Banzel 400mg Tablets
It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic Drug (AED)
Pharmacologic Class
Triazole derivative, Sodium channel modulator
Pregnancy Category
C
FDA Approved
Nov 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Rufinamide is a medication used to help control seizures in people with a specific type of epilepsy called Lennox-Gastaut Syndrome. It works by affecting certain electrical signals in the brain to reduce seizure activity.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food to help your body absorb it properly. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. Do not change your dose or stop taking your medication without talking to your doctor, as this can increase your risk of seizures.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets to avoid accidents. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food to help your body absorb it properly. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. Do not change your dose or stop taking your medication without talking to your doctor, as this can increase your risk of seizures.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets to avoid accidents. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take rufinamide with food to help your body absorb it better.
- Do not stop taking rufinamide suddenly, as this can cause seizures to worsen or occur more frequently. Always talk to your doctor before changing your dose or stopping the medication.
- Be cautious when driving or operating machinery until you know how rufinamide affects you, as it can cause dizziness, drowsiness, and vision problems.
- Avoid alcohol, as it can increase side effects like dizziness and drowsiness.
- If you are taking hormonal birth control, be aware that rufinamide may make it less effective. Discuss alternative or additional birth control methods with your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 400 mg/day, titrated by 400-600 mg every 2 days. Target dose 3200 mg/day (divided BID).
Dose Range:
400 - 3200 mg
Condition-Specific Dosing:
Lennox-Gastaut Syndrome (LGS):
Initial 400 mg/day, titrated by 400-600 mg every 2 days based on tolerability and clinical response, up to a maximum of 3200 mg/day (divided BID).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants <1 year of age. For children 1 to <4 years: Initial 10 mg/kg/day, titrated by 10 mg/kg every 2 days up to a maximum of 45 mg/kg/day (max 3200 mg/day).
Child:
For children 4 to <7 years: Initial 10 mg/kg/day, titrated by 10 mg/kg every 2 days up to a maximum of 45 mg/kg/day (max 3200 mg/day). For children âĨ7 years: Initial 400 mg/day, titrated by 400-600 mg every 2 days up to a maximum of 3200 mg/day.
Adolescent:
Initial 400 mg/day, titrated by 400-600 mg every 2 days up to a maximum of 3200 mg/day (divided BID).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment data available; use with caution.
Dialysis:
Not available; rufinamide is minimally dialyzable.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment data available; use with caution.
Pharmacology
Mechanism of Action
Rufinamide is a triazole derivative that is thought to exert its antiepileptic effect by prolonging the inactive state of voltage-gated sodium channels, thereby limiting sustained repetitive firing of sodium-dependent action potentials. It also modulates the activity of sodium channels, which may contribute to its anticonvulsant activity.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated as a percentage, but well absorbed. Food increases absorption.
Tmax:
4-6 hours
FoodEffect:
Administration with food increases Cmax and AUC by approximately 30% and 34%, respectively, compared to administration in the fasted state.
Distribution:
Vd:
Approximately 0.7 L/kg
ProteinBinding:
Approximately 34% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
6-10 hours
Clearance:
Not available (variable)
ExcretionRoute:
Renal (60-85%) and fecal (15-30%)
Unchanged:
<2%
Pharmacodynamics
OnsetOfAction:
Not precisely defined for seizure control, effects are gradual with titration.
PeakEffect:
Not precisely defined for seizure control, effects are gradual with titration.
DurationOfAction:
Related to half-life, requiring BID dosing.
