Qudexy XR

Qudexy XR is a prescription medication used to treat seizure disorders. This medication is also approved to prevent migraine headaches. 

Qudexy XR belongs to a group of drugs called anticonvulsants or anti-epileptic drugs. These work by altering the activity of neurotransmitters in the brain.

This medication comes in capsule form and is taken once a day, with or without food. Qudexy XR capsules may be swallowed whole or opened and sprinkled on a spoonful of soft food.

Common side effects of Qudexy XR include loss of appetite, weight loss, fatigue, nervousness, difficulty with memory, difficulty concentrating, cognitive problems, confusion, mood changes, fever, infection, and flushing.

Qudexy XR can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Qudexy XR affects you.

Qudexy XR is a prescription medicine used:

• alone to treat partial onset seizures and primary generalized tonic-clonic seizures in patients 2 years and older
• with other medications to treat partial onset seizures and primary generalized tonic-clonic seizures in patients 2 years and older
• with other medicines to treat seizures associated with Lennox-Gastaut syndrome in adults and children 2 years and older
• to prevent migraine headaches

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Upsher-Smith Laboratories, Inc.

Qudexy XR may cause serious side effects including. See "Drug Precautions".

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
• abnormal vision

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Qudexy XR. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines for epilepsy (phenytoin, carbamazepine, and valproic acid)
• birth control medicines taken by mouth (oral contraceptives)
• metformin
• lithium
• other carbonic anhydrase inhibitors (zonisamide, acetazolamide, dichlorphenamide)
• CNS depressants (medicines that impair your thinking, concentration or muscle coordination). For example:
  • medicines for anxiety 
  • medicines for insomnia
  • pain medicines
  • alcohol

This is not a complete list of possible drug interactions with Qudexy XR. Talk to your doctor or pharmacist for more information.

Qudexy XR may cause eye problems. Serious eye problems include:

• any sudden decrease in vision with or without eye pain and redness
• a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma)

These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare provider right away if you have any new eye symptoms.

Qudexy XR may cause 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. Call your healthcare provider right away if you have a fever or decreased sweating.

Qudexy XR can increase the level of acid in your 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 your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms.

Sometimes people with metabolic acidosis will:

• feel tired
• not feel hungry (loss of appetite)
• feel changes in heartbeat
• have trouble thinking clearly

Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Qudexy XR. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

Metabolic acidosis. Metabolic acidosis can cause:

• tiredness
• loss of appetite
• irregular heartbeat
• impaired consciousness

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 Qudexy XR is taken with a medicine called valproic acid (Depakene and Depakote).

Low body temperature. Taking Qudexy XR when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma.

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

Effects on thinking and alertness. Qudexy XR may affect how you think and 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.

Qudexy XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider 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

Watch for early symptoms of suicidal thoughts and actions.

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

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

Do not stop Qudexy XR without first talking to a healthcare provider. Stopping Qudexy XR suddenly can cause serious problems.

Qudexy XR can harm your unborn baby (see "Pregnant Section").

• Do not drink alcohol while taking Qudexy XR. Qudexy XR and alcohol can affect each other causing side effects such as sleepiness and dizziness.
• Do not drive a car 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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Qudexy XR there are no specific foods that you must exclude from your diet when receiving Qudexy XR.

Before taking Qudexy XR, tell your healthcare provider about all your medical conditions, including if you:

• are allergic to Qudexy XR or to any of its ingredients
• have or have had depression, mood problems, or suicidal thoughts or behavior
• have kidney problems, have 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. Qudexy XR passes into breast milk. It is not known if the Qudexy 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 Qudexy XR.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Qudexy XR and other medicines may affect each other causing side effects.

Especially tell your healthcare provider 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. Qudexy XR may make your birth control pills less effective. Tell your healthcare provider if your menstrual bleeding changes while you are taking birth control pills and Qudexy XR.

Ask your healthcare provider if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.

Qudexy XR can harm your unborn baby.

• 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.
• Cleft lip and cleft palate may happen even in children born to women who are not taking any medicines and do not have other risk factors.
• 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 healthcare providers about using other possible treatments instead of Qudexy XR. If the decision is made to use Qudexy XR, you should use effective birth control (contraception) unless you are planning to become pregnant. You should talk to your doctor about the best kind of birth control to use while you are taking Qudexy XR.
• Tell your healthcare provider right away if you become pregnant while taking Qudexy XR. You and your healthcare provider should decide if you will continue to take Qudexy XR while you are pregnant.
• Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if Qudexy XR has caused metabolic acidosis during your pregnancy.
• Pregnancy Registry: If you become pregnant while taking Qudexy XR, talk to your healthcare provider 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 antiepileptic drugs during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. Qudexy XR may be excreted in human breast milk. The effects of this exposure on infants are unknown.

Take Qudexy XR exactly as prescribed. Take Qudexy XR exactly as your healthcare provider tells you to.

• Qudexy XR can be taken before, during, or after a meal. Drink plenty of fluids during the day. This may help prevent kidney stones while taking Qudexy XR.
• If you are taking this medication to prevent migraines, take this medication at night for the first week. Then take once daily. 

Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.

Qudexy XR capsules may be swallowed whole or, if you cannot swallow the capsule whole, you may carefully open the Qudexy XR capsule and sprinkle the medicine on a spoonful of soft food like applesauce.

• Swallow the food and medicine mixture right away. Do not store the food and medicine mixture to use later.
• Drink fluids right after eating the food and medicine mixture to make sure it is all swallowed.
• Do not crush or chew the food and medicine mixture before swallowing.
• Do not crush or chew Qudexy XR capsules before swallowing.

If you take too much Qudexy XR, call your healthcare provider or poison control center right away or go to the nearest emergency room.

If you miss a single dose of Qudexy XR, take it as soon as you can. Do not double your dose. If you have missed more than one dose, you should call your healthcare provider for advice.

Do not stop taking Qudexy XR without talking to your healthcare provider. Stopping Qudexy XR suddenly may cause serious problems. 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.

Your healthcare provider may do blood tests while you take Qudexy XR.

Take Qudexy XR exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. For most patients, the dosage is gradually increased until the minimum effective dosage is reached. This occurs over at least four weeks.

Qudexy XR when used alone to treat Partial Onset or Primary Generalized Tonic-Clonic Seizures:

• The recommended dose for Qudexy XR in adults and children 10 years of age and older is 400 mg/day.
• The recommended dose for Qudexy XR in children 2 years to 10 years of age will be based on weight. 

Qudexy XR when used with other medications:

• The recommended dose of Qudexy XR to treat adults with partial onset seizures or Lennox-Gastaut syndrome is 200 mg to 400 mg once daily.
• The recommended dose of Qudexy XR to treat adults with primary generalized tonic-clonic seizures is 400 mg once daily.
• The recommended dose of Qudexy XR to treat pediatric patients 2 years and older with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome is 5 mg/kg to 9 mg/kg once daily.

Qudexy XR when used to prevent migraine headaches:

• Take Qudexy XR 25 mg once daily at nighttime for the first week. Your healthcare provider will increase the dose slowly. The recommended maintenance dose is 100 mg once daily. 

If you take too much Qudexy XR, call your local Poison Control Center or seek emergency medical attention right away.

• Store Qudexy XR capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Qudexy XR in a tightly closed container.
• Keep Qudexy XR dry and away from moisture.
• Keep Qudexy XR and all medicines out of the reach of children.