Topiramate

WHY is this medicine prescribed?

Topiramate is used alone or with other medications to treat certain types of seizures including primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) and partial onset seizures (seizures that involve only one part of the brain). Topiramate is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topiramate is also used to prevent migraine headaches but not to relieve the pain of migraine headaches when they occur in adults and children 12 years of age and older. Topiramate is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.

Are there OTHER USES for this medicine?

Topiramate is also sometimes used for the management of alcohol dependence and for the treatment of binge eating disorder and essential tremors (a movement disorder that causes involuntary shaking, especially in the hands). Talk to your doctor about the risks of using this medication for your condition.

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

HOW should this medicine be used?

Topiramate comes as a tablet, a sprinkle capsule (capsule that contains small beads of medication that can be sprinkled on food), an extended-release (long-acting) capsule and solution (liquid) to take by mouth. The tablets, sprinkle capsules, and solution are usually taken with or without food once or twice a day. The extended-release capsules are usually taken with or without food once a day. Take topiramate at around the same time(s) 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 topiramate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Be sure that the prescription your doctor gives you is clear and easy to read. Talk to your pharmacist to be sure that you are given topiramate. If you think you were given the wrong medication, talk to your pharmacist. Do not take any medication unless you are certain it is the medication that your doctor prescribed.

Topiramate tablets have a bitter taste so you should swallow them whole. It is especially important that you not take topiramate tablets that have been broken for any length of time because tablets that are broken may lose their effectiveness over time.

Swallow extended-release capsules (Trokendi XR brand only) whole; do not split, chew, or sprinkle on food.

The sprinkle and extended-release capsules (Qudexy XR brand only) may be swallowed whole or opened and poured over soft food. To take the sprinkle capsules or extended-release capsules (Qudexy XR brand only) mixed with food, you can carefully open the capsule and sprinkle the entire contents onto a spoonful of soft foods, such as applesauce. Swallow the mixture right after you mix it without chewing, and then drink fluids to make sure that you swallow all of the medication.

Use a marked (calibrated) measuring device to measure the topiramate solution dose to make sure the correct dose is being given. Do not use a household teaspoon or tablespoon. Ask your pharmacist for an measuring device if one is not included with your medication.

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

Topiramate may control your seizures or migraines but will not cure your condition. Continue to take topiramate even if you feel well. Do not stop taking topiramate without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking topiramate, you may have severe seizures, even if you have not had seizures in the past. Your doctor will probably decrease your dose gradually.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with topiramate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking topiramate,

• tell your doctor and pharmacist if you are allergic to topiramate, any other medications, or any of the ingredients in topiramate tablets, sprinkle capsules, extended-release capsules, and solution. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with topiramate: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking topiramate. Do not start any of these medications while taking topiramate without talking to your healthcare provider.

• tell your doctor if you or any family members have or have ever had kidney stones, and if you have ever thought about killing yourself or tried to do so. Also tell your doctor if you have or have ever had metabolic acidosis (a disturbance in the body's acid-base balance that results in excessive acidity of the blood); osteopenia, osteomalacia, or osteoporosis (conditions in which the bones are soft or brittle and may break easily); glaucoma (a type of eye disease); any disease that affects your breathing such as asthma or chronic obstructive pulmonary disease (COPD); depression or abnormal moods; a growth problem; or liver or kidney disease. Also tell your doctor if you have diarrhea or if you develop diarrhea during your treatment.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you are pregnant or plan to become pregnant, your doctor may prescribe a different medication instead of topiramate because topiramate may harm the fetus. If you do not plan to become pregnant, you should use birth control to prevent pregnancy during your treatment with topiramate. Talk to your doctor about what type of birth control you should use, because taking topiramate may decrease the effectiveness of hormonal contraceptives such as birth control pills, implants, patches, rings, or injections. If you become pregnant while you are taking topiramate, call your doctor right away, but do not stop taking topiramate before talking to your doctor.

