Lacosamide

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 or primary generalized tonic-clonic 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.
• (2.4, 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)
• 2.1 Dosage Information The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures 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) 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) ] .
• 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.
• 2.2 Alternate Initial Dosage Information to Achieve the Maintenance Dosage in a Shorter Timeframe For monotherapy and adjunctive therapy for partial-onset seizures and for adjunctive therapy for primary generalized tonic-clonic seizures in patients 17 years of age and older, an alternate initial dosing regimen for week 1 (e.g., including a loading dose and/or a higher initial dosage) may be administered in patients for whom achieving the recommended maintenance dosage in a shorter timeframe is clinically indicated (see Table 2).
• The alternate initial dosage regimen should be continued for one week.
• Lacosamide tablets may then be titrated based on clinical response and tolerability, no more frequently than once per week, if needed.
• The loading dose should be administered with medical supervision because of the possibility of increased incidence of adverse reactions, including central nervous system (CNS) and cardiovascular adverse reactions [see Warnings and Precautions (5.2 , 5.3) , Adverse Reactions (6.1) , and Clinical Pharmacology (12.3) ] .
• Titration increments should not exceed those shown in Table 2.
• Table 2:
• Alternate Initial Dosing Regimen to Achieve the Maintenance Dosage in a Shorter Timeframe if Clinically Indicated * Age and Body Weight Alternate Initial Dosage Titration Regimen Maintenance Dosage
• Adults (17 years and older) Single loading dose:
• 200 mg 12 hours later initiate:
• 100 mg twice daily (200 mg per day) Increase by 50 mg twice daily (100 mg per day) at weekly intervals, if needed 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) * 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.
• 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.
• 2.3 Converting From a Single Antiepileptic (AED) to Lacosamide Tablets Monotherapy for the Treatment of Partial-Onset Seizures For patients who are already on a single AED and will convert to lacosamide tablets monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide tablets is achieved and has been administered for at least 3 days.
• A gradual withdrawal of the concomitant AED over at least 6 weeks is recommended.
• 2.4 Dosage Information for Patients with Renal Impairment For patients with mild to moderate renal impairment, no dosage adjustment is necessary.
• For patients with severe renal impairment [creatinine clearance (CL CR ) less than 30 mL/min as estimated by the Cockcroft-Gault equation for
• adults;
• CL CR less than 30 mL/min/1.73m 2 as estimated by the Schwartz equation for pediatric patients] or end-stage renal disease, a reduction of 25% of the maximum dosage is recommended.
• In all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability.
• Hemodialysis Lacosamide tablets are effectively removed from plasma by hemodialysis.
• Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered.
• Concomitant Strong CYP3A4 or CYP2C9 Inhibitors Dose reduction may be necessary in patients with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 [see Drug Interactions (7.1) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] .
• 2.5 Dosage Information for Patients with Hepatic Impairment For patients with mild or moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended.
• The dose initiation and titration should be based on clinical response and tolerability in patients with hepatic impairment.
• Lacosamide tablets use is not recommended in patients with severe hepatic impairment.
• Concomitant Strong CYP3A4 and CYP2C9 Inhibitors Dose reduction may be necessary in patients with hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 [see Drug Interactions (7.1) , Use in Specific Populations (8.7) , and Clinical Pharmacology (12.3) ] .
• 2.6 Administration Instructions for Lacosamide Tablets Lacosamide tablets may be taken with or without food.
• Lacosamide tablets should be swallowed whole with liquid.
• Do not divide lacosamide tablets.
• 2.8 Discontinuation of Lacosamide Tablets When discontinuing lacosamide tablets, a gradual withdrawal over at least 1 week is recommended [see Warnings and Precautions (5.5) ] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Side effects

• 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)/Multi-Organ 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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 Clinical 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, 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 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 post-marketing 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 disorders Diplopia 2 6 10 16 11 Blurred Vision 3 2 9 16 8 Gastrointestinal disorders Nausea 4 7 11 17 11 Vomiting 3 6 9 16 9 Diarrhea 3 3 5 4 4 General disorders and administration site conditions Fatigue 6 7 7 15 9 Gait disturbance < 1 < 1 2 4 2 Asthenia 1 2 2 4 2 Injury, poisoning and procedural complications Contusion 3 3 4 2 3 Skin laceration 2 2 3 3 3 Nervous system disorders Dizziness 8 16 30 53 31 Headache 9 11 14 12 13 Ataxia 2 4 7 15 8 Somnolence 5 5 8 8 7 Tremor 4 4 6 12 7 Nystagmus 4 2 5 10 5 Balance disorder 0 1 5 6 4 Memory impairment 2 1 2 6 2 Psychiatric disorders Depression 1 2 2 2 2 Skin and subcutaneous disorders Pruritus 1 3 2 3 2 *600 mg dose is 1.5 times greater than the maximum recommended dose.
• The overall adverse reaction rate was similar in male and female patients.
• Although there were few non-Caucasian patients, no differences in the incidences of adverse reactions compared to Caucasian patients were observed.
• Lacosamide Tablets in Pediatric Patients Safety of lacosamide was evaluated in clinical studies of pediatric patients 4 to less than 17 years of age for the treatment of partial-onset seizures.
• Across studies in pediatric patients with partial-onset seizures, 328 patients 4 to less than 17 years of age received lacosamide oral solution or tablet, of whom 148 received lacosamide for at least 1 year.
• Adverse reactions reported in clinical studies of pediatric patients 4 to less than 17 years of age were similar to those seen in adult patients.
• Primary Generalized Tonic-Clonic Seizures in Patients (4 Years of Age and Older) Adjunctive Therapy Trial (Study 5) In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, adverse reactions that occurred in the study were generally similar to those that occurred in partial-onset seizure placebo-controlled studies.
• The most common adverse reactions (≥ 10% on lacosamide) reported in patients treated with lacosamide tablets were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%), compared to 7%, 14%, 10%, and 6%, respectively, of patients who received placebo.
• Additionally, an adverse reaction not previously reported of myoclonic epilepsy was reported in 3% of patients treated with lacosamide tablets compared to 1% of patients who received placebo.
• It is also noted that 2 patients receiving lacosamide had acute worsening of seizures shortly after drug initiation, including one episode of status epilepticus, compared to no patients receiving placebo.
• Laboratory Abnormalities Abnormalities in liver function tests have occurred in controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1 to 3 concomitant anti-epileptic drugs.
• Elevations of ALT to ≥ 3x ULN occurred in 0.7% (7/935) of lacosamide patients and 0% (0/356) of placebo patients.
• One case of hepatitis with transaminases > 20x ULN occurred in one healthy subject 10 days after lacosamide treatment completion, along with nephritis (proteinuria and urine casts).
• Serologic studies were negative for viral hepatitis.
• Transaminases returned to normal within one month without specific treatment.
• At the time of this event, bilirubin was normal.
• The hepatitis/nephritis was interpreted as a delayed hypersensitivity reaction to lacosamide.
• Other Adverse Reactions The following is a list of adverse reactions reported by patients treated with lacosamide in all clinical trials in adult patients, including controlled trials and long-term open-label extension trials.
• Adverse reactions addressed in other tables or sections are not listed here.
• Blood and lymphatic system disorders:
• neutropenia, anemia Cardiac disorders:
• palpitations Ear and labyrinth disorders:
• tinnitus Gastrointestinal disorders:
• constipation, dyspepsia, dry mouth, oral hypoaesthesia General disorders and administration site conditions:
• irritability, pyrexia, feeling drunk Injury, poisoning, and procedural complications:
• fall Musculoskeletal and connective tissue disorders:
• muscle spasms Nervous system disorders:
• paresthesia, cognitive disorder, hypoaesthesia, dysarthria, disturbance in attention, cerebellar syndrome Psychiatric disorders:
• confusional state, mood altered, depressed mood 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.
• 6.2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of lacosamide.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Blood and lymphatic system disorders:
• Agranulocytosis Psychiatric disorders:
• Aggression, agitation, hallucination, insomnia, psychotic disorder Skin and subcutaneous tissue disorders:
• Angioedema, rash, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis Neurologic disorders:
• Dyskinesia, new or worsening seizures

