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Vigabatrin

Generic Name
Vigabatrin
Brand Names
Sabril, Vigadrone, Kigabeq
Drug Type
Small Molecule
Chemical Formula
C6H11NO2
CAS Number
68506-86-5
Unique Ingredient Identifier
GR120KRT6K

Overview

Vigabatrin is an analog of gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the central nervous system, used in the treatment of refractory seizures and infantile spasms. It irreversibly inhibits the enzyme responsible for GABA metabolism, thereby increasing levels of circulating GABA. Although administered as a racemic mixture, only the S(+) enantiomer is pharmacologically active. It was first introduced as an antiepileptic agent in the United Kingdom in 1989 and was used extensively until 1997, when an association with vision loss became apparent. Its use is now generally reserved for patients who have failed alternative therapies, and its US approval by the FDA in 2009 mandated the creation of a drug registry to monitor patients for visual deficits.

Background

Vigabatrin is an analog of gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the central nervous system, used in the treatment of refractory seizures and infantile spasms. It irreversibly inhibits the enzyme responsible for GABA metabolism, thereby increasing levels of circulating GABA. Although administered as a racemic mixture, only the S(+) enantiomer is pharmacologically active. It was first introduced as an antiepileptic agent in the United Kingdom in 1989 and was used extensively until 1997, when an association with vision loss became apparent. Its use is now generally reserved for patients who have failed alternative therapies, and its US approval by the FDA in 2009 mandated the creation of a drug registry to monitor patients for visual deficits.

Indication

Vigabatrin is indicated as adjunctive therapy in the treatment of refractory complex partial seizures in patients 2 years of age and older who have had inadequate responses to multiple previous treatments (i.e. not to be used for first-line therapy). It is also indicated as monotherapy in the treatment of infantile spasms in patients between 1 month and 2 years of age for whom the potential benefits outweigh the risk of vision loss.

Associated Conditions

  • Infantile Spasms (IS)
  • Refractory Complex partial seizures

FDA Approved Products

VIGABATRIN
Manufacturer:Cipla USA, Inc.
Route:ORAL
Strength:500 mg in 1 mL
Approved: 2022/04/05
NDC:69097-964
Vigabatrin
Manufacturer:Dr. Reddys Laboratories Inc.,
Route:ORAL
Strength:500 mg in 1 1
Approved: 2018/09/14
NDC:43598-651
Vigabatrin
Manufacturer:Amneal Pharmaceuticals NY LLC
Route:ORAL
Strength:500 mg in 1 1
Approved: 2023/04/27
NDC:60219-1424
VIGABATRIN
Manufacturer:Par Pharmaceutical, Inc.
Route:ORAL
Strength:50 mg in 1 mL
Approved: 2021/10/19
NDC:49884-358
VIGPODER
Manufacturer:Pyros Pharmaceuticals, Inc.
Route:ORAL
Strength:50 mg in 1 mL
Approved: 2024/03/20
NDC:80789-117

Singapore Approved Products

SABRIL TABLET 500 mg
Manufacturer:Patheon France
Form:TABLET, FILM COATED
Strength:500 mg
Online:Yes
Approved: 1994/12/09
Approval:SIN07955P

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