Sodium benzoate

Generic name
Sodium benzoate
Brand name
ATC Code
V04CE
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Sodium benzoate

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

There is no information about the pharmacokinetic parameters for sodium benzoate in children.

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
    • 0 years up to 18 years
      • Initial dose: 250 mg/kg/dose, once only in 90 minutes.
      • Maintenance dose: 250 mg/kg/day, continuous infusion. Max: 500 mg/kg/day.
        • The liquid for injection (50 mg/ml) must be diluted in at least twice the quantity of physiological saline.
        • Together with phenylbutyrate, arginine or citrulline, depending on the diagnosis.

        Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using sodium benzoate for this indication.
Maintenance treatment for hyperammonaemia as a result of urea cycle defects
  • Oral
    • 0 years up to 18 years
      • 250 mg/kg/day in 3 - 4 doses. Max: 500 mg/kg/day.
      • Directions for administration:

        Take immediately after a meal

      • Treatment by or after consultations with a paediatric specialist (metabolic disorders) who has experience using sodium benzoate for this indication.

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 in children

Nausea, vomiting, metabolic acidosis.

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

Not for organic acid disorders. Depending on the plasma concentration if possible. A properly running infusion is needed because of necrosis in the event of extravasation. Nausea: give a strong antiemetic beforehand. Watch out for hypernatraemia.

The taste of oral sodium benzoate is very unpleasant, so taking it at mealtimes is difficult. It should therefore preferably be taken immediately after a meal.

Interactions

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

DIAGNOSTIC AGENTS

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 DIAGNOSTIC AGENTS
V04C

References

  1. Blau, Hoffmann, Leonard and Clarke, Physicians guide to the treatment and follow-up of metabolic diseases., Springer, 2006
  2. Batshaw ML, Inborn errors of urea synthesis, Ann Neurol, 1994, Feb;35(2), 133-41
  3. Enns GM, et all, Survival after treatment with phenylacetate and benzoate for urea-cycle disorders, N Engl J Med, 2007, May 31;356(22), 2282-92
  4. Praphanphoj V, et al, Three cases of intravenous sodium benzoate and sodium phenylacetate toxicity occurring in the treatment of acute hyperammonaemia, J Inherit Metab Dis, 2000, Mar;23(2), 129-36
  5. Ucyclyd Pharma, Inc.,, FDA Label Ammonul, http://www.accessdata.fda.gov

Changes

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