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Drug Information: Oxcarbazepine
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601245.html
(ox car baz' e peen)IMPORTANT WARNING:
| [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. |
Why is this medication prescribed?
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.
How should this medicine be used?
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.
Other uses for this medicine
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?
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:
- tell your doctor and pharmacist if you are allergic to oxcarbazepine, carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), any other medications, or any of the inactive ingredients in oxcarbazepine tablets or suspension. Ask your pharmacist for a list of the inactive ingredients in oxcarbazepine tablets or suspension.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone); amitriptyline (Elavil); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Covera, Isoptin, Verelan); chlorpromazine (Thorazine);clomipramine (Anafranil);cyclophosphamide (Cytoxan, Neosar); desmopressin (DDAVP, Minirin, Stimate);diazepam (Valium);diuretics ('water pills'); hormonal contraceptives (birth control pills, rings, patches, implants, injections, and intrauterine devices); indapamide (Natrilix); other medications for seizures such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin), and valproic acid (Depakene, Depakote); proton-pump inhibitors such as lansoprazole (Prevacid), omeprazole (Prilosec), and pantoprazole (Protonix); theophylline (Theo-Dur); and selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft).Other medications may interact with oxcarbazepine, so be sure to tell your doctor and pharmacist about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had kidney or liverdisease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you are using hormonal contraceptives , you should know that this type of birth control may not work well when taken with oxcarbazepine. Hormonal contraceptives should not be used as your only method of birth control while you are taking this medication. Talk to your doctor about birth control methods that will work for you. Call your doctor if you miss a period or think you may be pregnant while you are taking oxcarbazepine.
- you should know that this medication may make you drowsy or dizzy, or may cause vision changes. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
What should I do if I forget a dose?
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.
What side effects can this medication cause?
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:
- dizziness
- drowsiness
- vision changes
- double vision
- fast, repeating eye movements that you cannot control
- diarrhea
- constipation
- heartburn
- stomach pain
- loss of appetite
- changes in the way food tastes
- dry mouth
- weight gain
- shaking of a part of the body that you cannot control
- difficulty coordinating movements
- falling down
- slowed movements or thoughts
- speech problems
- forgetfulness
- difficulty concentrating
- nervousness
- mood swings
- back pain
- muscle weakness or sudden tightness
- acne
- toothache
- earache
- hot flushes
- increased sweating
- cold symptoms
- nosebleed
- swelling, redness, irritation, burning, or itching of the vagina
- white vaginal discharge
Some side effects can be serious. If you experience any of thefollowing symptoms, call your doctor immediately:
- Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- seizures that last longer or happen more often than in the past
- headache
- unusual thirst
- upset stomach
- vomiting
- weakness
- confusion
- decreased alertness
- rash
- bumps or blisters in the mouth, on skin, or genitals
- red or purple-colored blotches or dots on skin
- red, irritated eyes
- itching
- fever
- swollen glands in the neck or under the arms
- yellowing of the skin or eyes
- unusual bruising or bleeding
- bleeding from the rectum or blood in stools
- sore throat, cough, chills, and other signs of infection
- increased , decreased , or painful urination
- joint pain
- chest pain
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?
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
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?
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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