sodium phenylacetate and sodium benzoate
Drug Details
- Generic Name
- sodium phenylacetate and sodium benzoate
- Brand Names
- SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM PHENYLACETATE and SODIUM BENZOATE
- Application Number
- ANDA205880
- Sponsor
- Zydus Pharmaceuticals USA Inc.
- NDC Codes
- 5
- Dosage Forms
- INJECTION, SOLUTION, CONCENTRATE
- Routes
- INTRAVENOUS
- Active Ingredients
- SODIUM BENZOATE, SODIUM PHENYLACETATE
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) ].