Lakosamid Amarox (Lacosamide)
Antiepileptic medicine for the treatment of focal (partial-onset) seizures
Quick facts about Lakosamid Amarox
Key Takeaways About Lakosamid Amarox
- Treats focal seizures: Lakosamid Amarox is specifically approved for the treatment of focal (partial-onset) seizures with or without secondary generalization in patients aged 4 years and older
- Unique mechanism: Unlike many older antiepileptics, lacosamide works by selectively enhancing slow inactivation of sodium channels, offering a distinct therapeutic approach
- Gradual dose titration required: Treatment must be started at a low dose and increased gradually over several weeks to minimize side effects such as dizziness and nausea
- Never stop suddenly: Abrupt discontinuation can trigger dangerous breakthrough seizures; always taper under medical supervision over at least one week
- Heart monitoring may be needed: Lacosamide can prolong the PR interval on ECG, so patients with known cardiac conduction problems require careful monitoring
What Is Lakosamid Amarox and What Is It Used For?
Lakosamid Amarox is a prescription antiepileptic medicine containing lacosamide. It is used to treat focal (partial-onset) seizures in adults and children aged 4 years and older with epilepsy. It can be prescribed as a single therapy (monotherapy) or added to other antiepileptic medicines (adjunctive therapy).
Lakosamid Amarox belongs to a class of medicines known as antiepileptics or anticonvulsants. The active substance, lacosamide, was first approved by the European Medicines Agency (EMA) in 2008 and by the US Food and Drug Administration (FDA) in the same year. It has since been widely used around the world for the management of epilepsy, and generic formulations such as Lakosamid Amarox have become available as the original patent expired.
Epilepsy is a chronic neurological disorder characterized by recurrent seizures caused by abnormal electrical activity in the brain. Focal seizures, also known as partial-onset seizures, begin in a specific area of one hemisphere of the brain. They may remain localized or spread to involve both hemispheres, in which case they are termed focal to bilateral tonic-clonic seizures (previously called secondary generalization). According to the World Health Organization (WHO), approximately 50 million people worldwide live with epilepsy, making it one of the most common neurological diseases globally.
Lacosamide works through a unique mechanism of action that distinguishes it from many older antiepileptic drugs. Rather than blocking sodium channels outright as phenytoin or carbamazepine do, lacosamide selectively enhances the slow inactivation of voltage-gated sodium channels. This means it preferentially stabilizes neurons that are in a hyperexcitable state — the very neurons generating seizure activity — while having minimal effect on normal neuronal firing. This selective action is thought to contribute to its generally favorable side effect profile compared to some older antiepileptic medicines.
Clinical trials, including the pivotal Phase III studies published in peer-reviewed journals and evaluated by regulatory agencies, have demonstrated that lacosamide significantly reduces seizure frequency when used as both monotherapy and adjunctive therapy. The International League Against Epilepsy (ILAE) recognizes lacosamide as an effective treatment option for focal epilepsy.
Approved indications
- Monotherapy: Treatment of focal seizures with or without secondary generalization in adults and adolescents from 16 years of age (in some regulatory regions from 4 years)
- Adjunctive therapy: Treatment of focal seizures with or without secondary generalization in adults, adolescents, and children from 4 years of age weighing 50 kg or more
Lakosamid Amarox is not effective for all types of seizures. It is specifically indicated for focal (partial-onset) seizures and should not be used for primary generalized epilepsy syndromes such as absence seizures or juvenile myoclonic epilepsy unless directed by a specialist neurologist.
What Should You Know Before Taking Lakosamid Amarox?
Before starting Lakosamid Amarox, inform your doctor about any heart problems, liver or kidney disease, history of depression or suicidal thoughts, and all other medicines you are taking. Certain conditions and drug combinations require special caution or make this medicine unsuitable for you.
Like all prescription medicines, Lakosamid Amarox requires careful medical evaluation before it can be safely prescribed. Your doctor will consider your complete medical history, current medications, and individual risk factors to determine whether lacosamide is the right treatment choice for you. The following sections outline the most important safety considerations.
Contraindications
You must not take Lakosamid Amarox if:
- You are allergic to lacosamide or any of the other ingredients in this medicine
- You have a known second- or third-degree atrioventricular (AV) block, a serious heart conduction disorder
If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking this medicine. An electrocardiogram (ECG) may be recommended before starting treatment, particularly in patients over 65 years of age or those with a history of heart disease.
