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Eslicarbazepine Acetate 200 mg Tablet, 30-count — NDC 59651-0533-30 package photo
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Eslicarbazepine Acetate 200 mg Tablet, 30-count — NDC 59651-533-30 (Billing 59651-0533-30)

by Aurobindo Pharma Limited · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Eslicarbazepine Acetate 200 mg Tablet from Aurobindo Pharma Limited, marketed since Aug 2026 and currently FDA-listed; retail pharmacies pay about $1.68 per tablet (NADAC). It is this product's only package size.

NDC 59651-0533-30
🏷️ FDA NDC (as labeled) 59651-533-30 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59651-533-30
Product NDC 59651-533
11-digit billing NDC 59651053330
RxCUI 1482507, 1482515, 1482521, 1482525
UNII BEA68ZVB2K
Application # ANDA216481
SPL Set ID 2067fb77-9657-44da-b430-02e8a4efacb5
Mechanism of action Cytochrome P450 2C19 Inhibitors; Cytochrome P450 3A4 Inducers
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-05
Route ORAL
Dosage form TABLET
Substance ESLICARBAZEPINE ACETATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1482507
Why two NDCs? The FDA registers this code as 59651-533-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59651-0533-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Carboxamide derivatives class.

Drug family (ATC) Carboxamide derivatives
How it works Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inducers
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Eslicarbazepine treats partial-onset seizures, which start in one area of the brain. It is used in people 4 years of age and older. It comes as Aptiom or as generic eslicarbazepine...
  • You take one tablet-based dose by mouth once a day, with or without food. You can swallow it whole or crush it. Your prescriber will usually raise the dose gradually, so follow the...
  • No, please don't stop suddenly. Stopping abruptly can make seizures more frequent and can lead to status epilepticus, a prolonged and dangerous seizure. If you need to stop, your d...
  • Common ones are dizziness, sleepiness, nausea, headache, double vision, vomiting and tiredness. Be careful driving until you know how it affects you. Call your doctor promptly for...
📖 Read our full Eslicarbazepine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $1.676 $50.27 / 30 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Sep 2026 $1.676 $1.676
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59651-0533-30 You're viewing this Main listing 30 TABLET in 1 BOTTLE 2026-08-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eslicarbazepine Acetate 200 mg 67877-0585-30 Ascend 30 tablets $1.676 AB Availability likely —
Eslicarbazepine acetate 200 mg 31722-0428-30 Camber 30 tablets $1.676 AB Availability likely —
Eslicarbazepine Acetate 200 mg 43598-0684-30 Dr.Reddys 30 tablets $1.676 AB Availability likely —
Eslicarbazepine Acetate 200 mg 60505-4658-03 Apotex 30 tablets $1.676 AB Availability likely —
Eslicarbazepine Acetate 200 mg 68180-0290-06 Lupin 30 tablets $1.676 AB Availability likely —
Eslicarbazepine Acetate 200 mgthis 59651-0533-30 Aurobindo 30 tablets $1.676 AB Availability likely —
Aptiom 200 mg 63402-0202-28 Sumitomo 28 tablets — AB FDA listed —
Eslicarbazepine Acetate 200 mg 59746-0717-10 Jubilant 1000 tablets — AB FDA listed —
Eslicarbazepine acetate 200 mg 13668-0538-05 Torrent 500 tablets — AB FDA listed —
Eslicarbazepine Acetate 200 mg 51407-0779-30 Golden 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeOval
ImprintE;T;800
Size19 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • UNII ETJ7Z6XBU4
    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.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA216481 (ANDA)
Labeler code59651
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio1,456 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

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 ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adult Patients: The recommended initial dosage of eslicarbazepine acetate tablets 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 1600 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 tablets 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 1600 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 1200 mg daily dose. For patients on eslicarbazepine acetate tablets adjunctive therapy, the 1600 mg daily dose should generally be considered in patients who did not achieve a satisfactory response with a 1200 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 1200

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), the ini… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 159 words ▾

3 DOSAGE FORMS AND STRENGTHS Eslicarbazepine acetate tablets are available in the following shapes and color (Table 2) with respective two-sided debossing: Table 2: Eslicarbazepine Acetate Tablet Presentations Tablet Strength Tablet Color/Shape Tablet Markings Functional Score 200 mg White to off-white oblong bi-convex ‘E’ on the left side and ‘T’ on the right side of score line on one side and ‘200’ on the other side Yes 400 mg White to off-white round bi-convex ‘ET’ on one side and ‘400’ on the other side No 600 mg White to off-white oblong bi-convex ‘E’ on the left side and ‘T’ on the right side of score line on one side and ‘600’ on the other side Yes 800 mg White to off-white oblong bi-convex ‘E’ on the left side and ‘T’ on the right side of score line on one side and ‘800’ on the other side Yes Tablets: 200 mg, 400 mg, 600 mg, 800 mg ( 3 )

