Sodium benzoate + sodium phenylacetate

Generic name
Sodium benzoate + sodium phenylacetate
Brand name
ATC Code
A16AX

Sodium benzoate + sodium phenylacetate

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Hyperammoniaemia
  • Intravenous
    • < 20 kg
      • After dilution in 10% glucose:
        Initial dose:
        250 mg/kg sodium benzoate and 250 mg/kg sodium phenylacetate intravenous infusion in 90 to 120 minutes, only via a central line.
        Maintenance dose:
        250 mg/kg sodium benzoate and 250 mg/kg sodium phenylacetate intravenous infusion in 24 hours, only via a central line

    • ≥ 20 kg
      • After dilution in 10% glucose:
        Initial dose:
        Loading dose: 5.5 g/m² sodium benzoate and 5.5 g/m² sodium phenylacetate intravenous infusion in 90 to 120 minutes, only via a central line.
        Maintenance dose:
        Maintenance dose: 5.5 g/m² sodium benzoate and 5.5 g/m² sodium phenylacetate intravenous infusion in 24 hours, only via a central line.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Possible tissue necrosis on extravasation of Ammonul during rapid bolus infusion, particularly in infants.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16AB03
A16AB04
A16AB07
A16AB13
A16AB22
A16AA06
A16AA05
A16AB17
A16AX10
A16AB08
A16AX09
A16AX
A16AB09
A16AB02
A16AB05
A16AA01
A16AX18
A16AA04
A16AX06
A16AX04
A16AX07
A16AB14
A16AX08
A16AX07
A16AB10
A16AX05

References

  1. Ucyclyd Pharma, Inc, FDA Label Ammonul, http://www.accessdata.fda.gov, http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020645s008lbl.pdf
  2. Enns GM, et al, Survival after treatment with phenylacetate and benzoate for urea-cycle disorders, N Engl J Med, 2007, May 31;356(22), 2282-92
  3. Summar ML, et al, Diagnosis, symptoms, frequency and mortality of 260 patients with urea cycle disorders from a 21-year, multicentre study of acute hyperammonaemic episodes, Acta Paediatr, 2008, Oct;97(10), 1420-5

Changes

Therapeutic Drug Monitoring


Overdose