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide).
• Suicidal Thinking and Behavior Patients, their caregivers, and families should be counseled that AEDs, including lacosamide, 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 use may cause dizziness, double vision, abnormal coordination and balance, and somnolence.
• Patients taking lacosamide 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 [see Warnings and Precautions (5.2) ] .
• Cardiac Rhythm and Conduction Abnormalities Patients should be counseled that lacosamide 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 may cause serious hypersensitivity reactions affecting multiple organs such as the liver and kidney.
• Lacosamide 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 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 to monitor infants for excess sleepiness and to seek medical care if they notice this sign [see Use in Specific Populations (8.2) ].
• Manufactured by:
• Amneal Pharmaceuticals Private Limited Ahmedabad 382220, INDIA Distributed by:
• Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 05-2024-02 Dispense with Medication Guide available at:
• documents.amneal.com/mg/lacosamide-tab-in.pdf

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Lacosamide tablets, USP 50 mg :
• pink, oval shaped, film-coated tablets, debossed with "A93" on one side and plain on the other side.
• Lacosamide tablets, USP 100 mg :
• dark yellow, oval shaped, film-coated tablets, debossed with "A924" on one side and plain on the other side.
• Lacosamide tablets, USP 150 mg :
• beige, oval shaped, film-coated tablets, debossed with "A925" on one side and plain on the other side.
• Lacosamide tablets, USP 200 mg :
• blue, oval shaped, film-coated tablets, debossed with "A926" on one side and plain on the other side.
• Lacosamide tablets, USP 50 mg, 100 mg, 150 mg, 200 mg tablets.
• (3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Lacosamide tablets, USP 50 mg are supplied as pink, oval shaped, film-coated tablets debossed with "A93" on one side and plain on the other side.
• They are available as follows:
• Bottles of 60:
• NDC 53746-923-60 Bottles of 500:
• NDC 53746-923-05 Lacosamide tablets, USP 100 mg are supplied as dark yellow, oval shaped, film-coated tablets debossed with "A924" on one side and plain on the other side.
• They are available as follows:
• Bottles of 60:
• NDC 53746-924-60 Bottles of 500:
• NDC 53746-924-05 Lacosamide tablets, USP 150 mg are supplied as beige, oval shaped, film-coated tablets debossed with "A925" on one side and plain on the other side.
• They are available as follows:
• Bottles of 60:
• NDC 53746-925-60 Bottles of 500:
• NDC 53746-925-05 Lacosamide tablets, USP 200 mg are supplied as blue, oval shaped, film-coated tablets debossed with "A926" on one side and plain on the other side.
• They are supplied as follows:
• Bottles of 60:
• NDC 53746-926-60 Bottles of 500:
• NDC 53746-926-05
• Storage 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].

Quoted from the official label, section “How Supplied”.

What is in it

• The chemical name of lacosamide USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC).
• Lacosamide, USP is a functionalized amino acid.
• Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.30 g/mol.
• The chemical structure is: Lacosamide, USP is a white to light yellow powder.
• It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol. 1
• 11.1 Lacosamide Tablets Lacosamide tablets, USP for oral administration contain lacosamide, USP and the following inactive ingredients:
• colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose 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 #2, iron oxide black, iron oxide red, macrogol, polyvinyl alcohol, talc and titanium dioxide 100 mg tablets:
• iron oxide yellow, macrogol, polyvinyl alcohol, talc and titanium dioxide 150 mg tablets:
• iron oxide red, and iron oxide yellow, macrogol, polyvinyl alcohol, talc and titanium dioxide 200 mg tablets:
• FD&C Blue #2, macrogol, polyvinyl alcohol, talc and titanium dioxide

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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