sodium chloride, sodium lactate, potassium chloride and calcium chloride

FDA Drug Profile — Lactated Ringers Irrigation

Drug Details

Generic Name
sodium chloride, sodium lactate, potassium chloride and calcium chloride
Brand Names
Lactated Ringers Irrigation
Application Number
NDA018681
Sponsor
B. Braun Medical Inc.
NDC Codes
1
Dosage Forms
SOLUTION
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 all general irrigation, washing and rinsing 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 this irrigation must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading 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 administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. Do not warm container over 150°F (66°C).