Sodium Chloride for Irrigation

FDA Drug Profile — Sodium Chloride for Irrigation

Drug Details

Generic Name
Sodium Chloride for Irrigation
Brand Names
Sodium Chloride for Irrigation
Application Number
NDA016733
Sponsor
B. Braun Medical Inc.
NDC Codes
1
Dosage Forms
SOLUTION
Routes
IRRIGATION
Active Ingredients
SODIUM CHLORIDE

Indications and Usage

INDICATIONS AND USAGE 0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Warnings

WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Do not warm above 150°F (66°C). After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservatives.