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Eslicarbazepine acetate

Generic Name
Eslicarbazepine acetate
Brand Names
Aptiom, Zebinix
Drug Type
Small Molecule
Chemical Formula
C17H16N2O3
CAS Number
236395-14-5
Unique Ingredient Identifier
BEA68ZVB2K

Overview

Eslicarbazepine acetate (ESL) is an anticonvulsant medication approved for use in Europe, the United States and Canada as an adjunctive therapy for partial-onset seizures that are not adequately controlled with conventional therapy. Eslicarbazepine acetate is a prodrug that is rapidly converted to eslicarbazepine, the primary active metabolite in the body. Eslicarbazepine's mechanism of action is not well understood, but it is known that it does exert anticonvulsant activity by inhibiting repeated neuronal firing and stabilizing the inactivated state of voltage-gated sodium channels, thus preventing their return to the activated state during which seizure activity can occur. Eslicarbazepine acetate is marketed as Aptiom in North America and Zebinix or Exalief in Europe. It is available in 200, 400, 600, or 800mg tablets that are taken once daily, with or without food. Eslicarbazepine acetate is associated with numerous side effects including dizziness, drowsiness, nausea, vomiting, diarrhea, headache, aphasia, lack of concentration, psychomotor retardation, speech disturbances, ataxia, depression and hyponatremia. It is recommended that patients taking eslicarbazepine acetate be monitored for suicidality.

Background

Eslicarbazepine acetate (ESL) is an anticonvulsant medication approved for use in Europe, the United States and Canada as an adjunctive therapy for partial-onset seizures that are not adequately controlled with conventional therapy. Eslicarbazepine acetate is a prodrug that is rapidly converted to eslicarbazepine, the primary active metabolite in the body. Eslicarbazepine's mechanism of action is not well understood, but it is known that it does exert anticonvulsant activity by inhibiting repeated neuronal firing and stabilizing the inactivated state of voltage-gated sodium channels, thus preventing their return to the activated state during which seizure activity can occur. Eslicarbazepine acetate is marketed as Aptiom in North America and Zebinix or Exalief in Europe. It is available in 200, 400, 600, or 800mg tablets that are taken once daily, with or without food. Eslicarbazepine acetate is associated with numerous side effects including dizziness, drowsiness, nausea, vomiting, diarrhea, headache, aphasia, lack of concentration, psychomotor retardation, speech disturbances, ataxia, depression and hyponatremia. It is recommended that patients taking eslicarbazepine acetate be monitored for suicidality.

Indication

Eslicarbazepine acetate is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

Associated Conditions

  • Partial-Onset Seizures

FDA Approved Products

Aptiom
Manufacturer:Sumitomo Pharma America, Inc.
Route:ORAL
Strength:400 mg in 1 1
Approved: 2019/03/28
NDC:63402-204
Eslicarbazepine acetate
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:600 mg in 1 1
Approved: 2023/09/07
NDC:31722-430
Aptiom
Manufacturer:Sumitomo Pharma America, Inc.
Route:ORAL
Strength:600 mg in 1 1
Approved: 2019/03/28
NDC:63402-206
Eslicarbazepine acetate
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:400 mg in 1 1
Approved: 2023/09/07
NDC:31722-429
Eslicarbazepine acetate
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:800 mg in 1 1
Approved: 2023/09/07
NDC:31722-431

Singapore Approved Products

No Singapore products found for this drug

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