AMMONUL^® (sodium phenylacetate and sodium benzoate) Injection 10%/10% is the only FDA-approved drug for the adjunctive treatment of acute hyperammonemia and associated encephalopathy in patients with urea cycle disorders (UCDs). Left untreated, UCDs can cause dangerously heightened levels of ammonia in the bloodstream (hyperammonemia) resulting in brain damage, coma, and/or death.

Indication and Usage
AMMONUL Injection 10%/10% 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. In such cases, the concomitant administration of AMMONUL can help prevent the re-accumulation of ammonia by increasing waste nitrogen excretion.

Treatment of hyperammonemia also requires caloric supplementation and restriction of dietary protein; intravenous arginine is an essential component of therapy for patients with CPS, OTC, ASS, or ASL deficiency.

Key Safety Information
The most common adverse reactions are vomiting (9%), hypokalemia (7%), hyperglycemia (7%), convulsions (6%), and mental impairments (6%). Do not administer to patients with known hypersensitivity to sodium phenylacetate or sodium benzoate. Acute symptomatic hyperammonemia should be treated as life-threatening. Uncontrolled hyperammonemia can result in brain damage or death. Dialysis may be required, preferably hemodialysis, to remove a large burden of ammonia. Administration must be through a central line; use of a peripheral line may cause burns. Do not administer undiluted product. Because of prolonged plasma levels achieved by phenylacetate in pharmacokinetic studies, repeat loading doses should not be administered. Use caution when administering to patients with hepatic or renal insufficiency. AMMONUL may cause nausea and vomiting. An antiemetic may be administered during infusion.

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