Aptiom 600mg Tablets
It is used to help control certain kinds of seizures.
Drug Class
Antiepileptic drug (AED)
Pharmacologic Class
Voltage-gated sodium channel blocker
Pregnancy Category
Not assigned (PLLR)
FDA Approved
Nov 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aptiom (eslicarbazepine) is a medication used to treat partial-onset seizures in adults and children 4 years and older. It works by stabilizing electrical activity in the brain to help prevent 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 to feel 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 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, check with your pharmacist for guidance on proper disposal. 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. 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, consult 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 your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of 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, check with your pharmacist for guidance on proper disposal. 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. 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, consult 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.
- Use effective non-hormonal birth control if you are taking hormonal contraceptives, as Aptiom can make them less effective.
- Report any new or worsening mood changes, depression, or thoughts of self-harm to your doctor immediately.
- Carry a medical alert card or wear a medical alert bracelet indicating you have epilepsy and are taking this medication.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 400 mg once daily for 1-2 weeks, then 800 mg once daily. May increase to 1200 mg once daily based on response and tolerability.
Dose Range:
400 - 1200 mg
Condition-Specific Dosing:
partial-onset seizures:
Monotherapy or adjunctive therapy
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 4 years and older: Weight-based dosing. Initial 10 mg/kg/day (max 400 mg/day) for 1-2 weeks, then 20 mg/kg/day (max 800 mg/day). Max 30 mg/kg/day (max 1200 mg/day).
Adolescent:
For patients 4 years and older: Weight-based dosing. Initial 10 mg/kg/day (max 400 mg/day) for 1-2 weeks, then 20 mg/kg/day (max 800 mg/day). Max 30 mg/kg/day (max 1200 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >60 mL/min)
Moderate:
Initial 200 mg once daily for 1-2 weeks, then 400 mg once daily. Max 600 mg once daily (CrCl 30-60 mL/min).
Severe:
Initial 200 mg once daily for 1-2 weeks, then 200 mg once daily. Max 300 mg once daily (CrCl <30 mL/min).
Dialysis:
Administer after dialysis on dialysis days. Dosing as per severe renal impairment.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
Not studied; generally not recommended.
Pharmacology
Mechanism of Action
Eslicarbazepine acetate is a prodrug that is extensively metabolized to eslicarbazepine, the active metabolite. Eslicarbazepine stabilizes the inactivated state of voltage-gated sodium channels, thereby inhibiting repetitive neuronal firing and reducing the propagation of epileptic seizures.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100% (of eslicarbazepine from prodrug)
Tmax:
2-4 hours (for eslicarbazepine)
FoodEffect:
No clinically significant effect of food on absorption.
Distribution:
Vd:
Approximately 100 L
ProteinBinding:
Approximately 40%
CnssPenetration:
Yes
Elimination:
HalfLife:
10-20 hours (eslicarbazepine)
Clearance:
Not available (primarily renal excretion)
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 27% (as eslicarbazepine)
Pharmacodynamics
OnsetOfAction:
Not precisely defined for seizure control; therapeutic effects are achieved after titration to maintenance dose.
PeakEffect:
Steady state achieved within 4-5 days with once-daily dosing.
DurationOfAction:
24 hours (due to once-daily dosing)
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
+ Change 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 unusual 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. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Dizziness
Drowsiness
Fatigue
Weakness
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
+ Change 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 unusual 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. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Dizziness
Drowsiness
Fatigue
Weakness
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 facial swelling (signs of a severe allergic reaction)
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Persistent nausea, vomiting, or loss of appetite
- Severe dizziness, extreme drowsiness, or confusion
- Double vision or other vision changes
- Unsteadiness or difficulty walking
- New or worsening depression, anxiety, agitation, or irritability
- Thoughts of harming yourself
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 your ability to take this 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 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 your ability to take this 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 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. Stopping the medication suddenly may increase your risk of seizures. If you need to discontinue the 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 drugs 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. This risk may be higher in individuals with a history of suicidal thoughts or actions. If you or your family members notice any new or worsening symptoms, such as:
- Depression
- Feeling nervous, restless, or irritable
- Panic attacks
- Other changes in mood or behavior
Seek medical help immediately. 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.
Contraception 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 any 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. Stopping the medication suddenly may increase your risk of seizures. If you need to discontinue the 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 drugs 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. This risk may be higher in individuals with a history of suicidal thoughts or actions. If you or your family members notice any new or worsening symptoms, such as:
- Depression
- Feeling nervous, restless, or irritable
- Panic attacks
- Other changes in mood or behavior
Seek medical help immediately. 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.
Contraception 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 any 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
- Double vision
- Ataxia (loss of coordination)
- Nausea
- Vomiting
- Hyponatremia (low sodium)
- Seizures
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. There is no specific antidote.
Drug Interactions
Major Interactions
- Oral contraceptives (hormonal): Eslicarbazepine can decrease the efficacy of hormonal contraceptives. Advise alternative or additional non-hormonal contraception.
- Carbamazepine: Concomitant use may lead to increased levels of carbamazepine epoxide (active metabolite of carbamazepine) and increased risk of adverse effects. Consider dose reduction of carbamazepine.
- Phenytoin: May decrease eslicarbazepine levels and increase phenytoin levels. Monitor levels and adjust doses as needed.
- Rifampin: Strong CYP inducer, may significantly decrease eslicarbazepine levels.
