VIMPAT ORAL SOLUTION CV

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VIMPAT ORAL SOLUTION

Seizure disorders
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Generic Name and Formulations:

Lacosamide 10mg/mL; strawberry-flavored; contains phenylalanine 0.32mg/20mL.

Company:

UCB Inc.

Select therapeutic use:

Indications for VIMPAT ORAL SOLUTION:

Monotherapy or as adjunct in partial-onset seizures in patients ≥4yrs.

Adult:

See full labeling. Oral soln: use calibrated measuring device. Injection: may give without diluting, or mix in appropriate diluent and give by IV infusion preferably over 30–60 mins. For oral and injection: ≥17yrs: Monotherapy: initially 100mg twice daily (alternatively, may initiate with a 200mg single loading dose, followed 12hrs later by 200mg/day in 2 divided doses for 1 week); may increase at weekly intervals by 100mg/day in 2 divided doses. Maintenance dose: 300–400mg/day. Conversion from a single antiepileptic to lacosamide monotherapy: wait until the therapeutic dose is achieved and given for at least 3 days before withdrawing concomitant antiepileptic; should withdraw gradually over at least 6 weeks. Adjunct: initially 50mg twice daily (alternatively, may initiate with a 200mg single loading dose, followed 12hrs later by 200mg/day in 2 divided doses for 1 week); may increase at weekly intervals by 100mg/day in 2 divided doses. Maintenance dose: 200–400mg/day. Switching from oral to inj: give same initial dosing regimen as that used in orally administered. Severe renal impairment (CrCl<30mL/min), ESRD, mild-to-moderate hepatic impairment: reduce max dose by 25%; if concomitant strong CYP3A4/CYP2C9 inhibitors: may need dose reduction. Consider supplemental dose (up to 50%) after hemodialysis. Avoid abrupt cessation (withdraw over 1 week).

Children:

<4yrs or Injection: not established. Oral soln: use calibrated measuring device. 4–<17yrs: Monotherapy or adjunct (11–<30kg): initially 1mg/kg twice daily; may increase at weekly intervals by 2mg/kg/day in 2 divided doses; maintenance dose: 6–12mg/kg/day; (30–<50kg): initially 1mg/kg twice daily; may increase at weekly intervals by 2mg/kg/day in 2 divided doses; maintenance dose: 4–8mg/kg/day; (≥50kg): initially 50mg twice daily; may increase at weekly intervals by 100mg/day in 2 divided doses; maintenance dose: 300–400mg/day (monotherapy) or 200–400mg/day (adjunct). Severe renal impairment (CrCl<30mL/min), ESRD, mild-to-moderate hepatic impairment: reduce max dose by 25%; if concomitant strong CYP3A4/CYP2C9 inhibitors: may need dose reduction. Consider supplemental dose (up to 50%) after hemodialysis. Avoid abrupt cessation (withdraw over 1 week).

Warnings/Precautions:

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; monitor closely esp. with IV route. Diabetic neuropathy. Oral soln: phenylketonurics. Elderly. Pregnancy. Nursing mothers.

Interactions:

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).

See Also:

VIMPAT

VIMPAT INJECTION

Pharmacological Class:

Sodium channel inactivator.

Adverse Reactions:

Dizziness, headache, diplopia, nausea, vomiting, fatigue, ataxia; PR interval prolongation, AV block, syncope; rare: DRESS/multiorgan hypersensitivity reaction (discontinue if occurs).

Note:

To enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry call (888) 233-2334.

How Supplied:

Tabs—60; Oral soln—200mL, 465mL; Single-use vials (20mL)—10