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Lacosamide 150 mg Tablet, Film Coated, 30-count — NDC 62332-0173-30 package photo

Lacosamide 150 mg Tablet, Film Coated, 30-count

by Alembic Pharmaceuticals Inc. · 30 TABLET, FILM COATED in 1 BOTTLE (62332-173-30)
NDC 62332-0173-30
🏷️ FDA NDC (as labeled) 62332-173-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.5223/unit — full pricing hub ↓
Also comes in: 10 tablets 62332-0173-10 60 tablets 62332-0173-60 1000 tablets 62332-0173-91
Rx only Generic On market CV
🗂️ Data synced Jul 24, 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

⚠️
Other active recalls for Lacosamide (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 4, 2026 — Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. (Annora Pharma Private Limited) · FDA recall D-0626-2026
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0343-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0330-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0321-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0337-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 62332-173-30
Product NDC 62332-173
11-digit billing NDC 62332017330
RxCUI 809987, 809992, 809996, 810000
UNII 563KS2PQY5
UPC 0362332172306
Application # ANDA204974
SPL Set ID 07b7b3f2-16a0-4deb-883b-10522676d966
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule CV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-18
Route ORAL
Dosage form TABLET, FILM COATED
Substance LACOSAMIDE
GPI-14 72600036000340
GPI class Lacosamide
GCN Seq No 064434
GCN 14341
HICL code 035872
Ingredient (HICL) Lacosamide
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 28:12.24.00
AHFS class Ion Channel Inhibition Agents
FDB label name LACOSAMIDE 150 MG TABLET
FDB brand name Lacosamide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 62332-173-30 — 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 → 62332-0173-30. 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 Other antiepileptics class.

Drug family (ATC) Other antiepileptics
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.

🏭 Manufacturer & labeler

LabelerAlembic Pharmaceuticals Inc.
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA204974 (ANDA)
Labeler code62332
First marketedMar 2022
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio491 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.

🩺 Clinical

Label name LACOSAMIDE 150 MG TABLET Ingredient Lacosamide
📖 What it is MedlinePlus · NLM

Lacosamide is used to control partial onset seizures (seizures that involve only one part of the brain). Lacosamide is also used in combination with other medications to control primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body). Lacosamide is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Lacosamide is used to treat seizures — specifically partial-onset seizures, which start in one part of the brain, in adults and children. It's also approved as an add-on treatment...
  • Yes — dizziness is the most commonly reported side effect of lacosamide, and it's most likely to happen during the early weeks when your dose is being increased. It usually gets be...
  • Is it normal to feel dizzy when I start this medication?
  • Please don't stop suddenly. Stopping lacosamide abruptly can cause a sudden increase in seizures, which can be dangerous. If you're having side effects or want to stop, talk to you...
📖 Read our full Lacosamide 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.

💊 What it looks like

Color Pink / Yellow / Blue
ShapeOval
ImprintL426
Size16 mm
ScoringNot scored
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 OP1R32D61U
    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.
  • 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII UKE75GEA7F
    Hydroxypropyl cellulose is a plant-based polymer used as a binder and thickener. It helps hold tablet ingredients together, controls how fast the medicine dissolves, and improves the texture of liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

