Banzel 200mg 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
Category C
FDA Approved
Nov 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Rufinamide is a medicine used to help control seizures in people with a specific type of epilepsy called Lennox-Gastaut Syndrome. It works by affecting how nerve signals are sent in the brain to reduce seizure activity. It is usually taken twice a day with food.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food as directed.
Continue taking your medication exactly as prescribed by your doctor or healthcare provider, even if you start to feel better. Do not change your dose or stop taking the medication without consulting your doctor, as this can lead to seizures.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing 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, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food as directed.
Continue taking your medication exactly as prescribed by your doctor or healthcare provider, even if you start to feel better. Do not change your dose or stop taking the medication without consulting your doctor, as this can lead to seizures.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Always take rufinamide with food to help your body absorb it better.
- Do not stop taking rufinamide suddenly, as this can cause your seizures to get worse. Any dose changes should be made gradually under your doctor's supervision.
- Rufinamide can cause dizziness, drowsiness, and problems with coordination. Be careful when driving or operating machinery until you know how this medication affects you.
- Avoid alcohol and other medications that can cause drowsiness, as these can worsen the side effects of rufinamide.
- If you are using hormonal birth control, 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 mg/day every 2 days to a target dose of 3200 mg/day, divided into two doses.
Dose Range:
400 - 3200 mg
Condition-Specific Dosing:
Lennox-Gastaut Syndrome (LGS):
Adjunctive treatment. Max 3200 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants <1 year of age. For 1 to <4 years: Initial 10 mg/kg/day, titrated by 10 mg/kg/day every 2 days to a target dose of 45 mg/kg/day (max 3200 mg/day), divided into two doses.
Child:
For 4 years and older, weighing <30 kg: Initial 10 mg/kg/day, titrated by 10 mg/kg/day every 2 days to a target dose of 45 mg/kg/day (max 3200 mg/day), divided into two doses. For 4 years and older, weighing âĨ30 kg: Initial 400 mg/day, titrated by 400 mg/day every 2 days to a target dose of 3200 mg/day, divided into two doses.
Adolescent:
Same as adult dosing for patients âĨ30 kg (initial 400 mg/day, target 3200 mg/day). For those <30 kg, follow pediatric weight-based dosing.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but use with caution as data are limited.
Dialysis:
Not studied. Rufinamide is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended, but use with caution as data are limited.
Severe:
Not studied. Use with caution.
Pharmacology
Mechanism of Action
Rufinamide is a triazole derivative antiepileptic drug. Its precise mechanism of action is unknown, but it is thought to involve modulation of sodium channel activity, specifically by prolonging the inactive state of voltage-gated sodium channels. This action limits sustained repetitive firing of sodium-dependent action potentials, thereby reducing the spread of seizure activity.
Pharmacokinetics
Absorption:
Bioavailability:
Not formally determined, but well absorbed.
Tmax:
4-6 hours (fasted), 6-8 hours (with food)
FoodEffect:
Food increases Cmax by approximately 30% and AUC by approximately 34% compared to the fasted state. Rufinamide should be taken with food.
Distribution:
Vd:
Approximately 50 L
ProteinBinding:
Approximately 34%
CnssPenetration:
Yes
Elimination:
HalfLife:
6-10 hours
Clearance:
Approximately 2 L/hour (oral clearance)
ExcretionRoute:
Primarily renal (approximately 80% of dose), with a smaller portion excreted in feces (approximately 15%).
Unchanged:
Less than 2% of the dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Not precisely defined for seizure control, effects are gradual with titration.
PeakEffect:
Correlates with Tmax (4-8 hours post-dose).
DurationOfAction:
Related to half-life (requires twice-daily dosing).
