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Sterile Water
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- Active ingredient
- Water 100 mL/100 mL
- Other brand names
- Bacteriostatic Water (by Henry Schein, Inc.)
- Bacteriostatic Water (by Hospira, Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Becton Dickinson and Company)
- Sterile Water (by Cardinal Health 107, Llc)
- Sterile Water (by Cardinal Health 107, Llc)
- Sterile Water (by Chartwell Rx, Llc)
- Sterile Water (by Civica, Inc.)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by General Injectables and Vaccines, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Hikma Pharmaceuticals Usa Inc.)
- Sterile Water (by Hikma Pharmaceuticals Usa Inc.)
- Sterile Water (by Hospira, Inc.)
- Sterile Water (by Hospira, Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Medefil, Inc.)
- Sterile Water (by Nephron Pharmaceuticals Corporation)
- View full label-group details →
- Dosage form
- Irrigant
- Route
- Irrigation
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 1974
- Label revision date
- October 17, 2017
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Water 100 mL/100 mL
- Other brand names
- Bacteriostatic Water (by Henry Schein, Inc.)
- Bacteriostatic Water (by Hospira, Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by B. Braun Medical Inc.)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Becton Dickinson and Company)
- Sterile Water (by Cardinal Health 107, Llc)
- Sterile Water (by Cardinal Health 107, Llc)
- Sterile Water (by Chartwell Rx, Llc)
- Sterile Water (by Civica, Inc.)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by Fresenius Kabi Usa, Llc)
- Sterile Water (by General Injectables and Vaccines, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Henry Schein, Inc.)
- Sterile Water (by Hikma Pharmaceuticals Usa Inc.)
- Sterile Water (by Hikma Pharmaceuticals Usa Inc.)
- Sterile Water (by Hospira, Inc.)
- Sterile Water (by Hospira, Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Icu Medical Inc.)
- Sterile Water (by Medefil, Inc.)
- Sterile Water (by Nephron Pharmaceuticals Corporation)
- View full label-group details →
- Dosage form
- Irrigant
- Route
- Irrigation
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 1974
- Label revision date
- October 17, 2017
- Manufacturer
- Baxter Healthcare Corporation
- Registration numbers
- NDA017428, NDA017866
- NDC roots
- 0338-0003, 0338-0004
- FDA Insert
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
Sterile Water for Irrigation is a specially prepared solution that contains sterilized water, designed for use as an irrigant in medical procedures. It is hypotonic, meaning it has a lower concentration of solutes compared to body fluids, and is packaged in a flexible plastic container made from safe materials. This water is prepared through a distillation process, ensuring its purity and sterility, making it suitable for various medical applications where clean water is essential.
This solution does not contain any added antimicrobial agents or other substances, and it is important to use it as directed by a healthcare professional. Sterile Water for Irrigation is typically used to help cleanse or irrigate tissues during medical procedures, providing a safe and effective means of maintaining a sterile environment.
Uses
Sterile Water for Irrigation is used primarily as an irrigant, which means it helps to wash or cleanse a specific area during medical procedures. This sterile solution is important for maintaining a clean environment in surgical settings or other medical applications where irrigation is necessary.
It's worth noting that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe choice for its intended use in medical procedures.
Dosage and Administration
This medication is specifically designed for irrigation, which means it is used to wash or cleanse a specific area rather than being injected or infused into the body through standard methods. The amount of solution you will use and how quickly you apply it will depend on the type of procedure being performed and the size of the area that needs to be treated.
For detailed instructions on how to prepare and administer this medication, be sure to consult the full prescribing information. This will provide you with the necessary guidance to ensure safe and effective use.
What to Avoid
It's important to be aware of certain factors when considering this medication. There are no specific contraindications, meaning there are no known conditions or situations that would prevent you from using it. However, always consult with your healthcare provider to ensure it's safe for you, especially if you have any underlying health issues.
Additionally, be mindful that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Abuse refers to using the medication in a way not prescribed, while dependence (a condition where your body becomes reliant on a substance) can develop with prolonged use. Always follow your healthcare provider's instructions and never take more than the recommended dose.
Side Effects
You may experience some common side effects when using this product, including low sodium levels (hyponatremia), fluid overload, and imbalances in electrolytes. It's important to monitor for these issues, especially if you have conditions affecting your heart or kidneys, or if you are a pediatric patient, as you may be at a higher risk for complications.
