Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
SODIUM PHENYLACETATE (UNII: 48N6U1781G) (PHENYLACETIC ACID - UNII:ER5I1W795A), SODIUM BENZOATE (UNII: OJ245FE5EU) (BENZOIC ACID - UNII:8SKN0B0MIM)
Zydus Pharmaceuticals USA Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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) ]. None. Risk Summary Available data on the combination use of Sodium Phenylacetate and Sodium Benzoate in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Sodium Phenylacetate and Sodium Benzoate Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outc
Sodium Phenylacetate and Sodium Benzoate Injection 10% per 10% is clear and almost colorless solution supplied in a sterile, non-pyrogenic, single-dose glass vial. NDC 70710-1926-1 single-dose vial containing 20 mL of Sodium Phenylacetate and Sodium Benzoate Injection 10% per 10%. Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Abbreviated New Drug Application
SODIUM PHENYLACETATE AND SODIUM BENZOATE - SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE ZYDUS PHARMACEUTICALS USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION. SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1987 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) DOSAGE AND ADMINISTRATION Sodium Phenylacetate and Sodium Benzoate Injection 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 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) See Full Prescribing Information for complete dosing recommendations. 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 Decreased Potassium Levels: Plasma potassium levels should be carefully monitored and appropriate treatment given when necessary. (5.1) Conditions Associated with Fluid Overload: Sodium Phenylacetate and Sodium Benzoate Injection contains 30.5 mg of sodium per mL of undiluted product. Caution should be used if Sodium Phenylacetate and Sodium Benzoate Injection is administered to patients with congestive heart failure, severe renal insufficiency, or with cond Baca dokumen lengkapnya