INDICATION
MOTPOLY XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- Antiepileptic drugs increase the risk of suicidal behavior and ideation. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors.
- MOTPOLY XR may cause dizziness and ataxia in patients. Advise patients not to operate machinery or motor vehicles until they know how MOTPOLY XR affects them.
- Obtain ECG before beginning MOTPOLY XR, and after titration to steady-state maintenance dose in patients with underlying proarrhythmic conditions or those on concomitant medications that affect cardiac conduction. Closely monitor these patients.
- MOTPOLY XR may cause syncope in patients.
- Gradually withdraw MOTPOLY XR to minimize the potential of increased seizure frequency.
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/multi-organ hypersensitivity has been reported and can be life-threatening or fatal. If signs or symptoms are present, immediately evaluate the patient. Discontinue MOTPOLY XR if there is no alternative etiology.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence.
PREGNANCY: Based on animal data, MOTPOLY XR may cause fetal harm.
DRUG INTERACTIONS: Consider dose reduction in patients with renal or hepatic impairment taking strong inhibitors of CYP3A4 and CYP2C9.
Please refer to the full Prescribing Information and Medication Guide for MOTPOLY XR for additional important information.
