Carbamazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and nerve pain, such as trigeminal neuralgia and diabetic neuropathy.

Carbamazepine is also used to treat bipolar disorder.

Carbamazepine may also be used for purposes not listed in this medication guide.

Warnings

You should not take carbamazepine if you have a history of bone marrow suppression, if you are allergic to it, or take an antidepressant such as amitriptyline, desipramine, doxepin, imipramine, or nortriptyline.

TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE. Some drugs can raise or lower your blood levels of carbamazepine, which may cause side effects or make this medicine less effective. Carbamazepine can also affect blood levels of certain other drugs, making them less effective or increasing side effects.

Carbamazepine may cause serious blood problems or a life-threatening skin rash or allergic reaction. Call your doctor if you have a fever, unusual weakness, bleeding, bruising, or a skin rash that causes blistering and peeling.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop taking this medicine without asking your doctor first, even if you feel fine.

If you are pregnant, do not start or stop taking carbamazepine without your doctor’s advice.

Before taking this medicine

You should not take carbamazepine if you have a history of bone marrow suppression, or if you are allergic to carbamazepine or to an antidepressant such as amitriptyline, desipramine, doxepin, imipramine, or nortriptyline.

Do not use carbamazepine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Carbamazepine may cause severe or life-threatening skin rash, and especially in people of Asian ancestry. Your doctor may recommend a blood test before you start the medication to determine your risk.

Tell your doctor if you have ever had:

• heart problems;
• liver or kidney disease;
• glaucoma;
• porphyria;
• low sodium levels;
• depression, mood disorder; or
• suicidal thoughts or actions.

You may have thoughts about suicide while taking carbamazepine. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Carbamazepine may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. The benefit of preventing seizures may outweigh any risks to the baby.

Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this medicine on the baby.

Carbamazepine can make birth control pills or implants less effective. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy.

You should not breastfeed while you are using carbamazepine.

How should I take carbamazepine?

Take carbamazepine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take with food.

Swallow the extended-release tablet or capsule whole and do not crush, chew, or break it. Tell your doctor if you cannot swallow a pill whole.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and call your doctor promptly if this medicine seems to stop working as well in preventing your seizures.

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

Do not stop using carbamazepine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe drowsiness, weak or shallow breathing, and loss of consciousness.

What to avoid

Drinking alcohol with this medicine can cause side effects, and can also increase your risk of seizures.

Grapefruit may interact with carbamazepine and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Carbamazepine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Carbamazepine side effects

Get emergency medical help if you have signs of an allergic reaction to carbamazepine (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• a skin rash, no matter how mild;
• loss of appetite, right-sided upper stomach pain, dark urine;
• slow, fast, or pounding heartbeats;
• anemia or other blood problems – fever, chills, sore throat, mouth sores, bleeding gums, nosebleeds, pale skin, easy bruising, unusual tiredness, feeling light-headed or short of breath; or
• low levels of sodium in the body – headache, confusion, severe weakness, feeling unsteady, increased seizures.

Common carbamazepine side effects may include:

• dizziness, loss of coordination, problems with walking;
• nausea, vomiting; or
• drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect carbamazepine?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Using carbamazepine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with carbamazepine, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Banzel is a seizure medication, also called an anti-epileptic or anticonvulsant.

Banzel is used together with other medicines to treat seizures caused by Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Banzel is for use in adults and children who are at least 1 year old.

Warnings

You should not use Banzel if you have a severe liver disease, or a genetic heart rhythm disorder called short QT syndrome.

You should not stop taking Banzel suddenly, unless your doctor tells you to stop the medicine because of a serious side effect.

Some people have thoughts about suicide while taking seizure medication. Stay alert to changes in your mood or symptoms.

Before taking this medicine

You should not use Banzel if you are allergic to rufinamide, or if you have:

• a genetic heart rhythm disorder called short QT syndrome; or
• severe liver disease.

To make sure Banzel is safe for you, tell your doctor if you have ever had:

• heart disease;
• liver disease;
• kidney disease (or if you are on dialysis); or
• depression, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking Banzel. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of rufinamide on the baby.

Banzel can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using rufinamide, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Banzel should not be given to a child younger than 1 year old.

How should I take Banzel?

Take Banzel exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take Banzel with food.

The tablet may be swallowed whole, crushed, or cut in half.

Shake the oral suspension (liquid) well just before you measure a dose.

Measure the liquid using the dosing syringe and bottle adapter provided with this medicine. Insert the adapter into the bottle and snap it into place. Insert the syringe into the adapter and turn the bottle upside down. To measure your dose, pull the plunger to the correct number of milliliters marked on the side of the syringe. Rinse the syringe with water after each use.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your seizures get worse or you have them more often while taking Banzel.

You should not stop using Banzel suddenly, unless your doctor tells you to stop the medicine because of a serious side effect. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions very carefully.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Store the liquid medicine in an upright position. Do not try to remove the bottle adapter once it is in place. Throw away Banzel liquid 90 days after you first opened the bottle, even if there is medicine left inside.

In case of emergency, wear or carry medical identification to let others know you use rufinamide.

Dosing information

Usual Adult Dose for Lennox-Gastaut Syndrome:

Initial dose: 400 to 800 mg orally per day in 2 equally divided doses
-Titrate in 400 to 800 mg increments every other day until a maximum daily dose of 3200 mg/day is reached
Maintenance dose: 1600 mg orally twice a day

Comments:
-It is not known if doses lower than 3200 mg/day are effective.
-For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome.

Usual Pediatric Dose for Lennox-Gastaut Syndrome:

1 year of age or older:
Initial dose: 10 mg/kg/day orally in 2 equally divided doses
-Titrate in 10 mg/kg increments every other day to a target dose of 45 mg/kg/day
Maintenance dose: 45 mg/kg orally per day in 2 equally divided doses
Maximum dose: 3200 mg/day

Comments:
-It is not known if doses lower than 45 mg/kg (not to exceed 3200 mg/day) are effective.
-For patients concomitantly receiving valproate, initial doses should be lower; see dose adjustments section.

Use: For adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Drinking alcohol can increase certain side effects of rufinamide.

Banzel side effects

Get emergency medical help if you have signs of an allergic reaction to Banzel: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• loss of balance or coordination;
• trouble walking; or
• worsening or increased seizures.

Common Banzel side effects may include:

• headache;
• dizziness, drowsiness;
• nausea; or
• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Banzel?

Using Banzel with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• valproic acid (Depakene, Stavzor).

This list is not complete. Other drugs may interact with rufinamide, including prescription and over-the-counter medicines, vitamins, and herbal products.

What is oxcarbazepine?

Oxcarbazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain.

Oxcarbazepine is used either alone or with other medicines to treat partial seizures.

The Trileptal brand of oxcarbazepine is used as a single medicine in adults and children who are at least 4 years old. Trileptal is used with other medicines in adults and children who are at least 2 years old.

The Oxtellar XR brand of oxcarbazepine is used with other medicines in adults and children who are at least 6 years old.

Oxcarbazepine may also be used for purposes not listed in this medication guide.

Oxcarbazepine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Call your doctor right away if you have nausea, lack of energy, confusion, feeling tired or irritable, severe weakness, muscle pain, or increased seizures.

Report any new or worsening symptoms to your doctor, 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.

Common side effects of oxcarbazepine may include:

• dizziness, drowsiness, tiredness;
• balance or coordination problems;
• nausea, vomiting;
• tremors or shaking;
• double vision; or
• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Seek medical treatment if you have symptoms of a serious drug reaction: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising or bleeding, or yellowing of your skin or eyes.

Call your doctor right away if you have symptoms of low sodium levels in your body, such as nausea, confusion, severe weakness, muscle pain, or increased seizures.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not stop using oxcarbazepine suddenly.

