Drug Notebook

FDA Alerts

Special Alerts:

[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):

  • 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)

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.

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oxcarbazepine
(ox kar BAY zeh peen)

What is oxcarbazepine?
Oxcarbazepine is in a group of drugs called anticonvulsants, or antiepileptic drugs. It works by decreasing nerve impulses that cause seizures. Oxcarbazepine is used to treat partial seizures in adults and children who are at least 2 years old. Oxcarbazepine may also be used for other purposes not listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Oxcarbazepine 150MG Tablets GLENMARK PHARMACEUTICALS30/$45.99 or 90/$119.98
Oxcarbazepine 300MG Tablets GLENMARK PHARMACEUTICALS60/$129.99 or 180/$375.97
Oxcarbazepine 600MG Tablets GLENMARK PHARMACEUTICALS60/$259.98 or 180/$742.97
Trileptal 150MG Tablets NOVARTIS60/$98.74 or 180/$291.33
Trileptal 300MG/5ML Suspension NOVARTIS250/$155.23 or 750/$443.33
Trileptal 300MG Tablets NOVARTIS60/$175.98 or 180/$496.93
Trileptal 600MG Tablets NOVARTIS60/$329.96 or 180/$934.94

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What are the possible side effects of oxcarbazepine?

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.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have nausea, vomiting, weakness, thirst, loss of appetite, headache, confusion, hallucinations, muscle pain or weakness, and/or increased or more severe seizures.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • sore throat, and headache with a severe blistering, peeling, and red skin rash;

  • jaundice (yellowing of the skin or eyes);

  • fever, swollen glands, flu-like symptoms;

  • easy bruising or bleeding, unusual weakness;

  • urinating less than usual or not at all; or

  • increased seizures.

Less serious side effects may include:

  • mild nausea, vomiting, stomach pain, diarrhea;

  • problems with speech, balance, or coordination;

  • blurred vision;

  • mental slowness, trouble concentrating;

  • tremors or shaking;

  • dizziness, drowsiness; or

  • skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take oxcarbazepine?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Take oxcarbazepine with a full glass of water. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, use the oral dosing syringe provided with this medicine. If you did not receive an oral syringe with your medication, ask your pharmacist for one.

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What is the most important information I should know about oxcarbazepine?
Do not take this medication if you are allergic to oxcarbazepine or to a similar medicine called carbamazepine (Carbatrol, Tegretol). Before taking oxcarbazepine, tell your doctor if you have liver or kidney disease. Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Oxcarbazepine should not be used during pregnancy, but taking the medicine can make birth control pills less effective. Use a non-hormone method of birth control (not birth control pills) to prevent pregnancy while you are taking oxcarbazepine. Tell your doctor if you become pregnant during treatment.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect oxcarbazepine?
Before using oxcarbazepine, tell your doctor about all other seizure medications you are taking, including: carbamazepine (Carbatrol, Tegretol); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); or valproic acid (Depakene). There are many other medicines that can interact with oxcarbazepine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Oxcarbazepine has been assigned to pregnancy category C by the FDA. Animal studies have revealed increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation), fetal malformations (craniofacial, cardiovascular, and skeletal), embryofetal death, decreased fetal body weight, and maternal toxicity. There are no controlled data in human pregnancy. Oxcarbazepine should only be given during pregnancy when benefits outweigh risks.

One study has reported that oxcarbazepine is metabolized into its 10 hydroxy derivative to some extent in human placenta in vitro suggesting that the placenta also participates in the metabolism of oxcarbazepine in vivo.

Oxcarbazepine and its active 10-monohydroxy metabolite are excreted into human breast milk. A milk to plasma ratio of 0.5 has been reported for both. Because of the potential for serious adverse reactions to oxcarbazepine in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug in nursing women, taking into account the importance of the drug to the mother.

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Who should NOT use this medication?

  • Known hypersensitivity to oxcarbazepine or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an oxcarbazepine overdose are unknown.

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What should I discuss with my healthcare provider before taking oxcarbazepine?
Do not take this medication if you are allergic to oxcarbazepine or to a similar medicine called carbamazepine (Carbatrol, Tegretol). Before taking oxcarbazepine, tell your doctor if you have liver or kidney disease. If you have any of these conditions you may not be able to use oxcarbazepine, or you may require a dose adjustment or special tests during treatment. You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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