Vimpat is an anti-epileptic drug, also called an anticonvulsant.

Vimpat is used to treat partial-onset seizures in adults and children who are at least 1 month of age.

Vimpat is also used to treat primary generalized tonic-clonic seizures in people who are at least 4 years old.

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.

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.

Vimpat oral is taken by mouth. Vimpat injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Lacosamide doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

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 Epilepsy:

MONOTHERAPY FOR PARTIAL-ONSET SEIZURES:
Initial dose: 100 mg orally twice a day
-Titrate in increments of 100 mg (50 mg twice a day) no more frequently than once a week based on clinical response and tolerability
Maintenance dose: 150 to 200 mg orally twice a day

ADJUNCTIVE THERAPY FOR PARTIAL-ONSET SEIZURES OR GENERALIZED TONIC-CLONIC SEIZURES: :
Initial dose: 50 mg orally twice a day
-Titrate in increments of 100 mg (50 mg twice a day) no more frequently than once a week based on clinical response and tolerability
Maintenance dose: 100 to 200 mg orally twice a day

Alternatively, may initiate therapy with a loading dose:
LOADING DOSE: 200 mg oral/IV once, followed in 12 hours with 100 mg oral/IV every 12 hours for at least 1 week; subsequent dose titrations should be performed as described above
-Due to increased incidence of CNS adverse reactions, the loading dose should be administered under medical supervision

Comments:
-Therapy may be administered either orally or via IV infusion using the same dosing regimen; IV infusion should preferably be over 30 to 60 minutes, although may be infused over 15 minutes if needed; experience with IV therapy is limited to 5 days of consecutive treatment.
-In adult clinical trials, adjunctive doses higher than 200 mg twice a day were not more effective and were associated with a substantially higher rate of adverse reactions.
-If converting from a single antiepileptic drug (AED) to lacosamide monotherapy, withdrawal of concomitant AED should not occur until a therapeutic dose of lacosamide has been achieved and administered for 3 days, then the concomitant AED may be gradually withdrawn over 6 weeks.

Use: As monotherapy for partial-onset seizures or adjunctive therapy for partial-onset seizures or primary generalized tonic-clonic seizures in patients 17 years and older

Usual Adult Dose for Seizures:

MONOTHERAPY FOR PARTIAL-ONSET SEIZURES:
Initial dose: 100 mg orally twice a day
-Titrate in increments of 100 mg (50 mg twice a day) no more frequently than once a week based on clinical response and tolerability
Maintenance dose: 150 to 200 mg orally twice a day

ADJUNCTIVE THERAPY FOR PARTIAL-ONSET SEIZURES OR GENERALIZED TONIC-CLONIC SEIZURES: :
Initial dose: 50 mg orally twice a day
-Titrate in increments of 100 mg (50 mg twice a day) no more frequently than once a week based on clinical response and tolerability
Maintenance dose: 100 to 200 mg orally twice a day

Alternatively, may initiate therapy with a loading dose:
LOADING DOSE: 200 mg oral/IV once, followed in 12 hours with 100 mg oral/IV every 12 hours for at least 1 week; subsequent dose titrations should be performed as described above
-Due to increased incidence of CNS adverse reactions, the loading dose should be administered under medical supervision

Comments:
-Therapy may be administered either orally or via IV infusion using the same dosing regimen; IV infusion should preferably be over 30 to 60 minutes, although may be infused over 15 minutes if needed; experience with IV therapy is limited to 5 days of consecutive treatment.
-In adult clinical trials, adjunctive doses higher than 200 mg twice a day were not more effective and were associated with a substantially higher rate of adverse reactions.
-If converting from a single antiepileptic drug (AED) to lacosamide monotherapy, withdrawal of concomitant AED should not occur until a therapeutic dose of lacosamide has been achieved and administered for 3 days, then the concomitant AED may be gradually withdrawn over 6 weeks.

Use: As monotherapy for partial-onset seizures or adjunctive therapy for partial-onset seizures or primary generalized tonic-clonic seizures in patients 17 years and older

Usual Pediatric Dose for Epilepsy:

AGE: 1 month or older:
WEIGHT: Less than 6 kg: Monotherapy Only
-Initial dose: 2 mg/kg/day as 0.66 mg/kg IV 3 times a day OR 1 mg/kg orally 2 times a day
--Titrate by 2 mg/kg/day no more frequently than once a week based on response and tolerability
-Maintenance dose: 7.5 to 15 mg/kg/day as 2.5 to 5 mg/kg IV 3 times a day OR 3.75 to 7.5 mg/kg orally 2 times a day
WEIGHT: 6 to less than 11 kg: Monotherapy Only
-Initial dose: 1 mg/kg oral/IV 2 times a day
--Titrate by 1 mg/kg twice a day no more frequently than once a week based on response and tolerability
-Maintenance dose: 3 to 6 mg/kg oral/IV twice a day