14 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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · Q2 2026 $0.5223 $15.67 / 30 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lacosamide 150 mg 71921-0222-06 Florida 60 tablets $0.207 AB Availability likely —
Lacosamide 150 mg 00904-7246-68 Major 1 tablet $0.213 AB Availability likely —
Lacosamide 150 mg 16714-0550-01 NorthStar 60 tablets $0.213 AB Availability likely —
Lacosamide 150 mg 33342-0304-09 Macleods 60 tablets $0.213 AB Availability likely —
Lacosamide 150 mg 51991-0350-05 Breckenridge 500 tablets $0.213 AB Availability likely —
Lacosamide 150 mg 69367-0350-60 Westminster 60 tablets $0.213 AB Availability likely —
Lacosamide 150 mg 27808-0245-01 Tris 60 tablets $0.349 AB FDA listed —
Vimpat 150 mg 00131-2479-35 UCB, 60 tablets $19.645 AB Availability likely —
Lacosamide 150 mg 10135-0801-60 Marlex 60 tablets — AB FDA listed —
Lacosamide 150 mg 14445-0131-60 Indoco 60 tablets — AB FDA listed —
Lacosamide 150 mg 29300-0366-05 Unichem 500 tablets — AB FDA listed —
Lacosamide 150 mg 31722-0814-05 Camber 500 tablets — AB FDA listed —
Lacosamide 150 mg 46708-0173-10 Alembic 100 tablets — AB FDA listed —
Lacosamide 150 mg 47335-0943-18 Sun 1000 tablets — AB FDA listed —
Lacosamide 150 mg 50228-0194-10 ScieGen 1000 tablets — AB FDA listed —
Lacosamide 150 mg 51407-0723-60 Golden 60 tablets — AB FDA listed —
Lacosamide 150 mg 53746-0925-05 Amneal 500 tablets — — FDA listed —
Lacosamide 150 mg 58118-8814-08 Clinical 30 tablets — AB FDA listed —
Lacosamide 150 mgthis 62332-0173-30 Alembic 30 tablets — AB FDA listed —
Lacosamide 150 mg 65862-0749-03 Aurobindo 10 tablets — AB FDA listed —
Lacosamide 150 mg 67877-0735-05 Ascend 500 tablets — AB FDA listed —
lacosamide 150 mg 68462-0680-10 Glenmark 1000 tablets — AB FDA listed —
lacosamide 150 mg 69539-0027-05 MSN 500 tablets — AB FDA listed —
Lacosamide 150 mg 82804-0992-00 Proficient 100 tablets — AB FDA listed —
Lacosamide 150 mg 85742-0010-07 Kanchan 10 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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 tablets62332-0173-60 12,789 Rx · $388,729
10 tablets62332-0173-10 No Medicaid data
30 tablets this page62332-0173-30 No Medicaid data
1000 tablets62332-0173-91 No Medicaid data
Drug total (last 4 qtrs): 12,789 Rx · 805,932 units · $388,729 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Lacosamide — the program that covers self-administered drugs. 19 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 Lacosamide. 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
$22.96M
Claims incl. refills
274.3K
Beneficiaries
110.1K
Spend / beneficiary
$208.50
Spend / claim
$83.71
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 Lacosamide — the ingredient across all brands.

Top reported reactions

Seizure6,858
Dizziness1,669
Somnolence1,497
Fatigue1,446
Epilepsy1,418
Fall1,395
Overdose1,279

Age at onset

Neonate328
Infant111
Child299
Adolescent158
Adult2,071
Elderly709

Reporter sex

36,995 reports
Male · 45%
Female · 55%
Unknown · 1%

Serious outcomes

Hospitalization12,683
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,766 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
62332-0173-10 100 BLISTER PACK in 1 CARTON (62332-173-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK — — 2022-03-18 Active
62332-0173-30 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (62332-173-30) — — 2022-03-18 Active
62332-0173-60 60 TABLET, FILM COATED in 1 BOTTLE (62332-173-60) $0.2127 / ea $12.76 2022-03-18 Active
62332-0173-91 1000 TABLET, FILM COATED in 1 BOTTLE (62332-173-91) — — 2022-03-18 Active

This pack shows little to no recent Medicaid volume — the 60 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 62332-0173-30?
NDC 62332-0173-30 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 62332-0173-30 and NDC 62332-0173-60?
Both are Lacosamide 150 mg Tablet, Film Coated — the drug itself is identical. NDC 62332-0173-30 is the 30-count package, while NDC 62332-0173-60 is the 60 tablets package.
What NDC number is used to bill for this package of Lacosamide 150 mg Tablet, Film Coated?
Bill NDC 62332-0173-30 — the 11-digit billing format is 62332017330. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 62332-173-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62332-0173-30, written without dashes as 62332017330. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 62332-0173-30, the first segment (62332) is the labeler code FDA assigned to Alembic Pharmaceuticals Inc.; the middle segment (0173) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 10 tablets (62332-0173-10), 60 tablets (62332-0173-60), 1000 tablets (62332-0173-91). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Alembic Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🎯 Indications and Usage 122 words ▾

1 INDICATIONS AND USAGE Lacosamide tablets are indicated for: • Treatment of partial-onset seizures in patients 4 years of age and older (1.1) • Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2)

