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 injectable drugs. For intravenous injection, it is essential to add an adequate solute to achieve an approximately isotonic solution. The chemical designation of Water for Injection, USP is H₂O.

The container is available in two forms: a Type I or II borosilicate glass vial, which complies with the powdered glass test as per USP standards, and a semi-rigid vial made from a specially formulated polyolefin, a copolymer of ethylene and propylene. The safety of the plastic container 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 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. 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 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 reactions associated with the administration of this solution, particularly when combined with added drugs or due to the technique of reconstitution or administration, include tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, 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 intravenous administration of Sterile Water for Injection without a solute may result in hemolysis, which poses a significant risk to patients. Careful consideration should be given to the administration techniques to mitigate these potential adverse reactions.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnancy Category C. 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 a pregnant woman only if clearly needed, weighing the potential benefits against any possible risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects during lactation. 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 breastfed infants.

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, 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, particularly in neonates or very small infants, who may be more susceptible to such complications.

Should signs of fluid overload occur in these vulnerable populations, a thorough re-evaluation of the patient is warranted. Healthcare professionals should assess the patient's clinical status and implement appropriate corrective measures to manage the situation effectively. This may include adjusting fluid administration rates or employing diuretics as clinically indicated.

Continuous monitoring of the patient's response to treatment is essential to ensure optimal outcomes and to mitigate any potential adverse effects associated with overdosage.

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, Sterile Water for Injection with additives should only be administered to pregnant women if clearly needed.

No non-teratogenic effects have been specified in the available data.

The safety of the plastic used in the formulation has been confirmed through tests conducted in animals, adhering to the biological standards set forth by the United States Pharmacopeia (USP) 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 Sterile Water for Injection, USP must be made approximately isotonic prior to use to ensure safety during administration. 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.

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 impact fluid and electrolyte balance. It is also important to discuss the potential for incompatibility of some drugs for injection when combined in a given vehicle or in a vehicle containing benzyl alcohol, and to recommend consulting with a pharmacist if available.

Providers should stress the necessity of using aseptic technique for both single and multiple entries and withdrawals from all containers. When diluting or dissolving drugs, patients should be advised to mix thoroughly and use the solution promptly. They should not store reconstituted solutions of drugs for injection unless specifically directed by the manufacturer of the solute.

Patients must be informed to only use solutions that are clear and have an intact seal, and to discard any unused portions of single-dose containers. In the event of an adverse reaction, patients should be instructed to discontinue the infusion immediately, evaluate their condition, and implement appropriate countermeasures. If possible, they should retrieve and save the remainder of the unused vehicle for examination.

In cases of fluid overload, particularly in neonates or very small infants, healthcare providers should advise patients to re-evaluate their condition and take appropriate corrective measures. It is important to note that this parenteral preparation is unlikely to pose a threat of fluid overload except possibly in these vulnerable populations.

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 intramuscular, intravenous, or subcutaneous routes of administration. 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 injection.

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 Henry Schein, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)