Prescribing Information


Clinical Pharmacology
Efficacy
Safety
Dosage and Administration


 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



  

DOSAGE and ADMINISTRATION
  • Administration must be through a central line. Administration through a peripheral line may cause burns.
  • AMMONUL® is a sterile, concentrated solution intended for intravenous (IV) administration only after dilution with sterile Dextrose Injection, 10%.
  • AMMONUL® is administered via a bolus IV dose over a 90 to 120 minute period. A maintenance infusion of the same dose should be administered over 24 hours or until the patient is no longer hyperammonemic or until the patient can tolerate oral nutrition and medications.
  • Intravenous arginine is an essential component of therapy for patients with CPS, OTC, ASS, and ASL deficiency.
Patient Population
Components of Infusion Solution
AMMONUL® must be diluted with 10% sterile dextrose injection at > 25 mL/kg before administration
Dosage Provided

AMMONUL

10%
Arginine
HCl
Injection

Sodium Phenylacetate

Sodium Benzoate

Arginine
HCl
CPS and OTC Deficiency (0 to 20 kg)
Dose
Loading: over 90 to 120 minutes

Maintenance: over 24 hours

2.5
mL/kg
2.0
mL/kg
250
mg/kg
250 mg/kg
200 mg/kg
ASS and ASL Deficiency (0 to 20 kg)
Dose
Loading: over 90 to 120 minutes

Maintenance: over 24 hours

2.5
mL/kg
6.0
mL/kg
250
mg/kg
250 mg/kg
600 mg/kg
CPS and OTC Deficiency (>20 kg)
Dose
Loading: over 90 to 120 minutes

Maintenance: over 24 hours

55
mL/m2
2.0
mL/kg
5.5
g/m2
5.5
g/m2
200 mg/kg
ASS and ASL Deficiency (>20 kg)
Dose
Loading: over 90 to 120 min.
Maintenance: over 24 hours.

55
mL/m2
6.0
mL/kg
5.5
g/m2
5.5
g/m2
600 mg/kg

  • Because of prolonged plasma levels achieved by phenylacetate in pharmacokinetic studies, repeat loading doses should not be administered.
  • Dialysis is recommended for those patients who fail to have a significant reduction in plasma ammonia levels within four to eight hours after receiving AMMONUL®.
  • AMMONUL® can be continued during dialysis as it suppresses the production of ammonia from catabolism of endogenous proteins and dialysis eliminates the ammonia and ammonia conjugates.
  • Treatment of hyperammonemia also requires caloric supplementation and restriction of dietary protein.

Please see prescribing information for complete dosage and administration instructions.

Click here for important safety information

Click here for Full Prescribing Information

 
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