MOTPOLY XR

AbsorptionPharmacokinetic information for MOTPOLY XR following oral administration was obtained from studies conducted in healthy adult subjects. Lacosamide is completely absorbed after oral administration with negligible first-pass effect with a high absolute bioavailability of approximately 100%. In a multiple-dose pharmacokinetic study in healthy adult subjects, at steady-state, the peak plasma lacosamide concentrations (T max ) after oral administration of MOTPOLY XR was reached in 7 hours....

The efficacy of MOTPOLY XR is based on the relative bioavailability of MOTPOLY XR compared to immediate release lacosamide in healthy adults [see Clinical Pharmacology (12.3) ] . 14.1 Monotherapy in Patients with Partial-Onset Seizures The efficacy of immediate-release lacosamide in monotherapy was established in a historical-control, multicenter, randomized trial that included 425 patients, age 16 to 70 years, with partial-onset seizures (Study 1). To be included in Study 1, patients were required to be taking stable doses of 1 or 2 marketed antiepileptic drugs. This treatment continued into...

The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions (5.1) ] Dizziness and Ataxia [see Warnings and Precautions (5.2) ] Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions (5.3) ] Syncope [see Warnings and Precautions (5.4) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] Adjunctive...

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Monitor patients for suicidal behavior and ideation ( 5.1 ) MOTPOLY XR may cause dizziness and ataxia ( 5.2 ) Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before beginning and after titration to steady-state maintenance is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction; closely monitor these patients ( 5.3 , 7.2 ) MOTPOLY XR may cause syncope ( 5.4 ) MOTPOLY XR should be gradually withdrawn to minimize t...

7 DRUG INTERACTIONS 7.1 Strong CYP3A4 or CYP2C9 Inhibitors Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to MOTPOLY XR. Dose reduction may be necessary in these patients. 7.2 Concomitant Medications that Affect Cardiac Conduction MOTPOLY XR should be used with caution in patients on concomitant medication...