Eslicarbazepine Acetate 800 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Carboxamide derivatives class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Sure. Eslicarbazepine acetate (brand name Aptiom) is specifically approved to treat partial-onset seizures — that's when a seizure starts in just one area of the brain rather than...
- What exactly is this medicine for? My doctor said it's for seizures — can you tell me more?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Eslicarbazepine Acetate — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
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Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.099 | $62.96 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $6.52 | $195.54 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $12.79 | $383.66 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Eslicarbazepine acetate 800 mg 31722-0431-30 | Camber | 30 tablets | $2.099 | AB | Availability likely | — |
| Eslicarbazepine Acetate 800 mg 43598-0687-30 | Dr.Reddys | 30 tablets | $2.099 | AB | Availability likely | — |
| Eslicarbazepine Acetate 800 mg 60505-4661-03 | Apotex | 30 tablets | $2.099 | AB | Availability likely | — |
| Eslicarbazepine Acetate 800 mgthis 67877-0588-30 | Ascend | 30 tablets | $2.099 | AB | Availability likely | — |
| Eslicarbazepine Acetate 800 mg 68180-0293-06 | Lupin | 30 tablets | $2.099 | AB | Availability likely | — |
| Eslicarbazepine acetate 800 mg 13668-0541-05 | Torrent | 500 tablets | — | AB | FDA listed | — |
| Eslicarbazepine Acetate 800 mg 51407-0782-30 | Golden | 30 tablets | — | AB | FDA listed | — |
| Eslicarbazepine Acetate 800 mg 59746-0720-05 | Jubilant | 500 tablets | — | AB | FDA listed | — |
| Aptiom 800 mg 63402-0208-28 | Sumitomo | 28 tablets | — | AB | FDA listed | — |
| Eslicarbazepine Acetate 800 mg 59651-0536-30 | Aurobindo | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67877-0588-30 You're viewing this | 30 TABLET in 1 BOTTLE (67877-588-30) | 2025-05-06 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION · Adult Patients: The recommended initial dosage of eslicarbazepine acetate tablet is 400 mg once daily. For some patients, treatment may be initiated at 800 mg once daily if the need for seizure reduction outweighs an increased risk of adverse reactions. Increase the dose in weekly increments of 400 mg to 600 mg once daily, based on clinical response and tolerability, to a recommended maintenance dosage of 800 mg to 1,600 mg once daily.
( 2.2 ) · Pediatric Patients: The recommended dosage of eslicarbazepine acetate tablets is based on body weight and is administered orally once daily. Increase the dose in weekly intervals based on clinical response and tolerability, to the recommended maintenance dosage ( 2.2 ). · Patients with Moderate or Severe Renal Impairment: Reduce dosage by 50%. ( 2.4 )
2.1Important Administration Instructions Instruct patients to administer eslicarbazepine acetate tablets either as whole or as crushed tablets. Instruct patients to take eslicarbazepine acetate tablets either with or without food. The eslicarbazepine acetate tablets dosing regimen depends on age, weight, and renal function.
2.2General Dosing Recommendations Monotherapy and Adjunctive Therapy Adult Patients The recommended initial dosage of eslicarbazepine acetate tablet is 400 mg administered orally once daily. For some patients, treatment may be initiated at 800 mg once daily if the need for seizure reduction outweighs an increased risk of adverse reactions during initiation [see Adverse Reactions (6.1)]. Dosage should be increased in weekly increments of 400 mg to 600 mg, based on clinical response and tolerability, to a recommended maintenance dosage of 800 mg to 1,600 mg once daily.
For patients on eslicarbazepine acetate tablets monotherapy, the 800 mg once daily maintenance dose should generally be considered in patients who are unable to tolerate a 1,200 mg daily dose. For patients on eslicarbazepine acetate tablets adjunctive therapy, the 1,600 mg daily dose should generally be considered in patients who did not achieve a satisfactory response with a 1,200 mg daily dose. Pediatric Patients (4 to 17 Years of Age) In pediatric patients 4 to 17 years of age, the recommended dosing regimen is dependent upon body weight and is administered orally once daily.
