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Oxcarbazepine extended-release tablets

Pronunciation

Generic Name: oxcarbazepine (OX-kar-BAZ-e-peen)
Brand Name: Oxtellar XR

Oxcarbazepine extended-release tablets are used for:

Treating certain types of seizures. It is used in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Oxcarbazepine extended-release tablets are an anticonvulsant. It works by slowing abnormal nerve impulses in the brain.

Do NOT use oxcarbazepine extended-release tablets if:

  • you are allergic to any ingredient in oxcarbazepine extended-release tablets
  • you have severe liver problems
  • you are taking bortezomib, bosutinib, cabazitaxel, etravirine, nilotinib, pazopanib, or rilpivirine

Contact your doctor or health care provider right away if any of these apply to you.

Before using oxcarbazepine extended-release tablets:

Some medical conditions may interact with oxcarbazepine extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are allergic to carbamazepine
  • if you have kidney problems (including if you are on dialysis), liver problems, or low blood sodium levels
  • if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions
  • if you have trouble swallowing
  • if you have been tested and know whether or not you have a gene type called HLA-B*1502

Some MEDICINES MAY INTERACT with oxcarbazepine extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Monoamine oxidase inhibitors (MAOIs) (eg, selegiline) because a severe reaction, including severe high blood pressure and high fever, may occur
  • HIV protease inhibitors (eg, ritonavir), quetiapine, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of oxcarbazepine extended-release tablets's side effects and their effectiveness may be decreased by oxcarbazepine extended-release tablets
  • Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, or valproic acid because they may decrease oxcarbazepine extended-release tablets's effectiveness. The risk of their side effects may also be increased by oxcarbazepine extended-release tablets
  • Aripiprazole, bortezomib, bosutinib, cabazitaxel, cobicistat, cyclosporine, dienogest, elvitegravir, estradiol, etravirine, exemestane, hormonal contraceptives (eg, birth control pills), ixabepilone, maraviroc, perampanel, rilpivirine, tramadol, tyrosine kinase inhibitors (eg, dasatinib, nilotinib, pazopanib), or ulipristal because their effectiveness may be decreased by oxcarbazepine extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if oxcarbazepine extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use oxcarbazepine extended-release tablets:

Use oxcarbazepine extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Oxcarbazepine extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get oxcarbazepine extended-release tablets refilled.
  • Take oxcarbazepine extended-release tablets by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
  • Swallow oxcarbazepine extended-release tablets whole with water or another liquid. Do not break, crush, cut, or chew before swallowing.
  • Do not suddenly stop taking oxcarbazepine extended-release tablets without checking with your doctor. You may have an increased risk of seizures. If you need to stop oxcarbazepine extended-release tablets, your doctor will gradually lower your dose.
  • Taking oxcarbazepine extended-release tablets at the same time each day will help you remember to take it.
  • Continue to take oxcarbazepine extended-release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of oxcarbazepine extended-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use oxcarbazepine extended-release tablets.

Important safety information:

  • Oxcarbazepine extended-release tablets may cause drowsiness, dizziness, changes in vision, or difficulty with coordination. These effects may be worse if you take it with alcohol or certain medicines. Use oxcarbazepine extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using oxcarbazepine extended-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT change your dose of oxcarbazepine extended-release tablets without checking with your doctor.
  • Patients who take oxcarbazepine extended-release tablets may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take oxcarbazepine extended-release tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Patients who have a certain gene type called HLA-B*1502 may have an increased risk of these skin reactions from oxcarbazepine extended-release tablets. This gene type is found most commonly in Asian patients. Tell your doctor if you have been tested and know whether or not you have the HLA-B*1502 gene type. Discuss any questions or concerns with your doctor.
  • Carry identification (eg, MedicAlert) if oxcarbazepine extended-release tablets are used for seizures. Carry an ID card at all times that says you take oxcarbazepine extended-release tablets.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using oxcarbazepine extended-release tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Oxcarbazepine extended-release tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to oxcarbazepine extended-release tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Do not suddenly stop taking oxcarbazepine extended-release tablets. Oxcarbazepine extended-release tablets must be gradually decreased when discontinued. Talk to your doctor about the proper way to stop taking oxcarbazepine extended-release tablets.
  • Notify your doctor if seizure control worsens.
  • Lab tests, including sodium blood levels, may be performed while you use oxcarbazepine extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use oxcarbazepine extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects.
  • Oxcarbazepine extended-release tablets should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
  • Oxcarbazepine extended-release tablets may become less effective if used during pregnancy. Your doctor will closely monitor your condition. Discuss any questions or concerns with your doctor. If you think you may be pregnant, contact your doctor.
  • PREGNANCY and BREAST-FEEDING: Oxcarbazepine extended-release tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking oxcarbazepine extended-release tablets while you are pregnant. Oxcarbazepine extended-release tablets are found in breast milk. Do not breast-feed while taking oxcarbazepine extended-release tablets.

Possible side effects of oxcarbazepine extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; headache; indigestion; mild stomach pain; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, eyes, face, lips, or tongue; unusual hoarseness); blood in the stool; chest pain; decreased coordination; decreased urination; difficulty concentrating or speaking; double vision, changes in vision, or involuntary eye movement; dulled sense of touch; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint or muscle pain, swelling, or weakness; new or worsening mental, mood, or behavior changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, suicidal thoughts or actions); new or worsening seizures; nosebleed; problems with walking and coordination; severe or persistent dizziness or drowsiness; severe or persistent stomach pain; shortness of breath; swollen lymph nodes; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of low sodium levels (eg, nausea, general body discomfort, headache, lack of energy, confusion, decreased consciousness, increased frequency or severity of seizures); tremor; trouble sleeping; uncontrolled muscle movements; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of oxcarbazepine extended-release tablets:

Store oxcarbazepine extended-release tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly-closed container, away from heat, moisture, and light. Do not store in the bathroom. Keep oxcarbazepine extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about oxcarbazepine extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Oxcarbazepine extended-release tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take oxcarbazepine extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about oxcarbazepine extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to oxcarbazepine extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using oxcarbazepine extended-release tablets.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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