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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. |
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.
Oxcarbazepine is used alone or in combination with other medications to treat certain types of seizures in people who have epilepsy. Oxcarbazepine is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
Oxcarbazepine comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken every 12 hours (twice a day). , with or without food. Take oxcarbazepine 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 oxcarbazepine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Shake the suspension well right before each use to mix the medication evenly. Use the oral dosing syringe that came with the medication to withdraw the right amount of suspension from the bottle. You can swallow the suspension straight from the syringe, or you can mix it with a small glass of water and swallow the mixture. Wash the syringe with warm water and allow it to dry thoroughly after use.
Your doctor will probably start you on a low dose of oxcarbazepine and gradually increase your dose, not more often than once every three days. If you were taking another medication to treat your seizures and are switching to oxcarbazepine, your doctor may gradually decrease your dose of the other medication while increasing your dose of oxcarbazepine. Follow these directions carefully and ask your doctor if you are not sure how much medication you should take.
Oxcarbazepine may help control your seizures but will not cure your condition. Continue to take oxcarbazepine even if you feel well. Do not stop taking oxcarbazepine without talking to your doctor. If you suddenly stop taking oxcarbazepine, your seizures may get worse. Your doctor will probably decrease your dose gradually.
Oxcarbazepine is also sometimes used to treat bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of frenzied, abnormal excitement, and other abnormal moods). Talk to your doctor about the possible 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 oxcarbazepine:
Before you begin your treatment, talk to your doctor about what you should do if you accidentally miss a dose. Be sure to ask your doctor how long you should wait between taking a missed dose and taking your next scheduled dose of oxcarbazepineDo 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.
Oxcarbazepine may cause 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 thefollowing symptoms, call your doctor immediately:
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 and sight of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any unused suspension 7 weeks after the bottle is first opened and 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.
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 may order certain lab tests to check your response to oxcarbazepine.
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 -
10/01/2005
Last Reviewed -
04/01/2001

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 |