Frequently Asked Questions about Trokendi XR® (topiramate)

Look below for answers to questions you may have about Trokendi XR® (topiramate) for the prevention of migraine headaches

Trokendi XR (topiramate) is a prescription medicine used:

  • to prevent migraine headaches in adults and adolescents 12 years and older
  • to treat certain types of seizures (partial onset seizures and primary generalized tonic-clonic seizures) in people 6 years and older
  • with other medicines to treat certain types of seizures (partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 6 years and older

Before taking Trokendi XR (topiramate), tell your prescriber about all your medical conditions, including if you:

  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have kidney problems, kidney stones, or are getting kidney dialysis
  • have a history of metabolic acidosis (too much acid in the blood)
  • have liver problems
  • have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density)
  • have lung or breathing problems
  • have eye problems, especially glaucoma
  • have diarrhea
  • have a growth problem
  • are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet
  • are having surgery
  • are pregnant or plan to become pregnant
  • are breastfeeding. Trokendi XR (topiramate) passes into your breast milk. It is not known if the
    Trokendi XR that passes into breast milk can harm your baby. Talk to your prescriber about the best way to feed your baby if you take Trokendi XR

Tell your prescriber about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Trokendi XR (topiramate) and other medicines may affect each other, causing side effects. Especially, tell your prescriber if you take:

  • valproic acid (such as DEPAKENE® or DEPAKOTE®)
  • any medicines that impair or decrease your thinking, concentration, or muscle coordination
  • birth control pills. Trokendi XR (topiramate) may make your birth control pills less effective. Tell your prescriber if your menstrual bleeding changes while you are taking birth control pills and Trokendi XR (topiramate)
  • Take Trokendi XR (topiramate) capsules whole. Do not sprinkle Trokendi XR on food, or break, crush, dissolve, or chew Trokendi XR (topiramate) capsules before swallowing
  • If you cannot swallow Trokendi XR (topiramate) capsules whole, tell your prescriber. You may need a different medicine
  • Take Trokendi XR (topiramate) exactly as prescribed
  • Your prescriber may change your dose. Do not change your dose without talking to your prescriber
  • Do not stop taking Trokendi XR (topiramate) without talking to your prescriber. Stopping Trokendi XR (topiramate) suddenly may cause serious problems. If you have epilepsy and you stop taking Trokendi XR (topiramate) suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to slowly stop taking Trokendi XR (topiramate)

Talk to your prescriber on what you should do if you miss a dose.

  • Do not drink alcohol within 6 hours prior to and 6 hours after Trokendi XR (topiramate) administration. Trokendi XR (topiramate) and alcohol can cause serious side effects, such as severe sleepiness and dizziness and an increase in seizures.
  • Do not drive a car or operate heavy machinery until you know how Trokendi XR (topiramate) affects you. Trokendi XR (topiramate) can slow your thinking and motor skills, and may affect vision

Trokendi XR (topiramate) can harm your unborn baby.

  • If you take Trokendi XR (topiramate) during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant
  • Also, if you take Trokendi XR (topiramate) during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known.
  • There may be other medicines to treat your condition that have a lower chance of birth defects
  • All women of childbearing age should talk to their prescribers about using other possible treatments instead of Trokendi XR (topiramate). If the decision is made to use Trokendi XR (topiramate), you should use effective birth control (contraception) unless you are planning to become pregnant. You should talk to your prescriber about the best kind of birth control to use while you are taking Trokendi XR (topiramate)
  • Tell your prescriber right away if you become pregnant while taking Trokendi XR (topiramate). You and your prescriber should decide if you will continue to take Trokendi XR (topiramate) while you are pregnant
  • Metabolic acidosis may have harmful effects on your baby. Talk to your prescriber if Trokendi XR (topiramate) has caused metabolic acidosis during your pregnancy
  • Pregnancy Registry: If you become pregnant while taking Trokendi XR (topiramate), talk to your prescriber about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of Trokendi XR (topiramate) and other antiepileptic drugs during pregnancy

Trokendi XR (topiramate) may cause serious side effects, including:

  • High blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when Trokendi XR (topiramate) is taken with a medicine called valproic acid (DEPAKENE® and DEPAKOTE®)
  • Kidney stones. Drink plenty of fluids when taking Trokendi XR (topiramate) to decrease your chances of getting kidney stones
  • Low body temperature. Taking Trokendi XR (topiramate) when you are also taking valproic acid may cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma
  • Effects on thinking and alertness. Trokendi XR (topiramate) may affect how you think, and may cause confusion, problems with concentration, attention, memory, or speech. Trokendi XR (topiramate) may cause depression or mood problems, tiredness, and sleepiness
  • Dizziness or loss of muscle coordination

Call your prescriber right away if you have any of these symptoms. These are not all the possible side effects of Trokendi XR (topiramate). Please see the Patient Medication Guide or talk to your prescriber for more information about possible side effects of Trokendi XR (topiramate).

