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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.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
You should discuss the potential benefits and risks of
What should I tell my doctor BEFORE starting
- 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;
- 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 to your doctor about the best way to feed your baby if you take Qudexy XR.
Also tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor 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; medicines used to prevent seizures; or any other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide, or dichlorphenamide).
What should I watch for AFTER starting
- Eye problems. Serious eye problems include blurred vision, sudden decrease in vision with or without eye pain and redness, and a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). If left untreated, these 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 your 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 harm your baby if you are pregnant.
- High blood ammonia levels. High ammonia in the blood can affect mental activities, slow alertness, cause tiredness, or cause vomiting. This can also happen when
Qudexy XRis taken with a medicine called valproic acid (e.g., Depakene® and Depakote®).
- Kidney stones. Drink plenty of fluids when taking
Qudexy XRto decrease your chances of getting kidney stones.
- Low body temperature. Taking
Qudexy XRwhen 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 XRmay affect how you think, and can cause confusion, and problems with concentration, attention, memory, or speech. Qudexy XRmay cause depression or mood problems, tiredness, and sleepiness.
- Dizziness or loss of muscle coordination.
Call your doctor right away if you have any of the above symptoms.
The most common side effects of
Like other antiepileptic drugs,
- thoughts about suicide or dying;
- attempts to commit suicide;
- new or worse depression or anxiety;
- feel agitated or restless;
- experience panic attacks;
- trouble sleeping (insomnia);
- new or worse irritability;
- feel or act aggressive, angry, or violent;
- act on dangerous impulses;
- an extreme increase in activity and talking (mania);
- other unusual changes in behavior or mood.
Do not stop
What should I avoid while taking
Do not drink alcohol while taking
Do not drive a car, swim, climb, or operate heavy machinery until you know how
How should I take
This is the most important information to know about
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.