Lacosamide (Oral)

Lacosamide is used to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. It works on the central nervous system (CNS) to lower the number and severity of seizures. However, this medicine cannot cure epilepsy and will only help control seizures as long as you keep taking it.

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

It is very important for your doctor to check your or your child's progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

If you or your child experience any unusual or strange thoughts and behaviors while taking lacosamide, be sure to talk to your doctor. Some changes seen in people taking this medicine are similar to those seen in people who drink too much alcohol. Other changes may include 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these side effects are particularly bothersome, consult your doctor.

This medicine can cause changes in heart rhythms, including a condition called PR prolongation. It may alter the way your heart beats and cause lightheadedness, fainting, or serious side effects in some patients. Contact your doctor immediately if you have any symptoms of heart rhythm problems, such as a fast, slow, or irregular heartbeat.

Do not stop taking this medicine without first consulting your doctor. Stopping the medicine suddenly may cause your seizures to return or occur more frequently. Your doctor may want you to gradually decrease the amount you are using before stopping it completely.

Lacosamide may cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS), which is a serious allergic reaction affecting multiple body organs (e.g., liver or kidney). Contact your doctor right away if you have 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.

Breastfeeding while taking this medicine may make your baby more sleepy. Talk to your doctor if you have any concerns.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the chances of using the medicine must be weighed against the good it will do. This is a decision you and your physician will make. For this medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medication or any other medications. Additionally inform 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 Motpoly XR® in children weighing less than 50 kilograms (kg). Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Vimpat® in children younger than 4 years of age to treat primary generalized tonic-clonic seizures and in children younger than 1 month of age to treat partial-onset seizures. Safety and efficacy have not been established.

Geriatric

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

Breast Feeding

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

Interactions with Drugs

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 using this drug, it is especially essential 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 medications is usually not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how frequently you use one or both of the medicines.

• Acebutolol
• Acecainide
• Acepromazine
• Ajmaline
• Alfentanil
• Alprazolam
• Amiodarone
• Amitriptyline
• Amlodipine
• Amobarbital
• Anileridine
• Aprindine
• Aranidipine
• Aripiprazole
• Aripiprazole Lauroxil
• Asenapine
• Atazanavir
• Atenolol
• Baclofen
• Benperidol
• Benzhydrocodone
• Bepridil
• Betaxolol
• Bisoprolol
• Bretylium
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Carteolol
• Carvedilol
• Celiprolol
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Cilnidipine
• Clevidipine
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Disopyramide
• Dofetilide
• Dolasetron
• Doxylamine
• Dronedarone
• Droperidol
• Encainide
• Enflurane
• Esketamine
• Eslicarbazepine Acetate
• Esmolol
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Felodipine
• Fentanyl
• Flecainide
• Flibanserin
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxyzine
• Ibutilide
• Indecainide
• Isoflurane
• Isradipine
• Ketamine
• Ketazolam
• Ketobemidone
• Labetalol
• Lercanidipine
• Levobunolol
• Levocetirizine
• Levorphanol
• Lidocaine
• Lopinavir
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Manidipine
• Meclizine
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metipranolol
• Metoprolol
• Mexiletine
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nadolol
• Nalbuphine
• Nebivolol
• Nicardipine
• Nicomorphine
• Nifedipine
• Nimodipine
• Nisoldipine
• Nitrazepam
• Nitrendipine
• Nitrous Oxide
• Olanzapine
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Oxazepam
• Oxprenolol
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Penbutolol
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Pindolol
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prajmaline
• Prazepam
• Primidone
• Procainamide
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propofol
• Propranolol
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Ritonavir
• Saquinavir
• Secobarbital
• Sertindole
• Sodium Oxybate
• Sotalol
• Sparteine
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Tedisamil
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Timolol
• Tizanidine
• Tocainide
• Tolonium Chloride
• Topiramate
• Tramadol
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Verapamil
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine

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 medications may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following is normally not recommended, but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical issues may affect the use of this drug. Make sure you inform your physician if you have any other medical issues, especially:

• Brugada syndrome (genetic disease) or
• Depression, history of or
• Drug or alcohol abuse or dependence, history of or
• Heart attack or
• Heart block or
• Heart disease (eg, heart failure, myocardial ischemia) or
• Heart rhythm issues (eg, 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 adverse effects.

• Kidney disease, severe or
• Liver disease, mild to moderate—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

• Liver disease, serious—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.

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
• slurred speech
• sore throat
• trouble breathing
• trouble performing routine tasks
• trouble with balance
• trouble with speaking
• 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
• 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
• blistering, peeling, loosening of the skin
• constipation
• difficulty having a bowel movement
• dry mouth
• heartburn
• increased sweating
• indigestion
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• 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.

In the U.S.

• Motpoly XR
• Vimpat

Available Dosage Forms:

• Tablet
• Solution
• Capsule, Extended Release

Therapeutic Class: Anticonvulsant

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. To do so may increase the chance of side effects.

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

You may take this medicine with or without food.

Swallow the tablet or the extended-release capsule whole with liquid. Do not open, crush, break, or chew it.

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.

The oral liquid may also be given using a nasogastric tube or gastrostomy tube.

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 partial-onset seizures or primary generalized tonic-clonic seizures: For patients taking lacosamide alone: Adults and children 17 years of age and older—At first, 100 milligrams (mg) 2 times a day. Some patients may have a starting dose of 200 mg taken as a single dose, followed approximately 12 hours later by 100 mg 2 times a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Children 4 to 16 years of age—Dose is based on body weight and must be determined by your doctor. Weighing 50 kilograms (kg) or more—At first, 50 milligrams (mg) 2 times a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Weighing 30 kg to less than 50 kg—At first, 1 milligram per kilogram (mg/kg) body weight 2 times a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 8 mg/kg body weight per day. Weighing 6 kg to less than 30 kg—At first, 1 milligram per kilogram (mg/kg) body weight 2 times a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 12 mg/kg body weight per day. Weighing less than 6 kg—At first, 1 milligram per kilogram (mg/kg) body weight 2 times a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 15 mg/kg body weight per day. Children younger than 4 years of age—Use and dose must be determined by your doctor. For patients switching from other seizure medicines: Adults and children 17 years of age and older—At first, 150 to 200 milligrams (mg) 2 times a day. Children younger than 17 years of age—Use and dose must be determined by your doctor. For patients who are taking lacosamide together with other seizures medicines: Adults and children 17 years of age and older—At first, 50 milligrams (mg) 2 times a day. Some patients may have a starting dose of 200 mg taken as a single dose, followed approximately 12 hours later by 100 mg 2 times a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Children 4 to 16 years of age and weighs 50 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The usual dose is 100 mg 2 times a day. However, the dose is usually not more than 400 mg per day. Children younger than 4 years of age—Use and dose must be determined by your doctor.
• For oral dosage forms (extended-release capsules):For partial-onset seizures: For patients taking lacosamide alone: Adults and children 17 years of age and older—200 milligrams (mg) once a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Children weighing 50 kilograms (kg) or more—100 mg once a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Children weighing less than 50 kg—Use and dose must be determined by your doctor. For patients who are taking lacosamide together with other seizures medicines: Adults and children 17 years of age and older—At first, 100 milligrams (mg) once a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Children weighing 50 kilograms (kg) or more—At first, 100 milligrams (mg) once a day. Your doctor will slowly increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Children weighing less than 50 kg—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 6 months of first opening the bottle.