Sodium Benzoate is widely used as a preservative in various food-industries to extend the shelf-life of the product such as Jams and Jellies. It is used as an oral formulation for the treatment of patients with urea cycle disorders.

Sodium benzoate Uses:

• Urea cycle disorders:

  • It is used as an adjunctive treatment for the treatment and prevention of hyperammonemia due to urea cycle disorders.

Sodium Benzoate Dose in Adults

Note:

• Sodium benzoate is not available for use as a ready-to-use product. The drug needs compounding.
• Some patients may require intravenous administration of the drug. It is important to be aware of the serious adverse events associated with the intravenous formulation and see the drug monograph.

Sodium Benzoate Dose in Childrens

Note:

• Sodium benzoate is not available for use as a ready-to-use product. The drug needs compounding.
• Some patients may require intravenous administration of the drug. It is important to be aware of the serious adverse events associated with the intravenous formulation and see the drug monograph.

Sodium Benzoate Dose in the treatment of Urea cycle disorders, long-term therapy:

Note: Consult a metabolic specialist while treating patients with urea cycle disorders. Individualize the dose based on individual treatment response.

• Infants, Children, and Adolescents:

  • 250 to 500 mg/kg/day orally in 3 to 4 divided doses.
  • Administer the drug with meals.

Sodium Benzoate Pregnancy Risk Category: C

• Benzoic acid can cross the placental barriers when it is administered prior to delivery. It can also be detected in the umbilical cord, serum and blood of the newborn.
• Its use in the treatment of urea-cycle disorders and ornithine deficiency during pregnancy has not been documented.
• Because pregnancy is a hypermetabolic condition, it is important to monitor both symptomatic and non-symptomatic patients closely. It may trigger hyperammonemia episodes or last for one week.
• Treatment of pregnant women is recommended if serum ammonia levels exceed 1.5-2 times normal.
• It has been shown that the drug can prevent hyperammonemia in babies born to mothers with urea-cycle disorder.
• Patients with urea-cycle disorders should have good metabolic control before they can conceive.

Use during breastfeeding:

• It is unknown if the drug will be excreted into breastmilk.
• Nursing mothers need to be able to get enough energy.
• People with urea cycles disorders and other urologic conditions require careful protein monitoring

Dose in Kidney Disease:

Use with caution in patients with renal impairment as dosing recommendations in kidney disease is not available.

Dose in Liver disease:

Use with caution in patients with hepatic impairment as dosing recommendations in liver disease is not available.

Side effects of Sodium benzoate:

Adverse reactions are from multiple indications and dosing.

• Cardiovascular:

  • ECG Abnormality

• Gastrointestinal:

  • Anorexia
  • Dyspepsia
  • Epigastric Distress
  • Gastritis
  • Mucositis
  • Nausea.
  • Vomiting

• Endocrine & Metabolic:

  • Hypokalemia
  • Increased Serum Sodium
  • Metabolic Acidosis

• Renal:

  • Renal Tubular Disease

Contraindications to Sodium benzoate:

Warnings and precautions

• Acidemia:

  • Patients suffering from methylmalonic or propionic acidemia should be cautious about taking the drug.

• Reye syndrome:

  • Reye syndrome patients should be cautious when taking the drug.

Sodium benzoate: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

• Monitor Plasma ammonia levels,
• Quantitative plasma amino acid and glutamine concentrations,
• Blood glucose levels,
• Serum electrolytes,
• Liver and renal function tests,
• Blood gases,
• Neurologic status,
• Physical signs and symptoms of hyperammonemia may manifest as lethargy, drowsiness, confusion, ataxia, impaired memory, vomiting, and seizures.

How to administer Sodium benzoate?

• Administer orally with meals and abundant fluids.
• Since the drug is not available commercially and requires compounding, a metabolic specialist must be consulted beforehand.

Mechanism of action of Sodium benzoate:

• It lowers serum ammonia through activating the alternative benzoate–hippurate pathway, which is a non urea cycle pathway.
• This pathway allows ammonia to be metabolized by glycine, forming hippurate which is then excreted from the kidneys.

Half-life elimination:

• From 0.75 hours to 7.4hrs

Excretion:

• The urinary excretion hippurate, which is the main metabolite sodium benzoate, is responsible for drug clearance.

International Brand Names of Sodium benzoate:

• Amzoate
• Colufase
• Fu Tai

Sodium benzoate Brand Names in Pakistan:

No Brands Available in Pakistan.