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Ammonul (Sodium Phenylacetate / Sodium Benzoate) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Drug Interactions

Formal drug interaction studies have not been performed with AMMONUL®.

OVERDOSAGE

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].

CONTRAINDICATIONS

AMMONUL® should not be administered to patients with known hypersensitivity to sodium phenylacetate or sodium benzoate.

REFERENCES

  1. Brusilow SW, Danney M, Waber LJ, Batshaw M, Burton B, Levitsky L, Roth K, McKeethren C, Ward J. Treatment of episodic hyperammonemia in children with inborn errors of urea synthesis. N Engl J Med 1984; 310:1630–1634.
  2. Thibault A, Cooper MR, Figg WD, Venzon DJ, Sartor AO, Tompkins AC, Weinberger MS, Headlee DJ, McCall NA, Samid D, Myers CE. A Phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer. Cancer Research 1994; 54:1690–1694.
  3. Thibault A, Samid D, Cooper MR, Figg WD, Tompkins AC, Patronas N, Headlee DJ, Kohler DR, Venzon DJ, Myers CE. Phase I study of phenylacetate administered twice daily to patients with cancer. Cancer 1995; 75:2932–2938.
  4. Batshaw M, MacArthur RB, Tuchman M. Alternative pathway therapy for urea cycle disorders: Twenty years later. Proceedings of a Consensus Conference for the Management of Patients with Urea Cycle Disorders. J. Pediatr 2001; 138:S46–S55.
  5. The Urea Cycle Disorders Conference Group. Consensus statement from a conference for the management of patients with urea cycle disorders. Proceedings of a Consensus Conference for the Management of Patients with Urea Cycle Disorders. J. Pediatr 2001; 138:Sl–S5
  6. Legras A, Labarthe F, Maillot F, Garrigue MA, Kouatchet A, Ogier D. Late diagnosis of ornithine transcarbamylase defect in three related female patients: polymorphic presentations. Crit Care Med 2002 Jan;30(1)241–4.
  7. Tsuji A. Transporter-mediated drug interactions. Drug Metabol Pharmacokin 2002; 17(4):253–274.
  8. Williams CA, Tiefenbach S, McReynolds JW. Valproic acid-induced hyperammonemia in mentally retarded adults. Neurol 1984; 34: 550–553
  9. Batshaw ML, Brusilow SW. Valproate-induced hyperammonemia. Ann Neurol 1982; 11: 319–321.
  10. Msall M, Batshaw ML, Suss R, Brusilow SW, Mellits ED. Neurologic outcome in children with inborn errors of urea synthesis: outcome of urea-cycle enzymopathies. N Engl J Med 1984 Jun 7;310:1500–5.
  11. Schaefer F, Straube E, Oh J, Mehls O, Mayatepek E. Dialysis in neonates with inborn errors of metabolism. Nephrol Dial Transplant 1999;14:910–8.
  12. Neu AM, Christenson MJ, Brusilow SW. Hemodialysis for inborn errors of metabolism. In: Nissenson RA, Fine RN, editors. Dialysis therapy. 2nd ed. Philadelphia (PA): Hanley & Belfus; 1992. p. 371–372.
  13. Summar M. Current strategies for the management of neonatal urea cycle disorders. J Pediatr 2001; 138; S30–S39.
  14. Camp-Sorrell D. Developing extravasation protocols and monitoring outcomes. J lntrav Nurse 1998; 21:232–239.
  15. Wen GY, Wisniewski HM, Shek JW, Loo YH, Fulton TR. Neuropathology of phenylacetate poisoning in rats: An experimental model of phenylketonuria. Ann Neurol 1980; 7:557–566.
  16. Lacey DJ. Cortical dendritic spine loss in rat pups whose mothers were prenatally injected with phenylacetate ('maternal PKU' model). Dev Brain Res 1986; 27:283–285.
  17. Maestri NE, Hauser ER, Bartholomew D, Brusilow SW. Prospective treatment of urea cycle disorders. J. Pediatr 1991; 119:923–928.

Manufactured for:
Ucyclyd Pharma, Inc., a wholly-owned subsidiary of Medicis Pharmaceutical Corp., 8125 North Hayden Road, Scottsdale, AZ 85258

72050-08A

6800111762592C1

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