Eslicarbazepine Acetate 600mg Tabs
It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic drug (AED)
Pharmacologic Class
Voltage-gated sodium channel blocker; Dibenzazepine derivative
Pregnancy Category
Not available
FDA Approved
Nov 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Eslicarbazepine acetate is a medication used to treat partial-onset seizures in adults and children. It works by stabilizing electrical activity in the brain to prevent seizures. It's taken once daily.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, and it can be swallowed whole or crushed. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store this 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 medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on proper disposal. You may also want to check if there are drug take-back programs available in your area.
Missing 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. If you're unsure about what to do if you miss a dose, contact your doctor for advice.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, and it can be swallowed whole or crushed. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store this 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 medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on proper disposal. You may also want to check if there are drug take-back programs available in your area.
Missing 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. If you're unsure about what to do if you miss a dose, contact your doctor for advice.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily, with or without food.
- Do not stop taking this medication suddenly without consulting your doctor, as this can lead to increased seizures.
- Avoid driving or operating machinery until you know how this medication affects you, as it can cause dizziness, drowsiness, and vision problems.
- Avoid alcohol, as it can worsen side effects like dizziness and drowsiness.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
- Be aware of symptoms of low sodium (hyponatremia) such as nausea, headache, confusion, or increased seizures, and report them to your doctor.
- If you develop a rash, especially a severe one, seek immediate medical attention.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 400 mg once daily for 1-2 weeks; Maintenance: 800 mg once daily; Max: 1200 mg once daily
Dose Range:
400 - 1200 mg
Condition-Specific Dosing:
partial-onset seizures:
Initial 400 mg once daily, increase to 600 mg or 800 mg once daily after 1-2 weeks based on response and tolerability. May increase to 1200 mg once daily if needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For partial-onset seizures (4 to <18 years): Initial 10 mg/kg once daily (max 400 mg/day) for 1-2 weeks, then increase to 20 mg/kg once daily (max 800 mg/day). May increase to 30 mg/kg once daily (max 1200 mg/day) if needed. Doses should not exceed adult maximums.
Adolescent:
For partial-onset seizures (4 to <18 years): Initial 10 mg/kg once daily (max 400 mg/day) for 1-2 weeks, then increase to 20 mg/kg once daily (max 800 mg/day). May increase to 30 mg/kg once daily (max 1200 mg/day) if needed. Doses should not exceed adult maximums.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 50-80 mL/min)
Moderate:
Initial 200 mg once daily for 1-2 weeks, then 400 mg once daily (CrCl 30-49 mL/min)
Severe:
Initial 200 mg once daily for 1-2 weeks, then 400 mg once daily (CrCl <30 mL/min)
Dialysis:
Administer after dialysis on dialysis days. Supplemental dose not required. Monitor for adverse effects.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
Not studied; use with caution or avoid
Pharmacology
Mechanism of Action
Eslicarbazepine acetate is a prodrug that is rapidly and extensively metabolized to eslicarbazepine, its active metabolite. Eslicarbazepine stabilizes the inactivated state of voltage-gated sodium channels, thereby preventing repetitive neuronal firing and reducing the propagation of synaptic impulses. It does not appear to affect potassium or calcium channels, or neurotransmitter receptors.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100% (of eslicarbazepine from the prodrug)
Tmax:
2-3 hours (for eslicarbazepine)
FoodEffect:
No clinically significant effect of food on absorption.
Distribution:
Vd:
Approximately 100 L
ProteinBinding:
Low, <40% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
10-20 hours (eslicarbazepine)
Clearance:
Not available (primarily renal excretion)
ExcretionRoute:
Renal (primarily as glucuronide conjugates of eslicarbazepine)
Unchanged:
Approximately 66% (as eslicarbazepine and its glucuronide conjugates)
Pharmacodynamics
OnsetOfAction:
Not precisely defined for seizure control; therapeutic effects are achieved after titration to steady-state concentrations.
PeakEffect:
Steady-state concentrations typically reached within 4-5 days of once-daily dosing.
DurationOfAction:
Maintained with once-daily dosing due to half-life.
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
Rarely, allergic reactions can be fatal.
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Urination problems, such as inability to pass urine or changes in urine output
Shortness of breath, significant weight gain, or swelling in the arms or legs
Chest pain or pressure
Severe muscle pain or weakness
Changes in eyesight
Worsening or changes in seizure patterns after starting this medication
Inability to control eye movements
Difficulty walking
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can affect body organs and be life-threatening. Seek immediate medical help if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands
Angioedema
A severe reaction called angioedema has been reported with this medication. This reaction can be life-threatening. Seek immediate medical help if you experience:
Swelling of the hands, face, lips, eyes, tongue, or throat
Trouble breathing
Trouble swallowing
Unusual hoarseness
Other Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Feeling dizzy, sleepy, tired, or weak
Upset stomach or vomiting
Shakiness
This is not an exhaustive list of possible 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
Rarely, allergic reactions can be fatal.
