older. Dosing is weight-based for younger children. Safety and efficacy in neonates (<1 month) have not been established.

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Geriatric Use

No specific dose adjustment is required based on age alone, but dose selection should be cautious, generally starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Increased risk of dizziness and ataxia.

Clinical Information

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Clinical Pearls

  • Lacosamide has a low potential for drug-drug interactions due to minimal CYP450 metabolism.
  • Titration is crucial to minimize dose-related adverse effects like dizziness, nausea, and diplopia.
  • A loading dose can be used for rapid attainment of steady-state, but may increase the incidence of adverse effects.
  • Monitor for cardiac conduction abnormalities, especially in patients with pre-existing cardiac conditions or on other PR-prolonging drugs.
  • Patients should be advised about the risk of suicidal thoughts and behaviors, a class effect of AEDs.
  • Can be used as monotherapy or adjunctive therapy for partial-onset seizures.
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Alternative Therapies

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

Average Cost: Varies, check current 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 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 each time you refill your prescription. 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.