Rufinamide 400mg Tablets
It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic drug (AED)
Pharmacologic Class
Triazole derivative, sodium channel blocker
Pregnancy Category
Not available
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 to reduce seizure activity.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's essential to take this medication with food to ensure proper absorption.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. Do not alter the dose or stop taking the medication without consulting your doctor, as this may lead to seizures. If you have any concerns or questions, discuss them with your doctor.
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 medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
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, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's essential to take this medication with food to ensure proper absorption.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. Do not alter the dose or stop taking the medication without consulting your doctor, as this may lead to seizures. If you have any concerns or questions, discuss them with your doctor.
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 medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.
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
- Take rufinamide exactly as prescribed by your doctor, usually twice a day with food.
- Do not stop taking rufinamide suddenly, as this can cause seizures to worsen. Any dose changes should be made gradually under medical supervision.
- Rufinamide may cause dizziness, drowsiness, or problems with coordination. Be careful when driving or operating machinery until you know how this medication affects you.
- If you are taking hormonal birth control (pills, patch, ring, injection), rufinamide can make it less effective. Discuss alternative or additional birth control methods with your doctor.
- Avoid alcohol or other medications that cause drowsiness, as this can worsen side effects.
- Carry a medical alert card or wear a medical alert bracelet stating that you have epilepsy and are taking rufinamide.
Available Forms & 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 dose of 3200 mg/day in 2 divided doses.
Dose Range:
400 - 3200 mg
Condition-Specific Dosing:
Lennox-Gastaut Syndrome (LGS):
Initial 400 mg/day in 2 divided doses. Titrate by 400 mg/day every 2 days to a target dose of 3200 mg/day in 2 divided doses. Max 3200 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
For children 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 dose of 45 mg/kg/day (max 3200 mg/day).
Child:
For children 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 dose of 45 mg/kg/day (max 3200 mg/day).
Adolescent:
For children 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 dose of 3200 mg/day in 2 divided doses. Max 3200 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; no specific dose recommendations available.
Dialysis:
Not available; rufinamide is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; no specific dose recommendations available.
Pharmacology
Mechanism of Action
Rufinamide is a triazole derivative that is thought to exert its anticonvulsant effect by prolonging the inactive state of voltage-gated sodium channels, thereby limiting sustained repetitive firing of sodium-dependent action potentials. This action may stabilize hyperexcitable neuronal membranes and inhibit the spread of seizure activity.
Pharmacokinetics
Absorption:
Bioavailability:
Well absorbed, but not explicitly stated as a percentage.
Tmax:
4-6 hours
FoodEffect:
Food increases Cmax and AUC by approximately 30%.
Distribution:
Vd:
0.79 L/kg
ProteinBinding:
Approximately 34%
CnssPenetration:
Yes
Elimination:
HalfLife:
6-10 hours
Clearance:
Approximately 2.1-3.1 L/hr
ExcretionRoute:
Primarily renal (approximately 85% in urine, 15% in feces).
Unchanged:
Approximately 60% excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Not precisely defined, but therapeutic effects are observed with titration.
PeakEffect:
Correlates with Tmax (4-6 hours).
DurationOfAction:
Correlates with half-life (requires twice-daily dosing).
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 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 or tremors
Changes in vision
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. If you experience any new or worsening symptoms, such as:
Depression
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavioral changes
contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
Rare but Serious Side Effects
A severe and potentially life-threatening condition has occurred in people taking seizure medications like this one. If you experience any of the following symptoms, contact your doctor immediately:
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. If you experience any signs of infection, such as:
Fever
Chills
Sore throat
contact your doctor right away.
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, or weakness
Headache
Nausea or vomiting
Flu-like symptoms
Nose or throat irritation
Decreased appetite
If any of these side effects bother you or do not go away, contact your doctor or seek medical attention.
Reporting Side Effects
If you have questions about side effects or want to report any side effects, you can:
Contact your doctor for medical advice
Call the FDA at 1-800-332-1088
* Report side effects 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 or tremors
Changes in vision
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. If you experience any new or worsening symptoms, such as:
Depression
Anxiety, restlessness, or irritability
Panic attacks
Mood or behavioral changes
contact your doctor immediately. If you have suicidal thoughts or actions, seek help right away.
Rare but Serious Side Effects
A severe and potentially life-threatening condition has occurred in people taking seizure medications like this one. If you experience any of the following symptoms, contact your doctor immediately:
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. If you experience any signs of infection, such as:
Fever
Chills
Sore throat
contact your doctor right away.
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, or weakness
Headache
Nausea or vomiting
Flu-like symptoms
Nose or throat irritation
Decreased appetite
If any of these side effects bother you or do not go away, contact your doctor or seek medical attention.
Reporting Side Effects
If you have questions about side effects or want to report any side effects, you can:
Contact your doctor for medical advice
Call the FDA at 1-800-332-1088
* Report side effects online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- New or worsening thoughts about self-harm or suicide
- Any new or worsening rash, especially if accompanied by fever, swollen glands, or facial swelling (signs of DRESS syndrome)
- Severe dizziness, unsteadiness, or problems with walking
- Unusual tiredness or weakness
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Easy bruising or bleeding
- Changes in vision, such as double vision
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 in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dosage 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 in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dosage 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 your full attention, such as driving, wait until you understand how this medication affects you.
To minimize the risk of seizures, do not abruptly stop taking this medication without first consulting your doctor. If you need to discontinue this medication, your doctor will instruct you on how to gradually taper off the dosage.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
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 experience changes in your seizure patterns or severity after starting this medication, notify your doctor promptly.
