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Lacosamide 100 mg/10mL Solution — NDC 00121-2024-95 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lacosamide 100 mg/10mL Solution — NDC 0121-2024-95 (Billing 00121-2024-95)

by PAI Holdings, LLC dba PAI Pharma · 1 TRAY in 1 TRAY / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE

This is a package of Lacosamide 100 mg/10mL Solution from PAI Holdings, LLC dba PAI Pharma, marketed since Aug 2022 and currently FDA-listed. It is this product's only package size.

NDC 00121-2024-95
🏷️ FDA NDC (as labeled) 0121-2024-95 billing pads the labeler segment with a zero
Rx only Generic On market CV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0121-2024-95
Product NDC 0121-2024
11-digit billing NDC 00121202495
NCPDP billing unit ML — per mL (volume)
RxCUI 993856
UNII 563KS2PQY5
Application # ANDA216151
SPL Set ID 75de00d8-d2e7-4025-be4e-f49299068e7e
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 2022-08-26
Route ORAL
Dosage form SOLUTION
Substance LACOSAMIDE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 72600036002060
GCN Seq No 066386
GCN 28643
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 100 MG/10 ML CUP
FDB brand name Lacosamide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066386
  • GCN: 28643
  • GPI-14 (Medi-Span): 72600036002060
  • HICL (First Databank): 035872
  • AHFS class code: 28:12.24.00
  • RxCUI (RxNorm): 993856
Why two NDCs? The FDA registers this code as 0121-2024-95 — a 4-4-2 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 labeler segment → 00121-2024-95. 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.

Clinical

Label name LACOSAMIDE 100 MG/10 ML CUP Ingredient Lacosamide
📗 Our plain-language guide HelloPharmacist
  • It treats partial-onset seizures, and it is also used as add-on treatment for primary generalized tonic-clonic seizures. Which age groups it covers depends on the product, so your...
  • Tablets and oral solution are usually taken twice a day, with or without food. Motpoly XR is a once-daily capsule that you swallow whole, without opening, chewing or crushing. Foll...
  • Dizziness is the big one, along with headache, double or blurry vision, nausea, sleepiness and balance trouble. These are most noticeable when starting or raising the dose. Tell yo...
  • Call right away for fainting, a very slow or irregular heartbeat, or new or worsening depression or suicidal thoughts. Also call for fever with rash or swelling, which can be a ser...
📖 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.

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 mLPer 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 $0.2032 $20.32 / 100 ml
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
00121-2024-95 You're viewing this Main listing 1 TRAY in 1 TRAY / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE 2023-04-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lacosamide 200 mg/20mL 00121-4048-95 PAI 10 cups $0.083 AA Availability likely —
Lacosamide 10 mg/mL 31722-0627-26 Camber 1 bottle $0.083 AA Availability likely —
Lacosamide 10 mg/mL 59651-0016-02 Aurobindo 200 ml $0.083 AA Availability likely —
Lacosamide Oral Solution 10 mg/mL 67877-0732-95 Ascend 200 ml $0.083 AA Availability likely —
Lacosamide 10 mg/mL 68462-0940-86 Glenmark 200 ml $0.083 AA Availability likely —
Lacosamide 10 mg/mL 69315-0318-20 Leading 200 ml $0.083 AA Availability likely —
Lacosamide 10 mg/mL 70954-0488-10 ANI 200 ml $0.083 AA Availability likely —
Lacosamide Oral Solution 10 mg/mL 71921-0411-71 Florida 1 bottle $0.083 AA Availability likely —
Lacosamide 10 mg/mL 72205-0034-74 Novadoz 200 ml $0.083 AA Availability likely —
Lacosamide 10 mg/mL 72603-0305-01 NorthStar 200 ml $0.083 AA Availability likely —
Lacosamide Oral Solution 10 mg/mL 81033-0428-02 Kesin 200 ml $0.083 AA Availability likely —
Lacosamide Oral Solution 10 mg/mL 82983-0427-31 Ajenat 200 ml $0.083 AA Availability likely —
Lacosamide 50 mg/5mL 00121-1012-95 PAI 10 cups — AA FDA listed —
Lacosamide 100 mg/10mLthis 00121-2024-95 PAI 10 cups — AA FDA listed —
Lacosamide 150 mg/15mL 00121-3036-95 PAI 10 cups — AA FDA listed —
Vimpat 10 mg/mL 00131-5410-70 UCB, 465 ml — AA Discontinued —
Lacosamide 50 mg/5mL 00904-7463-68 Major 10 cups — AA FDA listed —
Lacosamide 100 mg/10mL 00904-7464-64 Major 10 cups — AA FDA listed —
Lacosamide 10 mg/mL 60687-0847-54 American 10 cups — AA FDA listed —
Lacosamide Oral Solution 10 mg/mL 62135-0885-22 Chartwell 200 ml — AA FDA listed —
Lacosamide 50 mg/5mL 68094-0076-62 Precision 10 cups — AA FDA listed —
Lacosamide 100 mg/10mL 68094-0176-62 Precision 10 cups — AA FDA listed —
Lacosamide Oral Solution 10 mg/mL 68999-0885-23 Chartwell 10 cups — AA FDA listed —
Lacosamide 10 mg/mL 72162-2637-02 Bryant 200 ml — AA FDA listed —
Lacosamide Oral Solution 10 mg/mL 81033-0427-14 Kesin 10 cups — AA FDA listed —
Lacosamide 10 mg/mL 85742-0014-13 Kanchan 200 ml — AA 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
Aug 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.

