SODIUM PHENYLACETATE AND SODIUM BENZOATE injection, solution, concentrate

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Mylan Institutional LLC

DCI (Dénomination commune internationale):

SODIUM PHENYLACETATE

Composition:

SODIUM PHENYLACETATE 100 mg in 1 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4%, and 15 to 20%, respectively. There are no data on the presence of sodium phenylacetate, sodium benzoate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sodium phenylacetate and sodium benzoate injection and any potential adverse effects on the breastfed infant from sodium phenylacetate and sodium benzoate injection or from the underlying maternal condition. Sodium phenylacetate and sodium benzoate injection has been used as a treatment for acute hyperammonemia in pediatric patients including patients in the early neonatal period [see Dosage and Administration (2) ]. Clinical studies of sodium phenylacetate and sodium benzoate injection did not include any patients aged 65 and over to determine whether they respond differently from younger patients. Urea cycle disorders are presently diseases of the pediatric and younger adult populations. No pharmacokinetic studies of sodium phenylacetate and sodium benzoate injection have been performed in geriatric patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population. Pharmacokinetic parameters of sodium phenylacetate and sodium benzoate injection were compared in healthy males and females. Bioavailability of both benzoate and phenylacetate was slightly higher in females than in males. However, conclusions cannot be drawn due to the limited number of subjects in this study. Limited information is available on the metabolism and excretion of sodium phenylacetate and sodium benzoate in patients with impaired hepatic function. However, metabolic conjugation of sodium phenylacetate and sodium benzoate is known to take place in the liver and kidney. Therefore, caution should be used in administering sodium phenylacetate and sodium benzoate injection to patients with hepatic insufficiency. The drug metabolites of sodium phenylacetate and sodium benzoate injection (phenylacetylglutamine and hippurate) and subsequently ammonia are primarily excreted by the kidney. Therefore, use caution and closely monitor patients with impaired renal function who receive sodium phenylacetate and sodium benzoate injection.

Descriptif du produit:

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).

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

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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•
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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. (