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Lacosamide (Oral route)

Pronunciation:

la-KOE-sa-mide

Brand Names:

  • Vimpat

Dosage Forms:

  • Tablet
  • Solution

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

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, this medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

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 children younger than 17 years of age. 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—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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
  • Orlistat

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:

  • 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 This Medicine:

Take this medicine 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.

This medicine 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.

This medicine 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 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 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 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.

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

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. 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 this medicine.

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 blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or trouble with thinking. 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, well-coordinated, or able to think or see well. If these side effects are especially bothersome, check with your doctor.

This medicine 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 this medicine 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 this medicine 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.

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
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.


Last Updated: 4/4/2014

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