Banzel 40mg/ml Suspension 460ml
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 medication used to help control seizures, especially in people with a severe form of epilepsy called Lennox-Gastaut Syndrome. It works by affecting certain electrical signals in the brain that can cause seizures. It's important to take this medicine exactly as prescribed, usually twice a day with food.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Always take your medication with food.
If the adapter is not already attached to the bottle when you receive it, prepare the bottle according to the instructions provided or follow the guidelines in the package insert.
Before using, shake the bottle well to mix the contents.
Only use the measuring device that comes with your medication to ensure accurate dosing.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better. Do not change your dose or stop taking the medication without consulting your doctor, as this may cause seizures.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Discard any unused portion 90 days after opening the bottle.
Keep the bottle upright with the cap tightly closed.
What to Do if You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
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 ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Always take your medication with food.
If the adapter is not already attached to the bottle when you receive it, prepare the bottle according to the instructions provided or follow the guidelines in the package insert.
Before using, shake the bottle well to mix the contents.
Only use the measuring device that comes with your medication to ensure accurate dosing.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better. Do not change your dose or stop taking the medication without consulting your doctor, as this may cause seizures.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Discard any unused portion 90 days after opening the bottle.
Keep the bottle upright with the cap tightly closed.
What to Do if You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
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 properly.
- Do not stop taking rufinamide suddenly, as this can cause your seizures to worsen. Any dose changes should be made gradually under your doctor's supervision.
- Rufinamide may cause dizziness or drowsiness, especially when you first start taking it or when your dose is changed. Avoid driving or operating heavy machinery until you know how this medication affects you.
- 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.
- Avoid alcohol and other CNS depressants, as they can increase drowsiness and dizziness.
- Maintain regular follow-up appointments with your doctor to monitor your condition and adjust your medication as needed.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 400 mg/day in 2 divided doses. Titrate by 400 mg/day every 2 days to a target of 3200 mg/day (1600 mg BID).
Dose Range:
400 - 3200 mg
Condition-Specific Dosing:
Lennox-Gastaut Syndrome (LGS):
Adjunctive treatment. Max 3200 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
1 to <4 years: Initial 10 mg/kg/day in 2 divided doses. Titrate by 10 mg/kg/day every 2 days to a target of 45 mg/kg/day (max 1200 mg/day).
Child:
4 to <12 years: Initial 10 mg/kg/day in 2 divided doses. Titrate by 10 mg/kg/day every 2 days to a target of 45 mg/kg/day (max 3200 mg/day).
Adolescent:
âĨ12 years: Same as adult dosing. Initial 400 mg/day in 2 divided doses. Titrate by 400 mg/day every 2 days to a target of 3200 mg/day (1600 mg BID).
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 due to limited data.
Dialysis:
Not available (limited data, rufinamide is minimally renally excreted unchanged).
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; no specific dose recommendations available. Monitor closely for adverse effects.
Pharmacology
Mechanism of Action
Rufinamide is a triazole derivative that is thought to exert its anticonvulsant effect by modulating the activity of sodium channels, specifically by prolonging the inactive state of voltage-gated sodium channels, thereby limiting sustained high-frequency repetitive firing of neurons.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated as a percentage, but well absorbed. Food increases Cmax and AUC.
Tmax:
4-6 hours (with food)
FoodEffect:
Food increases Cmax by 30% and AUC by 34% compared to fasting conditions. Should be taken with food.
Distribution:
Vd:
0.7-1 L/kg
ProteinBinding:
<34%
CnssPenetration:
Yes
Elimination:
HalfLife:
6-10 hours
Clearance:
Not available (variable)
ExcretionRoute:
Primarily renal (85% as metabolites, <2% unchanged drug); approximately 15% in feces.
Unchanged:
<2%
Pharmacodynamics
OnsetOfAction:
Not precisely defined; therapeutic effects are observed with titration over days to weeks.
PeakEffect:
Correlates with Tmax (4-6 hours post-dose).
DurationOfAction:
Correlates with half-life (dosed BID due to 6-10 hour half-life).
Confidence:
Medium
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 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 eyesight
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 attention 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:
+ Inability to pass urine
+ Changes in the amount of urine passed
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ 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, which can increase the risk of infection. Contact your doctor immediately if you experience signs of infection, such as:
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 eyesight
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 attention 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:
+ Inability to pass urine
+ Changes in the amount of urine passed
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ 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, which can increase the risk of infection. Contact your doctor immediately if you experience signs of infection, such as:
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 seizures
- Severe skin rash, blistering, or peeling skin (can be signs of serious skin reactions like SJS/TEN)
- Fever, swollen glands, or other signs of infection (may indicate a drug reaction with eosinophilia and systemic symptoms - DRESS)
- Unusual bruising or bleeding
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain)
- Significant dizziness, extreme drowsiness, or confusion
- Changes in mood or behavior, including new or worsening depression, anxiety, agitation, or thoughts of self-harm
- Severe nausea or vomiting that doesn't go away
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 symptoms you experienced as a result of the allergy.
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 symptoms you experienced as a result of the allergy.
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.
