Sterile Water

Description

Sterile Water for Injection USP is a clear, colorless, and odorless liquid that is sterile, hypotonic, and nonpyrogenic, containing no bacteriostatic or antimicrobial agents. It serves as a diluent or solvent 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, ensuring a high level of safety. The solution contact layer consists of a rubberized copolymer of ethylene and propylene, contributing to the container's nontoxic and biologically inert properties.

The container-solution unit operates as a closed system, eliminating the need for external air entry during administration. It is overwrapped to provide protection from the physical environment and to serve as an additional moisture barrier when necessary. The closure system features two ports: one for the administration set, equipped with a tamper-evident plastic protector, and another designated for medication addition. The addition of medication should be performed using complete aseptic technique.

Uses and Indications

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

Limitations of Use: There are no reported teratogenic or nonteratogenic effects associated with the use of Sterile Water for Injection USP.

Dosage and Administration

This solution is intended for intravenous use only. Prior to injection, it is essential to make the solution approximately isotonic by adding an appropriate solute. The specific dosage and administration of Sterile Water for Injection USP will depend on the recommended guidelines for 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 be incompatible; therefore, consultation with a pharmacist is advised before proceeding with any additions.

When introducing additives, healthcare professionals must employ aseptic techniques to ensure the sterility of the solution. After the addition of any solute, the mixture should be thoroughly mixed to ensure homogeneity. It is critical to avoid storing the prepared solution, as it is intended for immediate use.

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

Contraindications

Use of this product is contraindicated in situations where plastic containers are connected in series. 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

The use of this product necessitates careful consideration of several warnings and precautions to ensure patient safety and efficacy of treatment.

Warnings

This product is hypotonic and hemolytic; therefore, it must not be injected until it has been rendered approximately isotonic through the addition of an appropriate solute to prevent the risk of hemolysis. The administration of intravenous solutions carries the potential for 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.

It is critical to note that 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.

General Precautions

To mitigate the risk of incompatibilities from the mixing of additives, the final infusate should be inspected for cloudiness or precipitation immediately after mixing and periodically during administration. It is advised against using plastic containers in a series connection. If a pumping device controls administration, it is essential 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 (>300 mmHg) should be avoided to prevent distortion of the container, which could lead to breakage.

This solution is intended solely for intravenous administration 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. The drug product contains no more than 25 mcg/L of aluminum, which should be taken into account when considering patient safety.

Side Effects

Patients may experience a range of adverse reactions associated with the administration of this product. Serious reactions include the potential for aluminum toxicity, particularly in patients with impaired kidney function and in premature neonates. Prolonged parenteral administration of aluminum can lead to toxic levels, especially when doses exceed 4 to 5 mcg/kg/day, resulting in central nervous system and bone toxicity.

Common reactions that may occur due to the solution or the technique of administration include febrile responses, infections at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

Warnings regarding the administration of this product highlight the risks of hypotonic and hemolytic reactions. It is crucial to ensure that the solution is made approximately isotonic by the addition of an appropriate solute prior to injection to mitigate the risk of hemolysis. Additionally, the administration of intravenous solutions carries the risk of fluid and/or solute overload, which can lead to dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of these dilutional states is inversely proportional to the electrolyte concentration.

In cases of overdosage, manifestations of water intoxication may occur, including behavioral changes such as confusion, apathy, and disorientation, as well as central nervous system disturbances like weakness, muscle twitching, headaches, nausea, vomiting, and convulsions. Weight gain may also be observed. Treatment for overdosage involves withholding fluids until excessive water is excreted, and in severe cases of hyponatremia, cautious administration of hypertonic saline may be necessary to increase extracellular osmotic pressure and facilitate the excretion of excess water by the kidneys.

Drug Interactions

Certain additives may exhibit incompatibility with the drug, necessitating consultation with a pharmacist to ensure safe and effective use. It is essential for healthcare providers to remain vigilant regarding potential adverse reactions associated with drug additives. Therefore, it is recommended that prescribing information for any drug additives intended for administration in conjunction with this medication be thoroughly reviewed prior to use.

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 assessed for the potential risks associated with aluminum exposure, as outlined in the WARNINGS section of the package insert for the solute used. It is essential for healthcare professionals to refer to this information when considering treatment options for children, ensuring that any potential hazards are adequately addressed.

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 more susceptible to potential adverse effects. Monitoring for safety and efficacy is recommended, and dosage adjustments may be necessary based on individual patient factors.

