Sterile Water

Description

Sterile Water for Injection, USP is a sterile, nonpyrogenic, solute-free preparation of distilled water intended for injection. It is chemically designated as H2O and has a pH of 5.5, with a range of 5.0 to 7.0. This preparation does not contain any bacteriostat, antimicrobial agent, or added buffer.

Uses and Indications

Sterile Water for Injection, USP is indicated for use solely as a solvent or diluent vehicle for parenterally administered drugs or solutions. Additionally, it serves as a source of water for parenteral fluid replenishment following the introduction of suitable additives.

There are no teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

The dosage of the medication is determined by the patient's age, weight, and clinical condition.

For the addition of medication, the following steps should be followed:

1. Prepare the additive port using aseptic technique.

2. Using an appropriate length additive delivery needle, puncture the resealable additive port at the target area, specifically the inner diaphragm, and inject the medication. Withdraw the needle after the injection is complete.

3. The additive port may be protected by covering it with an additive cap.

4. Mix the contents of the container thoroughly to ensure uniform distribution.

Preparation for administration should also adhere to aseptic technique and include the following steps:

1. Close the flow control clamp of the administration set.

2. Remove the cover from the outlet port located at the bottom of the container.

3. Insert the piercing pin of the administration set into the port with a twisting motion until the set is firmly seated. Refer to the full directions provided on the administration set carton for detailed instructions.

4. Suspend the container from a hanger.

5. Squeeze and release the drip chamber to establish the proper fluid level within the chamber.

6. Open the flow control clamp to clear air from the set, then close the clamp.

7. Attach the set to the venipuncture device. If the device is not indwelling, prime it and perform venipuncture.

8. Regulate the rate of administration using the flow control clamp to ensure appropriate delivery of the medication.

Contraindications

Administration of this product is contraindicated without the addition of a solute. This is essential to ensure proper formulation and efficacy.

Warnings and Precautions

The use of this product is strictly limited to drug diluent purposes. Intravenous administration of Sterile Water for Injection, USP, without any additives, poses a significant risk of hemolysis. Healthcare professionals must exercise caution when administering this solution.

When sterile water for injection is used with additives, there is a potential for fluid and/or solute overload. This can lead to dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. It is important to note that the risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. Conversely, the risk of solute overload, which may result in congested states accompanied by peripheral and pulmonary edema, is directly proportional to the electrolyte concentrations of these solutions.

A critical warning pertains to the aluminum content of this product, which may be toxic. Prolonged parenteral administration can lead to toxic levels of aluminum, particularly in patients with impaired kidney function. Premature neonates are especially vulnerable due to their immature renal function and their need for large volumes of calcium and phosphate solutions that contain aluminum. Research indicates that patients with compromised kidney function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day are at risk of accumulating aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration.

Healthcare professionals are advised to monitor renal function closely in patients receiving this product, particularly in vulnerable populations such as premature neonates, to mitigate the risks associated with aluminum toxicity.

Side Effects

Adverse reactions associated with the administration of Sterile Water for Injection, USP may include both serious and common reactions.

Serious adverse reactions can occur due to the intravenous administration of sterile water for injection without additives, which may result in hemolysis. Additionally, the use of sterile water for injection with additives carries risks of fluid and/or solute overload, leading to dilution of serum electrolyte concentrations, overhydration, congested states, and pulmonary edema. Patients with impaired kidney function, particularly premature neonates, are at heightened risk for aluminum toxicity, which can occur with prolonged parenteral administration. Research indicates that aluminum levels exceeding 4 to 5 mcg/kg/day can lead to accumulation associated with central nervous system and bone toxicity, with tissue loading potentially occurring at even lower rates of administration.

Common reactions related to the technique of administration may include febrile responses, infections at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia. In cases of overhydration or solute overload, it is essential to re-evaluate the patient and implement appropriate corrective measures.

The safety and effectiveness of this product in the pediatric population are inferred from the similarity of clinical conditions between pediatric and adult populations. However, in neonates or very small infants, the volume of fluid administered may significantly impact fluid and electrolyte balance.

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

The safety and effectiveness of this product in the pediatric population are supported by the similarity of clinical conditions observed in both pediatric and adult populations.

In neonates and very small infants, careful consideration should be given to the volume of fluid administered, as it may impact fluid and electrolyte balance.

Additionally, this product contains no more than 25 mcg/L of aluminum, which is relevant for pediatric patients, particularly in the context of minimizing aluminum exposure.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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. Healthcare professionals should weigh the potential benefits against any possible risks when considering the use of this product in pregnant patients.

Lactation

Nursing mothers should be aware of the potential for excretion of this product in breast milk. It is not known whether sterile water for injection with additives can cause fetal harm when administered to a nursing mother or affect reproductive capacity. Caution should be exercised when administering this product to nursing mothers.

