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More migraine-free days may be possible

Ask your healthcare provider about a switch to once-a-day Trokendi XR.

It's a simple switch from twice-a-day topiramate

Switching to once-a-day Trokendi XR from twice-a-day Topamax® (topiramate) allows you to take the same medicine you are already taking—but less often.

Trokendi XR offers steady, all-day delivery

Once-a-day Trokendi XR

Trokendi XR rises in your body and maintains a relatively steady level to ensure medicine coverage all day with just 1 dose.

Twice-a-day Topamax

Topamax rises in your body and then drops down over the course of 12 hours before the second dose is taken.


Designed and approved for once-a-day dosing

Trokendi XR uses Microtrol® technology—3 types of specially coated microbeads that help achieve all-day coverage of your medicine.


A study found that a total daily dose of once-a-day Trokendi XR (topiramate) provided comparable medication levels in the blood as twice-a-day Topamax (topiramate).

Part 1:

  • 39 healthy adults were randomly assigned to take 200 mg of Trokendi XR once a day or 100 mg of Topamax twice a day
  • Over 3 weeks, the 39 adults in the study were adjusted up to their full 200-mg dose of medication and maintained on this full dose for 10 days

Part 2:

  • After the 10 days were complete, all of the adults took a break from the treatment for 32 days to clear the medication from their bodies
  • They were then switched to the opposite treatment and the same procedures were repeated

Proven for migraine prevention

Topiramate is prescribed more than 2.5 times as much as any other migraine prevention medicine. In 2 clinical studies, topiramate (100 mg/day) was proven to be effective in reducing the number of migraine headaches. At the end of the studies, almost half the patients had success with 100 mg/day of topiramate (at least a 50% reduction in monthly migraines).

Study design

The goal of the clinical studies was to measure the reduction in number of migraine headaches per month.

How the topiramate studies worked: In both clinical studies, patients with 3 to 12 migraine headaches (but no more than 15 headache days) per month were observed for 6 months.

Patients started with an average of approximately 5 migraine headaches a month.

Patients were maintained on placebo or 1 of 3 different doses (50, 100, or 200 mg/day) of topiramate.

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In addition to migraine prevention, Trokendi XR is used to treat certain types of seizures

It's time to talk to your healthcare provider about your migraines

Finding relief depends on good communication between you and your doctor. Our guide can help make that conversation easier.

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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.

Serious Skin Reactions. Trokendi XR may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). Trokendi XR may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.

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. Breastfed babies may be sleepy or have diarrhea. 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 Medication Guide for additional important patient information.

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.