The recommended initial dosage of eslicarbazepine acetate tablets is shown in Table 1. Dosage should be increased based on clinical response and tolerability, no more frequently than once per week. Titration increments should not exceed those shown in Table 1.
The daily maintenance dosage should not exceed the maintenance dosage for each body weight range shown in Table 1. Table 1: Eslicarbazepine Acetate Tablets Once Daily Dosage Schedule for Pediatric Patients 4 to 17 Years of Age Body Weight Range Initial and Maximum Titration Increment Dosage (mg/day) Maintenance Dosage (mg/day) 11 to 21 kg 200 400 to 600 22 to 31 kg 300 500 to 800 32 to 38 kg 300 600 to 900 more than 38 kg 400 800 to 1,200
2.3Dosage Modifications with Other Antiepileptic Drugs Some adverse reactions occur more frequently when patients take eslicarbazepine acetate tablets adjunctively with carbamazepine [see Warnings and Precautions (5.6)]. However, carbamazepine reduces the plasma concentration of eslicarbazepine [see Drug Interactions (7.1)]. When eslicarbazepine acetate tablets and carbamazepine are taken concomitantly, the dose of eslicarbazepine acetate tablets or carbamazepine may need to be adjusted based on efficacy and tolerability.
For patients taking other enzyme-inducing AEDs (i.e., phenobarbital, phenytoin, and primidone), higher doses of eslicarbazepine acetate tablets may be needed [see Drug Interactions ( 7.1 )]. Eslicarbazepine acetate tablets should not be taken as an adjunctive therapy with oxcarbazepine.
2.4Dosage Modifications in Patients with Renal Impairment In patients with moderate and severe renal impairment (i.e., creatinine clearance < 50 mL/min), th…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Eslicarbazepine acetate tablets are available in the following shapes and color (Table 2) with respective one-sided engraving: Table 2: Eslicarbazepine Acetate Tablets Presentations Tablet Strength Tablet Color/Shape Tablet Markings Functional Score 200 mg White biconvex capsule EL 200 Yes 400 mg White biconvex round EL 400 No 600 mg White biconvex capsule EL 600 Yes 800 mg White biconvex capsule EL 800 Yes Tablets: 200 mg, 400 mg, 600 mg, 800 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Eslicarbazepine acetate tablets are contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions ( 5.2 , 5.3 , and 5.4 )]. Hypersensitivity to eslicarbazepine acetate or oxcarbazepine. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS · Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior. ( 5.1 ) · Serious Dermatologic Reactions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Anaphylactic Reactions and Angioedema: Monitor and discontinue if another cause cannot be established. ( 5.2 , 5.3 , 5.4 ) · Hyponatremia: Monitor sodium levels in patients at risk or patients experiencing hyponatremia symptoms.
( 5.5 ) · Neurological Adverse Reactions: Monitor for dizziness, disturbance in gait and coordination, somnolence, fatigue, cognitive dysfunction, and visual changes. Use caution when driving or operating machinery. ( 5.6 ) · Withdrawal of Eslicarbazepine Acetate Tablets: Withdraw eslicarbazepine acetate tablets gradually to minimize the risk of increased seizure frequency and status epilepticus.
( 2.6 , 5.7 , 8.1 ) · Drug Induced Liver Injury: Discontinue eslicarbazepine acetate tablets in patients with jaundice or evidence of significant liver injury. ( 5.8 ) · Hematologic Adverse Reactions: Consider discontinuing. ( 5.10 )
5.1Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including eslicarbazepine acetate tablets, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% confidence interval [CI]: 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo.
In these trials, which had a median treatment duration of 12 weeks, the estimated incidence of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo- treated patients, but the number of events is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.
The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 3 shows absolute and relative risk by indication for all evaluated AEDs.
