Sterile Water

Description

Sterile Water for Irrigation, USP is a sterile, distilled, nonpyrogenic water intended exclusively for sterile irrigation, washing, rinsing, and dilution purposes. The product has a pH of 5.5, within the range of 5.0 to 7.0. It contains no bacteriostat, antimicrobial agent, or added buffer, and is designed for single-dose or short procedure irrigation; any unused portion should be discarded.

Chemically, Sterile Water for Irrigation, USP is designated as H₂O. The solution is packaged in a flexible plastic container made from a specially formulated polyvinylchloride, which allows for minimal water permeation into the overwrap without significantly affecting the solution. Additionally, a semi-rigid container made from a copolymer of ethylene and propylene is utilized, which does not require a vapor barrier to maintain the appropriate drug concentration.

While solutions in contact with the plastic container may leach small amounts of certain chemical components, biological testing has confirmed the safety of the materials used in the container. It is important to note that exposure to temperatures exceeding 25°C/77°F during transport and storage may result in minor moisture content losses, with higher temperatures leading to greater losses; however, these changes are unlikely to be clinically significant within the product's expiration period.

Uses and Indications

Sterile Water for Irrigation, USP is indicated for general irrigation, washing, rinsing, and dilution purposes that require the use of sterile, nonpyrogenic, solute-free water. This product is intended for irrigation only.

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

Dosage and Administration

The dose of the product is determined by the capacity or surface area of the structure to be irrigated, as well as the specific nature of the procedure being performed. When utilized as a diluent or vehicle for other drugs, healthcare professionals should adhere to the manufacturer's recommendations.

It is important to note that additives may exhibit incompatibility. Therefore, consultation with a pharmacist is advised when considering the introduction of any additives. If additives are to be used, aseptic technique must be employed, and the mixture should be thoroughly combined. Additionally, it is crucial that the prepared solution is not stored for future use.

Prior to administration, parenteral drug products should be visually inspected for any particulate matter or discoloration, as permitted by the solution container. This step is essential to ensure the safety and efficacy of the product being administered.

Contraindications

Use of this product is contraindicated for injection by usual parenteral routes. This restriction is in place to prevent potential adverse effects associated with improper administration methods.

Warnings and Precautions

This preparation is intended for irrigation purposes only. It is important to note that this solution is solute-free; therefore, its entry into the systemic circulation can lead to hemolysis.

Caution is advised when using solutions for urologic irrigation in patients with severe cardiopulmonary or renal dysfunction. During procedures such as transurethral prostatectomy, irrigating fluids, including Sterile Water for Irrigation, USP, have been shown to enter the systemic circulation in significant volumes. Consequently, Sterile Water for Irrigation, USP should be considered a systemic drug.

The absorption of large quantities of Sterile Water for Irrigation, USP, whether used alone or with additives, may result in fluid and/or solute overload. This can lead to dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of developing dilutional states is inversely related to the electrolyte concentrations of the administered solutions. Conversely, the likelihood of solute overload, which can cause congested states accompanied by peripheral and pulmonary edema, is directly proportional to the electrolyte concentrations of these solutions.

Additionally, it is critical to avoid heating the container above 66°C (150°F) to ensure the integrity of the solution.

Side Effects

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are completely avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distention or disruption of tissues. Accidental contamination from careless technique may transmit infection.

In the event of any adverse reaction, it is recommended to discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

The preparation is intended for irrigation only and is solute-free; its entry into the circulation can cause hemolysis. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. It has been demonstrated that irrigating fluids used during transurethral prostatectomy can enter the systemic circulation in relatively large volumes. Therefore, Sterile Water for Irrigation, USP must be regarded as a systemic drug. Absorption of large amounts of this solution, with or without additives, can lead to fluid and/or solute overloading, resulting 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 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.

Caution should be observed when solute-free water is used for continuous irrigation or allowed to "dwell" inside body cavities due to the potential for absorption into the bloodstream, which may lead to intravascular hemolysis and circulatory overload. Aseptic technique is essential when using sterile preparations for irrigation of body cavities, wounds, and urethral catheters, or for wetting dressings that come in contact with body tissues. When used as a "pour" irrigation, no part of the contents should contact the surface below the outer protected thread area of the semi-rigid wide mouth container.

The flexible container is designed for use with nonvented irrigation sets. When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded, and a fresh container of appropriate size should be used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient. It is crucial not to administer the solution unless the water is clear, the seal is intact, and the container is undamaged; any unused portion should be discarded.

Studies with Sterile Water for Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Caution should be exercised when administering this solution to nursing women. Animal reproduction studies have not been conducted, and it is unknown whether Sterile Water for Irrigation, USP can cause fetal harm when administered to pregnant women or affect reproductive capacity. It should be given to pregnant women only if clearly needed. Additionally, safety and effectiveness in pediatric patients have not been established.

