VIMPAT 100 MG 56 TAB

Indications

Approved Uses

Treatment of focal (partial-onset) seizures (monotherapy or adjunctive therapy) and adjunctive therapy for primary generalized tonic-clonic seizures (PGTCS) in patients ≥4 years.

Dosage & Administration

Dosing by Condition

Focal (partial-onset) seizures-Adjunctive (adults): start 50 mg twice daily; increase by 50 mg twice daily (100 mg/day) no more often than weekly to 100-200 mg twice daily (200-400 mg/day). Focal seizures-Monotherapy (adults): start 100 mg twice daily; maintenance 150-200 mg twice daily (300-400 mg/day). PGTCS-Adjunctive (≥4 years): weight-based in pediatrics; adults/≥50 kg typically start 50 mg twice daily and titrate weekly to 100-200 mg twice daily (200-400 mg/day).

Initial Dose

Adjunctive therapy: 50 mg twice daily. Monotherapy: 100 mg twice daily.

Maintenance Dose

200-400 mg/day, administered in two divided doses.

Maximum Dose

400 mg/day.

Children's Dosage

Approved for children ≥4 years weighing ≥50 kg: same as adult dosing; children ≥4 years weighing <50 kg: 2 mg/kg/day initial dose, titrate by 2 mg/kg/day weekly, maintenance 4-8 mg/kg/day, max 12 mg/kg/day

Dose Adjustment Notes

Titrate no more frequently than once weekly; severe renal impairment (CrCl ≤30 mL/min) or ESRD: reduce maximum dose to 300 mg/day and consider up to 50% supplemental dose after hemodialysis; mild-moderate hepatic impairment: maximum 300 mg/day; severe hepatic impairment: not recommended.

How to Take

Swallow tablet whole with water; may be taken with or without food; administer twice daily (approximately 12 hours apart).

Side Effects

Common Side Effects

Dizziness, headache, nausea, diplopia, blurred vision, somnolence, vomiting, ataxia/coordination problems, fatigue; vertigo may occur.

Side Effect Frequency

Very common (≥10%): dizziness, headache, diplopia, nausea. Common (1-10%): blurred vision, vomiting, somnolence, fatigue, ataxia/coordination or balance disorder, tremor, vertigo. Uncommon/rare: PR interval prolongation, atrioventricular block, syncope/bradycardia; serious hypersensitivity reactions (e.g., DRESS) and severe cutaneous reactions (e.g., SJS/TEN) are rare; suicidal ideation/behavior is a class warning.

Safety & Warnings

Contraindications

Known hypersensitivity to lacosamide or any excipients; known second- or third-degree atrioventricular (AV) block (unless paced)

Warnings & Precautions

Risk of PR prolongation/arrhythmias-consider baseline and follow-up ECG in patients with conduction disease, significant cardiac disease, or on PR-prolonging drugs; suicidal ideation/behavior monitoring; dizziness/ataxia and fall risk; serious hypersensitivity/skin reactions (e.g., DRESS/SJS/TEN)-stop if suspected; avoid abrupt discontinuation (taper) to reduce seizure worsening

Age Restriction

Approved for use in patients 4 years of age and older.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Additive PR-interval prolongation with other PR-prolonging drugs (e.g., beta-blockers, non-DHP calcium channel blockers, digoxin) and with other sodium-channel-acting antiseizure meds; CYP2C19 inhibitors may increase lacosamide exposure and CYP2C19 inducers may decrease exposure (generally modest effects)

Interaction Severity

MAJOR/CLINICALLY SIGNIFICANT: Additive PR-interval prolongation/AV block risk with other PR-prolonging agents (e.g., beta-blockers, non-DHP calcium channel blockers, digoxin, other sodium-channel-affecting drugs)-consider ECG/clinical monitoring. MODERATE: Additive CNS depression with alcohol, benzodiazepines, opioids (dizziness/somnolence). MODERATE: Enzyme-inducing ASMs (carbamazepine, phenytoin, phenobarbital) can modestly lower lacosamide exposure; strong CYP2C19 inhibitors may modestly increase exposure (usually not clinically large but consider in sensitive patients).

