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Ammonul (Sodium Phenylacetate / Sodium Benzoate) - Summary



AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10% / 10% is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate, used for the treatment of hyperammonemia in urea cycle disorders. 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.

AMMONUL® is indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. In acute neonatal hyperammonemic coma, in moderate to severe episodes of hyperammonemic encephalopathy, and in episodes of hyperammonemia which fail to respond to an initial course of AMMONUL® therapy, hemodialysis is the most rapid and effective technique for removing ammonia [12,13]. In such cases, the concomitant administration of AMMONUL® can help prevent the re-accumulation of ammonia by increasing waste nitrogen excretion [4,5,13].

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Published Studies Related to Ammonul (Sodium Phenylacetate / Sodium Benzoate)

Pharmacokinetics of sodium phenylacetate and sodium benzoate following intravenous administration as both a bolus and continuous infusion to healthy adult volunteers. [2004.04]
BACKGROUND: Ammunol (sodium phenylacetate/sodium benzoate) is an intravenously administered, investigational drug used for the treatment of acute hyperammonemia in infants, children, and adults with urea cycle enzyme deficiencies. A pharmacokinetic study of sodium phenylacetate/sodium benzoate (NAPA/NABZ) was performed in two groups of normal healthy volunteers, following the dosing regimen used to treat hyperammonemia... CONCLUSION: These data describe the pharmacokinetics of PA and BZ, and their respective metabolites, as observed in healthy adult volunteers, with the higher dose studied equivalent to that used to treat hyperammonemia. Dose optimization is required to maximize nitrogen removal, while minimizing the risk of toxicity, especially due to PA. Because of the slower elimination of PA, and the non-linear pharmacokinetic behavior displayed by both PA and BZ, only investigational protocol-specific doses should be used, and higher doses should be avoided unless blood level monitoring can be done promptly and frequently.

Three cases of intravenous sodium benzoate and sodium phenylacetate toxicity occurring in the treatment of acute hyperammonaemia. [2000.03]
Intravenous sodium benzoate and sodium phenylacetate have been used successfully in the treatment of acute hyperammonaemia in patients with urea cycle disorders. They provide alternative pathways for waste nitrogen disposal and help maintain nitrogen homeostasis...

Hyperammonemic encephalopathy after chemotherapy. Survival after treatment with sodium benzoate and sodium phenylacetate. [1997.12]
A 16-year-old boy had hyperammonemia and encephalopathy develop after high-dose chemotherapy for acute lymphoblastic leukemia. He was treated successfully with the ammonia-trapping agents sodium benzoate and sodium phenylacetate..

Effect of sodium benzoate and sodium phenylacetate on brain serotonin turnover in the ornithine transcarbamylase-deficient sparse-fur mouse. [1988.04]
Herein we examine the effects of sodium benzoate and sodium phenylacetate on feeding and central serotonin turnover in a child with citrullinemia and in an animal model of congenital hyperammonemia, the ornithine transcarbamylase-deficient sparse-fur (spf/y) mouse.

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Clinical Trials Related to Ammonul (Sodium Phenylacetate / Sodium Benzoate)

Efficacy and Safety Study of Ammonul´┐Ż in Patients With Grade 3 or 4 Hepatic Encephalopathy [Withdrawn]
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul« in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).

A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P) [Completed]

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Page last updated: 2007-06-01

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