Topiramate ER Capsule

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Topiramate ER Capsule

Detail Description

What is topiramate?


Topiramate is a seizure medicine, also called an anticonvulsant. Topiramate is used to treat certain types of seizures in adults and children who are at least 2 years old. Trokendi XR is for use in adults and children who are at least 6 years old.

Some brands of topiramate are also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. These medicines will only prevent migraine headaches or reduce the number of attacks, but will not treat a headache that has already begun.

Topiramate may also be used for purposes not listed in this medication guide.

Warnings


Topiramate 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.

Topiramate 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.

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

Before taking this medicine


You should not use topiramate if you are allergic to it. 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 topiramate 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 topiramate during pregnancy: The benefit of preventing seizures may outweigh any risks posed by topiramate. 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 topiramate.

Topiramate 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.

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

How should I take topiramate?


Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Topiramate can be taken with or without food.

Swallow the tablet whole and do not crush, chew, or break it. The Trokendi XR extended-release capsule must be swallowed whole. Do not break or open.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

If you cannot swallow a Qudexy XR or Topamax Sprinkle Capsule whole, open it and sprinkle the medicine into a spoonful of applesauce or other soft food. Swallow the mixture right away without chewing. Do not save it for later use.

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 topiramate, 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 topiramate. Any medical care provider who treats you should know that you take seizure medication.

Do not stop using topiramate 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 topiramate.

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

 


What happens if I miss a dose?


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.


What happens if I overdose?


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).

What should I avoid while taking topiramate?


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 topiramate.

Topiramate may cause blurred vision or impair your thinking or reactions. Avoid driving or operating machinery until you know how topiramate will affect you.

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

Topiramate side effects


Get emergency medical help if you have signs of an allergic reaction (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).

Report any new or worsening mood symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

a skin rash, no matter how mild;

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 side effects may 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.

 


What other drugs will affect topiramate?


Using topiramate 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 affect topiramate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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