Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Assists in lowering serum ammonia levels by activation of a nonurea cycle pathway (the benzoate-hippurate pathway); ammonia in the presence of benzoate will conjugate with glycine to form hippurate which is excreted by the kidney.
It is used in the treatment of Urea cycle disorders.
Sodium Benzoate is approved for use in the following clinical indications
Urea cycle disorders: Adjunctive therapy for the prevention and treatment of hyperammonemia due to suspected or proven urea cycle disorders
Adult
Oral: Administer with meals and abundant fluid. Not commercially available; must be compounded using chemical powder; consult metabolic specialist.
Pediatric:
Oral: Administer with meals or feeds. Not commercially available; must be compounded using chemical powder; consult metabolic specialist.
Sodium Benzoate is available in various strengths as 454 g.
Sodium Benzoate is available in the form of Powder.
Dosage Adjustment for Pediatric Patients
● Urea cycle disorders, long-term therapy:
Very limited data available: Dosage should be individualized based on patient response; consult metabolic specialist: Infants, Children, and Adolescents: Oral: 250 to 500 mg/kg/day in 3 to 4 divided doses given with meals .
Concerns related to adverse effects:
• Fluid overload: Use with caution, if at all, in patients at risk for fluid overload (eg, heart failure, severe renal impairment) or sodium retention; contains a significant amount of sodium
• Acidemia: Use with caution in patients with propionic or methylmalonic acidemia
• Reye syndrome: Use with caution in patients with Reye syndrome
Special populations:
• Neonates: Use with caution in neonates with hyperbilirubinemia due to potential displacement of bilirubin from albumin binding sites
Food Warning
Sodium benzoate contains ~81 mg (~3.5 mmol) of sodium per 500 mg of sodium benzoate .Dietary protein restriction should be part of treatment of urea cycle disorders. Caloric supplementation (goal ≥80 kcal/kg/day) is recommended for patients in a catabolic state.
Pharmacodynamic
Assists in lowering serum ammonia levels by activation of a nonurea cycle pathway (the benzoate-hippurate pathway); ammonia in the presence of benzoate will conjugate with glycine to form hippurate which is excreted by the kidney
Pharmacokinetics
- Half-life elimination: 0.75 to 7.4 hours
- Excretion: Clearance is largely attributable to metabolism with urinary excretion of hippurate, the major metabolite
- https://clinicaltrials.gov/ct2/show/NCT04430790
- https://clinicaltrials.gov/ct2/show/NCT02820025
- https://pubmed.ncbi.nlm.nih.gov/27612991/
- https://clinicaltrials.gov/ct2/show/NCT03894189
- https://www.rxlist.com/dopram-drug.htm
- https://www.mims.com/india/drug/info/Sodium Benzoate?type=full&mtype=generic
- https://go.drugbank.com/drugs/DB00561
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7003846/