Serious reactions can occur if the product is administered improperly, such as through excessive volume or pressure, which can lead to severe fluid absorption and potentially life-threatening conditions. If you are an older adult, please use this product with caution, as you may have underlying health issues that increase your risk. Always consult your healthcare provider for guidance tailored to your specific situation.
Warnings and Precautions
When using this product, be aware that it is intended for irrigation only and can cause serious reactions if administered in other ways. There is a risk of excessive water absorption, which can lead to conditions like hyponatremia (low sodium levels in the blood) and fluid overload. It's important to monitor for these issues, especially in patients who may be at higher risk, such as those with kidney or heart problems, young children, and women, particularly premenopausal women. Avoid using this product in procedures that require prolonged irrigation or high fluid pressure.
Make sure to keep an eye on how much fluid is absorbed during and after the procedure. If you notice any unusual symptoms or have concerns, it's crucial to reach out to your healthcare provider for guidance.
Overdose
Using too much hypotonic fluid, like Sterile Water for Irrigation, during medical procedures can lead to serious health issues, including excessive fluid absorption. This can cause conditions such as hyponatremia (low sodium levels in the blood), hypoosmolality (low concentration of substances in the blood), and fluid overload, which can be life-threatening. If you notice signs of these conditions, such as confusion, headache, nausea, or difficulty breathing, it’s important to seek immediate medical help.
To prevent complications, healthcare providers should closely monitor patients for any significant fluid absorption during and after procedures, especially those at higher risk, such as individuals with kidney or heart problems, young children, and women of childbearing age. If you or someone you know is undergoing a procedure that involves irrigation, be aware of the potential risks and ensure that proper precautions are taken to avoid excessive fluid use.
Pregnancy Use
Using Sterile Water for Irrigation during pregnancy is generally considered safe, as it is not expected to cause any harmful effects on your developing baby. However, there is currently no specific data on its use in pregnant women, so we cannot fully assess any potential risks. It's important to remember that all pregnancies carry a natural risk of complications, including birth defects and miscarriage, which in the U.S. is estimated to be about 2 to 4% for major birth defects and 15 to 20% for miscarriage.
If you are pregnant or planning to become pregnant, it's always best to discuss any medications or treatments with your healthcare provider to ensure the safest options for you and your baby.
Lactation Use
Using Sterile Water for Irrigation while breastfeeding is generally considered safe and is not expected to harm your breastfed infant. However, there is no specific information available about whether this solution appears in breast milk or how it might affect your milk production or your baby.
Since there is a lack of clinical data regarding the use of Sterile Water for Irrigation during breastfeeding, it's important to weigh the benefits of breastfeeding against your need for this treatment. Always discuss any concerns with your healthcare provider to ensure the best decision for both you and your baby.
Pediatric Use
When considering this medication for your child, it's important to note that its safety and effectiveness in children have not been established. This means that there isn't enough research to confirm how well it works or how safe it is for pediatric patients.
Additionally, children are at a higher risk than adults for developing a serious condition called encephalopathy (a brain disorder) if they absorb too much Sterile Water for Irrigation, which can lead to low sodium levels in the blood (hyponatremia). Always consult with your child's healthcare provider to discuss any concerns and ensure the best care for your child.
Geriatric Use
When using Sterile Water for Irrigation, it's important to be cautious if you are an older adult or caring for one. Older patients often have changes in heart, kidney, or liver function, which can affect how medications work in the body. Additionally, they may have other health conditions or be taking multiple medications at the same time, which can increase the risk of complications.
Always consult with a healthcare provider to ensure that the use of Sterile Water for Irrigation is safe and appropriate for your specific health situation. This careful approach helps to minimize any potential risks and ensures better health outcomes.
Renal Impairment
If you have kidney problems, it's important to be aware of some specific guidelines regarding your treatment. You may need additional monitoring to watch for complications related to fluid overload syndrome, especially if you also have heart issues. This means your healthcare provider will keep a closer eye on your condition to ensure you stay safe.
Additionally, if you're undergoing any procedures that involve irrigation (flushing with fluid), it's best to avoid those that require longer times or higher pressures, as these can lead to complications in patients with kidney impairment. Always discuss your treatment options and any concerns with your healthcare provider to ensure the best care for your situation.
Hepatic Impairment
If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.
