Vimpat 200mg 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, selective enhancer of slow inactivation of voltage-gated sodium channels
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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 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 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 specifically instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. Many communities have drug take-back programs that can help you dispose of your medication safely.

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 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 driving or operating heavy machinery until you know how lacosamide 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 increase side effects like dizziness and drowsiness.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially other seizure medications or heart medications.
  • Carry a medical alert card or wear medical identification indicating you have epilepsy and are taking lacosamide.

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 dose of 100-200 mg BID (200-400 mg/day).
Dose Range: 200 - 400 mg

Condition-Specific Dosing:

adjunctive_therapy_partial_onset_seizures: Initial 50 mg BID, titrate weekly by 50 mg BID increments to a target dose of 100-200 mg BID (200-400 mg/day). Max 400 mg/day.
monotherapy_partial_onset_seizures: Initial 50 mg BID, titrate weekly by 50 mg BID increments to a target dose of 100-200 mg BID (200-400 mg/day). Max 400 mg/day.
rapid_titration: Loading dose of 200 mg single dose, followed by 100 mg BID starting approximately 12 hours later. This can be considered when rapid attainment of steady-state plasma concentration is desired and patient can tolerate a loading dose.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for <1 month. For 1 month to <4 years, dosing is weight-based and complex, typically starting at 1 mg/kg BID and titrating.
Child: For 4 years to <17 years: Initial 1 mg/kg BID (oral) or 1.2 mg/kg BID (IV), titrated weekly by 1 mg/kg BID increments. Max 6 mg/kg BID (oral) or 7.2 mg/kg BID (IV) for patients weighing <30 kg; Max 4 mg/kg BID (oral) or 4.8 mg/kg BID (IV) for patients weighing 30 to <50 kg; Max 200 mg BID (oral) or 240 mg BID (IV) for patients weighing β‰₯50 kg.
Adolescent: For β‰₯17 years: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl >50 mL/min).
Moderate: For CrCl 30-50 mL/min, maximum dose is 300 mg/day. Titrate with caution.
Severe: For CrCl <30 mL/min, maximum dose is 200 mg/day. Titrate with caution.
Dialysis: A supplemental dose of up to 50% of the daily dose should be administered immediately after hemodialysis. Maximum dose 200 mg/day.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: For mild to moderate hepatic impairment, maximum dose is 300 mg/day. Titrate with caution.
Severe: Not recommended for severe hepatic impairment due to lack of data. Use with extreme caution if necessary, with reduced maximum dose and close monitoring.

Pharmacology

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Mechanism of Action

Lacosamide's precise mechanism of action is not fully understood. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels (VGSCs), leading to stabilization of hyperexcitable neuronal membranes and inhibition of 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 exact contribution of this binding to its anticonvulsant effect is unclear.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: Approximately 13 hours
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (urine)
Unchanged: Approximately 40% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Within hours of first dose (based on PK and clinical effect)
PeakEffect: Within 1-4 hours after oral dose (correlates with Tmax)
DurationOfAction: Approximately 12 hours (consistent with BID dosing)
Confidence: Medium

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 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

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
+ 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 notice any of the following symptoms and they bother you or do not go away, contact your doctor:

Dizziness, drowsiness, fatigue, 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.
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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
  • Nausea or vomiting that is severe or persistent
  • Problems with coordination or balance (ataxia)
  • New or worsening depression, anxiety, or irritability
  • Thoughts of harming yourself
  • Rash or severe skin reactions
  • Signs of liver problems (yellowing of skin/eyes, dark urine, severe stomach pain)
  • Signs of heart problems (palpitations, slow heart rate, shortness of breath, chest pain)
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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 symptoms you experienced.
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. They will help you determine if it is safe to take this medication with your existing treatments and health conditions.

Remember, do not start, stop, or modify the dosage 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, be cautious when performing tasks that require alertness, such as driving, 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 exercise caution when navigating 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, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor. If you experience 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 it is necessary to stop taking this medication, your doctor will provide guidance on gradually tapering off the dosage.

Be aware that this medication has been associated with abnormal heart rhythms, which can, in rare cases, lead to severe cardiac complications and death. If you have concerns, discuss them with your doctor. Additionally, 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 to both you and your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and close monitoring of vital signs and cardiac function.

