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Xcopri Generic Name & Formulations
Legal Class
CV
General Description
Cenobamate 12.5mg, 25mg, 50mg, 100mg, 150mg, 200mg; tabs.
Pharmacological Class
Antiepileptic.
How Supplied
Tabs 50mg, 100mg, 150mg, 200mg—30; Blister packs (Titration)—14; (Maintenance)—28
Manufacturer
Generic Availability
NO
Xcopri Indications
Indications
Partial-onset seizures.
Xcopri Dosage and Administration
Adult
Swallow whole. Initially (Weeks 1 & 2): 12.5mg once daily. Titration regimen (Weeks 3 & 4): 25mg once daily; (Weeks 5 & 6): 50mg once daily; (Weeks 7 & 8): 100mg once daily; (Weeks 9 & 10): 150mg once daily. Maintenance (Week 11 & thereafter): 200mg once daily. Maximum dose (if needed based on response and tolerability, may increase by increments of 50mg/day every 2 weeks): 400mg once daily. Mild to moderate hepatic impairment: max 200mg once daily. Withdraw gradually over ≥2 weeks, if discontinuation needed.
Children
Not established.
Xcopri Contraindications
Contraindications
Familial short QT syndrome.
Xcopri Boxed Warnings
Not Applicable
Xcopri Warnings/Precautions
Warnings/Precautions
Permanently discontinue if multiorgan hypersensitivity/DRESS occurs. Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes. Monitor for CNS depression, neurological reactions. Avoid abrupt cessation. Drug abuse. Mild to moderate hepatic impairment: see Adults. Severe hepatic impairment: not recommended. Renal impairment. ESRD on dialysis: not recommended. Elderly. Pregnancy. Advise females of reproductive potential to use additional or alternative non-hormonal contraceptive. Nursing mothers.
Xcopri Pharmacokinetics
See Literature
Xcopri Interactions
Interactions
May antagonize lamotrigine, carbamazepine, oral contraceptives, CYP2B6 and CYP3A substrates. May potentiate phenytoin (reduce phenytoin dose by up to 50%), phenobarbital, clobazam, CYP2C19 substrates. Caution with other drugs that shorten the QT interval. Increased risk of neurological reactions with other CNS depressants, including alcohol.
Xcopri Adverse Reactions
Adverse Reactions
Somnolence, dizziness, fatigue, diplopia, headache; multiorgan hypersensitivity/DRESS.
Xcopri Clinical Trials
See Literature
Xcopri Note
Not Applicable
Xcopri Patient Counseling
See Literature
