Water

Description

Sterile Water for Injection, USP, is a sterile, nonpyrogenic, distilled water intended for intravenous administration following the addition of a suitable solute. It is also suitable for use as a dispensing container for diluent purposes. The formulation contains no added antimicrobial or other substances. The pH of the solution is maintained at 5.5, within the range of 5.0 to 7.0, and it has an osmolarity of 0.

The product is packaged in a flexible plastic container made from polypropylene. The design of the container ensures that the amount of water permeating from inside to the overwrap is insufficient to significantly affect the solution. While solutions in contact with the plastic container may leach certain chemical components in very small amounts, biological testing has confirmed the safety of the materials used in the plastic container.

Uses and Indications

Sterile Water for Injection, USP is indicated for use in the aseptic preparation of parenteral solutions. This product serves as a diluent or solvent for medications intended for parenteral administration, ensuring the maintenance of sterility and compatibility in the preparation process.

Dosage and Administration

The dosage of the drug is determined by the patient's age, weight, clinical condition, and relevant laboratory determinations. Healthcare professionals should refer to the specific directions accompanying any additive drug used in conjunction with this medication.

Prior to administration, parenteral drug products must be visually inspected for particulate matter and discoloration, provided that the solution and container allow for such inspection. Injections are to be administered intravenously using sterile equipment, specifically from flexible plastic containers.

It is essential to note that certain additives may be incompatible with the drug. Additives known to be incompatible should not be utilized. If the introduction of additives is deemed necessary, consultation with a pharmacist is recommended. When additives are introduced, they must be mixed thoroughly, and solutions containing additives should not be stored.

Contraindications

Sterile Water for Injection, USP is contraindicated for intravenous administration without additives due to its hemolytic properties resulting from hypotonicity. The use of this product in such circumstances may lead to hemolysis and associated complications.

Warnings and Precautions

The use of this product for intravenous injection is contraindicated unless it has been adjusted to approximate isotonicity with a suitable solute. Administering the product in its unmodified form may lead to serious complications.

Healthcare professionals should be aware that hemolysis may occur following the infusion of Sterile Water for Injection, USP. This condition can result in hemoglobin-induced renal failure, which has been documented in clinical reports. It is imperative to monitor patients closely for signs of hemolysis and renal impairment during and after administration. Regular assessment of renal function may be warranted to ensure patient safety.

Side Effects

The administration of a suitable admixture of prescribed additives may be associated with various adverse reactions, primarily due to the solution or the technique of administration. Common adverse reactions observed include febrile responses, infections at the site of injection, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

Serious adverse reactions may also occur, including hemolysis, which can follow the infusion of Sterile Water for Injection, USP. Hemoglobin-induced renal failure has been reported in association with hemolysis.

It is crucial to note that Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity and is contraindicated for intravenous administration without additives. Therefore, it is imperative that the solution is clear and the seal is intact prior to administration to mitigate the risk of adverse reactions.

Drug Interactions

Additives may exhibit incompatibility with certain medications. While complete information regarding all potential interactions is not available, it is essential to avoid using those additives that are known to be incompatible. Healthcare professionals are advised to consult with a pharmacist when necessary to ensure safe and effective medication management.

Packaging & NDC

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

Pediatric Use

Pediatric patients may require dosage adjustments based on age, weight, clinical condition, and laboratory determinations. It is essential for healthcare professionals to consider these factors when prescribing to ensure appropriate dosing and therapeutic outcomes in children.

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

Pregnant patients should be aware that there is no specific information regarding the use of Sterile Water for Injection, USP during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for this population. Therefore, healthcare professionals are advised to exercise caution and consider the potential risks and benefits when administering this product to pregnant patients. Further studies may be necessary to fully understand the implications of its use in this demographic.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized.

Renal Impairment

Patients with renal impairment may experience hemolysis following the infusion of Sterile Water for Injection, USP. It is important to note that hemoglobin-induced renal failure has been reported as a consequence of hemolysis. Therefore, healthcare professionals should exercise caution and monitor renal function closely in patients with reduced kidney function when administering this product.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of the compound's potential effects in these areas.

Postmarketing Experience

Adverse reactions reported in the postmarketing experience include febrile responses, infections at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia. These events may be associated with the administration of a suitable admixture of prescribed additives, which can be influenced by the solution or the technique of administration.

In the event of an adverse reaction, it is recommended to discontinue the infusion, evaluate the patient, and institute appropriate therapeutic countermeasures. If necessary, the remainder of the fluid should be saved for examination.

For reporting suspected adverse reactions, healthcare professionals are encouraged to contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or through the website www.fda.gov/medwatch.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection, USP is not intended for intravenous injection unless it has been adjusted to approximate isotonicity with a suitable solute. Patients should be informed that hemolysis may occur following infusion, which can lead to hemoglobin-induced renal failure.

It is essential to instruct patients that the solution must be clear and the seal intact before administration. Providers should discuss the potential adverse reactions associated with the administration of a suitable admixture of prescribed additives, which may include febrile responses, infections at the injection site, venous thrombosis or phlebitis, extravasation, and hypervolemia.

In the event of an adverse reaction, healthcare providers should emphasize the importance of discontinuing the infusion, evaluating the patient, and instituting appropriate therapeutic countermeasures. They should also advise patients that the remainder of the fluid should be saved for examination if necessary.

Patients should be informed about the need for visual inspection of parenteral drug products for particulate matter and discoloration prior to administration. Providers should caution that additives may be incompatible, and complete information on compatibility is not available. If additives are deemed necessary, it is advisable to consult with a pharmacist and to use aseptic technique.

Healthcare providers should instruct patients not to store any unused portion of Sterile Water for Injection, USP, and to mix thoroughly when additives have been introduced. They should also warn against the use of plastic containers in series connections, as this could result in air embolism.

Finally, patients should be advised to visually inspect the container before use. If the port outlet protector is damaged, detached, or missing, the container should be discarded to maintain sterility. Some opacity of the plastic may occur due to moisture absorption during sterilization, which is normal and does not affect the solution's quality or safety. Providers should also check for minute leaks by squeezing the inner bag firmly and discard the solution if leaks are found, as sterility may be compromised.

Storage and Handling

Sterile Water for Injection, USP is supplied in flexible plastic containers, with each carton containing 12 bags. To ensure the integrity of the product, exposure to heat should be minimized, and excessive heat must be avoided. It is recommended that the product be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Brief exposure to temperatures up to 40°C does not adversely affect the product.

Additional Clinical Information

Intravenous administration of the medication should be performed using sterile equipment. Clinicians are advised to ensure that the solution is clear and the seal is intact before administration. In the event of an adverse reaction, it is crucial to discontinue the infusion, evaluate the patient, and implement appropriate therapeutic countermeasures. Additionally, the remainder of the fluid should be preserved for examination if necessary.

FDA Insert (PDF)

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

View full prescribing information (PDF)