Sterile Water

Description

Sterile Water for Injection, USP is a sterile, nonpyrogenic, distilled water formulation provided in a Pharmacy Bulk Package. This package is designed for parenteral use and contains multiple single doses intended for pharmacy admixture programs, specifically for the preparation of admixtures for intravenous infusion. The formulation does not contain any antimicrobial agents or other additives.

The pH of the solution is 5.5, with a permissible range of 5.0 to 7.0, and it has an osmolarity of 0 mOsmol/L (calculated). The VIAFLEX plastic container is constructed from a specially formulated polyvinyl chloride (PL 146 Plastic). It is important to note that exposure to temperatures exceeding 25°C (77°F) during transport and storage may result in minor moisture loss, with higher temperatures leading to greater losses. However, these minor changes are unlikely to have clinically significant effects within the product's expiration period.

The amount of water that may permeate from the container into the overwrap is insufficient to significantly impact the solution. Additionally, while solutions in contact with the plastic container may leach certain chemical components in very small amounts, biological testing has confirmed the safety of the materials used in the plastic container.

Uses and Indications

Sterile Water for Injection, USP is indicated for the aseptic preparation of parenteral admixtures. This product is designed to provide a sterile medium for the dilution or reconstitution of medications intended for parenteral administration.

There are no teratogenic or nonteratogenic effects associated with the use of Sterile Water for Injection, USP.

Dosage and Administration

The dosage of the medication is determined by the patient's age, weight, clinical condition, and relevant laboratory determinations. Healthcare professionals should refer to the specific directions accompanying the drug for detailed dosing information.

Prior to administration, parenteral drug products must be visually inspected for particulate matter and discoloration, whenever the solution and container permit. It is recommended to utilize a final filter during the administration of all parenteral solutions whenever feasible to ensure the safety and integrity of the medication.

Sterile Water for Injection, USP, available in the Pharmacy Bulk Package, is intended solely for the preparation of sterile intravenous admixtures. When compounding these admixtures, it is essential to employ aseptic technique and to mix the solutions thoroughly.

Unused portions of Sterile Water for Injection, USP should not be stored. Once the container closure has been penetrated, the withdrawal of contents should be completed without delay. After the initial entry, the contents should be maintained at room temperature (25°C/77°F) and dispensed within 4 hours to ensure optimal efficacy and safety.

Contraindications

Sterile Water for Injection, USP is contraindicated for intravenous administration without admixing due to its hemolytic properties resulting from hypotonicity. The use of this product in such a manner may lead to hemolysis and associated complications.

Warnings and Precautions

This solution is intended solely for compounding purposes and is not suitable for direct infusion. The infusion of Sterile Water for Injection, USP, may lead to hemolysis, which has been associated with cases of hemoglobin-induced renal failure. Healthcare professionals should exercise caution when administering this solution to avoid potential complications.

Aluminum Toxicity Warning This product contains aluminum, which poses 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 systems and their need for substantial amounts of calcium and phosphate solutions that contain aluminum. It is critical to monitor aluminum exposure in these patients, as research indicates that parenteral administration of aluminum exceeding 4 to 5 µg/kg/day can lead to accumulation at levels that may result in central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration, necessitating careful consideration of the risks associated with aluminum exposure in susceptible populations.

Healthcare professionals are advised to regularly assess kidney function and monitor aluminum levels in patients receiving this product, particularly in those with compromised renal function or in premature neonates.

Side Effects

The administration of a suitable admixture of prescribed drugs may be associated with various adverse reactions due to the solution or the technique of administration. Common adverse reactions observed 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. Hemolysis may occur following the infusion of Sterile Water for Injection, USP, and hemoglobin-induced renal failure has been reported as a consequence of hemolysis. Additionally, this product contains aluminum, which may be toxic, particularly with prolonged parenteral administration in patients with impaired kidney function. Premature neonates are at heightened 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 aluminum levels exceeding 4 to 5 µg/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.

Precautions should be taken to ensure that the solution is clear and the seal is intact prior to use. The drug product contains no more than 25 µg/L of aluminum. Safety and effectiveness have been established in pediatric patients; however, in neonates or very small infants, the volume of fluid administered may affect fluid and electrolyte balance.

Drug Interactions

Additives may exhibit incompatibility with the fluid withdrawn from this container. It is advisable to consult with a pharmacist, if available, when compounding admixtures to ensure safety and efficacy.

