Water

Description

This preparation is intended exclusively for parenteral use, specifically after 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, it is essential to dissolve an adequate amount of solute to achieve an approximately isotonic solution. The chemical designation of Water for Injection, USP is H2O, with a pH range of 5.0 to 7.0.

The plastic single-dose vial is constructed from polypropylene resin and features a twist-off cap. Upon removal of the cap, access to a luer-lock fitting is provided for connection to a luer-lock syringe. The twist-off cap serves as a one-time use tamper-evident mechanism, and the vial cannot be resealed once the cap has been removed.

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, provided that the solution and container allow for such inspection.

Healthcare professionals are advised to consult the INSTRUCTIONS FOR USE for detailed administration instructions.

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 used only as a diluent or solvent for medications and not administered as a standalone intravenous solution.

It is crucial to monitor patients for signs of hemolysis, which may include symptoms such as fever, chills, back pain, dark urine, and jaundice. Appropriate laboratory tests, including complete blood count and urinalysis, should be conducted to assess for hemolytic reactions if there is any suspicion of hemolysis following administration.

Healthcare providers should exercise caution and adhere to established guidelines when preparing and administering intravenous solutions to mitigate the risk of adverse effects associated with the use of Sterile Water for Injection.

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 hemolysis, particularly when Sterile Water for Injection is administered without a solute. Additionally, patients may experience local complications such as tissue necrosis or infection at the injection site, venous thrombosis, and phlebitis extending from the site of injection.

Common adverse reactions reported include febrile responses, local tenderness, abscess formation, and extravasation. These reactions may occur due to the solution itself, added drugs, or the technique of reconstitution or administration.

It is important to note that this parenteral preparation should only be used as a diluent or solvent. While the risk of fluid overload is generally low, it may be a concern in neonates or very small infants. In such cases, healthcare providers should re-evaluate the patient and implement appropriate corrective measures. For further details, refer to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections.

Drug Interactions

Certain injectable medications may exhibit incompatibility when combined in a specific vehicle, particularly those containing benzyl alcohol. It is advisable to consult with a pharmacist to ensure safe and effective administration of these drugs. This precaution is essential to prevent potential adverse reactions or diminished therapeutic efficacy due to incompatibility.

Packaging & NDC

The table below lists all NDC Code configurations of Sterile 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

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

Animal reproduction studies have not been conducted with Sterile Water for Injection. Therefore, it is not known 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 a pregnant woman only if clearly needed. Healthcare professionals should weigh the potential risks against the benefits when considering the use of this product in pregnant patients.

Lactation

Nursing mothers should be aware of the potential for excretion of this drug in breast milk. It is not known whether the components of this drug can affect nursing infants. Therefore, caution should be exercised when administering this drug to a nursing mother.

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, 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.

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. Healthcare professionals are encouraged to refer to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections for further guidance on managing potential complications associated with overdosage.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Sterile Water for Injection. The potential for fetal harm or effects on reproductive capacity when sterile water containing additives is administered to a pregnant woman is not known. Therefore, Sterile Water for Injection with additives should be administered to a pregnant woman only if clearly needed.

Postmarketing Experience

Reactions reported in postmarketing experience include febrile response, local tenderness, abscess, tissue necrosis, or infection at the injection site, as well as venous thrombosis or phlebitis extending from the injection site and extravasation. In cases where an adverse reaction occurs, 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. This parenteral preparation is generally not associated with a significant risk of fluid overload, except potentially in neonates or very small infants. Should fluid overload occur, patient re-evaluation and appropriate corrective measures should be undertaken.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection must be made approximately isotonic prior to use to prevent complications. It is critical to inform patients that intravenous administration of Sterile Water for Injection without a solute may result in hemolysis, which can have serious consequences.

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. They 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 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. It is important to communicate that Sterile Water for Injection with additives should only be administered to pregnant women if it is clearly needed.

Healthcare providers must stress the importance of using aseptic technique when withdrawing from the container. Patients should be informed that when diluting or dissolving drugs, the solution must be mixed thoroughly and used promptly. They should also be made aware that reconstituted solutions of drugs for injection should not be stored unless otherwise directed by the manufacturer of the solute, and that the solution must be clear before use.

Providers should advise against reusing single-dose containers and instruct patients to discard any unused portion. They should inform patients of potential reactions that may occur due to the solution, added drugs, or the technique of reconstitution or administration, which can include febrile response, local tenderness, abscess, tissue necrosis, infection at the injection site, venous thrombosis, phlebitis, or extravasation.

In the event of an adverse reaction, healthcare providers should instruct patients to discontinue the infusion, evaluate their condition, and institute appropriate countermeasures. If possible, they should retrieve and save the remainder of the unused vehicle for examination.

Patients should be reminded that this parenteral preparation is unlikely to pose a threat of fluid overload, except possibly in neonates or very small infants. In such cases, they should be re-evaluated, and appropriate corrective measures should be instituted. The volume of the preparation used for diluting or dissolving any drug for injection will depend on the vehicle concentration, dose, and route of administration as recommended by the manufacturer.

Finally, healthcare providers should advise patients to visually inspect the parenteral solution for particulate matter and discoloration prior to administration, whenever the solution and container permit. They should also inform patients that a sterile luer-lock syringe must be separately obtained for use with the luer-lock vial and that aseptic technique should be maintained throughout the withdrawal of the contents from the vial.

Storage and Handling

The product is supplied in vials made from polypropylene (PP) resin. Each vial must be stored at a temperature range of 2°C to 25°C (36°F to 77°F). It is important to discard any unused portion of the product to ensure safety and efficacy.

Additional Clinical Information

Patients should be administered the medication via intravenous, intramuscular, or subcutaneous routes. Clinicians are advised to counsel patients on the importance of using aseptic techniques when withdrawing the medication from its container. It is essential to mix any diluted or dissolved drugs thoroughly and to use them promptly. Reconstituted solutions should not be stored unless specifically directed by the manufacturer, and only clear solutions should be utilized. Additionally, single-dose containers must not be reused, and any unused portion should be discarded.

FDA Insert (PDF)

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

View full prescribing information (PDF)