lacosamide (Oral route)

Pronunciation

la-KOE-sa-mide

Commonly used brand name(s)

In the U.S.

  • Vimpat

Available Dosage Forms:

  • Tablet
  • Solution

Therapeutic Class: Anticonvulsant

Uses For lacosamide

Lacosamide is used together with other medicines to help control partial seizures (convulsions) in the treatment of epilepsy. It acts on the central nervous system (CNS) to reduce the number and severity of seizures. However, lacosamide cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

Slideshow: Flashback: FDA Drug Approvals 2013

lacosamide is available only with your doctor's prescription.

Before Using lacosamide

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 lacosamide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lacosamide 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lacosamide in children younger than 17 years of age. Safety and efficacy have not been established.

Geriatric

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

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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 lacosamide, 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 lacosamide 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
  • Orlistat

Interactions with Food/Tobacco/Alcohol

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 lacosamide. Make sure you tell your doctor if you have any other medical problems, especially:

  • Depression, history of or
  • Heart attack or
  • Heart block or
  • Heart failure or
  • Heart rhythm problems (e.g., prolonged PR interval) or
  • Mental illness, history of or
  • Sick sinus syndrome (type of abnormal heart rhythm), without pacemaker—Use with caution. May make these conditions worse.
  • Diabetic neuropathy (nerve problem caused by diabetes) or
  • Heart or blood vessel disease—May increase risk for more serious side effects.
  • Kidney disease, severe or
  • Liver disease, mild to moderate—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.
  • Phenylketonuria (PKU)—The oral liquid contains aspartame (a source of phenylalanine), which can make this condition worse.

Proper Use of lacosamide

Take lacosamide only as directed by your doctor, to help your condition as much as possible. 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. To do so may increase the chance of side effects.

lacosamide should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

lacosamide may be taken with or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Lacosamide may be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

Dosing

The dose of lacosamide 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 lacosamide. 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 forms (solution and tablets):
    • For epilepsy:
      • Adults and teenagers 17 years of age and older—At first, 50 milligrams (mg) two times a day. Your doctor may gradually increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day.
      • Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of lacosamide, 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.

Do not freeze the oral liquid. Throw away any unused medicine after 7 weeks of first opening the bottle.

Precautions While Using lacosamide

It is very important that your doctor check your progress at regular visits to make sure lacosamide is working properly. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you become pregnant or planning to become pregnant. Your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry and UCB AED Pregnancy Registry. These registries are used by pregnant patients who are taking lacosamide.

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 lacosamide 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.

lacosamide may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or trouble with thinking. Make sure you know how you react to lacosamide before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well. If these side effects are especially bothersome, check with your doctor.

lacosamide can cause changes in heart rhythms, such as a condition called PR prolongation. It may change the way your heart beats and cause lightheadedness, fainting, or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, slow, or irregular heartbeats.

Do not stop taking lacosamide without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. 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). Stop using lacosamide and check with your doctor right away if you have the following symptoms: fever; dark urine; headache; rash; stomach pain; swollen, painful, or tender lymph glands in the neck, armpit, or groin; unusual tiredness; or yellow eyes or skin.

lacosamide Side Effects

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
  • false or unusual sense of well-being
  • 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 with sleeping
  • trouble with walking
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 performing routine tasks
  • trouble with balance
  • trouble with speaking
  • 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.

See also: Side effects (in more detail)

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