Safety & Warnings
BLACK BOX WARNING
Antiepileptic drugs (AEDs), including rufinamide, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Unexplained bruising or bleeding
Severe muscle pain or weakness
Changes in balance or coordination
Difficulty walking
Shakiness or tremors
Changes in vision
Inability to control eye movements
Suicidal thoughts or actions (especially if you have a history of suicidal thoughts or behaviors)
New or worsening symptoms of depression, anxiety, or mood changes, such as:
+ Feeling nervous, restless, or irritable
+ Panic attacks
+ Changes in mood or behavior
Rare but Serious Side Effects
This medication, like other seizure medications, may rarely cause a severe and potentially life-threatening condition. Seek medical help immediately if you experience:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Unable to pass urine
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Low White Blood Cell Count
This medication may cause a decrease in white blood cell count, increasing the risk of infection. Contact your doctor immediately if you experience:
Fever
Chills
Sore throat
Other Side Effects
Most people taking this medication do not experience significant side effects. However, some common side effects may occur, including:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Flu-like symptoms
Nose or throat irritation
Decreased appetite
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Unexplained bruising or bleeding
Severe muscle pain or weakness
Changes in balance or coordination
Difficulty walking
Shakiness or tremors
Changes in vision
Inability to control eye movements
Suicidal thoughts or actions (especially if you have a history of suicidal thoughts or behaviors)
New or worsening symptoms of depression, anxiety, or mood changes, such as:
+ Feeling nervous, restless, or irritable
+ Panic attacks
+ Changes in mood or behavior
Rare but Serious Side Effects
This medication, like other seizure medications, may rarely cause a severe and potentially life-threatening condition. Seek medical help immediately if you experience:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Unable to pass urine
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Low White Blood Cell Count
This medication may cause a decrease in white blood cell count, increasing the risk of infection. Contact your doctor immediately if you experience:
Fever
Chills
Sore throat
Other Side Effects
Most people taking this medication do not experience significant side effects. However, some common side effects may occur, including:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach or vomiting
Flu-like symptoms
Nose or throat irritation
Decreased appetite
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening depression, anxiety, or agitation
- Thoughts of harming yourself or others (suicidal thoughts)
- Unusual changes in mood or behavior
- Severe skin rash, fever, swollen glands, or facial swelling (signs of a serious allergic reaction)
- Yellowing of the skin or eyes (jaundice)
- Unusual bleeding or bruising
- Severe dizziness or loss of coordination
- Significant vision changes or double vision
- Worsening seizures
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with Familial Short QT syndrome, a rare heart condition.
* If you have liver disease, as this may affect how your body processes the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with Familial Short QT syndrome, a rare heart condition.
* If you have liver disease, as this may affect how your body processes the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.
To minimize the risk of seizures, do not abruptly discontinue this medication without first consulting your doctor. If you need to stop taking this drug, your doctor will instruct you on how to gradually taper off the dosage.
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor.
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
If you experience changes in your seizure patterns or severity after starting this medication, notify your doctor promptly.
When taking this drug, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. To minimize the risk of unplanned pregnancy, use an additional form of birth control, such as a condom. If you are pregnant, planning to become pregnant, or are breast-feeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of action for you and your baby.
To minimize the risk of seizures, do not abruptly discontinue this medication without first consulting your doctor. If you need to stop taking this drug, your doctor will instruct you on how to gradually taper off the dosage.
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor.
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
If you experience changes in your seizure patterns or severity after starting this medication, notify your doctor promptly.
When taking this drug, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. To minimize the risk of unplanned pregnancy, use an additional form of birth control, such as a condom. If you are pregnant, planning to become pregnant, or are breast-feeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of action for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Dizziness
- Headache
- Nausea
- Vomiting
- Ataxia (loss of coordination)
- Coma
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. There is no specific antidote; treatment is supportive and symptomatic. Consider gastric lavage or activated charcoal if ingestion was recent.
Drug Interactions
Major Interactions
- Drugs that prolong the QT interval (e.g., Class IA and Class III antiarrhythmics, antipsychotics, certain antibiotics): Rufinamide can cause QT shortening, but caution is advised with other QT-prolonging drugs due to potential for additive effects on cardiac repolarization.
- Oral Contraceptives (estrogen-progestin combinations): Rufinamide is a weak inducer of CYP3A4 and may decrease the efficacy of oral contraceptives. Patients should use alternative or additional non-hormonal birth control methods.
