VIMPAT 50/MG FC TAB 56/FC TAB

Indications

Approved Uses

Epilepsy: (1) Partial-onset seizures as monotherapy or adjunctive therapy (≥1 month). (2) Adjunctive therapy for primary generalized tonic-clonic seizures (≥4 years

Off-Label Uses

Off‑label: neuropathic pain conditions (e.g., diabetic peripheral neuropathy) and trigeminal neuralgia have been studied/used; fibromyalgia/bipolar/mania are not well supported. Generalized tonic‑clonic seizures are not off‑label where PGTCS adjunctive use is approved.

Dosage & Administration

Dosing by Condition

Focal seizures-Adjunctive (adults): start 50 mg twice daily; increase by 50 mg twice daily (100 mg/day) weekly to 100-200 mg twice daily (maintenance 200-400 mg/day); max 400 mg/day. Focal seizures-Monotherapy (adults): start 100 mg twice daily; increase by 50 mg twice daily weekly to 150-200 mg twice daily (maintenance 300-400 mg/day); max 600 mg/day in some labels, but commonly 400 mg/day is typical target/maintenance. PGTCS-Adjunctive (where approved): start 50 mg twice daily; titrate weekly to 100-200 mg twice daily (max 400 mg/day).

Initial Dose

50 mg twice daily (adjunctive therapy) or 100 mg twice daily (monotherapy).

Maintenance Dose

100-200 mg twice daily (adjunctive); 150-300 mg twice daily (monotherapy)

Maximum Dose

400 mg/day (adjunctive therapy); 600 mg/day (monotherapy)

Children's Dosage

Children 4-17 years (≥50 kg): same as adult dosing. Children 4-17 years (<50 kg): 1-2 mg/kg/day initial dose, titrate to 4-8 mg/kg/day maintenance, max 12 mg/kg/day. Not approved under 4 years of age.

Dose Adjustment Notes

Titrate typically by 100 mg/day at weekly intervals as tolerated. Renal: in severe impairment (CrCl ≤30 mL/min) or ESRD, reduce maximum dose (commonly max 300 mg/day) and consider a supplemental dose after hemodialysis (up to ~50% of the divided daily dose). Hepatic: in mild-moderate impairment, reduce maximum dose (commonly max 300 mg/day); avoid in severe hepatic impairment unless benefits outweigh risks. Elderly: titrate cautiously.

How to Take

Swallow the film‑coated tablet whole with water; do not crush or chew. May be taken with or without food. Administer twice daily (about 12 hours apart) as prescribed.

Side Effects

Common Side Effects

Dizziness, headache, diplopia (double vision), nausea, somnolence (drowsiness), vomiting, ataxia (coordination problems), blurred vision, tremor, fatigue.

Side Effect Frequency

Very common (>10%): dizziness, headache, nausea, diplopia. Common (1-10%): vomiting, blurred vision, somnolence, fatigue, ataxia/coordination abnormal, tremor, balance disorder/vertigo, memory impairment; diarrhea can occur but is not consistently listed among the most typical common events across core labeling summaries.

Safety & Warnings

Contraindications

Known hypersensitivity to lacosamide or any component of the formulation.

Warnings & Precautions

Key warnings/precautions: cardiac conduction abnormalities (PR prolongation/AV block)-obtain ECG in at-risk patients or those on PR-prolonging drugs; suicidal ideation/behavior monitoring; dizziness/ataxia and fall risk; serious hypersensitivity/DRESS-discontinue if suspected; taper gradually to avoid seizure exacerbation; caution in significant cardiac disease.

Age Restriction

Approved for patients 1 month of age and older (for focal/partial-onset seizures); not established for <1 month.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Clinically important: additive PR-interval prolongation with other PR-prolonging drugs (e.g., beta-blockers, non-DHP calcium channel blockers, digoxin) and other agents affecting cardiac conduction; additive CNS effects with alcohol/CNS depressants; pharmacokinetic interactions are generally limited-strong CYP2C19 inhibitors may increase exposure and strong enzyme inducers (e.g., carbamazepine, phenytoin, rifampin) may decrease exposure.