⛔ Contraindications 37 words ▾

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 ~3 min read ▾

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: Withdraw eslicarbazepine acetate 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 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, 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 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Differences: Additional Drug Patients with Events Per 1000 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 or any other AED must balance this risk with the risk of untreated illness. Epilepsy and many other illnesses for wh… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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 (≥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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 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, 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, 1195 patients received eslicarbazepine acetate, 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), 1021 patients received eslicarbazepine acetate.

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 at the recommended doses of 1200 mg and 1600 mg once daily discontinued from the trials as a result of an adverse event. The adverse reaction most commonly (≥1% on eslicarbazepine acetate) 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 1200 mg dose, and 7% in subjects randomized to placebo. The adverse reactions most commonly (≥1% in any eslicarbazepine acetate 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, rash, dysarthria, and tremor.

The most frequently reported adverse reactions in patients… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Carbamazepine: May need dose adjustment for eslicarbazepine acetate or carbamazepine. ( 2.3 , 5.6 , 7.1 ) Phenytoin: Higher dosage of eslicarbazepine acetate 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 may be necessary.

( 2.3 , 7.1 ) Hormonal Contraceptives: Eslicarbazepine acetate 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 and can cause decreased plasma concentrations of eslicarbazepine [see Clinical Pharmacology (12.3) ]. Higher doses of eslicarbazepine acetate may be needed [see Dosage and Administration (2.4) ] .

7.2CYP2C19 Substrates Eslicarbazepine acetate 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 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 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 ~3 min read ▾

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, during pregnancy. Encourage women who are taking eslicarbazepine acetate 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 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, 1600 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 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 and any potential adverse effects on the breastfed infant from eslicarbazepine acetate or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Use of eslicarbazepine acetate with hormonal contraceptives containing ethinylestradiol or levonorgestrel is as… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as eslicarbazepine acetate, during pregnancy. Encourage women who are taking eslicarbazepine acetate 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 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, 1600 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 ~1 min read ▾

8.4Pediatric Use Safety and effectiveness of eslicarbazepine acetate have been established in the age groups 4 to 17 years. Use of eslicarbazepine acetate in these age groups is supported by evidence from adequate and well-controlled studies of eslicarbazepine acetate 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 (1200 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 94 words ▾

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 in this patient population. The pharmacokinetics of eslicarbazepine acetate 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 130 words ▾

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 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 2400 mg once daily.

10.2Treatment or Management of Overdose There is no specific antidote for overdose with eslicarbazepine acetate. 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. Hemodialysis may be considered based on the patient’s clinical state or in patients with significant renal impairment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Eslicarbazepine acetate 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 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 1200 mg once daily × 5 days, eslicarbazepine acetate 2400 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, 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 1600 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 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. 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 dose. Food has no effect on the pharmacokinetics of eslicarbazepine after oral administration of eslicarbazepine acetate. 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 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 in humans. Excretion Eslicarbazepine acetate 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 account for the remaining 10% excreted in the urine. In healthy subjects with normal renal function,… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 43 words ▾

12.1Mechanism of Action Eslicarbazepine acetate 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 ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Eslicarbazepine Acetate Tablets 200 mg are white to off-white, oblong shape, biconvex, uncoated tablet debossed with ‘E’ on the left side and ‘T’ on the right side of score line on one side and ‘200’ on the other side. Eslicarbazepine Acetate Tablets 400 mg are white to off-white, round shape, biconvex, uncoated tablet debossed with ‘ET’ on one side and ‘400’ on the other side. Eslicarbazepine Acetate Tablets 600 mg are white to off-white, oblong shape, biconvex, uncoated tablet debossed with ‘E’ on the left side and ‘T’ on the right side of score line on one side and ‘600’ on the other side.