Table 3: Risk of Suicidal Thoughts or Behaviors by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Differences: Additional Drug Patients with Events Per 1,000 Patients Epilepsy 1.0 3.4 3.5
2.4Psychiatric 5.7 8.5 1.5
2.9Other 1.0 1.8 1.9
0.9Total 2.4 4.3 1.8
1.9The relative risk for suicidal thoughts or behavior was higher in clinical trials in patients with epilepsy than in clinical trials in patients with psychiatric or other conditions, but the absolute risk differences were similar for epilepsy and psychiatric indications. Anyone considering prescribing eslicarbazepine acetate tablets or any other AED must balance this risk with the risk of u…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] • Serious Dermatologic Reactions [see Warnings and Precautions ( 5.2 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.3 )] • Anaphylactic Reactions and Angioedema [see Warnings and Precautions ( 5.4 )] • Hyponatremia [see Warnings and Precautions ( 5.5 )] • Neurological Adverse Reactions [see Warnings and Precautions ( 5.6 )] •Drug Induced Liver Injury [see Warnings and Precautions ( 5.8 )] • Abnormal Thyroid Function Tests [see Warnings and Precautions ( 5.9 )] • Pancytopenia, Agranulocytosis, and Leukopenia [see Warnings and Precautions ( 5.10 )] · Most common adverse reactions in adult patients receiving eslicarbazepine acetate tablets (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor.
( 6.1 ) · Adverse reactions in pediatric patients are similar to those seen in adult patients. To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Patients In monotherapy trials in patients with partial-onset seizures [Study 1 and Study 2, see Clinical Studies ( 14.1 )], 365 patients received eslicarbazepine acetate tablets, of whom 225 were treated for longer than 12 months and 134 for longer than 24 months.
Of the patients in those trials, 95% were between 18 and 65 years old; 48% were male, and 84% were Caucasian. Across controlled and uncontrolled trials in patients receiving adjunctive therapy for partial- onset seizures, 1,195 patients received eslicarbazepine acetate tablets, of whom 586 were treated for longer than 6 months and 462 for longer than 12 months. In the placebo controlled adjunctive therapy trials in patients with partial-onset seizures (Study 3, Study 4 and Study 5), 1,021 patients received eslicarbazepine acetate tablets.
Of the patients in those trials, approximately 95% were between 18 and 60 years old, approximately 50% were male, and approximately 80% were Caucasian. Monotherapy Historical Control Trials In the monotherapy epilepsy trials (Study 1 and Study 2), 13% of patients randomized to receive eslicarbazepine acetate tablets at the recommended doses of 1,200 mg and 1,600 mg once daily discontinued from the trials as a result of an adverse event. The adverse reaction most commonly (≥1% on eslicarbazepine acetate tablets) leading to discontinuation was hyponatremia.
Adverse reactions observed in these studies were generally similar to those observed and attributed to drug in adjunctive placebo-controlled studies. Because these studies did not include a placebo control group, causality could not be established. Dizziness, nausea, somnolence, and fatigue were all reported at lower incidences during the AED Withdrawal Phase and Monotherapy Phase compared with the Titration Phase.
Adjunctive Therapy Controlled Trials In the controlled adjunctive therapy epilepsy trials (Study 3, Study 4, and Study 5), the rate of discontinuation as a result of any adverse reaction was 14% for the 800 mg dose, 25% for the 1,200 mg dose, and 7% in subjects randomized to placebo. The adverse reactions most commonly (≥1% in any eslicarbazepine acetate tablets treatment group, and greater than placebo) leading to discontinuation, in descending order of frequency, were dizziness, nausea, vomiting, ataxia, diplopia, somnolence, headache, blurred vision, vertigo, asthenia, fatigue,…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS · Carbamazepine: May need dose adjustment for eslicarbazepine acetate tablets or carbamazepine. ( 2.3 , 5.6 , 7 .1 ) · Phenytoin: Higher dosage of eslicarbazepine acetate tablets may be necessary and dose adjustment may be needed for phenytoin. ( 2.3 , 7.1 , 7.2 ) · Phenobarbital or Primidone: Higher dosage of eslicarbazepine acetate tablets may be necessary.