Warnings and Precautions
Tell your doctor or pharmacist before taking Lakosamid Amarox if you:
- Have any heart problems, including heart failure, a history of heart attack, or known conduction abnormalities (first-degree AV block, sick sinus syndrome without pacemaker)
- Have severe liver disease (Child-Pugh C) — lacosamide is not recommended in this case
- Have moderate to severe kidney disease — a maximum daily dose of 250 mg may apply, and dosing in patients undergoing hemodialysis requires special adjustment
- Have a history of depression, suicidal thoughts, or mood disorders — antiepileptic medicines have been associated with a small increased risk of suicidal ideation
- Are taking other medicines that prolong the PR interval on ECG, such as certain beta-blockers, calcium channel blockers, or other sodium channel-blocking antiepileptics
A small number of people being treated with antiepileptic medicines such as lacosamide have had thoughts of harming themselves or committing suicide. If you experience such thoughts at any time, contact your doctor immediately. Family members and caregivers should watch for signs of depression, unusual behavior changes, or suicidal thoughts, especially during the first months of treatment or when doses are changed.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Lakosamid Amarox is not recommended during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the fetus. Animal studies have shown reproductive toxicity at high doses, and while human data are limited, antiepileptic medicines as a class carry a potential risk of birth defects. However, uncontrolled seizures during pregnancy also pose serious risks to both the mother and the unborn child, including injury, oxygen deprivation, and premature birth.
If you are a woman of childbearing potential, your doctor will discuss effective contraception and the need for careful pregnancy planning. If you discover you are pregnant while taking Lakosamid Amarox, do not stop the medicine without consulting your doctor first, as abrupt discontinuation can trigger seizures.
It is not known whether lacosamide passes into breast milk in clinically significant amounts. Your doctor will help you weigh the benefits of breastfeeding against the potential risk to the infant and may advise monitoring the baby for sedation or feeding difficulties.
Driving and using machines
Lakosamid Amarox may cause dizziness, blurred vision, and drowsiness, particularly during the initial dose titration phase. These effects can impair your ability to drive or operate machinery safely. Do not drive or use machines until you know how this medicine affects you. Note that epilepsy itself may restrict your ability to drive in many countries — check your local regulations.
How Does Lakosamid Amarox Interact with Other Drugs?
Lakosamid Amarox has relatively few clinically significant drug interactions compared to many older antiepileptics. However, combining it with other sodium channel-blocking antiepileptics (carbamazepine, phenytoin) may increase certain side effects, and co-administration with PR interval-prolonging drugs requires cardiac monitoring.
One of the pharmacological advantages of lacosamide is its relatively clean drug interaction profile. Unlike older antiepileptic drugs such as carbamazepine, phenytoin, and phenobarbital, lacosamide does not significantly induce or inhibit the major cytochrome P450 enzyme systems (CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP3A4). This means it is less likely to alter the blood levels of other medicines you may be taking, and conversely, fewer medicines affect lacosamide levels.
Nevertheless, some interactions are clinically relevant and require your doctor's awareness:
Major Interactions
| Drug / Drug Class | Type of Interaction | Clinical Effect | Recommendation |
|---|---|---|---|
| Carbamazepine | Pharmacodynamic + Pharmacokinetic | Increased risk of CNS side effects (dizziness, diplopia); carbamazepine may modestly reduce lacosamide levels via CYP3A4 induction | Use with caution; dose adjustment of lacosamide may be needed |
| Phenytoin | Pharmacodynamic + Pharmacokinetic | Increased risk of dizziness and ataxia; phenytoin may reduce lacosamide exposure by approximately 25% | Monitor for efficacy; consider dose increase of lacosamide |
| PR-prolonging agents (beta-blockers, calcium channel blockers, digoxin) | Pharmacodynamic | Additive PR interval prolongation; increased risk of AV block, bradycardia, syncope | ECG monitoring recommended; avoid combination with second/third-degree AV block |
| Other sodium channel-blocking AEDs (oxcarbazepine, eslicarbazepine, lamotrigine) | Pharmacodynamic | Increased incidence of dizziness, diplopia, nausea, and coordination difficulties | Careful dose titration; may need to reduce dose of one or both medicines |
Minor Interactions
| Drug / Drug Class | Type of Interaction | Clinical Significance |
|---|---|---|
| Phenobarbital / Primidone | Pharmacokinetic (enzyme induction) | May modestly reduce lacosamide levels; usually not clinically significant |
| Rifampicin | Pharmacokinetic (CYP3A4 induction) | May reduce lacosamide exposure; monitor seizure control |
| Oral contraceptives | None significant | Lacosamide does not affect the efficacy of combined oral contraceptives (ethinyl estradiol, levonorgestrel) |
| Warfarin | None significant | No clinically meaningful interaction; INR monitoring as per standard practice |
| Metformin, Omeprazole | None significant | No dose adjustment needed for either medicine |
Alcohol can enhance the central nervous system depressant effects of lacosamide, increasing dizziness and drowsiness. Patients should be advised to avoid or limit alcohol consumption while taking Lakosamid Amarox. Even moderate alcohol intake can worsen balance problems and increase the risk of falls, particularly in elderly patients.
