topiramate

Pronunciation

Generic Name: topiramate (toe PYRE a mate)
Brand Name: Qudexy XR, Topamax, Topamax Sprinkle, Trokendi XR, Topiragen

What is topiramate?

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.

What is the most important information I should know about topiramate?

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.

Slideshow: Living with Your Migraines: Tips for Treatment and Prevention

What should I discuss with my healthcare provider before taking topiramate?

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;

  • 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.

FDA pregnancy category D. 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.

How should I take topiramate?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Topiramate can be taken with or without food.

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

The Qudexy XR and Topamax Sprinkle Capsule can be swallowed whole. Or you may open the capsule and sprinkle the medicine into a spoonful of applesauce or other soft food. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Carefully follow the swallowing instructions for your medicine.

While using topiramate, you may need frequent blood tests.

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

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.

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

Store at cool room temperature away from moisture, light, and high heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if you are more than 6 hours late in taking it. Wait until your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss two or more doses.

What happens if I overdose?

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).

What should I avoid while taking topiramate?

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.

Topiramate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty 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;

  • changes in your sense of taste;

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

  • rapid back-and-forth movements of the eyes.

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.

See also: Side effects (in more detail)

Topiramate dosing information

Usual Adult Dose for Migraine Prophylaxis:

Maintenance dose: 50 mg orally 2 times daily, in the morning and in the evening

Titration to 100 mg:
-Week 1: 25 mg orally once daily in the evening
-Week 2: 25 mg orally 2 times a day, in the morning and in the evening
-Week 3: 25 mg orally in the morning and 50 mg orally in the evening
-Week 4: 50 mg orally in the morning and 50 mg orally in the evening

Longer intervals between dose adjustments may be used as needed.

FDA Approved Indication: For adults for the prophylaxis of migraine headache.

Usual Adult Dose for Seizure Prophylaxis:

IMMEDIATE RELEASE:

Monotherapy (adults and pediatric patients 10 years and older):
-Recommended dose: 400 mg orally daily in two divided doses
-The dose should be achieved by titration:
Week 1: 25 mg orally in the morning and 25 mg orally in the evening
Week 2: 50 mg orally in the morning and 50 mg orally in the evening
Week 3: 75 mg orally in the morning and 75 mg orally in the evening
Week 4: 100 mg orally in the morning and 100 mg orally in the evening
Week 5: 150 mg orally in the morning and 150 mg orally in the evening
Week 6: 200 mg orally in the morning and 200 mg orally in the evening

Adjunctive Therapy (adults 17 years and older): Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome:
-Recommended dose:
Partial onset seizures or Lennox-Gastaut Syndrome: 200 to 400 mg orally daily in two divided doses
Primary generalized tonic-clonic seizures: 400 mg orally daily in two divided doses
-Therapy should be initiated at 25 to 50 mg orally daily followed by titration to an effective dose in increments of 25 to 50 mg daily every week. Titrating in increments of 25 mg daily every week may delay the time to reach an effective dose.
-Doses above 400 mg daily have not been shown to improve responses in dose-response studies in adults with partial onset seizures. Daily doses above 1600 mg have not been studied.
-In the study of primary generalized tonic-clonic seizures, the initial titration rate was slower than in previous studies. The assigned dose was reached at the end of 8 weeks.

EXTENDED-RELEASE:

Monotherapy (adults and pediatric patients 10 years and older with partial onset or primary generalized tonic-clonic seizures):
-Recommended dose: 400 mg orally once daily
-The dose should be achieved by titration:
Week 1: 50 mg once daily
Week 2: 100 mg once daily
Week 3: 150 mg once daily
Week 4: 200 mg once daily
Week 5: 300 mg once daily
Week 6: 400 mg once daily

Adjunctive Therapy (adults 17 years and older): Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome:
-Recommended dose:
Partial onset seizures or Lennox-Gastaut Syndrome: 200 to 400 mg orally once daily
Primary generalized tonic-clonic seizures: 400 mg orally once daily
-Therapy should be initiated at 25 to 50 mg orally once daily followed by titration to an effective dose in increments of 25 to 50 mg daily every week.
-Daily doses above 1600 mg have not been studied.
-In the study of primary generalized tonic-clonic seizures, the assigned dose was reached at the end of 8 weeks.

Usual Pediatric Dose for Seizure Prophylaxis:

IMMEDIATE RELEASE:

Monotherapy:
The dose in children 2 to less than 10 years with partial onset or primary generalized tonic-clonic seizures is based on weight:
Titration schedule:
-Week 1: 25 mg orally daily in the evening
-Week 2 (if week 1 dose is tolerated): 25 mg orally 2 times daily
-Thereafter: Dosage can be increased by 25 to 50 mg orally daily each week as tolerated.
-Titration to the minimum maintenance dose should be attempted over 5 to 7 weeks of the total titration period.
-Based upon tolerability and seizure control, titration to a higher dose (up to the maximum maintenance dose) can be attempted with 25 to 50 mg daily in weekly increments.
-The total daily dose should not exceed the maximum maintenance dose for each range of body weight:
Monotherapy total daily maintenance dosing for patients 2 to less than 10 years:
Up to 11 kg: Minimum dose: 150 mg daily; Maximum dose: 250 mg daily
12 to 22 kg: Minimum dose: 200 mg daily; Maximum dose: 300 mg daily
23 to 31 kg: Minimum dose: 200 mg daily; Maximum dose: 350 mg daily
32 to 38 kg: Minimum dose: 250 mg; Maximum dose: 350 mg
Greater than 38 kg: Minimum dose: 250 mg daily; Maximum dose: 400 mg daily

Adjunctive therapy:
Pediatric patients ages 2 to 16 years with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut Syndrome:
-Recommended dose: 5 to 9 mg/kg/day in two divided doses
-Titration should begin at 25 mg orally daily (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1 or 2 week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal response. Dose titration should be guided by clinical outcome.

EXTENDED-RELEASE:

Monotherapy:
See adult dosing.

Adjunctive therapy:
Pediatric patients ages 6 to 16 years with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut Syndrome:
-Recommended dose: 5 to 9 mg/kg orally once daily.
-Titration should begin at 25 mg once daily (based on a range of 1 mg/kg/day to 3 mg/kg/day) given nightly for the first week). The dosage should then be increased at 1 or 2 week intervals by increments of 1 to 3 mg/kg to achieve optimal response. Dose titration should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used.

What other drugs will affect topiramate?

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, methazolamide; 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.

Where can I get more information?

  • Your pharmacist can provide more information about topiramate.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 13.03. Revision Date: 2014-05-12, 7:24:18 AM.

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