Aptiom 800mg 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 available
FDA Approved
Nov 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aptiom is a medication used to treat partial-onset seizures in adults and children 4 years and older. It works by calming overactive nerve signals 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 well.
Storing and Disposing of Your Medication
Store the 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, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.
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 in case of a missed 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 feeling well.
Storing and Disposing of Your Medication
Store the 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, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.
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 in case of a missed dose, consult your doctor for advice.
Lifestyle & Tips
- Take Aptiom exactly as prescribed, usually once daily, with or without food.
- Do not stop taking Aptiom suddenly without talking to your doctor, as this can cause seizures to worsen.
- Avoid alcohol and other medications that cause drowsiness, as Aptiom can increase these effects.
- Be cautious when driving or operating machinery until you know how Aptiom affects you, as it can cause dizziness and sleepiness.
- Report any new or worsening mood changes, depression, or suicidal thoughts to your doctor immediately.
- Use effective birth control if you are a woman of childbearing potential, as Aptiom can make hormonal birth control less effective.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
800 mg once daily (maintenance)
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. May increase to 1200 mg once daily based on clinical response and tolerability.
Monotherapy:
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.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4 to <11 years: Initial 10 mg/kg once daily (max 400 mg/day) for 1-2 weeks, then increase to 20 mg/kg once daily (max 600 mg/day). Max 30 mg/kg once daily (max 800 mg/day). Doses should be rounded to the nearest 50 mg.
11 to <18 years: Initial 400 mg once daily for 1-2 weeks, then increase to 600 mg once daily. Max 800 mg once daily.
Adolescent:
11 to <18 years: Initial 400 mg once daily for 1-2 weeks, then increase to 600 mg once daily. Max 800 mg once daily.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: No dose adjustment needed.
Moderate:
CrCl 30-50 mL/min: Initial 200 mg once daily for 1-2 weeks, then increase to 400 mg once daily. Max 600 mg once daily.
Severe:
CrCl <30 mL/min: Initial 100 mg once daily for 1-2 weeks, then increase to 200 mg once daily. Max 300 mg once daily.
Dialysis:
Considerations: Administer after dialysis on dialysis days. Supplemental dose may be needed. Specific recommendations for dialysis patients are not fully established, but dose reduction is necessary.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Not studied. Use with caution.
Pharmacology
Mechanism of Action
Eslicarbazepine acetate is a prodrug that is metabolized to eslicarbazepine, the active moiety. Eslicarbazepine exerts its anticonvulsant effect by blocking voltage-gated sodium channels. It preferentially binds to the inactivated state of the 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.
Pharmacokinetics
Absorption:
Bioavailability:
High (nearly complete)
Tmax:
2-3 hours (for eslicarbazepine)
FoodEffect:
Food does not affect the extent of absorption (AUC) but may delay Tmax by 1 hour.
Distribution:
Vd:
Not available (but generally low for AEDs)
ProteinBinding:
Low (<40%)
CnssPenetration:
Yes
Elimination:
HalfLife:
10-20 hours (for eslicarbazepine)
Clearance:
Primarily renal
ExcretionRoute:
Renal
Unchanged:
Not available (primarily excreted as glucuronide conjugates)
Pharmacodynamics
OnsetOfAction:
Within hours (after first dose)
PeakEffect:
Within days to weeks (after reaching steady state)
DurationOfAction:
24 hours (due to once-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
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 vision
Worsening or altered seizures
Inability to control eye movements
Difficulty walking
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can be life-threatening and may affect other organs. Seek immediate medical attention if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands
Angioedema
A severe reaction called angioedema has been reported with this medication. This reaction can be life-threatening. Seek immediate medical attention if you experience:
Swelling of the hands, face, lips, eyes, tongue, or throat
Trouble breathing
Trouble swallowing
Unusual hoarseness
Other Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or persist, contact your doctor:
Headache
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach or vomiting
Shakiness
Reporting Side Effects
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
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 vision
Worsening or altered seizures
Inability to control eye movements
Difficulty walking
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can be life-threatening and may affect other organs. Seek immediate medical attention if you experience:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands
Angioedema
A severe reaction called angioedema has been reported with this medication. This reaction can be life-threatening. Seek immediate medical attention if you experience:
Swelling of the hands, face, lips, eyes, tongue, or throat
Trouble breathing
Trouble swallowing
Unusual hoarseness
Other Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or persist, contact your doctor:
Headache
Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach or vomiting
Shakiness
Reporting Side Effects
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe skin rash (e.g., blistering, peeling, fever, swollen glands)
- Signs of low sodium (e.g., confusion, extreme tiredness, nausea, vomiting, muscle cramps, seizures)
- Unusual bruising or bleeding
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, severe stomach pain)
- New or worsening depression, anxiety, or suicidal thoughts
- Swelling of the face, lips, or tongue
- Difficulty breathing
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 the 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 may have. Your doctor and pharmacist need this information to ensure safe treatment. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 the 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 may have. Your doctor and pharmacist need this information to ensure safe treatment. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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. Stopping abruptly 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, discuss the potential risks with your doctor.
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 behaviors. If you or your caregiver 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 suicidal thoughts or actions occur, 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 any potential risks to your baby.
Pediatric Patients
If your child is taking this medication and experiences weight changes, consult your doctor, as the dose may need to be adjusted accordingly.