What it looks like

Color yellow
FlavorCherry
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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 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

LabelerPAI Holdings, LLC dba PAI Pharma
Application holderNOVITIUM PHARMA LLC
FDA applicationANDA216151 (ANDA)
Labeler code00121
First marketedAug 2022
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio142 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 73 words ▾

1 INDICATIONS AND USAGE Lacosamide is indicated for: Treatment of partial-onset seizures in patients 4 years of age and older (1.1)

1.1Partial-Onset Seizures Lacosamide is 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) oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & ADMINISTRATION Adults (17 years and older): Initial dosage for monotherapy for the treatment of partial-onset seizures is 100 mg twice daily ( 2.1 ) Initial dosage for adjunctive therapy for the treatment of partial-onset seizures is 50 mg twice daily ( 2.1 ) 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 ( 2.3 , 12.3 ) Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended ( 2.4 , 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 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* 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) Alternate Initial Dosage: 200 mg single loading dose, followed 12 hours later by 100 mg twice daily Pediatric patients weighing 50 kg or more 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) 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. † 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 oral solution 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 oral solution 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 [ see Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ]. The use of a loading dose in pediatric patients has not been studied. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT® (lacosamide) oral solution.

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

2.2Converting From a Single Antiepileptic (AED) to Lacosam… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS & STRENGTHS Lacosamide Oral Solution, USP 10 mg/mL 10 mg/mL: Clear colorless, cherry flavored solution, free from visible particulate matter. 10 mg/mL oral solution (3)

⛔ Contraindications 8 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 oral solution 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 oral solution may cause syncope ( 5.4 ) Lacosamide oral solution 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 oral solution, 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 2 shows absolute and relative risk by indication for all evaluated AEDs.

Table 2: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1,000 Patients Epilepsy 1.0 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1.0 1.8 1.9

0.9Total 2.4 4.3 1.8

1.9The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar. Anyone considering prescribing lacosamide oral solution 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 oral soluti… [Excerpted — this section continues on DailyMed.]

🤒 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 Pharmaceutical Associates at 1-800-845-8210 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 Oral Solution in Adults In the premarketing development of adjunctive therapy for partial-onset seizures, 1,327 adult patients received lacosamide tablets in controlled and uncontrolled trials, of whom 1,000 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 oral solution 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 oral solution) 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 oral solution 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 oral solution and greater than placebo) leading to discontinuation were dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and blurred vision. Table 3 gives the incidence of adverse reactions that occurred in ≥2% of adult patients with partial-onset seizures in the lacosamide oral solution total group and for which the incidence was greater than placebo. Table 3: 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 Oral Solution 200 mg/day N=270% Lacosamide Oral Solution 400 mg/d… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 145 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 oral solution. 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 oral solution, and after lacosamide oral solution 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 )

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 oral solution, during pregnancy. Encourage women who are taking lacomsamide oral solution 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 There are no adequate data on the developmental risks associated with the use of lacosamide oral solution in pregnant women.

