Sodium Phenylacetate and Benzoate Injection 20 mL Single-Dose Vial (RX)

Sodium Phenylacetate and Sodium Benzoate Injection is an advanced therapeutic solution designed for the acute management of urea cycle disorders (UCDs) in patients experiencing hyperammonemia. This combination injection provides critical care support by facilitating the detoxification and excretion of ammonia, which is crucial for patients unable to naturally eliminate waste nitrogen due to genetic urea cycle deficiencies. Its rapid action and proven effectiveness make it an essential choice in critical care settings, helping stabilize patient conditions and prevent the deleterious effects of elevated blood ammonia levels.

Product Details and Features:

Composition: Each 20 mL single-dose vial contains an equimolar combination of sodium phenylacetate and sodium benzoate. 
Concentration: Optimized molecular pairing for effective ammonia scavenging.
Format: Supplied as a sterile, clear solution that can be easily prepared and administered intravenously.
Quality Assurance: Manufactured by Zydus Pharmaceuticals, ensuring adherence to rigorous quality control standards.
Indication: Primarily utilized in hospitals for the management of acute hyperammonemia episodes associated with UCDs, including deficits in carbamoyl phosphate synthetase, ornithine transcarbamylase, and argininosuccinate synthetase.

Mechanism of Action:

Sodium phenylacetate and sodium benzoate serve as ammonia scavengers. Sodium phenylacetate works by converting to phenylacetylglutamine through conjugation with glutamine, which is then excreted through the kidneys. Phenylacetylglutamine is structurally similar to urea and aids in the excretion of excess nitrogen. Sodium benzoate, on the other hand, conjugates with glycine to form hippurate, which is also excreted in urine, further assisting in the removal of ammonia from the bloodstream. This dual action efficiently lowers ammonia levels, providing a vital therapeutic benefit in hyperammonemic emergencies.

Directions for Use:

Administration: Administer intravenously under the supervision of a healthcare professional.
Dosage: The typical starting dose is patient-specific and based on body weight and clinical condition; initiate treatment as promptly as possible in hyperammonemic crises.
Preparation: Dilute to appropriate volume according to medical guidance.

Warnings:

• Contraindications: Known hypersensitivity to sodium phenylacetate, sodium benzoate, or any formulation components.
  
• Precautions: Caution in patients with heart failure, renal impairment, or fluid retention concerns. Continually monitor essential biochemical parameters.
  
• Pregnancy and Lactation: Should be administered to pregnant or nursing mothers only if clearly needed and under strict medical guidance.
  
• Hypersensitive Reactions: Watch for any signs of allergic reactions, particularly in patients with common sensitivities to ingredients.

Side Effects:

While generally well-tolerated under medical supervision, potential side effects include:

• Metabolic Acidosis: Monitor changes in acid-base balance.
  
• Fluid and Electrolyte Disturbances: Possible due to sodium content.
  
• Injection Site Reaction: Includes pain, redness, or swelling at infusion site.
  
• Gastrointestinal Discomfort: Possible nausea, vomiting, or aversion reactions.
  
• Neurological Effects: Dizziness or headache in rare cases; necessitates regular monitoring.

In the event of adverse reactions, adjust the dosage or discontinue use according to clinical assessments. Ensure ongoing patient monitoring throughout and beyond treatment periods for optimal recovery and stable metabolic conditions. 

Note: This information is intended for healthcare professionals familiar with patient prescription formulations and hyperammonemia management. Please consult the official product insert and medical guidelines for comprehensive details and updates specific to clinical environments.