AMMONUL SUMMARY
AMMONUL®
(sodium phenylacetate and sodium benzoate) Injection
10% / 10%
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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