• you should know that topiramate may make you drowsy, dizzy, confused, or unable to concentrate. Do not drive a car or operate machinery until you know how this medication affects you.

• if you are taking topiramate to control seizures, you should know that you may continue to have seizures during your treatment. You may need to avoid activities such as swimming, driving, and climbing so that you will not harm yourself or others if you lose consciousness during a seizure.

• tell your doctor if you if you drink alcohol. You should not drink alcohol within 6 hours before and 6 hours after you take extended-release capsules (Trokendi XR brand only). Your doctor may tell you not to drink alcohol while taking topiramate.

• you should know that topiramate can prevent you from sweating and make it harder for your body to cool down when it gets very hot. This happens most often in warm weather and to children who take topiramate. Avoid exposure to heat, drink plenty of fluids and tell your doctor if you have a fever, headache, muscle cramps, or an upset stomach, or if you are not sweating as usual.

• you should know that you may be more likely to develop a kidney stone while you are taking topiramate. Drink plenty of water or other fluids every day to prevent kidney stones from forming.

• 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 topiramate for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as topiramate 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 topiramate, 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 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; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; 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.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor before changing your diet or beginning any type of weight loss program. Do not follow a ketogenic diet (a high-fat, low-carbohydrate diet used to control seizures) or any other high-fat, low-carbohydrate diet while you are taking this medication.

What should I do IF I FORGET to take a dose?

If you are taking topiramate tablets, sprinkle capsules, or solution, take the missed dose as soon as you remember it. However, if it is less than 6 hours before you are scheduled to take your 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.

If you are taking topiramate extended-release capsules, take the missed dose as soon as you remember it. However, if it is almost time for your 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. If you have missed more than one dose, contact your doctor.

What SIDE EFFECTS can this medicine cause?

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

• numbness, burning, or tingling in the hands or feet
• slowed reactions
• nervousness
• headache
• drowsiness
• weakness
• uncontrollable shaking of a part of the body
• uncontrollable eye movements
• weight loss
• constipation
• nausea
• stomach pain
• change in ability to taste food
• dry mouth
• nosebleed
• back, muscle, leg, or bone pain
• missed menstrual periods
• excessive menstrual bleeding

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

• rash, skin blisters, or skin peeling
• blurred vision
• loss of vision
• double vision
• eye pain
• eye redness
• worsening of seizures
• feeling cold, chills, or low body temperature
• difficulty concentrating
• speech problems, especially difficulty thinking of specific words
• confusion
• memory problems
• coma (loss of consciousness for a period of time)
• loss of coordination
• pounding or irregular heartbeat
• chest pain
• shortness of breath or trouble breathing
• fast, shallow breathing
• inability to respond to things around you
• excessive tiredness
• diarrhea
• vomiting
• loss of appetite
• intense back or side pain
• bloody, cloudy, or foul-smelling urine
• constant need to urinate
• difficulty urinating or pain when urinating
• fever or other signs of infection
• unusual bleeding or bruising

Topiramate may cause osteoporosis (a condition in which bones can break more easily) in adults and rickets (abnormal, curved bone growth) in children. Topiramate may also slow the growth of children and may decrease the final height that children reach. Talk to your doctor about the risks of taking topiramate.

Topiramate 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).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Tablets, extended-release capsules and solution should be stored at room temperature and away from excess heat and moisture (not in the bathroom). Sprinkle capsules should be stored at or below 77°F (25°C) and not in the bathroom. Never store mixtures of topiramate sprinkles and soft food. These should be used right away or discarded. Dispose of any unused solution 60 days 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.

What should I do in case of OVERDOSE?

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.

Symptoms of overdose may include the following:

• seizures
• drowsiness
• speech problems
• blurred vision
• double vision
• trouble thinking
• tiredness
• loss of coordination
• loss of consciousness
• dizziness
• stomach pain
• agitation
• depression
• loss of appetite
• pounding or irregular heartbeat
• fast, shallow breathing

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to topiramate.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.