Sterile Water

Description

This preparation is intended exclusively for parenteral use following the addition of drugs that necessitate dilution or dissolution 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 glass vial is constructed from Type I or II borosilicate glass, conforming to the powdered glass test requirements as per USP standards. Additionally, the semi-rigid vial is made from a specially formulated polyolefin, a copolymer of ethylene and propylene. The safety of this plastic material 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: There are no reported teratogenic or nonteratogenic effects associated with this preparation.

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 recommended 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. This step is crucial to ensure the safety and efficacy of the administered drug.

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 a solute is associated with the risk of hemolysis. Healthcare professionals must exercise caution and ensure that Sterile Water for Injection is not administered in isolation, as this can lead to serious complications.

It is imperative to monitor patients closely for any signs of hemolysis following the administration of intravenous fluids. Regular assessment of hemoglobin levels and other relevant laboratory parameters is recommended to detect any adverse effects promptly.

In summary, the use of Sterile Water for Injection should always be accompanied by an appropriate solute to mitigate the risk of hemolysis and ensure patient safety.

Side Effects

Reactions that may occur due to the use of this solution, added drugs, or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, and extravasation.

Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis, which is a significant concern. Therefore, it is crucial to ensure that the osmolar concentration of any additives results in an approximately isotonic admixture prior to intravenous injection.

Participants in clinical settings should be advised 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 also essential to inspect reconstituted drugs for clarity and to ensure they are free from unexpected precipitation or discoloration before administration.

In terms of specific populations, animal reproduction studies have not been conducted with Sterile Water for Injection, and it is unknown whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, this solution with additives should only be administered to pregnant women if clearly needed. Safety and effectiveness have been established in pediatric patients; however, caution is advised in neonates or very small infants, as the volume of fluid may impact fluid and electrolyte balance.

Drug interactions may occur, as some drugs for injection may be incompatible in a given vehicle or when combined in the same vehicle containing benzyl alcohol. It is recommended to consult with a pharmacist if available. Aseptic technique should be employed for single or multiple entries and withdrawals from all containers. When diluting or dissolving drugs, thorough mixing and prompt use are advised. Reconstituted solutions of drugs for injection should not be stored unless otherwise directed by the manufacturer of the solute. Additionally, the solution should only be used if it is clear and the seal is intact, and single-dose containers should not be reused.

In the event of overdosage, this parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. Should such a situation arise, it is important to re-evaluate the patient and implement appropriate corrective measures.

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 or therapeutic failures is recommended when using such combinations.

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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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, weighing the potential benefits against any unknown risks.

Lactation

It is not known whether sterile water containing additives can cause fetal harm when administered to a nursing mother or affect reproductive capacity. The potential for excretion in breast milk has not been established. Caution should be exercised when administering this product to nursing mothers.

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 this patient population.

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 low; however, caution is advised, particularly in neonates and very small infants.

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. Continuous monitoring and supportive care may be necessary to ensure patient safety and mitigate any potential complications arising from overdosage.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Sterile Water for Injection. It remains unclear whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.

No specific non-teratogenic effects are mentioned in the available data. Additionally, there are no specific nonclinical toxicology details provided.

The safety of the plastic container used for Sterile Water for Injection has been confirmed by tests in animals, adhering to USP biological standards for plastic containers.

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 saved 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 containing 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.

Providers should communicate that Sterile Water for Injection with additives should be administered to pregnant women only if clearly needed. While safety and effectiveness have been established in pediatric patients, caution should be exercised in neonates or very small infants, as the volume of fluid may impact fluid and electrolyte balance.

Patients should be made aware that some drugs for injection may be incompatible with a given vehicle or when combined in the same vehicle, particularly those containing benzyl alcohol. It is advisable to consult with a pharmacist if available. Providers should stress the importance of using aseptic technique for single or multiple entries and withdrawals from all containers.

When diluting or dissolving drugs, patients should be instructed to mix thoroughly and use the solution promptly. They should not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Additionally, patients should be informed not to use the solution unless it is clear and the seal is intact, and to discard any unused portion of single-dose containers.

In the event of an adverse reaction, healthcare providers should advise patients to discontinue the infusion, evaluate their condition, and institute appropriate countermeasures. If possible, the remainder of the unused vehicle should be retrieved and saved for examination. Lastly, in cases of fluid overload, patients should be re-evaluated, and appropriate corrective measures should be instituted.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20 to 25°C (68 to 77°F), in accordance with USP Controlled Room Temperature guidelines. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients receiving treatment should be administered the drug 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, including the specific route and rate of injection.

Prior to administration, it is essential to inspect reconstituted drugs for clarity and to ensure there is no unexpected precipitation or discoloration. Aseptic technique must be employed for both single and multiple entries and withdrawals from all containers. When preparing the drugs, thorough mixing is required, and solutions should be used promptly. Reconstituted solutions should not be stored unless specifically directed by the manufacturer, and only clear solutions with intact seals should be used. 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 Cardinal Health 107, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)