Moderate Interactions
- Oxcarbazepine: Concomitant use is not recommended due to potential for increased adverse effects and similar active metabolite.
- Phenobarbital: May decrease eslicarbazepine levels.
- Diuretics (e.g., hydrochlorothiazide, furosemide): Increased risk of hyponatremia.
- Rosuvastatin: Eslicarbazepine may decrease rosuvastatin exposure.
Monitoring
Baseline Monitoring
Renal function (serum creatinine, eGFR)
Rationale: To determine appropriate starting dose and dose adjustments for renal impairment.
Timing: Prior to initiation
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, although severe hepatic impairment is a contraindication.
Timing: Prior to initiation
Serum sodium
Rationale: To establish baseline, as hyponatremia is a known adverse effect.
Timing: Prior to initiation
Complete Blood Count (CBC)
Rationale: To assess baseline hematologic parameters, though severe hematologic effects are rare.
Timing: Prior to initiation
Routine Monitoring
Serum sodium
Frequency: Periodically, especially during the first few months of treatment, and in patients at risk for hyponatremia (e.g., concomitant diuretic use).
Target: 135-145 mEq/L
Action Threshold: <130 mEq/L or symptomatic hyponatremia (e.g., nausea, malaise, headache, confusion, seizures) requires immediate evaluation and potential dose reduction or discontinuation.
Clinical monitoring for signs/symptoms of hypersensitivity reaction (e.g., rash, fever, lymphadenopathy, facial swelling)
Frequency: Regularly, especially during the first few months.
Target: N/A
Action Threshold: Any signs of severe rash (e.g., SJS/TEN) or DRESS syndrome require immediate discontinuation.
Clinical monitoring for suicidal thoughts or behavior
Frequency: Regularly throughout treatment.
Target: N/A
Action Threshold: Any new or worsening mood changes, depression, or suicidal ideation require immediate evaluation and appropriate intervention.
Clinical monitoring for CNS adverse effects (e.g., dizziness, somnolence, ataxia, diplopia)
Frequency: Regularly, especially during titration.
Target: N/A
Action Threshold: Significant or debilitating CNS effects may require dose reduction or slower titration.
Symptom Monitoring
- Rash (especially severe, widespread, or blistering)
- Fever
- Swollen lymph nodes
- Facial swelling
- Difficulty breathing
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Persistent nausea or vomiting
- Severe fatigue
- Confusion
- Headache
- Dizziness
- Drowsiness
- Vision changes (e.g., double vision)
- Unsteadiness or difficulty with coordination (ataxia)
- Mood changes (e.g., new or worsening depression, anxiety, agitation)
- Suicidal thoughts or behavior
Special Patient Groups
Pregnancy
Data from pregnancy registries and observational studies suggest that infants exposed to eslicarbazepine during pregnancy may be at increased risk for major congenital malformations (e.g., neural tube defects) and other adverse developmental outcomes. The benefits of seizure control must be weighed against potential risks. Advise women of childbearing potential to use effective contraception.
Trimester-Specific Risks:
First Trimester:
Potential increased risk of major congenital malformations.
Second Trimester:
Continued exposure may contribute to developmental risks.
Third Trimester:
Continued exposure may contribute to developmental risks; potential for withdrawal symptoms in neonate if discontinued abruptly.
Lactation
Eslicarbazepine and its active metabolite 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 Aptiom, and any potential adverse effects on the breastfed infant from Aptiom or from the underlying maternal condition. Monitor breastfed infants for sedation, poor feeding, or other adverse effects.
Infant Risk:
Low to moderate risk (L3). Potential for infant drowsiness, poor feeding, or irritability. Monitor infant closely.
Pediatric Use
Approved for partial-onset seizures in patients 4 years of age and older. Dosing is weight-based. 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. Dosage adjustment is recommended for elderly patients with renal impairment. Start with lower doses and titrate slowly due to potential for increased sensitivity to adverse effects and higher likelihood of renal impairment.
Clinical Information
Clinical Pearls
- Eslicarbazepine is a prodrug of eslicarbazepine, which is structurally related to carbamazepine and oxcarbazepine but has a distinct metabolic pathway (primarily glucuronidation, not CYP oxidation), potentially leading to fewer drug interactions compared to carbamazepine.
- Titration is crucial to minimize CNS side effects like dizziness, somnolence, and diplopia. Do not rush the titration process.
- Monitor serum sodium, especially in the first few months of treatment and in patients concurrently taking diuretics, as hyponatremia is a common and potentially serious side effect.
- Counsel patients on the risk of severe skin reactions (e.g., SJS/TEN, DRESS) and to seek immediate medical attention if a rash develops.
- Advise women of childbearing potential about the need for effective contraception due to potential interaction with hormonal contraceptives and risks during pregnancy.
- Like other AEDs, eslicarbazepine carries a class warning for suicidal thoughts or behavior; counsel patients and caregivers to monitor for mood changes.
Alternative Therapies
- Carbamazepine
- Oxcarbazepine
- Lamotrigine
- Levetiracetam
- Lacosamide
- Phenytoin
- Valproic acid
- Topiramate
- Zonisamide
Cost & Coverage
Average Cost:
Varies widely, typically $300-$1000+ per 30 tablets
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 your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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 reporting the incident, be prepared to provide detailed information about the medication taken, the quantity, and the time it occurred.