( 2.3 , 7. 1) · Hormonal Contraceptives: Eslicarbazepine acetate tablets may decrease the effectiveness of hormonal contraceptives. ( 7.4 , 8.3 )
7.1Other Antiepileptic Drugs Several AEDs (e.g., carbamazepine, phenobarbital, phenytoin, and primidone) can induce enzymes that metabolize eslicarbazepine acetate tablets and can cause decreased plasma concentrations of eslicarbazepine [see Clinical Pharmacology ( 12.3 )] . Higher doses of eslicarbazepine acetate tablets may be needed [see Dosage and Administration ( 2.4 )].
7.2CYP2C19 Substrates Eslicarbazepine acetate tablets can inhibit CYP2C19, which can cause increased plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., phenytoin, clobazam, and omeprazole) [see Clinical Pharmacology ( 12.3 )]. Dose adjustment may be needed.
7.3CYP3A4 Substrates In vivo studies suggest that eslicarbazepine acetate tablets can induce CYP3A4, decreasing plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., simvastatin, lovastatin) [see Clinical Pharmacology ( 12.3 )] . Dose adjustment of simvastatin and lovastatin may be needed if a clinically significant change in lipids is noted.
7.4Oral Contraceptives Because concomitant use of eslicarbazepine acetate tablets and ethinylestradiol and levonorgestrel is associated with lower plasma levels of these hormones, females of reproductive potential should use additional or alternative non-hormonal birth control.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as eslicarbazepine acetate tablets, during pregnancy. Encourage women who are taking eslicarbazepine acetate tablets during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary Limited available data with eslicarbazepine acetate tablets use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.
In oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demonstrated developmental toxicity, including increased incidence of malformations (mice), embryolethality (rats), and fetal growth retardation (all species), at clinically relevant doses (see Data). Advise a pregnant woman of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When eslicarbazepine acetate was orally administered (150, 350, 650 mg/kg/day) to pregnant mice throughout organogenesis, increased incidences of fetal malformations was observed at all doses and fetal growth retardation was observed at the mid and high doses. A no-effect dose for adverse developmental effects was not identified.
At the lowest dose tested, plasma eslicarbazepine exposure (C max , AUC) is less than that in humans at the maximum recommended human dose (MRHD, 1,600 mg/day). Oral administration of eslicarbazepine acetate (40, 160, 320 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in fetal growth retardation and increased incidences of skeletal variations at the mid and high doses. The no-effect dose (40 mg/kg/day) is less than the MRHD on a mg/m 2 basis.
Oral administration to pregnant rats (65, 125, 250 mg/kg/day) throughout organogenesis resulted in embryolethality at all doses, increased incidences of skeletal variations at the mid and high doses, and fetal growth retardation at the high dose. The lowest dose tested (65 mg/kg/day) is less than the MRHD on a mg/m 2 basis. When eslicarbazepine acetate was orally administered to female mice during pregnancy and lactation (150, 350, 650 mg/kg/day), the gestation period was prolonged at the highest dose tested.
In offspring, a persistent reduction in offspring body weight and delayed physical development and sexual maturation were observed at the mid and high doses. The lowest dose tested (150 mg/kg/day) is less than the MRHD on a mg/m 2 basis. When eslicarbazepine acetate was orally administered (65, 125, 250 mg/kg/day) to rats during pregnancy and lactation, reduced offspring body weight was seen at the mid and high doses.
Delayed sexual maturation and a neurological deficit (decreased motor coordination) were observed at the highest dose tested. The no-effect dose for adverse developmental effects (65 mg/kg/day) is less than the MRHD on a mg/m 2 basis. The rat data are of uncertain relevance to humans because of differences in metabolic profile between species.
8.2Lactation Eslicarbazepine is present in human milk. The effects of eslicarbazepine acetate tablets on the breastfed infant or on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for eslicarbazepine acetate tablets and any potential adverse effects on the breastfed infant from eslicarbazepine acetate tablets or from the underlying maternal condition.
8.3Females and Males of Reproductive Potential Contraception Use of eslicarbazepine acetate tablets with hormonal contracep…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as eslicarbazepine acetate tablets, during pregnancy. Encourage women who are taking eslicarbazepine acetate tablets during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary Limited available data with eslicarbazepine acetate tablets use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.
In oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demonstrated developmental toxicity, including increased incidence of malformations (mice), embryolethality (rats), and fetal growth retardation (all species), at clinically relevant doses (see Data). Advise a pregnant woman of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When eslicarbazepine acetate was orally administered (150, 350, 650 mg/kg/day) to pregnant mice throughout organogenesis, increased incidences of fetal malformations was observed at all doses and fetal growth retardation was observed at the mid and high doses. A no-effect dose for adverse developmental effects was not identified.
At the lowest dose tested, plasma eslicarbazepine exposure (C max , AUC) is less than that in humans at the maximum recommended human dose (MRHD, 1,600 mg/day). Oral administration of eslicarbazepine acetate (40, 160, 320 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in fetal growth retardation and increased incidences of skeletal variations at the mid and high doses. The no-effect dose (40 mg/kg/day) is less than the MRHD on a mg/m 2 basis.
Oral administration to pregnant rats (65, 125, 250 mg/kg/day) throughout organogenesis resulted in embryolethality at all doses, increased incidences of skeletal variations at the mid and high doses, and fetal growth retardation at the high dose. The lowest dose tested (65 mg/kg/day) is less than the MRHD on a mg/m 2 basis. When eslicarbazepine acetate was orally administered to female mice during pregnancy and lactation (150, 350, 650 mg/kg/day), the gestation period was prolonged at the highest dose tested.
In offspring, a persistent reduction in offspring body weight and delayed physical development and sexual maturation were observed at the mid and high doses. The lowest dose tested (150 mg/kg/day) is less than the MRHD on a mg/m 2 basis. When eslicarbazepine acetate was orally administered (65, 125, 250 mg/kg/day) to rats during pregnancy and lactation, reduced offspring body weight was seen at the mid and high doses.
Delayed sexual maturation and a neurological deficit (decreased motor coordination) were observed at the highest dose tested. The no-effect dose for adverse developmental effects (65 mg/kg/day) is less than the MRHD on a mg/m 2 basis. The rat data are of uncertain relevance to humans because of differences in metabolic profile between species.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of eslicarbazepine acetate tablets have been established in the age groups 4 to 17 years. Use of eslicarbazepine acetate tablets in these age groups is supported by evidence from adequate and well-controlled studies of eslicarbazepine acetate tablets in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data from clinical studies in 393 pediatric patients 4 to 17 years of age [see Adverse Reactions ( 6.1 ) and Clinical Pharmacology ( 12.3 )] .
Safety and effectiveness in pediatric patients below the age of 4 years have not been established. Animal Data In a juvenile animal study in which eslicarbazepine acetate (40, 80, 160 mg/kg/day) was orally administered to young dogs for 10 months starting on postnatal day 21, adverse effects on bone growth (decreased bone mineral content and density) were seen in females at all doses at the end of the dosing period, but not at the end of a 2-month recovery period. Convulsions were seen at the highest dose tested.
A no-effect dose for adverse effects in juvenile dogs was not identified. The lowest dose tested is less than the maximum recommended pediatric dose (1,200 mg/day) on a body surface area (mg/m 2 ) basis. A separate juvenile animal study was conducted to assess possible adverse effects on the immune system.
Eslicarbazepine acetate (10, 40, 80 mg/kg/day) was orally administered to young dogs for 17 weeks starting on postnatal day 21. No effects on the immune system were observed.
🧓 Geriatric Use ▾
8.5Geriatric Use There were insufficient numbers of patients ≥65 years old enrolled in the controlled adjunctive epilepsy trials (N=15) to determine the efficacy of eslicarbazepine acetate tablets in this patient population. The pharmacokinetics of eslicarbazepine acetate tablets were evaluated in elderly healthy subjects (N=12) (Figure 1). Although the pharmacokinetics of eslicarbazepine are not affected by age independently, dose selection should take in consideration the greater frequency of renal impairment and other concomitant medical conditions and drug therapies in the elderly patient.