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. Stopping abruptly 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, discuss the potential risks with your doctor.
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 behaviors. If you or your caregiver 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 suicidal thoughts or actions occur, 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 any potential risks to your baby.
Pediatric Patients
If your child is taking this medication and experiences weight changes, consult your doctor, as the dose may need to be adjusted accordingly.
Overdose Information
Overdose Symptoms:
- Severe dizziness
- Extreme drowsiness
- Blurred vision or double vision
- Nausea
- Vomiting
- Ataxia (loss of coordination)
- Coma
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is generally supportive, including gastric lavage, activated charcoal, and monitoring of vital signs.
Drug Interactions
Major Interactions
- Oral contraceptives (decreased efficacy)
- Simvastatin (decreased exposure)
- Phenytoin (increased phenytoin levels)
- Carbamazepine (increased carbamazepine-10,11-epoxide levels)
- Oxcarbazepine (increased eslicarbazepine levels)
Moderate Interactions
- Rifampin (decreased eslicarbazepine levels)
- Diuretics (increased risk of hyponatremia)
- Other CNS depressants (additive CNS depression)
Monitoring
Baseline Monitoring
Serum Sodium
Rationale: Risk of hyponatremia, especially in the first 3 months of treatment or with concomitant diuretic use.
Timing: Before initiation
Renal Function (CrCl)
Rationale: Dose adjustment required for renal impairment.
Timing: Before initiation
Liver Function Tests (ALT, AST, Bilirubin)
Rationale: Although rare, severe hepatic reactions can occur.
Timing: Before initiation
Routine Monitoring
Serum Sodium
Frequency: Periodically, especially during the first 3 months of treatment, and if symptoms of hyponatremia develop. More frequently in patients on diuretics.
Target: 135-145 mEq/L
Action Threshold: <130 mEq/L or symptomatic hyponatremia (consider dose reduction or discontinuation)
Seizure Frequency and Severity
Frequency: Ongoing
Target: Reduction in seizure frequency
Action Threshold: Increased seizure frequency or lack of efficacy (consider dose adjustment or alternative therapy)
Adverse Effects (CNS, dermatologic, psychiatric)
Frequency: Ongoing
Target: Absence or tolerability of side effects
Action Threshold: Severe or intolerable side effects (e.g., severe rash, significant dizziness, mood changes) warranting dose adjustment or discontinuation.
Symptom Monitoring
- Dizziness
- Somnolence
- Nausea
- Diplopia (double vision)
- Headache
- Fatigue
- Hyponatremia symptoms (e.g., confusion, lethargy, nausea, vomiting, muscle cramps, seizures)
- Skin rash (e.g., Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS)
- Mood changes (e.g., depression, suicidal thoughts or behavior)
- Coordination problems (ataxia)
Special Patient Groups
Pregnancy
Eslicarbazepine may cause fetal harm when administered to a pregnant woman. Data from pregnancy registries suggest an increased risk of major congenital malformations (e.g., cardiac, craniofacial, skeletal) with antiepileptic drugs. Use only if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception.
Trimester-Specific Risks:
First Trimester:
Increased risk of major congenital malformations, consistent with other AEDs.
Second Trimester:
Not specifically studied, but continued exposure carries risk.
Third Trimester:
Not specifically studied, but continued exposure carries risk. Potential for withdrawal symptoms in neonate if exposure continues until delivery.
Lactation
Eslicarbazepine and its active metabolite are excreted into human milk. The effects on the breastfed infant are unknown. A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother. Monitor breastfed infants for sedation, poor feeding, and developmental milestones.
Infant Risk:
L3 (Moderate risk) - Potential for sedation, poor feeding, and other adverse effects. Monitor infant closely.
Pediatric Use
Approved for children 4 years and older. Dosing is weight-based for children 4 to <11 years. Adolescents (11 to <18 years) follow adult-like dosing. Safety and efficacy in children younger than 4 years have not been established.
Geriatric Use
Use with caution in elderly patients, as they may be more susceptible to adverse reactions (e.g., dizziness, somnolence, hyponatremia) and may have age-related decreases in renal function requiring dose adjustment. Start at the lower end of the dosing range and titrate slowly.
Clinical Information
Clinical Pearls
- Eslicarbazepine is a prodrug of eslicarbazepine, which is structurally related to carbamazepine and oxcarbazepine but has a distinct metabolic pathway, potentially leading to fewer drug-drug interactions compared to carbamazepine.
- Hyponatremia is a known side effect, especially in the first 3 months of treatment and in patients on diuretics. Monitor serum sodium levels.
- Patients should be advised about the risk of serious dermatologic reactions (SJS/TEN, DRESS) and instructed to seek immediate medical attention if a rash develops.
- Like other AEDs, eslicarbazepine carries a risk of suicidal thoughts or behavior. Patients and caregivers should be monitored for changes in mood or behavior.
- Aptiom can reduce the effectiveness of hormonal contraceptives; advise patients to use alternative or additional non-hormonal birth control methods.
Alternative Therapies
- Carbamazepine
- Oxcarbazepine
- Lamotrigine
- Levetiracetam
- Lacosamide
- Phenytoin
- Topiramate
- Zonisamide
Cost & Coverage
Average Cost:
Varies widely, typically $300-$1000+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand, generic may be Tier 1)
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 reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.