Sterile Water

Description

Sterile WATER for Injection USP is a nonpyrogenic and sterile solution. It has an approximate pH of 5.5 and an approximate osmolality of 0 mOsmol/L. The solution contains no more than 25 µg/L of aluminum and is classified as hypotonic.

Uses and Indications

Sterile Water for Injection USP is indicated for use as a diluent or solvent in the preparation of parenteral solutions.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with the use of Sterile Water for Injection USP.

Dosage and Administration

Prescribing information for the dosage of the medication is available upon request.

The medication is to be administered via the intravenous route. Healthcare professionals should ensure proper preparation and administration techniques are followed to maintain sterility and efficacy. Specific dosing ranges and intervals will be provided in the prescribing information upon request.

Contraindications

Use of this product is contraindicated for direct infusion due to the potential for adverse effects associated with this method of administration. Additionally, the product must not be used in series connections, as this may lead to complications that could compromise patient safety.

Warnings and Precautions

The product is contraindicated for direct infusion and must not be utilized in series connections to ensure patient safety and efficacy of treatment.

General precautions should be observed when administering this product. It contains no more than 25 µg/L of aluminum, ensuring minimal exposure to this element. The formulation is nonpyrogenic, sterile, and apyrogenic, which is critical for maintaining the integrity of the treatment. Additionally, it is hypotonic and intended solely for admixture purposes.

Currently, there are no specific laboratory tests recommended for the safe use of this product. Healthcare professionals should remain vigilant and monitor patients as necessary, although no specific tests have been identified.

In the event of an emergency, there are no specific instructions provided for seeking medical help. Similarly, there are no defined guidelines for discontinuing use or contacting a physician. Healthcare providers should exercise clinical judgment in these situations.

Side Effects

Patients receiving Sterile Water for Injection did not report any specific adverse reactions or side effects in the available data. It is important to note that this product is not intended for direct infusion and does not contain any antimicrobial agents or other substances. Additionally, Sterile Water for Injection is characterized as nonpyrogenic and sterile, which further supports its safety profile in the intended use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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

There is no specific pediatric use information available for this medication, including recommended ages, dosing differences, safety concerns, or special precautions for children. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the absence of relevant 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety and efficacy of this drug during pregnancy have not been established, as it has not been approved by the FDA for use in this population. There is no specific information available regarding the use of this drug in pregnant patients, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to exercise caution and consider the potential risks when prescribing this medication to women of childbearing potential. Given the lack of data, the use of this drug during pregnancy should be approached with careful consideration of the potential benefits and risks.

Lactation

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

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 indicated 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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

3. Decontamination: If appropriate and within a reasonable time frame, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

4. Specific Antidotes: If a specific antidote is available for the substance involved, it should be administered according to established protocols.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on management strategies tailored to the specific circumstances of the overdose. Continuous monitoring and supportive care are paramount until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any interventions performed, is critical for ongoing patient management and future reference.

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 compound in these areas.

Postmarketing Experience

Adverse events and quality issues associated with the use of these imported products have been reported voluntarily and through surveillance programs. Healthcare professionals and consumers are encouraged to report any adverse events or quality problems to Baxter at 1-866-888-2472 or via fax at 1-800-759-1801. Additionally, reports can be submitted to the FDA's MedWatch Adverse Event Reporting program through various methods: online at www.fda.gov/medwatch/report.htm, by regular mail, or by fax. For reporting by mail or fax, individuals may download the necessary forms from www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form. Completed forms should be returned to the address provided on the pre-addressed form or submitted by fax to 1-800-FDA-0178 (1-800-332-0178). For product quality issues, Baxter Product Surveillance can be contacted through the Baxter Product Feedback Portal at https://productfeedback.baxter.com.

Patient Counseling

Healthcare providers should inform patients that this drug has not been found by the FDA to be safe and effective, and that the labeling has not received FDA approval. It is important to advise patients to report any adverse events associated with these imported products by contacting Baxter at 1-866-888-2472 or by faxing 1-800-759-1801. Additionally, patients should be made aware that they can report adverse events or quality problems to the FDA's MedWatch Adverse Event Reporting program through online submission, regular mail, or fax.

Providers should emphasize that this product is not intended for direct infusion and that any unused portion must be discarded. It is crucial to inform patients that the product must not be used in series connections. Proper storage conditions should be communicated, specifying that the product should be stored at temperatures between 15°C to 25°C.

Patients should be made aware that the product contains no more than 25 µg/L of aluminum and is characterized as nonpyrogenic, sterile, and apyrogenic. Lastly, it should be noted that the product is hypotonic and should only be admixed as directed. Providers are encouraged to refer patients to the FDA-approved prescribing information for each drug product listed for further details.

Storage and Handling

The product is supplied in configurations that adhere to the National Drug Code (NDC) standards. It is essential to store the product at a temperature range of 15°C to 25°C to maintain its efficacy and safety.

Healthcare professionals are advised to discard any unused portion of the product after administration to ensure proper disposal and prevent misuse. Additionally, it is important to note that the product must not be used in series connections to avoid potential complications in administration.

Additional Clinical Information

The route of administration for the medication is intravenous. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)