Sterile Water

Description

This preparation is intended exclusively for parenteral use following the addition to drugs that necessitate dilution or require dissolution in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic formulation 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 injectable drugs. For intravenous injection, 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 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 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 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. Appropriate laboratory tests should be conducted to assess hemolytic activity, including but not limited to hemoglobin levels, haptoglobin levels, and reticulocyte counts.

Healthcare providers are advised to adhere strictly to established guidelines for the preparation and administration of intravenous solutions to mitigate the risk of adverse events.

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 occur, such 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 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

There is no specific information 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. The potential effects of sterile water containing additives on fetal outcomes 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.

Lactation

Nursing mothers should be aware of the potential for excretion of this medication in breast milk. There is an associated risk to breastfed infants when this medication is used during lactation. Caution is advised when administering this medication to lactating mothers.

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 relation to the use of this medication. Consequently, there are no 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, 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 minimal; however, caution should be exercised in specific populations, particularly neonates and very small infants.

Should signs of fluid overload manifest in these vulnerable groups, a thorough re-evaluation of the patient's condition is warranted. Appropriate corrective measures should be instituted promptly to address any complications arising from overdosage. Healthcare professionals are advised to monitor the patient closely and implement necessary interventions 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 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 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 Sterile Water for Injection must be made approximately isotonic prior to use. It is crucial to inform patients that intravenous administration of Sterile Water for Injection without a solute may result in hemolysis, and therefore, it should not be used for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.

Providers should emphasize the importance of consulting 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 freedom from unexpected precipitation or discoloration prior to administration.

While safety and effectiveness have been established in pediatric patients, healthcare providers should caution that in neonates or very small infants, the volume of fluid may affect fluid and electrolyte balance. It is also important to discuss the potential for incompatibility of some drugs for injection in a given vehicle or when combined in the same vehicle, particularly those containing benzyl alcohol. Providers should recommend consulting with a pharmacist if available.

Patients should be informed about the necessity of using aseptic technique for single or multiple entry and withdrawal from all containers. When diluting or dissolving drugs, they should mix thoroughly and use promptly, as reconstituted solutions of drugs for injection should not be stored unless otherwise directed by the manufacturer of the solute.

Healthcare providers must stress that the solution should not be used unless it is clear and the seal is intact. Patients should be advised not to reuse single-dose containers and to discard any unused portion. They should be made aware of possible reactions that may occur due to this solution, added drugs, or the technique of reconstitution or administration, which may include febrile response, local tenderness, abscess, tissue necrosis or infection at the injection site, venous thrombosis or phlebitis extending from the site of injection, and extravasation. In the event of an adverse reaction, patients should be instructed to discontinue the infusion, evaluate their condition, and institute appropriate countermeasures, while also retrieving and saving the remainder of the unused vehicle for examination if possible.

Finally, healthcare providers should clarify that this parenteral preparation is intended only as a diluent or solvent and is unlikely to pose a threat of fluid overload, except possibly in neonates or very small infants. In such cases, they should re-evaluate the patient and implement appropriate corrective measures. The volume of the preparation to be 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. Patients should also be advised to visually inspect this 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, with each tray containing 25 vials. Each vial is intended for single-dose use and does not contain any preservatives. It is essential to inspect the solution prior to use; the product should only be utilized if the solution is clear and the seal is intact. Any unused portion of the vial must be discarded.

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. Proper handling and storage are crucial to ensure the integrity and safety 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 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 Fresenius Kabi USA, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)