Sterile Water

Description

AQUALITE™ is a sterile water for irrigation, USP, composed of 100% sterile water. It is intended exclusively for intraperitoneal, irrigation, and topical use, and is not suitable for injection. The product is nonpyrogenic and provided in a single-use container, containing no antimicrobial or other added substances. The recommended dosage is as directed, and it is advised not to heat the container above 66°C. Any unused portion should be discarded. AQUALITE™ should be stored at a temperature range of 20 to 25°C and protected from freezing. The pH of the solution is approximately 5.5.

Uses and Indications

AQUALITE™ is indicated for intraperitoneal, irrigation, and topical use only. This drug is not intended for injection.

There are no teratogenic effects associated with AQUALITE™, and no nonteratogenic effects have been reported.

Dosage and Administration

The dosage of the product should be administered as directed by the healthcare professional. It is imperative that the container is not heated above 66°C to maintain the integrity of the formulation. Any unused portion of the product must be discarded to ensure safety and efficacy.

For optimal storage, the product should be kept at a temperature range of 20 to 25°C and must be protected from freezing to preserve its quality.

The route of administration is via irrigation. Healthcare professionals should ensure that the method of administration is performed in accordance with established protocols for irrigation procedures.

Contraindications

Use of this product is contraindicated in the following situations:

• The product is not intended for injection.

• Heating the container above 66°C is contraindicated, as it may compromise the integrity of the product.

Warnings and Precautions

This drug has not been evaluated by the FDA for safety and efficacy, and the labeling has not received FDA approval. Healthcare professionals should exercise caution when considering its use.

General precautions must be observed regarding the accuracy of barcode scanning systems. It has been noted that the barcode may not register correctly on U.S. scanning systems. Therefore, institutions are advised to manually input the product into their systems to ensure that the barcode systems provide accurate information upon scanning. Alternative procedures should be implemented to guarantee that the correct drug product is utilized and administered to each patient.

No specific laboratory tests have been identified for monitoring during the use of this drug. However, healthcare providers should remain vigilant and consider appropriate clinical assessments as necessary.

Side Effects

The available data for Sterile Water for Irrigation, USP, does not specify any adverse reactions or side effects associated with its use. It is important to note that this product is labeled as "NOT FOR INJECTION" and contains no antimicrobial or other added substances. As such, healthcare professionals should be aware that while no specific adverse reactions are documented, the absence of such information does not preclude the possibility of adverse events occurring in clinical practice. Careful consideration should be given to the intended use and administration of this product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary 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

There is no specific pediatric use information available for this medication, including recommended ages, dosing differences, safety concerns, or special precautions for children. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the absence of relevant data.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Sterile Water for Irrigation. As there is no available information regarding the use of this product in geriatric populations, healthcare providers should exercise caution and consider individual patient factors when administering this solution to elderly patients. Monitoring for any potential adverse effects or complications is advisable, given the lack of targeted data for this demographic.

Pregnancy

The safety and efficacy of this drug during pregnancy have not been established, as it has not been approved by the FDA. There are no specific statements regarding the use of this drug in pregnant patients, nor are there any documented safety concerns, dosage modifications, or special precautions related to its use during pregnancy. Healthcare professionals should exercise caution and consider the potential risks when prescribing this medication to women of childbearing potential. It is advisable to weigh the benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information available regarding the use of Sterile Water for Irrigation in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating patients.

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 these patients to ensure safety and efficacy.

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 consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient’s safety.

Healthcare professionals should also consult local poison control centers or relevant clinical guidelines for further recommendations on the management of overdose cases.

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 assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Adverse events and quality problems associated with the use of this product have been reported voluntarily through various channels. Healthcare professionals and consumers are encouraged to report any adverse events or quality issues to ICU Medical Global Complaint Management at (844) 654-7780 or via email at ProductComplaintsPP@icumed.com.

Additionally, reports can be submitted to the FDA's MedWatch Adverse Event Reporting Program. This can be done online at www.fda.gov/medwatch/report.htm, or through regular mail or fax. For mail or fax submissions, individuals may download the reporting form from www.fda.gov/MedWatch/getforms.htm or contact (800) 332-1088 to request a form. Completed forms should be returned to the address provided on the pre-addressed form or submitted by fax to (800) FDA-0178 (1-800-332-0178).

Patient Counseling

Healthcare providers should inform patients that this drug has not been found by the FDA to be safe and effective, and that the labeling has not received FDA approval. It is important to clarify that U.S. FDA-approved products are available by prescription only in the United States, while Canadian products may not carry the "Rx only" designation on their labeling.

Patients should be advised on the importance of reporting any adverse events or quality problems they experience while using this product. They can do so by contacting ICU Medical Global Complaint Management at (844) 654-7780 or by emailing ProductComplaintsPP@icumed.com. Additionally, patients may report adverse events or quality issues to the FDA's MedWatch Adverse Event Reporting Program through online submission, regular mail, or fax.

Encouraging open communication about any concerns or side effects will help ensure patient safety and proper management of their treatment.

Storage and Handling

The product is supplied in accordance with the following 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 imperative that the container is not heated above 66°C to maintain product integrity. Additionally, the product must be protected from freezing to ensure its efficacy. Any unused portion of the product should be discarded to prevent potential safety risks.

Additional Clinical Information

The route of administration for the product is through irrigation. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)