Sterile Water

Description

This preparation is designed solely for parenteral use after the addition to drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent, or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For intravenous injection, a sufficient amount should be added to a solute to create an approximately isotonic solution, with a pH range of 5.0 to 7.0. Water for Injection, USP is chemically designated as H2O.

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 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

Sterile Water for Injection 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, 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 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

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. Serious reactions can occur, such as tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the injection site, and abscess formation. Additionally, patients may experience local tenderness and extravasation.

A febrile response has also been noted among participants receiving this treatment.

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

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, the volume of fluid administered may impact fluid and electrolyte balance, necessitating careful monitoring and adjustment of dosages as appropriate.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 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, taking into consideration the potential risks versus benefits. Healthcare professionals are advised to exercise caution and evaluate the necessity of its use in this population.

Lactation

There is no relevant information 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 mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in terms of 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in this population to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 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 assessment of the patient's condition is critical. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status. Monitor for any signs of toxicity or adverse reactions.

2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, intravenous fluids, and monitoring in a controlled environment.

3. Decontamination: If the overdose is recent and the patient is alert, consider activated charcoal administration to limit further absorption of the substance. Gastric lavage may be indicated in certain cases, but only if performed within a suitable timeframe and under appropriate clinical circumstances.

4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific management strategies tailored to the substance involved.

5. Documentation: Ensure thorough documentation of the incident, including the substance involved, estimated dose, time of ingestion, and all interventions performed.

Healthcare professionals should remain informed about the specific characteristics and management protocols associated with the substances they encounter, as this knowledge is crucial for effective intervention in cases of overdose.

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 provided in the insert. 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, and infection at the injection site. Additionally, venous thrombosis or phlebitis extending from the injection site, as well as 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 preserved for examination.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection must be made approximately isotonic prior to use. It is essential 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.

Patients should be informed 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 Sterile Water for Injection with additives should only be administered to pregnant women if clearly needed.

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 affect fluid and electrolyte balance. Providers should also 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. Consulting with a pharmacist is recommended if available.

Healthcare providers must emphasize the importance of using aseptic technique for single or multiple entries and withdrawals from all containers. When diluting or dissolving drugs, patients should be instructed to mix thoroughly and use promptly, as reconstituted solutions should not be stored unless otherwise directed by the manufacturer of the solute.

Patients should be advised 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. In the event of an adverse reaction, healthcare providers should instruct patients to discontinue the infusion, evaluate their condition, institute appropriate countermeasures, and, if possible, 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 a single-dose vial format, ensuring that each dose is used once and that no preservatives are included. It is essential to inspect the solution prior to use; only utilize the product if the solution is clear and the seal remains intact.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Any unused portion of the vial must be discarded to ensure safety and efficacy.

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 Cardinal Health 107, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)