Sterile Water

Description

This preparation is intended exclusively for parenteral use, requiring dilution or dissolution in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic solution of water for injection, devoid of bacteriostats, antimicrobial agents, or added buffers. It is supplied in single-dose containers for the purpose of diluting or dissolving injectable drugs. For intravenous administration, an adequate volume should be added to a solute to achieve an approximately isotonic solution. The pH of the solution ranges from 5.0 to 7.0. Chemically, Water for Injection, USP is designated as H₂O.

Uses and Indications

This parenteral preparation is indicated solely for the dilution or dissolution of drugs intended for intravenous, intramuscular, or subcutaneous injection, in accordance with the manufacturer's instructions for the specific drug to be administered.

Limitations of Use: This preparation should not be used for any other purpose outside of the specified indications.

Dosage and Administration

The volume of the preparation utilized for diluting or dissolving any drug for injection is contingent upon the vehicle concentration, the prescribed dose, and the route of administration as advised by the manufacturer.

Prior to administration, the parenteral solution must be visually inspected for particulate matter and discoloration, whenever the solution and container allow for such inspection.

Contraindications

Use of Sterile Water for Injection is contraindicated in situations where it has not been made approximately isotonic prior to administration. This is essential to prevent potential complications associated with the administration of hypotonic solutions, which can lead to cellular edema and other adverse effects.

Warnings and Precautions

Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. Healthcare professionals are advised to ensure that Sterile Water for Injection is not administered in its pure form, as this can lead to serious complications, including the destruction of red blood cells.

It is imperative to monitor patients closely for any signs of hemolysis, particularly in those receiving intravenous fluids. Regular assessment of hemoglobin levels and other relevant laboratory parameters is recommended to detect any adverse effects promptly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this solution, which may be influenced by added drugs or the technique of reconstitution or administration. Common reactions include febrile response, local tenderness, and extravasation. More serious reactions that have been reported include abscess formation, tissue necrosis or infection at the injection site, and venous thrombosis or phlebitis extending from the site of injection.

It is important to note that intravenous administration of Sterile Water for Injection without a solute may lead to hemolysis, which poses a significant risk to patients. Careful consideration should be given to the administration technique to minimize the potential for these adverse reactions.

Drug Interactions

Certain injectable medications may exhibit incompatibility when administered in the same vehicle or when combined with vehicles containing benzyl alcohol. It is advisable to consult with a pharmacist to ensure safe and effective administration of these drugs. Monitoring for potential adverse effects is recommended when using such combinations, and appropriate dosage adjustments should be considered based on the specific drugs involved and their compatibility profiles.

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 have been established in pediatric patients. However, in neonates or very small infants, caution is advised as the volume of fluid administered may impact fluid and electrolyte balance.

Geriatric Use

Elderly patients may not have specific geriatric use information available for this medication. The prescribing information does not provide recommended age considerations, dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in elderly individuals.

Pregnancy

Animal reproduction studies have not been conducted with Sterile Water for Injection. The potential effects of sterile water containing additives on fetal harm or reproductive capacity in pregnant patients are not known. Therefore, Sterile Water for Injection with additives should be administered to pregnant women only if clearly needed, taking into consideration the potential risks versus benefits.

Lactation

Nursing mothers should be aware of the potential for excretion of this medication in breast milk. There is an associated risk to breastfed infants when this medication is used during lactation. Caution is advised when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, it is important to note that this parenteral preparation is intended solely for use as a diluent or solvent. The risk of fluid overload is generally low; however, caution should be exercised in specific populations, particularly neonates and very small infants.

Should signs of fluid overload manifest in these vulnerable groups, a thorough re-evaluation of the patient's condition is warranted. Appropriate corrective measures should be instituted promptly to address any complications arising from the overdosage. Healthcare professionals are advised to monitor the patient closely and implement necessary interventions to ensure patient safety and well-being.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Sterile Water for Injection. The potential for sterile water containing additives to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity is not known. Therefore, Sterile Water for Injection with additives should be administered to a pregnant woman only if clearly needed.

No non-teratogenic effects have been specified. Additionally, there are no details available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Reactions reported in the postmarketing experience include febrile response, local tenderness, abscess, tissue necrosis, or infection at the injection site. Additionally, venous thrombosis or phlebitis extending from the injection site and extravasation have been observed. In the event of an adverse reaction, it is recommended to discontinue the infusion, evaluate the patient, and implement appropriate countermeasures. If feasible, the remainder of the unused vehicle should be retrieved and saved for examination.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection must be made approximately isotonic prior to use to prevent potential complications. It is crucial to inform patients that intravenous administration of Sterile Water for Injection without a solute may lead to hemolysis, a serious condition that can occur if the osmolar concentration of additives does not result in an approximate isotonic admixture.

Providers should emphasize the importance of consulting the manufacturer’s instructions regarding the choice of vehicle, appropriate dilution, or volume for dissolving the drugs to be injected, including the recommended route and rate of injection. Patients should be instructed to inspect reconstituted drugs for clarity and to ensure there is no unexpected precipitation or discoloration prior to administration.

Aseptic technique should be highlighted as essential for both single and multiple entry and withdrawal from all containers. When diluting or dissolving drugs, patients should be advised to mix thoroughly and use the solution promptly, as reconstituted solutions should not be stored unless directed by the manufacturer of the solute.

Patients must be informed not to use the solution unless it is clear and the seal is intact. They should also be cautioned against reusing single-dose containers and should discard any unused portions appropriately.

While safety and effectiveness have been established in pediatric patients, healthcare providers should discuss with patients that in neonates or very small infants, the volume of fluid may impact fluid and electrolyte balance. It is also important to note that some drugs for injection may be incompatible in a given vehicle or when combined with other substances, particularly those containing benzyl alcohol. Consulting with a pharmacist is recommended if available.

In the event of adverse reactions, healthcare providers should instruct patients to discontinue the infusion immediately, evaluate their condition, and institute appropriate countermeasures. If possible, they should retrieve and save the remainder of the unused vehicle for examination.

Storage and Handling

The product is supplied in a single-dose vial format, ensuring that each vial is intended for one-time use only. It is important to note that no preservative has been added to the solution. Therefore, any unused portion of the vial must be discarded after use.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Additionally, the solution must be used only if it is clear and the seal of the vial remains intact to ensure safety and efficacy.

Additional Clinical Information

Patients should be informed that the medication can be administered via intramuscular, subcutaneous, or intravenous routes. Clinicians are advised to consult the manufacturer’s instructions regarding the choice of vehicle, appropriate dilution, and volume for dissolving the drugs prior to injection, including the recommended route and rate of administration.

It is essential to employ aseptic techniques during the preparation and administration of the medication, whether for single or multiple entries and withdrawals from containers. When diluting or dissolving drugs, thorough mixing is required, and solutions should be used promptly without storage unless specified by the manufacturer. Additionally, clinicians must ensure that the solution is clear and that the seal is intact before use. Single-dose containers should not be reused, and any unused portions must be discarded.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Sterile Water as submitted by Fresenius Kabi USA, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)