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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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[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions. Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. The drugs included in the analyses include (some of these drugs are also available in generic form):
Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. 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/InfoSheets/HCP/antiepilepticsHCP.htm. |
Topiramate is used with 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.
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. 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:
Topiramate is also used for the management of alcohol dependence. Talk to your doctor about the risks of using this medication for your condition.
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.
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. Never store broken tablets or mixtures of sprinkles and soft food. These should be used right away or thrown away. 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:
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 -
02/01/2008
Last Reviewed -
04/01/2000
The MedMaster™ Patient Drug Information database provides information copyrighted by the American Society of Health-System Pharmacists, Inc., Bethesda, Maryland Copyright© 2008. All Rights Reserved.
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Page last updated: 17 April 2008 |