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Ammonul Generic Name & Formulations
Legal Class
Rx
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
Manufacturer
Ammonul Indications
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
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
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
