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Sterile Water
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- Active ingredient
- Water 1 mL/1 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 Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Corporation)
- 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 1970
- Label revision date
- September 6, 2023
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Water 1 mL/1 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 Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Company)
- Sterile Water (by Baxter Healthcare Corporation)
- 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 1970
- Label revision date
- September 6, 2023
- Manufacturer
- B. Braun Medical Inc.
- Registration number
- NDA016734
- NDC root
- 0264-2101
- 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 USP is a specially prepared, sterile fluid that is used primarily as an irrigating solution or as a pharmaceutic aid (a substance used to help prepare medications). It is made entirely from sterile water and does not contain any antimicrobial agents or added buffers. This fluid is typically used in medical settings to help cleanse or irrigate tissues during procedures, and it can also serve as an adjunct in preparing nutrient mixtures that are not given through an intravenous route.
The water is hypotonic, meaning it has a lower concentration of solutes compared to the fluids in your body, which can be beneficial in certain medical applications. It is packaged in a plastic container designed to be safe and effective for use with parenteral (administered by injection) drugs, ensuring that it remains uncontaminated and maintains its intended properties.
Uses
Sterile Water for Irrigation is primarily used as an irrigating fluid or as a pharmaceutic aid in various medical procedures. This means it helps to clean or wash out areas during surgeries or other treatments. Additionally, it can be used to help prepare nutrient mixtures that are not given through an intravenous (IV) line, making it a versatile option in medical settings.
It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with Sterile Water for Irrigation. This makes it a safe choice for its intended uses.
Dosage and Administration
Before using this medication, make sure to follow your physician's instructions carefully. It's important to visually inspect the drug for any particles or discoloration before you administer it, whenever possible. This ensures that the medication is safe to use.
If you need to prepare a nutrient mixture that is not given through a vein (non-intravenous), you can use Sterile Water for Irrigation USP. This type of water is free from electrolytes and other added substances, so be sure to check the specific preparation instructions for the mixture you are using. You can also use the plastic container provided for administering the nutrient mixture to the patient, as appropriate.
What to Avoid
You should be aware that this medication is not intended for injection. It's important to follow this guideline to ensure your safety and the effectiveness of the treatment. Always consult with your healthcare provider if you have any questions or concerns about how to use this medication properly.
Side Effects
You should be aware that there are no known adverse reactions associated with this product. However, it is important to note that Sterile Water for Irrigation is hypotonic, which means it can cause hemolysis (the breakdown of red blood cells) and is not recommended for use during surgical procedures. After opening the container, use the solution promptly to reduce the risk of bacterial growth or the formation of harmful substances. Any unused portion should be discarded, as it does not contain preservatives.
Make sure to only use the solution if it is clear and the container and seal are intact. Additionally, this product is not intended for injection. There are no known issues related to overdosage.
Warnings and Precautions
It's important to be aware that Sterile Water for Irrigation USP is hypotonic, meaning it can cause hemolysis (the breakdown of red blood cells), and should not be used during surgical procedures. To ensure safety, use the solution promptly after opening the container to reduce the risk of bacterial growth or the formation of pyrogens (substances that can cause fever).
Make sure to discard any unused portion of the irrigating solution, as it does not contain preservatives to keep it safe for later use. If you experience any unusual symptoms or reactions after using this solution, stop use immediately and contact your doctor for further guidance.
Overdose
If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific known signs of overdose for this medication, it's always best to be cautious. If you experience unusual symptoms or feel unwell after taking the medication, seek medical help right away.
In case of an overdose, contact your healthcare provider or local poison control center for guidance. If you or someone else is experiencing severe symptoms, such as difficulty breathing or loss of consciousness, call emergency services immediately. Always keep medications out of reach and follow the prescribed dosage to prevent any potential risks.
Pregnancy Use
There is currently no specific information available about the use of this medication during pregnancy. This means that the insert does not provide any warnings, safety concerns, or recommendations for dosage adjustments if you are pregnant or planning to become pregnant.
As always, it's important to discuss any medications you are taking or considering with your healthcare provider, especially during pregnancy, to ensure the best outcomes for you and your baby.
