Parenteral Manual

Ammonul (SPECIAL ACCESS PROGRAM)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Sodium Benzoate/Sodium Phenylacetate
Classification: 
Urea cycle disorder treatment agent
Original Date: 
August 2005
Revised Date: 
September 2011
Indications: 
  • Acute treatment of hyperammonemia associated with urea cycle disorders
Reconstitution and Stability: 
  • Store at room temperature
  • Available as a 10% solution which equals:
    - 100 mg/mL sodium phenylacetate
    - 100 mg/mL sodium benzoate
  • Must be diluted before administration
  • Filter through a Millex-GV mm sterile filter 0.22 micron while injecting drug into D10W minibag
  • Solutions with sodium bicarbonate are stable 24 hours at room temperature
  • Solutions with D10W and/or arginine stable 24 hours
Compatibility: 

- Solutions Compatible: D10W ONLY

- Additive/Above Cassette Compatible: arginine HCl, sodium bicarbonate

- Y-site Compatibility: arginine HCL, sodium bicarbonate

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM NO
IV Direct

NO
IV Intermittent Infusion YES; central line preferred
Usual dilution: 10 mg/mL
Infusion time: 90 minutes
IV Continuous Infusion YES; central line preferred
Usual dilution: 10 mg/mL
Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

  • Loading: 250 mg/kg/dose IV as a loading dose. Give IV over 90 minutes
  • Maintenance: Followed by 250 mg/kg/day as a continuous IV infusion
                                    OR
  • Loading: 5.5 g/m2/dose IV as a loading dose. Give IV over 90 minutes
  • Maintenance: Followed by 5.5 g/m2/day as a continuous IV infusion

 

Potential hazards of parenteral administration: 
  • IV infiltration may cause necrosis and phlebitis
  • Nausea, vomiting (especially with loading dose)
  • Metabolic acidosis, hyperglycemia, hypokalemia, hypocalcemia, hyperammonemia, hypernatremia
  • Convulsions, mental impairment
Notes: 
  • Monitor plasma ammonia levels, neurological status, blood pH and pCO2
  • Use caution in patients with renal or hepatic insufficiency
  • Caution in neonates: displaces bilirubin from protein-binding sites
  • Administration of analogous oral drugs (Buphenyl), should be stopped prior to sodium phenylacetate/sodium benzoate infusion.
  • Ammonul® 100 mg/mL contains 0.52 mmol of sodium/mL
  • Available in metabolic kit in resus room in emergency
References: 

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