Eslicarbazepine Acetate 400mg Tabs
It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic drug (AED)
Pharmacologic Class
Voltage-gated sodium channel blocker
Pregnancy Category
Category C
FDA Approved
Oct 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 4 years and older. It works by calming overactive nerves in the brain that cause seizures.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it can be taken as a whole tablet or crushed if needed. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets. When you no longer need your medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, ask your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular 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 guidance.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it can be taken as a whole tablet or crushed if needed. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets. When you no longer need your medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, ask your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular 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 guidance.
Lifestyle & Tips
- Take the medication exactly as prescribed, usually once daily, with or without food.
- Do not stop taking this medication suddenly without talking to your doctor, as this can cause seizures to worsen.
- Avoid alcohol, as it can increase side effects like dizziness and drowsiness.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness, drowsiness, and vision problems.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
- Report any signs of a severe skin rash or allergic reaction (e.g., fever, swollen glands, facial swelling) to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
800 mg once daily
Dose Range:
400 - 1200 mg
Condition-Specific Dosing:
initial:
400 mg once daily for 1-2 weeks, then increase to 800 mg once daily. May increase to 1200 mg once daily based on clinical response and tolerability.
adjunctiveTherapy:
Same as monotherapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 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) based on clinical response and tolerability. Doses should not exceed 1200 mg/day.
Adolescent:
For patients 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) based on clinical response and tolerability. Doses should not exceed 1200 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 60-90 mL/min)
Moderate:
Initial 200 mg once daily for 1-2 weeks, then 400 mg once daily (CrCl 30-59 mL/min)
Severe:
Initial 200 mg once daily for 1-2 weeks, then 400 mg once daily (CrCl <30 mL/min)
Dialysis:
Administer 400 mg once daily, with a supplemental dose of 50% of the daily dose after each dialysis session. Monitor closely.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Not recommended due to lack of data
Pharmacology
Mechanism of Action
Eslicarbazepine acetate is a prodrug that is extensively metabolized to eslicarbazepine, the active moiety. Eslicarbazepine is a voltage-gated sodium channel blocker. It selectively binds to the inactivated state of the voltage-gated sodium channel, preventing its return to the resting state and thereby stabilizing neuronal membranes, inhibiting repetitive neuronal firing, and decreasing the propagation of synaptic impulses. This action is thought to be responsible for its anticonvulsant effects.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly measured for eslicarbazepine acetate, but eslicarbazepine is rapidly and extensively absorbed after oral administration.
Tmax:
2-3 hours (for eslicarbazepine)
FoodEffect:
Food does not affect the extent of absorption (AUC) or Tmax of eslicarbazepine.
Distribution:
Vd:
Approximately 1.2 L/kg
ProteinBinding:
Less than 40% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
10-20 hours (for eslicarbazepine)
Clearance:
Approximately 0.06 L/h/kg
ExcretionRoute:
Primarily renal (over 90% of the dose is excreted in urine as eslicarbazepine and its glucuronide conjugate)
Unchanged:
Less than 1% (of eslicarbazepine acetate); approximately 66% of eslicarbazepine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within hours of first dose
PeakEffect:
Steady-state concentrations are reached within 4-5 days of once-daily dosing.
DurationOfAction:
Sustained effect allowing for once-daily dosing.
Safety & Warnings
BLACK BOX WARNING
Antiepileptic drugs (AEDs), including Eslicarbazepine Acetate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
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, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
Signs of severe skin reactions may include:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Angioedema, a severe reaction that can be life-threatening, may occur. Signs include:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. 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
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach or vomiting
Shakiness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
Signs of severe skin reactions may include:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands
Angioedema, a severe reaction that can be life-threatening, may occur. Signs include:
+ Swelling of the hands, face, lips, eyes, tongue, or throat
+ Trouble breathing
+ Trouble swallowing
+ Unusual hoarseness
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. 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
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach or vomiting
Shakiness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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, blistering, or peeling skin
- Fever, swollen glands, or facial swelling (signs of a severe allergic reaction)
- New or worsening depression, anxiety, agitation, or suicidal thoughts
- Unusual tiredness, confusion, severe headache, or nausea/vomiting (signs of low sodium)
- Vision changes (double vision, blurred vision)
- Unusual bleeding or bruising
- Yellowing of skin or eyes (jaundice)
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 how your body processes 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 discuss all your medications, health conditions, and supplements with your doctor. This includes:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Your doctor and pharmacist need to be aware of all your medications and health problems to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without first consulting 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 how your body processes 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 discuss all your medications, health conditions, and supplements with your doctor. This includes:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Your doctor and pharmacist need to be aware of all your medications and health problems to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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 suddenly stop taking this medication 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
In rare cases, 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.
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, discuss the potential risks with your doctor.
Suicidal Thoughts and Actions
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 mood and behavior, and immediately report any new or worsening symptoms to your doctor, including:
- Depression
- Feeling nervous, restless, or irritable
- Panic attacks
- Other changes in mood or behavior
If you experience suicidal thoughts or actions, seek medical help 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.
Children
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 suddenly stop taking this medication 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
In rare cases, 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.
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, discuss the potential risks with your doctor.
Suicidal Thoughts and Actions
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 mood and behavior, and immediately report any new or worsening symptoms to your doctor, including:
- Depression
- Feeling nervous, restless, or irritable
- Panic attacks
- Other changes in mood or behavior
If you experience suicidal thoughts or actions, seek medical help 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.
