Eslicarbazepine Acetate 800mg Tabs
It is used to help control certain kinds of seizures.
Drug Class
Anticonvulsant
Pharmacologic Class
Voltage-gated sodium channel blocker
Pregnancy Category
Category D
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 people with epilepsy. It works by calming overactive nerves in the brain that cause seizures.
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 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 your pharmacist for guidance on the best disposal method. You may also have access to local drug take-back programs.
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. Avoid taking two doses at the same time or taking extra doses. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
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 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 your pharmacist for guidance on the best disposal method. You may also have access to local drug take-back programs.
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. Avoid taking two doses at the same time or taking extra doses. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
Lifestyle & Tips
- Take this 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 and other medications that cause drowsiness, as this can increase side effects like dizziness and sleepiness.
- Be cautious when driving or operating machinery until you know how this medication affects you.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
- Carry an identification card or wear a medical alert bracelet stating you have epilepsy and are taking this medication.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 400 mg once daily for 1 week. 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 for 1 week, then increase to 800 mg once daily. May increase to 1200 mg once daily based on clinical response and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Approved for patients 4 years and older for partial-onset seizures)
Adolescent:
For patients 4 to <17 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 response and tolerability. For patients âĨ17 years: Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 50-80 mL/min)
Moderate:
Initial: 200 mg once daily for 1 week, then 400 mg once daily (CrCl 30-49 mL/min)
Severe:
Initial: 200 mg once daily for 1 week, then 400 mg once daily (CrCl <30 mL/min)
Dialysis:
Administer 400 mg once daily, with supplemental dose after dialysis if administered on dialysis days. Specific recommendations vary, consult prescribing information.
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 rapidly metabolized to eslicarbazepine, the active moiety. Eslicarbazepine stabilizes the inactivated state of voltage-gated sodium channels, thereby inhibiting repetitive neuronal firing and reducing the propagation of synaptic impulses. This action is thought to be responsible for its anticonvulsant effects.
Pharmacokinetics
Absorption:
Bioavailability:
Not directly quantifiable for the prodrug, but eslicarbazepine bioavailability is high (nearly 100%)
Tmax:
2-3 hours (for eslicarbazepine after oral administration of eslicarbazepine acetate)
FoodEffect:
Food does not affect the extent of absorption, but may delay Tmax by 1 hour.
Distribution:
Vd:
Approximately 1.1 L/kg
ProteinBinding:
Approximately 40%
CnssPenetration:
Yes
Elimination:
HalfLife:
10-20 hours (for eslicarbazepine)
Clearance:
Not readily available, primarily renal excretion
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 67% of the dose is excreted in urine as eslicarbazepine glucuronide, and 27% as unchanged eslicarbazepine.
Pharmacodynamics
OnsetOfAction:
Not acutely quantifiable; therapeutic effects are achieved after reaching steady-state concentrations (typically within 4-5 days of once-daily dosing).
PeakEffect:
Steady-state concentrations are reached within 4-5 days.
DurationOfAction:
Sustained effect with once-daily dosing due to half-life.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 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
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 activity
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 affect other body organs and may be life-threatening. 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 mild side effects. 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
Feeling dizzy, sleepy, tired, or weak
Upset stomach or vomiting
* Shakiness
Reporting Side Effects
If you have questions about side effects or want to report a side effect, 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 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
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 activity
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 affect other body organs and may be life-threatening. 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 mild side effects. 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
Feeling dizzy, sleepy, tired, or weak
Upset stomach or vomiting
* Shakiness
Reporting Side Effects
If you have questions about side effects or want to report a side effect, 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., blistering, peeling, widespread redness)
- Fever, swollen glands, or other signs of a severe allergic reaction (DRESS syndrome)
- Unusual bruising or bleeding
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe stomach pain)
- Symptoms of low sodium (e.g., confusion, severe drowsiness, nausea, vomiting, muscle weakness, seizures)
- New or worsening depression, anxiety, agitation, or suicidal thoughts
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 health problems you are experiencing. 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 all 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 health problems you are experiencing. 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 all 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
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 and adjust your 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 family members notice:
- New or worsening symptoms of depression
- Feeling nervous, restless, or irritable
- 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 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 and adjust your 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 family members notice:
- New or worsening symptoms of depression
- Feeling nervous, restless, or irritable
- 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
- Nausea
- Vomiting
- Ataxia (loss of coordination)
- Tremor
- Hyponatremia
- Coma
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive; there is no specific antidote.
