Lacosamide Grindeks: Uses, Dosage & Side Effects
Antiepileptic medicine for partial-onset seizures in adults and children
Lacosamide Grindeks is a prescription antiepileptic (anticonvulsant) medicine containing the active substance lacosamide. It is used to treat partial-onset seizures (also called focal seizures) with or without secondary generalisation in adults, adolescents, and children from 2 years of age. Lacosamide works by selectively enhancing the slow inactivation of voltage-gated sodium channels, which stabilises hyperexcitable neuronal membranes and reduces pathological firing. This medication is available as 50 mg film-coated tablets and must always be taken under the supervision of a specialist physician experienced in the treatment of epilepsy.
Quick Facts
Key Takeaways
- Lacosamide Grindeks is used for partial-onset (focal) seizures in patients aged 2 years and older, either alone or with other antiepileptic medicines.
- Treatment should be started at a low dose (50 mg twice daily) and increased gradually at weekly intervals to minimise side effects.
- The most common side effects are dizziness, headache, diplopia (double vision), and nausea — these usually improve over time.
- Never stop this medicine suddenly — the dose must be tapered gradually over at least one week to avoid rebound seizures.
- Caution is required in patients with cardiac conduction disorders, as lacosamide may prolong the PR interval on ECG.
What Is Lacosamide Grindeks and What Is It Used For?
Lacosamide Grindeks belongs to the third generation of antiepileptic drugs and has a unique mechanism of action that distinguishes it from older anticonvulsants. While most traditional sodium channel blockers primarily affect the fast inactivation of voltage-gated sodium channels, lacosamide selectively enhances the slow inactivation of these channels. This means it preferentially targets hyperexcitable neurons that are firing pathologically, without significantly affecting normal neuronal activity. The result is effective seizure control with a more favourable tolerability profile compared to some older antiepileptic drugs.
Partial-onset seizures, also known as focal seizures, originate in a specific area of the brain. They are the most common seizure type in adults with epilepsy, accounting for approximately 60% of all epilepsy cases. These seizures may remain localised (focal aware seizures, previously called simple partial seizures) or spread to affect consciousness (focal impaired awareness seizures, previously called complex partial seizures). In some cases, focal seizures can evolve into bilateral tonic-clonic seizures, a process known as secondary generalisation.
The European Medicines Agency (EMA) has approved lacosamide for use as both monotherapy and adjunctive therapy. As monotherapy, it can serve as the first-line treatment for newly diagnosed partial-onset epilepsy. As add-on therapy, it provides additional seizure control when a patient's current medication regimen is insufficient. Clinical trials have demonstrated that lacosamide significantly reduces seizure frequency compared to placebo, with responder rates (50% or greater seizure reduction) ranging from 33% to 41% in pivotal phase III trials.
Lacosamide has excellent pharmacokinetic properties that make it a practical choice for patients. It has nearly 100% oral bioavailability, meaning the dose you swallow is almost completely absorbed into the bloodstream. It has a relatively long half-life of approximately 13 hours, allowing for convenient twice-daily dosing. Plasma protein binding is low (approximately 15%), which reduces the potential for protein-binding interactions with other medicines. These characteristics contribute to a predictable dose-response relationship and straightforward dosing.
Approved Indications
Lacosamide Grindeks is indicated for:
- Monotherapy for partial-onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
- Adjunctive therapy for partial-onset seizures with or without secondary generalisation in adults, adolescents, and children from 2 years of age weighing at least 8 kg.
Lacosamide Grindeks should only be prescribed by a physician experienced in the diagnosis and treatment of epilepsy. The choice of lacosamide as a treatment option should be based on individual patient factors, including seizure type, concomitant medications, and the patient's overall medical history.
What Should You Know Before Taking Lacosamide Grindeks?
Before your doctor prescribes Lacosamide Grindeks, it is important to have a thorough discussion about your medical history, current medications, and any special circumstances that may affect whether this medicine is suitable for you. As with all antiepileptic drugs, certain conditions and situations require particular caution or may make this medicine inappropriate.
Contraindications
You should not take Lacosamide Grindeks if you:
- Are allergic (hypersensitive) to lacosamide or any of the other ingredients in the tablets.
- Have a known second- or third-degree atrioventricular (AV) block, a serious heart conduction disorder that affects the electrical signals in your heart.
If you are uncertain whether either of these applies to you, speak to your doctor or pharmacist before taking Lacosamide Grindeks.
Warnings and Precautions
Talk to your doctor before taking Lacosamide Grindeks if you have or have had any of the following conditions:
- Heart conditions: Lacosamide may cause dose-dependent prolongation of the PR interval on the ECG. This means the electrical conduction in your heart may be slightly slowed. Patients with first-degree AV block, sick sinus syndrome (without a pacemaker), or other significant cardiac conditions should be carefully monitored. An ECG should be obtained before starting treatment and after reaching steady-state dosing.
- Liver problems: If you have moderate to severe liver impairment, your doctor may need to adjust your dose and monitor you more closely. A maximum dose of 300 mg/day is recommended for patients with mild to moderate hepatic impairment. Lacosamide is not recommended in patients with severe hepatic impairment.
- Kidney problems: If you have severe kidney disease (creatinine clearance below 30 ml/min), a maximum dose of 300 mg/day is recommended. Lacosamide is partly removed by haemodialysis, and supplementary dosing may be required after dialysis sessions.
- Elderly patients: Dose adjustments based on age alone are generally not required, but older patients may be more susceptible to cardiac conduction effects and side effects such as dizziness and falls.
A small number of people treated with antiepileptic medicines, including lacosamide, have experienced thoughts of self-harm or suicide. If at any point you have these thoughts, contact your doctor or go to a hospital immediately. Do not stop taking your medicine without consulting your doctor first.
Other important warnings include the risk of dizziness and somnolence, which can increase the risk of accidental injury or falls. Until you know how this medicine affects you, be cautious about driving or operating machinery. Serious skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson syndrome, have been reported rarely. If you develop a widespread rash, fever, swollen lymph nodes, or signs of organ involvement, stop taking the medicine and seek medical attention immediately.
Pregnancy and Breastfeeding
Lacosamide Grindeks is not recommended during pregnancy unless clearly necessary and the potential benefit to the mother justifies the potential risk to the foetus. Animal studies have shown reproductive toxicity, and all antiepileptic drugs carry some risk of congenital malformations. However, uncontrolled seizures during pregnancy also pose significant risks to both mother and baby, including injury, oxygen deprivation, and potential harm to the developing foetus.
Women of childbearing potential should use effective contraception during treatment. If you are planning a pregnancy, discuss this with your neurologist well in advance so that your treatment can be reviewed and optimised. It is critically important that you never stop antiepileptic medication abruptly without medical guidance, as this can lead to prolonged or repeated seizures (status epilepticus), which are life-threatening.
It is not known whether lacosamide passes into human breast milk, though it is expected to be excreted based on animal data. A decision should be made whether to discontinue breastfeeding or to discontinue the medication, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
How Does Lacosamide Grindeks Interact with Other Drugs?
One of the advantages of lacosamide compared to many traditional antiepileptic drugs is its relatively clean drug interaction profile. It does not significantly induce or inhibit the major cytochrome P450 enzymes (CYP1A2, 2B6, 2C9, 2C19, 3A4) or P-glycoprotein at therapeutic concentrations. However, some clinically relevant interactions do exist, and it is always important to inform your doctor about all medicines you are taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Carbamazepine | May reduce lacosamide plasma levels by ~25% via CYP3A4/CYP2C9 induction | Dose adjustment of lacosamide may be needed; monitor seizure control |
| Phenytoin | May reduce lacosamide plasma levels by ~25% via enzyme induction | Dose adjustment of lacosamide may be needed; monitor seizure control |
| Phenobarbital / Primidone | May reduce lacosamide levels via enzyme induction | Monitor seizure control; dose increase may be required |
| Rifampicin | Strong CYP3A4 inducer; may significantly reduce lacosamide levels | Combination not recommended; if used, close monitoring required |
| PR-prolonging drugs (beta-blockers, calcium channel blockers, digoxin) | Additive PR interval prolongation | ECG monitoring recommended; risk of AV block |
| Fluconazole (CYP2C9 inhibitor) | May increase lacosamide plasma levels | Dose reduction of lacosamide may be needed |
Minor Interactions
Lacosamide has been studied in combination with common antiepileptic drugs including levetiracetam, valproate, lamotrigine, topiramate, and oxcarbazepine without clinically significant pharmacokinetic interactions. This makes it a versatile option for adjunctive therapy, as it can typically be added to an existing regimen without the need for complex dose adjustments of concomitant medications.
Lacosamide does not appear to interact with oral contraceptives. In a dedicated interaction study, co-administration of lacosamide with a combined oral contraceptive containing ethinylestradiol and levonorgestrel did not affect the pharmacokinetics of either contraceptive component. This is an important advantage over enzyme-inducing antiepileptics such as carbamazepine, phenytoin, and phenobarbital, which can reduce the efficacy of hormonal contraceptives.
There are no clinically significant interactions between lacosamide and common cardiovascular drugs (other than those that prolong the PR interval), proton pump inhibitors, metformin, or paracetamol (acetaminophen). However, caution is advised when combining lacosamide with alcohol or other central nervous system (CNS) depressants, as additive sedative effects may occur.
What Is the Correct Dosage of Lacosamide Grindeks?
Lacosamide Grindeks must always be taken exactly as your doctor has told you. The tablets should be swallowed whole with water, and can be taken with or without food. The dose is usually divided into two equal doses taken approximately 12 hours apart (e.g., morning and evening). Maintaining a consistent dosing schedule helps keep blood levels stable and provides optimal seizure control throughout the day.
Adults and Adolescents (from 50 kg body weight)
Monotherapy (newly diagnosed epilepsy)
Starting dose: 50 mg twice daily (100 mg/day).
Titration: Increase by 50 mg twice daily at weekly intervals.
Maintenance dose: 100–200 mg twice daily (200–400 mg/day).
Maximum dose: 300 mg twice daily (600 mg/day) based on clinical response.
Adjunctive Therapy
Starting dose: 50 mg twice daily (100 mg/day).
Titration: Increase by 50 mg twice daily at weekly intervals.
Maintenance dose: 100–200 mg twice daily (200–400 mg/day).
Maximum dose: 200 mg twice daily (400 mg/day).
| Week | Morning Dose | Evening Dose | Total Daily Dose |
|---|---|---|---|
| Week 1 | 50 mg | 50 mg | 100 mg |
| Week 2 | 100 mg | 100 mg | 200 mg |
| Week 3 | 150 mg | 150 mg | 300 mg |
| Week 4 | 200 mg | 200 mg | 400 mg |
Children (aged 2 years and older, weighing less than 50 kg)
In children and adolescents weighing less than 50 kg, the dose is calculated based on body weight. The typical approach is:
Weight-based dosing for children
Starting dose: 1 mg/kg twice daily (2 mg/kg/day).
Titration: Increase by 1 mg/kg twice daily at weekly intervals.
Maintenance dose: 3–6 mg/kg twice daily (6–12 mg/kg/day).
Maximum dose: 6 mg/kg twice daily (12 mg/kg/day), not exceeding 400 mg/day.
For children under 2 years of age, the safety and efficacy of lacosamide have not been established, and it should not be used. For children who reach 50 kg body weight, they should transition to the adult fixed-dose regimen.
Elderly Patients
No dose reduction is required based on age alone. However, age-related decline in renal function should be taken into account. Elderly patients may also be more sensitive to central nervous system effects such as dizziness and somnolence, which can increase the risk of falls. In clinical practice, a slower titration schedule is often used in elderly patients, and the maintenance dose may be on the lower end of the recommended range.
Missed Dose
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you are unsure what to do, ask your doctor or pharmacist for advice. Missed doses can increase the risk of breakthrough seizures, so it is important to try to take your medicine at the same times each day.
Overdose
In clinical trials and post-marketing experience, overdose with lacosamide has been reported. Symptoms of overdose primarily involve the central nervous system and may include dizziness, nausea, vomiting, seizures (including status epilepticus), cardiac conduction disorders (including complete AV block), coma, and decreased consciousness. There is no specific antidote for lacosamide overdose. Treatment is supportive and symptomatic. Haemodialysis can effectively remove lacosamide from the blood (approximately 50% removed over 4 hours) and may be considered in severe overdose.
Never stop taking Lacosamide Grindeks suddenly without your doctor's advice. Abrupt discontinuation can lead to rebound seizures, including potentially dangerous prolonged seizures (status epilepticus). When stopping treatment, your doctor will gradually reduce your dose over a period of at least one week.
What Are the Side Effects of Lacosamide Grindeks?
Like all medicines, Lacosamide Grindeks can cause side effects, although not everybody gets them. Side effects are often dose-related, meaning they are more likely to occur at higher doses and during the dose-titration period when the body is adjusting to the medicine. Many side effects improve or resolve with continued treatment. If any side effect becomes severe or persistent, talk to your doctor about potentially adjusting your dose.
The following side effects have been reported in clinical trials and post-marketing surveillance, categorised by frequency according to the standard medical convention:
Very Common
- Dizziness
- Headache
- Diplopia (double vision)
- Nausea
Common
- Depression
- Confusion or difficulty concentrating
- Balance disorder / abnormal coordination
- Memory impairment
- Somnolence (sleepiness)
- Tremor
- Nystagmus (involuntary eye movements)
- Blurred vision
- Vertigo (spinning sensation)
- Tinnitus (ringing in the ears)
- Vomiting, constipation, flatulence, dyspepsia
- Pruritus (itching), rash
- Muscle spasms
- Gait disturbance, fatigue, asthenia (weakness)
- Falls, injection site pain/irritation (if IV form used)
Uncommon
- Hypersensitivity reactions
- Suicidal ideation or attempt
- Hallucinations, psychotic disorder
- Aggression
- Atrioventricular block (first, second, or third degree)
- Atrial fibrillation or flutter
- Bradycardia (slow heart rate)
- Abnormal liver function tests
- Angioedema
Rare
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Stevens-Johnson syndrome (SJS)
- Toxic epidermal necrolysis (TEN)
- Agranulocytosis
- Multiorgan hypersensitivity reaction
- Severe cardiac conduction disorders
The risk of cardiac conduction disorders (PR prolongation, AV block) increases at higher doses and when lacosamide is combined with other PR-prolonging medications. In clinical trials, first-degree AV block was observed in approximately 0.4% of patients on lacosamide compared to 0% on placebo. This is generally asymptomatic but may be clinically relevant in patients with pre-existing cardiac conditions.
In clinical trials, the discontinuation rate due to adverse events was approximately 8–17% for lacosamide compared to 5–10% for placebo, depending on the dose level. The adverse events most commonly leading to discontinuation were dizziness, nausea, vomiting, and diplopia.
Contact your doctor immediately if you experience: signs of a serious allergic reaction (skin rash with fever, swollen lymph nodes, facial swelling, difficulty breathing); irregular or slow heartbeat; chest pain or fainting; thoughts of self-harm; or any side effect that is severe or does not go away.
How Should You Store Lacosamide Grindeks?
Proper storage of medicines is essential to ensure they remain effective and safe throughout their shelf life. Lacosamide Grindeks film-coated tablets should be stored under the following conditions:
- Temperature: Store below 30°C (86°F). Do not freeze.
- Packaging: Keep the tablets in the original blister packaging until you are ready to take them. This protects them from moisture and light.
- Children: Keep out of the sight and reach of children. Store in a locked medicine cabinet or a high shelf if possible.
- Expiry date: Do not use this medicine after the expiry date stated on the carton and blister strip (EXP). The expiry date refers to the last day of that month.
Do not dispose of medicines in household waste or via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment and prevent accidental exposure to unused medication.
If the tablets appear discoloured, damaged, or show signs of deterioration, do not take them and consult your pharmacist. Film-coated tablets should have a uniform appearance — any irregularity may indicate that the product has been compromised.
What Does Lacosamide Grindeks Contain?
Understanding the composition of your medicine can be important, particularly if you have known allergies or sensitivities to certain ingredients. Each Lacosamide Grindeks 50 mg film-coated tablet contains:
Active Substance
- Lacosamide 50 mg — the pharmacologically active component responsible for the antiepileptic effect.
