VIGABATRIN
VIGABATRIN
Manufacturer: Hikma Pharmaceuticals USA Inc
Black Box Warning (Boxed Warning)
A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.
FDA-Approved Indications (2)
For infantile spasms (IS) - 1 month to 2 years of age.
Vigabatrin tablets are 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 al…
Population: adults and pediatric patients ≥2 years
Indications & Usage
1 INDICATIONS AND USAGE Vigabatrin tablets are 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; vigabatrin tablets are 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) Vigabatrin tablets are 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) ] . Vigabatrin tablets are not indicated as a first line agent for complex partial seizures. 1.2 Infantile Spasms (IS) Vigabatrin 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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