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Oxcarbazepine

(ox car baz' e peen)

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IMPORTANT WARNING:   Return to top

[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):

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)

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.

Why is this medication prescribed?   Return to top

Oxcarbazepine is used alone or in combination with other medications to control certain types of seizures . Oxcarbazepine is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

How should this medicine be used?   Return to top

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 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 3 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, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking oxcarbazepine, your seizures may get worse. Your doctor will probably decrease your dose gradually.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with oxcarbazepine 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.

Other uses for this medicine   Return to top

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.

What special precautions should I follow?   Return to top

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:

What special dietary instructions should I follow?   Return to top

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?   Return to top

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 oxcarbazepine. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?   Return to top

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 the following 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].

What storage conditions are needed for this medicine?   Return to top

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 emergency/overdose   Return to top

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.

What other information should I know?   Return to top

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.

Brand names   Return to top

  • Trileptal®

Last Revised - 03/01/2009


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