Dose adjustment is necessary if CrCl is <50 mL/min [see Clinical Pharmacology ( 12.3 )].
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Signs, Symptoms, and Laboratory Findings of Acute Overdose in Humans Symptoms of overdose are consistent with the known adverse reactions of eslicarbazepine acetate tablets and include hyponatremia (sometimes severe), dizziness, nausea, vomiting, somnolence, euphoria, oral paraesthesia, ataxia, walking difficulties, and diplopia. The maximum dosage studied in open-label adult monotherapy treatment following withdrawal of concomitant AEDs was 2,400 mg once daily.
10.2Treatment or Management of Overdose There is no specific antidote for overdose with eslicarbazepine acetate tablets. Symptomatic and supportive treatment should be administered as appropriate. Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered.
Standard hemodialysis procedures result in partial clearance of eslicarbazepine acetate tablets. Hemodialysis may be considered based on the patient’s clinical state or in patients with significant renal impairment.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Eslicarbazepine acetate tablets is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.
12.2Pharmacodynamics The effect of eslicarbazepine acetate tablets on cardiac repolarization was evaluated in a randomized, double-blind, placebo- and active-controlled 4-period crossover trial in healthy adult men and women. Subjects received eslicarbazepine acetate tablets 1,200 mg once daily × 5 days, eslicarbazepine acetate tablets 2,400 mg once daily × 5 days, an active-control, moxifloxacin 400 mg × 1 dose on Day 5, and placebo once daily × 5 days. At both doses of eslicarbazepine acetate tablets, no significant effect on the QTc interval was detected.
12.3Pharmacokinetics The pharmacokinetics of eslicarbazepine is linear and dose-proportional in the dose range of 400 mg to 1,600 mg once daily, both in healthy adult subjects and patients. The apparent half-life of eslicarbazepine in plasma was 13 to 20 hours in adult epilepsy patients. Steady-state plasma concentrations are attained after 4 to 5 days of once daily dosing.
Absorption, Distribution, Metabolism, and Excretion Absorption Eslicarbazepine acetate tablets is mostly undetectable (0.01% of the systemic exposure) after oral administration. Eslicarbazepine, the major metabolite, is primarily responsible for the pharmacological effect of eslicarbazepine acetate tablets. Peak plasma concentrations (C max ) of eslicarbazepine are attained at 1 to 4 hours post-dose.
Eslicarbazepine is highly bioavailable, because the amount of eslicarbazepine and glucuronide metabolites recovered in urine corresponded to more than 90% of an eslicarbazepine acetate tablets dose. Food has no effect on the pharmacokinetics of eslicarbazepine after oral administration of eslicarbazepine acetate tablets. Distribution The binding of eslicarbazepine to plasma proteins is relatively low (<40%) and independent of concentration.
In vitro studies have shown that plasma protein binding was not relevantly affected by the presence of warfarin, diazepam, digoxin, phenytoin, or tolbutamide. Similarly, the binding of warfarin, diazepam, digoxin, phenytoin or tolbutamide was not significantly affected by the presence of eslicarbazepine. The apparent volume of distribution of eslicarbazepine is 61 L for body weight of 70 kg based on population PK analysis.
Metabolism Eslicarbazepine acetate tablets is rapidly and extensively metabolized to its major active metabolite eslicarbazepine by hydrolytic first-pass metabolism. Eslicarbazepine corresponds to 91% of systemic exposure. The systemic exposure to minor active metabolites of (R)-licarbazepine is 5% and oxcarbazepine is 1%.
The inactive glucuronides of these active metabolites correspond to approximately 3% of systemic exposure. In in vitro studies in human liver microsomes, eslicarbazepine had no clinically relevant inhibitory effect on the activity of CYP1A2, CYP2A6, CYP2B6, CYP2D6, CYP2E1, and CYP3A4, and only a moderate inhibitory effect on CYP2C19. Studies with eslicarbazepine in fresh human hepatocytes showed no induction of enzymes involved in glucuronidation and sulfation of 7-hydroxy-coumarin.