1.1Partial-Onset Seizures Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

1.2Primary Generalized Tonic-Clonic Seizures Lacosamide tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Adults (17 years and older): o Initial dosage for monotherapy for the treatment of partial-onset seizures is 100 mg twice daily (2.1) o Initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures is 50 mg twice daily (2.1) o Maximum recommended dosage for monotherapy and adjunctive therapy is 200 mg twice daily (2.1) • Pediatric Patients 4 years to less than 17 years: The recommended dosage is based on body weight and is administered orally twice daily (2.1) • Increase dosage based on clinical response and tolerability, no more frequently than once per week (2.1) • Dose adjustment is recommended for severe renal impairment (2.4, 12.3) • Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended (2.5, 12.3)

2.1Dosage Information The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures in patients 4 years of age and older and for adjunctive therapy for primary generalized tonic-clonic seizures in patients 4 years of age and older and for adjunctive therapy for primary generalized tonic-clonic seizures in patients 4 years of age and older is included in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. 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. Table 1: Recommended Dosages for Partial-Onset Seizures (Monotherapy or Adjunctive Therapy) in Patients 4 Years of Age and Older, and for Primary Generalized Tonic-Clonic Seizures (Adjunctive Therapy) in Patients 4 Years of Age and Older, and for Primary Generalized Tonic-Clonic Seizures (Adjunctive Therapy) in Patients 4 Years of Age and Older* Age and Body Weight Initial Dosage Titration Regimen Maintenance Dosage Adults (17 years and older) Monotherapy**: 100 mg twice daily (200 mg per day) Adjunctive Therapy: 50 mg twice daily (100 mg per day) Increase by 50 mg twice daily (100 mg per day) every week Monotherapy**: 150 mg to 200 mg twice daily (300 mg to 400 mg per day) Adjunctive Therapy: 100 mg to 200 mg twice daily (200 mg to 400 mg per day) 50 mg twice daily (100 mg per day) Pediatric patients weighing at least 50 kg Increase by 50 mg twice daily (100 mg per day) every week Monotherapy**: 150 mg to 200 mg twice daily (300 mg to 400 mg per day) Adjunctive Therapy: 100 mg to 200 mg twice daily (200 mg to 400 mg per day) Pediatric patients weighing 30 kg to less than 50 kg 1 mg/kg twice daily (2 mg/kg/day) Increase by 1 mg/kg twice daily (2 mg/kg/day) every week 2 mg/kg to 4 mg/kg twice daily (4 mg/kg/day to 8 mg/kg/day) Pediatric patients weighing 11 kg to less than 30 kg 1 mg/kg twice daily (2 mg/kg/day) Increase by 1 mg/kg twice daily (2 mg/kg/day) every week 3 mg/kg to 6 mg/kg twice daily (6 mg/kg/day to 12 mg/kg/day) * when not specified, the dosage is the same for monotherapy for partial-onset seizures and adjunctive therapy for partial-onset seizures or primary generalized tonic-clonic seizures. ** Monotherapy for partial-onset seizures only In adjunctive clinical trials in adult patients with partial-onset seizures, a dosage higher than 200 mg twice daily (400 mg per day) was not more effective and was associated with a substantially higher rate of adverse reactions [see Adverse Reactions (6.1) and Clinical Studies (14.2)].

Loading Dose in Adult Patients (17 Years and Older) Lacosamide tablets may be initiated in adult patients with a single loading dose of 200 mg, followed approximately 12 hours later by 100 mg twice daily (200 mg per day). The maintenance dose regimen should be continued for one week. Lacosamide tablets can then be titrated as recommended in Table 1.

The adult loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions [s…

💊 Dosage Forms and Strengths 87 words ▾

3 DOSAGE FORMS AND STRENGTHS Lacosamide Tablets, USP 50 mg: pink, oval, film-coated tablets debossed with “423” on one side and plain on other side 100 mg: dark yellow, oval, film-coated tablets debossed with “L424” on one side and plain on other side 150 mg: salmon, oval, film-coated tablets debossed with “L425” on one side and plain on other side 200 mg: blue, oval, film-coated tablets debossed with “L426” on one side and plain on other side 50 mg, 100 mg, 150 mg, 200 mg tablets (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. None. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Monitor patients for suicidal behavior and ideation (5.1) Lacosamide may cause dizziness and ataxia (5.2) Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before beginning and after titration to steady-state maintenance is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction; closely monitor these patients (5.3, 7.2) Lacosamide may cause syncope (5.4) Lacosamide should be gradually withdrawn to minimize the potential of increased seizure frequency (5.5) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity: Discontinue if no alternate etiology (5.6)

5.1Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including lacosamide, 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% 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 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 Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy 1 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1 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 for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar. Anyone considering prescribing lacosamide or any other AED must balance this risk with the risk of untreated illness. Epilepsy and many other illnesses for which antiepileptics are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.

Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

5.2Dizziness and Ataxia Lacosamide may cause dizziness and ataxia in adult and pediatric patients. In adult patients with partial-onset…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Suicidal Behavior and Ideation [see Warnings and Precautions (5.1)] • Dizziness and Ataxia [see Warnings and Precautions (5.2)] • Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions (5.3)] • Syncope [see Warnings and Precautions (5.4)] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions (5.6)] • Adjunctive therapy: Most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence (6.1) • Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies (6.1) • Pediatric patients: Adverse reactions are similar to those seen in adult patients (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 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. Lacosamide Tablets in Adults In the premarketing development of adjunctive therapy for partial-onset seizures, 1327 adult patients received lacosamide tablets in controlled and uncontrolled trials, of whom 1000 were treated for longer than 6 months, and 852 for longer than 12 months.

The monotherapy development program for partial-onset seizures included 425 adult patients, 310 of whom were treated for longer than 6 months, and 254 for longer than 12 months. Partial-Onset Seizures Monotherapy Historical-Control Trial (Study 1) In the monotherapy trial for partial-onset seizures, 16% of patients randomized to receive lacosamide at the recommended doses of 300 and 400 mg/day discontinued from the trial as a result of an adverse reaction. The adverse reaction most commonly (≥1% on lacosamide) leading to discontinuation was dizziness.

Adverse reactions that occurred in this study were generally similar to those that occurred in adjunctive placebo-controlled studies. One adverse reaction, insomnia, occurred at a rate of ≥2% and was not reported at a similar rate in previous studies. This adverse reaction has also been observed in postmarketing experience [see Adverse Reactions (6.2)].

Because this study did not include a placebo control group, causality could not be established. Dizziness, headache, nausea, somnolence, and fatigue all occurred at lower incidences during the AED Withdrawal Phase and Monotherapy Phase, compared with the Titration Phase [see Clinical Studies (14.1)]. Adjunctive Therapy Controlled Trials (Studies 2, 3, and 4) In adjunctive therapy controlled clinical trials for partial-onset seizures, the rate of discontinuation as a result of an adverse reaction was 8% and 17% in patients randomized to receive lacosamide at the recommended doses of 200 and 400 mg/day, respectively, 29% at 600 mg/day (1.5 times greater than the maximum recommended dose), and 5% in patients randomized to receive placebo.

The adverse reactions most commonly (>1% on lacosamide and greater than placebo) leading to discontinuation were dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and blurred vision. Table 4 gives the incidence of adverse reactions that occurred in ≥2% of adult patients with partial-onset seizures in the lacosamide total group and for which the incidence was greater than placebo. Table 4: Adverse Reactions Incidence in Adjunctive Therapy Pooled, Placebo-Controlled Trials in Adult Patients with Partial-Onset Seizures (Studies 2, 3, and 4) Adverse Reaction Placebo N=364 % Lacosamide 200 mg/day N=270 % Lacosamide 400 mg/day N=471 % Lacosamide 600 mg/day* N=203 % Lacosamide Total N=944 % Ear and labyrinth disorder Vertigo 1 5 3 4 4 Eye d…

🔄 Drug Interactions 135 words ▾

7 DRUG INTERACTIONS

7.1Strong CYP3A4 or CYP2C9 Inhibitors Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to lacosamide. Dose reduction may be necessary in these patients.

7.2Concomitant Medications that Affect Cardiac Conduction Lacosamide should be used with caution in patients on concomitant medications that affect cardiac conduction (sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers) including those that prolong PR interval (including sodium channel blocking AEDs), because of a risk of AV block, bradycardia, or ventricular tachyarrhythmia. In such patients, obtaining an ECG before beginning lacosamide, and after lacosamide is titrated to steady-state, is recommended.

In addition, these patients should be closely monitored if they are administered lacosamide through the intravenous route [see Warnings and Precautions (5.3)].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1) Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) tablet. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as lacosamide, during pregnancy. Encourage women who are taking lacosamide 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 Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. These effects were observed at doses associated with clinically relevant plasma exposures (see Data) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.