Eslicarbazepine Acetate Tablets 800 mg are white to off-white, oblong shape, biconvex, uncoated tablet debossed with ‘E’ on the left side and ‘T’ on the right side of score line on one side and ‘800’ on the other side. 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 59651-533-30 400 mg Bottles of 30 59651-534-30 600 mg Bottles of 60 59651-535-60 800 mg Bottles of 30 59651-536-30

16.2Storage and Handling Store eslicarbazepine acetate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

📋 Description 94 words ▾

11 DESCRIPTION The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[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, USP is a white to off-white, powder. It is soluble in methanol and acetonitrile and practically insoluble in hexane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, povidone and sodium starch glycolate. str

💬 Information for Patients ~2 min read ▾

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 childbearing pot… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Eslicarbazepine Acetate (es" li kar baz' e peen as' e tate) Tablets 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. 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: thoughts about suicide or dying new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, being angry, or violent an extreme increase in activity and talking (mania) attempt to commit suicide new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. 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: swelling of your face, eyes, lips, or tongue a skin rash fever, swollen glands, or sore throat that do not go away or come and go yellowing of your skin or eyes severe fatigue or weakness frequent infections or infections that do not go away trouble swallowing or breathing hives painful sores in the mouth or around your eyes unusual bruising or bleeding severe muscle pain Eslicarbazepine acetate tablets may cause the level of sodium in your blood to be low.

Symptoms of low blood sodium include: nausea irritability muscle weakness or muscle spasms tiredness, lack of energy confusion 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 tablet?

Eslicarbazepine acetate tablet is 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 about the best birth control method to use. are pregnant or plan to become pregnan… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 118 words ▾

8.3Females and Males of Reproductive Potential Contraception Use of eslicarbazepine acetate with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with lower plasma levels of these hormones. Advise women of reproductive potential taking eslicarbazepine acetate who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see Drug Interactions (7.4) ]. Infertility Eslicarbazepine acetate was evaluated in rats and mice for potential adverse impact on fertility of the parental and first generation [see Nonclinical Toxicology (13.1) ].

In a fertility study in male and female mice, adverse developmental outcomes were observed in embryos. In a fertility study in male and female rats, impairment of female fertility by eslicarbazepine acetate was shown.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of eslicarbazepine is linear and dose-proportional in the dose range of 400 mg to 1600 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 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. 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 dose. Food has no effect on the pharmacokinetics of eslicarbazepine after oral administration of eslicarbazepine acetate. 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 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 in humans. Excretion Eslicarbazepine acetate 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 account for the remaining 10% excreted in the urine. In healthy subjects with normal renal function, the renal clearance of eslicarbazepine (approximately 20 mL/min) is substantially lower than glomerular filtration rate (80 to 120 mL/min), suggesting that renal tubular reabsorption occurs.

The apparent plasma half-life of eslicarbazepine was 13 to 20 hours in epilepsy patients [see Dosage and Administration (2.4) and Use in Specific Populations (8.6) ]. Specific Populations Geriatric Patients (≥65 Years of Age) The pharmacokinetic profile of eslicarbazepine was unaffected in elderly subjects with creatinine clearance >60 mL/min compared to healthy subjects (18 to 40 years) after single and repeated doses of 600 mg eslicarbazepine acetate during 8 days of dosing. No dose adjustment is necessary in adults based on age, if CrCl is ≥50 mL/min.

Pediatric Patients (4 to 17 Years of Age) A pharmacokinetic study of eslicarbazepine acetate was performed in 29 pediatric patients wi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 81 words ▾

12.2Pharmacodynamics The effect of eslicarbazepine acetate 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 1200 mg once daily × 5 days, eslicarbazepine acetate 2400 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, no significant effect on the QTc interval was detected.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Monotherapy for Partial-Onset Seizures The effectiveness of eslicarbazepine acetate as monotherapy for partial-onset seizures was established in two identical, dose-blinded historical control trials in a total of 365 patients with epilepsy (Study 1 and Study 2). In these trials, patients were randomized in a 2:1 ratio to receive either eslicarbazepine acetate 1600 mg or 1200 mg once daily, and their responses were compared to those of a historical control group. The historical control methodology is described in a publication by French et al. [see References (15) ].

The historical control consisted of a pooled analysis of the control groups from 8 trials of similar design, which utilized a subtherapeutic dose of an AED as a comparator. Statistical superiority to the historical control was considered to be demonstrated if the upper limit from a 2-sided 95% confidence interval for the percentage of patients meeting exit criteria in patients receiving eslicarbazepine acetate remained below the lower 95% prediction interval of 65% derived from the historical control data. In Study 1 and Study 2, patients ≥16 years of age experienced at least 4 seizures during the baseline period with no 28-day seizure free period while receiving 1 or 2 AEDs (both could not be sodium-channel blocking drugs, and at least one AED was limited to 2/3 of a typical dose).

