Sterile Water

Description

Sterile Water for Injection, USP is a sterile, nonpyrogenic water intended solely for dilution purposes. It is chemically designated as H₂O and has a pH of 5.4, falling within the range of 5.0 to 7.0. This product is provided in a Pharmacy Bulk Package, which is a sterile dosage form containing multiple single doses specifically for use in a pharmacy bulk admixture program.

Sterile Water for Injection, USP does not contain any bacteriostat, antimicrobial agent, or added buffer, classifying it as a sterile diluent and pharmaceutical vehicle. The flexible plastic container is made from a specially formulated polyvinylchloride, designed to maintain sterility. While water may permeate from inside the container into the overwrap, it does so in amounts insufficient to significantly affect the solution. Additionally, the solutions within the plastic container may leach out certain chemical components in very small amounts prior to the expiration date. The safety of the plastic has been validated through tests in animals, adhering to USP biological standards for plastic containers.

Uses and Indications

Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for the preparation of intravenous admixtures in the pharmacy. This drug is specifically designed to facilitate the preparation of intravenous admixtures utilizing automated compounding technology.

Limitations of Use: There are no reported teratogenic or nonteratogenic effects associated with the use of this product.

Dosage and Administration

Sterile Water for Injection, USP in the 2000 mL flexible Pharmacy Bulk Package is intended for use with automated compounding devices to prepare intravenous admixtures. Dosages should be determined in accordance with the prescribing physician's recommendations.

It is important to note that Sterile Water for Injection, USP is not suitable for direct infusion. All admixtures must be prepared by or under the supervision of a pharmacist, utilizing strict aseptic techniques within a laminar flow hood. When compounding admixtures, thorough mixing is essential, and the compounded solutions should not be stored.

Compounded admixtures may be refrigerated for up to 24 hours; however, administration must be completed within 24 hours following removal from refrigeration. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever the solution container allows.

During the preparation process, the container must be stored and all manipulations conducted within an appropriate laminar flow hood. To initiate the transfer, the cover from the outlet port at the bottom of the container should be removed. The piercing pin of the transfer set should be inserted into the outlet port, and the unit should be suspended in the laminar flow hood. It is critical that the piercing pin is inserted into the outlet port only once. Once the outlet site has been accessed, the withdrawal of the container's contents should be completed promptly in a single continuous operation. If this is not feasible, the fluid transfer operations must be completed within a maximum of 4 hours from the insertion of the transfer set pin; otherwise, the container should be discarded.

Sequential aliquots of Sterile Water for Injection, USP should be dispensed into intravenous containers using the appropriate transfer set. Throughout the fluid transfer operations, the Pharmacy Bulk Package must be maintained under the recommended storage conditions as indicated in the labeling.

Contraindications

Direct infusion of this product is contraindicated. Additionally, it should not be used for non-automated admixture preparations.

Warnings and Precautions

Healthcare professionals should exercise caution when using this preparation, which is intended for dilution only. It is imperative that the solution is not heated above 66°C (150°F) to maintain its integrity and safety.

The preparation is solute-free; therefore, undiluted entry into the circulation can lead to hemolysis. Additionally, the absorption of large volumes of Sterile Water for Injection, USP, particularly when combined with additives, poses a risk of fluid and/or solute overload. This can result in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered solutions, while the risk of solute overload leading to congested states, including peripheral and pulmonary edema, is directly proportional to the electrolyte concentrations present.

A significant warning pertains to the aluminum content of this product, which may be toxic. Prolonged parenteral administration can lead to toxic levels of aluminum, especially in patients with impaired kidney function. Premature neonates are particularly vulnerable due to their immature renal function and their need 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 are at risk of accumulating aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration.

Healthcare professionals are advised to monitor renal function closely in patients receiving this preparation, particularly in vulnerable populations such as premature neonates, to mitigate the risks associated with aluminum toxicity and fluid overload.

Side Effects

Accidental contamination from careless technique may transmit infection. It is critical to adhere to aseptic techniques when using sterile preparations for compounding admixtures to minimize this risk.

The product carries a boxed warning indicating that it is a pharmacy bulk package and is not intended for direct infusion. It is to be used only with automated compounding devices. Additionally, this preparation is for dilution only and should not be heated above 66°C (150°F). The undiluted entry of this preparation into the circulation can cause hemolysis.

Patients receiving large amounts of Sterile Water for Injection, USP with additives may experience fluid and/or solute overloading, which can lead to dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered solutions, while the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

A significant warning 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 the requirement 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 levels of aluminum exceeding 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions must be taken to ensure that the water is clear, the seal is intact, and the container is undamaged before use. Containers should be discarded within 4 hours of entering closure to maintain sterility. This product is contraindicated for direct infusion and should not be used for non-automated admixture preparations.

