Normosol-R

NORMOSOL-R- sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride and magnesium chloride injection, solution
ICU Medical Inc.

MULTIPLE ELECTROLYTES INJECTION TYPE 1, USP

For Replacing Acute Losses of Extracellular Fluid

Flexible Plastic Container

Rx only

DESCRIPTION

Normosol® -R pH 7.4 is a sterile, nonpyrogenic, isotonic solution of balanced electrolytes in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid.

Each 100 mL of Normosol-R pH 7.4 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride, hexahydrate 30 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH range 6.5 to 7.6; 295 mOsmol/liter (calc.).

Electrolytes per 1000 mL (not including pH adjustment): Sodium 140 mEq; potassium 5 mEq; magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq.

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 pH 7.4 is a parenteral fluid and electrolyte replenisher.

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 O) deliquescent crystals very soluble in water.

Sodium Acetate, USP is chemically designated sodium acetate, anhydrous (C2 H3 NaO2 ), a hygroscopic powder soluble in water. It has the following structural formula:

structural formula sodium acetate

Sodium gluconate is chemically designated C6 H11 NaO7 , the normal sodium salt of gluconic acid soluble in water. It has the following structural formula:

structural formula sodium gluconate

Water for Injection, USP is chemically designated H2 O.

The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. 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 pH 7.4 provides water and electrolytes 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.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl) are largely under the control of the kidney which maintains a balance between intake and output.

Potassium chloride in water dissociates to provide potassium (K+) and chloride (Cl) ions. Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult and child over 10 days old; 3.5 to 6.0 mEq/liter in a child less than 10 days old). Potassium plays an important role in electrolyte balance.

Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion.

Magnesium chloride in water dissociates to provide magnesium (Mg++) and chloride (Cl) ions. Magnesium is the second most plentiful cation of the intracellular fluids. It is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability. Normal plasma concentration ranges from 1.5 to 2.5 or 3.0 mEq per liter. Magnesium is excreted solely by the kidney at a rate proportional to the plasma concentration and glomerular filtration.

Sodium acetate provides sodium (Na+) and acetate (CH3 COO) ions, the latter anion (a source of hydrogen ion acceptors) serving as an alternate source of bicarbonate (HCO3 ) by metabolic conversion in the liver. This has been shown to proceed readily even in the presence of severe liver disease. Thus, acetate anion exerts a mild systemic antiacidotic action that may be advantageous during fluid and electrolyte replacement therapy.

Sodium gluconate provides sodium (Na+) and gluconate (C6 H11 O7 ) ions. Although gluconate is a theoretical alternate metabolic source of bicarbonate (HCO3 ) anion, a significant antiacidotic action has not been established. Thus, the gluconate anion serves primarily to complete the cation-anion balance of the solutions.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Average normal pediatric daily requirements are based on the child’s weight as described in the table below:

Weight

Fluid Requirements

Up to 10 kg

100 mL/kg

11 to 20 kg

1,000 mL + 50 mL/kg for each kg above 10 kg

Above 20 kg

1,500 mL + 20 mL/kg for each kg above 20 kg

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE

Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R pH 7.4 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.

Normosol-R pH 7.4 is particularly valuable as a solution for use in starting blood, i.e., as a priming solution for the infusion set. No hemolysis of blood is seen at the interface or with mixed solution and blood. It may also be used as a diluent to aid in the transfusion of packed red blood cells (PRBC). Normosol-R pH 7.4 and physiologic saline solution (0.9% Sodium Chloride Injection, USP) are compatible with both young and old PRBC.

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