Eslicarbazepine Acetate 200mg Tabs
It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic drug (AED)
Pharmacologic Class
Dibenzazepine derivative, voltage-gated sodium channel blocker
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 seizures (epilepsy). It works by calming overactive nerves in the brain that cause seizures. It's taken once a day.
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 feeling better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, 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 your pharmacist for guidance on the best disposal method. You may also want to check if there are 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. 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 feeling better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, 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 your pharmacist for guidance on the best disposal method. You may also want to check if there are 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. 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 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 suicidal thoughts to your doctor immediately.
- Report any new skin rash, fever, or swelling to your doctor immediately, as these could be signs of a serious reaction.
- If you are taking birth control pills, this medication may make them less effective. Discuss alternative or additional birth control methods with your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 400 mg once daily for 1-2 weeks, then increase to 800 mg once daily. Max: 1200 mg once daily.
Dose Range:
400 - 1200 mg
Condition-Specific Dosing:
adjunctive_therapy:
Initial: 400 mg once daily for 1-2 weeks, then increase to 800 mg once daily. Max: 1200 mg once daily.
monotherapy:
Initial: 400 mg once daily for 1-2 weeks, then increase to 800 mg once daily. After 2 weeks, may increase to 1200 mg once daily based on clinical response and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Approved for patients 4 years and older for partial-onset seizures. Dosing is weight-based for pediatric patients.)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 50 mL/min)
Moderate:
Initial: 200 mg once daily for 1-2 weeks, then 400 mg once daily (CrCl 30-50 mL/min)
Severe:
Initial: 200 mg once daily for 1-2 weeks, then 300 mg once daily (CrCl < 30 mL/min)
Dialysis:
Not recommended in patients on dialysis due to lack of data. If used, consider supplemental dose after dialysis.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Not studied; use with caution or avoid
Pharmacology
Mechanism of Action
Eslicarbazepine acetate is a prodrug that is metabolized to eslicarbazepine, the active moiety. Eslicarbazepine is a voltage-gated sodium channel blocker. It selectively targets the fast inactivated state of the voltage-gated sodium channel, preventing the return of the channel to the resting state and thereby stabilizing hyperexcitable neuronal membranes, inhibiting repetitive neuronal firing, and decreasing the propagation of synaptic impulses.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (prodrug, rapidly and extensively converted)
Tmax:
2-3 hours (for eslicarbazepine after oral eslicarbazepine acetate)
FoodEffect:
No clinically significant effect of food on absorption
Distribution:
Vd:
1.2 L/kg
ProteinBinding:
Approximately 40%
CnssPenetration:
Yes
Elimination:
HalfLife:
10-20 hours (eslicarbazepine)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as glucuronide conjugates)
Unchanged:
Approximately 67% (as eslicarbazepine and its glucuronide)
Pharmacodynamics
OnsetOfAction:
Within hours (based on Tmax and steady-state achievement)
PeakEffect:
Steady state reached within 4-5 days with once-daily dosing
DurationOfAction:
24 hours (due to once-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
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
+ 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 altered seizures
Inability to control eye movements
Trouble 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 be life-threatening and may affect other organs. Seek medical help immediately 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 medical help immediately 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 minor ones. However, if you experience 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
Reporting Side Effects
If you have questions about side effects or want to report any 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
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
+ 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 altered seizures
Inability to control eye movements
Trouble 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 be life-threatening and may affect other organs. Seek medical help immediately 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 medical help immediately 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 minor ones. However, if you experience 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
Reporting Side Effects
If you have questions about side effects or want to report any 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)
- Signs of hypersensitivity reaction (e.g., fever, swollen lymph nodes, facial swelling, liver problems)
- New or worsening suicidal thoughts or behavior
- Symptoms of low sodium (hyponatremia) such as confusion, lethargy, nausea, vomiting, or seizures
- Significant dizziness, drowsiness, or vision changes
- Unexplained fever, sore throat, or easy bruising/bleeding (signs of blood dyscrasias)
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
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 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 existing medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
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 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 existing 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
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 discontinue the medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.
Monitoring for Rare but Serious Side Effects
Although rare, 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 actions, particularly in individuals with a history of such behaviors. Monitor your mental health and seek immediate medical attention if you or your loved ones notice:
- New or worsening symptoms of depression
- Feelings of nervousness, restlessness, or irritability
- Panic attacks
- Other changes in mood or behavior
If you experience suicidal thoughts or actions, call 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 a condom, 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 discontinue the medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.
Monitoring for Rare but Serious Side Effects
Although rare, 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 actions, particularly in individuals with a history of such behaviors. Monitor your mental health and seek immediate medical attention if you or your loved ones notice:
- New or worsening symptoms of depression
- Feelings of nervousness, restlessness, or irritability
- Panic attacks
- Other changes in mood or behavior
If you experience suicidal thoughts or actions, call 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 a condom, 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
- Ataxia (loss of coordination)
- Nausea
- Vomiting
- Hyponatremia
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and monitoring of vital signs and electrolytes.
