Sterile Water

Description

This preparation is intended exclusively for parenteral use following the addition to 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. It is utilized to dilute or dissolve drugs for injection. For intravenous administration, an adequate volume should be added to a solute to achieve an approximately isotonic solution, with a pH range of 5.0 to 7.0. The chemical designation of Water for Injection, USP is H₂O.

Uses and Indications

This parenteral preparation is indicated solely for the purpose of diluting or dissolving 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 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 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, which can lead to cellular edema and other adverse effects.

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 not administered in its pure form, as this can lead to serious complications, including the destruction of red blood cells.

It is imperative to use appropriate solutes when preparing intravenous solutions to mitigate the risk of hemolysis. Monitoring for signs of hemolysis, such as changes in hemoglobin levels and the presence of hemoglobinuria, is recommended following administration. Regular assessment of the patient's clinical status and laboratory parameters is essential to ensure safe and effective use of intravenous solutions.

Side Effects

Patients receiving this solution may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions associated with the intravenous administration of this solution include tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the injection site, and abscess formation. Additionally, extravasation may occur, leading to further complications.

Common reactions reported include febrile responses and local tenderness at the injection site.

It is important to note that the intravenous administration of Sterile Water for Injection without a solute carries a risk of hemolysis, which should be considered when preparing and administering this solution.

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, the volume of fluid administered may impact fluid and electrolyte balance, necessitating careful monitoring and adjustment of dosages as appropriate.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Animal reproduction studies have not been conducted with Sterile Water for Injection. The potential effects of sterile water containing additives on fetal harm or reproduction capacity in pregnant patients are not known. Therefore, Sterile Water for Injection with additives should be administered to pregnant women only if clearly needed, taking into consideration the potential risks versus benefits. Healthcare professionals are advised to exercise caution and evaluate the necessity of its use in this population.

Lactation

There is no relevant information regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in terms of 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in this population to ensure safety and efficacy.

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 should be exercised in specific populations, particularly neonates and very small infants.

Should signs of fluid overload manifest in these vulnerable patients, a thorough re-evaluation of the patient's condition is warranted. Appropriate corrective measures should be instituted promptly to mitigate any potential adverse effects. Healthcare professionals are advised to monitor these patients closely and to implement supportive care as necessary.

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 or nonclinical toxicology details are available in the provided data. Additionally, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Reactions reported in the postmarketing experience include febrile response, local tenderness, abscess, tissue necrosis, and infection at the injection site. Additionally, venous thrombosis or phlebitis extending from the injection site, as well as 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 Sterile Water for Injection must be made approximately isotonic prior to use to ensure safety and efficacy. It is crucial to inform patients that intravenous administration of Sterile Water for Injection without a solute may lead to hemolysis, a serious condition that can occur when red blood cells are destroyed.

Providers should emphasize that Sterile Water for Injection should not be used for intravenous injection unless the osmolar concentration of any additives results in an approximate isotonic admixture. It is recommended that healthcare providers 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.

Patients should be instructed to inspect reconstituted drugs for clarity and to ensure there is no unexpected precipitation or discoloration prior to administration. Aseptic technique must be used for single or multiple entry and withdrawal from all containers to prevent contamination.

When diluting or dissolving drugs, healthcare providers should advise patients that the solutions should be mixed thoroughly and used promptly. Reconstituted solutions of drugs for injection should not be stored unless otherwise directed by the manufacturer of the solute. Patients should also be informed not to use the solution unless it is clear and the seal is intact. Single-dose containers should not be reused, and any unused portion should be discarded.

Finally, the volume of the preparation used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose, and route of administration as recommended by the manufacturer. Healthcare providers should remind patients to visually inspect the parenteral solution for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Storage and Handling

The product is supplied in a plastic vial designed for single-dose use. Each vial is intended for immediate use upon opening, as it contains no preservatives. Any unused portion of the vial must be discarded to ensure safety and efficacy.

Storage conditions require the product to be maintained at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. It is essential to verify that the solution is clear and that the seal remains intact before use.

Additional Clinical Information

Patients may receive the medication via intravenous, intramuscular, or subcutaneous routes. Clinicians are advised to consult the manufacturer’s instructions for guidance on the selection of the appropriate vehicle, as well as the correct dilution or volume for dissolving the drugs intended for injection, including details on the route and rate of administration. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)