Sterile Water

Description

Water for Injection, USP is chemically designated H2O. It is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent, or added buffer. The glass vial is made of Type I borosilicate glass and meets the requirements according to USP standards.

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

Sterile Water for Injection, USP is contraindicated for use unless it has been made approximately isotonic prior to administration. This is essential to prevent potential complications associated with the administration of hypotonic solutions.

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 use appropriate solutes when preparing intravenous solutions to mitigate the risk of hemolysis. Monitoring of patients receiving intravenous fluids is essential, and healthcare providers should remain vigilant for any signs of adverse reactions. Regular assessment of hemoglobin levels and other relevant laboratory parameters may be warranted to ensure patient safety and to promptly address any potential complications arising from improper administration.

Side Effects

Patients receiving this solution may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions associated with the intravenous administration of this solution include hemolysis, particularly when Sterile Water for Injection is used without a solute. Additionally, local reactions at the injection site may occur, such as tissue necrosis or infection, abscess formation, and venous thrombosis or phlebitis extending from the site of injection. Extravasation is also a potential risk.

Common adverse reactions reported include febrile responses and local tenderness at the injection site.

It is important to note that this parenteral preparation should only be used as a diluent or solvent. While the risk of fluid overload is generally low, it may be a concern in neonates or very small infants. In such cases, healthcare providers should re-evaluate the patient and implement appropriate corrective measures as necessary. For further details, refer to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections.

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 injection), 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, the volume of fluid administered may impact fluid and electrolyte balance, necessitating careful monitoring and consideration of dosing adjustments.

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

Animal reproduction studies have not been conducted with Sterile Water for Injection. The potential effects of sterile water containing additives on fetal harm or reproduction 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

There are no available data from animal reproduction studies regarding the use of Sterile Water for Injection in lactating mothers. Additionally, it is unknown whether sterile water containing additives is excreted in human breast milk or if it can cause harm to breastfed infants.

Given the lack of information on the effects of sterile water with additives on lactation and breastfed infants, it should be administered to lactating mothers only if clearly needed.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in individuals with kidney problems to assess their renal status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on managing overdose situations.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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 specific non-teratogenic effects or additional nonclinical toxicology details have been provided. Furthermore, there are no specific animal pharmacology and toxicology details available in the current data.

Postmarketing Experience

Reactions reported in the postmarketing experience may include febrile response, local tenderness, abscess, tissue necrosis, or infection at the injection site. Additional events noted are venous thrombosis or phlebitis extending from the injection site, as well as extravasation. 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 preserved for examination.

Healthcare professionals are encouraged to report suspected adverse reactions to Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or to the FDA at 1-800-FDA-1088 or via www.fda.gov/medwatch.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection, USP must be made approximately isotonic prior to use. It is important to inform patients that this solution should not be used for intravenous injection unless the osmolar concentration of any additives results in an approximate isotonic admixture.

Providers should emphasize the necessity 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.

While safety and effectiveness have been established in pediatric patients, healthcare providers should caution that in neonates or very small infants, the volume of fluid may impact fluid and electrolyte balance. It is also essential to discuss the potential for incompatibility of some drugs for injection in a given vehicle or when combined in the same vehicle, particularly those containing benzyl alcohol. Providers should recommend consulting with a pharmacist if available.

Patients should be informed about the importance of using aseptic technique for single or multiple entries and withdrawals from all containers. When diluting or dissolving drugs, they should be advised to mix thoroughly and use the solution promptly. Providers should stress that reconstituted solutions of drugs for injection should not be stored unless otherwise directed by the manufacturer of the solute.

Additionally, patients must be cautioned not to use the solution unless it is clear and the seal is intact. They should be instructed not to reuse single-dose containers and to discard any unused portions. In the event of an adverse reaction, healthcare providers should advise patients to discontinue the infusion, evaluate their condition, and institute appropriate countermeasures. If possible, they should retrieve and save the remainder of the unused vehicle for examination.

Finally, in cases of fluid overload, patients should be re-evaluated, and appropriate corrective measures should be instituted.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F), as defined by the United States Pharmacopeia (USP) guidelines. It is imperative to avoid freezing the product to maintain its integrity and efficacy. Special handling precautions should be observed to ensure that the product remains within the specified temperature range throughout its storage period.

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 Henry Schein, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)