Sterile Water

Description

This preparation is intended exclusively for parenteral use following the addition of drugs that necessitate dilution or require 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, 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 amount of 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: 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 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 medication.

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 always used in conjunction with an appropriate solute to prevent this serious adverse effect.

Monitoring for signs of hemolysis is essential when administering intravenous solutions. Clinicians should remain vigilant for symptoms such as fever, chills, back pain, and dark urine, which may indicate hemolytic reactions. Regular assessment of laboratory parameters, including complete blood count and renal function tests, is recommended to detect any potential complications early.

Side Effects

Adverse reactions associated with the use of this solution, as well as added drugs or the techniques of reconstitution or administration, may include a range of local and systemic responses. Common reactions observed in patients include febrile responses, local tenderness, and abscess formation. More serious adverse reactions can occur, such as tissue necrosis or infection at the injection site, venous thrombosis or phlebitis extending from the site of injection, and extravasation.

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 techniques to mitigate these potential adverse reactions.

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 (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, caution is advised when administering to neonates or very small infants, as the volume of fluid 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.

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 a pregnant woman only if clearly needed, taking into consideration the potential risks versus benefits.

Lactation

There is no information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating patients.

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, 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, particularly in neonates and very small infants.

Should signs of fluid overload manifest 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. Continuous monitoring and supportive care are essential to manage any potential complications arising from overdosage effectively.

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, USP must be made approximately isotonic prior to use to ensure safety during administration. It is critical 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.

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 administered may impact fluid and electrolyte balance. It is also important to discuss the potential for incompatibility of some drugs for injection when combined in a given vehicle or in a vehicle containing benzyl alcohol, and to recommend consulting with a pharmacist if available.

Providers should stress the necessity of using aseptic technique for both single and multiple entries and withdrawals from all containers. When diluting or dissolving drugs, patients should be advised to mix thoroughly and use the solution promptly. They should not store reconstituted solutions of drugs for injection unless specifically 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 be instructed not to reuse single-dose containers and to discard any unused portion. 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, particularly in neonates or very small infants, healthcare providers should re-evaluate the patient and implement 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.

Additional Clinical Information

Patients receiving injections should be aware of the various routes of administration, which include intramuscular, intravenous, and subcutaneous methods. 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.

It is essential to inspect reconstituted drugs for clarity and to ensure there is no unexpected precipitation or discoloration before administration. Aseptic techniques must be employed during the preparation and administration processes, including single or multiple entries and withdrawals from containers. When diluting or dissolving drugs, thorough mixing and prompt use are critical. Reconstituted solutions should not be stored unless specifically directed by the manufacturer, and solutions must be clear with intact seals before use. Single-dose containers should not be reused, and any unused portions should be discarded.

FDA Insert (PDF)

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

View full prescribing information (PDF)