Mediclarum
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Lacosamide

200 mg/20mL · Solution

  • Prescription only
  • Controlled substance · CV
Active substance
Lacosamide
Made by
PAI Holdings, LLC dba PAI Pharma

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-05-30

Used for
  • Treatment of partial-onset seizures in patients 4 years of age and older (1.1)
The label’s usual adult dose

100 mg twice daily (200 mg per day) Adjunctive Therapy:

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:

Full directions ↓
Do not take it if

None . None ( 4 )

All warnings ↓
Good to know
  • Prescription only
  • Controlled substance (schedule V) — extra rules apply to prescribing and refills
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
156other products contain Lacosamide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Lacosamide is indicated for:

  • Treatment of partial-onset seizures in patients 4 years of age and older (1.1)
  • 1.1 Partial-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.

From the official label · 2024-05-30 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Half-life13 h
Mostly cleared after≈ 3 daysfive half-lives — our arithmetic
How the body breaks it down

Drug Interactions In Vitro Assessment of Drug Interactions In vitro metabolism studies indicate that lacosamide does not induce the enzyme activity of drug metabolizing cytochrome P450 isoforms CYP1A2, 2B6, 2C9, 2C19 and 3A4.

How it leaves the body

Metabolism and Elimination Lacosamide oral solution is primarily eliminated from the systemic circulation by renal excretion and biotransformation.

With food

Food does not affect the rate and extent of absorption.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-05-30

Do not take it if

None . None ( 4 )

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 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 )
  • 2.1 Dosage 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.
  • 2.2 Converting From a Single Antiepileptic (AED) to Lacosamide Oral Solution Monotherapy for the Treatment of Partial-Onset Seizures For patients who are already on a single AED and will convert to lacosamide oral solution monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide oral solution 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.
  • 2.3 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, the dose titration should be performed with caution.
  • Hemodialysis Lacosamide oral solution is 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 ) ].
  • 2.4 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 titration should be performed with caution in patients with hepatic impairment.
  • Lacosamide oral solution 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 ) ].
  • 2.5 Administration Instructions for Lacosamide Oral Solution Lacosamide oral solution may be taken with or without food.
  • Lacosamide Oral Solution A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately.
  • A household teaspoon or tablespoon is not an adequate measuring device.
  • Lacosamide oral solution may also be administered using a nasogastric tube or gastrostomy tube.
  • Discard any unused Lacosamide oral solution remaining after 6 months of first opening the bottle.
  • 2.7 Discontinuation of Lacosamide Oral Solution When discontinuing Lacosamide oral solution, 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