Eslicarbazepine acetate was titrated over a 1- to 2-week period followed by the gradual withdrawal of the background AED over a 6-week period, followed by a 10-week monotherapy period. The exit criteria were one or more of the following: (1) an episode of status epilepticus, (2) emergence of a generalized tonic-clonic seizure in patients who had not had one in the past 6 months, (3) doubling of average monthly seizure count during any 28 consecutive days, (4) doubling of highest consecutive 2-day seizure frequency during the entire treatment phase, or (5) worsening of seizure severity considered by the investigator to require intervention.

The primary endpoint was the cumulative 112-day exit rate in the efficacy population. Additionally, in Studies 1 and 2, if the discontinuation rate exceeded 10%, patients were randomly reassigned to be counted as exits. The most commonly used baseline AEDs were carbamazepine, levetiracetam, valproic acid, and lamotrigine.

Oxcarbazepine was used as a baseline AED in 6.6% of patients. In Study 1, the Kaplan-Meier (K-M) estimate of the percentage of patients meeting at least 1 exit criterion was 29% (95% CI: 21%, 38%) in the 1600 mg group and 44% (95% CI 33%, 58%) in the 1200 mg group. In Study 2, the K-M estimate of the percentage of patients meeting at least 1 exit criterion was 13% (95% CI: 8%, 22%) in the 1600 mg group and 16% (95% CI: 8%, 29%) in the 1200 mg group.

The upper limit of the 2-sided 95% CI of both doses in both trials were below the threshold of 65% derived from the historical control data, meeting the pre-specified criteria for efficacy (see Figure 4). Figure 4: Kaplan-Meier Estimates of Cumulative 112-Day Exit Rates for Studies 1 and 2 fig5

14.2Adjunctive Therapy for Partial-Onset Seizures The efficacy of eslicarbazepine acetate as adjunctive therapy in partial-onset seizures was established in three randomized, double-blind, placebo-controlled, multicenter trials in adult patients with epilepsy (Study 3, Study 4, and Study 5). Patients enrolled had partial-onset seizures with or without secondary generalization and were not adequately controlled with 1 to 3 concomitant AEDs. During an 8-week baseline period, patients were required to have an average of ≥4 partial-onset seizures per 28 days with no seizure-free period exceeding 21 days.

In these three trials, patients had a median duration of epilepsy of 19 years and a median baseline seizure frequency of 8 seizures per 28 days. Two-thirds (69%) of subjects used 2 concomitant AEDs and 28% used 1 concomitant AED. The most commonly used AEDs were carbamazepine… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~1 min read ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Eslicarbazepine acetate is not a controlled substance.

9.2Abuse Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see Drug Abuse and Dependence (9.3) ].

In a human abuse study in recreational sedative abusers eslicarbazepine acetate showed no evidence of abuse. In Phase 1, 1.5% of the healthy volunteers taking eslicarbazepine acetate reported euphoria compared to 0.4% taking placebo.

9.3Dependence Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. There was some evidence of physical dependence or a withdrawal syndrome with eslicarbazepine acetate in a physical dependence study conducted in healthy volunteers who were maintained at a daily dose of 800 mg eslicarbazepine acetate for 4 weeks prior to discontinuation. The primary endpoint was the maximum change from steady-state baseline in the total score of the Physician’s Withdrawal Checklist (PWC-34) during the 21-day discontinuation period.

Eslicarbazepine acetate and placebo were shown to be equivalent on the primary endpoint. Two out of 8 secondary endpoints (visual analog scales for anxiety and nausea) showed some increase in these symptoms for subjects who were maintained on eslicarbazepine acetate and discontinued, versus subjects who were maintained on placebo. In general, AEDs should not be abruptly discontinued in patients with epilepsy because of the risk of increased seizure frequency and status epilepticus.

🔒 Controlled Substance 10 words ▾

9.1Controlled Substance Eslicarbazepine acetate is not a controlled substance.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a two-year carcinogenicity study in mice, eslicarbazepine acetate was administered orally at doses of 100, 250, and 600 mg/kg/day. An increase in the incidence of hepatocellular adenomas and carcinomas was observed at 250 and 600 mg/kg/day in males and at 600 mg/kg/day in females. The dose not associated with an increase in tumors (100 mg/kg/day) is less than the MRHD (1600 mg/day for monotherapy) on a mg/m 2 basis.