What Is the Correct Dosage of Lakosamid Amarox?
The usual starting dose for adults is 50 mg twice daily, increased weekly by 50 mg twice daily to a maintenance dose of 150–200 mg twice daily. The maximum recommended dose is 400 mg per day (200 mg twice daily). Dosage must always be determined by your doctor based on your individual circumstances.
Lakosamid Amarox should always be taken exactly as your doctor has told you. The tablets should be swallowed whole with a glass of water and can be taken with or without food. It is important to take the medicine at approximately the same times each day to maintain consistent blood levels. Treatment is typically initiated at a low dose and gradually increased (titrated) to reduce the risk of dose-related side effects.
Adults
Standard dosing for adults (aged 16 years and above)
- Starting dose: 50 mg twice daily (100 mg/day total)
- Dose titration: Increase by 50 mg twice daily at weekly intervals
- Recommended maintenance dose: 150–200 mg twice daily (300–400 mg/day)
- Maximum dose: 200 mg twice daily (400 mg/day)
In situations where rapid seizure control is needed (e.g., in a hospital setting), a single loading dose of 200 mg may be used, followed by the standard maintenance dose approximately 12 hours later. Loading doses should only be administered under medical supervision due to the increased risk of cardiac and CNS side effects.
Children and Adolescents
Dosing for children and adolescents (aged 4–17 years, weighing 50 kg or more)
- Starting dose: 50 mg twice daily (100 mg/day)
- Dose titration: Increase by 50 mg twice daily at weekly intervals
- Recommended maintenance dose: 150–200 mg twice daily (300–400 mg/day)
For children weighing less than 50 kg, an oral solution formulation of lacosamide (not this tablet form) is typically used with weight-based dosing. Consult your doctor or pediatric neurologist for appropriate dosing.
Elderly
Dosing considerations for patients aged 65 years and above
No specific dose reduction is required based on age alone. However, elderly patients are more likely to have reduced kidney function and are more susceptible to dizziness and falls. Your doctor may:
- Perform an ECG before starting treatment due to higher prevalence of cardiac conduction disorders
- Use a slower dose titration schedule
- Consider a lower maximum dose if kidney function is impaired (creatinine clearance ≤ 30 mL/min: max 250 mg/day)
- Monitor more frequently for side effects including dizziness, balance problems, and cardiac events
Patients with kidney or liver impairment
| Condition | Dose Adjustment | Maximum Daily Dose |
|---|---|---|
| Mild kidney impairment (CrCl > 50 mL/min) | No adjustment needed | 400 mg/day |
| Moderate to severe kidney impairment (CrCl ≤ 30 mL/min) | Standard titration, reduced maximum | 250 mg/day |
| Hemodialysis | Supplementary dose of up to 50% after each 4-hour dialysis session | 250 mg/day + post-dialysis supplement |
| Mild to moderate liver impairment (Child-Pugh A or B) | Caution; consider slower titration | 300 mg/day |
| Severe liver impairment (Child-Pugh C) | Not recommended | N/A |
Missed Dose
If you forget to take a dose of Lakosamid Amarox, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose. If you are unsure about what to do, contact your doctor or pharmacist.
If you have missed more than one dose, contact your doctor for advice. Consistency in taking this medicine is important because fluctuations in blood levels can increase the risk of breakthrough seizures.
