Sterile Water

Description

No description information is available for the specified drug.

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 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 reactions associated with the administration of this solution, particularly when combined with added drugs or due to the technique of reconstitution or administration, include tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, and abscess formation. Additionally, extravasation may occur, leading to further complications.

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

It is important to note that intravenous administration of Sterile Water for Injection without a solute may result in 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

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), 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 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 consult with their healthcare provider regarding the use of Sterile Water for Injection, as it is not known whether it can cause harm when administered to a breastfeeding woman or affect lactation. There is a potential for excretion in breast milk; however, specific data regarding the effects on nursing infants are not provided. Caution is advised when administering this preparation to nursing mothers, particularly in the context of any additives that may be used with the Sterile Water for Injection.

Renal Impairment

There is no specific information available 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 the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

Nonclinical Toxicology

Pregnancy Category C has been assigned to Sterile Water for Injection, indicating that animal reproduction studies have not been conducted. The potential for fetal harm or effects on reproductive capacity when administered to a pregnant woman remains unknown. Therefore, Sterile Water for Injection with additives should only be administered to pregnant women if clearly needed.

No non-teratogenic effects have been specified in the available data.

The safety of the plastic used in the formulation has been confirmed through tests conducted in animals, adhering to the biological standards set forth by the United States Pharmacopeia (USP) for plastic containers.

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 prevent complications. It is crucial 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.

When discussing the use of Sterile Water for Injection with additives, healthcare providers should caution that it should only be administered to pregnant women if clearly needed. While safety and effectiveness have been established in pediatric patients, providers should note that in neonates or very small infants, the volume of fluid may impact fluid and electrolyte balance.

It is important to inform patients that some drugs for injection may be incompatible with a given vehicle or when combined in the same vehicle, particularly those containing benzyl alcohol. Providers should encourage patients to consult with a pharmacist if available for guidance on compatibility.

Healthcare providers should stress the necessity of using aseptic technique for single or 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 also be informed not to store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

Patients must be instructed not to use the solution unless it is clear and the seal is intact. They should be made aware that single-dose containers should not be reused and any unused portion should be discarded. In the event of an adverse reaction, patients should be advised 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, 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 controlled room temperature of 20 to 25°C (68 to 77°F), as defined by the United States Pharmacopeia (USP) guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

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)