SODIUM PHENYLACETATE AND SODIUM BENZOATE injection, solution, concentrate

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

SODIUM PHENYLACETATE (UNII: 48N6U1781G) (PHENYLACETIC ACID - UNII:ER5I1W795A), SODIUM BENZOATE (UNII: OJ245FE5EU) (BENZOIC ACID - UNII:8SKN0B0MIM)

Disponible desde:

Trigen Laboratories, LLC

Designación común internacional (DCI):

sodium phenylacetate

Composición:

sodium phenylacetate 100 mg in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% is supplied in a single-dose glass vial. NDC 13811-705-50 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).

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

SODIUM PHENYLACETATE AND SODIUM BENZOATE- SODIUM PHENYLACETATE
AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE
TRIGEN LABORATORIES, 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) (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) (3)
CONTRAINDICATIONS
None (4) (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 In