Sterile Water

Description

This preparation is intended exclusively for parenteral use following the addition of drugs that necessitate dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic solution of water for injection, devoid of bacteriostats, antimicrobial agents, or added buffers, and is available only in single-dose containers for the purpose of diluting or dissolving drugs for injection. For intravenous administration, sufficient solute should be added to achieve an approximately isotonic solution. The chemical designation of Water for Injection, USP is H₂O.

The container is provided in a Type I or II borosilicate glass vial, which complies with the powdered glass test as per USP standards. Alternatively, the semi-rigid vial is constructed from a specially formulated polyolefin, a copolymer of ethylene and propylene. The safety of this plastic has been validated through animal testing in accordance with USP biological standards for plastic containers. This container does not require a vapor barrier to maintain the specified labeled volume.

Uses and Indications

This parenteral preparation is indicated solely for the dilution or dissolution of drugs intended for intravenous, intramuscular, or subcutaneous injection, in accordance with the manufacturer's instructions for the specific drug to be administered.

Limitations of Use: This preparation should not be used for any other purpose outside of the specified indications.

Dosage and Administration

The volume of the preparation utilized for diluting or dissolving any drug for injection is contingent upon the vehicle concentration, the prescribed dose, and the route of administration as advised by the manufacturer.

Prior to administration, the parenteral solution must be visually inspected for particulate matter and discoloration, whenever the solution and container allow for such inspection.

Contraindications

Sterile Water for Injection, USP is contraindicated for use unless it has been made approximately isotonic prior to administration. This is essential to prevent potential complications associated with the administration of hypotonic solutions.

Warnings and Precautions

Intravenous administration of Sterile Water for Injection without the addition of a solute is associated with a significant risk of hemolysis. Healthcare professionals must exercise caution and ensure that Sterile Water for Injection is not administered in its pure form intravenously.

To mitigate the risk of hemolysis, it is imperative to use appropriate solutes when preparing intravenous solutions. Monitoring for signs of hemolysis, such as changes in hemoglobin levels and the presence of hemoglobinuria, is recommended following any intravenous administration of fluids.

Healthcare providers should remain vigilant and adhere to established protocols for intravenous fluid administration to ensure patient safety and prevent adverse reactions.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this solution, which may be influenced by added drugs or the technique of reconstitution or administration. Common reactions include febrile response, local tenderness, and abscess formation. More serious reactions can occur, such as tissue necrosis or infection at the injection site, venous thrombosis or phlebitis extending from the site of injection, and extravasation.

It is important to note that intravenous administration of Sterile Water for Injection without a solute may lead to hemolysis, which is a significant warning for healthcare providers to consider during administration.

Drug Interactions

Certain injectable medications may exhibit incompatibility when administered in the same vehicle or when combined with a vehicle containing benzyl alcohol. It is advisable to consult with a pharmacist to ensure safe and effective administration of these drugs. Monitoring for potential adverse effects is recommended when using multiple injectable medications concurrently.

Packaging & NDC

The table below lists all NDC Code configurations of Sterile Water (water), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants, caution is advised as the volume of fluid administered may impact fluid and electrolyte balance.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Animal reproduction studies have not been conducted with Sterile Water for Injection. Therefore, the effects of this product on fetal outcomes are not well understood. It is also unknown whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Given the lack of data, Sterile Water for Injection with additives should be administered to pregnant patients only if clearly needed, and the potential risks should be carefully weighed against the benefits.

Lactation

Sterile Water for Injection has not been studied in animal reproduction studies, and there is no available data regarding its excretion in human breast milk. Consequently, it is unknown whether the use of sterile water containing additives can affect breastfed infants or lactating mothers. Therefore, sterile water with additives should be administered to lactating mothers only if clearly needed, weighing the potential benefits against any unknown risks to the nursing infant.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In cases of overdosage, this parenteral preparation is intended solely for use as a diluent or solvent. The risk of fluid overload is generally minimal; however, caution is advised, particularly in neonates and very small infants, who may be more susceptible to such complications.

Should signs of fluid overload manifest in these vulnerable populations, it is imperative to re-evaluate the patient's condition promptly. Appropriate corrective measures should be instituted based on the clinical assessment. Healthcare professionals are encouraged to monitor the patient closely and adjust treatment protocols as necessary to ensure patient safety and optimal outcomes.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Sterile Water for Injection. The potential for sterile water containing additives to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity is not known. Therefore, Sterile Water for Injection with additives should be administered to a pregnant woman only if clearly needed.

No specific non-teratogenic effects have been identified in the available data.

The safety of the plastic used in the containers for Sterile Water for Injection has been confirmed through tests in animals, adhering to the biological standards set forth by the United States Pharmacopeia (USP).

Postmarketing Experience

Reactions reported in the postmarketing experience include febrile response, local tenderness, abscess, tissue necrosis, or infection at the injection site. Additionally, venous thrombosis or phlebitis extending from the injection site and extravasation have been observed. In the event of an adverse reaction, it is recommended to discontinue the infusion, evaluate the patient, and implement appropriate countermeasures. If feasible, the remainder of the unused vehicle should be retrieved and preserved for examination.

Patient Counseling

Healthcare providers should advise patients that this preparation is intended exclusively for parenteral use after the addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. It is important to inform patients that Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation that contains no bacteriostat, antimicrobial agent, or added buffer, and is supplied only in single-dose containers for the purpose of diluting or dissolving drugs for injection.

Patients should be instructed that for intravenous (I.V.) injection, sufficient solute must be added to create an approximately isotonic solution. Emphasize that Sterile Water for Injection, USP must be made approximately isotonic prior to use and should not be used for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.

Healthcare providers should encourage patients to consult the manufacturer's instructions regarding the choice of vehicle, appropriate dilution, or volume for dissolving the drugs to be injected, including the route and rate of injection. It is essential to inspect reconstituted drugs for clarity and to ensure there is no unexpected precipitation or discoloration prior to administration.

Patients should be reminded to use aseptic technique for both single and multiple entry and withdrawal from all containers. When diluting or dissolving drugs, they should mix thoroughly and use the solution promptly. It is critical to inform patients not to store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

Additionally, patients should be cautioned not to use the solution unless it is clear and the seal is intact. They should not reuse single-dose containers and must discard any unused portion. In the event of an adverse reaction, patients should be instructed to discontinue the infusion, evaluate their condition, and seek appropriate countermeasures. If possible, they should retrieve and save the remainder of the unused vehicle for examination.

Finally, in cases of fluid overload, patients should be advised to re-evaluate their condition and implement appropriate corrective measures.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 20 to 25°C (68 to 77°F), as defined by the United States Pharmacopeia (USP) guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients may receive the medication via intravenous, intramuscular, or subcutaneous routes. Clinicians are advised to consult the manufacturer's instructions regarding the choice of vehicle, appropriate dilution, and volume for dissolving the drugs intended for injection, including the specific route and rate of administration.

It is essential to employ aseptic techniques during both single and multiple entries and withdrawals from all containers. When preparing the drugs, thorough mixing is required, and the solutions should be used promptly. Reconstituted solutions should not be stored unless explicitly directed by the manufacturer. Additionally, clinicians should ensure that the solution is clear and that the seal is intact before use. Single-dose containers should not be reused, and any unused portions must be discarded.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Sterile Water as submitted by Hospira, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)