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sodium phenylacetate and sodium benzoate

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Overview

What is SODIUM PHENYLACETATE and SODIUM BENZOATE?

Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% (a nitrogen binding agent), is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a crystalline, white to off-white powder with a strong, offensive odor. It is soluble in water. Sodium benzoate is a white and odorless, crystalline powder that is readily soluble in water.

Figure 1

Sodium phenylacetate has a molecular weight of 158.13 and the molecular formula CHNaO. Sodium benzoate has a molecular weight of 144.11 and the molecular formula CHNaO.

Each mL of Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment.

Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% injection is a sterile, concentrated solution intended for intravenous administration via a central line only after dilution [see ].



What does SODIUM PHENYLACETATE and SODIUM BENZOATE look like?



What are the available doses of SODIUM PHENYLACETATE and SODIUM BENZOATE?

Injection: 10% per 10% sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. ()

What should I talk to my health care provider before I take SODIUM PHENYLACETATE and SODIUM BENZOATE?

How should I use SODIUM PHENYLACETATE and SODIUM BENZOATE?

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].

Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% must be diluted with sterile 10% Dextrose Injection (D10W) before administration. The dilution and dosage of Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% 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).


What interacts with SODIUM PHENYLACETATE and SODIUM BENZOATE?

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What are the warnings of SODIUM PHENYLACETATE and SODIUM BENZOATE?

Sorry No Records found


What are the precautions of SODIUM PHENYLACETATE and SODIUM BENZOATE?

Sorry No Records found


What are the side effects of SODIUM PHENYLACETATE and SODIUM BENZOATE?

Sorry No records found


What should I look out for while using SODIUM PHENYLACETATE and SODIUM BENZOATE?

None.


What might happen if I take too much SODIUM PHENYLACETATE and SODIUM BENZOATE?

Overdosage has been reported during Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% treatment in urea cycle-deficient patients. All patients in the uncontrolled open-label study were to be treated with the same dose of Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10%. However, some patients received more than the dose level specified in the protocol. In 16 of the 64 deaths, the patient received a known overdose of Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10%. Causes of death in these patients included cardiorespiratory failure/arrest (6 patients), hyperammonemia (3 patients), increased intracranial pressure (2 patients), pneumonitis with septic shock and coagulopathy (1 patient), error in dialysis procedure (1 patient), respiratory failure (1 patient), intractable hypotension and probable sepsis (1 patient), and unknown (1 patient). Additionally, other signs of intoxication may include obtundation (in the absence of hyperammonemia), hyperventilation, a severe compensated metabolic acidosis, perhaps with a respiratory component, large anion gap, hypernatremia and hyperosmolarity, progressive encephalopathy, cardiovascular collapse, and death.

In case of overdose of Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10%, discontinue the drug and institute appropriate emergency medical monitoring and procedures. In severe cases, the latter may include hemodialysis (procedure of choice) or peritoneal dialysis (when hemodialysis is unavailable).


How should I store and handle SODIUM PHENYLACETATE and SODIUM BENZOATE?

TabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).TabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).TabletsStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).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%.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%.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Urea cycle disorders can result from decreased activity of any of the following enzymes: -acetylglutamate synthetase (NAGS), carbamyl phosphate synthetase (CPS), argininosuccinate synthetase (ASS), ornithine transcarbamylase (OTC), argininosuccinate lyase (ASL), or arginase (ARG).

Sodium phenylacetate and sodium benzoate are metabolically active compounds that can serve as alternatives to urea for the excretion of waste nitrogen. Figure 2 is a schematic illustrating how the components of Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10%, phenylacetate and benzoate, provide an alternative pathway for nitrogen disposal in patients without a fully functioning urea cycle. Phenylacetate conjugates with glutamine in the liver and kidneys to form phenylacetylglutamine, via acetylation. Phenylacetylglutamine is excreted by the kidneys via glomerular filtration and tubular secretion. The nitrogen content of phenylacetylglutamine per mole is identical to that of urea (both contain two moles of nitrogen). Two moles of nitrogen are removed per mole of phenylacetate when it is conjugated with glutamine. Similarly, preceded by acylation, benzoate conjugates with glycine to form hippuric acid, which is rapidly excreted by the kidneys by glomerular filtration and tubular secretion. One mole of hippuric acid contains one mole of waste nitrogen. Thus, one mole of nitrogen is removed per mole of benzoate when it is conjugated with glycine.

Figure 2

CPS = carbamyl phosphate synthetase;OTC = ornithine transcarbamylase;ASS = argininosuccinate synthetase;ASL = argininosuccinate lyase;ARG = arginase;NAGS = -acetylglutamate synthetase

Non-Clinical Toxicology
None.

Any episode of acute symptomatic hyperammonemia should be treated as a life-threatening emergency. Uncontrolled hyperammonemia can rapidly result in brain damage or death, and prompt use of all therapies necessary, including hemodialysis, to reduce ammonia levels is essential.

Hyperammonemic coma (regardless of cause) in the newborn infant should be aggressively treated while the specific diagnosis is pursued. Hemodialysis should be promptly initiated in all newborn patients. A blood flow rate of 150 mL/min/m should be targeted (ammonia clearance [mL/min] is similar to the blood flow rate [mL/min] through the dialyzer). Clearance of ammonia is approximately ten times greater by hemodialysis than by peritoneal dialysis or hemofiltration. Exchange transfusion is ineffective in the management of hyperammonemia. Hemodialysis may be repeated until the plasma ammonia level is stable at normal or near normal levels.

Hyperammonemia due to urea cycle disorders should be managed in coordination with medical personnel experienced in metabolic disorders. Ongoing monitoring of plasma ammonia levels, neurological status, laboratory tests, and clinical response in patients receiving Sodium Phenylacetate and Sodium Benzoate Injection, 10%/10% is crucial to assess patient response to treatment.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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