Drugplain

SODIUM PHENYLACETATE and SODIUM BENZOATE 100 mg/mL

sodium phenylacetate and sodium benzoate · INJECTION, SOLUTION, CONCENTRATE · Omnivium Pharmaceuticals LLC

No Recall HistoryCurrently in Shortage
Plain English

SODIUM PHENYLACETATE and SODIUM BENZOATE is a injection, solution, concentrate containing sodium phenylacetate and sodium benzoate at 100 mg/mL, taken intravenous. Manufactured by Omnivium Pharmaceuticals LLC.

Key Facts

Brand Name
SODIUM PHENYLACETATE and SODIUM BENZOATE
Generic Name
sodium phenylacetate and sodium benzoate
NDC Code (Product)
81665-203
Manufacturer
Omnivium Pharmaceuticals LLC
Strength
100 mg/mL
Dosage Form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Marketing Status
Application #
ANDA207096
Marketing Start
02/25/2025

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 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 paediatric and adult patients with deficiencies in enzymes of the urea cycle. ( 1 ) 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) ].

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 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. 2.1 Recommended Dosage Sodium Phenylacetate and Sodium Benzoate Injection must be diluted with sterile 10% Dextrose Injection (D10W) before administration. The dilution and dosage of Sodium Phenylacetate and Sodium Benzoate Injection are determined by weight for neonates, infants and young children, and by body surface area for larger patients, including older children, adolescents, and adults (Table 1). Table 1: Dosage and Administration Abbreviations: CPS - carbamyl phosphate synthetase; OTC - ornithine transcarbamylase; ASS - argininosuccinate synthetase; ASL - argininosuccinate lyase Patient Population Co…

Contraindications

4 CONTRAINDICATIONS None ( 4 ) None.

Drug Interactions

7 DRUG INTERACTIONS Some antibiotics such as penicillin may affect the overall disposition of the infused drug. ( 7 ) Probenecid may affect renal excretion of phenylacetylglutamine and hippurate. ( 7 ) Valproic acid given to patients with urea cycle disorders may exacerbate their condition and antagonize the efficacy of Sodium Phenylacetate and Sodium Benzoate Injection through inhibition of the synthesis of N-acetylglutamate, a co-factor for carbamyl phosphate synthetase. ( 7 ) Use of corticosteroids may cause the breakdown of body protein and potentially increase plasma ammonia levels in patients with impaired ability to form urea. ( 7 ) Formal drug interaction studies have not been performed with Sodium Phenylacetate and Sodium Benzoate Injection. Some antibiotics such as penicillin may compete with phenylacetylglutamine and hippurate for active secretion by renal tubules, which may affect the overall disposition of the infused drug. Probenecid is known to inhibit the renal transport of many organic compounds, including aminohippuric acid, and may affect renal excretion of phenylacetylglutamine and hippurate. There have been reports that valproic acid can induce hyperammonemia t…

Adverse Reactions

6 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 Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data were obtained from 316 patients who received Sodium Phenylacetate and Sodium Benzoate Injection as emergency (rescue) or prospective treatment for hyperammonemia as part of an uncontrolled, open-label study. The study population included patients between the ages of 0 to 53 years with a mean (SD) of 6.2 (8.54) years; 51% were male and 49% were female who had the following diagnoses: OTC (46%), ASS (22%), CPS (12%), ASL (2%), ARG (<1%), THN (<1%), and other (18%). Adverse reactions were reported with similar frequency in patients with OTC, ASS, CPS,…

Frequently Asked Questions

What is SODIUM PHENYLACETATE and SODIUM BENZOATE used for?

SODIUM PHENYLACETATE and SODIUM BENZOATE contains sodium phenylacetate and sodium benzoate. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.

Is SODIUM PHENYLACETATE and SODIUM BENZOATE a controlled substance?

SODIUM PHENYLACETATE and SODIUM BENZOATE is not classified as a controlled substance by the DEA.

What is the generic name for SODIUM PHENYLACETATE and SODIUM BENZOATE?

The generic name for SODIUM PHENYLACETATE and SODIUM BENZOATE is sodium phenylacetate and sodium benzoate. There are 7 other brand versions of sodium phenylacetate and sodium benzoate.

What is the NDC code for SODIUM PHENYLACETATE and SODIUM BENZOATE 100 mg/mL?

The NDC (National Drug Code) for SODIUM PHENYLACETATE and SODIUM BENZOATE 100 mg/mL is 81665-203, listed by Omnivium Pharmaceuticals LLC.

Product NDC

81665-203

Package NDC

81665-203-01

Other Sodium Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)