Seizure Disorder/Epilepsy

A seizure occurs as a result of a sudden burst of excess electrical activity in the brain, causing a temporary disruption in the communication between brain cells. This disruption may result in abnormal brain function and consequent mental and physical manifestations. Epilepsy, also known as seizure disorder, is a chronic neurological disorder characterized by a tendency for patients to have recurrent seizures.

According to the Centers for Disease Control and Prevention (CDC), epilepsy affects about 2.4 million adults and over 450,000 children in the United States.1 In fact, about 150,000 new cases of epilepsy will be diagnosed in the United States each year.1 At Upsher-Smith, we understand the life-altering impact that seizure disorder/epilepsy can have for those who suffer from this condition.

To address this critical need, Upsher-Smith has established a focused effort on making a difference in seizure disorder/epilepsy management. Our growing portfolio of medications for seizure disorder/epilepsy includes Qudexy® XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.

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To learn more about Qudexy® XR, visit www.QudexyXR.com.

WHAT IS QUDEXY XR?

Qudexy® XR (topiramate) Extended-Release Capsules is a prescription medicine used to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) and 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 2 years and older.

WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW?

Qudexy® XR should not be used in patients with metabolic acidosis who are also taking a medicine called metformin (e.g., Glucophage®).

Qudexy® XR can cause serious side effects, including:

  • Serious eye problems, which may include blurred or sudden decrease in vision, eye pain and redness or a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). If left untreated, this can lead to permanent vision loss.
  • Decreased sweating and 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 acid level in the blood (metabolic acidosis). This may or may not cause symptoms. Symptoms may include feeling tired, decreased appetite, change in heartbeat, or trouble thinking clearly. 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 blood ammonia levels. High ammonia in the blood can affect mental activities, slow alertness and cause tiredness or vomiting. This can also happen when Qudexy XR is taken with a medicine called valproic acid (e.g., Depakene® and Depakote®).
  • Kidney stones. Drink plenty of fluids when taking Qudexy XR to decrease your chances of getting kidney stones.
  • Low body temperature. Taking Qudexy 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. Qudexy XR may affect how you think, and can cause confusion, problems with concentration, attention, memory, or speech. Qudexy XR may cause depression or mood problems, tiredness, and sleepiness.
  • Dizziness or loss of muscle coordination.

Call your healthcare provider right away if you have any of the above symptoms.

Like other antiepileptic drugs, Qudexy XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Before taking Qudexy 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; attempt to commit suicide; have new or worsening depression or anxiety; feel agitated or restless; experience panic attacks, have trouble sleeping (insomnia), new or worsening irritability; feel or act aggressive, angry, or violent; act on dangerous impulses; experience an extreme increase in activity and talking (mania); or other unusual changes in your behavior or mood.

Qudexy XR can harm your unborn baby. All women of childbearing age should talk to their healthcare provider about possible alternative treatments. If you take Qudexy XR 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. If the decision is made to use Qudexy XR, you should use effective birth control (contraception). Tell your healthcare provider right away if you become, or plan to become pregnant while taking Qudexy XR.

The most common side effects of Qudexy XR include: tingling of the arms and legs (paresthesia), not feeling hungry, weight loss, nervousness, speech problems, tiredness, dizziness, sleepiness/drowsiness, slow reactions, difficulty with memory, fever, and abnormal vision. These are not all the possible side effects of Qudexy XR. For more information, ask your healthcare provider or pharmacist.

Before taking Qudexy XR, tell your healthcare provider about all of your medical conditions, including if you: 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 planning to become pregnant; or if you are breastfeeding. The medicine in Qudexy XR (topiramate) passes into your breast milk. It is not known if the medicine, topiramate, that passes into breast milk can harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Qudexy XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take metformin (e.g., Glucophage); valproic acid (e.g., Depakene or Depakote); any medicines that impair or decrease your thinking, concentration, or muscle coordination; birth control pills (Qudexy XR may make birth control pills less effective); medicines used to prevent seizures; or any other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide, or dichlorphenamide).

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

Do not drink alcohol while taking Qudexy XR. Qudexy XR and alcohol can cause serious side effects such as severe sleepiness and dizziness and an increase in seizures.

Do not drive a car, swim, climb, or operate heavy machinery until you know how Qudexy XR affects you. Qudexy XR can slow your thinking and motor skills, and may affect vision. Even when taking Qudexy XR, some patients with epilepsy will continue to have unpredictable seizures.

This is the most important information to know about Qudexy XR, but is not comprehensive. For more information, talk to your healthcare provider and read the Medication Guide for Qudexy XR. You can also visit www.upsher-smith.com or call 1-888-650-3789.

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.

Qudexy is a registered trademark of Upsher-Smith Laboratories, Inc.
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