Drug Interactions
It's important to talk to your healthcare provider about any medications or tests you may be undergoing. For instance, if you're using equipment for electrosurgery or cautery, make sure that the medications you take are compatible with that equipment.
Additionally, if you're receiving Sterile Water for Irrigation, your healthcare team will need to monitor you closely for fluid absorption during and after the procedure. This is especially crucial for individuals with certain health conditions, such as severe kidney issues or heart problems, as they may be at higher risk for complications. Always keep your healthcare provider informed about your medications and any changes in your health to ensure your safety.
Storage and Handling
To ensure the best performance of your product, store it at room temperature, ideally around 25°C. It's okay if it briefly experiences temperatures up to 40°C, but try to minimize any exposure to heat, as excessive heat can negatively impact the product's effectiveness.
When handling the product, always do so with care to maintain its integrity. Following these storage and handling guidelines will help ensure that you get the most out of your product.
Additional Information
No further information is available.
FAQ
What is Sterile Water for Irrigation?
Sterile Water for Irrigation is water that is sterilized and packaged for use as an irrigant, with a pH of 5.5 and an osmolarity of zero mOsmol/L.
What are the indications for using Sterile Water for Irrigation?
It is indicated for use as an irrigant only and should not be used for injection or infusion.
What precautions should I take when using Sterile Water for Irrigation?
You should warm it in an oven to no more than 50ºC for a maximum of 60 days and discard it after that period. Ensure the solution is clear and the seal is intact before use.
What are the most common adverse reactions associated with Sterile Water for Irrigation?
Common adverse reactions include hyponatremia, fluid overload, fluid absorption, and electrolyte imbalance.
Is Sterile Water for Irrigation safe for pediatric patients?
Safety and effectiveness in pediatric patients have not been established, and they are at higher risk for developing complications like encephalopathy due to hyponatremia.
Can older patients use Sterile Water for Irrigation?
Yes, but it should be used cautiously as older patients may have decreased cardiac, renal, or hepatic function.
What should I monitor for when using Sterile Water for Irrigation?
You should monitor for absorption of clinically relevant amounts of fluid during and after the procedure, especially in patients at risk for fluid overload.
What should I do in case of overdosage with Sterile Water for Irrigation?
Excessive irrigation can lead to serious conditions like hyponatremia and fluid overload, requiring immediate medical intervention.
Is there any risk associated with using Sterile Water for Irrigation during pregnancy or breastfeeding?
There are no data on its use in pregnant women or its effects on breastfed infants, so the benefits of breastfeeding should be weighed against the mother's need for the product.
How should I store Sterile Water for Irrigation?
Store it at room temperature (25°C) and avoid excessive heat, as brief exposure up to 40°C does not adversely affect the product.
Packaging Info
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.
Details | ||||
|---|---|---|---|---|
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Sterile Water, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Sterile Water for Irrigation is a sterile solution composed solely of water, specifically prepared for use as an irrigant. It contains no added antimicrobial agents or other substances. The pH of the solution is 5.5, with a permissible range of 5.0 to 7.0. This product is hypotonic, exhibiting an osmolarity of zero mOsmol/L.
The solution is packaged in a flexible plastic container made from a specially formulated polyvinyl chloride, designed to minimize the permeation of water from the container into the overwrap, ensuring the integrity of the fluid. Although there may be minimal leaching of certain chemical components from the plastic into the water, biological testing has confirmed the safety of the materials used in the container.
Additionally, Sterile Water for Irrigation is available in a plastic pour bottle constructed from a specially formulated polyolefin, which is a copolymer of ethylene and propylene. This container does not require a vapor barrier, further enhancing its suitability for medical use.
Uses and Indications
Sterile Water for Irrigation is indicated for use as an irrigant in various medical procedures.
There are no teratogenic effects associated with this product, nor are there any nonteratogenic effects mentioned.
Dosage and Administration
The product is intended for irrigation purposes only and is not suitable for injection or infusion via standard parenteral routes. The volume and rate of irrigation should be determined based on the specific procedure being performed, as well as the capacity or surface area of the structure that requires irrigation.
For detailed preparation and administration instructions, healthcare professionals should refer to the full prescribing information.
Contraindications
There are no contraindications associated with the use of this product.
Warnings and Precautions
Administration of this product via parenteral routes may lead to serious adverse reactions, particularly due to hypotonicity. It is indicated for irrigation use only.