Interaction Severity

MAJOR/Clinically significant: additive PR‑interval prolongation/AV block risk with other PR‑prolonging agents (e.g., beta‑blockers, non‑DHP CCBs such as verapamil/diltiazem, digoxin, amiodarone) and in patients with conduction disease. MODERATE: enzyme inducers (carbamazepine, phenytoin, phenobarbital) may lower lacosamide concentrations; strong CYP2C19 inhibitors may modestly increase levels (usually limited clinical impact). CNS depressants/alcohol: additive dizziness/sedation (typically moderate).

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Pregnancy Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VIMPAT during pregnancy

Breastfeeding

Consult Doctor

Children

Children 4-17 years (≥50 kg): same as adult dosing. Children 4-17 years (<50 kg): 1-2 mg/kg/day initial dose, titrate to 4-8 mg/kg/day maintenance, max 12 mg/kg/day. Not approved under 4 years of age.

Elderly

No specific dose adjustment required based on age alone; however, titrate cautiously due to increased risk of cardiac conduction effects 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 hemodialysis, consider a supplemental dose of up to 50% of the daily dose.

Liver Impairment

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

Storage & Patient Advice

Missed Dose

Take as soon as remembered. If it is close to the time of the next dose, skip the missed dose and resume the usual dosing schedule. Do not double the dose.

Stopping the Medicine

Do not stop abruptly - taper gradually over a minimum of one week to reduce the risk of increased seizure frequency.

Overdose

Overdose may cause CNS depression (dizziness, somnolence, seizures, coma) and cardiac conduction disturbances (PR prolongation, bradycardia, AV block, arrhythmias/cardiac arrest); management is supportive with airway/ventilation as needed and continuous ECG monitoring; no specific antidote; consider activated charcoal if appropriate; hemodialysis removes a substantial fraction (about 50%) of drug.

Patient Counseling

Take twice daily at the same times; with or without food; swallow tablets whole. Do not stop abruptly-taper only under prescriber guidance. May cause dizziness/blurred vision/somnolence-avoid driving/machinery until effects are known; avoid alcohol and other sedatives. Report mood changes/suicidal thoughts. Report palpitations, fainting, or slow/irregular heartbeat (PR‑interval/AV block risk), especially if on heart‑rate/conduction medicines. Store below 30°C (per SFDA storage).

Monitoring Requirements

Monitor seizure control and adverse effects (dizziness, ataxia). Screen/monitor for suicidal ideation and mood changes. ECG (PR interval) at baseline and after titration in patients with known conduction abnormalities, significant cardiac disease, or taking PR‑prolonging drugs. Monitor renal/hepatic function when impairment is present or suspected.

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 not established.

Onset of Action

Tmax ~1-4 hours after oral dosing; clinical antiseizure benefit may begin early but is typically assessed after titration to an effective dose over days to weeks.

Duration of Effect

Clinical effect supports twice‑daily dosing; elimination half‑life is ~13 hours.

Half-Life

Approximately 13 hours.

Bioavailability

Approximately 100% (complete oral bioavailability).

Metabolism

Metabolized mainly by CYP2C19 (O-demethylation to an inactive metabolite), with minor contributions from CYP2C9 and CYP3A4; lacosamide is not a clinically significant CYP inducer/inhibitor.

Excretion

Primarily renal: ~95% of the administered dose recovered in urine (about ~40% as unchanged lacosamide, ~30% as inactive O-desmethyl metabolite, and the remainder as other polar metabolites); fecal excretion is minimal.

Protein Binding

Less than 15%.

Product Information

Available Dosage Forms

Film‑coated tablet (oral); oral solution; solution for intravenous infusion (IV).

Composition per Dose

Each film-coated tablet: 50 mg lacosamide

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antiepileptic

Controlled Substance

No

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