SODIUM PHENYLACETATE AND SODIUM BENZOATE injection, solution, concentrate

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

sodium phenylacetate (UNII: 48N6U1781G) (phenylacetic acid - UNII:ER5I1W795A), sodium benzoate (UNII: OJ245FE5EU) (benzoic acid - UNII:8SKN0B0MIM)

Tilgjengelig fra:

Ailex Pharmaceuticals, LLC

INN (International Name):

sodium phenylacetate

Sammensetning:

sodium phenylacetate 100 mg in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

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%