Data Animal Data Oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. However, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. These doses were associated with maternal plasma lacosamide exposures (AUC) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (MRHD) of 400 mg/day.

In two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. The no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide AUC similar to that in humans at the MRHD. Oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory).

The early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide AUC less than that in humans at the MRHD. In Vitro Data Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth.

Potential adverse effects on CNS development related to this activity cannot be ruled out.

8.2Lactation Risk Summary Data from published literature indicate that lacosamide is present in human milk. There are reports of increased sleepiness in breastfed infants exposed to lacosamide (see Clinical Considerations). There is no information on the effects of lacosamide on mil…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as lacosamide, during pregnancy. Encourage women who are taking lacosamide 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 Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. These effects were observed at doses associated with clinically relevant plasma exposures (see Data) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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.

Data Animal Data Oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. However, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. These doses were associated with maternal plasma lacosamide exposures (AUC) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (MRHD) of 400 mg/day.

In two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. The no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide AUC similar to that in humans at the MRHD. Oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory).

The early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide AUC less than that in humans at the MRHD. In Vitro Data Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth.

Potential adverse effects on CNS development related to this activity cannot be ruled out.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Partial-Onset Seizures Safety and effectiveness of lacosamide for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. Use of lacosamide in this age group is supported by evidence from adequate and well-controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see Adverse Reactions (6.1), and Clinical Pharmacology (12.3), and Clinical Studies (14.1, 14.2)].

Safety and effectiveness in pediatric patients below 1 month of age have not been established. Primary Generalized Tonic-Clonic Seizures Safety and effectiveness of lacosamide as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients with idiopathic generalized epilepsy 4 years of age and older was established in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study (Study 5), which included 37 pediatric patients 4 years to less than 17 years of age [see Adverse Reactions (6.1) and Clinical Studies (14.3)].

Safety and effectiveness in pediatric patients below the age of 4 years have not been established. Animal Data Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential related adverse effects on CNS development cannot be ruled out.

Administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (AUC) less than that in humans at the maximum recommended human dose of 400 mg/day. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) tablets.

However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use There were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. No lacosamide dose adjustment based on age is necessary. In elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy [see Dosage and Administration (2.1, 2.4, 2.5) and Clinical Pharmacology (12.3)] .

🆘 Overdosage 148 words ▾

10 OVERDOSAGE Events reported after an intake of more than 800 mg (twice the maximum recommended daily dosage) of lacosamide include dizziness, nausea, and seizures (generalized tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, confusion, decreased level of consciousness, cardiogenic shock, cardiac arrest, and coma have also been observed. Fatalities have occurred following lacosamide overdoses of several grams.

There is no specific antidote for overdose with lacosamide. Standard decontamination procedures should be followed. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of patient.

A Certified Poison Control Center should be contacted for up to date information on the management of overdose with lacosamide. Standard hemodialysis procedures result in significant clearance of lacosamide (reduction of systemic exposure by 50% in 4 hours). Hemodialysis may be indicated 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 The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.

12.2Pharmacodynamics A pharmacokinetic-pharmacodynamic (efficacy) analysis was performed based on the pooled data from the 3 efficacy trials for partial-onset seizures. Lacosamide exposure is correlated with the reduction in seizure frequency. However, doses above 400 mg/day do not appear to confer additional benefit in group analyses.

Cardiac Electrophysiology Electrocardiographic effects of lacosamide were determined in a double-blind, randomized clinical pharmacology trial of 247 healthy subjects. Chronic oral doses of 400 and 800 mg/day (equal to and two times the maximum daily recommended dose, respectively) were compared with placebo and a positive control (400 mg moxifloxacin). Lacosamide did not prolong QTc interval and did not have a dose-related or clinically important effect on QRS duration.

Lacosamide produced a small, dose-related increase in mean PR interval. At steady-state, the time of the maximum observed mean PR interval corresponded with t max . The placebo-subtracted maximum increase in PR interval (at t max ) was 7.3 ms for the 400 mg/day group and 11.9 ms for the 800 mg/day group.

For patients who participated in the controlled trials, the placebo-subtracted mean maximum increase in PR interval for a 400 mg/day lacosamide dose was 3.1 ms in patients with partial-onset seizures and 9.4 ms for patients with diabetic neuropathy.

