Vimpat 150mg 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
Anticonvulsant
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Pharmacologic Class
Functionalized amino acid; Sodium channel blocker (selective enhancement of slow inactivation)
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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 medicine used to treat certain types of seizures (epilepsy). It works by calming overactive nerves in the brain that cause seizures. It can be used alone or with other seizure medicines.
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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 feeling better. It's crucial to maintain your treatment schedule to ensure the best possible outcome.

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 disposal method, 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 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, with or without food.
  • Do not stop taking this medicine suddenly, as it can increase the risk of seizures. Your doctor will tell you how to slowly reduce the dose if needed.
  • Avoid driving or operating machinery until you know how this medicine affects you, as it can cause dizziness, drowsiness, and vision problems.
  • Report any new or worsening symptoms of depression, suicidal thoughts, or unusual changes in mood or behavior to your doctor immediately.
  • Limit or avoid alcohol consumption while taking this medication, as it can increase side effects like dizziness and drowsiness.
  • Carry a medical alert card or wear a medical alert bracelet indicating you have epilepsy and are taking this medication.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

partial-onset_seizures: Initial 50 mg BID, titrate weekly by 50 mg BID increments to a target maintenance dose of 100-200 mg BID (200-400 mg/day). Max 400 mg/day. For rapid titration, a loading dose of 200 mg can be given once, followed by 100 mg BID approximately 12 hours later.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (approved for 4 years and older)
Child: 4 to <17 years (oral): Initial 1 mg/kg BID, titrate weekly by 1 mg/kg BID increments. Maintenance dose depends on weight: 11 to <30 kg: 3-6 mg/kg BID; 30 to <50 kg: 2-4 mg/kg BID; â‰Ĩ50 kg: 100-200 mg BID.
Adolescent: â‰Ĩ17 years: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 50-80 mL/min)
Moderate: Max dose 300 mg/day (CrCl 30-50 mL/min)
Severe: Max dose 300 mg/day (CrCl <30 mL/min)
Dialysis: Supplementation of up to 50% of the daily dose immediately after hemodialysis is recommended for patients with end-stage renal disease on hemodialysis.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: Max dose 300 mg/day
Severe: Not recommended due to lack of data

Pharmacology

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Mechanism of Action

Lacosamide is a functionalized amino acid that 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: No clinically significant effect on absorption or Cmax.

Distribution:

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

Elimination:

HalfLife: Approximately 13 hours
Clearance: Approximately 0.48 L/h/kg
ExcretionRoute: Renal (approximately 95% of dose)
Unchanged: Approximately 40% (unchanged drug), approximately 30% (O-desmethyl metabolite)
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Pharmacodynamics

OnsetOfAction: Within hours (after loading dose or initial titration)
PeakEffect: Within 1-4 hours after oral dose
DurationOfAction: Approximately 12 hours (consistent with 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 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 been reported 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 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 that is severe or persistent
  • Unusual tiredness or weakness
  • Numbness, tingling, or burning pain in your hands or feet
  • Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain)
  • Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • New or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, severe restlessness, or suicidal thoughts/behavior.
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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 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 with your existing medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Regular blood tests will be necessary, as directed by your doctor. 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 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 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 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. You and your doctor 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 (loss of coordination)
  • Seizures
  • Coma
  • Cardiac conduction abnormalities (e.g., PR interval prolongation, AV block, bradycardia)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and may include gastric lavage, activated charcoal, and monitoring of vital signs and ECG.

Drug Interactions

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Moderate Interactions

  • Drugs known to prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, class I antiarrhythmics, tricyclic antidepressants) - increased risk of AV block or bradycardia.
  • Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine) - may increase lacosamide exposure, but generally not clinically significant due to minor CYP metabolism.
  • Strong CYP2C19 inducers (e.g., rifampin, St. John's Wort) - may decrease lacosamide exposure, but generally not clinically significant.

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 conditions or on other PR-prolonging medications.

Timing: Prior to initiation

Renal function (CrCl)

Rationale: To determine appropriate starting and maintenance doses, as lacosamide is primarily renally eliminated.

Timing: Prior to initiation

Hepatic function (LFTs)

Rationale: To determine appropriate starting and maintenance doses in patients with 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 or seizure freedom

Action Threshold: Increased seizure frequency or lack of efficacy may warrant dose adjustment or alternative therapy.

Adverse effects (e.g., dizziness, nausea, diplopia, fatigue)

Frequency: Regularly, at each follow-up visit

Target: Minimization of side effects

Action Threshold: Intolerable side effects may require dose reduction or discontinuation.

ECG (PR interval)

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

Target: Normal PR interval (typically <200 ms)

Action Threshold: Significant PR prolongation or development of AV block may require dose reduction or discontinuation.

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Symptom Monitoring

  • Dizziness
  • Nausea
  • Vomiting
  • Diplopia (double vision)
  • Blurred vision
  • Fatigue
  • Ataxia (impaired coordination)
  • Tremor
  • Headache
  • Cardiac symptoms (palpitations, syncope, bradycardia)
  • Mood changes (depression, anxiety, suicidal thoughts or behavior)

Special Patient Groups

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Pregnancy

Lacosamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Data from pregnancy registries and observational studies are ongoing. 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: No specific data indicating unique risks beyond general AED risks.
Third Trimester: No specific data indicating unique risks beyond general AED risks. Consider monitoring for withdrawal symptoms in neonates if exposure continues until delivery.
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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: L3 (Moderate risk) - Monitor breastfed infants for sedation, poor feeding, and developmental milestones. Consider therapeutic drug monitoring in the infant if concerns arise.
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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 efficacy in children 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 based on renal function, which commonly declines with age. Elderly patients may be more susceptible to adverse effects such as dizziness, ataxia, and fatigue.

Clinical Information

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Clinical Pearls

  • Lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, a unique mechanism among AEDs.
  • Titration is crucial to minimize common dose-related adverse effects like dizziness, nausea, and diplopia.
  • Monitor ECG (PR interval) in patients with pre-existing cardiac conduction problems or those taking 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 flexible administration and IV loading doses.
  • Patients should be advised not to discontinue the medication abruptly due to the risk of increased seizure frequency or status epilepticus.
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Alternative Therapies

  • Levetiracetam (Keppra)
  • Carbamazepine (Tegretol)
  • Oxcarbazepine (Trileptal)
  • Lamotrigine (Lamictal)
  • Topiramate (Topamax)
  • Zonisamide (Zonegran)
  • Phenytoin (Dilantin)
  • Valproic Acid (Depakote)
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Cost & Coverage

Average Cost: $200 - $800+ per 30 tablets (for 150mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
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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, and the time it occurred.