Trokendi XR extended-release capsules

Generic Name: topiramate (toe-PYRE-a-mate)
Brand Name: Trokendi XR

Trokendi XR extended-release capsules is used for:

Treating seizures in certain patients. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Trokendi XR extended-release capsules is an anticonvulsant. It works by affecting several chemicals in the brain that help to reduce seizure activity.

Do NOT use Trokendi XR extended-release capsules if:

  • you are allergic to any ingredient in Trokendi XR extended-release capsules
  • you have high blood acid levels (metabolic acidosis) and you 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 Trokendi XR extended-release capsules:

Some medical conditions may interact with Trokendi XR extended-release 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, or 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 other medicine for seizures

Some MEDICINES MAY INTERACT with Trokendi XR extended-release 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 Trokendi XR extended-release capsules with pioglitazone
  • Hydrochlorothiazide or metformin because they may increase the risk of Trokendi XR extended-release capsules's side effects
  • Carbamazepine or hydantoins (eg, phenytoin) because they may decrease Trokendi XR extended-release capsules's effectiveness
  • Amitriptyline or lithium because the risk of their side effects may be increased by Trokendi XR extended-release capsules
  • Bosutinib, cabazitaxel, dienogest, hormonal birth control (eg, birth control pills), or ulipristal because their effectiveness may be decreased by Trokendi XR extended-release capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Trokendi XR extended-release 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 Trokendi XR extended-release capsules:

Use Trokendi XR extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Trokendi XR extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Trokendi XR extended-release capsules refilled.
  • Take Trokendi XR extended-release capsules by mouth with or without food.
  • Swallow Trokendi XR extended-release capsules whole. Do not sprinkle on food, break, crush, chew, open, or dissolve before swallowing. If you cannot swallow Trokendi XR extended-release capsules whole, talk to your doctor. You may need a different medicine.
  • Drinking extra fluids while you are taking Trokendi XR extended-release capsules is recommended. Doing so may help to prevent kidney stones from forming. Check with your doctor for instructions.
  • Do not suddenly stop taking Trokendi XR extended-release capsules. Suddenly stopping Trokendi XR extended-release capsules may increase the risk of seizures. If you need to stop Trokendi XR extended-release capsules, your doctor will gradually lower your dose.
  • If you miss a dose of Trokendi XR extended-release capsules, take it as soon as possible. If it is almost time for 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 Trokendi XR extended-release capsules.

Ask your health care provider any questions you may have about how to use Trokendi XR extended-release capsules.

Important safety information:

  • Trokendi XR extended-release 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 Trokendi XR extended-release 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 within 6 hours before and 6 hours after you take Trokendi XR extended-release capsules.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Trokendi XR extended-release capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Trokendi XR extended-release 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 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.
  • Trokendi XR extended-release 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, trouble thinking clearly, persistent loss of appetite, or fast or irregular heartbeat.
  • Trokendi XR extended-release 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 Trokendi XR extended-release 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 Trokendi XR extended-release 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.
  • Trokendi XR extended-release 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 Trokendi XR extended-release 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 Trokendi XR extended-release 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 Trokendi XR extended-release 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 Trokendi XR extended-release capsules in CHILDREN; they may be more sensitive to its effects, especially decreased sweating and decreased bicarbonate levels.
  • Trokendi XR extended-release capsules may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Trokendi XR extended-release capsules.
  • Trokendi XR extended-release capsules is not approved for use in CHILDREN younger than 6 years old.
  • Trokendi XR extended-release 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 Trokendi XR extended-release 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 Trokendi XR extended-release capsules, if you are planning to become pregnant, and if you have questions or concerns about this information.
  • PREGNANCY and BREAST-FEEDING: Trokendi XR extended-release 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 Trokendi XR extended-release capsules while you are pregnant. You and your doctor will need to decide if you will continue to take Trokendi XR extended-release capsules while you are pregnant. Trokendi XR extended-release capsules is found in breast milk. If you are or will be breast-feeding while you take Trokendi XR extended-release capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Trokendi XR extended-release 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, running 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 Trokendi XR extended-release capsules:

Store Trokendi XR extended-release capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, light, and moisture. Do not store in the bathroom. Keep Trokendi XR extended-release capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about Trokendi XR extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Trokendi XR extended-release 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 Trokendi XR extended-release 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 Trokendi XR extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Trokendi XR extended-release 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 healthcare provider for complete information about the risks and benefits of using Trokendi XR extended-release capsules.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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.

Hide
(web4)