• Inborn errors of metabolism

Ammonul Generic Name & Formulations

General Description

Sodium phenylacetate 100mg, sodium benzoate 100mg; per mL; soln for IV infusion after dilution; contains 30.5mg Na+/mL; preservative-free.

How Supplied

Single-use vial—1

Ammonul Indications


Acute hyperammonemia with encephalopathy in urea cycle disorders, as adjunctive therapy.

Ammonul Dosage and Administration

Adults and Children

Discontinue sodium phenylbutyrate first. Give by IV infusion through central venous catheter. Loading dose: Infuse over 90–120 minutes. Maintenance dose: Infuse over 24 hours; continue until ammonia levels normalize or patient can tolerate oral nutrition and medications. 0–20kg: 2.5mL/kg. >20kg: 55mL/m2. Discontinue if extravasation occurs; may resume infusion at different site. Concomitant L-arginine dose dependent upon specific enzyme defiency. See full labeling.

Ammonul Contraindications

Not Applicable

Ammonul Boxed Warnings

Not Applicable

Ammonul Warnings/Precautions


Do not administer undiluted product. Uncontrolled hyperammonemia (may require hemodialysis). Renal or hepatic insufficiency. CHF. Sodium retention with edema. Perform blood chemistry profiles. Monitor ammonia levels, blood pH and pCO2, electrolytes, neurological status, and clinical response. May give antiemetic to reduce nausea and vomiting. Restrict dietary protein. Maintain adequate caloric intake. Labor & delivery. Pregnancy. Nursing mothers.

Ammonul Pharmacokinetics

See Literature

Ammonul Interactions


Corticosteroids may increase ammonia levels. May be antagonized by drugs that compete for active renal tubule secretion (eg, penicillin), probenecid, valproic acid.

Ammonul Adverse Reactions

Adverse Reactions

GI upset, convulsions, mental impairment, hyperglycemia, hypokalemia.

Ammonul Clinical Trials

See Literature

Ammonul Note

Not Applicable

Ammonul Patient Counseling

See Literature