About Trokendi XR® (topiramate) for Migraine Prevention

Help prevent migraine headache with the #1 prescribed branded migraine prevention treatment—Just 1 dose a day

Once-a-day Trokendi XR (topiramate) provides continuous 24-hour coverage of migraine prevention medicine and may help you get back into the picture.

Mystory is about getting fed up with migraine ruining my plans

Missing out on life because of migraines makes you feel angry and disappointed because everybody else is having fun.

Once-a-day Trokendi XR (topiramate) reduced the frequency of Laurie’s migraine headache.


Individual results may vary.
Laurie

In 2 clinical studies, topiramate (100 mg/day) was proven to be effective in reducing the number of migraine headaches

This effect of topiramate was most noticeable after one month of treatment. The goal of the medical studies was to measure the reduction in number of migraine headaches per month.

How the topiramate studies worked

  • In both medical 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
  • At the end of the study, almost half the patients had success with 100 mg/day of topiramate

Topiramate is prescribed more than 2.5 times as much as any other migraine prevention medicine. Medical guidelines list topiramate as having level A evidence for use in migraine prevention based on its established safety and efficacy.

Just one dose a day—Trokendi XR (topiramate) provides 24 hours of migraine prevention coverage

Once-a-day Trokendi XR (topiramate) uses Microtrol Technology®—3 types of specially coated microbeads that help achieve all-day coverage of your medicine.

Trokendi XR Extended Release Migraine Medicine

100 mg is the recommended total daily dose of topiramate for migraine

If you are currently taking topiramate and your dose doesn’t seem to be working for you, it might be time to ask yourself:

  • Are you still suffering from migraine headache more days than you’d like?
  • Are you missing more days or activities than you’d like?

If you answered yes to either of these questions, it is time to talk to a prescriber—preferably, a headache specialist or neurologist who specializes in headaches—about how you are feeling. It may also be time for a new migraine prevention plan. Ask your prescriber about migraine prevention medicine with once-a-day Trokendi XR (topiramate).

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If you are taking twice-a-day Topamax (topiramate), try once-a-day Trokendi XR (topiramate) for 24 hours of migraine prevention medicine

Many people may find it easier to remember to take their topiramate migraine medicine once a day rather than twice a day. When the level of topiramate in your body rises and falls because you have missed a dose or take too much, you may not have appropriate coverage.

See a study that compares how once-a-day Trokendi XR (topiramate) and twice-a-day Topamax (topiramate) are absorbed

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. 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 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.