Safety & Warnings
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 immediate medical attention:
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
Changes in eyesight
Inability to control eye movements
Suicidal thoughts or actions, especially if you have a history of suicidal behavior (see below)
Suicidal Thoughts or Actions
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. Monitor your mood and behavior, and contact your doctor immediately if you experience:
New or worsening symptoms of depression
Anxiety, restlessness, or irritability
Panic attacks
Other changes in mood or behavior
Suicidal thoughts or actions
Rare but Serious Side Effects
A severe and potentially life-threatening condition has occurred in people taking seizure medications like this one. Seek medical help right away if you experience:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Low White Blood Cell Count
This medication may decrease your white blood cell count, increasing your 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, but some may occur. If you experience any of the following, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Nausea or vomiting
Flu-like symptoms
Nose or throat irritation
Decreased appetite
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. 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 immediate medical attention:
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
Changes in eyesight
Inability to control eye movements
Suicidal thoughts or actions, especially if you have a history of suicidal behavior (see below)
Suicidal Thoughts or Actions
Like other seizure medications, this drug may increase the risk of suicidal thoughts or actions, particularly in people with a history of suicidal behavior. Monitor your mood and behavior, and contact your doctor immediately if you experience:
New or worsening symptoms of depression
Anxiety, restlessness, or irritability
Panic attacks
Other changes in mood or behavior
Suicidal thoughts or actions
Rare but Serious Side Effects
A severe and potentially life-threatening condition has occurred in people taking seizure medications like this one. Seek medical help right away if you experience:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Low White Blood Cell Count
This medication may decrease your white blood cell count, increasing your 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, but some may occur. If you experience any of the following, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Nausea or vomiting
Flu-like symptoms
Nose or throat irritation
Decreased appetite
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. 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 rash, especially if accompanied by fever, swollen glands, or facial swelling (signs of a severe skin reaction like SJS or TEN). Seek immediate medical attention.
- Any thoughts of harming yourself or others, or changes in mood or behavior (e.g., new or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, aggression). Contact your doctor immediately.
- Severe dizziness or drowsiness that interferes with daily activities.
- Unusual bruising or bleeding.
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, persistent nausea/vomiting, severe stomach pain).
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 heart condition that may affect the way your heart functions.
* If you have liver disease, as this may impact the way 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 in combination 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 heart condition that may affect the way your heart functions.
* If you have liver disease, as this may impact the way 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 in combination 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. Until you are aware of how this drug affects you, avoid operating a vehicle and engaging in other activities that require alertness.
Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of experiencing seizures. If you need to stop taking this drug, your doctor will instruct you on how to gradually taper off the medication to minimize potential risks.
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your healthcare provider.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor. If you notice any changes or worsening of your seizures after starting this medication, promptly discuss this with your doctor.
If you are using birth control pills or other hormone-based contraceptives, be aware that this medication may reduce their effectiveness. To prevent pregnancy, consider using an additional form of birth control, such as condoms, while taking this drug. If you are pregnant, planning to become pregnant, or are breast-feeding, consult with your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of experiencing seizures. If you need to stop taking this drug, your doctor will instruct you on how to gradually taper off the medication to minimize potential risks.
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your healthcare provider.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor. If you notice any changes or worsening of your seizures after starting this medication, promptly discuss this with your doctor.
If you are using birth control pills or other hormone-based contraceptives, be aware that this medication may reduce their effectiveness. To prevent pregnancy, consider using an additional form of birth control, such as condoms, while taking this drug. If you are pregnant, planning to become pregnant, or are breast-feeding, consult with your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Dizziness
- Headache
- Nausea
- Vomiting
- Diplopia (double vision)
- Ataxia (loss of coordination)
- Coma
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). There is no specific antidote. Treatment is supportive and may include gastric lavage, activated charcoal, and close monitoring of vital signs.
Drug Interactions
Major Interactions
- Valproate (valproic acid): Co-administration significantly decreases rufinamide clearance, leading to increased rufinamide plasma concentrations. Rufinamide dose reduction may be necessary.
- Phenytoin, Carbamazepine, Phenobarbital: These strong enzyme inducers may decrease rufinamide plasma concentrations. Increased rufinamide dose may be necessary.
- Oral Contraceptives: Rufinamide may decrease the efficacy of hormonal contraceptives. Patients should use additional or alternative non-hormonal birth control methods.