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) .

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 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 There are no data on the presence of lacosamide in human milk, the effects on the breastfed infant, or the effects on milk production. Studies in lactating rats have shown excretion of lacosamide and/or its metabolites in milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide oral solution and any potential adverse effects on the breastfed infant from lacosamide oral solution or from the underlying maternal condition.

8.4Pediatric Use Partial-Onset Seizures Safety and effectiveness of lacosamide oral solution for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of… [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 antiepileptic drugs (AEDs), such as lacosamide oral solution, during pregnancy. Encourage women who are taking lacomsamide oral solution 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 There are no adequate data on the developmental risks associated with the use of lacosamide oral solution in pregnant women.

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) .

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 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 ~1 min read ▾

8.4Pediatric Use Partial-Onset Seizures Safety and effectiveness of lacosamide oral solution 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 oral solution in this age group is supported by evidence from adequate and well- controlled studies of lacosamide oral solution 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), 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. 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) oral solution.

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

🧓 Geriatric Use 93 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 oral solution 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 , 2.3 , 2.4 ) and Clinical Pharmacology ( 12.3 ) ].

🆘 Overdosage 156 words ▾

10 OVERDOSAGE Events reported after an intake of more than 800 mg (twice the maximum recommended daily dosage) of lacosamide oral solution 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 oral solution. 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 oral solution. Standard hemodialysis procedures result in significant clearance of lacosamide oral solution (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 oral solution 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 oral solution were determined in a double-blind, randomized clinical pharmacology trial of 247 healthy subjects. Chronic oral doses of 400 and 800 mg/day were compared with placebo and a positive control (400 mg moxifloxacin). Lacosamide oral solution did not prolong QTc interval and did not have a dose-related or clinically important effect on QRS duration.

Lacosamide oral solution 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 oral solution 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 oral solution 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 oral solution are similar in healthy subjects, patients with partial-onset seizures, and patients with primary generalized tonic-clonic seizures. Lacosamide oral solution 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 oral solution 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 oral solution 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. After intravenous administration, C max is reached at the end of infusion. The 30- and 60-minute intravenous infusions are bioequivalent to the oral tablet.

For the 15-minute intravenous infusion, bioequivalence was met for AUC (0-tz) but not for C max . The point estimate of C max was 20% higher than C max for oral tablet and the 90% CI for C max exceeded the upper boundary of the bioequivalence range. 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 oral solution i… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 52 words ▾

12.1Mechanism of Action The precise mechanism by which lacosamide oral solution 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 193 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Lacosamide Oral Solution, USP 10 mg/mL 10 mg/mL is a clear colorless, cherry flavored solution, free from visible particulate matter. It is supplied as follows: NDC 0121-1012-05: 5 mL unit dose cup. Case contains 10 unit dose cups of 5 mL (NDC 0121-1012-95), packaged in 1 tray of 10 unit dose cups each.

NDC 0121-2024-10: 10 mL unit dose cup. Case contains 10 unit dose cups of 10 mL (NDC 0121-2024-95), packaged in 1 tray of 10 unit dose cups each. NDC 0121-3036-15: 15 mL unit dose cup.

Case contains 10 unit dose cups of 15 mL (NDC 0121-3036-95), packaged in 1 tray of 10 unit dose cups each. NDC 0121-4048-74: 20 mL unit dose cup. Case contains 10 unit dose cups of 20 mL (NDC 0121-4048-95), packaged in 1 tray of 10 unit dose cups each.

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze lacosamide oral solution. Discard any unused lacosamide oral solution remaining after seven (7) weeks of first opening the bottle.

📋 Description 125 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 light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile, and practically insoluble in heptane. laco-structure

11.3Lacosamide Oral Solution, USP Lacosamide oral solution, USP 10 mg/mL contains 10 mg of lacosamide, USP per mL. The inactive ingredients are purified water, methyl paraben, polyethylene glycol, non-crystallizing sorbitol solution, glycerin, sodium carboxymethyl cellulose, acesulfame potassium, anhydrous citric acid, sodium chloride, artificial cherry flavour (including flavoring ingredients and alcohol).

