Motpoly XR Dosage

Dosage Information

The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures and for adjunctive therapy for primary generalized tonic-clonic seizuresin in adults and in pediatric patients weighing at least 50 kg is included in Table 1. Dosage should be increased based on clinical response and tolerability, no more frequently than once per week. Titration increments should not exceed those shown in Table 1.

*when not specified, the dosage is the same for monotherapy for partial-onset seizures and adjunctive therapy for partial-onset seizures or primary generalized tonic-clonic seizures .
**Monotherapy for partial-onset seizures only

In adjunctive clinical trials in adult patients with partial-onset seizures, a dosage higher than 400 mg per day was not more effective and was associated with a substantially higher rate of adverse reactions .

Additional pediatric use information is approved for UCB Inc.'s Vimpat (lacosamide) tablets, oral solution, and intravenous solution. However, due to UCB Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Converting From a Single Antiepileptic (AED) to MOTPOLY XR Monotherapy for the Treatment of Partial-Onset Seizures

For patients who are already on a single AED and will convert to MOTPOLY XR monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of MOTPOLY XR is achieved and has been administered for at least 4 days. A gradual withdrawal of the concomitant AED over at least 6 weeks is recommended.

Dosage Information for Patients with Renal Impairment

For patients with mild to moderate renal impairment, no dosage adjustment is necessary.
For patients with severe renal impairment [creatinine clearance (CL CR) less than 30 mL/min as estimated by the Cockcroft-Gault equation for adults; CL CRless than 30 mL/min/1.73m 2as estimated by the Schwartz equation for pediatric patients] or end-stage renal disease, the maximum recommended dosage is 300 mg.
In all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability.

Dosage Information for Patients with Hepatic Impairment

For patients with mild or moderate hepatic impairment, the maximum recommended dosage is 300 mg. The dose initiation and titration should be based on clinical response and tolerability in patients with hepatic impairment. MOTPOLY XR use is not recommended in patients with severe hepatic impairment.

Administration Instructions for MOTPOLY XR Capsules

MOTPOLY XR may be taken with or without food.
MOTPOLY XR capsules should be swallowed whole with liquid. Do not open, chew, or crush the capsules.

Discontinuation of MOTPOLY XR

When discontinuing MOTPOLY XR, a gradual withdrawal over at least 1 week is recommended .