Vimpat

DRUG DESCRIPTION

The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3?­methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is:

VIMPAT® (lacosamide) Structural Formula Illustration

Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.

VIMPAT (lacosamide tablet and injection) Tablets

VIMPAT (lacosamide tablet and injection) tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and dye pigments as specified below:

VIMPAT (lacosamide tablet and injection) tablets are supplied as debossed tablets and contain the following coloring agents:

50 mg tablets: red iron oxide, black iron oxide, FD&C Blue #2/indigo carmine aluminum lake
100 mg tablets: yellow iron oxide
150 mg tablets: yellow iron oxide, red iron oxide, black iron oxide
200 mg tablets: FD&C Blue #2/indigo carmine aluminum lake

VIMPAT (lacosamide tablet and injection) Injection

VIMPAT injection is a clear, colorless, sterile solution containing 10 mg lacosamide per mL for intravenous infusion. One 20-mL vial contains 200 mg of lacosamide drug substance. The inactive ingredients are sodium chloride and water for injection. Hydrochloric acid is used for pH adjustment. VIMPAT (lacosamide tablet and injection) injection has a pH of 3.5 to 5.0.

What are the possible side effects of lacosamide (Vimpat)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, panic, or if you feel hyperactive, talkative, restless, agitated, aggressive, angry, impulsive, or have thoughts about suicide or hurting yourself.

Stop using lacosamide and call your doctor at once if you have a serious side effect such as:

    ...

Read All Potential Side Effects and See Pictures of Vimpat »

What are the precautions when taking lacosamide tablet and injection (Vimpat)?

Before taking lacosamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as chest pain, sick sinus syndrome, heart failure, AV block), liver problems, kidney problems (including dialysis treatment), mental/mood problems (such as depression, psychosis).

This drug may make you dizzy/drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid...

Read All Potential Precautions of Vimpat »


Vimpat Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, blurred/double vision, nausea, vomiting, tiredness, loss of balance, difficulty walking, shakiness (tremor), or memory problems may occur. These side effects are more common when you first start taking the drug and usually lessen as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if any of these rare but serious side effects occur: fast/slow/pounding heartbeat, shortness of breath, severe dizziness, fainting.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

This medication may rarely cause a serious immune system problem (Drug Reaction with Eosinophilia and Systemic Symptoms). Tell your doctor immediately if you experience any of these unlikely but serious side effects: unusual fever, swollen glands, yellowing skin/eyes, unusual tiredness, dark urine, severe stomach/abdominal pain, change in amount of urine, side/back pain (flank pain), bloody/pink urine, chest pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking lacosamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as chest pain, sick sinus syndrome, heart failure, AV block), liver problems, kidney problems (including dialysis treatment), mental/mood problems (such as depression, psychosis).

This drug may make you dizzy/drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

The liquid form of this medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.


Vimpat Patient Information Including Side Effects

Brand Names: Vimpat

Generic Name: lacosamide (Pronunciation: la KOE sa mide)

  • What is lacosamide (Vimpat)?
  • What are the possible side effects of lacosamide (Vimpat)?
  • What is the most important information I should know about lacosamide (Vimpat)?
  • What should I discuss with my health care provider before taking lacosamide (Vimpat)?
  • How should I take lacosamide (Vimpat)?
  • What happens if I miss a dose (Vimpat)?
  • What happens if I overdose (Vimpat)?
  • What should I avoid while taking lacosamide (Vimpat)?
  • What other drugs will affect lacosamide (Vimpat)?
  • Where can I get more information?

What is lacosamide (Vimpat)?

Lacosamide is an antiepileptic drug.

Lacosamide is used together with other medications to treat partial-onset seizures in people with epilepsy who are at least 17 years old.

Lacosamide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of lacosamide (Vimpat)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, panic, or if you feel hyperactive, talkative, restless, agitated, aggressive, angry, impulsive, or have thoughts about suicide or hurting yourself.

Stop using lacosamide and call your doctor at once if you have a serious side effect such as:

  • confusion, thoughts of hurting yourself;
  • double vision;
  • feeling like you might pass out;
  • fast or pounding heartbeats;
  • feeling short of breath;
  • fever, swollen glands, easy bruising or bleeding;
  • nausea, pain in your upper stomach, jaundice (yellowing of your skin or eyes);
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
  • lower back pain, cloudy or bloody urine, swelling, rapid weight gain, urinating less than usual.

Less serious side effects may include:

  • headache, ringing in your ears;
  • tremors, muscle spasms, numbness or tingly feeling;
  • drowsiness, trouble concentrating;
  • dizziness, spinning sensation;
  • loss of balance or coordination;
  • constipation, diarrhea, upset stomach, vomiting; or
  • blurred vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What is the most important information I should know about lacosamide (Vimpat)?

You should not use this medication if you are allergic to lacosamide.

Before you take lacosamide, tell your doctor if you have kidney or liver disease, or a serious heart condition such as "AV block," heart failure, or sick sinus syndrome (unless you have a pacemaker).

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, panic, or if you feel hyperactive, talkative, restless, agitated, aggressive, angry, impulsive, or have thoughts about suicide or hurting yourself.

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