Rufinamide 200mg Tablets
It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic drug
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 treat a severe form of epilepsy called Lennox-Gastaut Syndrome. It works by helping to stabilize electrical activity in the brain to reduce the number and severity of seizures.
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.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well. Do not adjust the dose or stop taking the medication without consulting your doctor, as this can lead to seizures.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs available 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, 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.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well. Do not adjust the dose or stop taking the medication without consulting your doctor, as this can lead to seizures.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs available 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
- Take rufinamide exactly as prescribed by your doctor, usually twice a day with food.
- Do not stop taking rufinamide suddenly, as this can cause your 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, rufinamide may make it less effective. Discuss alternative or additional birth control methods with your doctor.
- Avoid alcohol while taking rufinamide, as it can increase side effects like dizziness and drowsiness.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
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 up to a target dose of 3200 mg/day (max). If co-administered with valproate, initial 400 mg/day, titrate to 600 mg/day, then up to 1000 mg/day, and then up to 45 mg/kg/day or 3200 mg/day (max).
Dose Range:
400 - 3200 mg
Condition-Specific Dosing:
Lennox-Gastaut Syndrome (LGS):
Initial 400 mg/day, titrated to 3200 mg/day (max). Dose adjustments if co-administered with valproate.
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 up to 45 mg/kg/day or 3200 mg/day (max), whichever is less.
Child:
For children 4 years and older: Initial 10 mg/kg/day in 2 divided doses. Titrate by 10 mg/kg/day every 2 days up to 45 mg/kg/day or 3200 mg/day (max), whichever is less.
Adolescent:
Same as adult dosing for patients 12 years and older, or pediatric dosing for those under 12 based on weight.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution. No studies in severe renal impairment.
Dialysis:
Not available. Rufinamide is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, use with caution. No studies in moderate or severe hepatic impairment.
Severe:
No specific adjustment recommended, use with caution. No studies in moderate or severe hepatic impairment.
Pharmacology
Mechanism of Action
Rufinamide is a triazole derivative that modulates the activity of sodium channels, specifically by prolonging the inactive state of voltage-gated sodium channels. This action limits sustained repetitive firing of sodium-dependent action potentials, thereby stabilizing hyperexcitable neuronal membranes and reducing seizure propagation.
Pharmacokinetics
Absorption:
Bioavailability:
Not fully determined, but well absorbed.
Tmax:
4-6 hours (fasted state)
FoodEffect:
Food increases Cmax and AUC by 30-50%.
Distribution:
Vd:
Approximately 0.7 L/kg
ProteinBinding:
Approximately 34%
CnssPenetration:
Yes
Elimination:
HalfLife:
6-10 hours
Clearance:
Not precisely quantified, but primarily renal excretion.
ExcretionRoute:
Renal (approximately 85%) and fecal (approximately 15%).
Unchanged:
<2%
Pharmacodynamics
OnsetOfAction:
Not precisely defined for antiepileptic effect, related to pharmacokinetic profile.
PeakEffect:
Not precisely defined for antiepileptic effect, related to pharmacokinetic profile.
DurationOfAction:
Related to half-life, requiring twice-daily dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
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 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 right away if you experience:
Signs of infection, such as:
+ Fever
+ Chills
+ Sore throat
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. If you experience any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach 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 medical help right away:
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 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 right away if you experience:
Signs of infection, such as:
+ Fever
+ Chills
+ Sore throat
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. If you experience any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Headache
Upset stomach 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:
- Severe skin rash (especially with fever, swollen glands, or facial swelling)
- New or worsening suicidal thoughts or behavior
- Unusual changes in mood or behavior
- Worsening of seizures
- Signs of an allergic reaction (e.g., hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Severe dizziness or drowsiness that interferes with daily activities
- Vision changes (e.g., 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 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.
Until you are aware of how this drug affects you, avoid operating a vehicle and engaging in other activities that require your full attention.
Do not abruptly discontinue this medication without first 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.
As directed by your doctor, undergo regular blood tests to monitor your condition. Discuss any concerns or questions you have with your doctor.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reaction time, consult with your doctor.
If you experience changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly.
Note that birth control pills and other hormone-based contraceptives may be less effective while taking this medication. To prevent pregnancy, consider using an additional form of birth control, such as condoms. If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision.
Until you are aware of how this drug affects you, avoid operating a vehicle and engaging in other activities that require your full attention.
Do not abruptly discontinue this medication without first 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.
As directed by your doctor, undergo regular blood tests to monitor your condition. Discuss any concerns or questions you have with your doctor.
Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reaction time, consult with your doctor.
If you experience changes in the frequency or severity of seizures after starting this medication, notify your doctor promptly.
Note that birth control pills and other hormone-based contraceptives may be less effective while taking this medication. To prevent pregnancy, consider using an additional form of birth control, such as condoms. If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision.
Overdose Information
Overdose Symptoms:
- Ataxia (loss of coordination)
- Somnolence (extreme drowsiness)
- Nausea
- Vomiting
- Headache
- Diplopia (double vision)
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. There is no specific antidote.
Drug Interactions
Major Interactions
- Hormonal Contraceptives (decreased efficacy of contraceptives)
- Valproate (increased rufinamide levels)
Moderate Interactions
- Phenytoin (decreased rufinamide levels)
- Carbamazepine (decreased rufinamide levels)
- Phenobarbital (decreased rufinamide levels)
Monitoring
Baseline Monitoring
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for potential hepatic adverse effects, though rufinamide is not primarily hepatically metabolized.
Timing: Prior to initiation.
Renal Function Tests
Rationale: To establish baseline, as rufinamide is primarily renally excreted.
Timing: Prior to initiation.
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for potential hematologic abnormalities.
Timing: Prior to initiation.
Electrocardiogram (ECG)
Rationale: To assess baseline cardiac rhythm, as rufinamide can cause QT interval shortening.
Timing: Prior to initiation, especially in patients with pre-existing cardiac conditions.
Routine Monitoring
Seizure frequency and severity
Frequency: Regularly, at each follow-up visit.
Target: Reduction in seizure frequency and/or severity.
Action Threshold: Worsening seizures or lack of efficacy may require dose adjustment or alternative therapy.
Adverse effects (e.g., dizziness, somnolence, nausea, vomiting, fatigue, rash)
Frequency: Regularly, at each follow-up visit.
Target: Minimization of side effects.
Action Threshold: Significant or intolerable side effects may require dose reduction or discontinuation.
Mood and behavior changes (e.g., suicidal ideation)
Frequency: Regularly, at each follow-up visit, especially during initial therapy and dose changes.
Target: Absence of suicidal thoughts or behaviors.
Action Threshold: Any new or worsening suicidal thoughts or behaviors require immediate clinical evaluation and intervention.
Skin integrity (for rash)
Frequency: Regularly, especially during initial therapy.
Target: Absence of severe rash.
Action Threshold: Any severe rash (e.g., Stevens-Johnson Syndrome, DRESS) requires immediate discontinuation and medical attention.
Symptom Monitoring
- Dizziness
- Somnolence
- Nausea
- Vomiting
- Fatigue
- Headache
- Diplopia (double vision)
- Rash
- Suicidal thoughts or behavior
- Changes in mood or behavior
- Worsening of seizures
- Signs of hypersensitivity reaction (e.g., fever, swollen lymph nodes, facial swelling)
Special Patient Groups
Pregnancy
Category C. Rufinamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients should be counseled on the risks and benefits and encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, though data are limited. Weigh risks vs. benefits.
Second Trimester:
Continued monitoring for maternal and fetal well-being.
Third Trimester:
Continued monitoring for maternal and fetal well-being. Consider potential for withdrawal symptoms in neonate if exposure is high.
Lactation
L3 (Moderately Safe). Rufinamide is excreted into human milk. The decision to breastfeed should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor breastfed infants for sedation, poor feeding, or other adverse effects.
Infant Risk:
Low to moderate risk. Monitor 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.
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.
Clinical Information
Clinical Pearls
- Always take rufinamide with food to optimize absorption and reduce gastrointestinal side effects.
- Do not discontinue rufinamide abruptly due to the risk of increased seizure frequency or status epilepticus.
- Monitor patients for signs of hypersensitivity reactions, including rash, fever, and lymphadenopathy, especially during the first few weeks of treatment.
- Counsel patients and caregivers about the risk of suicidal thoughts and behaviors, and instruct them to report any changes in mood or behavior immediately.
- Advise women of childbearing potential about the potential for decreased efficacy of hormonal contraceptives and recommend alternative or additional birth control methods.
Alternative Therapies
- Clobazam
- Felbamate
- Lamotrigine
- Topiramate
- Valproate
- Cannabidiol (Epidiolex)
- Ketogenic diet
- Vagus nerve stimulation (VNS)
- Corpus callosotomy
Cost & Coverage
Average Cost:
$100 - $300 per 30 tablets (generic 200mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand), varies by insurance plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or 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.