Drug Information for AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% / 10% (Ucyclyd Pharma Inc.): OVERDOSAGE

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  • Overdosage has been reported during AMMONUL® treatment in urea cycle-deficient patients [17]. All patients in the uncontrolled open-label study were to be treated at the same dose of AMMONUL®. 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 AMMONUL®. 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 AMMONUL®, 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) [17].

  • Drug Information Provided by National Library of Medicine (NLM).
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