Before taking this medicine

You should not take oxcarbazepine if you are allergic to oxcarbazepine or eslicarbazepine.

Tell your doctor if you have ever had:

• liver disease;
• kidney disease;
• mood problems or suicidal thoughts; or
• an allergy to carbamazepine (Carbatrol, Tegretol).

Some people have thoughts about suicide while taking oxcarbazepine. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking oxcarbazepine during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking oxcarbazepine for seizures.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of oxcarbazepine on the baby.

Oxcarbazepine can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

You should not breast-feed while you are taking oxcarbazepine.

Do not give this medicine to a child without medical advice. There are specific age restrictions for the use of oxcarbazepine in children, depending on the dose form and whether it is used alone or with other medicines.

How should I take oxcarbazepine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Give the liquid directly from the oral syringe, or mix the medicine with a small glass of water. After using the syringe, rinse it with water and allow it to air dry.

Take the oxcarbazepine extended-release tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

You may take the oxcarbazepine oral liquid or regular tablet with or without food.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

You may need frequent blood tests.

Do not stop using oxcarbazepine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

In case of emergency, wear or carry medical identification to let others know you use oxcarbazepine.

Seizures are often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

Store at room temperature away from moisture and heat. Throw away any unused liquid 7 weeks after opening the bottle.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking oxcarbazepine?

Do not drink alcohol. Drinking alcohol can increase certain side effects, and may increase the risk of seizures.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink.

Avoid driving or hazardous activity until you know how oxcarbazepine will affect you. Your reactions could be impaired.

What other drugs will affect oxcarbazepine?

Using oxcarbazepine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

What is Oxtellar XR?

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.

Important information

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.

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 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.

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.

Dosing information

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)WeightTarget Daily Dose20 kg to 29 kg900 mg/day29.1 kg to 39 kg1200 mg/dayGreater than 39 kg1800 mg/day

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

What are the side effects of Oxtellar XR?

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.

Interactions

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.

Pregnancy and breastfeeding

Tell your doctor if you 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.

Tell your doctor if you 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.

Storage

• 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.

Oxtellar XR is manufactured by Patheon Inc. Whitby, Ontario L1N 5Z5 Canada and distributed by Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA.

What is Aptiom?

Aptiom is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain.

Aptiom is used alone or with other medications to treat partial-onset seizures in adults and children who are at least 4 years old.

Aptiom may also be used for purposes not listed in this medication guide.

Warnings

Do not stop using Aptiom suddenly.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using Aptiom.

Call your doctor right away if you have symptoms of low sodium levels in your body such as nausea, confusion, severe weakness, muscle pain, or increased seizures.

Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine

You should not use Aptiom if you are allergic to eslicarbazepine or oxcarbazepine.

To make sure Aptiom is safe for you, tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• a blood cell disorder; or
• mood problems or suicidal thoughts.

Some people have thoughts about suicide while taking an anticonvulsant. Your doctor will need to check your progress at regular visits while you are taking Aptiom. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking Aptiom during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking Aptiom for seizures.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of eslicarbazepine on the baby.

Aptiom can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Aptiom.

Eslicarbazepine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Aptiom not approved for use by anyone younger than 18 years old.

How should I take Aptiom?

Aptiom is usually given once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Aptiom with or without food. The Aptiom tablet may be crushed or swallowed whole.

Do not stop using Aptiom suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Get your prescription refilled before you run out of medicine completely.

