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:

Mylan Institutional 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 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. Available data with sodium phenylacetate and sodium benzoate injection use 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 outcomes. In the U.S. g

Produkt oppsummering:

Sodium Phenylacetate and Sodium Benzoate Injection, 10% per 10% is supplied in a sterile, non-pyrogenic, single-dose glass vial. NDC 67457-844-50 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°C to 30°C (59°F to 86°F).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SODIUM PHENYLACETATE AND SODIUM BENZOATE- SODIUM PHENYLACETATE
AND SODIUM BENZOATE INJECTION, SOLUTION, CONCENTRATE
MYLAN INSTITUTIONAL LLC
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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 patients with
deficiencies in enzymes of the urea cycle. (1)
DOSAGE AND ADMINISTRATION
•
•
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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
•
•
•
•
•
ADVERSE REACTIONS
The most frequently reported adverse reactions (incidence ≥ 6%) are
vomiting, hyperglycemia,
hypokalemia, convulsions, and mental impairment. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
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.
Decreased Potassium Levels: Plasma potassium levels should be
carefully monitored and appropriate
treatment given when necessary. (