מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
sodium phenylacetate (UNII: 48N6U1781G) (phenylacetic acid - UNII:ER5I1W795A), sodium benzoate (UNII: OJ245FE5EU) (benzoic acid - UNII:8SKN0B0MIM)
Ailex Pharmaceuticals, LLC
sodium phenylacetate
sodium phenylacetate 100 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% 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) ]. None. Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10%. It is not known whether Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Thus, Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% should be given to a pregnant woman only if clearly needed. It is not known whether sodium phenylacetate, sodium benzoate, or their conjugation p
Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% is supplied in a single-dose glass vial. NDC 70556-100-50 single-dose vial containing 50 mL of sodium phenylacetate and sodium benzoate injection 10% per 10%. Storage: Store at 25°C (77°F), excursions permitted to 15°–30°C (59°–86°F).
Abbreviated New Drug Application
SODIUM PHENYLACETATE AND SODIUM BENZOATE- SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE AILEX PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, 10%/10% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, 10%/10%. SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1987 INDICATIONS AND USAGE Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% is a nitrogen binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. (1) DOSAGE AND ADMINISTRATION Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% must be diluted with sterile 10% Dextrose Injection (D10W) before administration. Administration must be through a central venous catheter. Administration through a peripheral line may cause burns. (2) Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% is administered intravenously as a loading dose infusion administered over 90 to 120 minutes, followed by an equivalent maintenance dose infusion administered over 24 hours. (2) DOSAGE FORMS AND STRENGTHS Injection: 10% per 10% sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Management of Acute Hyperammonemia: Monitor plasma ammonia levels during treatment. Prolonged exposure to elevated plasma ammonia levels can rapidly result in injury to the brain or death. Prompt use of all therapies necessary to reduce plasma ammonia levels is essential. (5.1) Decreased Potassium Levels: Plasma potassium levels should be carefully monitored and appropriate treatment given when necessary. (5.2) Conditions Associated with Fluid Overload: Sodium Phenylacetate and Sodium Benzoate Injection, 10% קרא את המסמך השלם