12.3Pharmacokinetics The pharmacokinetics of lacosamide have been studied in healthy adult subjects (age range 18 to 87), adults with partial-onset seizures, adults with diabetic neuropathy, and subjects with renal and hepatic impairment. The pharmacokinetics of lacosamide are similar in healthy subjects, patients with partial-onset seizures, and patients with primary generalized tonic-clonic seizures. Lacosamide is completely absorbed after oral administration with negligible first-pass effect with a high absolute bioavailability of approximately 100%.

The maximum lacosamide plasma concentrations occur approximately 1-to-4-hour post-dose after oral dosing, and elimination half-life is approximately 13 hours. Steady state plasma concentrations are achieved after 3 days of twice daily repeated administration. Pharmacokinetics of lacosamide are dose proportional (100 to 800 mg) and time invariant, with low inter- and intra-subject variability.

Compared to lacosamide the major metabolite, O-desmethyl metabolite, has a longer T max (0.5 to 12 hours) and elimination half-life (15 to 23 hours). Absorption and Bioavailability Lacosamide is completely absorbed after oral administration. The oral bioavailability of lacosamide tablets is approximately 100%.

Food does not affect the rate and extent of absorption. In a trial comparing the oral tablet with an oral solution containing 10 mg/mL lacosamide, bioequivalence between both formulations was shown. A single loading dose of 200 mg approximates steady-state concentrations comparable to the 100 mg twice daily oral administration.

Distribution The volume of distribution is approximately

0.6L/kg and thus close to the volume of total body water. Lacosamide is less than 15% bound to plasma proteins. Metabolism and Elimination Lacosamide is primarily eliminated from the systemic circulation by renal excretion and biotransformation.

After oral administration of 100 mg [14C]-lacosamide approximately 95% of radioactivity administered was recovered in the urine and less than 0.5% in the feces. The major compounds excreted were unchanged lacosamide (approximately 40% of the dose), its O-desmethyl metabolite (approximately 30%), and a structur…

🧬 Mechanism of Action 50 words ▾

12.1Mechanism of Action The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Lacosamide tablets USP, 50 mg are pink, oval, film-coated tablets debossed with “423” on one side and plain on other side. They are supplied as follows: Bottle of 30 tablets with child-resistant closure, NDC 62332-171-30 Bottle of 60 tablets with child-resistant closure, NDC 62332-171-60 Bottle of 1000 tablets, NDC 62332-171-91 100 (10 X 10) unit-dose tablets, NDC 62332-171-10 Lacosamide tablets USP, 100 mg are dark yellow, oval, film-coated tablets debossed with “L424” on one side and plain on other side.

They are supplied as follows: Bottle of 30 tablets with child-resistant closure, NDC 62332-172-30 Bottle of 60 tablets with child-resistant closure, NDC 62332-172-60 Bottle of 1000 tablets, NDC 62332-172-91 100 (10 X 10) unit-dose tablets, NDC 62332-172-10 Lacosamide tablets USP, 150 mg are salmon, oval, film-coated tablets debossed with “L425” on one side and plain on other side. They are supplied as follows: Bottle of 30 tablets with child-resistant closure, NDC 62332-173-30 Bottle of 60 tablets with child-resistant closure, NDC 62332-173-60 Bottle of 1000 tablets, NDC 62332-173-91 100 (10 X 10) unit-dose tablets, NDC 62332-173-10 Lacosamide tablets USP, 200 mg are blue, oval, film-coated tablets debossed with “L426” on one side and plain on other side.

They are supplied as follows: Bottle of 30 tablets with child-resistant closure, NDC 62332-174-30 Bottle of 60 tablets with child-resistant closure, NDC 62332-174-60 Bottle of 500 tablets, NDC 62332-174-71 100 (10 X 10) unit-dose tablets, NDC 62332-174-10

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

📋 Description 158 words ▾

11 DESCRIPTION The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.30. The chemical structure is: Lacosamide, USP is a white to off-white crystalline powder. It is freely soluble in dimethyl sulphoxide and in ethanol.

11.1Lacosamide Tablets, USP Lacosamide tablets, USP for oral administration contain lacosamide, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, hypromellose, polyethylene glycol, talc, titanium dioxide, and dye pigments as specified below: Lacosamide tablets, USP are supplied as debossed tablets and contain the following coloring agents: 50 mg tablets: FD&C Blue No. 2 aluminum lake, iron oxide red, iron oxide black 100 mg tablets: iron oxide yellow 150 mg tablets: iron oxide yellow, iron oxide red, iron oxide black 200 mg tablets: FD&C Blue No.

