Lacosamide

Lacosamide is used to control partial onset seizures (seizures that involve only one part of the brain) in adults and children 1 month of age and older. Lacosamide is also used in combination with other medications to control primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) in adults and children 4 years of age and older. Lacosamide is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Lacosamide comes as a tablet and as an solution (liquid) to take by mouth. It is usually taken twice a day with or without food. Take lacosamide at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lacosamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not chew, split. or crush them.

If you are taking the oral solution, use a dose measuring spoon or oral syringe to measure the correct amount of liquid needed for each dose. Do not use a regular household spoon. If you have a nasogastric (NG) or gastric tube, your doctor or pharmacist will explain how to prepare lacosamide to administer it.

Your doctor will probably start you on a low dose of lacosamide and gradually increase your dose, not more often than once a week.

Lacosamide may help control your condition but will not cure it. It may take a few weeks or longer before you feel the full benefit of lacosamide. Continue to take lacosamide even if you feel well. Do not stop taking lacosamide without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking lacosamide, your seizures may happen more often. Your doctor will probably decrease your dose gradually.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking lacosamide,

• tell your doctor and pharmacist if you are allergic to lacosamide, any other medications, or any of the ingredients in lacosamide tablets or oral solution. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Hemangeol, Inderal); calcium channel blockers such as amlodipine (Norvasc, in Caduet, in Lotrel, in Exforge, others), diltiazem (Cardizem, Cartia, Tiazac, others), felodipine, isradipine, nicardipine, nifedipine (Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Verelan, in Tarka); and medications for irregular heartbeat such as amiodarone (Nexterone, Pacerone), digoxin (Lanoxin), dronedarone (Multaq), flecainide (Tambocor), propafenone (Rythmol), quinidine (in Nuedexta), and sotalol (Betapace, Sorine, Sotylize). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with lacosamide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you currently or have ever drunk large amounts of alcohol, used street drugs, or over-used prescription medications. Also tell your doctor if you have or have ever had depression, mood problems, suicidal thoughts or behavior; an irregular heartbeat, a heart attack, a pacemaker, heart failure, or other heart problems; diabetic neuropathy (nerve damage caused by diabetes); or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking lacosamide, call your doctor.

• you should know that lacosamide may make you dizzy or drowsy and may cause blurred vision or problems with coordination and balance. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how this medication affects you.

• you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking lacosamide. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants like lacosamide to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as 1 week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as lacosamide, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling asleep or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

• you should know that lacosamide may cause dizziness, lightheadedness, fainting, or irregular heartbeat, especially when you get up too quickly from a lying position. If you develop these symptoms, lie down with your legs raised until you feel better, and call your doctor right away.

• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent damage to your brain that can cause severe intellectual disability), you should know that lacosamide oral solution contains aspartame that forms phenylalanine.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Lacosamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea

  • vomiting

  • diarrhea

  • blurred or double vision

  • uncontrollable eye movements

  • dizziness

  • headache

  • drowsiness

  • uncontrollable shaking of a part of the body

  • problems with coordination, balance, or walking

  • weakness

  • itching

• Some side effects can be serious. If you experience any of these symptoms, or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

  • fast or pounding heartbeat or pulse

  • shortness of breath

  • slow heartbeat

  • chest pain

  • fainting

  • swelling of the face, throat, tongue, lips, and eyes

  • fever

  • rash

  • tiredness

  • yellowing of the skin or eyes

  • dark urine

• Lacosamide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze the oral solution. Discard any unused oral solution 6 months after first opening the bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Lacosamide is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.