Qudexy XR sprinkle capsules

Generic Name: topiramate (toe-PYRE-a-mate)
Brand Name: Examples include Qudexy XR and Topamax

Qudexy XR sprinkle capsules is used for:

Treating seizures in certain patients. It may be used alone or with other medicines. Some products are also used to prevent migraine headaches. It may also be used for other conditions as determined by your doctor.

Qudexy XR sprinkle capsules is an anticonvulsant that is also effective for preventing migraine headaches. It works by affecting several chemicals in the brain that help to reduce seizure activity and prevent migraine headaches from occurring.

Do NOT use Qudexy XR sprinkle capsules if:

  • you are allergic to any ingredient in Qudexy XR sprinkle capsules
  • you have high blood acid levels (metabolic acidosis) and are also taking a medicine that contains metformin. Check with your doctor or pharmacist if you are not sure if a medicine you take contains metformin

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Qudexy XR sprinkle capsules:

Some medical conditions may interact with Qudexy XR sprinkle capsules. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have eye problems (eg, glaucoma), liver or kidney problems, kidney stones, metabolism problems, osteoporosis (weak bones), or soft bones
  • if you have diarrhea, lung or breathing problems, low bicarbonate levels in the blood, or a growth problem, or you will be having surgery
  • if you drink alcohol regularly, you are on a diet high in fat and low in carbohydrates (ketogenic diet), or you are receiving kidney dialysis
  • if you have a history of status epilepticus (continuous seizure activity or a series of seizures without a full return to consciousness) or metabolic acidosis
  • if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions
  • if you take any other medicine for seizures

Some MEDICINES MAY INTERACT with Qudexy XR sprinkle capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticholinergics (eg, benztropine) or carbonic anhydrase inhibitors (eg, acetazolamide, dichlorphenamide, zonisamide) because the risk of decreased sweating may be increased
  • Valproic acid because the risk of high blood ammonia levels or low body temperature may be increased
  • Pioglitazone because blood glucose control may be altered; monitor your blood sugar carefully if you use Qudexy XR sprinkle capsules with pioglitazone
  • Hydrochlorothiazide or metformin because they may increase the risk of Qudexy XR sprinkle capsules's side effects
  • Carbamazepine or hydantoins (eg, phenytoin) because they may decrease Qudexy XR sprinkle capsules's effectiveness
  • Amitriptyline or lithium because the risk of their side effects may be increased by Qudexy XR sprinkle capsules
  • Lithium because Qudexy XR sprinkle capsules may have an effect on lithium blood levels
  • Cabazitaxel, hormonal birth control (eg, birth control pills), or ulipristal because their effectiveness may be decreased by Qudexy XR sprinkle capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Qudexy XR sprinkle capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Qudexy XR sprinkle capsules:

Use Qudexy XR sprinkle capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Qudexy XR sprinkle capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Qudexy XR sprinkle capsules refilled.
  • Take Qudexy XR sprinkle capsules by mouth with or without food.
  • Drinking extra fluids while you are taking Qudexy XR sprinkle capsules is recommended. Doing so may help to prevent kidney stones from forming. Check with your doctor for instructions.
  • The capsules may either be swallowed whole or opened and sprinkled over a spoonful of soft food, such as applesauce, custard, ice cream, oatmeal, pudding, or yogurt. Do not crush or chew the beads inside the capsule.
  • If mixing Qudexy XR sprinkle capsules with soft food, swallow the mixture right away. Do not crush or chew Qudexy XR sprinkle capsules before swallowing. Drink fluid immediately after taking the medicine to be sure all of the mixture is swallowed. Do not store the mixture for future use.
  • Do not suddenly stop taking Qudexy XR sprinkle capsules. Suddenly stopping Qudexy XR sprinkle capsules may increase the risk of seizures. If you need to stop Qudexy XR sprinkle capsules, your doctor will gradually lower your dose.
  • If you miss a dose of Qudexy XR sprinkle capsules, take it as soon as possible. If it is within 6 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Contact your doctor if you miss more than 1 dose of Qudexy XR sprinkle capsules.

Ask your health care provider any questions you may have about how to use Qudexy XR sprinkle capsules.