Excessive water absorption during procedures can result in significant complications such as hyponatremia, hypoosmolality, and fluid overload. Healthcare professionals are advised to closely monitor patients for the absorption of clinically relevant amounts of fluid both during and after the procedure. This monitoring is especially critical for patients at heightened risk of developing complications associated with fluid overload syndrome, including those with renal or cardiac impairment. Additionally, pediatric patients, particularly premenopausal women, individuals with hypoxemia, and those with central nervous system diseases should be monitored for signs of hyponatremic encephalopathy. It is recommended to avoid the use of this product in procedures that necessitate prolonged irrigation times or where the irrigation fluid pressure may encourage absorption.
When utilizing this product in conjunction with electrosurgery or cautery, it is essential to ensure compatibility with the equipment being used to prevent any adverse interactions.
Routine laboratory tests should include monitoring for fluid absorption to ensure patient safety and mitigate the risk of complications.
Side Effects
Administration of Sterile Water for Irrigation may lead to several adverse reactions, which can be categorized by seriousness and frequency.
Most commonly reported adverse reactions include hyponatremia, fluid overload, fluid absorption, and electrolyte imbalance. These reactions are particularly concerning when the fluid is administered via parenteral routes, as this can result in serious adverse outcomes. It is important to note that Sterile Water for Irrigation is intended for irrigation use only.
Excessive water absorption during procedures may lead to hyponatremia, hypoosmolality, and fluid overload. Patients should be monitored for clinically relevant fluid absorption during and after the procedure, especially those at increased risk for complications associated with fluid overload syndrome. This includes individuals with renal or cardiac impairment, pediatric patients, premenopausal women, patients with hypoxemia, and those with central nervous system diseases. Caution is advised in procedures requiring prolonged irrigation times or higher irrigation fluid pressures that may promote absorption.
In cases of overdosage, characterized by excessive rate, volume, pressure, or duration of irrigation with hypotonic fluid, there is a risk of significant fluid absorption leading to permanent morbidity or death due to hyponatremia, hypoosmolality, and/or fluid overload. Immediate intervention may be necessary if clinically relevant absorption of Sterile Water for Irrigation occurs.
The safety and effectiveness of Sterile Water for Irrigation in pediatric patients have not been established. Pediatric patients are at a heightened risk for developing encephalopathy as a complication of hyponatremia due to excessive absorption.
In geriatric patients, caution is advised when using Sterile Water for Irrigation, as this population is more likely to experience decreased cardiac, renal, or hepatic function, along with other diseases or concomitant drug therapies that may increase the risk of adverse reactions.
Drug Interactions
Compatibility with electrosurgery or cautery equipment must be ensured to prevent adverse interactions during procedures.
In terms of laboratory test interactions, it is essential to monitor patients closely for the absorption of clinically relevant amounts of fluid during and for an appropriate period following the procedure. Should absorption occur, Sterile Water for Irrigation should be discontinued immediately.
Additionally, patients at increased risk for complications related to hypotonicity, such as those with severe renal impairment, impaired cardiac function, or other conditions associated with edematous states, require additional close monitoring during and after the procedure. This vigilance is crucial to mitigate potential adverse effects.
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.
Details | ||||
|---|---|---|---|---|
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Irrigant | 100 mL/100 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
| ||||
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Pediatric patients are at a higher risk compared to adults for developing encephalopathy as a complication of hyponatremia, particularly if there is excessive absorption of Sterile Water for Irrigation. Caution is advised when administering this product to children and adolescents.
Geriatric Use
Elderly patients should be treated with caution when using Sterile Water for Irrigation. This population is more likely to exhibit decreased cardiac, renal, or hepatic function, which may affect the pharmacokinetics and safety profile of the product. Additionally, geriatric patients often have comorbid conditions or are on concomitant drug therapies that could further complicate their clinical management.
Healthcare providers are advised to closely monitor elderly patients for any adverse effects and consider potential dose adjustments based on individual patient assessments. It is essential to evaluate the overall health status and functional capacity of geriatric patients to ensure safe and effective use of Sterile Water for Irrigation.
Pregnancy
The appropriate administration of Sterile Water for Irrigation is not expected to cause adverse developmental outcomes. However, there are no available data on the use of Sterile Water for Irrigation in pregnant women to determine a drug-associated risk of adverse developmental outcomes. Additionally, animal reproduction studies have not been conducted with Sterile Water for Irrigation.