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

Safety and effectiveness have been established in pediatric patients. However, caution is advised when administering the medication to neonates or very small infants, as the volume of fluid may impact fluid and electrolyte balance.

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 Sterile Water for Injection, USP during pregnancy. The prescribing information does not indicate any safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine safety and efficacy in this population.

Renal Impairment

Patients with renal impairment may experience increased risk of aluminum toxicity due to the presence of aluminum in this product. Prolonged parenteral administration in individuals with reduced kidney function can lead to toxic levels of aluminum. This risk is particularly pronounced in premature neonates, whose immature kidneys may struggle to excrete aluminum effectively, especially when they require large volumes of calcium and phosphate solutions that contain aluminum.

Clinical research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral aluminum at doses exceeding 4 to 5 µg/kg/day are at risk of accumulating aluminum to levels associated with central nervous system and bone toxicity. It is important to monitor aluminum exposure closely in these patients, as tissue loading may occur even at lower rates of administration. Therefore, healthcare professionals should exercise caution and consider appropriate dosing adjustments and monitoring strategies for patients with reduced renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is vital for ongoing management and potential reporting requirements.

Nonclinical Toxicology

Prolonged parenteral administration of aluminum may lead to toxic levels, 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 has demonstrated that patients with compromised kidney function, including premature neonates, who receive parenteral aluminum at doses exceeding 4 to 5 µg/kg/day are at risk of accumulating aluminum to levels that can result in central nervous system and bone toxicity. Additionally, tissue loading of aluminum may occur even at lower rates of administration.

No information is available regarding teratogenic effects, carcinogenicity, or mutagenicity.

Postmarketing Experience

The administration of a suitable admixture of prescribed drugs has been associated with various adverse reactions, which may arise from the solution or the technique of administration. Reported events include febrile responses, infections at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia. In instances where an adverse reaction occurs, it is recommended to discontinue the infusion, evaluate the patient, implement appropriate therapeutic countermeasures, and retain the remainder of the fluid for examination if necessary.

Additionally, hemolysis has been noted following the infusion of Sterile Water for Injection, USP, with subsequent reports of hemoglobin-induced renal failure linked to this hemolysis. Research has indicated that patients with impaired kidney function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 µg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading of aluminum may occur even at lower rates of administration.

Patient Counseling

Healthcare providers should advise patients that this solution is intended solely for compounding and is not suitable for direct infusion. It is essential to ensure that the solution is clear and that the seal is intact before use. Patients should be informed that the drug product contains no more than 25 µg/L of aluminum.

While safety and effectiveness have been established in pediatric patients, healthcare providers should caution that in neonates or very small infants, the volume of fluid may impact fluid and electrolyte balance. In the event of an adverse reaction, healthcare providers should instruct patients to discontinue the infusion immediately, evaluate the patient's condition, implement appropriate therapeutic countermeasures, and retain any remaining fluid for examination if necessary.

Healthcare providers should emphasize the importance of visually inspecting parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution and container allow. The use of a final filter during the administration of all parenteral solutions is recommended whenever possible.

Patients should be made aware that additives may be incompatible with the fluid withdrawn from this container, and they should consult with a pharmacist, if available, when compounding admixtures. When compounding admixtures, it is crucial to use aseptic technique and mix thoroughly. Patients should be informed that any unused portion of Sterile Water for Injection, USP, should not be stored.

Once the container closure has been penetrated, healthcare providers should instruct patients to complete the withdrawal of contents without delay. After the initial entry, the contents should be maintained at room temperature (25°C/77°F) and dispensed within 4 hours. Patients should also be advised to check for minute leaks by squeezing the inner bag firmly; if any leaks are detected, the solution should be discarded as sterility may be compromised.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. To ensure optimal stability and efficacy, exposure to heat should be minimized, and excessive heat must be avoided. It is recommended that the product be stored at room temperature, specifically at 25°C (77°F). Proper storage conditions are essential to maintain the integrity of the pharmaceutical product.

Additional Clinical Information

The drug is administered intravenously. Clinicians should ensure that the solution is clear and the seal is intact before use. The formulation contains no more than 25 µg/L of aluminum.

Safety and effectiveness have been established in pediatric patients; however, caution is advised in neonates or very small infants, as the volume of fluid may impact fluid and electrolyte balance.

FDA Insert (PDF)

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

View full prescribing information (PDF)