Excipients (Inactive Ingredients)
The tablet core typically contains:
- Microcrystalline cellulose — a binder and filler
- Hydroxypropylcellulose — a binder
- Crospovidone — a disintegrant to help the tablet break down in the stomach
- Magnesium stearate — a lubricant used in tablet manufacturing
- Colloidal anhydrous silica — a glidant
The film-coating contains:
- Polyvinyl alcohol — film-forming agent
- Macrogol (polyethylene glycol) — plasticiser
- Talc — anti-tacking agent
- Titanium dioxide (E171) — white colourant
- Iron oxide yellow (E172) — colourant (may vary by strength)
The 50 mg tablets are typically small, oval or round, film-coated tablets. The exact appearance may vary slightly between manufacturers. Always check the patient information leaflet included in your specific pack for the most accurate description of your particular tablets.
Lacosamide Grindeks does not contain lactose, gluten, sucrose, or azo dyes. However, if you have known hypersensitivity to any of the excipients listed above, inform your doctor or pharmacist before taking this medicine.
Frequently Asked Questions About Lacosamide Grindeks
Lacosamide Grindeks is an antiepileptic medicine used to treat partial-onset seizures (focal seizures) with or without secondary generalisation. It is approved for adults, adolescents, and children from 2 years of age. It can be used either as the sole antiepileptic medicine (monotherapy) or alongside other antiepileptic drugs (adjunctive therapy). It works by selectively enhancing the slow inactivation of voltage-gated sodium channels, stabilising overactive neurons without affecting normal brain function.
The most frequently reported side effects are dizziness, headache, diplopia (double vision), and nausea. These are typically dose-related, meaning they are more likely at higher doses, and often occur during the initial titration period. Most side effects are mild to moderate in severity and tend to diminish as the body adjusts to the medication. If side effects persist or are troublesome, your doctor may slow the titration or adjust your dose.
Lacosamide may cause dizziness, blurred vision, and somnolence, which can impair your ability to drive or operate machinery. Until you know how this medicine affects you, it is advisable to avoid driving, cycling, or using complex machinery. Your doctor can advise you on when it is safe to resume these activities. Note that in many countries, epilepsy itself may affect your driving licence status — consult your local regulations and neurologist.
It is generally advisable to limit or avoid alcohol while taking lacosamide. Alcohol can enhance the central nervous system depressant effects of the medicine, including dizziness and somnolence. Additionally, excessive alcohol consumption can lower the seizure threshold, potentially counteracting the protective effects of the medication. If you choose to drink, do so in moderation and discuss your alcohol intake with your doctor.
Lacosamide Grindeks and Vimpat both contain the same active ingredient, lacosamide, and are therapeutically equivalent. Vimpat is the original brand-name product manufactured by UCB Pharma, while Lacosamide Grindeks is a generic version manufactured by AS Grindeks. Generic medicines must meet the same stringent quality, safety, and efficacy standards as the original product and must demonstrate bioequivalence, meaning they deliver the same amount of active substance to the body at the same rate.
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Never take two doses at the same time to make up for a missed dose. If you frequently forget doses, consider setting an alarm or using a pill organiser to help you stay on track. Consistent dosing is important for maintaining stable blood levels and optimal seizure control.
References
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Lacosamide — Summary of Product Characteristics (SmPC). Last updated 2024. Available at: www.ema.europa.eu
- 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
- 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.
- 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.
- International League Against Epilepsy (ILAE). Updated classification and treatment recommendations for epilepsies. Available at: www.ilae.org
- National Institute for Health and Care Excellence (NICE). Epilepsies in children, young people and adults (NG217). Updated 2024. Available at: www.nice.org.uk
- U.S. Food and Drug Administration (FDA). Vimpat (lacosamide) prescribing information. Available at: www.fda.gov
- Doty P, Hebert D, Mathy FX, et al. Development of lacosamide for the treatment of partial-onset seizures. Annals of the New York Academy of Sciences. 2013;1291:56-68.
- World Health Organization (WHO). Epilepsy Fact Sheet. Available at: www.who.int
- British National Formulary (BNF). Lacosamide monograph. Available at: bnf.nice.org.uk
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising specialist physicians with expertise in neurology, epileptology, and clinical pharmacology.
iMedic Medical Editorial Team — specialists in neurology and clinical pharmacology with experience in evidence-based pharmaceutical content.
iMedic Medical Review Board — independent review panel ensuring accuracy against international guidelines (EMA, FDA, ILAE, NICE, WHO).
All claims in this article are supported by Level 1A evidence from systematic reviews, randomised controlled trials, and international regulatory documentation.
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