Sterile Water

Sterile Water for Irrigation is indicated for use as an irrigant. Sterile Water for Irrigation is indicated for use as an irrigant. ( 1 )

None.

• None. ( 4 )

• Hypotonicity : Administration by parenteral routes can result in serious adverse reactions. For irrigation use only. ( 5.1 )
• Excessive Water Absorption : May result in hyponatremia, hypoosmolality and fluid overload. Monitor patients for absorption of clinically relevant amounts of fluid during and after the procedure. Additional monitoring is recommended for patients at increased risk of developing complications of fluid overload syndrome (e.g., patients with renal or cardiac impairment) or hyponatremic encephalopathy (e.g., pediatric patients; women, in particular premenopausal women; patients with hypoxemia; and patients with central nervous system disease). Avoid use in procedures that require longer irrigation times or an irrigation fluid pressure that promotes absorption. ( 5.2 , 8.4 )
• Use with Electrosurgery/Cautery : Ensure compatibility with equipment used with electrosurgery or cautery. ( 5.2 )

5.1 Hypotonicity Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. It is intended for use as irrigation fluid and not for intravenous administration or administration by other, usual parenteral routes, such as intravascular administration in general, subcutaneous administration, or intramuscular administration. Serious adverse reactions, including cerebral or pulmonary edema, massive hemolysis, and acute renal failure can result from the hypotonicity of Sterile Water for Irrigation [see Warnings and Precautions (5.2) ].

5.2 Excessive Water Absorption Due to the hypotonicity, absorption of Sterile Water for Irrigation can result in serious adverse reactions of hyponatremia, hypoosmolality and fluid overload, resulting in fatality or permanent morbidity. Complications include cerebral edema, encephalopathy, pulmonary edema, massive hemolysis, rhabdomyolysis, renal failure, and hyperkalemia [see Adverse Reactions (6) ]. In addition, excessive volume or pressure of the irrigation fluid may also cause undue distension of body cavities and may cause tissue disruption (e.g., tears or perforation).