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. As directed by your doctor, undergo regular blood tests and discuss the results with them.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor. If you experience changes in the frequency or severity of seizures after initiating this medication, notify your doctor promptly.
When taking this drug, be aware that 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, in conjunction with your primary method. If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to both 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. As directed by your doctor, undergo regular blood tests and discuss the results with them.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor. If you experience changes in the frequency or severity of seizures after initiating this medication, notify your doctor promptly.
When taking this drug, be aware that 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, in conjunction with your primary method. If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness
- Dizziness
- Ataxia (loss of coordination)
- Nausea
- Vomiting
- Headache
- Diplopia (double vision)
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Management is primarily supportive, as there is no specific antidote. Gastric lavage or activated charcoal may be considered if ingestion is recent. Hemodialysis is unlikely to be effective due to low protein binding and metabolism.
Drug Interactions
Major Interactions
- Valproate (decreases rufinamide clearance, may require rufinamide dose reduction)
- Phenytoin (induces rufinamide metabolism, may require rufinamide dose increase)
- Carbamazepine (induces rufinamide metabolism, may require rufinamide dose increase)
- Phenobarbital (induces rufinamide metabolism, may require rufinamide dose increase)
- Oral Contraceptives (rufinamide may decrease efficacy of hormonal contraceptives)
Moderate Interactions
Confidence Interactions
Monitoring
Baseline Monitoring
Baseline seizure frequency and severity
Rationale: To establish a baseline for efficacy assessment.
Timing: Prior to initiation of therapy
Electrocardiogram (ECG)
Rationale: Rufinamide can cause dose-dependent shortening of the QT interval. While generally not clinically significant, baseline assessment is prudent.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC)
Rationale: General safety monitoring for AEDs, though hematologic abnormalities are rare with rufinamide.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: General safety monitoring for AEDs, though hepatic injury is rare with rufinamide.
Timing: Prior to initiation of therapy
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, worsening seizures, or unacceptable adverse effects warrant dose adjustment or discontinuation.
Adverse effects (e.g., dizziness, somnolence, nausea, vomiting, headache, fatigue, diplopia, tremor, skin rash)
Frequency: Regularly, especially during titration and dose adjustments.
Target: Tolerable side effect profile
Action Threshold: Intolerable or severe adverse effects (e.g., severe rash, significant CNS depression) warrant dose reduction or discontinuation.
QT interval on ECG
Frequency: Periodically, especially if other QT-shortening drugs are used or if cardiac symptoms develop. Routine monitoring is generally not required unless clinically indicated.
Target: Within normal limits or stable from baseline
Action Threshold: Significant or symptomatic QT shortening.
Drug interactions
Frequency: Upon initiation or discontinuation of concomitant medications, and periodically.
Target: Stable rufinamide levels and efficacy
Action Threshold: Changes in seizure control or adverse effects may indicate a drug interaction requiring dose adjustment.
Symptom Monitoring
- Dizziness
- Somnolence
- Fatigue
- Nausea
- Vomiting
- Headache
- Diplopia (double vision)
- Tremor
- Ataxia (lack of coordination)
- Skin rash (e.g., Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis - rare but serious)
- Worsening of seizures or new seizure types
- Mood changes, suicidal thoughts or behavior
Special Patient Groups
Pregnancy
Category C. 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, as with other AEDs. Data are limited.
Second Trimester:
Continued exposure may affect fetal development.
Third Trimester:
Continued exposure may affect fetal development; potential for withdrawal symptoms in neonate if discontinued abruptly.
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. Monitor breastfed infants for sedation, poor feeding, or other adverse effects.
Infant Risk:
L3 (Moderately safe). Potential for infant exposure and adverse effects (e.g., drowsiness, irritability). Weigh benefits of breastfeeding against potential risks.
Pediatric Use
Approved for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older. Dosing is weight-based for younger 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. 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 for increased sensitivity to adverse effects.
Clinical Information
Clinical Pearls
- Always administer rufinamide with food to maximize absorption and ensure consistent drug levels.
- Strict adherence to the titration schedule is crucial to minimize CNS-related adverse effects such as dizziness and somnolence.
- Counsel female patients of childbearing potential about the potential for rufinamide to decrease the efficacy of hormonal contraceptives and discuss alternative birth control methods.
- While rufinamide can shorten the QT interval, this effect is generally not clinically significant and does not typically require routine ECG monitoring unless other QT-shortening drugs are used or cardiac symptoms are present.
- Patients should be advised not to discontinue rufinamide abruptly due to the risk of increased seizure frequency or status epilepticus.
Alternative Therapies
- Clobazam (Onfi, Sympazan)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
- Valproate (Depakote)
- Felbamate (Felbatol)
- Cannabidiol (Epidiolex)
- Ketogenic diet
- Vagus nerve stimulation (VNS)
- Corpus callosotomy
Cost & Coverage
Average Cost:
Varies widely, typically $500-$1500+ per 460ml bottle (40mg/ml)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 for brand (Banzel); Tier 1 or Tier 2 for generic rufinamide. Coverage varies by insurance plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.