Children
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 or drowsiness
- Nausea, vomiting
- Double vision
- Uncontrolled eye movements (nystagmus)
- Ataxia (loss of coordination)
- Tremor
- Hyponatremia (low sodium)
- Coma
What to Do:
Seek immediate medical attention. There is no specific antidote. Treatment is supportive and symptomatic. Consider gastric lavage or activated charcoal if ingestion is recent. Dialysis may be considered for severe overdose. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Carbamazepine (may decrease eslicarbazepine levels and increase carbamazepine epoxide levels)
- Phenytoin (may decrease eslicarbazepine levels and increase phenytoin levels)
- Phenobarbital (may decrease eslicarbazepine levels)
- Oral Contraceptives (may decrease efficacy of estrogen and progestin-containing contraceptives)
Moderate Interactions
- Oxcarbazepine (additive effects, increased risk of adverse reactions)
- Rufinamide (potential for additive effects)
- Lamotrigine (potential for additive effects)
- Topiramate (potential for additive effects)
- Valproic Acid (potential for additive effects)
- Hormone Replacement Therapy (potential for decreased efficacy)
Monitoring
Baseline Monitoring
Serum Sodium
Rationale: Risk of hyponatremia, especially in the first 3 months of treatment.
Timing: Before initiating treatment
Renal Function (CrCl)
Rationale: Dose adjustment required for renal impairment.
Timing: Before initiating treatment
Hepatic Function (ALT, AST, Bilirubin)
Rationale: Although not extensively metabolized by liver, baseline assessment is prudent.
Timing: Before initiating treatment
Complete Blood Count (CBC)
Rationale: Rare risk of hematologic abnormalities.
Timing: Before initiating treatment
Routine Monitoring
Serum Sodium
Frequency: Monthly for the first 3 months, then periodically or as clinically indicated.
Target: 135-145 mEq/L
Action Threshold: <130 mEq/L or symptomatic hyponatremia requires dose reduction or discontinuation.
Seizure Frequency and Severity
Frequency: Regularly, at each clinical visit.
Target: Reduction or elimination of seizures
Action Threshold: Increased seizure frequency or severity may indicate need for dose adjustment or alternative therapy.
Adverse Effects (e.g., dizziness, somnolence, nausea, diplopia, rash)
Frequency: Regularly, at each clinical visit.
Target: Minimization of side effects
Action Threshold: Significant or persistent adverse effects may require dose reduction or discontinuation.
Mood and Behavior Changes (e.g., suicidal ideation)
Frequency: Regularly, at each clinical visit.
Target: Stable mood and behavior
Action Threshold: New or worsening depression, suicidal thoughts, or unusual changes in mood/behavior require immediate evaluation.
Symptom Monitoring
- Symptoms of hyponatremia (e.g., nausea, malaise, headache, lethargy, confusion, seizures)
- Signs of hypersensitivity reaction (e.g., rash, fever, lymphadenopathy, facial swelling, multi-organ involvement)
- New or worsening depression, suicidal thoughts or behavior, or unusual changes in mood or behavior
- Dizziness, somnolence, fatigue, vision changes (diplopia, blurred vision), gait disturbance
- Nausea, vomiting, abdominal pain
Special Patient Groups
Pregnancy
Eslicarbazepine acetate is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data from animal studies show developmental toxicity (e.g., increased fetal malformations, reduced fetal weight) at clinically relevant exposures. Women of childbearing potential should be advised to use effective contraception.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, consistent with other AEDs. Discuss risks and benefits with physician.
Second Trimester:
Not specifically studied, but continued monitoring of maternal and fetal health is important.
Third Trimester:
Not specifically studied, but continued monitoring of maternal and fetal health is important. Consider potential for withdrawal symptoms in neonate if exposed late in pregnancy.
Lactation
Eslicarbazepine and its metabolites are excreted into human breast milk. The amount of drug transferred to the infant is relatively low, but potential for adverse effects in the breastfed infant (e.g., drowsiness, poor feeding, rash) exists. 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 the drug or from the underlying maternal condition. Monitor the infant for sedation, irritability, and poor weight gain.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for sedation, irritability, and poor weight gain.
Pediatric Use
Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based for children 4 to <18 years. Safety and efficacy in pediatric patients younger than 4 years have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is recommended for elderly patients with renal impairment. Elderly patients may be at increased risk for hyponatremia and CNS adverse events.
Clinical Information
Clinical Pearls
- Eslicarbazepine acetate is a prodrug of eslicarbazepine, which is the active moiety. It is structurally related to carbamazepine and oxcarbazepine but has a different metabolic pathway, leading to fewer drug-drug interactions compared to carbamazepine.
- Once-daily dosing improves patient adherence.
- Monitor serum sodium levels, especially during the first 3 months of treatment, due to the risk of hyponatremia.
- Counsel patients on the risk of suicidal thoughts and behaviors, and advise them to report any mood changes immediately.
- Advise women of childbearing potential about the potential for decreased efficacy of hormonal contraceptives and the need for alternative or additional birth control methods.
- Titrate dose slowly to minimize CNS side effects like dizziness and somnolence.
Alternative Therapies
- Carbamazepine
- Oxcarbazepine
- Lamotrigine
- Levetiracetam
- Phenytoin
- Valproic Acid
- Topiramate
- Lacosamide
- Zonisamide
- Perampanel
Cost & Coverage
Average Cost:
Varies widely, typically $300-$1000+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/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, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them 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 substance taken, the amount, and the time it occurred.