Eslicarbazepine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Aptiom.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of Aptiom for Epilepsy:

Monotherapy and Adjunctive Therapy:
-Initial dose: 400 mg orally once a day; some patients may be initiated at 800 mg orally once a day if the need for seizure reduction outweighs an increased risk of adverse reactions
-Dose titration: Increase dosage by 400 to 600 mg weekly, based on response and tolerability
-Maintenance dose: 800 to 1600 mg orally once a day; for patients on monotherapy, the 800 mg once daily maintenance dose should be considered in patients who are unable to tolerate a 1200 mg daily dose; for patients on adjunctive therapy, the 1600 mg daily dose should be considered in patients who did not achieve a satisfactory response with a 1200 mg daily dose

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures as monotherapy or adjunctive therapy

Usual Adult Dose of Aptiom for Seizures:

Monotherapy and Adjunctive Therapy:
-Initial dose: 400 mg orally once a day; some patients may be initiated at 800 mg orally once a day if the need for seizure reduction outweighs an increased risk of adverse reactions
-Dose titration: Increase dosage by 400 to 600 mg weekly, based on response and tolerability
-Maintenance dose: 800 to 1600 mg orally once a day; for patients on monotherapy, the 800 mg once daily maintenance dose should be considered in patients who are unable to tolerate a 1200 mg daily dose; for patients on adjunctive therapy, the 1600 mg daily dose should be considered in patients who did not achieve a satisfactory response with a 1200 mg daily dose

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures as monotherapy or adjunctive therapy

Usual Pediatric Dose of Aptiom for Epilepsy:

4 to less than 18 years:
Monotherapy and Adjunctive Therapy:
11 to 21 kg:
-Initial dose: 200 mg orally once a day; increase once a week in increments of no more than 200 mg, based on tolerability and response
-Maintenance dose: 400 to 600 mg orally once a day
-Maximum dose: 600 mg orally once a day
22 to 31 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 500 to 800 mg orally once a day
-Maximum dose: 800 mg orally once a day
32 to 38 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 600 to 900 mg orally once a day
-Maximum dose: 900 mg orally once a day
Greater than 38 kg:
-Initial dose: 400 mg orally once a day; increase once a week in increments of no more than 400 mg, based on tolerability and response
-Maintenance dose: 800 to 1200 mg orally once a day
-Maximum dose: 1200 mg orally once a day

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures in patients 4 years of age and older

Usual Pediatric Dose of Aptiom for Seizures:

4 to less than 18 years:
Monotherapy and Adjunctive Therapy:
11 to 21 kg:
-Initial dose: 200 mg orally once a day; increase once a week in increments of no more than 200 mg, based on tolerability and response
-Maintenance dose: 400 to 600 mg orally once a day
-Maximum dose: 600 mg orally once a day
22 to 31 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 500 to 800 mg orally once a day
-Maximum dose: 800 mg orally once a day
32 to 38 kg:
-Initial dose: 300 mg orally once a day; increase once a week in increments of no more than 300 mg, based on tolerability and response
-Maintenance dose: 600 to 900 mg orally once a day
-Maximum dose: 900 mg orally once a day
Greater than 38 kg:
-Initial dose: 400 mg orally once a day; increase once a week in increments of no more than 400 mg, based on tolerability and response
-Maintenance dose: 800 to 1200 mg orally once a day
-Maximum dose: 1200 mg orally once a day

Comments:
-This drug may be taken without regard to meals.
-Tablets may be swallowed whole or crushed.

Use: For the treatment of partial-onset seizures in patients 4 years of age and older

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What to avoid

Aptiom may impair your thinking or reactions. Avoid driving or operating machinery until you know how Aptiom will affect you.

Aptiom side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using eslicarbazepine.

Eslicarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Call your doctor right away if you have nausea, lack of energy, confusion, feeling tired or irritable, severe weakness, muscle pain, or increased seizures.

Report any new or worsening symptoms to your doctor, 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.

Also call your doctor at once if you have:

• severe dizziness or drowsiness, vision changes, thinking problems, trouble with walking or coordination;
• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores; or
• liver problems – nausea, loss of appetite, upper stomach pain, dark urine, jaundice (yellowing of the skin or eyes).

Common Aptiom side effects may include:

• dizziness, drowsiness, headache;
• feeling tired;
• nausea, vomiting;
• coordination problems, feeling shaky; or
• double vision.