Call a prescriber right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood
  • if you have any new eye symptoms, including any new problems with your vision
  • if a high fever, a fever that does not go away, or decreased sweating develops
  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings
  • Keep all follow-up visits with your prescriber as scheduled
  • Call your prescriber between visits as needed, especially if you are worried about symptoms
  • Store Trokendi XR (topiramate) capsules at room temperature between 59°F to 86°F (15°C to 30°C)
  • Keep Trokendi XR (topiramate) in a tightly closed container
  • Keep Trokendi XR (topiramate) dry and away from moisture and light
  • Keep Trokendi XR (topiramate) and all medicines out of the reach of children and pets

IMPORTANT SAFETY INFORMATION

Do not take Trokendi XR if you have recently consumed or plan to consume alcohol (i.e., within 6 hours prior to and 6 hours after Trokendi XR use)

Swallow Trokendi XR capsules whole. Do not sprinkle on food, chew, or crush.

What are the possible side effects of Trokendi XR?

Trokendi XR can cause serious side effects, including: Eye problems. Serious eye problems include sudden decrease in vision with or without eye pain or redness, a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). Call your healthcare provider right away if you have new eye symptoms, including any new problems with your vision.

Decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.

Increased levels of acid in the blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm the unborn child of pregnant patients.

High levels of ammonia in the blood. High ammonia in the blood can affect mental activities, slow alertness, cause tiredness, or cause vomiting. Blood ammonia levels have been shown to rise when Trokendi XR is taken with a medicine called valproic acid (e.g., DEPAKENE® and DEPAKOTE®).

Kidney stones. Drink plenty of fluids when taking Trokendi XR to decrease your chances of getting kidney stones.

Low body temperature. Taking Trokendi XR when you are also taking valproic acid may cause a drop in body temperature to less than 95°F, tiredness, confusion, or coma.

Effects on thinking and alertness. Trokendi XR may affect how you think, and can cause confusion and problems with concentration, attention, memory, or speech. Trokendi XR may cause depression or mood problems, tiredness, and sleepiness.

Dizziness or loss of muscle coordination.

The most common side effects include tingling of the arms and legs (paresthesia), not feeling hungry, nausea, weight loss, abnormal vision, a change in the way foods taste, nervousness, speech problems, dizziness, slow reactions, upper respiratory tract infection, sleepiness, diarrhea, pain in abdomen and difficulty with memory. These are not all the possible side effects of Trokendi XR. For more information, ask your healthcare provider or pharmacist.

Like other antiepileptic drugs, Trokendi XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Before you take Trokendi XR, tell your healthcare provider if you have or have had depression, mood problems, or suicidal thoughts or behavior. Call a healthcare provider right away if you have thoughts about suicide or dying; have attempted to commit suicide; have new or worsening depression or anxiety; feel agitated or restless; experience panic attacks, trouble sleeping (insomnia), or new or worsening irritability; feel or act more aggressive, angry, or violent; act on dangerous impulses; have an extreme increase in activity and talking (mania); or experience other unusual changes in behavior or mood.

Before taking Trokendi XR, tell your healthcare provider about any other medical conditions, including if you have kidney problems, kidney stones, or are getting kidney dialysis; have a history of metabolic acidosis (too much acid in the blood); have liver problems; have weak, brittle or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density); have lung or breathing problems; have eye problems, especially glaucoma; have diarrhea; have a growth problem; are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet; are having surgery; are pregnant or plan to become pregnant; or if you are breastfeeding. Trokendi XR passes into your breast milk. It is not known if the Trokendi XR that passes into breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Trokendi XR.

Trokendi XR can harm your unborn baby. If you take Trokendi XR during pregnancy, your baby has a higher risk for the birth defects of cleft lip, cleft palate, and being smaller than expected at birth. These defects can begin early in pregnancy, even before you know you are pregnant. The long term effects of this are unknown.

Tell your healthcare provider about any other medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Trokendi XR and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take valproic acid (e.g., DEPAKENE or DEPAKOTE); any medicines that impair or decrease your thinking, concentration, or muscle coordination; or birth control pills. Trokendi XR may make your birth control pills less effective.

Do not stop Trokendi XR without first talking to a healthcare provider. If you have epilepsy and you stop taking Trokendi XR suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Trokendi XR slowly.

Do not drive a car or operate heavy machinery until you know how Trokendi XR affects you. Trokendi XR can slow your thinking and motor skills, and may affect vision.

INDICATION Trokendi XR® (topiramate) extended-release capsules are used to prevent migraine headaches in adults and adolescents 12 years and older.

Please refer to the full Prescribing Information and Medication Guide for additional important information on Trokendi XR.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.