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, an adequate amount of solute should be added to achieve an approximately isotonic solution. The chemical designation of Water for Injection, USP is H₂O.

The semi-rigid vial is constructed from a specially formulated polyolefin, specifically 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. The container does not require a vapor barrier to preserve the 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. The use of non-isotonic solutions can lead to cellular damage and adverse reactions in patients.

Warnings and Precautions

Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. Healthcare professionals are advised to ensure that Sterile Water for Injection is always used in conjunction with an appropriate solute to prevent this serious adverse effect.

Monitoring for signs of hemolysis is essential when administering intravenous solutions. Clinicians should remain vigilant for symptoms such as fever, chills, back pain, and dark urine, which may indicate hemolytic reactions. Regular assessment of laboratory parameters, including hemoglobin levels and renal function tests, is recommended to detect any potential complications early.

It is imperative that healthcare providers adhere to established guidelines for the safe use of intravenous fluids to mitigate risks associated with the administration of Sterile Water for Injection.

Side Effects

Adverse reactions associated with the use of this solution, as well as added drugs or the technique of reconstitution or administration, may include a range of local and systemic responses. Serious reactions can manifest as tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the injection site, and abscess formation. Additionally, patients may experience local tenderness and extravasation.

A febrile response has also been noted among participants receiving this treatment.

It is important to note that intravenous administration of Sterile Water for Injection without a solute may lead to hemolysis, which poses a significant risk to patients.

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, particularly in the presence of known incompatibilities.

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, caution is advised when administering the medication to neonates or very small infants, as the volume of fluid 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, 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, weighing the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. It is recommended to weigh the potential benefits against any unknown risks to the nursing infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In cases of overdosage, it is important to note that 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 or very small infants, who may be more susceptible to such complications.

Should signs of fluid overload occur, it is essential to re-evaluate the patient promptly. Appropriate corrective measures should be instituted based on the clinical assessment. This may include adjusting fluid administration rates or implementing other supportive interventions as necessary to ensure patient safety and well-being.

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 non-teratogenic effects have been provided in the insert.

The safety of the plastic used in the formulation 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 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 made aware that for intravenous (I.V.) injection, it is necessary to add sufficient solute to create an approximately isotonic solution. Emphasize that Sterile Water for Injection, USP must be made approximately isotonic prior to use, and it 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 recommended route and rate of injection. It is essential to inspect reconstituted (diluted or dissolved) drugs for clarity and to ensure there is no unexpected precipitation or discoloration prior to administration.

Providers should stress the importance of using aseptic technique for both single and multiple entry and withdrawal from all containers. When diluting or dissolving drugs, patients should be instructed to mix thoroughly and use the solution promptly. Additionally, patients should be informed not to store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

Finally, healthcare providers should remind patients not to use the solution unless it is clear and the seal is intact. They should also be advised not to reuse single-dose containers and to discard any unused portion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

Patients may receive the medication via intravenous, intramuscular, or subcutaneous routes. Clinicians are advised to consult the manufacturer’s instructions for selecting the appropriate vehicle, as well as for the correct dilution or volume for dissolving the drugs intended for injection, including guidance on the 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 solutions should be used promptly. Reconstituted solutions should not be stored unless specifically directed by the manufacturer. Clinicians must 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)