Normosol-R

Generic: SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE

Prescription DrugINTRAVENOUS

Drug Information

Brand Name
Normosol-R
Generic Name
SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
Manufacturer
ICU Medical Inc.
Product Type
Prescription Drug
Route
INTRAVENOUS
Application Number
0e089a44-0cee-4804-8f6f-8508508ddb5c

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 a...

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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.

Warnings

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 ...

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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.

Adverse Reactions

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.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.