Sterile Water

Description

Sterile Water for Injection USP is a clear, colorless, and odorless liquid that is sterile, hypotonic, and nonpyrogenic. It contains no bacteriostatic or antimicrobial agents and serves as a diluent suitable for intravascular injection after being made approximately isotonic through the addition of an appropriate solute. The pH of the solution is 5.5, within the range of 5.0 to 7.0.

The product is packaged in a plastic container made from a multilayered film specifically designed for parenteral drugs, which is free from natural rubber latex, PVC, and DEHP. This container contains no plasticizers and exhibits virtually no leachables. The solution contact layer consists of a rubberized copolymer of ethylene and propylene, ensuring that the container is nontoxic and biologically inert.

The container-solution unit operates as a closed system, eliminating the need for external air entry during use. Additionally, the container is overwrapped to provide protection from the physical environment and to serve as an extra moisture barrier when necessary.

Uses and Indications

Sterile Water for Injection USP is indicated for use in adults and pediatric patients as a diluent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration following admixture or dilution.

There are no teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

This solution is intended for intravenous use only after appropriate admixture or dilution. Prior to injection, it is essential to ensure that the solution is made approximately isotonic by the addition of an appropriate solute.

The dosage of the solution is typically determined by the patient's age, weight, clinical condition, and relevant laboratory determinations. Healthcare professionals should refer to the specific directions accompanying the prescribed drugs for accurate dosing information.

The administration of Sterile Water for Injection USP is contingent upon the recommended dosage and administration guidelines of the solute being used. Fluid administration should be tailored to meet the calculated maintenance or replacement fluid requirements for each individual patient.

It is important to note that some additives may exhibit incompatibility. Therefore, consultation with a pharmacist is advised prior to admixture. When performing admixture or dilution, aseptic techniques must be employed to ensure safety and efficacy. The solution should be mixed thoroughly and not stored for future use.

Prior to administration, parenteral drug products should be visually inspected for particulate matter and discoloration, whenever the solution and container permit.

Contraindications

Use of this product is contraindicated in situations where a plastic container is used in a series connection. This practice may compromise the integrity of the product and lead to potential safety concerns. No other contraindications are known at this time.

Warnings and Precautions

This solution is intended solely for compounding and must not be used for direct infusion. It is important to note that the solution is hypotonic and hemolytic; therefore, it should not be injected until it has been rendered approximately isotonic through the addition of an appropriate solute to mitigate the risk of hemolysis.

The administration of intravenous solutions carries the potential risk of fluid and/or solute overload, which may lead to dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The likelihood of dilutional states occurring is inversely proportional to the electrolyte concentration present in the solution.

Aluminum Toxicity Warning This product contains aluminum, which may pose a risk of toxicity, particularly with prolonged parenteral administration in patients with impaired kidney function. Premature neonates are especially vulnerable due to their immature renal function and their requirement for large volumes of calcium and phosphate solutions that contain aluminum. Research indicates that patients with compromised kidney function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day may accumulate aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration.

Compatibility and Administration Precautions To reduce the risk of incompatibilities from mixing additives, the final infusate should be inspected for cloudiness or precipitation immediately after mixing and periodically during administration. It is advised not to use plastic containers in a series connection. If the administration of Sterile Water for Injection USP after admixture or dilution is managed by a pumping device, it is crucial to discontinue the pumping action before the container is empty to prevent air embolism. In cases where administration is not controlled by a pumping device, excessive pressure (greater than 300 mmHg) should be avoided to prevent distortion of the container, which could lead to breakage.

This solution is intended for intravenous administration only after proper admixture or dilution using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. The solution should only be used if it is clear and the container and seals are intact. Notably, the drug product contains no more than 25 mcg/L of aluminum.

