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Vimpat (lacosamide) is an anti-epileptic drug, also called an anticonvulsant.
Vimpat is used together with other medications to treat partial-onset seizures in adults and children with epilepsy.
Vimpat tablets and oral solution are for use in adults and children who are at least 4 years old. Vimpat injection is for use only in adults.
Do not stop using Vimpat suddenly or you may have increased seizures.
Some people have thoughts about suicide while using Vimpat. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
You may feel faint while using Vimpat. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.
You should not use Vimpat if you are allergic to lacosamide.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
heart problems;
kidney disease;
liver disease;
depression, a mood disorder, suicidal thoughts or actions;
drug or alcohol addiction; or
nerve problems caused by diabetes.
Vimpat oral solution may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).
Some people have thoughts about suicide while using Vimpat. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Call your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.
Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Vimpat on the baby.
It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.
Vimpat oral (taken by mouth) should not be given to a child younger than 4 years old. Vimpat injection should not be given to a child younger than 18 years old.
Take Vimpat exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Lacosamide may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Vimpat tablets or oral solution can be taken with or without food.
Swallow the tablet whole and do not crush, chew, or break it.
Measure oral solution carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Call your doctor if your seizures get worse or you have them more often while using this medicine.
Do not stop using Vimpat suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.
In case of emergency, wear or carry medical identification to let others know you use seizure medication.
Store at room temperature away from moisture and heat. Do not freeze the oral solution. Throw away any oral solution not used within 7 weeks after opening the bottle.
Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Usual Adult Dose for Seizures:
MONOTHERAPY:
-Initial dose: 100 mg orally or IV twice a day (200 mg per day)
-Titration: Increase the dose by 50 mg twice a day (100 mg per day) every 7 days
-Maintenance dose: 150 to 200 mg orally or IV twice a day (300 to 400 mg per day)
-Alternate dosing: Initiate therapy with a single loading dose of 200 mg orally or IV, followed 12 hours later by 100 mg orally or IV twice a day for 7 days; based on individual response and tolerability, the dose can be increased by 50 mg twice a day (100 mg per day) every 7 days, as needed, up to a maintenance dose of 150 to 200 mg orally or IV twice a day (the loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions)
ADJUNCTIVE THERAPY:
-Initial dose: 50 mg orally or IV twice a day (100 mg per day)
-Titration: Increase the dose by 50 mg twice a day (100 mg per day) every 7 days
-Maintenance dose: 100 to 200 mg orally or IV twice a day (200 to 400 mg per day)
-Alternate dosing: Initiate therapy with a single loading dose of 200 mg orally or IV, followed 12 hours later by 100 mg orally or IV twice a day for 7 days; based on individual response and tolerability, the dose can be increased by 50 mg twice a day, as needed, up to the maximum maintenance dose of 200 mg orally or IV twice a day (the loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions)
Comments:
-Therapy can be initiated with either oral or IV administration.
-The oral formulation may be taken with or without food.
-The IV formulation is intended as an alternative when oral administration is temporarily not feasible.
-The IV formulation can be administered in the same dosing regimens used for oral dosing, including the loading dose.
-The IV formulation should be infused over a period of 15 to 60 minutes; IV infusion over 30 to 60 minutes is preferable, and should be used when a 15-minute administration is not required.
Use: As monotherapy or adjunctive therapy for partial-onset seizures in patients 4 years of age and older
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Get emergency medical help if you have signs of an allergic reaction to Vimpat: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
a light-headed feeling, like you might pass out;
severe dizziness;
problems with balance or muscle movement;
chest pain, shortness of breath;
fast or pounding heartbeats;
very slow heartbeats; or
dark urine.
Common Vimpat side effects may include:
headache, dizziness;
double vision; or
nausea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.
Other drugs may interact with lacosamide, including prescription and over-the-counter medicines, vitamins, and herbal products.
Tell your doctor about all your other medicines, especially:
heart or blood pressure medication.
This list is not complete. Other drugs may interact with lacosamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Tell your doctor about all your current medicines and any medicine you start or stop using. Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Vimpat only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Vimpat (www.drugs.com/vimpat.html).
Note: This document contains side effect information about lacosamide. Some of the dosage forms listed on this page may not apply to the brand name Vimpat.