  • 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 )
  • 5.1 Suicidal 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
  • 2.4 Psychiatric 5.7 8.5 1.5
  • 2.9 Other 1.0 1.8 1.9
  • 0.9 Total 2.4 4.3 1.8
  • 1.9 The 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.
  • 5.2 Dizziness and Ataxia Lacosamide oral solution may cause dizziness and ataxia in adult and pediatric patients.
  • In adult patients with partial-onset seizures taking 1 to 3 concomitant AEDs, dizziness was experienced by 25% of patients randomized to the recommended doses (200 to 400 mg/day) of lacosamide oral solution (compared with 8% of placebo patients) and was the adverse event most frequently leading to discontinuation (3%).
  • Ataxia was experienced by 6% of patients randomized to the recommended doses (200 to 400 mg/day) of lacosamide oral solution (compared to 2% of placebo patients).
  • The onset of dizziness and ataxia was most commonly observed during titration.
  • There was a substantial increase in these adverse events at doses higher than 400 mg/day [ see Adverse Reactions ( 6.1 ) ].
  • 5.3 Cardiac Rhythm and Conduction Abnormalities PR Interval Prolongation, Atrioventricular Block, and Ventricular Tachyarrhythmia Dose-dependent prolongations in PR interval with lacosamide oral solution have been observed in clinical studies in adult patients and in healthy volunteers [ see Clinical Pharmacology ( 12.2 ) ].
  • In adjunctive clinical trials in adult patients with partial-onset seizures, asymptomatic first-degree atrioventricular (AV) block was observed as an adverse reaction in 0.4% (4/944) of patients randomized to receive lacosamide oral solution and 0% (0/364) of patients randomized to receive placebo.
  • One case of profound bradycardia was observed in a patient during a 15-minute infusion of 150 mg lacosamide oral solution.
  • When lacosamide oral solution is given with other drugs that prolong the PR interval, further PR prolongation is possible.
  • In the postmarketing setting, there have been reports of cardiac arrhythmias in patients treated with lacosamide oral solution, including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death.
  • Most, although not all, cases have occurred in patients with underlying proarrhythmic conditions, or in those taking concomitant medications that affect cardiac conduction or prolong the PR interval.
  • These events have occurred with both oral and intravenous routes of administration and at prescribed doses as well as in the setting of overdose [ see Overdosage ( 10 ) ].
  • Lacosamide oral solution should be used with caution in patients with underlying proarrhythmic conditions such as known cardiac conduction problems (e.g., marked first-degree AV block, second-degree or higher AV block and sick sinus syndrome without pacemaker), severe cardiac disease (such as myocardial ischemia or heart failure, or structural heart disease), and cardiac sodium channelopathies (e.g., Brugada Syndrome).
  • Lacosamide oral solution should also be used with caution in patients on concomitant medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval [ see Drug Interactions ( 7.2 ) ].
  • In such patients, obtaining an ECG before beginning lacosamide oral solution, and after lacosamide oral solution is titrated to steady-state maintenance dose, is recommended.
  • In addition, these patients should be closely monitored if they are administered lacosamide through the intravenous route [ see Adverse Reactions ( 6.1 ) and Drug Interactions ( 7.2 ) ] .
  • Atrial Fibrillation and Atrial Flutter In the short-term investigational trials of lacosamide oral solution in adult patients with partial-onset seizures there were no cases of atrial fibrillation or flutter.
  • Both atrial fibrillation and atrial flutter have been reported in open label partial-onset seizure trials and in postmarketing experience.
  • In adult patients with diabetic neuropathy, for which lacosamide oral solution is not indicated, 0.5% of patients treated with lacosamide oral solution experienced an adverse reaction of atrial fibrillation or atrial flutter, compared to 0% of placebo-treated patients.
  • Lacosamide oral solution administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease.
  • 5.4 Syncope In the short-term controlled trials of lacosamide oral solution in adult patients with partial-onset seizures with no significant system illnesses, there was no increase in syncope compared to placebo.
  • In the short-term controlled trials in adult patients with diabetic neuropathy, for which lacosamide oral solution is not indicated, 1.2% of patients who were treated with lacosamide oral solution reported an adverse reaction of syncope or loss of consciousness, compared with 0% of placebo- treated patients with diabetic neuropathy.
  • Most of the cases of syncope were observed in patients receiving doses above 400 mg/day.
  • The cause of syncope was not determined in most cases.
  • However, several were associated with either changes in orthostatic blood pressure, atrial flutter/fibrillation (and associated tachycardia), or bradycardia.
  • Cases of syncope have also been observed in open-label clinical partial-onset seizure studies in adult and pediatric patients.
  • These cases were associated with a history of risk factors for cardiac disease and the use of drugs that slow AV conduction.
  • 5.5 Withdrawal of Antiepileptic Drugs (AEDs) As with all AEDs, lacosamide oral solution should be withdrawn gradually (over a minimum of 1 week) to minimize the potential of increased seizure frequency in patients with seizure disorders.
  • 5.6 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, has been reported in patients taking antiepileptic drugs, including lacosamide oral solution.
  • Some of these events have been fatal or life-threatening.
  • DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection.
  • Eosinophilia is often present.
  • This disorder is variable in its expression, and other organ systems not noted here may be involved.
  • It is important to note that early manifestations of hypersensitivity (e.g., fever, lymphadenopathy) may be present even though rash is not evident.
  • If such signs or symptoms are present, the patient should be evaluated immediately.
  • Lacosamide oral solution should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • 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.
  • IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )
  • 8.1 Pregnancy 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.
  • 8.2 Lactation 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.
  • 8.4 Pediatric 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.
  • 8.5 Geriatric 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 ) ].
  • Renal Impairment Based on data in
  • adults, no dose adjustment is necessary in adult and pediatric patients with mild to moderate renal impairment (CL CR ≥30 mL/min).
  • In adult and pediatric patients with severe renal impairment (CL CR <30 mL/min) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended [ see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 ) ].
  • In all patients with renal impairment, dose titration should be performed with caution.
  • Lacosamide oral solution is effectively removed from plasma by hemodialysis.
  • Dosage supplementation of up to 50% following hemodialysis should be considered.
  • Hepatic Impairment Based on data in
  • adults, for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended.
  • Patients with mild to moderate hepatic impairment should be observed closely during dose titration [ see Dosage and Administration ( 2.4 ), Clinical Pharmacology ( 12.3 ) ].
  • The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment.
  • Lacosamide oral solution use is not recommended in patients with severe hepatic impairment.

