Trokendi XR

Trokendi XR is a seizure medicine, also called an anticonvulsant.

Trokendi XR is used to help prevent certain types of seizures in adults and children who are at least 6 years old.

Trokendi XR is used along 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 6 years and older.

Trokendi XR is also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. Topiramate will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun.

Take Trokendi XR exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Trokendi XR can be taken with or without food.

Trokendi XR extended-release capsules must be swallowed whole. Do not break or open.

Carefully follow the swallowing instructions for your medicine.

Topiramate doses are sometimes based on weight in children. Your child's dose needs may change if the child gains or loses weight.

Drink plenty of liquids while you are taking Trokendi XR, to prevent kidney stones or an electrolyte imbalance.

You will need frequent medical tests. If you need surgery, tell the surgeon ahead of time that you are using Trokendi XR. Any medical care provider who treats you should know that you take seizure medication.

Do not stop using Trokendi XR suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Call your doctor if your seizures get worse or you have them more often while taking Trokendi XR.

Store at cool room temperature away from moisture, light, and high heat.

Trokendi XR may cause vision problems that can be permanent if not treated quickly. Call your doctor right away if you have a sudden decrease in vision.

Trokendi XR may increase the risk of a birth defect called cleft lip and palate in a newborn. There may be other medications that are safer to use during pregnancy. Tell your doctor right away if you become pregnant.

Trokendi XR can increase body temperature and decrease sweating, which may lead to life-threatening dehydration. Tell your doctor if you have decreased sweating, high fever, and hot dry skin.

Trokendi XR can also increase the level of acid in your blood (metabolic acidosis). Tell your doctor if you have irregular heartbeats, shortness of breath, loss of appetite, or trouble thinking.

Some people have thoughts about suicide while taking Trokendi XR. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop using Trokendi XR suddenly or you could have increased seizures.

You should not use Trokendi XR if you are allergic to topiramate. Do not take Trokendi XR within 6 hours before or 6 hours after drinking alcohol.

Tell your doctor if you are sick with diarrhea, or if you have ever had:

• glaucoma or other eye problems;
• metabolic acidosis (high levels of acid in your blood);
• kidney disease, kidney stones, or dialysis;
• lung disease, breathing problems;
• mood problems, depression, or suicidal thoughts or actions;
• liver disease;
• a growth disorder; or
• soft or brittle bones (osteoporosis, osteomalacia).

Topiramate can increase the level of acid in your blood (metabolic acidosis). This can weaken your bones, cause kidney stones, or cause growth problems in children or harm to an unborn baby. You may need blood tests to make sure you do not have metabolic acidosis, especially if you are pregnant.

Some people have thoughts about suicide while taking an anticonvulsant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking Trokendi XR during pregnancy may increase the risk of cleft lip and/or cleft palate, a birth defect that can develop early in pregnancy even before you know you are pregnant. However, having a seizure during pregnancy could harm both the mother and the baby. Tell your doctor right away if you become pregnant.

If you take Trokendi XR during pregnancy: The benefit of preventing seizures may outweigh any risks posed by this medicine. There may be other medications that are safer to use. Do not start or stop taking topiramate without your doctor's advice.

If you are not pregnant or planning to become pregnant, use effective birth control to prevent pregnancy while taking Trokendi XR.

Trokendi XR can make birth control pills less effective. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of topiramate on the baby.

It may not be safe to breastfeed a baby while you are using Trokendi XR. Ask your doctor about any risks.

Get emergency medical help if you have signs of an allergic reaction to Trokendi XR (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• a skin rash, no matter how mild;
• dizziness or loss of coordination;
• vision problems, blurred vision, eye pain or redness, sudden vision loss (can be permanent if not treated quickly);
• confusion, problems with thinking or memory, trouble concentrating, problems with speech;
• dehydration symptoms--decreased sweating, high fever, hot and dry skin;
• signs of a kidney stone--severe pain in your side or lower back, painful or difficult urination;
• signs of too much acid in your blood--irregular heartbeats, feeling tired, loss of appetite, trouble thinking, feeling short of breath; or
• signs of too much ammonia in your blood--vomiting, unexplained weakness, feeling like you might pass out.

Common Trokendi XR side effects may include include:

• dizziness, drowsiness, tiredness, slow reactions;
• problems with speech or memory, abnormal vision;
• numbness or tingling in your arms and legs, decreased sensation (especially in the skin);
• changes in your sense of taste, feeling nervous;
• nausea, diarrhea, stomach pain, loss of appetite;
• fever, weight loss; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as you can. Do not take two doses at one time. Skip a missed Topamax dose if your next dose is due in less than 6 hours. Call your doctor if you have missed more than one dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of topiramate can be fatal. Overdose can cause drowsiness, agitation, depression, double vision, thinking problems, problems with speech or coordination, fainting, and seizure (convulsions).

Do not drink alcohol. Dangerous side effects or increased seizures may occur.

Avoid becoming overheated or dehydrated in hot weather. Topiramate can increase body temperature and decrease sweating, leading to life-threatening dehydration (especially in children).

Avoid the use of a ketogenic or "ketosis" diet (high in fat, low in carbohydrates) while you are taking Trokendi XR.

Trokendi XR may cause blurred vision and may impair your thinking or reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Also avoid activities that could be dangerous if you have an unexpected seizure, such as swimming or climbing in high places.

Using Trokendi XR with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or depression.

Tell your doctor about all your other medicines, especially:

• zonisamide;
• birth control pills;
• divalproex, valproic acid; or
• other glaucoma medications, including eye drops.

This list is not complete. Other drugs may interact with topiramate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.