Qudexy XR Sprinkle

Topiramate is a seizure medicine, also called an anticonvulsant. Topiramate is used to treat 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.

Extended-release topiramate has a higher minimum age (at least 10 years old) when used as the child's only seizure medicine.

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

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

You should not use extended-release topiramate if you have metabolic acidosis and are also taking metformin. Do not take Trokendi XR within 6 hours of drinking alcohol.

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. You should not use extended-release topiramate if you have metabolic acidosis (high levels of acid in your blood) and are also taking metformin for diabetes.

To make sure topiramate is safe for you, tell your doctor if you have:

• glaucoma or other eye problems;
• diabetes, or a history of metabolic acidosis;
• kidney disease, a history of kidney stones, or if you are on dialysis;
• severe breathing problems;
• a history of mood problems, depression, or suicidal thoughts or actions;
• liver disease;
• soft or brittle bones (osteoporosis, osteomalacia);
• a growth disorder;
• if you take lithium; or
• if you are sick with diarrhea.

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

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.

Do not start or stop taking topiramate during pregnancy without your doctor's advice. Taking topiramate during pregnancy may increase the risk of cleft lip and/or cleft palate in the newborn. But having a seizure during pregnancy could harm both mother and baby. There may be other seizure medicine that can be more safely used during pregnancy. Tell your doctor right away if you become pregnant while taking topiramate.

Topiramate can make birth control pills less effective. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy while taking topiramate. Tell your doctor if you become pregnant during treatment.

Topiramate can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not drink alcohol. Dangerous side effects or increased seizures can occur when alcohol is combined with topiramate.

Avoid becoming overheated or dehydrated in hot weather. Topiramate can decrease sweating and increase body temperature, leading to life-threatening dehydration (especially in children). This effect can be worse if you also use: cold or allergy medicine, bladder or urinary medicine, a bronchodilator, medicine for Parkinson's disease, or medicine to treat stomach ulcers or irritable bowel syndrome.

Ketogenic or "ketosis" diets that are high in fat and low in carbohydrates can increase the risk of kidney stones. Avoid the use of such diets 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 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.

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking topiramate with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with topiramate, especially:

• birth control pills;
• metformin;
• glaucoma medicine--acetazolamide, dichlorphenamide; or
• other seizure medicines--carbamazepine, divalproex sodium, phenytoin, valproic acid, or zonisamide.

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 interactions are listed in this medication guide.

Topiramate is a seizure medicine, also called an anticonvulsant. Topiramate is used to treat 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.

Extended-release topiramate has a higher minimum age (at least 10 years old) when used as the child's only seizure medicine.

The Topamax and Qudexy brands of this medicine are also used to prevent migraine headaches in adults and teenagers who are at least 12 years old. Topamax will only prevent migraine headaches or reduce the number of attacks. It will not treat a headache that has already begun.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include 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 decrease sweating and increase body temperature, leading to life-threatening dehydration (especially in children). This effect can be worse if you also use: cold or allergy medicine, bladder or urinary medicine, a bronchodilator, medicine for Parkinson's disease, or medicine to treat stomach ulcers or irritable bowel syndrome.

Ketogenic or "ketosis" diets that are high in fat and low in carbohydrates can increase the risk of kidney stones. Avoid the use of such diets 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 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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:

• vision problems, eye pain or redness, sudden vision loss (can be permanent if not treated quickly);

• confusion, slowed thinking, memory problems, 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:

• numbness or tingling in your arms and legs;

• flushing (warmth, redness, or tingly feeling);

• headache, dizziness, drowsiness, tired feeling;

• mood problems, confusion, feeling nervous, problems with thinking or memory;

• slow reactions, problems with speech or vision;

• nausea, diarrhea, stomach pain, loss of appetite, indigestion, weight loss;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• changes in your sense of taste.

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.