Overdose
If you have taken more Lakosamid Amarox than prescribed, or if someone else has accidentally taken your medicine, seek emergency medical attention immediately. Symptoms of overdose may include severe dizziness, nausea, vomiting, seizures (paradoxically), and cardiac conduction abnormalities including AV block. Lacosamide can be removed from the body by hemodialysis (approximately 50% is removed during a 4-hour session).
What Are the Side Effects of Lakosamid Amarox?
The most common side effects of Lakosamid Amarox are dizziness, headache, nausea, and double vision (diplopia). These are usually dose-related, mild to moderate, and tend to improve during the first weeks of treatment. Serious but rare side effects include cardiac conduction disorders and severe skin reactions.
Like all medicines, Lakosamid Amarox can cause side effects, although not everybody gets them. Side effects are generally dose-dependent, meaning they are more likely at higher doses and during the initial dose titration period. Many patients find that side effects diminish or resolve entirely as the body adjusts to the medicine over the first few weeks of treatment.
The following side effects have been reported in clinical trials and post-marketing surveillance, organized by frequency according to international reporting conventions:
Very Common
- Dizziness
- Headache
- Diplopia (double vision)
- Nausea
Common
- Blurred vision
- Balance disorder / ataxia (unsteadiness)
- Memory impairment
- Cognitive disorder (difficulty thinking clearly)
- Somnolence (drowsiness)
- Tremor
- Nystagmus (involuntary eye movements)
- Vomiting
- Constipation
- Flatulence
- Pruritus (itching)
- Fatigue
- Gait disturbance (difficulty walking)
- Tinnitus (ringing in ears)
- Falls
- Depression
Uncommon
- First-degree atrioventricular (AV) block
- Abnormal liver function tests
- Hypersensitivity reactions (rash, urticaria)
- Suicidal ideation
- Hallucinations
- Confusional state
- Palpitations
- Muscle spasms
Rare
- Second- or third-degree AV block
- Severe bradycardia (very slow heart rate)
- Agranulocytosis (severe reduction in white blood cells)
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Stevens-Johnson syndrome / Toxic epidermal necrolysis
- Multiorgan hypersensitivity reaction
- Angioedema
- Atrial fibrillation or flutter
Stop taking Lakosamid Amarox and seek emergency medical attention if you experience:
- Severe skin rash, blistering, or peeling of skin (may indicate Stevens-Johnson syndrome)
- Fever with rash, swollen lymph nodes, and organ involvement (may indicate DRESS syndrome)
- Swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema)
- Very slow or irregular heartbeat, fainting, or persistent chest pain
- Thoughts of self-harm or suicide
If you experience any side effects not listed above, or if any side effects become bothersome or do not go away, talk to your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance authority to help ensure the ongoing safety monitoring of this medicine.
How Should You Store Lakosamid Amarox?
Store Lakosamid Amarox at room temperature below 30°C (86°F) in the original packaging. Keep out of reach and sight of children. Do not use the medicine after the expiry date printed on the packaging.
Proper storage of medicines is essential to maintain their effectiveness and safety throughout their shelf life. Follow these storage guidelines for Lakosamid Amarox:
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze.
- Light and moisture: Keep the tablets in the original blister pack or container to protect from moisture and light
- Children: Store in a location that is out of the reach and sight of children. Consider using a lockable medicine cabinet.
- Expiry date: Do not use this medicine after the expiry date stated on the carton and blister after "EXP." The expiry date refers to the last day of that month.
- Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures help to protect the environment.
If the tablets appear discolored, damaged, or the blister packaging is torn or tampered with, do not take the medicine. Return it to your pharmacy for safe disposal and obtain a replacement.
What Does Lakosamid Amarox Contain?
Each film-coated tablet contains 50 mg of the active substance lacosamide. The tablets also contain several inactive ingredients (excipients) that help form the tablet and its film coating.
Understanding what is in your medicine is important, particularly if you have known allergies or intolerances to specific substances. The full composition of Lakosamid Amarox 50 mg film-coated tablets is as follows:
Active ingredient
- Lacosamide – 50 mg per tablet
Lacosamide is a functionalized amino acid, chemically known as (R)-2-acetamido-N-benzyl-3-methoxypropionamide. It has a molecular formula of C13H18N2O3 and a molecular weight of 250.30 g/mol. It is a white to slightly yellow crystalline powder that is sparingly soluble in water.