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

Other medicines

  • 7.1 Strong 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.
  • 7.2 Concomitant 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 ) ].

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.

  • 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.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

  • 9.1 Controlled Substance Lacosamide is a Schedule V controlled substance.
  • 9.2 Abuse 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%.
  • 9.3 Dependence 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.
  • Lacosamide is a Schedule V controlled substance.

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

Use in children

  • 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • 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 ) ].

Quoted from the official label, section “Geriatric Use”.

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)/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
  • 6.1 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 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/day N=471% Lacosamide Oral Solution 600 mg/day* N=203% Lacosamide Oral Solution 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 Oral Solution in Pediatric Patients Safety of lacosamide oral solution 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.
  • Laboratory Abnormalities Abnormalities in liver function tests have occurred in controlled trials with lacosamide oral solution 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 oral solution 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 oral solution 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 oral solution.
  • Other Adverse Reactions The following is a list of adverse reactions reported by patients treated with lacosamide oral solution 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) oral solution.
  • However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of lacosamide oral solution.
  • 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).
  • 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

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

Strengths and forms

  • 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)

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

What it looks like and how it is packed

  • 16.1 How 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.
  • Storage 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.

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

What is in it

  • 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
  • 11.3 Lacosamide 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).

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Sugar alcoholsnon-crystallizing sorbitol solutionSorbitol and similar can upset the stomach and matter with fructose intolerance.
  • Alcohol (ethanol)artificial cherry flavour (including flavoring ingredients and alcohol)Matters for children, in pregnancy, in recovery and with some medicines.
  • Parabensmethyl parabenPreservatives some people prefer to avoid or are sensitive to.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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European UnionNo exact match for this strength and form

Every strength and form (4)

FranceNo exact match for this strength and form

Every strength and form (47)

CanadaNo exact match for this strength and form

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NetherlandsNo exact match for this strength and form

Every strength and form (68)

Details

Made byPAI Holdings, LLC dba PAI Pharma
Active substanceLacosamide
Strength200 mg/20mL
FormSolution
RouteOral
Packs1 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE
NDC0121-4048

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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Other strengths and forms

142 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Lacosamide50 mg/5mLPrescription onlySolution PAI Holdings, LLC dba PAI Pharma · LacosamideLacosamide100 mg/10mLPrescription onlySolution PAI Holdings, LLC dba PAI Pharma · LacosamideLacosamide150 mg/15mLPrescription onlySolution PAI Holdings, LLC dba PAI Pharma · LacosamideLacosamide50 mgPrescription onlyTablet, Film Coated Major Pharmaceuticals · LacosamideLacosamide100 mgPrescription onlyTablet, Film Coated Major Pharmaceuticals · LacosamideLacosamide150 mgPrescription onlyTablet, Film Coated Major Pharmaceuticals · Lacosamide

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