It is important to note that all pregnancies carry a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Healthcare professionals should consider these factors when advising pregnant patients or women of childbearing potential regarding the use of Sterile Water for Irrigation.
Lactation
Appropriate administration of Sterile Water for Irrigation is not expected to cause harm to a breastfed infant. However, there are no data on the presence of Sterile Water for Irrigation in either human or animal milk, nor are there any known effects on the breastfed infant or on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Sterile Water for Irrigation to a breastfed infant. Therefore, healthcare professionals should consider the developmental and health benefits of breastfeeding alongside the lactating mother's clinical need for Sterile Water for Irrigation and any potential adverse effects on the breastfed infant from the use of Sterile Water for Irrigation or from the underlying maternal condition.
Renal Impairment
Patients with renal impairment require additional monitoring due to an increased risk of developing complications associated with fluid overload syndrome, particularly in those with concurrent cardiac impairment. It is advised to avoid the use of this medication in procedures that necessitate prolonged irrigation times or involve irrigation fluid pressures that may enhance absorption in patients with reduced kidney function.
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
Excessive irrigation with hypotonic fluid, particularly Sterile Water for Irrigation, can lead to significant clinical complications, including excessive fluid absorption, hyponatremia, hypoosmolality, and fluid overload. These conditions may result in permanent morbidity or even death. Therefore, it is crucial for healthcare professionals to be vigilant regarding the rate, volume, pressure, and duration of irrigation during procedures.
In cases of clinically relevant absorption of hypotonic fluid, immediate intervention is warranted. Healthcare providers should closely monitor patients for signs of excessive water absorption during and after the procedure. This monitoring is especially important for individuals at heightened risk of developing complications associated with fluid overload syndrome. Such at-risk populations include patients with renal or cardiac impairment, as well as those susceptible to hyponatremic encephalopathy, which may include pediatric patients, particularly premenopausal women, individuals with hypoxemia, and patients with central nervous system diseases.
To mitigate the risk of overdosage, it is advisable to avoid the use of hypotonic irrigation fluids in procedures that necessitate prolonged irrigation times or involve fluid pressures that could promote absorption. Continuous assessment and appropriate management strategies should be implemented to ensure patient safety and prevent adverse outcomes related to fluid overload and electrolyte imbalances.
Nonclinical Toxicology
There are no available data on the use of Sterile Water for Irrigation in pregnant women to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with Sterile Water for Irrigation. It is important to note that all pregnancies carry a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is between 2 to 4% and 15 to 20%, respectively.
Appropriate administration of Sterile Water for Irrigation is not expected to cause hyponatremic encephalopathy in pediatric patients, premenopausal women, patients with hypoxemia, or patients with underlying central nervous system disease.
No additional nonclinical toxicology data or animal pharmacology and toxicology information has been provided.
Postmarketing Experience
Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hypotonicity and excessive water absorption.
Patient Counseling
Healthcare providers should inform patients, caregivers, or home healthcare providers about the potential risks associated with Sterile Water for Irrigation. It is essential to discuss the following points:
Patients should be made aware of the risks of hypotonicity and excessive water absorption, as outlined in the Warnings and Precautions section. Additionally, it is crucial to emphasize that this solution is not isotonic and is hemolytic, which may pose significant risks if not used correctly.
Providers should instruct patients to only use the solution if it is clear and the seal is intact. Any unused portion should be discarded to ensure safety.
Caution should be taken regarding the warming of the solution. Patients should be advised to warm the solution in an oven to no more than 50ºC for a maximum of 60 days. After this period, the solution should be discarded to prevent any potential risks associated with prolonged warming.
Finally, it is important to inform patients about the proper storage conditions. The unit should be kept in its moisture barrier overwrap at room temperature (25ºC) until it is ready for use, and patients should be advised to avoid exposing the solution to excessive heat.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, ideally at 25°C. Brief exposure to temperatures up to 40°C is acceptable and does not adversely affect the product; however, it is essential to minimize exposure to heat and avoid excessive temperatures to maintain product integrity. Proper handling and storage conditions are crucial to ensure the efficacy and safety of the pharmaceutical product.
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 Baxter Healthcare Corporation. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.