A mild activation of UGT1A1- mediated glucuronidation was observed in human hepatic microsomes. No apparent autoinduction of metabolism has been observed with eslicarbazepine acetate tablets in humans. Excretion Eslicarbazepine acetate tablets metabolites are eliminated from the systemic circulation primarily by renal excretion, in the unchanged and glucuronide conjugate forms.
In total, eslicarbazepine and its glucuronide account for more than 90% of total metabolites excreted in urine, approximately two thirds in the unchanged form and one third as glucuronide conjugate. Other minor metabolites…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Eslicarbazepine acetate tablets is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Eslicarbazepine acetate tablets are white to off white, biconvex, capsule shaped tablets debossed with functional scoring between “E L” on one side (200 mg, 600 mg, and 800 mg) or white to off white, biconvex round shaped tablets debossed with “E L” on one side (400 mg) and identified with strength-specific one-sided engraving on the other side, “200” (200 mg), “400” (400 mg), “600” (600 mg), or “800” (800 mg). Tablets are supplied in the following strengths and package configurations (Table 6): Table 6: Package Configuration for Eslicarbazepine Acetate Tablets Tablet Strength Package Configuration NDC Code 200 mg Bottles of 30 67877-585-30 Bottles of 60 67877-585-60 Bottles of 90 67877-585-90 Bottles of 500 67877-585-05 Carton of 10 (1 X 10 Unit-dose Tablets) 67877-585-33 400 mg Bottles of 30 67877-586-30 Bottles of 60 67877-586-60 Bottles of 90 67877-586-90 Bottles of 500 67877-586-05 Carton of 10 (1 X 10 Unit-dose Tablets) 67877-586-33 600 mg Bottles of 30 67877-587-30 Bottles of 60 67877-587-60 Bottles of 90 67877-587-90 Bottles of 500 67877-587-05 Carton of 10 (1 X 10 Unit-dose Tablets) 67877-587-33 800 mg Bottles of 30 67877-588-30 Bottles of 60 67877-588-60 Bottles of 90 67877-588-90 Bottles of 500 67877-588-05 Carton of 10 (1 X 10 Unit-dose Tablets) 67877-588-33
16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Keep tightly closed.
📋 Description ▾
11 DESCRIPTION The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5Hdibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17 H 16 N 2 O 3 and its molecular weight is 296.32.
The chemical structure is: Eslicarbazepine acetate is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each eslicarbazepine acetate tablets contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: copovidone, croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide and sodium stearyl fumarate.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). Inform patients and caregivers of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking eslicarbazepine acetate tablets. Instruct patients and caregivers that eslicarbazepine acetate tablets should only be taken as prescribed.
Suicidal Behavior and Ideation Counsel patients, their caregivers, and families that AEDs, including eslicarbazepine acetate tablets, may increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients, caregivers, and families to report behaviors of concern immediately to healthcare providers [see Warnings and Precautions ( 5.1 )].
Serious Dermatologic Reactions Advise patients and caregivers about the risk of potentially fatal serious skin reactions. Educate patients and caregivers about the signs and symptoms that may signal a serious skin reaction. Instruct patients and caregivers to consult with their healthcare provider immediately if a skin reaction occurs during treatment with eslicarbazepine acetate tablets [see Warnings and Precautions ( 5.2 )].
DRESS/Multi-organ Hypersensitivity Instruct patients and caregivers that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately [see Warnings and Precautions ( 5.3 )]. Anaphylactic Reactions and Angioedema Advise patients and caregivers of life threatening symptoms suggesting anaphylaxis or angioedema (swelling of the face, eyes, lips, tongue, or difficulty in swallowing or breathing) that can occur with eslicarbazepine acetate tablets.
Instruct them to immediately report these symptoms to their healthcare provider [see Warnings and Precautions ( 5.4 )]. Hyponatremia Advise patients and caregivers that eslicarbazepine acetate tablets may reduce serum sodium concentrations, especially if they are taking other medications that can lower sodium. Advise patients and caregivers to report symptoms of low sodium such as nausea, tiredness, lack of energy, irritability, confusion, muscle weakness/spasms, or more frequent or more severe seizures [see Warnings and Precautions ( 5.5 )].
