Sterile Water

Description

Sterile Water for Injection, USP is chemically designated H2O. It has a pH of 5.4, which falls within the range of 5.0 to 7.0. This product contains no bacteriostat, antimicrobial agent, or added buffer. The flexible plastic container is made from a specially formulated polyvinylchloride.

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 associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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

Premature neonates are particularly at risk due to immature kidney function, necessitating careful consideration when administering calcium and phosphate solutions that contain aluminum. Research indicates that pediatric patients, especially those with impaired kidney function, may accumulate aluminum when parenteral levels exceed 4 to 5 mcg/kg/day. This accumulation is associated with potential central nervous system and bone toxicity. Furthermore, tissue loading of aluminum may occur even at lower rates of administration, highlighting the need for vigilant monitoring in this vulnerable population.

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 available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with any medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

Management of an overdose typically involves supportive care, which may include the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's needs.

3. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific antidotes or additional management strategies, if applicable.

It is crucial for healthcare professionals to document the incident thoroughly and report any adverse events to the appropriate regulatory authorities. Continuous education on the signs of overdose and the importance of prompt intervention can significantly improve patient outcomes in such scenarios.

Nonclinical Toxicology

Prolonged parenteral administration of aluminum may lead to toxic accumulation, particularly in individuals with impaired kidney function. Premature neonates are especially vulnerable due to their immature renal systems and their need for substantial amounts of calcium and phosphate solutions, which often contain aluminum. Research indicates that patients with compromised kidney function, including premature neonates, who receive parenteral aluminum at doses exceeding 4 to 5 mcg/kg/day are at risk of accumulating aluminum levels that can result in central nervous system and bone toxicity. Notably, tissue loading may occur even at lower rates of administration.

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

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 Sterile Water for Injection, USP is intended solely for dilution purposes. It is crucial to inform patients not to heat the solution above 66°C (150°F) as this may compromise its integrity. Providers must emphasize that this preparation is solute-free; therefore, undiluted entry into the circulation can lead to hemolysis.

Patients should be made aware that the absorption of large amounts of Sterile Water for Injection, USP, especially when combined with additives, can result in fluid and/or solute overload. This may 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, including peripheral and pulmonary edema, is directly proportional to the electrolyte concentrations of such solutions.

Providers must communicate the warning regarding aluminum content in this product, which may be toxic. Patients with impaired kidney function, including premature neonates, are particularly at risk, as their kidneys are immature and they often require large amounts of calcium and phosphate solutions that contain aluminum. Research indicates that parenteral administration of aluminum at levels greater than 4 to 5 mcg/kg/day can lead to accumulation at levels associated with central nervous system and bone toxicity, with tissue loading potentially occurring at even lower rates of administration.

Healthcare providers should instruct patients to only use the solution if it is clear, the seal is intact, and the container is undamaged. Aseptic technique is essential when using sterile preparations for compounding admixtures, and providers should remind patients to discard the container within 4 hours of entering the closure to minimize the risk of contamination. Accidental contamination from careless technique may transmit infection, so it is vital to maintain strict aseptic practices during all manipulations performed in an appropriate laminar flow hood.

Once the outlet site has been entered, the withdrawal of the container's contents should be completed promptly in one continuous operation. Providers should also advise patients to visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution container permits. It is normal to observe some opacity of the plastic due to moisture absorption during the sterilization process, and this does not affect the solution's quality or safety.

In the event of any adverse reaction, healthcare providers should evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

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

No further data are available.

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)