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Urination problems, such as inability to pass urine or changes in urine output
Shortness of breath, significant weight gain, or swelling in the arms or legs
Chest pain or pressure
Severe muscle pain or weakness
Changes in eyesight
Worsening or changes in seizure patterns after starting this medication
Inability to control eye movements
Difficulty walking
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can affect body organs and be life-threatening. Seek immediate medical help if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands
Angioedema
A severe reaction called angioedema has been reported with this medication. This reaction can be life-threatening. Seek immediate medical help if you experience:
Swelling of the hands, face, lips, eyes, tongue, or throat
Trouble breathing
Trouble swallowing
Unusual hoarseness
Other Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Feeling dizzy, sleepy, tired, or weak
Upset stomach or vomiting
Shakiness
This is not an exhaustive list of possible 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 (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Swelling of the face, lips, eyes, or tongue (angioedema)
- Difficulty breathing or swallowing
- Fever, swollen glands, or other signs of 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)
- New or worsening depression, anxiety, agitation, or suicidal thoughts
- Symptoms of low sodium (e.g., nausea, headache, confusion, lethargy, increased seizures)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the safety and efficacy of the medication.
* If you are currently taking oxcarbazepine, as this may interact with the medication.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Your doctor and pharmacist need this information to ensure safe treatment.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
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 liver disease, as this may affect the safety and efficacy of the medication.
* If you are currently taking oxcarbazepine, as this may interact with the medication.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Your doctor and pharmacist need this information to ensure safe treatment.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness. This will help prevent accidents and ensure your safety.
Stopping the Medication
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will guide you on how to gradually taper off the dose to minimize potential risks.
Monitoring for Rare but Serious Side Effects
Rarely, this medication can cause low blood cell counts. Be aware of the following symptoms and seek medical attention immediately if you experience:
- Unexplained bruising or bleeding
- Signs of infection, such as fever, chills, or sore throat
- Feeling extremely tired or weak
Regular blood tests, as scheduled by your doctor, are crucial to monitor your condition and adjust the treatment plan as needed.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor. These substances can interact with your medication and increase the risk of adverse effects.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or behaviors, particularly in individuals with a history of such thoughts or actions. Monitor your mental health and seek immediate medical attention if you experience:
- New or worsening symptoms of depression
- Feelings of nervousness, restlessness, or irritability
- Panic attacks
- Other changes in mood or behavior
If you or someone you know is experiencing suicidal thoughts or behaviors, contact your doctor right away.
Special Considerations for Older Adults
If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects.
Birth Control and Pregnancy
Birth control pills and other hormone-based contraceptives may be less effective while taking this medication. Use an additional form of birth control, such as condoms, to prevent pregnancy. If you become pregnant or plan to become pregnant, inform your doctor immediately, as this medication may harm the unborn baby.
Breastfeeding
If you are breastfeeding, consult your doctor to discuss potential risks to your baby.
Pediatric Patients
If your child is taking this medication and experiences weight changes, consult your doctor, as the dosage may need to be adjusted.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require alertness. This will help prevent accidents and ensure your safety.
Stopping the Medication
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this medication, your doctor will guide you on how to gradually taper off the dose to minimize potential risks.
Monitoring for Rare but Serious Side Effects
Rarely, this medication can cause low blood cell counts. Be aware of the following symptoms and seek medical attention immediately if you experience:
- Unexplained bruising or bleeding
- Signs of infection, such as fever, chills, or sore throat
- Feeling extremely tired or weak
Regular blood tests, as scheduled by your doctor, are crucial to monitor your condition and adjust the treatment plan as needed.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor. These substances can interact with your medication and increase the risk of adverse effects.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or behaviors, particularly in individuals with a history of such thoughts or actions. Monitor your mental health and seek immediate medical attention if you experience:
- New or worsening symptoms of depression
- Feelings of nervousness, restlessness, or irritability
- Panic attacks
- Other changes in mood or behavior
If you or someone you know is experiencing suicidal thoughts or behaviors, contact your doctor right away.
Special Considerations for Older Adults
If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects.
Birth Control and Pregnancy
Birth control pills and other hormone-based contraceptives may be less effective while taking this medication. Use an additional form of birth control, such as condoms, to prevent pregnancy. If you become pregnant or plan to become pregnant, inform your doctor immediately, as this medication may harm the unborn baby.
Breastfeeding
If you are breastfeeding, consult your doctor to discuss potential risks to your baby.
Pediatric Patients
If your child is taking this medication and experiences weight changes, consult your doctor, as the dosage may need to be adjusted.
Overdose Information
Overdose Symptoms:
- Severe dizziness
- Extreme drowsiness
- Blurred or double vision
- Nausea
- Vomiting
- Ataxia (loss of coordination)
- Confusion
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive.
Drug Interactions
Major Interactions
- Hormonal contraceptives (decreased efficacy of contraceptives)
- Phenytoin (increased phenytoin levels)
- Carbamazepine (decreased eslicarbazepine levels)
- Phenobarbital (decreased eslicarbazepine levels)
- Primidone (decreased eslicarbazepine levels)
Moderate Interactions
- Rosuvastatin (increased rosuvastatin exposure)
- Simvastatin (increased simvastatin exposure)
- Other CNS depressants (additive CNS depression)
- Diuretics (increased risk of hyponatremia)
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: To determine appropriate initial dosing and titration schedule.
Timing: Prior to initiation
Serum sodium
Rationale: Risk of hyponatremia, especially in the first few months.
Timing: Prior to initiation
Complete Blood Count (CBC)
Rationale: Rare risk of hematologic abnormalities.
Timing: Prior to initiation
Liver function tests (LFTs)
Rationale: Although not extensively metabolized by liver, general baseline assessment.
Timing: Prior to initiation
Routine Monitoring
Serum sodium
Frequency: Periodically, especially during the first 3 months and with dose increases, or if symptoms of hyponatremia develop.
Target: 135-145 mEq/L
Action Threshold: <130 mEq/L or symptomatic hyponatremia (consider dose reduction or discontinuation)
Seizure frequency and severity
Frequency: Ongoing
Target: Reduction or elimination of seizures
Action Threshold: Increased seizure activity or inadequate control (consider dose adjustment or alternative therapy)
Adverse effects (e.g., dizziness, somnolence, nausea, diplopia, rash)
Frequency: Regularly, especially during titration and dose changes.
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects (consider dose reduction or discontinuation)
Mood and behavior changes (e.g., suicidal ideation)
Frequency: Regularly, especially during initial therapy and dose changes.
Target: Stable mood and behavior
Action Threshold: New or worsening depression, suicidal thoughts, or unusual changes in mood/behavior (prompt psychiatric evaluation)
Symptom Monitoring
- Dizziness
- Somnolence
- Nausea
- Vomiting
- Diplopia (double vision)
- Blurred vision
- Ataxia (impaired coordination)
- Headache
- Fatigue
- Rash (especially severe skin reactions like SJS/TEN)
- Symptoms of hyponatremia (e.g., nausea, malaise, headache, confusion, lethargy, seizures)
- Mood changes, depression, suicidal thoughts or behavior
- Swelling (angioedema)
Special Patient Groups
Pregnancy
Eslicarbazepine acetate may cause fetal harm when administered to a pregnant woman. Data from animal studies show developmental toxicity. A pregnancy registry is available for women exposed to antiepileptic drugs during pregnancy (North American Antiepileptic Drug Pregnancy Registry: 1-888-233-2334). The decision to use during pregnancy should weigh the potential benefits against the risks.
Trimester-Specific Risks:
First Trimester:
Potential for major congenital malformations, consistent with other AEDs. Risk should be discussed with patient.
Second Trimester:
Not specifically studied, but continued exposure carries risk.
Third Trimester:
Not specifically studied, but continued exposure carries risk. Potential for withdrawal symptoms in neonate if discontinued abruptly.
Lactation
Eslicarbazepine and its metabolites are excreted into human breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for eslicarbazepine acetate, and any potential adverse effects on the breastfed infant from eslicarbazepine acetate or from the underlying maternal condition. Monitor breastfed infants for drowsiness, feeding difficulties, and developmental milestones.
Infant Risk:
Low to moderate risk. Monitor for sedation, poor feeding, and weight gain.
Pediatric Use
Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based. Safety and effectiveness in patients younger than 4 years have not been established.
Geriatric Use
Use with caution in elderly patients, as they are more likely to have decreased renal function. Dosage adjustments are recommended for patients with renal impairment. Start with lower doses and titrate slowly, monitoring for adverse effects, particularly hyponatremia and CNS effects.
Clinical Information
Clinical Pearls
- Eslicarbazepine acetate is a once-daily prodrug of eslicarbazepine, offering convenience for patients.
- Titration is crucial to minimize CNS-related adverse effects (dizziness, somnolence, diplopia).
- Monitor serum sodium levels, especially in the first 3 months of treatment and in patients predisposed to hyponatremia (e.g., those on diuretics).
- Counsel patients on the risk of severe skin reactions (SJS/TEN) and to report any rash immediately.
- Like other AEDs, it carries a risk of suicidal ideation; patients and caregivers should be educated on monitoring for mood changes.
- Consider drug interactions, particularly with hormonal contraceptives (use alternative birth control) and other AEDs (phenytoin, carbamazepine, phenobarbital).
Alternative Therapies
- Carbamazepine
- Oxcarbazepine
- Lamotrigine
- Levetiracetam
- Lacosamide
- Phenytoin
- Valproic acid
Cost & Coverage
Average Cost:
Varies, typically $300-$600 per 30 tablets (600mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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, a patient fact sheet that provides crucial information. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.