SAFETY

Adverse Events Occurring in ≥3% of Patients Treated With AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%
Adverse Event No. of Patients (%)
(n=316)
Number of patients with any adverse event 163 (52%)

Blood and lymphatic system disorders
         Anemia
         Disseminated intravascular coagulation

 35 (11%)
12 (4%)
11 (3%)
Cardiac disorders 28 (9%)

Gastrointestinal disorders
         Diarrhea
         Nausea
         Vomiting

 42 (13%)
10 (3%)
9 (3%)
29 (9%)

General disorders and administration-site conditions
         Injection-site reactions
         Pyrexia

45 (14%)
11 (3%)
17 (5%)

Infections
         Urinary tract infection

 39 (12%)
9 (3%)
Injury, poisoning, and procedural complications 12 (4%)
Investigations 32 (10%)

Metabolism and nutrition disorders
         Acidosis
         Hyperammonemia
         Hyperglycemia
         Hypocalcemia
         Hypokalemia
         Metabolic acidosis

67 (21%)
8 (3%)
17 (5%)
22 (7%)
8 (3%)
23 (7%)
13 (4%)

Nervous system disorders
         Brain edema
         Coma
         Convulsions
         Mental impairment

71 (22%)
17 (5%)
10 (3%)
19 (6%)
18 (6%)

Psychiatric disorders
         Agitation

16 (5%)
8 (3%)
Renal and urinary disorders 14 (4%)

Respiratory, thoracic, and mediastinal disorders
         Respiratory distress

 47 (15%)
9 (3%)
Skin and subcutaneous tissue disorders 19 (6%)

Vascular disorders
         Hypotension

 19 (6%)
14 (4%)
 
  • Adverse events leading to study drug discontinuation occurred in 4% of patients.
  • AMMONUL should not be administered to patients with known hypersensitivity to sodium phenylacetate or sodium benzoate.
  • See the prescribing information for a complete listing of warnings, precautions, drug interactions, and overdosage information.

Important Safety Information for AMMONUL Injection 10% / 10%

  • IMPORTANT: Filtration required. Due to the possibility that particulate matter may impact the safe use of this product and to ensure optimal patient care, you are instructed to use the Millex® Durapore GV 33 mm Sterile Syringe Filter (0.22 μm) during the admixture process when injecting AMMONUL into the 10% dextrose IV bag. Note that particulate matter may not be readily seen on visual inspection, so this filter must be employed in all cases regardless of whether particulate matter is seen in the vial.
  • The most common adverse reactions are vomiting (9%), hyperglycemia (7%), hypokalemia (7%), convulsions (6%), and mental impairment (6%).
  • Dilute AMMONUL with sterile 10% Dextrose Injection (D10W) before administration. Use a central venous catheter line; use of a peripheral line may cause burns.
  • Monitor patients for prolonged exposure to elevated plasma ammonia levels as this can rapidly result in injury to the brain or death. Promptly use any therapies necessary to reduce plasma ammonia levels.
  • Monitor plasma potassium levels carefully and treat as necessary.
  • Use caution if AMMONUL is administered to patients with congestive heart failure, severe renal insufficiency, or with a condition in which there is sodium retention with edema.
  • Monitor the infusion site for possible tissue infiltration since extravasation of AMMONUL into the perivenous tissues during high flow bolus infusion may lead to skin necrosis, especially in infants.
  • Do not administer repeat loading doses because of prolonged plasma levels achieved by phenylacetate in pharmacokinetic studies.
  • Monitor patient blood chemistry profiles and perform frequent blood pH and pCO2 measurements because AMMONUL may cause side effects typically associated with salicyclate overdose such as hyperventilation and metabolic acidosis.
  • Administration of valproic acid to patients with urea cycle disorders may exacerbate their condition and antagonize the efficacy of AMMONUL.

Click here for Full Prescribing Information for AMMONUL