Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride

Prescription

Brand names: Normosol-R

Dosage Form

Injection

Route

INTRAVENOUS

Manufacturer

ICU Medical Inc.

About This Medication

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 (MgCl 2 • 6H 2 O) deliquescent crystals very soluble in water. Sodium Acetate, USP is chemically designated sodium acetate, anhydrous (C 2 H 3 NaO 2 ), a hygroscopic powder soluble in water. It has the following structural formula: Sodium gluconate is chemically designated C 6 H 11 NaO 7 , the normal sodium salt of gluconic acid soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 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. structural formula sodium acetate structural formula sodium gluconate

Active Ingredients

Ingredient	Strength
Magnesium Chloride	-
Potassium Chloride	-
Sodium Acetate Anhydrous	-
Sodium Chloride	-
Sodium Gluconate	-

Indications & Usage

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.

Dosage & Administration

DOSAGE AND ADMINISTRATION Normosol-R pH 7.4 is administered by intravenous infusion. It may also be administered subcutaneously. The amount to be infused is based on replacement of losses of extracellular fluid volume in the individual patient. Up to three times the volume of estimated blood loss during and after surgery can be given to correct circulatory volume when there is only a moderate loss of blood. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS. INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. If supplemental medication is desired, follow directions below before preparing for administration. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly. To Administer Attach administration set per manufacturer’s instructions. Regulate rate of administration per institutional policy. WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

Side Effects Overview

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Warnings & Precautions

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function during fluid replacement with Normosol-R. Solutions containing acetate or gluconate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate or gluconate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency. The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Elderly patients may be at increased risk for the development of fluid overloading and dilutional hyponatremia following Normosol-R administration. 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.

Contraindications

CONTRAINDICATIONS None known.

Frequently Asked Questions

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 …

DOSAGE AND ADMINISTRATION Normosol-R pH 7.4 is administered by intravenous infusion. It may also be administered subcutaneously. The amount to be infused is based on replacement of losses of extracellular fluid volume in the individual patient. Up to three times the volume of estimated blood loss during and after surgery can be given to correct circulatory volume when there is only a moderate loss of blood. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to …

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result …

CONTRAINDICATIONS None known.

Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride drug label (National Library of Medicine)
• openFDA — Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 800985 (NLM Normalized Drug Names)
• NDC Directory — Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride (FDA National Drug Code)

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The information on this page is intended for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.

Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.

Data sources: DailyMed (NLM), openFDA, MFDS