SODIUM PHENYLACETATE AND SODIUM BENZOATE injection, solution, concentrate

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Zydus Pharmaceuticals USA Inc.

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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. Risk Summary Available data with Sodium Phenylacetate and Sodium Benzoate Injection 10% / 10% 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 10% / 10%. 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, los

ملخص المنتج:

Sodium Phenylacetate and Sodium Benzoate Injection 10% per 10% is supplied in a sterile, non-pyrogenic, single use glass vial. NDC 68382-396-01 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).

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

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 10% / 10% SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION 10%
/ 10%
SODIUM PHENYLACETATE AND SODIUM BENZOATE INJECTION 10% / 10%, 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)
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 10% /
10% contains 30.5 mg of sodium per mL of undiluted product. Caution
should be used if Sodium
Phenylacetate and Sodium Benzoate Injection 10% / 10% is administered
to patients with congestiv