Important safety information:

  • Qudexy XR sprinkle capsules may cause drowsiness, dizziness, confusion, trouble concentrating, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Qudexy XR sprinkle capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not change your dose without checking with your doctor.
  • Do not drink alcohol while you are using Qudexy XR sprinkle capsules.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Qudexy XR sprinkle capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Qudexy XR sprinkle capsules may reduce sweating, which could raise body temperature, especially in children. This risk is greater in hot weather and/or during vigorous exercise. Drink plenty of fluids. Dress lightly while in hot climates or when exercising. Check carefully for signs of decreased sweating. If this occurs, promptly seek cooler or air-conditioned shelter and/or stop exercising. Seek medical attention right away if you have decreased sweating, fever, mental or mood changes, headache, or dizziness.
  • Qudexy XR sprinkle capsules may cause high blood acid levels (metabolic acidosis). The risk may be greater in children and in patients with kidney problems, severe breathing problems, or diarrhea. It may also be greater in patients who are taking certain other medicines (eg, acetazolamide), will be having surgery, or are on a ketogenic diet. Over a period of time, metabolic acidosis may cause kidney stones, bone problems, or decreased growth in children. Contact your doctor immediately if you experience fast breathing, unusual tiredness or weakness, sluggishness, persistent loss of appetite, or fast or irregular heartbeat.
  • Qudexy XR sprinkle capsules may cause high blood ammonia levels (hyperammonemia). This risk may be greater in patients with metabolism problems or certain liver problems. It may also be greater in patients who are taking valproic acid. Contact your doctor immediately if you experience decreased alertness, mental changes, sluggishness, unusual tiredness, or vomiting.
  • Patients who take Qudexy XR sprinkle capsules may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Qudexy XR sprinkle capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Qudexy XR sprinkle capsules may cause serious eye problems that could lead to permanent loss of vision if not treated. Seek medical attention right away if you experience new eye symptoms (eg, blurred vision or other vision changes, eye pain or redness).
  • Tell your doctor or dentist that you take Qudexy XR sprinkle capsules before you receive any medical or dental care, emergency care, or surgery.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Qudexy XR sprinkle capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms). Discuss any questions or concerns with your doctor.
  • Lab tests, including serum bicarbonate levels, may be performed while you use Qudexy XR sprinkle capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Caution is advised when using Qudexy XR sprinkle capsules in CHILDREN; they may be more sensitive to its effects, especially decreased sweating and decreased bicarbonate levels.
  • Qudexy XR sprinkle capsules may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Qudexy XR sprinkle capsules.
  • Qudexy XR sprinkle capsules may cause birth defects if you take it while you are pregnant. If you may become pregnant, discuss other possible treatment options with your doctor. If a decision is made to take Qudexy XR sprinkle capsules, use effective birth control while you are taking it. Talk with your doctor about the best kind of birth control to use while taking Qudexy XR sprinkle capsules, if you are planning to become pregnant, and if you have questions or concerns about this information.
  • PREGNANCY and BREAST-FEEDING: Qudexy XR sprinkle capsules may cause birth defects if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of taking Qudexy XR sprinkle capsules while you are pregnant. You and your doctor will need to decide if you will continue to take Qudexy XR sprinkle capsules while you are pregnant. Qudexy XR sprinkle capsules is found in breast milk. If you are or will be breast-feeding while you take Qudexy XR sprinkle capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Qudexy XR sprinkle capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; flushing; headache; loss of appetite; nausea; nervousness; stomach pain or upset; symptoms of upper respiratory tract infection (eg, cough, mild sore throat, runny or stuffy nose, sneezing); taste changes; tiredness; trouble sleeping; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bone pain; burning, numbness, or tingling; chest pain; confusion; decreased coordination; decreased or painful urination; fever, chills, or persistent cough or sore throat; loss of consciousness; memory problems; menstrual changes; muscle or joint pain, cramps, or weakness; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent drowsiness; severe stomach, side, or back pain; significant weight loss; speech problems; stupor; suicidal thoughts or actions; tremor; trouble walking; unusual bruising or bleeding; unusual eye movements.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Qudexy XR sprinkle capsules:

Store Qudexy XR sprinkle capsules at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Qudexy XR sprinkle capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about Qudexy XR sprinkle capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Qudexy XR sprinkle capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Qudexy XR sprinkle capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Qudexy XR sprinkle capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Qudexy XR sprinkle capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Qudexy XR sprinkle capsules.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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