💬 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 accessed by calling 1-800-845-8210. Suicidal Thinking and Behavior Patients, their caregivers, and families should be counseled that AEDs, including lacosamide oral solution, 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 oral solution use may cause dizziness, double vision, abnormal coordination and balance, and somnolence. Patients taking lacosamide oral solution 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 oral solution [ see Warnings and Precautions ( 5.2 ) ].

Cardiac Rhythm and Conduction Abnormalities Patients should be counseled that lacosamide oral solution 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 oral solution may cause serious hypersensitivity reactions affecting multiple organs such as the liver and kidney.

Lacosamide oral solution 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 oral solution 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 ) ]. All trademarks are the property of their respective owners.

DISTRIBUTED BY: Issued: 12/2022 logo

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Lacosamide (la-KOE-sa-mide) Oral Solution, USP CV Read this Medication Guide before you start taking lacosamide oral solution and each time you get a refill. There may be new information. This Medication Guide describes important safety information about lacosamide oral solution.

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 oral solution? Do not stop taking lacosamide oral solution without first talking to your healthcare provider.

Stopping lacosamide oral solution 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 oral solution can cause serious side effects, including: 1.

Like other antiepileptic drugs, lacosamide oral solution 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 oral solution 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 oral solution affects you. 3. Lacosamide oral solution 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 oral solution is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your lacosamide oral solution in a safe place, to protect it from theft. Never give your lacosamide oral solution to anyone else, because it may harm them.

Selling or giving away this medicine is against the law. What is lacosamide oral solution? Lacosamide oral solution is a prescription medicine used: • to treat partial-onset seizures in people 4 years of age and older.

It is not known if lacosamide oral solution is safe and effective for partial-onset seizures in children under 1 month of age. What should I tell my healthcare provider before taking lacosamide oral solution? Before you take lacosamide oral solution, 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.

It is not known if lacosamide can harm your unborn baby. Tell your healthcare provider right a… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of lacosamide oral solution 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 oral solution are similar in healthy subjects, patients with partial-onset seizures, and patients with primary generalized tonic-clonic seizures. Lacosamide oral solution 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 oral solution 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 oral solution 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. After intravenous administration, C max is reached at the end of infusion. The 30- and 60-minute intravenous infusions are bioequivalent to the oral tablet.

For the 15-minute intravenous infusion, bioequivalence was met for AUC (0-tz) but not for C max . The point estimate of C max was 20% higher than C max for oral tablet and the 90% CI for C max exceeded the upper boundary of the bioequivalence range. 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 oral solution is less than 15% bound to plasma proteins. Metabolism and Elimination Lacosamide oral solution 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 structurally unknown polar fraction (~20%). The plasma exposure of the major human metabolite, O­ desmethyl-lacosamide, is approximately 10% of that of lacosamide.

This metabolite has no known pharmacological activity. The CYP isoforms mainly responsible for the formation of the major metabolite (O-desmethyl) are CYP3A4, CYP2C9, and CYP2C19. The elimination half-life of the unchanged drug is approximately 13 hours and is not altered by different doses, multiple dosing or intravenous administration.

There is no enantiomeric interconversion of lacosamide. Specific Populations Renal Impairment Lacosamide and its major metabolite are eliminated from the systemic circulation primarily by renal excretion. The AUC of lacosamide oral solution was increased approximately 25% in mildly (CL CR 50 to 80 mL/min) and moderately (CL CR 30 to 50 mL/min) and 60% in severely (CL CR ≤30 mL/min) renally impaired patients compared to subjects with normal renal function (CL CR >80 mL/min), whereas C max was unaffected.

