Water

Description

Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid, composed entirely of Sterile Water for Injection USP. It is prepared through a distillation process and does not contain antimicrobial or bacteriostatic agents, nor added buffers. The pH of the solution is 5.7, falling 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. This container is free from plasticizers and exhibits virtually no leachables. The solution contact layer consists of a rubberized copolymer of ethylene and propylene, ensuring that the container is nontoxic and biologically inert. The container-solution unit operates as a closed system, eliminating the need for external air entry during administration. Additionally, the container is overwrapped to protect against environmental factors and to provide an extra moisture barrier when necessary. The formulation is not made with natural rubber latex, PVC, or DEHP.

Uses and Indications

Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid in various medical procedures. Additionally, Sterile Water may be utilized as an adjunct in the preparation of non-intravenously administered nutrient mixtures.

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

Dosage and Administration

Healthcare professionals should administer this drug product as directed by the physician. Prior to administration, the solution must be visually inspected for particulate matter and discoloration, whenever the solution and container permit.

For the preparation of non-intravenously administered nutrient mixtures, Sterile Water for Irrigation USP may be utilized. This preparation contains no electrolytes or other added substances. It is essential to refer to the specific preparation instructions for the nutrient mixture being used. The plastic container provided may be employed for the administration of the non-intravenous nutrient mixture to the patient, as deemed appropriate.

Contraindications

The product is contraindicated for injection.

Warnings and Precautions

Sterile Water for Irrigation USP is classified as hypotonic and is contraindicated for use during surgical procedures due to the risk of hemolysis. Healthcare professionals should exercise caution and avoid its application in such settings to prevent potential complications.

To ensure patient safety, it is imperative that the contents of the container are utilized promptly after opening. This practice minimizes the risk of bacterial growth and the formation of pyrogens, which could compromise the sterility of the solution and pose a risk to patient health.

Any unused portion of the irrigating solution must be discarded, as it does not contain preservatives. This precaution is essential to maintain the integrity of the solution and to prevent any adverse effects associated with prolonged exposure to environmental contaminants.

Side Effects

Patients receiving Sterile Water for Irrigation USP may experience adverse reactions; however, none are known at this time. It is important to note that the solution is hypotonic and can cause hemolysis, which makes it unsuitable for use during surgical procedures.

To ensure safety, the contents of the container should be used promptly after opening to minimize the risk of bacterial growth or pyrogen formation. Any unused portion of the irrigating solution should be discarded, as it does not contain a preservative.

Precautions should be taken to use the solution only if it is clear and the container and seal are intact. Additionally, it is contraindicated for injection. There are no known concerns regarding overdosage.

Drug Interactions

There are no known drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no dosage adjustments or monitoring are necessary in relation to drug or laboratory test interactions.

Packaging & NDC

The table below lists all NDC Code configurations of Sterile Water, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric use has not been specifically addressed in the prescribing information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients, including children and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the lack of available data.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that there is no specific information regarding the use of this product during pregnancy. The absence of data necessitates caution when considering its use in this population.

The product is contraindicated for injection and is associated with warnings of being hypotonic and hemolytic, which may pose risks during surgical procedures. Therefore, it is not recommended for use in such settings.

Healthcare professionals should ensure that the solution is clear and that the container and seal are intact before administration. Given the lack of established safety data, the potential risks to fetal outcomes remain unclear, and the decision to use this product in pregnant patients should be made with careful consideration of the benefits and risks involved.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 event of an overdosage, there are currently no known symptoms or adverse effects associated with excessive intake of the medication.

Given the absence of documented overdosage effects, standard emergency procedures should be followed. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms or reactions, even in the absence of specific overdosage data.

In case of suspected overdosage, it is recommended to provide supportive care as needed and to consult local poison control or a medical toxicologist for further guidance. Continuous assessment of the patient's condition is essential to ensure appropriate management.

Nonclinical Toxicology

Teratogenic effects have not been observed in nonclinical studies. Additionally, there are no known non-teratogenic effects associated with the compound. No further nonclinical toxicology data or specific findings from animal pharmacology and toxicology studies have been provided.

Postmarketing Experience

Postmarketing experience has not identified any adverse reactions associated with the use of the product. Reports received voluntarily or through surveillance programs have not indicated any additional safety concerns.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Irrigation USP is intended solely for irrigation purposes and is not suitable for injection. Patients should be instructed to use the solution only if it appears clear and the container and seal are intact.

It is important for healthcare providers to emphasize the need for prompt use of the solution after opening the container to minimize the risk of bacterial growth or pyrogen formation. Patients should be informed to discard any unused portion of the irrigating solution, as it does not contain preservatives.

Healthcare providers should also stress the necessity of employing aseptic technique during the use of this product. Patients should be advised to visually inspect the solution for any particulate matter or discoloration prior to administration, whenever the solution and container allow for such inspection.

Additionally, healthcare providers should inform patients to avoid exposing the product to excessive heat and to protect it from freezing. While it is recommended to store the product at room temperature (25°C), brief exposure to temperatures up to 40°C is not expected to adversely affect the product.

Storage and Handling

Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in single-dose flexible irrigation containers, available in volumes of 2000 mL and 3000 mL, with each case containing four containers.

To ensure product integrity, exposure to heat should be minimized, and excessive heat should be avoided. The product should be stored at room temperature, ideally at 25°C. Brief exposure to temperatures up to 40°C does not adversely affect the product. Additionally, it is essential to protect the product from freezing to maintain its quality.

Additional Clinical Information

The product is administered via irrigation. Clinicians should advise patients to use the solution only if it is clear and the container and seal are intact. After opening the container, the contents should be used promptly to reduce the risk of bacterial growth or pyrogen formation. Any unused portion of the irrigating solution should be discarded, as it does not contain a preservative.

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)