Side Effects

Adverse reactions associated with the administration of this product may include a range of responses due to the solution itself or the technique of administration. Common reactions observed in patients include febrile responses, infections at the site of injection, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

Serious warnings are associated with the use of this product. It contains aluminum, which may reach toxic levels with prolonged parenteral administration, particularly in patients with impaired kidney function. Premature neonates are especially at risk due to their immature kidneys and the necessity for large amounts of calcium and phosphate solutions that contain aluminum. Research indicates that patients receiving parenteral aluminum levels exceeding 4 to 5 mcg/kg/day may accumulate aluminum at levels linked to central nervous system and bone toxicity, with tissue loading potentially occurring at even lower rates of administration.

The administration of intravenous solutions can lead to fluid and/or solute overload, resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. Additionally, the product is hypotonic and hemolytic; therefore, it should not be injected until it has been made approximately isotonic by the addition of an appropriate solute to mitigate the risk of hemolysis.

In cases of overdosage, manifestations of water intoxication may occur, presenting as behavioral changes such as confusion, apathy, and disorientation, alongside central nervous system disturbances including weakness, muscle twitching, headaches, nausea, vomiting, and convulsions. Weight gain may also be observed in affected patients.

Drug Interactions

Certain additives may exhibit incompatibility with the primary formulation. It is essential to consult with a pharmacist prior to the introduction of any additives. When incorporating additives, strict aseptic techniques should be employed to ensure safety and efficacy. Thorough mixing is required, and it is advised not to store the mixture after preparation.

For comprehensive information regarding potential carcinogenicity, mutagenicity, effects on fertility, and considerations for use during pregnancy, lactation, pediatric, and geriatric populations, refer to the package insert of the solute utilized. This information is critical for ensuring appropriate patient management and safety.

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

Pediatric patients should be evaluated for the potential risks associated with aluminum exposure, as outlined in the WARNINGS section of the package insert for the solute used. Healthcare professionals are advised to refer to this section for specific guidance on the implications of aluminum in pediatric populations.

Geriatric Use

Elderly patients may have specific considerations regarding the use of this medication. It is essential to refer to the package insert of the solute used for detailed information. Notably, the WARNINGS section contains important information regarding aluminum, which may be particularly relevant for geriatric patients.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may be at an increased risk for adverse effects. Monitoring for potential complications is advised, and dosage adjustments may be necessary based on individual patient assessments and clinical findings.

Pregnancy

Pregnant patients should refer to the package insert of the solute used for specific information regarding the use of this medication during pregnancy. Available data from clinical and animal studies should be considered when evaluating the potential risks and benefits of treatment in this population. Healthcare professionals are advised to assess the individual circumstances of pregnant patients, including the potential for known or unknown fetal impacts, before prescribing this medication. Caution is recommended, and alternative therapies should be considered if the risks outweigh the benefits.

Lactation

Lactating mothers should refer to the package insert of the solute used for specific information regarding excretion in breast milk and any potential effects on breastfed infants. Data on the presence of the drug in human milk and its impact on nursing infants are not provided in the extracted information. Therefore, healthcare professionals are advised to consult the relevant package insert for comprehensive guidance on the use of this medication during lactation.

Renal Impairment

Patients with renal impairment may require careful consideration when using this product due to the presence of aluminum, which can be toxic if accumulated. Prolonged parenteral administration of aluminum in patients with reduced kidney function can lead to toxic levels. This risk is particularly pronounced in premature neonates, whose immature kidneys may struggle to excrete aluminum effectively, especially when they require large amounts of calcium and phosphate solutions that contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral aluminum at doses exceeding 4 to 5 mcg/kg/day are at risk of accumulating aluminum to levels associated with central nervous system and bone toxicity. Furthermore, tissue loading of aluminum may occur even at lower rates of administration. Therefore, it is essential to monitor aluminum exposure and consider dose adjustments in patients with renal impairment to mitigate the risk of toxicity.