Inactive ingredients (excipients)
The inactive ingredients are used for tablet formation, stability, and to create the film coating. While they have no therapeutic effect, some individuals may have sensitivities to certain excipients. Typical excipients found in lacosamide film-coated tablets include:
- Microcrystalline cellulose (tablet filler)
- Hydroxypropyl cellulose (binder)
- Crospovidone (disintegrant)
- Magnesium stearate (lubricant)
- Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG, talc, and coloring agents (varies by strength)
Lakosamid Amarox tablets do not contain lactose, gluten, or sucrose. However, if you have known hypersensitivity to any of the listed excipients, inform your doctor or pharmacist before starting this medicine. The full list of excipients can be found in the patient information leaflet supplied with your medicine.
Frequently Asked Questions About Lakosamid Amarox
Lakosamid Amarox contains lacosamide and is used to treat focal (partial-onset) seizures in adults and adolescents aged 4 years and older with epilepsy. It can be used as monotherapy (the only antiepileptic medicine) or as adjunctive therapy (added to other antiepileptic medicines). It works by stabilizing overactive nerve cells in the brain that cause seizures.
Lakosamid Amarox may cause dizziness, blurred vision, and drowsiness, which can impair your ability to drive or operate machinery. Do not drive or use machines until you know how this medicine affects you. Epilepsy itself may also restrict driving in many countries. Consult your doctor and check local regulations regarding driving with epilepsy.
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one. If you miss more than one dose, contact your doctor for advice, as inconsistent dosing can increase the risk of breakthrough seizures.
No, you should never stop taking Lakosamid Amarox suddenly without your doctor's guidance. Abrupt discontinuation of antiepileptic medicines can trigger breakthrough seizures or even status epilepticus, which can be life-threatening. If your doctor decides you should stop treatment, the dose will be gradually reduced over at least one week.
Lakosamid Amarox should not be used during pregnancy unless clearly necessary and only after your doctor has carefully weighed the benefits against the risks. Antiepileptic drugs may carry a risk of harm to the unborn baby, but uncontrolled seizures during pregnancy also pose serious risks. If you are pregnant or planning to become pregnant, discuss your treatment options with your neurologist. Never stop taking the medicine without medical advice.
The most common side effects are dizziness, headache, nausea, and double vision (diplopia). These are usually dose-related and tend to occur more frequently during the initial dose titration period. Most side effects are mild to moderate in severity and often improve as your body adjusts to the medication over the first few weeks.
References and Medical Sources
All information in this article is based on evidence-based international guidelines and peer-reviewed research. The following sources were used:
- European Medicines Agency (EMA). Lacosamide – Summary of Product Characteristics (SmPC). Last updated 2024. Available at: ema.europa.eu
- U.S. Food and Drug Administration (FDA). Vimpat (lacosamide) – Prescribing Information. Revised 2024. Available at: fda.gov
- World Health Organization (WHO). Epilepsy Fact Sheet. 2024. Available at: who.int
- National Institute for Health and Care Excellence (NICE). Epilepsies in children, young people and adults. NICE guideline [NG217]. Updated 2024. Available at: nice.org.uk
- Halász P, Kälviäinen R, Mazurkiewicz-Beldzińska M, et al. Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009;50(3):443-453. doi:10.1111/j.1528-1167.2008.01951.x
- Wechsler RT, Li G, French J, et al. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: Results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014;55(7):1088-1098. doi:10.1111/epi.12681
- Ben-Menachem E, Biton V, Jatuzis D, et al. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007;48(7):1308-1317. doi:10.1111/j.1528-1167.2007.01188.x
- International League Against Epilepsy (ILAE). Updated classification and management of seizures and epilepsy. 2022.
- British National Formulary (BNF). Lacosamide monograph. Updated 2025. Available at: bnf.nice.org.uk
- Beydoun A, D'Souza J, Hebert D, Doty P. Lacosamide: pharmacology, mechanisms of action, and pooled efficacy and safety data in partial-onset seizures. Expert Review of Neurotherapeutics. 2009;9(1):33-42. doi:10.1586/14737175.9.1.33
Editorial Team
This article was written and medically reviewed by the iMedic Medical Editorial Team, comprising licensed physicians, pharmacologists, and medical writers with expertise in neurology and clinical pharmacology.
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