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Approved for children ≥4 years weighing ≥50 kg: same as adult dosing; children ≥4 years weighing <50 kg: 2 mg/kg/day initial dose, titrate by 2 mg/kg/day weekly, maintenance 4-8 mg/kg/day, max 12 mg/kg/day

Elderly

No specific dose adjustment required based on age alone; however, titrate cautiously due to increased risk of cardiac conduction abnormalities and falls; monitor renal function as dose adjustment may be needed if CrCl ≤30 mL/min

Kidney Impairment

CrCl >30 mL/min: no adjustment. Severe renal impairment (CrCl ≤30 mL/min) or ESRD: maximum 300 mg/day; after a 4-hour hemodialysis session, consider a supplemental dose of up to 50% of the daily dose

Liver Impairment

Mild-to-moderate hepatic impairment (Child-Pugh A/B): titrate cautiously; maximum 300 mg/day. Severe hepatic impairment (Child-Pugh C): not recommended

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly - taper gradually over at least 1 week to minimize the risk of increased seizure frequency.

Overdose

Symptoms: CNS depression (dizziness, ataxia, somnolence), nausea/vomiting, seizures, and cardiac conduction disturbances (notably PR prolongation, bradycardia, AV block; possible QRS widening), hypotension, coma. Management: no specific antidote; supportive care with ECG/cardiac monitoring, consider activated charcoal if early; hemodialysis can remove a substantial fraction (~50%)

Patient Counseling

Take lacosamide exactly as prescribed (usually twice daily at the same times); swallow tablets with or without food. Do not stop suddenly-taper only under prescriber direction to avoid seizure worsening. May cause dizziness, drowsiness, blurred vision or double vision-avoid driving/operating machinery until effects are known; avoid alcohol/CNS depressants as they can worsen these effects. Seek medical advice urgently for palpitations, slow/irregular heartbeat, fainting or syncope (risk of PR prolongation/AV block; ECG monitoring may be needed in at‑risk patients). Report new/worsening depression, mood/behavior changes, or suicidal thoughts immediately. Seek urgent care for severe rash or hypersensitivity symptoms (e.g., rash with fever, swollen glands).

Monitoring Requirements

Monitor for suicidal ideation/behavior and CNS adverse effects (dizziness, ataxia); obtain ECG in patients with known conduction disease, significant cardiac disease, or taking PR-prolonging drugs, and reassess after titration/at steady state; monitor renal/hepatic function in patients with impairment.

Pharmacology

Mechanism of Action

Enhances slow inactivation of voltage-gated sodium channels, stabilizing hyperexcitable neuronal membranes and reducing repetitive firing; CRMP-2 binding has been described but its clinical relevance is unproven.

Onset of Action

Tmax ~1-4 hours after an oral dose; clinical seizure control may begin after initiation but is typically assessed after titration to an effective maintenance dose (days to weeks).

Duration of Effect

Clinical coverage is maintained with twice-daily dosing; elimination half-life is ~13 hours.

Half-Life

Approximately 13 hours.

Bioavailability

Approximately 100% (high oral bioavailability).

Metabolism

Metabolized mainly by CYP2C19 to an inactive O-desmethyl metabolite; minor contribution from CYP3A4 and CYP2C9; not a clinically significant CYP inducer/inhibitor.

Excretion

Primarily renal: about 40% excreted unchanged in urine, with additional urinary excretion as metabolites (including O-desmethyl) and other polar fractions.

Protein Binding

Low protein binding (<15%).

Product Information

Available Dosage Forms

Film-coated tablet (oral), oral solution, and solution for intravenous infusion (IV).

Composition per Dose

Each film-coated tablet: 100 mg lacosamide

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Partial-onset seizures

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