Drug Interactions
Major Interactions
- Oral contraceptives (decreased efficacy)
- Phenytoin (increased phenytoin levels)
- Carbamazepine (decreased eslicarbazepine levels, increased carbamazepine epoxide levels)
- Oxcarbazepine (additive effects, increased risk of adverse reactions)
- Rosuvastatin (decreased rosuvastatin levels)
- Simvastatin (decreased simvastatin levels)
Moderate Interactions
- Lamotrigine (potential for decreased lamotrigine levels)
- Topiramate (potential for decreased topiramate levels)
- Phenobarbital (potential for decreased phenobarbital levels)
- Primidone (potential for decreased primidone levels)
- Warfarin (potential for decreased warfarin efficacy)
- Drugs metabolized by CYP2C19 (e.g., clopidogrel, omeprazole) - potential for increased levels of these drugs
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
Liver function tests (ALT, AST, bilirubin)
Rationale: Although rare, severe hepatic reactions have been reported with other AEDs; caution in severe hepatic impairment.
Timing: Before initiating treatment
Complete Blood Count (CBC)
Rationale: Rare reports of hematologic abnormalities with related drugs.
Timing: Before initiating treatment
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 requires intervention (dose reduction/discontinuation).
Renal function (CrCl)
Frequency: Periodically, especially in elderly patients or those with risk factors for renal impairment.
Target: >50 mL/min for standard dosing
Action Threshold: CrCl <50 mL/min requires dose adjustment.
Clinical signs/symptoms of hypersensitivity reaction (e.g., rash, fever, lymphadenopathy)
Frequency: Regularly, especially during the first few months of treatment.
Target: Absence of symptoms
Action Threshold: Any signs of severe rash (SJS/TEN) or DRESS syndrome require immediate discontinuation.
Mood and behavioral changes, suicidal ideation
Frequency: Regularly, especially at treatment initiation and with dose changes.
Target: Stable mood, absence of suicidal thoughts
Action Threshold: New or worsening depression, suicidal thoughts, or unusual changes in behavior require immediate evaluation.
Symptom Monitoring
- Dizziness
- Somnolence
- Nausea
- Vomiting
- Diplopia
- Blurred vision
- Headache
- Fatigue
- Ataxia
- Tremor
- Rash (especially severe, e.g., SJS, TEN, DRESS)
- Symptoms of hyponatremia (e.g., confusion, lethargy, seizures, nausea, vomiting)
- Mood changes, depression, suicidal thoughts or behavior
- Signs of liver injury (e.g., jaundice, dark urine, abdominal pain)
Special Patient Groups
Pregnancy
Eslicarbazepine acetate can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Women of childbearing potential should be advised about the risks and the need for effective contraception. A pregnancy registry is available.
Trimester-Specific Risks:
First Trimester:
Increased risk of major congenital malformations (e.g., cardiac defects, neural tube defects) based on data from related AEDs.
Second Trimester:
Potential for continued exposure to risks.
Third Trimester:
Potential for continued exposure to risks; withdrawal symptoms in neonates possible if exposure continues until delivery.
Lactation
Eslicarbazepine and its metabolites are excreted in human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother and the potential adverse effects on the infant. Monitor breastfed infants for drowsiness, feeding difficulties, and developmental milestones.
Infant Risk:
L3 (Moderate risk - compatible with caution; monitor infant for adverse effects).
Pediatric Use
Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based for younger children. Monitor for behavioral changes and growth.
Geriatric Use
Use with caution due to increased likelihood of renal impairment and potential for increased sensitivity to adverse effects (e.g., hyponatremia, dizziness, falls). Dose adjustment is recommended for renal impairment.
Clinical Information
Clinical Pearls
- Eslicarbazepine acetate is a prodrug of eslicarbazepine, which is the active metabolite of oxcarbazepine, but it is a distinct chemical entity with a different pharmacokinetic profile.
- Once-daily dosing improves adherence compared to multiple daily doses of other AEDs.
- Monitor serum sodium levels, especially in the first 3 months of treatment and in patients at risk for hyponatremia (e.g., elderly, those on diuretics).
- Counsel patients on the risk of serious dermatologic reactions (SJS/TEN, DRESS) and suicidal ideation, and instruct them to seek immediate medical attention if symptoms occur.
- May decrease the effectiveness of hormonal contraceptives; advise patients to use alternative or additional non-hormonal birth control methods.
- Dose adjustments are crucial in patients with renal impairment.
Alternative Therapies
- Carbamazepine
- Oxcarbazepine
- Lamotrigine
- Levetiracetam
- Phenytoin
- Valproic acid
- Lacosamide
- Topiramate
- Zonisamide
Cost & Coverage
Average Cost:
Varies widely, typically $300-$600+ per 30 tablets (800mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3, may require prior authorization
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, 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 quantity, and the time it occurred.