Sodium Benzoate

FDA Drug Profile

Drug Details

Generic Name
Sodium Benzoate
Brand Names
N/A
Application Number
Sponsor
MSN Life Sciences Private Limited
NDC Codes
2
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
SODIUM BENZOATE

Indications and Usage

1 INDICATIONS AND USAGE Sodium Phenylacetate and Sodium Benzoate Injection is a nitrogen binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in paediatric and adult patients with deficiencies in enzymes of the urea cycle. ( 1 ) Sodium Phenylacetate and Sodium Benzoate Injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [ see Warnings and Precautions (5) ].