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, sufficient solute should be added to achieve an approximately isotonic solution, with a pH range of 5.0 to 7.0.

Chemically, Water for Injection, USP is designated as H2O. The accompanying plastic syringe is manufactured from a specially formulated polypropylene, which allows for an extremely slow rate of water permeation from within the container, resulting in an insignificant impact on solution concentration throughout the expected shelf life. While solutions in contact with the plastic container may leach certain chemical components in minimal amounts, biological testing has confirmed the safety of the syringe material.

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 is not intended for any other routes of administration or for use outside 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 recommended 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

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no noted risks of abuse, misuse, or dependence. Therefore, no specific "Do not take" or "Do not use" instructions are applicable.

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 assessment of the patient's clinical status and laboratory parameters is essential to ensure safe and effective use of intravenous solutions.

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 administered 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 is intended solely as a diluent or solvent. While it is unlikely to pose a risk of fluid overload, caution should be exercised in neonates or very small infants, as they may be more susceptible. In cases where fluid overload is suspected, it is essential to re-evaluate the patient and implement appropriate corrective measures.

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 adjustments to the administration method may be necessary to avoid complications.

Packaging & NDC

The table below lists all NDC Code configurations of Sterile Water (sterile water for 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, caution is advised when administering to neonates or very small infants, as the volume of fluid may impact fluid and electrolyte balance.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined for the use of Sterile Water for Injection, USP. As there is no available information regarding geriatric use, healthcare providers should exercise clinical judgment when administering this product to elderly patients. Monitoring for any potential adverse effects or complications is advisable, given the general considerations 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 a pregnant woman 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 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

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 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, particularly in neonates or very small infants, who may be more susceptible to such complications.

Should signs of fluid overload occur in these vulnerable populations, healthcare professionals are advised to re-evaluate the patient's condition promptly. Appropriate corrective measures should be instituted based on the clinical assessment. This may include adjusting fluid administration rates, monitoring vital signs closely, and providing supportive care as necessary to ensure patient safety and well-being.

Nonclinical Toxicology

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

Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants, the volume of fluid may affect fluid and electrolyte balance.

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 any suspected adverse reactions to Medefil, Inc. at 1-630-682-4600 or via their website at www.medefilinc.com, or to the FDA at 1-800-FDA-1088 or 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 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.

When diluting or dissolving drugs, healthcare providers should advise patients to mix thoroughly and use the solution promptly. It is critical to inform patients not to store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Additionally, patients should be cautioned not to use 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.

Patients should be made aware of potential reactions that may occur due to the solution, added drugs, or the technique of reconstitution or administration. These reactions may include febrile response, local tenderness, abscess, tissue necrosis or infection at the injection site, venous thrombosis or phlebitis extending from the injection site, and extravasation. In the event of an adverse reaction, patients should be instructed to discontinue the infusion, evaluate their condition, and seek appropriate countermeasures. If possible, they should retrieve and save the remainder of the unused vehicle for examination.

Healthcare providers should inform patients about the process for reporting suspected adverse reactions, directing them to contact Medefil, Inc. at 1-630-682-4600 or visit www.medefilinc.com, or to report to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Finally, it should be communicated that this parenteral preparation is intended solely as a diluent or solvent and is unlikely to pose a threat of fluid overload, except possibly in neonates or very small infants. In such cases, patients should be advised to re-evaluate their condition and implement appropriate corrective measures. Patients should also be reminded to visually inspect the parenteral solution for particulate matter and discoloration prior to administration, whenever the solution and container permit.

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), in compliance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing to maintain its integrity. Any unused portion of the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients receiving this medication may be administered via intravenous, intramuscular, or subcutaneous injection. Clinicians should counsel patients to inspect reconstituted drugs for clarity and to ensure there is no unexpected precipitation or discoloration prior to administration. It is important to note that this parenteral preparation is intended solely as a diluent or solvent and is unlikely to cause fluid overload, except potentially in neonates or very small infants. In such cases, clinicians should re-evaluate the patient and implement appropriate corrective measures.

FDA Insert (PDF)

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

View full prescribing information (PDF)