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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication. The drugs included in the analyses include (some of these drugs are also available in generic form):
For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm. [UPDATE 12/16/2008] The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic and http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm. |
Topiramate is used alone or with other medications to treat certain types of seizures in people who have epilepsy. Topiramate is also used with other medications to control seizures in people who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). Topiramate is used to treat patients who continue to have seizures even when they take other anti-seizure medications. Topiramate is also used to prevent migraine headaches, but not to relieve the pain of migraine headaches when they occur. Topiramate is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Topiramate comes as a tablet and a sprinkle capsule (capsule that contains small beads of medication that can be sprinkled on food) to take by mouth. It is usually taken with or without food twice a day in the morning and evening. Take topiramate at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take topiramate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
There is another medication with a name similar to the brand name for topiramate. You should be sure that you receive topiramate and not the similar medication each time you fill your prescription. Be sure that the prescription your doctor gives you is clear and easy to read. Talk to your pharmacist to be sure that you are given topiramate. After you receive your medication, compare the tablets to the pictures in the manufacturer's patient information sheet. If you think you were given the wrong medication, talk to your pharmacist. Do not take any medication unless you are certain it is the medication that your doctor prescribed.
Topiramate tablets have a bitter taste and lose their effectiveness quickly when broken, so you should swallow them whole. Do not split, chew, or crush them.
Your doctor will probably start you on a low dose of topiramate and gradually increase your dose, not more than once every week.
Topiramate may control your seizures or migraines, but will not cure your condition. Continue to take topiramate even if you feel well. Do not stop taking topiramate without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking topiramate, you may have severe seizures, even if you have not had seizures in the past. Your doctor will probably decrease your dose gradually.
The sprinkle capsules may be swallowed whole or opened and poured over food. To take the sprinkle capsule with food, follow these steps:
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with topiramate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide.
Topiramate is also used for the management of alcohol dependence. Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before taking topiramate,
Talk to your doctor about increasing the amount of food you eat if you lose weight while you are taking topiramate.
Talk to your doctor before changing your diet or beginning any type of weight loss program. Do not follow a ketogenic diet (a high-fat, low-carbohydrate diet used to control seizures) or any other high-fat, low-carbohydrate diet, such as the Atkins diet, while you are taking this medication.
Take the missed dose as soon as you remember it. However, if it is less than 6 hours before you are scheduled to take your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Topiramate may cause other side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
Topiramate may cause osteoporosis (a condition in which bones can break more easily) in adults and rickets (abnormal, curved bone growth) in children. Topiramate may also slow the growth of children and may decrease the final height that children reach. Talk to your doctor about the risks of taking topiramate.
Topiramate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Tablets should be stored at room temperature and away from excess heat and moisture (not in the bathroom). Sprinkle capsules should be stored at or below 77 °F (25 °C). Never store broken tablets or mixtures of sprinkles and soft food. These should be used right away or discarded. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to topiramate.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Last Revised - 03/01/2009
AHFS® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
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Page last updated: 16 June 2009 |