Oxtellar XR (oxcarbazepine) is a once-a-day anticonvulsant drug used to treat partial-onset seizures in people with epilepsy. Oxtellar XR is an extended-release tablet, which means it slowly releases the drug steadily over the course of the day.

After you take Oxtellar XR, your body processes the drug into an active form called licarbazepine - a metabolite - that is responsible for most of Oxtellar XR's antiepileptic activity. Oxcarbazepine undergoes a process called metabolism to produce licarbazepine, its active 10-monohydroxy metabolite (MHD).

Oxtellar XR works to help prevent seizure spread in the intact brain. During a seizure many neurons or nerve cells fire at the same time, creating a surge of excessive electrical activity. Oxtellar XR is thought to work by blocking voltage-sensitive sodium channels (VSSC).

VSSC are integral membrane proteins that play key roles in the electrical signaling of cells. It's thought that by blocking VSSC, Oxtellar XR helps to stabilize hyper-excited nerve cell membranes, stop repetitive neuronal firing and diminish impulses between nerve cells. Oxtellar XR also affects calcium channels and increases potassium conductance, and this may also contribute to its antiepileptic activity.

Oxtellar XR was approved by the US Food and Drug Administration (FDA) in 2012. No generic versions of Oxteallar XR are available.

What is Oxtellar XR used for?

Oxtellar XR is a prescription medicine used to treat partial onset seizures in adults and children 6 years of age and older.

Oxtellar XR is not for use in children under 6 years of age.

It is not known if Oxtellar XR is safe and effective in children under 6 years of age.

Do not stop taking Oxtellar XR without first talking to your healthcare provider. Stopping Oxtellar XR suddenly can cause serious problems.

Oxtellar XR can cause serious side effects, including:

• Oxtellar XR may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include:
  • nausea
  • tiredness, lack of energy
  • headache
  • confusion
  • more frequent or more severe seizures
    
    Similar symptoms that are not related to low sodium may occur from taking Oxtellar XR. You should tell your healthcare provider if you have any of these side effects and if they bother you or they do not go away.
    
    Some other medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking.
    
    Your healthcare provider may do blood tests to check your sodium levels during your treatment with Oxtellar XR .
• Oxtellar XR may also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following:
  • swelling of your face, eyes, lips, or tongue
  • trouble swallowing or breathing
  • a skin rash
  • hives
  • fever, swollen glands, or sore throat that does not go away or comes and goes
  • painful sores in the mouth or around your eyes
  • yellowing of your skin or eyes
  • unusual bruising or bleeding
  • severe fatigue or weakness
  • severe muscle pain
  • frequent infections that do not go away
    
    Many people who are allergic to carbamazepine are also allergic to Oxtellar XR. Tell your healthcare provider if you are allergic to carbamazepine.
• Like other antiepileptic drugs, Oxtellar XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood
    
    How can I watch for early symptoms of suicidal thoughts and actions?
    • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled.
      
      Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop taking Oxtellar XR without first talking to a healthcare provider.

• Stopping Oxtellar XR suddenly can cause serious problems.
• Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

• Do not stop taking Oxtellar XR without talking to your healthcare provider. Stopping Oxtellar XR suddenly can cause serious problems, including seizures that will not stop (status epilepticus).
• Take Oxtellar XR exactly as prescribed. Your healthcare provider may change your dose. Your healthcare provider will tell you how much Oxtellar XR to take.
• Take Oxtellar XR 1 time each day.
• Take Oxtellar XR on an empty stomach. This means you should take Oxtellar XR at least 1 hour before or at least 2 hours after a meal.
• Take Oxtellar XR tablets whole with water or other liquid.
• Do not cut, crush, or chew the tablets before swallowing.
• If you take too much Oxtellar XR call your healthcare provider right away.

The recommended dose of Oxtellar XR for adults and pediatric patients when used as monotherapy or adjuvant therapy are listed below.

Adults

• Initiate treatment at a dosage of 600 mg a day given orally once daily for one week. Subsequent dosage increases can be made at weekly intervals in 600 mg a day increments to achieve the recommended daily dosage.
• The recommended daily dosage of Oxtellar XR is 1200 mg to 2400 mg a day, given once daily.

Pediatric Patients (6 to Less than 17 Years of Age)

• Initiate treatment at a daily dosage of 8 mg/kg to 10 mg/kg orally once daily, not to exceed 600 mg per day in the first week. Subsequent dosage increases can be made at weekly intervals in 8 mg/kg to 10 mg/kg increments once daily, not to exceed 600 mg, to achieve the target daily dosage.
• The target maintenance dosage, achieved over two to three weeks, is displayed in the table below.
  
  Target Daily Dosage in Pediatric Patients (6 to Less Than 17 Years of Age)

  Weight	Target Daily Dose
  20 kg to 29 kg	900 mg/day
  29.1 kg to 39 kg	1200 mg/day
  Greater than 39 kg	1800 mg/day

See full prescribing information for more information about Oxtellar XR dosing.

Do not take Oxtellar XR if you are allergic to oxcarbazepine or any of the other ingredients in Oxtellar XR, or to eslicarbazepine acetate. See below for a complete list of ingredients in Oxtellar XR.

What should I tell my doctor before taking Oxtellar XR?

Before taking Oxtellar XR, tell your healthcare provider about all your medical conditions, including if you:

• have or have had suicidal thoughts or actions, depression or mood problems.
• have liver problems.
• have kidney problems.
• are allergic to carbamazepine. Many people who are allergic to carbamazepine are also allergic to Oxtellar XR.
• use birth control medicine. Oxtellar XR may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use.

See " Important information" above.

Oxtellar XR may cause other serious side effects including seizures that can happen more often or become worse, especially in children.

The most common side effects of Oxtellar XR include:

• dizziness
• sleepiness
• headache
• balance problems
• tremors
• vomiting
• double vision
• weakness or lack of energy (asthenia)

These are not all the possible side effects of Oxtellar XR. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Oxtellar XR with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you take:

• carbamazepine
• phenobarbital
• phenytoin
• birth control medicine

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.