sodium chloride, soldium lactate, potassium chloride and calcium chloride

FDA Drug Profile — Lactated Ringers

Drug Details

Generic Name
sodium chloride, soldium lactate, potassium chloride and calcium chloride
Brand Names
Lactated Ringers
Application Number
NDA018921
Sponsor
Baxter Healthcare Company
NDC Codes
1
Dosage Forms
IRRIGANT
Routes
IRRIGATION
Active Ingredients
CALCIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE

Indications and Usage

INDICATIONS AND USAGE Lactated Ringer’s Irrigation is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.

Warnings

WARNINGS Absorption of large volume of irrigation fluids through a perforation or open wound may result in circulatory overload, cardiac failure, or electrolyte disturbances and acid-base imbalance. Patients and fluid balance should be monitored accordingly. If absorption of clinically relevant amounts of fluid is suspected, the fluid administration should be interrupted, and the patient evaluated for possible adverse consequences. Particularly close monitoring is required in patients with: • Severely impaired renal function • Impaired cardiac function, or • Clinical states in which there is edema with sodium retention as a fluid overload syndrome may develop in these patients following absorption of even small quantities of irrigation fluid. Appropriate therapy should be initiated, as indicated. Lactated Ringer’s Irrigation must not be used when types of electrocautery are used that are not safe and effective when performed in the presence of electrolyte solutions. Excessive volume or pressure during irrigation may cause excessive fluid absorption, undue distention of cavities, and/or disruption of tissue.