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.

Chemically, Water for Injection, USP is designated as H2O. The glass vial utilized for this preparation is composed of Type I or II borosilicate glass, conforming to the powdered glass test requirements established by USP standards. Additionally, the semi-rigid vial is constructed from a specially formulated polyolefin, specifically 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: 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, 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 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 of patients receiving intravenous fluids is essential, and healthcare providers should remain vigilant for any signs of adverse reactions. Regular assessment of hemoglobin levels and other relevant laboratory parameters may be warranted to ensure patient safety and to promptly address any potential complications arising from improper administration.

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 a febrile response or local tenderness at the injection site. Extravasation is also a potential complication.

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.

This parenteral preparation is intended solely as a diluent or solvent and is generally not associated with a risk of fluid overload, except in neonates or very small infants. In cases where fluid overload is suspected, it is crucial 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 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, caution is advised when administering to neonates, particularly very small infants, as the volume of fluid 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

Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Injection. The 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, weighing the potential benefits against any unknown risks.

Lactation

Sterile Water for Injection is classified as Pregnancy Category C. There are no animal reproduction studies conducted with Sterile Water for Injection, and it is unknown whether sterile water containing additives can be excreted in human breast milk. Additionally, the potential effects on breastfed infants have not been established. Therefore, lactating mothers should use Sterile Water for Injection with additives only if clearly needed, and the risks versus benefits should be carefully considered.

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 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, 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. Continuous monitoring and supportive care are essential to manage any adverse effects effectively.

Nonclinical Toxicology

Pregnancy Category C has been assigned to Sterile Water for Injection, indicating that animal reproduction studies have not been conducted. The potential for fetal harm or effects on reproductive capacity when administered to a pregnant woman remains unknown. Therefore, the use of Sterile Water for Injection with additives in pregnant women should be considered only when clearly necessary.

The safety of the plastic used in the containers for Sterile Water for Injection has been validated through testing 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 institute 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 Sterile Water for Injection, USP must be made approximately isotonic prior to use to ensure safety and efficacy. It is critical to inform patients that intravenous administration of Sterile Water for Injection without a solute may lead to hemolysis, a serious condition that can occur if the osmolar concentration of additives does not result 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 recommended 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 both single and multiple entry and withdrawal from all containers to prevent contamination. When diluting or dissolving drugs, patients should be reminded to mix thoroughly and use the solution promptly. It is essential to inform patients not to store reconstituted solutions of drugs for injection unless specifically directed by the manufacturer of the solute.

Patients should be cautioned against using 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 to avoid potential risks.

In the event of an adverse reaction, healthcare providers should instruct patients to discontinue the infusion immediately, evaluate their condition, and institute appropriate countermeasures. If possible, the remainder of the unused vehicle should be retrieved and saved for examination. Additionally, in cases of fluid overload, particularly in neonates or very small infants, patients should be re-evaluated, and appropriate corrective measures should be instituted.

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 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 experiences.

FDA Insert (PDF)

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

View full prescribing information (PDF)