Lactation Use
When it comes to breastfeeding, there is currently no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). This means that if you are breastfeeding, you should consult your healthcare provider for personalized advice and to discuss any potential risks or concerns related to your situation. It's always best to ensure that both you and your baby are safe and healthy while breastfeeding.
Pediatric Use
The information provided does not specifically address the use of this medication in children. There are no recommended ages, dosage differences, or safety concerns outlined for pediatric use (which refers to the treatment of children). As a parent or caregiver, it's important to consult with a healthcare professional for guidance on the appropriate use of this medication for your child, as they can provide tailored advice based on your child's specific needs.
Geriatric Use
When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
Renal Impairment
If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).
Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent tests to avoid any potential issues. Your health and safety should always come first.
Storage and Handling
To ensure the best quality and safety of your Sterile Water for Irrigation, store it at room temperature, ideally around 25°C (77°F). It's important to keep the product away from excessive heat and freezing temperatures, as these conditions can affect its effectiveness. While brief exposure to temperatures up to 40°C (104°F) is acceptable, do not warm the product above 150°F (66°C).
When handling the Sterile Water for Irrigation, remember that it comes in sterile, nonpyrogenic (meaning it does not contain fever-causing substances) plastic containers. Always ensure that the containers remain sealed until you are ready to use them to maintain their sterility. Following these guidelines will help you use the product safely and effectively.
Additional Information
When using this irrigating solution, make sure to only use it if the solution is clear and the container and seal are intact. It's important to inspect the solution in good light for any cloudiness, haze, or particles, and to check the container for any leaks or damage. Always practice aseptic technique (a method to prevent contamination) during use.
If you have any unused portion of the solution, be sure to discard it, as it does not contain preservatives to keep it safe for later use.
FAQ
What is Sterile Water for Irrigation USP?
Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid composed entirely of Sterile Water for Injection USP.
What are the uses of Sterile Water for Irrigation USP?
It is indicated for use as an irrigating fluid or pharmaceutic aid and may also be used as an adjunct in preparing non-intravenously administered nutrient mixtures.
What precautions should I take before using Sterile Water for Irrigation USP?
You should only use it if the solution is clear and the container and seal are intact. Inspect the solution for particulate matter and discoloration before administration.
Are there any warnings associated with Sterile Water for Irrigation USP?
Yes, it is hypotonic and can cause hemolysis, and it is not for injection. After opening, use the contents promptly to minimize bacterial growth.
How should Sterile Water for Irrigation USP be stored?
Store at room temperature (25°C), avoid excessive heat, and protect from freezing. Do not warm above 150°F (66°C).
Is there any information regarding the use of Sterile Water for Irrigation USP during pregnancy?
No specific information regarding its use during pregnancy is provided, and there are no contraindications or safety concerns mentioned.
What should I do with unused Sterile Water for Irrigation USP?
Discard any unused portion since it contains no preservative.
What is the pH of Sterile Water for Irrigation USP?
The pH of Sterile Water for Irrigation USP is 5.7, within the range of 5.0 to 7.0.
What materials are used in the container for Sterile Water for Irrigation USP?
The container is made from a copolymer of ethylene and propylene, which is nontoxic, biologically inert, and does not contain plasticizers.
Are there any known adverse reactions to Sterile Water for Irrigation USP?
There are no known adverse reactions associated with Sterile Water for Irrigation USP.
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 | 1 mL/1 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 | 1 mL/1 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 | 1 mL/1 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 | 1 mL/1 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
| ||||
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 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, within the range of 5.0 to 7.0.
The product is packaged in a plastic container made from a copolymer of ethylene and propylene, specifically formulated for parenteral drugs. This copolymer is free from plasticizers and demonstrates virtually no leachability. Additionally, the container is nearly impermeable to vapor transmission, eliminating the need for overwrap to maintain the appropriate drug concentration. The safety of the plastic container has been validated through biological evaluation procedures, and it meets Class VI testing requirements as outlined in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These evaluations confirm that the container is nontoxic and biologically inert. The product is not manufactured 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, ensuring that both the solution and container permit such inspection.
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 by the healthcare provider.
Contraindications
Use of this product is contraindicated for injection.
