XCOPRI Film-coated tablet Ref.[10091] Active ingredients: Cenobamate

2.1 Important Administration Instructions

XCOPRI may be taken any time with or without food. Swallow tablets whole with liquid. Do not crush or chew.

2.2 General Dosing Recommendations

Monotherapy and Adjunctive Therapy

XCOPRI is administered orally once daily. The recommended dosage and titration, which should not be exceeded because of the potential for serious adverse reactions [see Warnings and Precautions (5.2)], is included in Table 1.

Table 1. Recommended Dosage for Partial-Onset Seizures in Adults:

2.3 Dosage Modifications in Patients with Hepatic Impairment

For patients with mild to moderate (5-9 points on Child-Pugh assessment) hepatic impairment, the maximum recommended dosage is 200 mg once daily [see Use in Specific Populations (8.7)]. XCOPRI is not recommended for use in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

2.4 Discontinuation of XCOPRI

If XCOPRI is discontinued, the dosage should be gradually reduced over a period of at least 2 weeks, unless safety concerns require abrupt withdrawal [see Warnings and Precautions (5.1, 5.5)].

There is limited clinical experience with XCOPRI overdose in humans.

There is no specific antidote for overdose with XCOPRI. In the event of overdose, standard medical practice for the management of any overdose should be used. An adequate airway, oxygenation and ventilation should be ensured; monitoring of cardiac rate and rhythm and vital signs is recommended. A certified poison control center should be contacted for updated information on the management of overdose with XCOPRI. There are no data on the removal of XCOPRI using dialysis.

Store XCOPRI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) (See USP Controlled Room Temperature).