Drug Interactions

There are currently no documented drug interactions or drug and laboratory test interactions associated with the use of this medication. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time. Healthcare professionals should continue to evaluate the patient's overall medication regimen and clinical status to ensure safe and effective 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, particularly premature neonates, are at increased risk for aluminum toxicity due to the immaturity of their kidneys. This product contains aluminum, which may reach toxic levels with prolonged parenteral administration, especially in those with impaired kidney function. Research indicates that when pediatric patients receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day, there is a 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. Caution is advised when administering this product to pediatric patients, particularly those requiring large amounts of calcium and phosphate solutions that contain aluminum.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy. The prescribing information does not indicate any safety concerns related to pregnancy, nor does it provide data from clinical or animal studies that would suggest potential risks to fetal outcomes. Additionally, there are no dosage modifications specified for pregnant patients, and no special precautions regarding the use of this medication during pregnancy are mentioned. Healthcare professionals should consider the absence of data when prescribing this medication to women of childbearing potential and weigh the benefits against any potential risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized.

Renal Impairment

Patients with renal impairment may require careful consideration when using this product due to the presence of aluminum, which can be toxic, particularly with prolonged parenteral administration. In patients with reduced kidney function, including premature neonates, there is an increased risk of aluminum accumulation. Research indicates that parenteral administration of aluminum at levels exceeding 4 to 5 mcg/kg/day can lead to accumulation 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 closely in patients with impaired kidney function, especially in vulnerable populations such as premature neonates, who have immature kidneys and require significant amounts of calcium and phosphate solutions that may contain aluminum.

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

The administration of large volumes of Sterile Water for Injection, USP, particularly when combined with additives, poses significant risks of overdosage. Such overdosage can lead to fluid and/or solute overload, resulting in 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 concentrations of the administered solutions. Conversely, the risk of solute overload, which can lead to congested states characterized by peripheral and pulmonary edema, is directly proportional to the electrolyte concentrations present in these solutions.

Healthcare professionals should be particularly vigilant regarding the aluminum content in this product. Prolonged parenteral administration of aluminum can lead to toxic levels, especially in patients with impaired kidney function. This risk is heightened in premature neonates, whose immature kidneys are less capable of excreting aluminum. These patients often require substantial amounts of calcium and phosphate solutions, which may contain aluminum, thereby increasing their exposure.

Research indicates that patients with compromised renal function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day are at risk of accumulating aluminum to levels associated with central nervous system and bone toxicity. It is crucial to recognize that tissue loading of aluminum may occur even at lower rates of administration.

In the event of suspected overdosage, immediate assessment of the patient's clinical status is essential. Monitoring of fluid balance, serum electrolyte levels, and renal function should be conducted. Management may include supportive care, adjustment of fluid and electrolyte administration, and, if necessary, consultation with a toxicologist or nephrologist for further guidance on managing aluminum toxicity and fluid overload.

Nonclinical Toxicology

The safety of the plastic used in the formulation has been confirmed through testing in animals, adhering to the biological standards set forth by the United States Pharmacopeia (USP) for plastic containers.

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 to levels associated with central nervous system and bone toxicity. It is noteworthy that tissue loading of aluminum may occur even at lower rates of administration.

No information is available regarding teratogenic or non-teratogenic effects, nor is there specific data on animal pharmacology and toxicology.

Postmarketing Experience

Accidental contamination resulting from careless technique has been reported, which may lead to the transmission of infection. In the event of any adverse reaction, it is recommended that the patient be evaluated promptly. Appropriate therapeutic countermeasures should be instituted, and if deemed necessary, the remainder of the fluid should be preserved for examination.

Patient Counseling

Healthcare providers should advise patients that this medication is intended solely for use with automated compounding devices for the preparation of intravenous admixtures and is not suitable for direct infusion. It is crucial to inform patients that this product should not be used for non-automated admixture preparations.

Patients must be instructed to ensure that the solution is clear and that the container is undamaged prior to use. Emphasizing the importance of aseptic technique, healthcare providers should explain that sterile preparations are essential for compounding admixtures to prevent contamination.

Providers should counsel patients to discard the container within 4 hours of entering the closure to minimize the risk of infection due to accidental contamination from careless technique. They should also inform patients that if any adverse reactions occur, it is important to evaluate the patient, implement appropriate therapeutic countermeasures, and retain the remaining fluid for examination if necessary.

It is critical to use aseptic technique during all manipulations performed in an appropriate laminar flow hood. Once the outlet site has been accessed, the withdrawal of the container's contents should be completed promptly in one continuous operation. Additionally, patients should be reminded to visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution container allows for such inspection. If any leaks are detected after removing the overwrap, the solution should be discarded, as sterility may be compromised.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20 to 25°C (68 to 77°F), in compliance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing to maintain its integrity and efficacy. Proper handling and storage conditions must be adhered to in order to ensure optimal product performance.

Additional Clinical Information

The route of administration for the medication is intravenous. Clinicians are advised to use the product only in a laminar flow hood to ensure proper sterile conditions. Once the outlet site has been accessed, the withdrawal of the container's contents should be completed promptly in one continuous operation. It is important to discard the container no later than four hours after the initial closure puncture to maintain safety and efficacy.

FDA Insert (PDF)

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

View full prescribing information (PDF)