Drug Interactions
Major Interactions
- Oral contraceptives (decreased efficacy)
- Phenytoin (increased phenytoin levels)
- Carbamazepine (decreased eslicarbazepine levels, increased carbamazepine epoxide levels)
- Oxcarbazepine (increased oxcarbazepine active metabolite levels)
- Simvastatin (decreased simvastatin levels)
- Rosuvastatin (decreased rosuvastatin levels)
Monitoring
Baseline Monitoring
Serum Sodium
Rationale: Risk of hyponatremia, especially in the first few months of treatment.
Timing: Before initiation
Renal Function (CrCl)
Rationale: Dose adjustment required for renal impairment.
Timing: Before initiation
Liver Function Tests (ALT, AST, ALP, Bilirubin)
Rationale: Although rare, severe hepatic reactions can occur with AEDs.
Timing: Before initiation
Complete Blood Count (CBC)
Rationale: Risk of hematologic abnormalities (e.g., leukopenia, aplastic anemia) with AEDs.
Timing: Before initiation
Routine Monitoring
Serum Sodium
Frequency: Periodically, especially during the first few months and with dose increases, or if symptoms of hyponatremia develop.
Target: 135-145 mEq/L
Action Threshold: < 130 mEq/L or symptomatic hyponatremia requires dose reduction or discontinuation.
Renal Function (CrCl)
Frequency: Periodically, especially in elderly or patients with risk factors for renal impairment.
Target: Not applicable
Action Threshold: Significant decline may require dose adjustment.
Liver Function Tests (ALT, AST, ALP, Bilirubin)
Frequency: Periodically, or if symptoms of hepatic dysfunction develop.
Target: Within normal limits
Action Threshold: Significant elevation (e.g., >3x ULN) requires investigation and potential discontinuation.
Suicidal Ideation/Behavior
Frequency: Ongoing, especially during the initial weeks of treatment and with dose changes.
Target: Not applicable
Action Threshold: Any new or worsening suicidal thoughts or behavior requires immediate clinical evaluation.
Skin Rash
Frequency: Ongoing, especially during the initial weeks of treatment.
Target: Not applicable
Action Threshold: Any new rash requires immediate clinical evaluation and potential discontinuation due to risk of SJS/TEN.
Symptom Monitoring
- Dizziness
- Somnolence
- Nausea
- Vomiting
- Diplopia
- Blurred vision
- Ataxia
- Fatigue
- Headache
- Hyponatremia symptoms (e.g., confusion, lethargy, nausea, vomiting, seizures)
- Signs of hypersensitivity reaction (e.g., rash, fever, lymphadenopathy, facial swelling)
- Mood changes, agitation, depression, suicidal thoughts or behavior
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. There is a pregnancy registry for women exposed to antiepileptic drugs during pregnancy. Advise pregnant women 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 specifically for eslicarbazepine is limited. Class effect of AEDs.
Second Trimester:
Not available
Third Trimester:
Not available
Lactation
Eslicarbazepine is excreted into human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother. Monitor breastfed infants for drowsiness, poor feeding, and developmental milestones.
Infant Risk:
L3 (Moderate risk; compatible with careful monitoring)
Pediatric Use
Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based. Safety and effectiveness in pediatric patients younger than 4 years of age have not been established.
Geriatric Use
Dose adjustment is recommended for elderly patients with renal impairment. Elderly patients may be more susceptible to adverse effects such as hyponatremia, dizziness, and falls. Monitor renal function and serum sodium closely.
Clinical Information
Clinical Pearls
- Eslicarbazepine acetate is a once-daily prodrug of eslicarbazepine, offering convenience for patients.
- It is structurally related to carbamazepine and oxcarbazepine but has a different metabolic pathway, which may lead to fewer drug interactions compared to carbamazepine.
- Hyponatremia is a common and potentially serious side effect, especially in the first few months of treatment and in patients also taking diuretics. Monitor serum sodium levels.
- Like other AEDs, it carries a risk of serious dermatologic reactions (SJS/TEN) and hypersensitivity reactions (DRESS syndrome). Patients should be advised to report any rash immediately.
- It can decrease the effectiveness of hormonal contraceptives; advise patients on alternative birth control methods.
- Renal dose adjustments are crucial for patients with impaired kidney function.
Alternative Therapies
- Carbamazepine
- Oxcarbazepine
- Lacosamide
- Lamotrigine
- Levetiracetam
- Phenytoin
- Topiramate
- Zonisamide
Cost & Coverage
Average Cost:
Varies widely, check current prices per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for generic), Tier 3 or 4 (for brand)
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 your prescription is refilled. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.