Warnings and Precautions
Sterile Water for Irrigation USP is classified as hypotonic and is associated with the risk of hemolysis. Therefore, its use during surgical procedures is not recommended due to the potential for adverse effects.
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 or the formation of pyrogens, which could compromise the sterility and safety of the solution.
Healthcare professionals should also be aware that any unused portion of the irrigating solution must be discarded, as it does not contain any preservative. This precaution is essential to prevent the risk of contamination and to maintain the integrity of the solution for patient use.
Side Effects
Patients receiving Sterile Water for Irrigation USP may experience adverse reactions; however, no specific adverse reactions are known. It is important to note that Sterile Water for Irrigation USP is hypotonic and can cause hemolysis, which makes it unsuitable for use during surgical procedures.
To ensure safety, the solution should only be used if it is clear and the container and seal are intact. After opening the container, the contents should be used promptly to minimize the risk of bacterial growth or pyrogen formation. Any unused portion of the irrigating solution should be discarded, as it contains no preservative.
Additionally, it is crucial to emphasize that Sterile Water for Irrigation USP is contraindicated for injection. There are no known concerns regarding overdosage associated with this product.
Drug Interactions
No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.
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 | 1 mL/1 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 | 1 mL/1 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 | 1 mL/1 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 | 1 mL/1 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
| ||||
Pediatric Use
Pediatric patients have not been specifically addressed in the prescribing information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for children provided in the insert. Therefore, healthcare professionals should exercise caution when considering the use of this medication in pediatric populations, as the efficacy and safety profile in this demographic remains undefined.
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
There is no specific information regarding the use of this medication during pregnancy. The prescribing information does not indicate any contraindications, safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable for healthcare providers to remain vigilant and to counsel patients regarding the absence of established safety data in pregnant individuals.
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. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.
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.
Due to the absence of documented overdosage cases, specific management procedures or recommended actions have not been established. Healthcare professionals are advised to monitor patients closely and provide supportive care as needed.
In the case of suspected overdosage, it is recommended to contact a poison control center or seek immediate medical attention for further guidance.
Nonclinical Toxicology
Teratogenic effects have not been observed in nonclinical studies. Additionally, there are no known non-teratogenic effects associated with the compound.
No specific data regarding animal pharmacology and toxicology have been provided.
Postmarketing Experience
No postmarketing experience has been reported.
Patient Counseling
Healthcare providers should advise patients to use the solution only if it is clear and the container and seal are intact. It is important to inform patients that after opening the container, the contents should be used promptly to minimize the risk of bacterial growth or pyrogen formation. Patients should be instructed to discard any unused portion of the irrigating solution, as it does not contain a preservative.
Before use, healthcare providers should emphasize the necessity of performing specific checks. Patients should read the label carefully to ensure that the solution is the one that was ordered and that it is within the expiration date. They should also invert the container and inspect the solution in good light for any signs of cloudiness, haze, or particulate matter, and check the container for any leakage or damage. Any container that appears suspect should not be used.
Patients should be made aware that the solution comes in a single-dose container, and any unused portion must be discarded. Additionally, healthcare providers should caution patients against warming the solution above 150°F (66°C) to prevent minimal bottle distortion and advise them to keep the bottles upright.
Finally, it is recommended that patients store the solution at room temperature (25°C), avoiding excessive heat and protecting it from freezing.
Storage and Handling
Sterile Water for Irrigation USP is supplied in sterile and nonpyrogenic plastic irrigating containers. It is essential to store the product at room temperature, specifically at 25°C. Care should be taken to minimize exposure to heat, as excessive heat can compromise the integrity of the product. Additionally, the product must be protected from freezing conditions.
While brief exposure to temperatures up to 40°C does not adversely affect the product, it is crucial not to warm the Sterile Water for Irrigation above 150°F (66°C) to ensure its quality and efficacy.
Additional Clinical Information
The product is administered via irrigation. Clinicians should counsel patients to use the solution only if it is clear and the container and seal are intact. It is important to discard any unused portion of the irrigating solution, as it does not contain a preservative. Aseptic technique is required during administration, and the solution should be inspected in good light for any cloudiness, haze, or particulate matter, as well as checking the container for any leakage or damage.
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.