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 medication. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
To minimize the risk of seizures, do not abruptly stop taking this medication without first consulting your doctor. If you need to discontinue this medication, your doctor will instruct you on how to gradually taper off the dosage.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
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 experience changes in your seizure patterns or severity after starting this medication, notify your doctor promptly.
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 medication. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Ataxia (loss of coordination)
- Somnolence (extreme drowsiness)
- Nystagmus (involuntary eye movements)
- Headache
- Nausea
- Vomiting
What to Do:
In case of suspected overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Management is primarily supportive, including gastric lavage or activated charcoal if appropriate, and monitoring of vital signs.
Drug Interactions
Major Interactions
- Oral contraceptives (estrogen/progestin): Rufinamide can decrease the efficacy of hormonal contraceptives due to enzyme induction (CYP3A4, UGT1A1).
- Phenytoin: Rufinamide can decrease phenytoin levels.
- Phenobarbital: Rufinamide can decrease phenobarbital levels.
- Primidone: Rufinamide can decrease primidone levels.
- Carbamazepine: Rufinamide can decrease carbamazepine levels.
- Lamotrigine: Rufinamide can decrease lamotrigine levels.
- Topiramate: Rufinamide can decrease topiramate levels.
Moderate Interactions
- Valproate: Valproate can increase rufinamide plasma concentrations (by up to 50%). Dose adjustment of rufinamide may be necessary.
- Digoxin: Rufinamide may decrease digoxin levels (monitor digoxin levels).
Confidence Interactions
Monitoring
Baseline Monitoring
Baseline ECG
Rationale: Although not a primary effect, caution in patients with short QT syndrome or family history of short QT syndrome.
Timing: Prior to initiation, especially if cardiac risk factors are present.
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for potential hematologic abnormalities (rare).
Timing: Prior to initiation.
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for potential hepatic dysfunction, especially with DRESS syndrome risk.
Timing: Prior to initiation.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly throughout treatment
Target: Reduction in seizure frequency
Action Threshold: Worsening seizures or lack of efficacy may require dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, somnolence, nausea, vomiting, fatigue, headache, diplopia, tremor, ataxia)
Frequency: Regularly, especially during titration and dose changes
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Signs/symptoms of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome
Frequency: Regularly, especially during the first 3 months of treatment
Target: Absence of symptoms
Action Threshold: Presence of rash, fever, lymphadenopathy, facial swelling, or organ involvement (e.g., hepatitis, nephritis) requires immediate discontinuation and medical evaluation.
Plasma concentrations of co-administered AEDs (e.g., phenytoin, phenobarbital, carbamazepine, lamotrigine)
Frequency: As clinically indicated, especially after rufinamide initiation or dose changes
Target: Therapeutic range for co-administered AEDs
Action Threshold: Subtherapeutic levels may require dose adjustment of the co-administered AED.
Rufinamide plasma concentrations (if co-administered with valproate)
Frequency: As clinically indicated, especially after valproate initiation or dose changes
Target: Not routinely monitored, but can be considered if toxicity suspected
Action Threshold: Elevated levels may require rufinamide dose reduction.
Symptom Monitoring
- Worsening seizures
- New or worsening suicidal thoughts or behavior
- Rash (especially if accompanied by fever, swollen lymph nodes, facial swelling, or signs of organ involvement)
- Severe dizziness or somnolence
- Nausea, vomiting, or abdominal pain
- Unusual fatigue or weakness
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Easy bruising or bleeding
- Changes in vision (e.g., double vision)
Special Patient Groups
Pregnancy
Based on animal data, rufinamide may cause fetal harm. 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. Pregnancy exposure registries are available.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations based on animal studies.
Second Trimester:
Not specifically studied, but continued exposure carries risk.
Third Trimester:
Not specifically studied, but continued exposure carries risk.
Lactation
Rufinamide is excreted in 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 for adverse effects in the breastfed infant. Monitor breastfed infants for drowsiness, poor feeding, and developmental milestones.
Infant Risk:
L3 (Moderately Safe) - Limited human data, potential for adverse effects.
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 effectiveness in pediatric patients younger than 1 year of age have not been established.
Geriatric Use
No specific dose adjustment is recommended based on age alone. However, elderly patients may be more sensitive to the adverse effects of rufinamide (e.g., dizziness, somnolence) and should be monitored closely. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Always take rufinamide with food to optimize absorption and reduce gastrointestinal side effects.
- Titrate the dose slowly over several weeks to minimize adverse effects such as dizziness, somnolence, and nausea.
- Counsel female patients of childbearing potential about the significant interaction with hormonal contraceptives and the need for alternative or additional birth control methods.
- Be vigilant for signs and symptoms of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, especially during the first 3 months of treatment. Discontinue immediately if suspected.
- Rufinamide can affect the levels of other antiepileptic drugs; monitor co-administered AED levels as clinically indicated.
- Patients should be advised not to discontinue rufinamide abruptly due to the risk of increased seizure frequency or status epilepticus.
Alternative Therapies
- Clobazam
- Lamotrigine
- Topiramate
- Valproate
- Felbamate
- Cannabidiol (Epidiolex)
Cost & Coverage
Average Cost:
Varies widely, typically $200-$1000+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often Tier 2, brand Tier 3)
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 is a patient fact sheet that provides important information. Please read this guide carefully and review it again each time you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.