Drug Interactions

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Major Interactions

  • Drugs that prolong PR interval (e.g., beta-blockers, calcium channel blockers, digoxin, class I antiarrhythmics, tricyclic antidepressants): Concomitant use may increase the risk of PR interval prolongation. ECG monitoring is recommended.
  • Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine): May increase lacosamide exposure, especially in patients who are poor metabolizers of CYP2C19. Dose adjustment may be necessary.
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Moderate Interactions

  • Strong CYP3A4/2C9 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, rifampin, carbamazepine, phenytoin): While lacosamide metabolism is minor via these enzymes, significant changes in their activity could theoretically alter lacosamide levels. Clinical significance is generally low.
  • Ethanol: May enhance CNS depressant effects.
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Minor Interactions

  • Oral contraceptives: Lacosamide does not significantly affect the pharmacokinetics of oral contraceptives.

Monitoring

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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 pre-existing cardiac conduction problems or severe cardiac disease.

Timing: Prior to initiation of therapy, particularly in patients with cardiac risk factors.

Renal function (CrCl)

Rationale: Lacosamide is primarily renally eliminated, and dose adjustments are required for renal impairment.

Timing: Prior to initiation of therapy.

Hepatic function (LFTs)

Rationale: Dose adjustments are required for moderate hepatic impairment.

Timing: Prior to initiation of therapy.

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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, new seizure types, or inadequate control may warrant dose adjustment or alternative therapy.

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

Frequency: Regularly, especially during titration and dose changes

Target: Tolerable side effect profile

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

ECG (PR interval)

Frequency: Periodically, or if symptoms of cardiac conduction abnormalities develop. More frequent monitoring for patients with cardiac risk factors or on concomitant PR-prolonging drugs.

Target: Normal PR interval (typically <200 ms in adults)

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

Signs of suicidal ideation or behavior

Frequency: Regularly, especially during initial therapy and dose changes

Target: Absence of suicidal thoughts or behaviors

Action Threshold: Any new or worsening suicidal thoughts or behaviors require immediate clinical evaluation and intervention.

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Symptom Monitoring

  • Dizziness
  • Nausea
  • Vomiting
  • Diplopia (double vision)
  • Blurred vision
  • Ataxia (impaired coordination)
  • Fatigue
  • Headache
  • Tremor
  • Somnolence (drowsiness)
  • Paresthesia (tingling/numbness)
  • Pruritus (itching)
  • Rash
  • Cardiac symptoms (palpitations, syncope, chest pain)
  • Signs of suicidal thoughts or behavior (new or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania)

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. Data from pregnancy registries and observational studies suggest a potential increased risk of major congenital malformations (e.g., cardiovascular malformations, cleft lip/palate) compared to the general population, though the absolute risk is low. The risk of seizures to the mother and fetus if epilepsy is untreated must also be considered.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of major congenital malformations. Discuss risks and benefits with healthcare provider.
Second Trimester: Continued monitoring for maternal and fetal well-being.
Third Trimester: Continued monitoring. Consider potential for withdrawal symptoms in neonate if exposure continues until delivery.
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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. Monitor breastfed infants for sedation, poor feeding, and weight gain.

Infant Risk: L3 (Moderate risk - limited data, but possible adverse effects on infant)
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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. Pediatric patients may experience similar adverse effects as adults, with some differences in frequency (e.g., nasopharyngitis, pyrexia, irritability).

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Geriatric Use

No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have age-related decreases in renal function, which may necessitate dose adjustments based on creatinine clearance. They may also be more susceptible to adverse effects such as dizziness and ataxia.

Clinical Information

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Clinical Pearls

  • Lacosamide can cause PR interval prolongation. An ECG should be considered at baseline, especially in patients with pre-existing cardiac conduction abnormalities or those taking other medications that prolong the PR interval.
  • Rapid titration with a loading dose (200 mg single dose) can be used for faster seizure control, but may increase the risk of acute adverse events like dizziness and nausea.
  • Patients should be advised not to discontinue lacosamide abruptly due to the risk of increased seizure frequency or status epilepticus.
  • While not a controlled substance, there have been rare reports of euphoria and abuse potential, particularly at higher doses.
  • Lacosamide has a relatively low potential for drug-drug interactions compared to many other AEDs, as it is primarily eliminated renally and undergoes minimal CYP-mediated metabolism.
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Alternative Therapies

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

Average Cost: Varies widely, typically $100-$400+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (generic often Tier 1 or 2, brand Tier 3 or 4)
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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 is a valuable resource 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, we encourage you to discuss them with 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.