Sodium Phenylacetate and Sodium Benzoate Injection

Dosage form: injection
Drug class:Miscellaneous uncategorized agents

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Indications and Usage for Sodium Phenylacetate and Sodium Benzoate Injection

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)].

Sodium Phenylacetate and Sodium Benzoate Injection Dosage and Administration

Recommended Dosage

Sodium Phenylacetate and Sodium Benzoate Injection must be diluted with sterile 10% Dextrose Injection (D10W) before administration. The dilution and dosage of Sodium Phenylacetate and Sodium Benzoate Injection are determined by weight for neonates, infants and young children, and by body surface area for larger patients, including older children, adolescents, and adults (Table 1).

Administration

Sodium Phenylacetate and Sodium Benzoate Injection is a concentrated solution and must be diluted before intravenous administration via a central venous catheter. Administration through a peripheral intravenous catheter may cause burns. Sodium Phenylacetate and Sodium Benzoate Injection may not be administered by any other route.

Sodium Phenylacetate and Sodium Benzoate Injection should be administered as a loading dose infusion over 90 to 120 minutes, followed by the same dose repeated as a maintenance infusion administered over 24 hours. Because of prolonged plasma levels achieved by phenylacetate in pharmacokinetic studies, repeat loading doses of Sodium...