Bacteriostatic 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. Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic solution containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) benzyl alcohol as a bacteriostatic preservative. It is provided in a multiple-dose container, allowing for repeated withdrawals to dilute or dissolve injectable drugs. The pH of the solution is 5.7, within the range of 4.5 to 7.0.

Water for Injection, USP is chemically identified as H₂O. The semi-rigid vial is constructed from a specially formulated polyolefin, a copolymer of ethylene and propylene. The safety of this plastic has been validated through animal testing in accordance with USP biological standards for plastic containers. The container is designed without a vapor barrier to ensure the maintenance of the labeled volume.

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, parenteral drug products 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

Solutions containing benzyl alcohol are contraindicated in neonates due to the potential toxicity associated with this compound.

Additionally, parenteral preparations that include benzyl alcohol should not be utilized for fluid replacement purposes.

Furthermore, the use of parenteral preparations containing benzyl alcohol is contraindicated in epidural or spinal anesthesia procedures to avoid adverse effects.

Warnings and Precautions

Benzyl alcohol, a preservative present in Bacteriostatic Water for Injection, USP, has been linked to toxicity in neonates. Due to the lack of available data regarding the toxicity of other preservatives in this age group, it is imperative that only preservative-free Sterile Water for Injection is utilized for preparing or diluting medications intended for neonates.

Healthcare professionals should be aware that the intravenous administration of Bacteriostatic Water for Injection without an accompanying solute may lead to hemolysis.

It is crucial to emphasize that Bacteriostatic Water for Injection is contraindicated for use in neonates. This warning must be strictly adhered to in order to prevent potential adverse effects.

Side Effects

Adverse reactions associated with the use of this solution, as well as added drugs or the technique of reconstitution or administration, may include a febrile response, local tenderness, abscess formation, tissue necrosis or infection at the injection site, venous thrombosis or phlebitis extending from the injection site, and extravasation.

It is important to note that the use of this solution is contraindicated in neonates due to the potential toxicity of benzyl alcohol, a preservative present in Bacteriostatic Water for Injection, USP. The safety and effectiveness of this product have not been established in pediatric patients, and intravenous administration without a solute may lead to hemolysis.

In clinical practice, the administration of solutions containing benzyl alcohol should be avoided in neonates, and only preservative-free Sterile Water for Injection should be utilized for preparing or diluting medications intended for this age group. Additionally, parenteral preparations containing benzyl alcohol are contraindicated for fluid replacement and should not be used in epidural or spinal anesthesia procedures.

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, particularly in cases where compatibility is uncertain.

Packaging & NDC

The table below lists all NDC Code configurations of Bacteriostatic Water (water), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The safety and effectiveness of Bacteriostatic Water for Injection, USP, have not been established in pediatric patients. Caution is advised when considering its use in this population. Specifically, solutions containing benzyl alcohol should not be used in neonates due to the potential for toxicity.

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 Bacteriostatic Water for Injection. Therefore, the effects of Bacteriostatic Water for Injection on fetal outcomes or reproduction capacity in humans are not known. Given the lack of data, Bacteriostatic Water for Injection, USP containing additives should be administered to pregnant patients only if clearly needed. Healthcare professionals should weigh the potential risks against the benefits when considering the use of this product in pregnant women.

Lactation

Nursing mothers should be aware of the potential for excretion of Bacteriostatic Water for Injection, USP in breast milk. However, there is no specific information available regarding the safety of this product in nursing mothers or its effects on breastfed infants.

Caution is advised when administering medications that may be diluted or dissolved in Bacteriostatic Water for Injection, USP to lactating mothers, as the effects on lactation and breastfed infants have not been well studied.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance 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 primarily intended for use as a diluent or solvent. The risk of fluid overload is generally low; however, it may be a concern in very small infants.

Should signs of fluid overload occur, it is imperative to re-evaluate the patient promptly. Appropriate corrective measures should be instituted based on the clinical assessment. Healthcare professionals are advised 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 Bacteriostatic Water for Injection. It is not known whether Bacteriostatic Water for Injection containing additives can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, Bacteriostatic Water for Injection, USP containing additives should be given to a pregnant woman only if clearly needed.

Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP, has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group.

Although adverse reactions to intravenous, intramuscular, or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in humans, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose of up to 30 mL may be safely administered to an adult without toxic effects. However, administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes.

The safety of the plastic container has been confirmed by tests in animals according to USP biological standards for plastic containers.

Postmarketing Experience

Postmarketing experience has identified several important considerations regarding the use of Bacteriostatic Water for Injection, USP, which contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with toxicity in neonates; however, data on the toxicity of other preservatives in this age group remain unavailable. It is recommended that only preservative-free Sterile Water for Injection be utilized when preparing or diluting medications for neonates.

Reactions that may occur due to this solution, the addition of drugs, or the technique of reconstitution or administration include febrile responses, local tenderness, abscess formation, tissue necrosis, or infection at the injection site. Additionally, venous thrombosis or phlebitis extending from the injection site and extravasation have been reported.

In the event of an adverse reaction, it is advised 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.

While adverse reactions to intravenous, intramuscular, or subcutaneous injection of 0.9% benzyl alcohol are not documented in humans, experimental studies in various animal species suggest that an estimated intravenous dose of up to 30 mL may be safely administered to an adult without toxic effects. However, the administration of approximately 9 mL to a 6 kg infant or neonate may potentially lead to changes in blood pressure.

Patient Counseling

Healthcare providers should advise patients that the medication is not intended for use in neonates. It is essential to consult the manufacturer's instructions regarding the selection of the appropriate vehicle, as well as the correct dilution or volume for dissolving the drugs intended for injection, including the specified route and rate of injection.

Patients should be informed about the importance of inspecting reconstituted drugs for clarity and ensuring there is no unexpected precipitation or discoloration prior to administration. Additionally, it is crucial to note that Bacteriostatic Water for Injection, USP, which contains additives, should only be administered to pregnant women if it is clearly necessary.

Healthcare providers must emphasize the need for aseptic technique during both single and multiple entries and withdrawals from all containers. When diluting or dissolving drugs, patients should be instructed to mix thoroughly and use the solution promptly. It is important to inform patients that reconstituted solutions of drugs for injection should not be stored unless specifically directed by the manufacturer of the solute.

Patients should also be cautioned against using the solution unless it is clear and the seal is intact. Finally, parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever the solution and container allow for such inspection.

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. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients may receive the medication via intravenous, intramuscular, or subcutaneous routes. Clinicians are advised to consult the manufacturer's instructions regarding the choice of vehicle, appropriate dilution, and volume for dissolving the drugs intended for injection, including the recommended route and rate of administration.

Prior to administration, it is essential to inspect the reconstituted drugs for clarity and to ensure there is no unexpected precipitation or discoloration.

FDA Insert (PDF)

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

View full prescribing information (PDF)