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lacosamide (Rx)Brand and Other Names:Vimpat

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet: Schedule V

  • 50mg
  • 100mg
  • 150mg
  • 200mg

injectable solution: Schedule V

  • 200mg/20mL

oral solution: Schedule V

  • 10mg/mL
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Partial Onset Seizures

Indicated as monotherapy or adjunctive therapy for partial onset seizures

Monotherapy

  • 100 mg PO/IV q12hr initially, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 150-200 mg BID
  • Alternate loading dose schedule: 200 mg PO/IV as a single dose, followed ~12 hr later by starting 100 mg PO/IV BID x 1 week, THEN increase dose at weekly intervals by 50 mg BID; up to a recommended dose of 150-200 mg BID
  • In patients already taking an antiepileptic drug (AED), maintain lacosamide at recommended maintenance dose of 150-200 mg PO BID for at least 3 days before initiating withdrawal of the previous AED

Adjunctive therapy

  • Initial: 50 mg PO/IV q12hr
  • Based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 100-200 mg BID

Dosage Modifications

Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction

Renal impairment

  • Severe (CrCl <30 mL/min): Not to exceed 300 mg/day
  • Hemodialysis: Supplement with up to 50% of dose after dialysis

Hepatic impairment

  • Mild to moderate: Not to exceed 300 mg/day
  • Severe: Not recommended

Dosing Considerations

IV administration indicated as short-term replacement when PO administration is not feasible

Administration

Oral: May take with or without food

<17 years: Safety and efficacy not established

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Interactions

Interaction Checker

lacosamide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dizziness (31%)

            Headache (13%)

            Diplopia (11%)

            Nausea (11%)

            1-10%

            Vomiting (9%)

            Ataxia (8%)

            Blurred vision (8%)

            Tremor (7%)

            Nystagmus (5%)

            Balance disorder (4%)

            Diarrhea (4%)

            Injection site discomfort (2.5%)

            Depression (2%)

            Memory impairment (2%)

            Pruritus (2%)

            Increased ALT (1%)

            Local irritation (1%)

            <1%

            Anemia

            Cerebellar syndrome

            Dyspepsia

            Hepatitis

            Atrial fibrillation/flutter

            Atrioventricular block

            Mood changes

            Muscle spasm

            Hypoesthesia

            Neutropenia

            Xerostomia

            Nephritis

            Palpitation

            Postmarketing Reports

            Blood and lymphatic system disorders: Agranulocytosis

            Cardiac disorders: Bradycardia

            Psychiatric disorders: Aggression, agitation, hallucination, insomnia, psychotic disorder

            Skin and subcutaneous tissue disorders: Angioedema, rash, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis

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            Warnings

            Contraindications

            None

            Cautions

            Increase the risk of suicidal thoughts or behavior; monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior

            Dizziness and ataxia reported; may impair ability to perform hazardous tasks

            Dose-dependent prolongations in PR interval observed in clinical studies in patients and in healthy volunteers; caution in patients with known conduction problems (eg, marked first-degree AV block, second-degree or higher AV block, and sick sinus syndrome without pacemaker), sodium channelopathies (eg, Brugada Syndrome), on concomitant medications that prolong PR interval, or with severe cardiac disease (eg, myocardial ischemia, heart failure, or structural heart disease)

            Increased incidence of syncope in patients with diabetic neuropathy

            Oral solution contains aspartame, a source of phenylalanine; 200 mg dose (20 mL) contains 0.32 mg of phenylalanine

            One case of multiorgan hypersensitivity reaction reported consisting of symptomatic hepatitis and nephritis

            Withdraw gradually over 1 week; do not discontinue abruptly because of risk for increased frequency of seizures

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown if distributed in breast milk; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Antiepileptic effects unknown; may slowly inactivate voltage-gated Na channels

            Binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein that is expressed mainly in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth

            Absorption

            Bioavailability: ~100%

            Peak plasma time: 1-4 hr

            Distribution

            Protein bound: <15%

            Vd: 0.6 L/kg

            Metabolism

            Predominantly by CYP isoenzymes 3A4 and 2C9; also 2C19

            Major metabolite: O-desmethyl-lacosamide (inactive)

            Elimination

            Half-life: 13 hr

            Excretion: Urine

            Dialyzable: Yes (hemodialysis)

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            Administration

            IV Preparation

            May be administered without dilution or diluted in compatible solutions: 0.9% NaCl, D5W, LR

            IV Administration

            Infuse IV over 15-60 min; 30 to 60 min preferable, and should be used when a 15 min administration is not required

            IV lacosamide may cause bradycardia or AV bock in patients with underlying cardiac disease

            Monitor infusion closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (eg, myocardial ischemia, heart failure)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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