Moderate Interactions
- Phenytoin: Rufinamide may decrease phenytoin concentrations.
- Carbamazepine: Rufinamide may decrease carbamazepine concentrations.
- Phenobarbital: Rufinamide may decrease phenobarbital concentrations.
- Valproate: Valproate may increase rufinamide concentrations. Dose adjustment of rufinamide may be necessary.
- Lamotrigine: Rufinamide may decrease lamotrigine concentrations.
- Topiramate: Rufinamide may decrease topiramate concentrations.
- Warfarin: Rufinamide may decrease warfarin concentrations due to CYP3A4 induction, requiring increased INR monitoring.
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess baseline QT interval, as rufinamide can cause dose-dependent shortening of the QT interval.
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: Although not extensively metabolized by the liver, baseline assessment is prudent.
Timing: Prior to initiation
Complete Blood Count (CBC)
Rationale: To assess baseline hematologic parameters.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure frequency/severity)
Frequency: Ongoing, especially during titration and dose adjustments
Target: Reduction in seizure frequency/severity
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, somnolence, nausea, vomiting, headache, fatigue, diplopia, tremor, rash, suicidal ideation)
Frequency: Regularly, especially during titration and dose adjustments
Target: Absence or tolerability of side effects
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Mood and behavior changes (e.g., suicidal thoughts or behavior)
Frequency: Regularly
Target: Stable mood and behavior
Action Threshold: Any new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior should prompt immediate evaluation.
Symptom Monitoring
- Dizziness
- Somnolence
- Nausea
- Vomiting
- Headache
- Fatigue
- Diplopia (double vision)
- Tremor
- Rash
- Changes in gait or coordination
- Mood changes (e.g., depression, agitation, anxiety)
- Suicidal thoughts or behavior
- Signs of hypersensitivity reaction (e.g., fever, rash, lymphadenopathy, facial swelling, liver dysfunction)
Special Patient Groups
Pregnancy
Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Rufinamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients should be enrolled in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, though human data are limited. Discuss risks vs. benefits with physician.
Second Trimester:
Continued monitoring for fetal development. Maintain seizure control.
Third Trimester:
Continued monitoring for fetal development. Maintain seizure control. Consider potential for withdrawal symptoms in neonate if exposure is high.
Lactation
Rufinamide is excreted into human milk. The amount of rufinamide transferred to the infant is low, but potential for adverse effects on the breastfed infant (e.g., drowsiness, poor feeding) exists. Monitor the infant for side effects. Weigh the benefits of breastfeeding against the potential risks.
Infant Risk:
L3 (Moderately safe; monitor infant for drowsiness, poor feeding, or developmental milestones).
Pediatric Use
Approved for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in children 1 year of age and older. Dosing is weight-based for younger children. Safety and efficacy in pediatric patients under 1 year of age have not been established.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Always take rufinamide with food to optimize absorption and reduce gastrointestinal side effects.
- Titrate the dose slowly to minimize adverse effects, especially dizziness and somnolence.
- Counsel patients on the risk of suicidal thoughts or behavior, and advise them to report any mood or behavioral changes immediately.
- Inform female patients of childbearing potential about the potential for decreased efficacy of hormonal contraceptives and the need for alternative birth control.
- Monitor for signs of hypersensitivity reactions (e.g., DRESS syndrome), which can be severe and life-threatening.
- Rufinamide can cause dose-dependent shortening of the QT interval; consider baseline ECG and caution with other QT-prolonging drugs.
Alternative Therapies
- Clobazam (Onfi, Sympazan)
- Felbamate (Felbatol)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Valproate (Depakote)
- Cannabidiol (Epidiolex)
- Fenfluramine (Fintepla)
- Stiripentol (Diacomit)
Cost & Coverage
Average Cost:
Varies widely, check current pricing per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for generic), Tier 3 or 4 (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.