In SummaryCommon side effects of Vimpat include: blurred vision, diplopia, dizziness, fatigue, headache, nausea, nystagmus disorder, tremor, vomiting, and ataxia. Other side effects include: abnormal gait, asthenia, memory impairment, and vertigo. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to lacosamide: oral solution, oral tablet
Other dosage forms:
Along with its needed effects, lacosamide (the active ingredient contained in Vimpat) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking lacosamide:
More common
Less common
Incidence not known
Some side effects of lacosamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Incidence not known
For Healthcare Professionals
Applies to lacosamide: intravenous solution, oral solution, oral tablet
GeneralThe most commonly reported adverse reactions have included diplopia, headache, dizziness, and nausea.
Nervous systemDizziness was reported in 25% of patients randomized to the recommended doses (200 to 400 mg/day) of this drug compared with 8% of placebo patients in studies in adult patients with partial-onset seizures taking 1 to 3 concomitant AEDs. It was the event most frequently leading to discontinuation (3%). Ataxia was reported by 6% of patients randomized to the recommended doses (200 to 400 mg/day) compared to 2% in placebo patients. Dizziness and ataxia were also observed in pediatric clinical trials.
Very common (10% or more): Dizziness (up to 60%), headache (up to 13%), ataxia (up to 15%)
Common (1% to 10%): Somnolence, tremor, balance disorder, nystagmus, memory impairment, coordination abnormal, cognitive disorder, somnolence, tremor, dysarthria, disturbance in attention, paresthesia
Frequency not reported: Oral hypoesthesia, pyrexia
Postmarketing reports: Hypoesthesia, cerebellar syndrome, new or worsening seizures
GastrointestinalVery common (10% or more): Nausea (up to 24%), vomiting (up to 16%)
Common (1% to 10%): Diarrhea, constipation, flatulence, dyspepsia, dry mouth
OcularVery common (10% or more): Diplopia (up to 16%), blurred vision (up to 16%)
HypersensitivityUncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, or DRESS)
OtherVery common (10% or more): Fatigue (up to 15%)
Common (1% to 10%): Asthenia, vertigo, gait disturbance
Frequency not reported: Tinnitus, fall
LocalCommon (1% to 10%): Injection site pain or discomfort
Uncommon (0.1% to 1%): Irritation, erythema
PsychiatricCommon (1% to 10%): Depression, confusional state, insomnia
Uncommon (0.1% to 1%): Aggression, agitation, euphoric mood, suicide attempt, suicidal ideation, hallucination
Frequency not reported: Irritability, feeling drunk
Postmarketing reports: Psychotic disorder
DermatologicCommon (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Angioedema, urticaria
Frequency not reported: Neutropenia, anemia
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis
CardiovascularDuring clinical trials in adult patients with partial-onset seizures, asymptomatic first-degree atrioventricular (AV) block was observed in 0.4% (4/944) of patients randomized to this drug and 0% (0/364) of placebo patients. One case of profound bradycardia was observed in a patient during a 15-minute 150 mg IV infusion.
In short-term trials in adult patients with diabetic neuropathy, atrial fibrillation occurred in 0.5% of patients (placebo=0%). Syncope occurred in 1.2% of patients (placebo=0%).
A clinical pharmacology study in healthy subjects (n=247) did not shown any QTc interval prolongation or dose-related or clinically important effects on QRS duration. This drug did produce a dose-related increase in mean PR interval; the maximum mean PR interval increase corresponded with Tmax. The placebo-subtracted maximum increase in PR interval was 7.3 ms for the 400 mg/day group and 11.9 ms for the 800 mg/day group. In clinical trials, the placebo-subtracted mean maximum increase in PR interval for a 400 mg/day dose was 3.1 ms in patients with partial-onset seizures and 9.4 ms for patients with diabetic neuropathy.
Very common (10% or more): Chest pain (up to 12%)
Common (1% to 10%): Syncope
Uncommon (0.1% to 1%): Atrioventricular block, bradycardia, atrial fibrillation, atrial flutter
Frequency not reported: Palpitations
Postmarketing reports: Cardiac arrhythmias including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death
MusculoskeletalCommon (1% to 10%): Muscle spasms
Frequency not reported: Connective tissue disorders
HematologicFrequency not reported: Neutropenia, anemia
Postmarketing reports: Agranulocytosis
HepaticUncommon (0.1% to 1%): Liver function test abnormal
Frequency not reported: Hepatitis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Vimpat (www.drugs.com/vimpat.html).
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