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 designation of Water for Injection, USP is H2O. The container is a Type I borosilicate glass vial, compliant with the standards set forth by the 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 reported teratogenic or nonteratogenic effects associated with this preparation.

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. This step is crucial to ensure the safety and efficacy of the administered drug.

Contraindications

Use of Sterile Water for Injection, USP 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 use appropriate solutes when preparing intravenous solutions to mitigate the risk of hemolysis. Monitoring of patients receiving intravenous fluids is recommended to promptly identify any adverse reactions. Regular assessment of hemoglobin levels and other relevant laboratory parameters may be necessary to ensure patient safety and to detect any potential hemolytic events early.

Side Effects

Adverse reactions that may occur due to the use of this solution, added drugs, or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, and extravasation.

Serious adverse reactions associated with intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. Therefore, it is crucial to adhere to the precautions outlined for safe administration.

Patients should not use this solution for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. It is recommended to consult the manufacturer’s instructions regarding the choice of vehicle, appropriate dilution, or volume for dissolving the drugs to be injected, including the route and rate of injection.

Prior to administration, it is essential to inspect reconstituted drugs for clarity (if soluble) and to ensure freedom from unexpected precipitation or discoloration.

In terms of specific populations, safety and effectiveness have been established in pediatric patients; however, caution is advised in neonates or very small infants, as the volume of fluid may affect fluid and electrolyte balance.

Additionally, some drugs for injection may be incompatible in a given vehicle or when combined in the same vehicle containing benzyl alcohol. Consultation with a pharmacist is recommended when necessary.

To minimize the risk of adverse reactions, aseptic technique should be employed for single or multiple entries and withdrawals from all containers. When diluting or dissolving drugs, it is important to mix thoroughly and use promptly. Reconstituted solutions of drugs for injection should not be stored unless otherwise directed by the manufacturer of the solute.

Finally, the solution should only be used if it is clear and the seal is intact. Single-dose containers should not be reused, and any unused portion should be discarded.

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 and effective administration of these drugs. Monitoring for potential adverse effects is recommended when using multiple injectable medications concurrently.

Packaging & NDC

The table below lists all NDC Code configurations of Sterile 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. It is important for healthcare professionals to monitor these patients closely to ensure appropriate management of their fluid status.

Geriatric Use

There is no specific information 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.

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 unknown risks.

Lactation

It is not known whether Sterile Water for Injection is excreted in human milk. Caution should be exercised when administering this product to lactating mothers. There are no specific studies regarding the excretion of Sterile Water for Injection in breast milk or its effects on breastfed infants.

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 cases of overdosage, this parenteral preparation is intended solely for use as a diluent or solvent. The risk of fluid overload is generally minimal; however, caution is advised in neonates and very small infants, as they may be more susceptible to such complications.

Should signs of fluid overload occur in these vulnerable populations, 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 encouraged to refer to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections for further guidance on managing potential complications associated with 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 specific non-teratogenic effects or nonclinical toxicology details are available in the provided data. Additionally, there are no specific animal pharmacology and toxicology details mentioned.

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.

For the reporting of suspected adverse reactions, healthcare professionals are encouraged to contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or via the website www.fda.gov/medwatch.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection, USP is intended exclusively for parenteral use after the addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. It is essential to consult the manufacturer’s instructions regarding the choice of vehicle, appropriate dilution, and volume for dissolving the drugs, as well as 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 before administration. Emphasizing the importance of aseptic technique, healthcare providers should guide patients on the proper methods for single or multiple entry and withdrawal from all containers.

When diluting or dissolving drugs, patients should be reminded to mix thoroughly and use the solution promptly. It is critical to inform them not to store reconstituted solutions of drugs for injection unless specifically directed by the manufacturer of the solute. Patients must also be cautioned against using the solution unless it is clear and the seal is intact. Single-dose containers should not be reused, and any unused portion should be discarded.

In the event of an adverse reaction, healthcare providers should instruct patients to discontinue the infusion immediately, evaluate their condition, and implement appropriate countermeasures. If possible, they should retrieve and save the remainder of the unused vehicle for examination. Additionally, in cases of fluid overload, particularly in neonates or very small infants, patients should be advised to seek immediate re-evaluation and corrective measures.

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). It is imperative to avoid freezing the product to maintain its integrity and efficacy. Proper storage conditions must be adhered to in order to ensure optimal performance.

Additional Clinical Information

Patients may receive the medication via intravenous, intramuscular, or subcutaneous routes. Clinicians are advised to consult the manufacturer’s instructions for guidance on the selection of the appropriate vehicle, as well as the correct dilution or volume for dissolving the drugs intended for injection, including details on the route and rate of administration.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

FDA Insert (PDF)

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

View full prescribing information (PDF)