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

Overdosage, characterized by hypotonic expansion, results from an imbalance between fluid intake and output, specifically when the increase in body fluid volume is attributed solely to water. This condition may arise in patients who receive substantial amounts of electrolyte-free water to compensate for significant fluid losses, in those whose renal capacity to manage water loads is surpassed, or in postoperative patients who retain water due to stress responses.

The clinical manifestations of water intoxication include a range of behavioral changes such as confusion, apathy, and disorientation, often accompanied by hyponatremia. Additionally, central nervous system disturbances may present as weakness, muscle twitching, headaches, nausea, vomiting, and convulsions. Patients may also experience weight gain as a result of fluid retention.

Management of overdosage involves the immediate cessation of fluid intake until the excess water is adequately excreted. In cases of severe hyponatremia, it may be necessary to administer hypertonic saline cautiously. This intervention aims to elevate extracellular osmotic pressure, thereby facilitating the renal excretion of excess water.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Reactions reported in the postmarketing experience include febrile responses, infections at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia. Additionally, healthcare professionals are advised to remain vigilant for potential adverse reactions related to drug additives. It is recommended that prescribing information for any drug additives administered concurrently be consulted. In the event of an adverse reaction, it is advised to discontinue the infusion, evaluate the patient, implement appropriate therapeutic countermeasures, and retain the remaining fluid for examination if necessary.

Patient Counseling

Healthcare providers should inform patients that this solution is intended solely for compounding and not for direct infusion. It is crucial to emphasize that the solution is hypotonic and hemolytic; therefore, it should not be injected until it has been made approximately isotonic by the addition of an appropriate solute to prevent the risk of hemolysis.

Providers should discuss the potential risks associated with the administration of intravenous solutions, including the possibility of fluid and/or solute overload, which can lead to dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. It is important to note that the risk of dilutional states is inversely proportional to the electrolyte concentration.

A significant warning to relay is that this product contains aluminum, which may be toxic, particularly with prolonged parenteral administration in patients with impaired kidney function. Premature neonates are especially at risk due to their immature kidneys and their need for large amounts of calcium and phosphate solutions that contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity, with tissue loading potentially occurring at even lower rates of administration.

Healthcare providers should advise patients to be aware of the importance of inspecting the final infusate for cloudiness or precipitation immediately after mixing and periodically during administration to minimize the risk of incompatibilities from mixing additives. It is also essential to inform patients not to use plastic containers in series connection and to take precautions when administering Sterile Water for Injection USP, particularly if controlled by a pumping device, to avoid air embolism.

If administration is not controlled by a pumping device, patients should be cautioned against applying excessive pressure that could distort the container, as this may lead to breakage. The solution is intended for intravenous administration only after proper admixture or dilution using sterile equipment, and it is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Patients should only use the solution if it is clear and the container and seals are intact. The drug product contains no more than 25 mcg/L of aluminum, and parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever possible. The use of a final filter during the administration of all parenteral solutions is recommended where feasible.

When compounding admixtures, healthcare providers should emphasize the importance of using aseptic technique and mixing thoroughly. Patients should be informed that any unused portion of Sterile Water for Injection USP should not be stored. Finally, once the container closure has been penetrated, the withdrawal of content should be completed within 4 hours.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. To ensure optimal quality, exposure to heat should be minimized, and excessive heat should be avoided. The product must be protected from freezing to maintain its integrity.

It is recommended that the product be stored at room temperature, ideally at 25°C. However, brief exposure to temperatures up to 40°C does not adversely affect the product. Proper storage conditions are essential for preserving the efficacy and safety of the pharmaceutical product.

Additional Clinical Information

This solution is intended for intravenous administration following admixture or dilution with sterile equipment. Clinicians should ensure that the final infusate is inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. It is crucial to use the solution only if it is clear and the container and seals are intact. Additionally, clinicians are advised to consult with a pharmacist regarding potential incompatibilities with any additives.

FDA Insert (PDF)

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

View full prescribing information (PDF)