Monitoring
Baseline Monitoring
Baseline seizure frequency and type
Rationale: To establish a baseline for assessing treatment efficacy.
Timing: Prior to initiation of therapy.
Liver function tests (LFTs)
Rationale: Although not primarily metabolized by liver enzymes, caution is advised in hepatic impairment. Baseline assessment is prudent.
Timing: Prior to initiation of therapy.
Electrocardiogram (ECG)
Rationale: Rufinamide can cause QT interval shortening. While rare, baseline ECG may be considered in patients with pre-existing cardiac conditions.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly throughout treatment, especially during titration and dose adjustments.
Target: Reduction in seizure frequency and/or severity.
Action Threshold: Lack of efficacy or worsening seizures may require dose adjustment or alternative therapy.
Adverse effects (e.g., somnolence, dizziness, nausea, vomiting, headache, fatigue)
Frequency: Regularly, especially during titration.
Target: Minimization of intolerable side effects.
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Skin reactions (e.g., rash, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN))
Frequency: Closely monitor, especially during the first few weeks/months of treatment.
Target: Absence of severe skin reactions.
Action Threshold: Any new or worsening rash should prompt immediate evaluation and consideration of drug discontinuation.
Mood and behavior changes (e.g., suicidal ideation, depression, aggression)
Frequency: Regularly, especially during the initial weeks of therapy and with dose changes.
Target: Stable mood and behavior.
Action Threshold: Emergence or worsening of suicidal thoughts or behaviors requires immediate clinical intervention.
Symptom Monitoring
- Dizziness
- Somnolence
- Nausea
- Vomiting
- Headache
- Fatigue
- Diplopia (double vision)
- Tremor
- Rash (especially severe or widespread)
- Fever
- Lymphadenopathy (swollen lymph nodes)
- Facial swelling
- Difficulty breathing
- Changes in mood or behavior (e.g., agitation, depression, suicidal thoughts)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy registry is available (North American Antiepileptic Drug Pregnancy Registry: 1-888-233-2334).
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, as with other AEDs. Data are limited.
Second Trimester:
Not specifically studied, but continued monitoring of maternal and fetal health is important.
Third Trimester:
Not specifically studied. Consider potential for withdrawal symptoms in neonate if exposure continues until delivery.
Lactation
Rufinamide is excreted into human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother and the potential adverse effects on the infant. Monitor breastfed infants for sedation, poor feeding, or other adverse effects.
Infant Risk:
L3 (Moderate risk) - Excreted into human milk; monitor infant for sedation, poor feeding, and developmental milestones.
Pediatric Use
Approved for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 1 year of age and older. Dosing is weight-based for younger and lighter children. Safety and efficacy in patients younger than 1 year 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. No specific dose adjustment is recommended based on age alone, but caution is advised due to potential for age-related decreases in renal or hepatic function and increased sensitivity to adverse effects.
Clinical Information
Clinical Pearls
- Rufinamide is an adjunctive therapy for Lennox-Gastaut Syndrome (LGS) and is not typically used as monotherapy.
- Always administer rufinamide with food to optimize absorption and reduce gastrointestinal side effects.
- Titration is crucial: start low and go slow to minimize adverse effects, especially CNS-related ones like dizziness and somnolence.
- Counsel patients on the importance of not abruptly discontinuing the medication due to the risk of increased seizure frequency or status epilepticus.
- Be aware of significant drug interactions, particularly with valproate (requiring rufinamide dose reduction) and enzyme-inducing AEDs (requiring rufinamide dose increase).
- Emphasize the need for alternative or additional contraception for women of childbearing potential due to potential reduction in efficacy of hormonal contraceptives.
Alternative Therapies
- Clobazam (Onfi, Sympazan)
- Fenfluramine (Fintepla)
- Cannabidiol (Epidiolex)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Valproate (Depakote)
- Felbamate (Felbatol)
- Ketogenic diet
- Vagus nerve stimulation (VNS)
- Corpus callosotomy
Cost & Coverage
Average Cost:
Not available per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (varies by plan)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. 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, consult 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.