Oxtellar XR

What is Oxtellar XR?

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.

Description

Oxtellar XR ® is an antiepileptic drug (AED). Oxtellar XR ® extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is

Oxcarbazepine is off-white to yellow crystalline powder.

Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15H 12N 2O 2 and its molecular weight is 252.27.

Oxtellar XR ® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, yellow iron oxide (150 mg, 300 mg tablets only), red iron oxide (300 mg, 600 mg tablets only), black iron oxide (300 mg tablet only), magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide. Each tablet is printed on one side with edible black ink.

Mechanism of Action

The pharmacological activity of Oxtellar XR ® is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine . The precise mechanism by which oxcarbazepine and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxc

What is the most important information I should know about Oxtellar XR?

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 seizuresSimilar 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 awayMany 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 moodHow 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.

Who should not take Oxtellar XR?

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 the end of this Medication Guide for a complete list of ingredients in Oxtellar XR.

What should I tell my healthcare provider 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.
• are pregnant or plan to become pregnant. Oxtellar XR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Oxtellar XR. You and your healthcare provider will decide if you should take Oxtellar XR while you are pregnant.
  • If you become pregnant while taking Oxtellar XR, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
  • The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
• are breastfeeding or plan to breastfeed. Oxtellar XR passes into breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Oxtellar XR.

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, or 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.

How should I take Oxtellar XR?

• 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.

What are the possible side effects of Oxtellar XR?

See “What is the most important information I should know about Oxtellar XR?”
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.

General information about the safe and effective use of Oxtellar XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Oxtellar XR for a condition for which it was not prescribed. Do not give Oxtellar XR to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about Oxtellar XR that is written for health professionals.

How should I store Oxtellar XR?

• Store Oxtellar XR at room temperature between 68°F to 77°F (20°C and 25°C).
• Keep Oxtellar XR in a tightly closed container and out of the light.
• Keep Oxtellar XR tablets dry.

Keep Oxtellar XR and all medicines out of the reach of children.

What are the ingredients in Oxtellar XR?

Active ingredient: oxcarbazepine

Inactive ingredients:

150 mg tablets: colloidal silicon dioxide, hypromellose, yellow iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide.

300 mg tablets: colloidal silicon dioxide, hypromellose, yellow iron oxide, red iron oxide, black iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide.

600 mg tablets: colloidal silicon dioxide, hypromellose, red iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium lauryl sulfate, talc, and titanium dioxide.

Label

PRINCIPAL DISPLAY PANEL – 150 MG TABLET BOTTLE LABEL

PRINCIPAL DISPLAY PANEL – 300 MG TABLET BOTTLE LABEL

PRINCIPAL DISPLAY PANEL – 600 MG TABLET BOTTLE LABEL