Pronunciation:

la-KOE-sa-mide

Brand Names:

• Vimpat

Dosage Forms:

• Tablet
• Solution

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

Lacosamide is used to control certain seizures (convulsions) in the treatment of epilepsy. It acts on the central nervous system (CNS) to reduce the number and severity of seizures.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lacosamide in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lacosamide in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution in patients receiving lacosamide.

Pregnancy—

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketorolac
• Naproxen

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetic neuropathy or
• Heart attack or
• Heart block or
• Heart failure or
• Heart or blood vessel disease or
• Heart rhythm problems (e.g., prolonged PR interval) or
• Sick sinus syndrome—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe——Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine may be taken with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (film-coated tablets):
  • For seizures:
    • Adults—At first, 50 milligrams (mg) two times a day. Your doctor may increase your dose gradually if needed. However, the dose is usually not more than 400 mg a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you develop any unusual or strange thoughts and behavior while taking lacosamide, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause some people to become drowsy, dizzy, lightheaded, unconscious, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Lacosamide may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you have the following symptoms: fever, dark urine, headache, rash, stomach pain, unusual tiredness, or yellow eyes or skin.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

Dizziness

shakiness and unsteady walk

sleepiness or unusual drowsiness

trembling or shaking of the hands or feet

unsteadiness, trembling, or other problems with muscle control or coordination

Less common

Being forgetful

discouragement

feeling sad or empty

irritability

itching skin

lack of appetite

loss of balance control

loss of interest or pleasure

mood or mental changes

tearing of the skin

tiredness

trouble concentrating

trouble in walking

trouble sleeping

Incidence not known

Abnormal or decreased touch sensation

black, tarry stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in patterns and rhythms of speech

chills

continuing ringing or buzzing or other unexplained noise in the ears

cough

fast, irregular, pounding, or racing heartbeat or pulse

feeling drunk

fever

hearing loss

lower back or side pain

painful or difficult urination

pale skin

shortness of breath

slurred speech

sore throat

trouble in speaking

trouble performing routine tasks

trouble with balance

troubled breathing with exertion

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Some side effects 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

Blurred vision

double vision

headache

nausea

seeing double

vomiting

Less common

Diarrhea

feeling of constant movement of self or surroundings

lack or loss of strength

sensation of spinning

uncontrolled eye movements

Incidence not known

Acid or sour stomach

belching

difficulty having a bowel movement (stool)

dry mouth

heartburn

indigestion

muscle spasms

stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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