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.

Briviact (brivaracetam) is an anti-epileptic drug (also called an anticonvulsant) that may be used to treat partial onset seizures in adults and children 1 month and older with epilepsy.

• Briviact is often used along with other seizure medicines to give better control over seizures.

Briviact works in the brain to help control seizures and is thought to target a specific protein called SV2A that helps nerve cells communicate with each other. By attaching to this protein, Briviact helps balance the brain’s electrical activity and this mechanism can stop the sudden bursts of electricity that cause seizures.

Briviact gained FDA approval on February 18, 2016. There is currently no Briviact generic available.

Is Briviact a controlled substance?

Briviact is a federally controlled substance (Schedule V) because it can be abused or lead to dependence.

Keep Briviact in a safe place to prevent misuse and abuse. Selling or giving away Briviact may harm others and is against the law. 

Briviact side effects

The most common side effects of Briviact are:

• sleepiness
• dizziness
• feeling tired
• nausea and vomiting.

Side effects of Briviact in children 1 month to less than 16 years of age are similar to those seen in adults.

Serious side effects and warnings

Briviact may cause the following serious side effects.

Suicidal thoughts and behaviors. Like other antiepileptic drugs, Briviact may cause suicidal thoughts or actions in a very small number of people; about 1 in 500 people taking it. Call a 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
• new or worse depression
• feeling agitated or restless
• trouble sleeping (insomnia)
• acting aggressive, feeling angry, or being violent
• an extreme increase in activity and talking (mania)
• attempts to commit suicide
• new or worse anxiety
• panic attacks
• new or worse irritability
• acting on dangerous impulses
• other unusual changes in behavior or mood.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 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 Briviact without first talking to a healthcare provider. Stopping Briviact suddenly can cause seizures that will not stop (status epilepticus). 

Nervous system problems. Drowsiness, tiredness, and dizziness are common with Briviact but can be severe. Do not drive or operate machinery until you know how Briviact affects you. Briviact can also cause problems with balance and coordination.

Mental (psychiatric) symptoms. Briviact can cause mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. Irritability and anxiety are common with Briviact and can be severe. People who take Briviact can also get psychotic symptoms such as hallucinations (seeing or hearing things that are not there), delusions (false or strange thoughts or beliefs), and unusual behavior.

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

These are not all the possible side effects of Briviact. For more information, ask your healthcare provider or
pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not use Briviact if you are allergic to brivaracetam, Briviact, or any of the inactive ingredients in the formulation you are taking/receiving.

Before taking Briviact, tell your healthcare provider about all of your medical conditions, including if you:

• have or had depression, mood problems, or suicidal thoughts or behavior
• have liver problems
• have abused or been dependent on prescription medicines, street drugs, or alcohol
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Briviact is not approved for use by anyone younger than 1 month of age.

Pregnancy

It is not known if Briviact will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Briviact. You and your healthcare provider will have to decide if you should take Briviact while you are pregnant. Follow your doctor’s instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor’s advice, and tell your doctor right away if you become pregnant.

If you do become pregnant while taking Briviact, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of Briviact and other antiepileptic medicines during pregnancy.

Breastfeeding

Briviact passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briviact.

How should I take Briviact?

Take Briviact exactly as prescribed by your doctor. Your healthcare provider will tell you how much Briviact to take and when to take it. Your healthcare provider may change your dose if needed. Do not change your dose without talking to your healthcare provider.

• Briviact is usually taken/given 2 times a day.

Take Briviact oral tablets or oral solution with or without food.

• Swallow Briviact tablets whole with a liquid and do not chew or crush the tablets before swallowing.
• Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Briviact injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Briviact may be habit-forming and is a federally controlled substance (Schedule V). Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

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

Briviact dosing information

Usual Briviact Adult Dose for Epilepsy

Initial oral dose: Briviact 50 mg orally 2 times a day

• Adjust the dose up or down based on individual patient tolerability and response.

Maintenance dose: 25 mg to 100 mg orally twice a day based on clinical response and tolerability

Maximum dose: 200 mg/day

IV Administration: Briviact 50 mg by IV injection over 2 to 15 minutes

• May be used when oral administration is temporarily not feasible.
• Administer at the same dose and frequency as oral formulations.
• Experience with IV injection is limited to 4 consecutive days of treatment.

Usual Briviact Child Dose for Epilepsy

Briviact doses are based on weight in children. Your child’s dose needs may change if the child gains or loses weight.

Briviact ablets, oral solution, and injection can be used interchangeably.

1 month to 16 years

Weight: Less than 11 kg: Initial dose: Briviact 0.75 to 1.5 mg/kg orally twice a day; Maintenance dose: 0.75 to 3 mg/kg orally twice a day
Weight: 11 kg to less than 20 kg: Initial dose: Briviact 0.5 to 1.25 mg/kg orally twice a day; Maintenance dose: 0.5 to 2.5 mg/kg orally twice a day
Weight: 20 kg to less than 50 kg: Initial dose: Briviact 0.5 to 1 mg/kg orally twice a day; Maintenance dose: 0.5 to 2 mg/kg orally twice a day
Weight: 50 kg or greater: Initial dose: Briviact 25 to 50 mg orally twice a day; Maintenance dose: 25 to 100 mg orally twice a day

16 years of age and older

Initial dose: Briviact 50 mg orally 2 times a day.
Maintenance dose: 25 mg to 100 mg orally twice a day.

IV Administration may be used in patients 16 years or older when oral administration is temporarily not feasible.

• Administer at the same dose and same frequency as oral formulations.
• Experience with the IV injection is limited to 4 consecutive days of treatment.

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 take too much Briviact?

If you take too much Briviact call your Poison Control Center or go to the nearest emergency room right away. 

What to avoid

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

What other drugs will affect Briviact?

Other drugs may interact with brivaracetam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your other medicines. Especially tell your healthcare provider if you take:

• Rifampin — the dosage of Briviact may need to be increased
• Carbamazepine — the dosage of carbamazepine may need to be reduced
• Phenytoin — the dosage of phenytoin may need to be reduced.

Levetiracetam — Briviact had no added therapeutic benefit when coadministered with levetiracetam.

When you start or stop taking Briviact, your doctor may need to adjust the doses of any other medicines you take regularly.

Not all possible drug interactions are listed here. See the Briviact Prescribing Information for a full list of interactions. 

Storage

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze. Throw away unused liquid after 5 months.

Briviact ingredients

Active ingredient: brivaracetam

Tablet inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, and magnesium stearate.

Tablet film coating contains the inactive ingredients listed below:

• 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide
• 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide
• 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide
• 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. 

Oral solution inactive ingredients: sodium citrate, anhydrous citric acid, methylparaben, sodium
carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water.

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.