Carbamate anticonvulsants
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Xcopri Dosage

Drug Detail:Xcopri (Cenobamate)

Generic Name: CENOBAMATE 12.5mg; CENOBAMATE 25mg

Dosage Form: tablets

Drug Class: Carbamate anticonvulsants

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Important Administration Instructions

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

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
Initial Dosage
Week 1 and 2 12.5 mg once daily
Titration Regimen
Week 3 and 4 25 mg once daily
Week 5 and 6 50 mg once daily
Week 7 and 8 100 mg once daily
Week 9 and 10 150 mg once daily
Maintenance Dosage
Week 11 and thereafter 200 mg once daily
Maximum Dosage
If needed based on clinical response and
tolerability, dose may be increased above 200 mg
by increments of 50 mg once daily every two
weeks to 400 mg.		 400 mg once daily

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)].

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)].

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