Sodium benzoate is a widely used food preservative, with the E number E211. It's the sodium salt of benzoic acid and is commonly used to inhibit the growth of bacteria and fungi in acidic foods like fruit juices, soft drinks, pickles, and salad dressings. It's also used in some medicines, cosmetics, and industrial settings. Despite its effectiveness as a preservative, there have been some concerns about its safety, particularly when used in combination with certain additives like citric acid. However, regulatory agencies like the FDA and EFSA have deemed it safe for consumption within specified limits.

To increase the shelf-life of products like jams and jellies, sodium benzoate is frequently employed as a preservative in the food industry. For the therapy of people with abnormalities of the urea cycle, it is administered orally.

Sodium benzoate Uses:

• Urea cycle disorders:
  • It is used in conjunction with other therapies to treat and prevent hyperammonemia brought on by urea cycle diseases.

Sodium Benzoate Dose in Adults

Note:

• Sodium benzoate is a common preservative used in foods like soft drinks and salad dressings to stop bacteria and fungi from growing.
• It's made from benzoic acid and sodium hydroxide.
• Some people worry about its safety, but experts say it's okay in small amounts.
• When people need it for serious health issues, like acute episodes, it's often given through a vein.
• But you won't find sodium benzoate as a standalone product in stores; it's usually mixed with other things by professionals.

Sodium Benzoate Dose in Children

Note:

• Sodium benzoate isn't something you can buy off the shelf.
• Instead, it's often mixed with other ingredients by professionals when needed.
• For serious situations, like acute episodes, it's given through a vein.
• If you need it that way, there's a special product combining sodium benzoate and sodium phenylacetate that doctors can use.

Long-term therapy with a sodium benzoate dose for diseases of the urea cycle:

• In long-term therapy for urea cycle disorders, the dosage of sodium benzoate isn't set in stone.
• It should be tailored to each patient's response, and it's best to consult a metabolic specialist for guidance.
• Typically, for infants, children, and adolescents, it's given orally in doses of 250 to 500 mg per kilogram of body weight per day, spread out over 3 to 4 doses with meals.
• This information is based on limited available data from various sources such as Häberle (2012), Kliegman (2016), Maestri (1991), and Maestri (1996).

Sodium Benzoate Pregnancy Risk Category: C

• Sodium benzoate administered to pregnant women can be detected in both the umbilical cord and newborn serum.
• However, information on its use for urea cycle disorders (UCD) during pregnancy is limited.
• Pregnancy increases metabolic activity, potentially triggering hyperammonemic episodes in women with OTC deficiency or asymptomatic carriers.
• Close monitoring during pregnancy and for five days postpartum is recommended.
• Maternal treatment with oral sodium benzoate is advised if serum ammonia levels are elevated.
• Additionally, sodium benzoate may be administered to mothers to prevent adverse events in newborns prenatally diagnosed with a UCD.
• Generally, females with inherited metabolic diseases should achieve adequate metabolic control before conception.
• These recommendations are based on various studies and expert opinions cited in the medical literature.

Use during breastfeeding:

• The presence of sodium benzoate in breast milk is currently unknown.
• For women with inherited metabolic diseases, ensuring adequate energy intake is crucial if they choose to breastfeed.
• Close monitoring of protein intake is necessary for breastfed infants with urea cycle disorders.
• These recommendations are based on expert opinions and studies cited in the medical literature.

Dose in Kidney Disease:

• When it comes to using sodium benzoate in individuals with renal impairment, specific dosing information isn't available.
• Therefore, caution should be exercised.

Dose in Liver disease:

• In cases of hepatic impairment, dosing information for sodium benzoate isn't readily available.
• Consequently, it's advisable to approach its use with caution in such situations.

Side effects of Sodium benzoate:

Adverse reactions are from multiple indications and dosing.

• Endocrine & Metabolic:
  • Hypokalemia
  • Increased Serum Sodium
  • Metabolic Acidosis
• Cardiovascular:
  • ECG Abnormality
• Renal:
  • Renal Tubular Disease
• Gastrointestinal:
  • Nausea.
  • Vomiting
  • Epigastric Distress
  • Gastritis
  • Anorexia
  • Dyspepsia
  • Mucositis

Contraindications to Sodium benzoate:

Warnings and precautions

Reye syndrome:

• It's important to exercise caution when using sodium benzoate in patients with propionic or methylmalonic acidemia, conditions characterized by acidemia.
• These patients may require special monitoring and adjustments in treatment due to the nature of their metabolic disorders.

Acidemia:

• Using sodium benzoate requires caution in patients with Reye syndrome.
• This condition, although rare, involves potentially severe liver and brain damage, and certain medications, including sodium benzoate, may exacerbate these complications.
• Therefore, careful consideration and monitoring are necessary when administering sodium benzoate to individuals with Reye syndrome.

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:

• Plasma Ammonia: Check levels regularly to ensure they are within normal range.
• Plasma Amino Acid (Quantitative) and Glutamine Concentrations: Monitor to assess metabolic balance.
• Blood Glucose: Keep an eye on glucose levels to ensure they remain stable.
• Serum Electrolytes: Regularly check electrolyte levels to maintain balance.
• Hepatic and Renal Function Tests: Monitor liver and kidney function for any abnormalities.
• Blood Gases: Assess blood gas levels to ensure proper oxygenation and acid-base balance.
• Neurologic Status: Regularly evaluate neurological function to detect any changes or abnormalities.
• Physical Signs/Symptoms of Hyperammonemia: Watch for lethargy, ataxia, confusion, vomiting, seizures, and memory impairment, as they may indicate elevated ammonia levels.

How to administer Sodium benzoate?

• Timing: Administer with meals.
• Fluid Intake: Ensure abundant fluid intake alongside administration.
• Availability: Sodium benzoate is not commercially available in ready-to-use form.
• Compounding: It must be compounded using chemical powder. Consultation with a metabolic specialist is necessary for proper compounding and administration.

Mechanism of action of Sodium benzoate:

• Sodium benzoate helps reduce serum ammonia levels by activating a pathway called the benzoate-hippurate pathway.
• In this pathway, ammonia combines with benzoate and glycine to form hippurate, which the kidneys then excrete from the body.
• This process offers an alternative to the urea cycle for eliminating excess ammonia, thereby lowering ammonia levels in the bloodstream.

Half-life elimination:

• Sodium benzoate has a half-life elimination ranging from 0.75 to 7.4 hours, indicating the time it takes for half of the administered dose to be eliminated from the body.

Excretion:

• Its clearance primarily occurs through metabolism, with the major metabolite, hippurate, being excreted in the urine.
• This urinary excretion of hippurate contributes significantly to the elimination of sodium benzoate from the body.

International Brand Names of Sodium benzoate:

• Amzoate
• Colufase
• Fu Tai

Sodium benzoate Brand Names in Pakistan:

No Brands Available in Pakistan.