Mutagenesis Eslicarbazepine acetate and eslicarbazepine were not mutagenic in the in vitro Ames assay. In in vitro assays in mammalian cells, eslicarbazepine acetate and eslicarbazepine were not clastogenic in human peripheral blood lymphocytes; however, eslicarbazepine acetate was clastogenic in Chinese hamster ovary (CHO) cells, with and without metabolic activation. Eslicarbazepine acetate was positive in the in vitro mouse lymphoma tk assay in the absence of metabolic activation.

Eslicarbazepine acetate was not clastogenic in the in vivo mouse micronucleus assay. Impairment of Fertility When eslicarbazepine acetate (150, 350, and 650 mg/kg/day) was orally administered to male and female mice prior to and throughout the mating period, and continuing in females to gestation day 6, there was an increase in embryolethality at all doses. The lowest dose tested is less than the MRHD on a mg/m 2 basis.

When eslicarbazepine acetate (65, 125, 250 mg/kg/day) was orally administered to male and female rats prior to and throughout the mating period, and continuing in females to implantation, lengthening of the estrus cycle was observed at the highest dose tested. The data in rats are of uncertain relevance to humans because of differences in metabolic profile between species.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a two-year carcinogenicity study in mice, eslicarbazepine acetate was administered orally at doses of 100, 250, and 600 mg/kg/day. An increase in the incidence of hepatocellular adenomas and carcinomas was observed at 250 and 600 mg/kg/day in males and at 600 mg/kg/day in females. The dose not associated with an increase in tumors (100 mg/kg/day) is less than the MRHD (1600 mg/day for monotherapy) on a mg/m 2 basis.

Mutagenesis Eslicarbazepine acetate and eslicarbazepine were not mutagenic in the in vitro Ames assay. In in vitro assays in mammalian cells, eslicarbazepine acetate and eslicarbazepine were not clastogenic in human peripheral blood lymphocytes; however, eslicarbazepine acetate was clastogenic in Chinese hamster ovary (CHO) cells, with and without metabolic activation. Eslicarbazepine acetate was positive in the in vitro mouse lymphoma tk assay in the absence of metabolic activation.

Eslicarbazepine acetate was not clastogenic in the in vivo mouse micronucleus assay. Impairment of Fertility When eslicarbazepine acetate (150, 350, and 650 mg/kg/day) was orally administered to male and female mice prior to and throughout the mating period, and continuing in females to gestation day 6, there was an increase in embryolethality at all doses. The lowest dose tested is less than the MRHD on a mg/m 2 basis.

When eslicarbazepine acetate (65, 125, 250 mg/kg/day) was orally administered to male and female rats prior to and throughout the mating period, and continuing in females to implantation, lengthening of the estrus cycle was observed at the highest dose tested. The data in rats are of uncertain relevance to humans because of differences in metabolic profile between species.

📚 References 22 words ▾

15 REFERENCES French JA, Wang S, Warnock B, Temkin N. Historical control monotherapy design in the treatment of epilepsy . Epilepsia 2010;51(10):1936-43.

📄 Package Label / Principal Display Panel 172 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (30 Tablets Bottle) NDC 59651-533-30 Rx only ONCE DAILY Eslicarbazepine Acetate Tablets 200 mg Dispense the Medication Guide provided separately to each patient. AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (30 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg (30 Tablets Bottle) NDC 59651-534-30 Rx only ONCE DAILY Eslicarbazepine Acetate Tablets 400 mg Dispense the Medication Guide provided separately to each patient. AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg (30 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (60 Tablets Bottle) NDC 59651-535-60 Rx only ONCE DAILY Eslicarbazepine Acetate Tablets 600 mg Dispense the Medication Guide provided separately to each patient. AUROBINDO 60 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (60 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 800 mg (30 Tablets Bottle) NDC 59651-536-30 Rx only ONCE DAILY Eslicarbazepine Acetate Tablets 800 mg Dispense the Medication Guide provided separately to each patient. AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 80 mg (30 Tablets Bottle)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Eslicarbazepine Acetate — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Eslicarbazepine Acetate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.91M
Claims incl. refills
15.9K
Beneficiaries
5.7K
Spend / beneficiary
$1,219.43
Spend / claim
$433.11
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Eslicarbazepine Acetate — the ingredient across all brands.

Top reported reactions

Seizure1,002
Dizziness222
Somnolence191
Hyponatraemia172
Fatigue154
Headache136
Generalised Tonic-clonic Seizure117

Reporter sex

3,247 reports

Serious outcomes

Death94
Disabling38
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 397 116
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 59651-0532-03 · Aurobindo 59651-0534-30 · Aurobindo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.