Lacosamide oral solution is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, AUC of lacosamide oral solution is reduced by approximately 50% [ see Dosage and Administration ( 2.3 ) ]. Hepatic Impairment Lacosamide undergoes metabolis… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 202 words ▾

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 oral solution were determined in a double-blind, randomized clinical pharmacology trial of 247 healthy subjects. Chronic oral doses of 400 and 800 mg/day were compared with placebo and a positive control (400 mg moxifloxacin). Lacosamide oral solution did not prolong QTc interval and did not have a dose-related or clinically important effect on QRS duration.

Lacosamide oral solution 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 oral solution dose was 3.1 ms in patients with partial-onset seizures and 9.4 ms for patients with diabetic neuropathy.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Monotherapy in Patients with Partial-Onset Seizures The efficacy of lacosamide oral solution in monotherapy was established in a historical-control, multicenter, randomized trial that included 425 patients, age 16 to 70 years, with partial-onset seizures (Study 1). To be included in Study 1, patients were required to be taking stable doses of 1 or 2 marketed antiepileptic drugs. This treatment continued into the 8 week baseline period.

To remain in the study, patients were required to have at least 2 partial-onset seizures per 28 days during the 8 week baseline period. The baseline period was followed by a 3 week titration period, during which lacosamide oral solution was added to the ongoing antiepileptic regimen. This was followed by a 16-­week maintenance period (i.e., a 6-week withdrawal period for background antiepileptic drugs, followed by a 10-week monotherapy period).

Patients were randomized 3 to 1 to receive lacosamide oral solution 400 mg/day or lacosamide oral solution 300 mg/day. Treatment assignments were blinded. Response to treatment was based upon a comparison of the number of patients who met exit criteria during the maintenance phase, compared to historical controls.

The historical control consisted of a pooled analysis of the control groups from 8 studies of similar design, which utilized a sub-therapeutic dose of an antiepileptic drug. 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 lacosamide oral solution remained below the lower 95% prediction limit of 65% derived from the historical control data. The exit criteria were one or more of the following: (1) doubling of average monthly seizure frequency during any 28 consecutive days, (2) doubling of highest consecutive 2-day seizure frequency, (3) occurrence of a single generalized tonic-clonic seizure, (4) clinically significant prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator to require trial discontinuation, (5) status epilepticus or new onset of serial/cluster seizures.

The study population profile appeared comparable to that of the historical control population. For the lacosamide oral solution 400 mg/day group, the estimate of the percentage of patients meeting at least 1 exit criterion was 30% (95% CI: 25%, 36%). The upper limit of the 2-sided 95% CI (36%) was below the threshold of 65% derived from the historical control data, meeting the pre-specified criteria for efficacy.

Lacosamide oral solution 300 mg/day also met the pre-specified criteria for efficacy.

14.2Adjunctive Therapy in Patients with Partial-Onset Seizures The efficacy of lacosamide oral solution as adjunctive therapy in partial-onset seizures was established in three 12-week, randomized, double-blind, placebo-controlled, multicenter trials in adult patients (Study 2, Study 3, and Study 4). Enrolled patients 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 3 trials, patients had a mean duration of epilepsy of 24 years and a median baseline seizure frequency ranging from 10 to 17 per 28 days. 84% of patients were taking 2 to 3 concomitant AEDs with or without concurrent vagal nerve stimulation. Study 2 compared doses of lacosamide oral solution 200, 400, and 600 mg/day with placebo.

Study 3 compared doses of lacosamide oral solution 400 and 600 mg/day with placebo. Study 4 compared doses of lacosamide oral solution 200 and 400 mg/day with placebo. In all three trials, following an 8-week baseline phase to establish baseline seizure frequency prior to randomization, patients were… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 204 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Lacosamide is a Schedule V controlled substance.

9.2Abuse In a human abuse potential study, single doses of 200 mg and 800 mg lacosamide produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a Schedule IV drug. The duration of the euphoria-type responses following lacosamide was less than that following alprazolam. A high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300 to 800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%).

However, the rate of euphoria reported as an adverse event in the lacosamide oral solution development program at therapeutic doses was less than 1%.

9.3Dependence Abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. However, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans.

🔒 Controlled Substance 10 words ▾

9.1Controlled Substance Lacosamide is a Schedule V controlled substance.