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 available information. Therefore, healthcare professionals are advised to consider the benefits of breastfeeding alongside the potential risks associated with the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment should be closely monitored due to the potential for aluminum toxicity associated with this product. Prolonged parenteral administration in individuals with reduced kidney function may lead to toxic levels of aluminum. Research indicates that patients, including premature neonates, receiving parenteral aluminum at doses exceeding 4 to 5 mcg/kg/day are at risk of accumulating aluminum to levels that can cause central nervous system and bone toxicity. It is important to note that tissue loading of aluminum may occur even at lower rates of administration. Therefore, careful consideration of dosing and monitoring is essential for patients with impaired kidney function.

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 indicated 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 primarily involves the 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 surplus water.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

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 the 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 advise patients that the solution is hypotonic and hemolytic, and it should not be injected until it has been made approximately isotonic by the addition of an appropriate solute. They should inform patients that the administration of intravenous solutions can lead to fluid and/or solute overload, which may result in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration.

Providers must warn patients that this product contains aluminum, which may be toxic, particularly with prolonged parenteral administration in individuals 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. It is important to communicate that research indicates patients with impaired kidney function, including premature neonates, who receive parenteral aluminum levels greater than 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.

Patients should be instructed to inspect the final infusate for cloudiness or precipitation immediately after mixing and periodically during administration to minimize the risk of incompatibilities from mixing additives. They should be advised against using plastic containers in series connection and to ensure that if administration is controlled by a pumping device, the pumping action is discontinued before the container runs dry to prevent air embolism. If administration is not controlled by a pumping device, patients should avoid applying excessive pressure that could distort the container, as this may lead to breakage.

Healthcare providers should emphasize that the solution is intended for intravenous administration using sterile equipment, and it is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Patients must 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.

For specific concerns regarding carcinogenesis, mutagenesis, impairment of fertility, usage in pregnancy, nursing mothers, pediatric use, and geriatric use, healthcare providers should refer to the package insert of the solute used. They should also inform patients about potential reactions that may occur due to the solution or the technique of administration, including febrile response, infection at the injection site, venous thrombosis or phlebitis, extravasation, and hypervolemia. In the event of an adverse reaction, patients should be instructed to discontinue the infusion, evaluate their condition, and seek appropriate therapeutic countermeasures, while saving the remainder of the fluid for examination if necessary.

Patients should be made aware that overdosage, characterized by hypotonic expansion, occurs when there is an increase in fluid intake over fluid output, primarily due to water alone. Treatment for this condition consists of withholding fluids until excessive water is excreted, and in cases of severe hyponatremia, cautious administration of hypertonic saline may be necessary to increase extracellular osmotic pressure and facilitate the excretion of excess water by the kidneys.

Finally, healthcare providers should instruct patients to inspect each container, read the label to ensure the solution is the one ordered and is within the expiration date, and to check for cloudiness, haze, or particulate matter in good light. Any suspect container should not be used. They should also advise on proper storage conditions, recommending room temperature (25°C), avoiding excessive heat, and protecting from freezing. Patients should not remove the overwrap until ready for use and should check for minute leaks after removing the overwrap, discarding any solution if leaks are found, as sterility may be compromised.

Storage and Handling

Pharmaceutical products should be stored at room temperature, ideally at 25°C, to maintain their integrity. Brief exposure to temperatures up to 40°C is acceptable and does not adversely affect the product. It is essential to minimize exposure to heat and to protect the product from freezing.

When utilizing automated dispensing machines, the product may be exposed to ultraviolet or fluorescent light for brief periods, up to 2 weeks, without compromising the legibility of the labeling. However, prolonged exposure may lead to fading of the red label.

To ensure optimal quality, it is recommended to rotate stock frequently.

Additional Clinical Information

This solution is intended for intravenous use only. Clinicians should ensure that the solution is clear and that the container and seals are intact before administration. Each container must be inspected carefully; the label should be read to confirm that the solution is the one ordered and is within the expiration date.

It is important to invert the container and examine the solution in good light for any cloudiness, haze, or particulate matter. Any container that appears suspect should not be used. Additionally, clinicians should be aware that some additives may be incompatible with the solution. Consultation with a pharmacist is recommended when introducing additives, and aseptic techniques should be employed. Thorough mixing is essential, and the solution should not be stored after additives are introduced.

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)