Sterile Water

Description

This preparation is intended exclusively for parenteral use following the addition of drugs that necessitate dilution or must be dissolved 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, and is available only in single-dose containers for the purpose of diluting or dissolving drugs for injection. For intravenous administration, it is essential to add an adequate solute to achieve an approximately isotonic solution. The chemical composition of Water for Injection, USP is designated as H₂O. The container is composed of Type I borosilicate glass, conforming to the standards set forth by the United States Pharmacopeia (USP).

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: There are no teratogenic or nonteratogenic effects reported in the available data.

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 for signs of hemolysis, such as changes in hemoglobin levels and the presence of hemoglobinuria, is recommended following administration. Regular laboratory tests should be conducted to assess the patient's hematological status and to ensure safe and effective use of intravenous fluids.

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 tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the injection site, and extravasation. Additionally, there is a risk of hemolysis if Sterile Water for Injection is administered intravenously without a solute.

Common adverse reactions reported include febrile response, local tenderness, and the formation of abscesses. These reactions may arise due to the solution itself, added drugs, or the technique of reconstitution or administration.

Healthcare professionals should monitor patients for these adverse reactions and manage them appropriately to ensure patient safety.

Drug Interactions

Certain injectable medications may exhibit incompatibility when administered in the same vehicle or when combined with a vehicle containing benzyl alcohol. It is advisable to consult with a pharmacist to ensure safe administration and to avoid potential adverse interactions. Monitoring for any signs of incompatibility is recommended when these medications are used concurrently.

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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnancy Category C. 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, weighing the potential benefits against any possible risks.

Lactation

Nursing mothers should be aware of the potential for excretion of this drug in breast milk. It is not known whether the drug can affect breastfed infants or the production of breast milk. Caution should be exercised when administering this drug to a nursing mother.

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 neonates and very small infants, as they may be more susceptible to such complications.

Should signs of fluid overload occur, it is imperative to re-evaluate the patient's condition promptly. Appropriate corrective measures should be instituted based on the clinical assessment. Healthcare professionals are advised to monitor the patient closely and manage any symptoms that may arise as a result of overdosage.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 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, and therefore, it should not be used for intravenous injection unless the osmolar concentration of additives results 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.

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 important 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 reminded to use aseptic technique for single or multiple entries and withdrawals from all containers. When diluting or dissolving drugs, they should mix thoroughly and use the solution promptly. Providers should inform patients not to store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

Additionally, patients should be advised not to use the solution unless it is clear and the seal is intact. They should not reuse single-dose containers and must discard any unused portion. In the event of an adverse reaction, patients should be instructed 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, particularly in neonates or very small infants, healthcare providers should recommend re-evaluating the patient and instituting appropriate corrective measures.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature. It is imperative to avoid freezing the product to maintain its integrity and efficacy. Proper storage conditions must be observed to ensure optimal quality and performance.

Additional Clinical Information

Patients may receive the medication via intravenous, intramuscular, or subcutaneous routes. Clinicians are advised to consult the manufacturer’s instructions regarding the choice of vehicle, appropriate dilution, and volume for dissolving the drugs intended for injection, including the recommended route and rate of injection.

It is essential to employ aseptic techniques during single or multiple entries and withdrawals from all containers. When preparing the drugs, they should be mixed thoroughly and used promptly. Reconstituted solutions should not be stored unless specifically directed by the manufacturer. Additionally, clinicians should ensure that the solution is clear and that the seal is intact before use. Single-dose containers should not be reused, and any unused portion must be discarded.

FDA Insert (PDF)

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

View full prescribing information (PDF)