FDA Approves 0.9% Sodium Chloride Injection in 10, 20 mL Single-Dose Vials

The FDA has approved 0.9% sodium chloride injection (Nexus Pharmaceuticals LLC) in the strengths of 10 mL and 20 mL single-dose vials.¹

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“This product is part of an expanding portfolio of products that address critical healthcare challenges,” Omair Ahmed, the chief operating officer at Nexus Pharmaceuticals said in a statement. “Sodium chloride injection is used to treat patients every day in every hospital in the United States. We are grateful to be able to bolster the supply of this critical-need product.”¹

Sodium chloride injection contains sodium chloride in water and is administered intravenously. It is intended for a single-dose injection to replenish fluids and electrolytes.²

There are no know contradictions for the solution, but there should be caution when used with corticosteroids or cortictropin. Clinical evaluations and periodic laboratory determinations should be used to monitor fluid balance, electrolyte concentrations, and acid-base balance.²

Adverse reactions can include febrile response, infection at injection side, venous thrombosis or phlebitis from the side of injection, extravasation, and hypervolemia.²

The dosage depends on age, weight, and clinical conditions of the patient.²

According to the prescribing information of sodium chloride injection, approximately 70% of total body weight is made of water, with the average individual needing 2 to 3 liters of water per day.²

The company’s sodium chloride injection is expected to launch in October with cartons of 25 vials.¹

References

1. Nexus Pharmaceuticals receives FDA approval for 0.9% sodium chloride injection. News release. Business Wire. August 29, 2023. Accessed August 30, 2023. https://www.businesswire.com/news/home/20230829739554/en/
2. 0.9% Sodium Chloride Injection, USP. Prescribing Information. FDA. Accessed August 30, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016366s214lbl.pdf