Description

Arginine Hydrochloride Injection is a specialized pharmaceutical preparation designed for intravenous use. It is available in various concentrations, such as 60% and 5%, and is typically supplied in sterile, clear, and colorless solutions. This product is presented in glass vials or bottles, ensuring a high standard of sterility and quality.

Composition

• Active Ingredient: Arginine hydrochloride
• Concentration: Up to 600 mg/mL
• Excipients: None, apart from water for injection
• pH Level: Approximately 5.6 to 5.8

The formulation is free from preservatives, dyes, lactose, sucrose, gluten, and tartrazine, making it suitable for patients with specific sensitivities. Additionally, the vial stopper is free from natural rubber latex, reducing the risk of allergic reactions.

Indications

This injection is primarily used for:

• Stimulating growth hormone release to evaluate pituitary function and growth disorders
• Acting as an acidifying agent in severe metabolic alkalosis
• Treating hyperammonaemia related to urea cycle disorders (excluding arginase deficiency)

Administration

The administration of Arginine Hydrochloride Injection requires careful handling and is typically conducted under the supervision of a healthcare professional experienced in managing metabolic disorders. Key aspects include:

• Dilution: Required to a 10% solution for safe infusion
• Infusion Method: Intravenous, preferably through a central line for high concentrations
• Inspection: Ensure solution clarity and container integrity before use

Unused portions should be discarded, and the solution should not be used if discolored or expired.

Storage

• Temperature: Store below 25–30°C
• Conditions: Do not freeze
• Stability: Once prepared, stable for up to 4 hours at room temperature or 24 hours if refrigerated

Contraindications and Precautions

Contraindications include hypersensitivity to arginine hydrochloride, severe acidosis, hypotension, and certain nitric oxide-related conditions. Precautions should be taken for patients with renal or hepatic impairment, electrolyte imbalances, and those who are pregnant or lactating.

Monitoring during therapy should include serum electrolytes, urea, glucose, plasma ammonia, acid-base status, and infusion site condition to mitigate risks such as extravasation and tissue injury.

Adverse Effects

Common adverse effects may include nausea, vomiting, flushing, headache, and local venous irritation. More serious effects, though less common, can involve hypotension, anaphylactic reactions, and hyperkalaemia.

Additional Information

Arginine Hydrochloride Injection is not classified as hazardous under normal conditions and does not pose environmental risks such as marine pollution. It is generally available without specific scheduling in regions like Australia, allowing for broader accessibility in clinical settings.