VIMPAT ORAL SOLUTION CV
Generic Name and Formulations:
Lacosamide 10mg/mL; strawberry-flavored; contains phenylalanine 0.32mg/20mL.
Indications for VIMPAT ORAL SOLUTION:
Monotherapy or as adjunct in partial-onset seizures.
See full labeling. Oral soln: use calibrated measuring device. Inj: may give without diluting, or mix in appropriate diluent and give by IV infusion preferably over 30–60 mins. For oral and inj: ≥17yrs: Monotherapy: initially 100mg twice daily; may increase at weekly intervals by 100mg/day in 2 divided doses. Maintenance dose: 300–400mg/day. Alternatively: may initiate with a 200mg single loading dose, then after 12hrs give 200mg/day in 2 divided doses for 1 week; may increase at weekly intervals by 100mg/day in 2 divided doses, up to maintenance dose: 300–400mg/day. Conversion to lacosamide monotherapy: 300–400mg/day in 2 divided doses for at least 3 days before withdrawing concomitant antiepileptic; should withdraw gradually over at least 6 weeks. Adjunct: initially 50mg twice daily; may increase at weekly intervals by 100mg/day in 2 divided doses. Maintenance dose: 200–400mg/day. Alternatively: may initiate with a 200mg single loading dose, then after 12hrs give 200mg/day in 2 divided doses for 1 week; may increase at weekly intervals by 100mg/day in 2 divided doses as needed, up to max maintenance dose: 400mg/day. Switching from oral to inj: give same initial dosing regimen as that used in orally administered. Renal impairment (CrCl≤30mL/min), ESRD, mild-to-moderate hepatic impairment: max 300mg/day; if concomitant strong CYP3A4/CYP2C9 inhibitors: may need dose reduction. Consider supplemental dose (50%) after hemodialysis. Avoid abrupt cessation (withdraw over 1 week).
<17yrs: not established.
Severe hepatic impairment: not recommended. Increased risk of suicidal thinking and behavior; monitor for clinical worsening or unusual changes. Cardiac conduction disturbances (eg, marked 1st or 2nd degree AV block, sick sinus syndrome unless paced, sodium channelopathies) or severe cardiac disease (eg, myocardial ischemia, HF, structural heart disease); obtain ECG before therapy and after titration. Diabetic neuropathy. Oral soln: phenylketonurics. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Caution with concomitant drugs that prolong PR interval. May be potentiated by strong CYP3A4/2C9 inhibitors in patients with renal or hepatic impairment (see Adults dose).
Sodium channel inactivator.
Dizziness, diplopia, headache, nausea, vomiting, fatigue, ataxia; PR interval prolongation, AV block, syncope; rare: DRESS/multiorgan hypersensitivity reaction (discontinue if occurs).
To enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry call (888) 233-2334.
Tabs—60; Oral soln—200mL, 465mL; Single-use vials (20mL)—10
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