2 aluminum lake structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). The Medication Guide accompanies the product and can also be assessed on http://www.alembicusa.com/medicationguide.aspx or call 1-866-210-9797. Suicidal Thinking and Behavior Patients, their caregivers, and families should be counseled that AEDs, including lacosamide tablets, may increase the risk of suicidal thoughts and behavior and should be advised 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.

Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (5.1)] . Dizziness and Ataxia Patients should be counseled that lacosamide tablets use may cause dizziness, double vision, abnormal coordination and balance, and somnolence. Patients taking lacosamide tablets should be advised not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with lacosamide tablets [see Warnings and Precautions (5.2)] .

Cardiac Rhythm and Conduction Abnormalities Patients should be counseled that lacosamide tablet is associated with electrocardiographic changes that may predispose to irregular heart beat and syncope. Cardiac arrest has been reported. This risk is increased in patients with underlying cardiovascular disease, with heart conduction problems, or who are taking other medications that affect the heart.

Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away. Patients who develop syncope should lay down with raised legs and contact their health care provider [see Warnings and Precautions (5.3)] . Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity Patients should be aware that lacosamide tablets may cause serious hypersensitivity reactions affecting multiple organs such as the liver and kidney.

Lacosamide tablets should be discontinued if a serious hypersensitivity reaction is suspected. Patients should also be instructed to report promptly to their physicians any symptoms of liver toxicity (e.g., fatigue, jaundice, dark urine) [see Warnings and Precautions (5.6)] . Pregnancy Registry Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during lacosamide tablets therapy.

Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. This registry is collecting information about the safety of AEDs during pregnancy [see Use in Specific Populations (8.1)] . Lactation Advise breastfeeding women using lacosamide tablets to monitor infants for excess sleepiness and to seek medical care if they notice this sign [see Use in Specific Populations (8.2)].

Medication Guide available at http://www.alembicusa.com/medicationguide.aspx or call 1-866-210-9797. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 11/2023

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Lacosamide ( la KOE sa mide ) film coated tablet, for oral use, CV Read this Medication Guide before you start taking lacosamide tablets and each time you get a refill. There may be new information. This Medication Guide describes important safety information about lacosamide tablets.

This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about lacosamide tablets? Do not stop taking lacosamide tablets without first talking to your healthcare provider.

Stopping lacosamide tablets suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). Lacosamide tablets can cause serious side effects, including: Like other antiepileptic drugs, lacosamide 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 • trouble sleeping (insomnia) • attempt to commit suicide • new or worse irritability • new or worse depression • acting aggressive, being angry, or violent • new or worse anxiety • acting on dangerous impulses • feeling agitated or restless • an extreme increase in activity and talking (mania) • panic attacks • 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 can be caused by things other than medicines.

If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 2. Lacosamide tablets may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide tablets affects you. 3. Lacosamide tablets may cause you to have an irregular heartbeat or may cause you to faint.

In rare cases, cardiac arrest has been reported. Call your healthcare provider right away if you: • have a fast, slow, or pounding heartbeat or feel your heart skip a beat • feel lightheaded • fainted or if you feel like you are going to faint • have shortness of breath • have chest pain If you have fainted or feel like you are going to faint you should lay down with your legs raised. 4.

Lacosamide tablet is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your lacosamide tablets in a safe place, to protect it from theft. Never give your lacosamide tablets to anyone else, because it may harm them.

Selling or giving away this medicine is against the law. What is lacosamide tablet? Lacosamide tablet is a prescription medicine used: • to treat partial-onset seizures in people 4 years of age and older. • with other medicines to treat primary generalized tonic-clonic seizures in people 4 years of age and older.

It is not known if lacosamide tablet is safe and effective for partial-onset seizures in children under 1 month of age or for primary generalized tonic-clonic seizures in children under 4 years of age. What should I tell my healthcare provider before taking lacosamide tablets? Before you take lacosamide tablets, tell your healthcare provider about all of your medical conditions, including if you: • have or have had depression, mood problems or suicidal thoughts or behavior. • have heart problems. • have kidney problems. • have liver problems. • have abused prescription medicines, street drugs or alcohol in the past. • are pregnant or plan to become pregnant.…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62332-0172-10 · Alembic 62332-0174-10 · Alembic →
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.