Basic Information
TROKENDI XR® EXTENDED-RELEASE CAPSULE 100MG
CAPSULE, EXTENDED RELEASE
Regulatory Information
SIN16664P
January 5, 2023
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XN03AX11
Company Information
Active Ingredients
Strength: 100mg
Detailed Information
Contraindications
**4 CONTRAINDICATIONS** TROKENDI XR® is contraindicated in patients: - Hypersensitivity to any component of this product. - With recent alcohol use ( i.e., within 6 hours prior to and 6 hours after TROKENDI XR® use) \[ _see Warnings and Precautions (5.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] - Migraine prophylaxis: in pregnancy and in women of childbearing potential if not using a highly effective method of contraception.
Indication Information
**1 INDICATIONS AND USAGE** **1.1 Monotherapy Epilepsy** TROKENDI XR® is indicated in patients 6 years of age and older as initial monotherapy for partial onset or primary generalized tonic-clonic seizures \[ _see Clinical Studies (14.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. **1.2 Adjunctive Therapy Epilepsy** TROKENDI XR® is indicated as adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome \[ _see Clinical Studies (14.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. **1.3 Migraine** TROKENDI XR® is indicated for the prophylaxis of migraine headache in adult patients \[ _see Clinical Studies (14.4)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].