Drug Interactions

Additives may exhibit incompatibility with certain medications. It is advisable to consult with a pharmacist to ensure safe and effective use of these additives in conjunction with the prescribed therapy. Monitoring for potential adverse effects or therapeutic failures is recommended when combining these substances.

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 in pediatric patients have not been established. Therefore, the use of this medication in children, infants, and adolescents should be approached with caution until further data is available.

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

Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Irrigation, USP. It is not known whether Sterile Water for Irrigation, USP can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Therefore, Sterile Water for Irrigation, USP should be given to a pregnant woman only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against the risks when considering the use of this product in pregnant patients.

Lactation

Caution should be exercised when Sterile Water for Irrigation, USP is administered to lactating mothers. There is limited data available regarding the excretion of this product in breast milk and its effects on breastfed infants. Therefore, healthcare professionals should carefully consider the potential risks and benefits before administering this product to nursing women.

Renal Impairment

Patients with renal impairment should use solutions for urologic irrigation with caution, particularly those with severe renal dysfunction. It is important to monitor these patients closely due to the potential for altered pharmacokinetics and the risk of adverse effects associated with reduced kidney function. Dosing adjustments may be necessary based on the severity of renal impairment to ensure safety and efficacy.

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 cases of overdosage, particularly related to overhydration or solute overload, it is essential to promptly re-evaluate the patient. This assessment should focus on identifying any signs of fluid imbalance or adverse reactions resulting from the excess solutes introduced during irrigation.

Recommended Actions

Upon identification of overhydration or solute overload, healthcare professionals should implement appropriate corrective measures. These may include adjusting fluid intake, administering diuretics if indicated, and closely monitoring the patient's vital signs and laboratory values to ensure a return to homeostasis.

Potential Symptoms

Patients experiencing overdosage may present with symptoms indicative of fluid overload, such as edema, hypertension, or respiratory distress. It is crucial for healthcare providers to remain vigilant for these signs and to act swiftly to mitigate any potential complications associated with overdosage.

In summary, timely recognition and management of overhydration or solute overload are vital to ensuring patient safety and effective treatment outcomes.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects associated with the use of Sterile Water for Irrigation, USP. Additionally, studies have not been conducted to assess the carcinogenic potential, mutagenic potential, or effects on fertility in animal models.

Postmarketing Experience

Postmarketing experience has identified several potential adverse effects associated with the irrigation of body cavities, tissues, or the use of indwelling catheters and tubes. These effects are generally avoidable when proper procedures are adhered to. Reports indicate that displaced catheters or drainage tubes may result in the irrigation or infiltration of unintended structures or cavities. Additionally, excessive volume or pressure during the irrigation of closed cavities has been associated with undue distention or disruption of tissues.

There have also been instances of accidental contamination due to careless technique, which may lead to the transmission of infection. In cases where an adverse reaction occurs, it is recommended to discontinue the use of the irrigant, evaluate the patient, and implement appropriate therapeutic countermeasures. If necessary, the remainder of the fluid should be preserved for examination. Furthermore, in situations of overhydration or solute overload—particularly when solutes have been added to the irrigation—re-evaluation of the patient and the initiation of corrective measures are advised.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Irrigation, USP is intended solely for sterile irrigation, washing, rinsing, and dilution purposes, and is not suitable for injection by usual parenteral routes. It is important to inform patients that this preparation is solute-free, and its entry into the circulation can lead to hemolysis.

Providers should exercise caution when using solutions for urologic irrigation in patients with severe cardiopulmonary or renal dysfunction. Emphasizing the necessity of aseptic technique is crucial when utilizing sterile preparations for irrigation of body cavities, wounds, and urethral catheters, or for wetting dressings that come into contact with body tissues.

When administering Sterile Water for Irrigation as a "pour" irrigation, healthcare providers should instruct patients that no part of the contents should contact the surface below the outer protected thread area of the semi-rigid wide mouth container. The flexible container is designed for use with nonvented irrigation sets, and it is essential that the administration set be attached promptly when used for irrigation via appropriate irrigation equipment.

Unused portions of the solution should be discarded, and a fresh container of appropriate size should be utilized for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient to prevent cross-contamination.

Patients should be informed that Sterile Water for Irrigation should not be administered unless the water is clear, the seal is intact, and the container is undamaged. Additionally, caution should be exercised when administering this solution to nursing women, and it should only be given to pregnant women if clearly needed. Providers should communicate that the safety and effectiveness of this product in pediatric patients have not been established.

In the event of any adverse reactions, healthcare providers should discontinue the irrigant, evaluate the patient, and institute appropriate therapeutic countermeasures. It is advisable to save the remainder of the fluid for examination if deemed necessary. Furthermore, in cases of overhydration or solute overload (if solutes have been added to the irrigation), providers should re-evaluate the patient and implement appropriate corrective measures.

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 performance.

Additional Clinical Information

The route of administration for the product is irrigation. Clinicians should counsel patients to use the solution only if it is clear and the container is undamaged. Any unused portion should be discarded, and aseptic technique must be employed during use.

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)