Sterile Water

Description

Sterile Water for Injection, USP, is a sterile, nonpyrogenic, distilled water provided in a single-dose container intended for intravenous administration following the addition of a suitable solute. This product may also serve as a dispensing container for diluent use. It contains no added antimicrobial or other substances. The pH of the solution is 5.5, with a range of 5.0 to 7.0, and it has an osmolarity of 0.

The VIAFLEX plastic container is constructed from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is minimal and does not significantly affect the solution. While solutions in contact with the plastic container may leach certain chemical components in very small amounts, biological testing has demonstrated 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 solutions. This product is intended for use in healthcare settings where sterile conditions are essential for the preparation of injectable medications.

Limitations of Use: There are no reported 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 any additive drug used in conjunction with this medication.

Prior to administration, parenteral drug products must be visually inspected for particulate matter and discoloration, provided that the solution and container allow for such inspection. Injections contained in VIAFLEX plastic containers are designated for intravenous administration and should be administered using sterile equipment to ensure patient safety.

It is essential to note that certain additives may be incompatible with the medication. Healthcare professionals are advised to consult with a pharmacist when available to confirm compatibility. If, in the physician's informed judgment, the introduction of additives is deemed necessary, aseptic technique must be employed to prevent contamination.

Unused portions of Sterile Water for Injection, USP, should not be stored. After the introduction of any additives, the solution must be mixed thoroughly and should not be stored for future use. Solutions containing additives are to be used immediately to ensure efficacy and safety.

Contraindications

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

Warnings and Precautions

The use of this product for intravenous injection is contraindicated unless it has been adjusted to approximate isotonicity with a suitable solute. Administering the product in its unmodified form may lead to serious complications.

Healthcare professionals should be aware that hemolysis may occur following the infusion of Sterile Water for Injection, USP. This condition can result in significant adverse effects, including hemoglobin-induced renal failure, which has been documented in clinical reports.

It is imperative to monitor patients closely for signs of hemolysis and renal impairment during and after administration. Regular assessment of renal function and hemoglobin levels is recommended to ensure patient safety and to mitigate potential risks associated with the use of this product.

Side Effects

The administration of a suitable admixture of prescribed additives may be associated with various adverse reactions, which can occur due to the solution or the technique of administration. Common adverse reactions include febrile responses, infections at the site of injection, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

Serious adverse reactions may include hemolysis, which can occur following the infusion of Sterile Water for Injection, USP. Hemoglobin-induced renal failure has been reported in patients following instances of hemolysis.

It is crucial to note that Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity; therefore, it is contraindicated for intravenous administration without additives. Additionally, precautions should be taken to ensure that the solution is clear and the seal is intact prior to administration to mitigate the risk of adverse reactions.

Drug Interactions

Additives may exhibit incompatibility with certain medications. While complete information regarding all potential interactions is not available, it is essential to avoid using known incompatible additives. Healthcare professionals are advised to consult with a pharmacist when considering the use of additives in conjunction with medications 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

Pediatric patients may require dosage adjustments based on age, weight, clinical condition, and laboratory determinations. While the need for age-dependent dosing is acknowledged, specific pediatric dosing guidelines are not provided in the available information. Healthcare professionals should consider these factors when prescribing to ensure appropriate and safe use in children.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no specific information regarding the use of Sterile Water for Injection, USP, in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. 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 to fetal outcomes.

Lactation

There are no specific warnings or precautions regarding the use of Sterile Water for Injection, USP in lactating mothers. Additionally, there is no information available concerning the potential for excretion of this product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may experience hemolysis following the infusion of Sterile Water for Injection, USP. This hemolysis can lead to hemoglobin-induced renal failure, which has been reported in clinical settings. Therefore, caution should be exercised when administering this product to patients with reduced kidney function, and appropriate monitoring for signs of hemolysis and renal function is recommended.

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 information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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

The administration of a suitable admixture of prescribed additives has been associated with various adverse reactions, as reported voluntarily or through surveillance programs. These reactions may include febrile responses, infections at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

In the event of an adverse reaction, it is recommended to discontinue the infusion, evaluate the patient, and institute appropriate therapeutic countermeasures. If deemed necessary, the remainder of the fluid should be saved for examination.

Patient Counseling

Healthcare providers should advise patients not to use Sterile Water for Injection, USP for intravenous injection unless it has been adjusted to approximate isotonicity with a suitable solute. It is important to inform patients that hemolysis may occur following infusion, which can lead to hemoglobin-induced renal failure.

Patients should be instructed to ensure that the solution is clear and that the seal is intact before administration. They should be made aware that the administration of a suitable admixture of prescribed additives may be associated with adverse reactions, including febrile response, infection at the injection site, venous thrombosis or phlebitis extending from the site, extravasation, and hypervolemia.

In the event of an adverse reaction, healthcare providers should counsel patients on the importance of discontinuing the infusion, evaluating their condition, and instituting appropriate therapeutic countermeasures. Patients should be informed that the remainder of the fluid should be saved for examination if deemed necessary.

Healthcare providers should emphasize the need for visual inspection of parenteral drug products for particulate matter and discoloration prior to administration whenever the solution and container permit. Patients should be made aware that additives may be incompatible, and complete information on compatibility is not available. They should be encouraged to consult with a pharmacist if available, especially if the physician deems it advisable to introduce additives, in which case aseptic technique should be used.

Patients should be informed that any unused portion of Sterile Water for Injection, USP should not be stored, and that solutions containing additives should not be stored either. They should be warned against using plastic containers in series connections, as this could result in air embolism due to residual air being drawn from the primary container before the fluid from the secondary container is fully administered.

Healthcare providers should instruct patients to discard the container if the port outlet protector is damaged, detached, or not present, as this may impair sterility. Patients should also be advised to check for minute leaks by squeezing the inner bag firmly; if leaks are found, the solution should be discarded due to potential sterility impairment.

Finally, patients should be counseled to avoid excessive heat and to store the product at room temperature (25°C), noting that brief exposure up to 40°C does not adversely affect the product.

Storage and Handling

Sterile Water for Injection, USP is supplied in VIAFLEX plastic containers. It is recommended that the product be stored at room temperature, specifically at 25°C. Care should be taken to minimize exposure of the product to heat, as excessive heat may compromise its integrity. However, brief exposure to temperatures up to 40°C does not adversely affect the product.

Additional Clinical Information

Intravenous administration of the medication should be performed using sterile equipment. Clinicians are advised to ensure that the solution is clear and the seal is intact before administration. It is important to consult with a pharmacist regarding the compatibility of any additives, as they may be incompatible. Unused portions of Sterile Water for Injection, USP, should not be stored, and solutions containing additives must be mixed thoroughly and not stored.

Patients should be counseled on these points to ensure safe and effective use of the medication.

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)