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

Interactions
PK
Renal impairment
References

Sodium benzoate + sodium phenylacetate

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

Pharmacokinetics in children

No information

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

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Available formulations

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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.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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.

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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.

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Interactions

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

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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

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Changes

Changes