NORMOSOL-R AND DEXTROSE- dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride and magnesium chloride injection, solution
Hospira, Inc.
MULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP
For Replacing Acute Losses of Extracellular Fluid
Flexible Plastic Container
Rx only
DESCRIPTION
Normosol-R and 5% Dextrose Injection is a sterile, nonpyrogenic solution of balanced electrolytes (with dextrose) in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid (with minimal carbohydrate calories).
Each 100 mL of Normosol-R and 5% Dextrose Injection contains dextrose 5 g; sodium chloride 526 mg; sodium acetate, anhydrous 222 mg; sodium gluconate 502 mg; potassium chloride 37 mg; magnesium chloride, hexahydrate 30 mg; pH adjusted with hydrochloric acid.
See TABLE for summary of electrolyte content, caloric value and characteristics of this solution.
The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.
Normosol-R and 5% Dextrose Injection is a parenteral fluid, electrolyte and nutrient replenisher.
Dextrose, USP is chemically designated D-glucose monohydrate (C6 H12 O6 � H2 0), a hexose sugar freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.
Magnesium Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl2 � 6H2 0) deliquescent crystals very soluble in water.
Sodium Acetate, USP, is chemically designated sodium acetate anhydrous (C2 H3 NaO2 ), a hygroscopic powder soluble in water. Sodium gluconate is chemically designated C6 H11 NaO7 , the normal sodium salt of gluconic acid soluble in water. Water for Injection, USP is chemically designated H2 0.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25�C/77�F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
CLINICAL PHARMACOLOGY
When administered intravenously, Normosol-R and 5% Dextrose Injection provides water and electrolytes with carbohydrate calories for replacement of acute extracellular fluid losses without disturbing normal electrolyte relationships. The electrolyte composition approaches that of the principal ions of normal plasma (extracellular fluid). The electrolyte concentration is approximately isotonic in relation to the extracellular fluid (approx. 280 mOsmol/liter) and provides a physiologic sodium to chloride ratio, normal plasma concentrations of potassium and magnesium and two bicarbonate alternates, acetate and gluconate. Dextrose provides minimal calories and renders the solution hypertonic. INDICATIONS AND USAGE
Normosol-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R and 5% Dextrose also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. The solution is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume.