AGE: 4 to less than 17 years:
WEIGHT: 11 to less than 30 kg:
-Initial dose: 1 mg/kg oral/IV 2 times a day
--Titrate by 1 mg/kg oral/IV twice a day no more frequently than once a week based on response and tolerability
-Maintenance dose: 3 to 6 mg/kg oral/IV twice a day
WEIGHT: 30 to less than 50 kg:
-Initial dose: 1 mg/kg oral/IV twice a day
--Titrate by 1 mg/kg twice a day no more frequently than once a week based on clinical response and tolerability
-Maintenance dose: 2 to 4 mg/kg oral/IV twice a day
WEIGHT 50 kg or greater:
-Initial dose: 50 mg oral/IV twice a day
--Titrate by 50 mg twice a day no more frequently than once a week based on clinical response and tolerability
-MONOTHERAPY: Maintenance dose: 150 to 200 mg oral/IV twice a day
-ADJUNCTIVE THERAPY: Maintenance dose: 100 to 200 mg oral/IV twice a day

17 years and older: See Adult Dosing

Comments:
-The use of loading dose in pediatric patients has not been established.
-Oral and IV doses are the same unless specified; IV doses should be administered as an IV infusion over 30 to 60 minutes; experience with IV therapy is limited to 5 days of consecutive treatment.
-In adult clinical trials, adjunctive doses higher than 200 mg twice a day were not more effective and were associated with a substantially higher rate of adverse reactions.
-If converting from a from a single antiepileptic drug (AED) to lacosamide monotherapy, withdrawal of concomitant AED should not occur until a therapeutic dose of lacosamide has been achieved and administered for 3 days, then the concomitant AED may be gradually withdrawn over 6 weeks.

Uses: For the treatment of partial onset seizures in patients 1 month or older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years or older.

Usual Pediatric Dose for Seizures:

AGE: 1 month or older:
WEIGHT: Less than 6 kg: Monotherapy Only
-Initial dose: 2 mg/kg/day as 0.66 mg/kg IV 3 times a day OR 1 mg/kg orally 2 times a day
--Titrate by 2 mg/kg/day no more frequently than once a week based on response and tolerability
-Maintenance dose: 7.5 to 15 mg/kg/day as 2.5 to 5 mg/kg IV 3 times a day OR 3.75 to 7.5 mg/kg orally 2 times a day
WEIGHT: 6 to less than 11 kg: Monotherapy Only
-Initial dose: 1 mg/kg oral/IV 2 times a day
--Titrate by 1 mg/kg twice a day no more frequently than once a week based on response and tolerability
-Maintenance dose: 3 to 6 mg/kg oral/IV twice a day

AGE: 4 to less than 17 years:
WEIGHT: 11 to less than 30 kg:
-Initial dose: 1 mg/kg oral/IV 2 times a day
--Titrate by 1 mg/kg oral/IV twice a day no more frequently than once a week based on response and tolerability
-Maintenance dose: 3 to 6 mg/kg oral/IV twice a day
WEIGHT: 30 to less than 50 kg:
-Initial dose: 1 mg/kg oral/IV twice a day
--Titrate by 1 mg/kg twice a day no more frequently than once a week based on clinical response and tolerability
-Maintenance dose: 2 to 4 mg/kg oral/IV twice a day
WEIGHT 50 kg or greater:
-Initial dose: 50 mg oral/IV twice a day
--Titrate by 50 mg twice a day no more frequently than once a week based on clinical response and tolerability
-MONOTHERAPY: Maintenance dose: 150 to 200 mg oral/IV twice a day
-ADJUNCTIVE THERAPY: Maintenance dose: 100 to 200 mg oral/IV twice a day

17 years and older: See Adult Dosing

Comments:
-The use of loading dose in pediatric patients has not been established.
-Oral and IV doses are the same unless specified; IV doses should be administered as an IV infusion over 30 to 60 minutes; experience with IV therapy is limited to 5 days of consecutive treatment.
-In adult clinical trials, adjunctive doses higher than 200 mg twice a day were not more effective and were associated with a substantially higher rate of adverse reactions.
-If converting from a from a single antiepileptic drug (AED) to lacosamide monotherapy, withdrawal of concomitant AED should not occur until a therapeutic dose of lacosamide has been achieved and administered for 3 days, then the concomitant AED may be gradually withdrawn over 6 weeks.

Uses: For the treatment of partial onset seizures in patients 1 month or older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years or older.

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 should not be given to a child younger than 4 years old.

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;

• drowsiness;

• 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.