Neurological Adverse Reactions Counsel patients and caregivers that eslicarbazepine acetate tablets may cause dizziness, gait disturbance, somnolence/fatigue, cognitive dysfunction, and visual changes. These adverse reactions, if observed, are more likely to occur during the titration period compared to the maintenance period. Advise patients not to drive or operate machinery until they have gained sufficient experience on eslicarbazepine acetate tablets to gauge whether it adversely affects their ability to drive or operate machinery [see Warnings and Precautions ( 5.6 )].
Withdrawal of Eslicarbazepine Acetate Tablets Advise patients and caregivers not to discontinue use of eslicarbazepine acetate tablets without consulting with their healthcare provider. Eslicarbazepine acetate tablets should be gradually withdrawn to minimize the potential of increased seizure frequency and status epilepticus [see Warnings and Precautions ( 5.7 )]. Hematologic Adverse Reactions Advise patients and caregivers that there have been rare reports of blood disorders reported in patients treated with eslicarbazepine acetate tablets.
Instruct patients to immediately consult with their physician if they experience symptoms suggestive of blood disorders [see Warnings and Precautions ( 5.10 )]. Interaction with Oral Contraceptives Inform patients and caregivers that eslicarbazepine acetate tablets can significantly decrease the effectiveness of hormonal contraceptives. Recommend that female patients of childbeari…
💬 Medication Guide ▾
MEDICATION GUIDE Eslicarbazepine Acetate Tablets (es-lye-kar-bay-ze-peen ac-etate) What is the most important information I should know about eslicarbazepine acetate tablets? • Do not stop taking eslicarbazepine acetate tablets without first talking to your healthcare provider. o Stopping eslicarbazepine acetate tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus). 1.
Like other antiepileptic drugs, eslicarbazepine acetate tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: o thoughts about suicide or dying o attempt to commit suicide o new or worse depression o new or worse anxiety o feeling agitated or restless o panic attacks o trouble sleeping (insomnia) o new or worse irritability o acting aggressive, being angry, or violent o acting on dangerous impulses o an extreme increase in activity and talking (mania) o other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? o Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. o Keep all follow-up visits with your healthcare provider as scheduled. o Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 2.
Eslicarbazepine acetate tablets may cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following: o swelling of your face, eyes, lips, or tongue o trouble swallowing or breathing o a skin rash o hives o fever, swollen glands, or sore throat that do not go away or come and go o painful sores in the mouth or around your eyes o yellowing of your skin or eyes o unusual bruising or bleeding o severe fatigue or weakness o severe muscle pain o frequent infections or infections that do not go away • Eslicarbazepine acetate tablets may cause the level of sodium in your blood to be low.
Symptoms of low blood sodium include: o nausea o tiredness, lack of energy o irritability o confusion o muscle weakness or muscle spasms o more frequent or more severe seizures Some medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking. What is eslicarbazepine acetate tablets?
Eslicarbazepine acetate tablets are a prescription medicine used to treat partial-onset seizures. It is not known if eslicarbazepine acetate tablets are safe and effective in children under 4 years of age. Who should not take eslicarbazepine acetate tablets?
Do not take eslicarbazepine acetate tablets if you are allergic to eslicarbazepine acetate, any of the other ingredients in eslicarbazepine acetate tablets, or oxcarbazepine. See the end of this Medication Guide for a complete list of ingredients in eslicarbazepine acetate tablets. What should I tell my healthcare provider before taking eslicarbazepine acetate tablets?
Before taking eslicarbazepine acetate tablets , tell your healthcare provider about all your medical conditions, including if you: • have or have had suicidal thoughts or actions, depression or mood problems • have liver, kidney, or blood problems • are allergic to oxcarbazepine. Some people who are allergic to oxcarbazepine may also be allergic to eslicarbazepine acetate tablets. • use birth control medicine. Eslicarbazepine acetate tablets may cause your birth control medicine to be less effective.
Talk to your healthcare provider ab…