🧪 Nonclinical Toxicology 129 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis There was no evidence of drug related carcinogenicity in mice or rats. Mice and rats received lacosamide once daily by oral administration for 104 weeks at doses producing plasma exposures (AUC) up to approximately 1 and 3 times, respectively, the plasma AUC in humans at the maximum recommended human dose (MRHD) of 400 mg/day. Mutagenesis Lacosamide was negative in an in vitro Ames test and an in vivo mouse micronucleus assay.

Lacosamide induced a positive response in the in vitro mouse lymphoma assay. Fertility No adverse effects on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the MRHD.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 126 words ▾

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis There was no evidence of drug related carcinogenicity in mice or rats. Mice and rats received lacosamide once daily by oral administration for 104 weeks at doses producing plasma exposures (AUC) up to approximately 1 and 3 times, respectively, the plasma AUC in humans at the maximum recommended human dose (MRHD) of 400 mg/day. Mutagenesis Lacosamide was negative in an in vitro Ames test and an in vivo mouse micronucleus assay.

Lacosamide induced a positive response in the in vitro mouse lymphoma assay. Fertility No adverse effects on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the MRHD.

📄 Recent Major Changes 27 words ▾

Indications and Usage ( 1.1 , 1.2 ) 10/2021 Dosage and Administration ( 2.1 , 2.5 , 2.6 ) 10/2021 Warnings and Precautions ( 5.2 ) 11/2020

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Delivers 5 mL NDC 0121-1012-05 Lacosamide Oral Solution USP CV 50 mg/5 mL Package Not Child-Resistant Rx ONLY PKG. by: PAI Pharma Greenville, SC 29605 SEE INSERT A1012051222 5 mL

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Delivers 10 mL NDC 0121-2024-10 Lacosamide Oral Solution USP CV 100 mg/10 mL Package Not Child-Resistant Rx ONLY PKG. by: PAI Pharma Greenville, SC 29605 SEE INSERT A1012101222 5 mL

PRINCIPAL DISPLAY PANEL - 15 mL Unit Dose Cup Delivers 15 mL NDC 0121-3036-15 Lacosamide Oral Solution USP CV 150 mg/15 mL Package Not Child-Resistant Rx ONLY PKG. by: PAI Pharma Greenville, SC 29605 SEE INSERT A1012151222 15 mL

PRINCIPAL DISPLAY PANEL - 20 mL Unit Dose Cup Delivers 20 mL NDC 0121-4048-74 Lacosamide Oral Solution USP CV 200 mg/20 mL Package Not Child-Resistant Rx ONLY PKG. by: PAI Pharma Greenville, SC 29605 SEE INSERT A1012151222 20 mL

PRINCIPAL DISPLAY PANEL - 50 mg/5 mL Delivers 5 mL NDC 0121-0992-05 Lacosamide Oral Solution USP CV 50 mg/5 mL Package Not Child-Resistant Rx ONLY PKG. by: PAI Pharma Greenville, SC 29605 Lacosamide Oral Solution 50 mg/5 mL

PRINCIPAL DISPLAY PANEL - 100 mg/10 mL Delivers 10 mL NDC 0121-1984-10 Lacosamide Oral Solution USP CV 100 mg/10 mL Package Not Child-Resistant Rx ONLY PKG. by: PAI Pharma Greenville, SC 29605 Lacosamide Oral Solution 100 mg/10 mL

PRINCIPAL DISPLAY PANEL - 150 mg/15 mL Delivers 15 mL NDC 0121-2976-15 Lacosamide Oral Solution USP CV 150 mg/15 mL Package Not Child-Resistant Rx ONLY PKG. by: PAI Pharma Greenville, SC 29605 Lacosamide Oral Solution 150 mg/15 mL

PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Delivers 20 mL NDC 0121-3968-74 Lacosamide Oral Solution USP CV 200 mg/20 mL Package Not Child-Resistant Rx ONLY PKG. by: PAI Pharma Greenville, SC 29605 Lacosamide Oral Solution 200 mg/20 mL

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 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 PAI Holdings, LLC dba PAI Pharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PAI Holdings, LLC dba PAI Pharma 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.
← 00121-1971-00 · PAI 00121-2036-30 · PAI →
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.