Renal Impairment

Patients with renal impairment may experience increased risk of aluminum toxicity due to the presence of aluminum in this product. Prolonged parenteral administration in individuals with reduced kidney function can lead to toxic levels of aluminum. This risk is particularly pronounced in premature neonates, whose immature kidneys are less capable of excreting aluminum, especially when they require large volumes of calcium and phosphate solutions that contain aluminum.

Clinical research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral aluminum at doses exceeding 4 to 5 mcg/kg/day are at risk of accumulating aluminum to levels associated with central nervous system and bone toxicity. Furthermore, tissue loading of aluminum may occur even at lower rates of administration. Therefore, careful monitoring and consideration of dosing adjustments are essential for patients with renal impairment to mitigate the risk of aluminum accumulation and associated toxicities.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available 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.

Overdosage

In cases of overdosage, particularly related to fluid and solute overload, it is essential to re-evaluate the patient and implement appropriate corrective measures. Overhydration or solute overload can lead to significant complications, necessitating prompt medical intervention.

The intravenous administration of sterile water for injection, especially when combined with additives, poses a risk of fluid and solute overload. This can result in dilution of serum electrolyte concentrations, leading to overhydration, congested states, or pulmonary edema. The likelihood of developing congested states, characterized by peripheral and pulmonary edema, is directly proportional to the electrolyte concentrations present in the administered solutions.

Particular attention should be given to patients with impaired kidney function, as they are at an increased risk of aluminum toxicity. Prolonged parenteral administration of aluminum can lead to toxic levels, especially in individuals with compromised renal function. Premature neonates are especially vulnerable in this regard. It is critical to monitor aluminum exposure in these patients; levels exceeding 4 to 5 mcg/kg/day can result in accumulation associated with central nervous system and bone toxicity.

Healthcare professionals are advised to closely monitor patients for signs of overdosage and to take immediate action to mitigate any adverse effects.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with sterile water for injection, which is classified as Pregnancy Category C. It remains unclear 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 administered to a pregnant woman only if clearly needed.

The safety of the plastic used in the formulation has been confirmed through tests in animals, adhering to USP biological standards for plastic containers. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum exceeding 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration.

Postmarketing Experience

Postmarketing experience has identified several reactions associated with the technique of administration. These include febrile responses, infections at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia. In the event of an adverse reaction, it is recommended to discontinue the infusion, evaluate the patient, implement appropriate therapeutic countermeasures, and retain the remaining fluid for examination if necessary.

It is important to note that this product contains aluminum, which may pose a risk of toxicity, particularly with prolonged parenteral administration in patients with impaired kidney function. Premature neonates are especially vulnerable due to their immature renal function and the requirement for large volumes of calcium and phosphate solutions that contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral aluminum levels exceeding 4 to 5 mcg/kg/day may accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur even at lower rates of administration.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection, USP is intended solely as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced. It is crucial to emphasize that this product must not be administered without the addition of a solute, as intravenous administration of Sterile Water for Injection, USP without additives may lead to hemolysis.

Providers should inform patients that the intravenous administration of Sterile Water for Injection with additives can result in fluid and/or solute overload, which may cause dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. A warning should be issued regarding the presence of aluminum in this product, which may be toxic, particularly with prolonged parenteral administration in patients with impaired kidney function. Premature neonates are especially at risk due to their immature kidneys and the need for large amounts of calcium and phosphate solutions that contain aluminum.

Healthcare providers should discuss the potential for aluminum accumulation in patients with impaired kidney function, including premature neonates, who receive parenteral levels exceeding 4 to 5 mcg/kg/day, as this may lead to central nervous system and bone toxicity. It is important to ensure that the osmolar concentration of any additives totals at least 112 mOsmol/liter before intravenous injection, as this is necessary to avoid complications.

Patients should be instructed not to use the solution if it is not clear or if the container is damaged, and any unused portion should be discarded. Providers should also communicate that Sterile Water for Injection with additives falls under Pregnancy Category C, meaning it should only be administered to pregnant women if clearly needed.

In pediatric populations, particularly neonates or very small infants, the volume of fluid administered may impact fluid and electrolyte balance, and the safety and effectiveness of this product in these populations are based on similarities with adult clinical conditions. The product contains no more than 25 mcg/L of aluminum.

In the event of an adverse reaction, healthcare providers should discontinue the infusion, evaluate the patient, and implement appropriate therapeutic countermeasures, while saving the remainder of the fluid for examination if necessary. Should overhydration or solute overload occur, a re-evaluation of the patient is warranted, along with appropriate corrective measures.

Providers should also caution that additives may be incompatible and recommend consulting with a pharmacist when available. When introducing additives, it is essential to use aseptic technique, mix thoroughly, and avoid storing the mixture. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever possible. Additionally, it is critical to warn against using flexible containers in series connections. Finally, the product should be stored at 20 to 25°C (68 to 77°F) and protected from freezing.

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 and efficacy. Proper handling and storage conditions must be adhered to in order to ensure optimal performance.

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 ICU Medical Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)