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Outline
What is the generic name?
VIGABATRIN
What is the Trade Name for VIGABATRIN?
SABRIL
What are the Indications for VIGABATRIN?
- 1 INDICATIONS AND USAGE SABRIL is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; SABRIL is not indicated as a first line agent ( 1.1 ) Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2 ) 1.1 Refractory Complex Partial Seizures (CPS) SABRIL is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions ( 5.1 )] . SABRIL is not indicated as a first line agent for complex partial seizures. 1.2 Infantile Spasms (IS) SABRIL is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions ( 5.1 ) ].
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References: https://open.fda.gov/
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