Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride
FDA Drug Information • Also known as: Normosol-R And Dextrose
- Brand Names
- Normosol-R And Dextrose
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
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 (C 6 H 12 O 6
What Is Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride Used For?
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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Normosol-R and 5% Dextrose Injection is administered by intravenous infusion. The amount to be infused is based on replacement of losses of extracellular fluid volume in the individual patient. Up to 3 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. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Normosol-R and 5% Dextrose solution does not contain calcium to avoid precipitation of calcium salts that may occur when certain drugs are added. 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. 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 (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.
Warnings and 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 and 5% Dextrose. 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 and 5% Dextrose 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.
Pregnancy and Breastfeeding
Pregnancy Category C Animal reproduction studies have not been conducted with Normosol-R and 5% Dextrose Injection. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed.
Overdosage
OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .)
How Supplied
HOW SUPPLIED Normosol-R and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in a 1000 mL single-dose flexible plastic container (NDC No. 0409–7968–09 and 0990-7968-09). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. TABLE Electrolyte Content, Caloric Value and Characteristics Milliequivalents per Liter HC0 - 3 (alternates) Cal* mOsmol/L Tonicity Na + K + Mg ++ Cl - Acetate Gluconate per Liter (calc.) (total contents) pH Normosol-R and 5% Dextrose 140 5 3 98** 27 23 185 547 Hypertonic 5.2 (4.0 to 6.5) * Normosol-R and 5% Dextrose calories derived from dextrose (170) and gluconate (15). **Not including hydrochloric acid. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. ® Normosol − multiple electrolyte solution, ICU Medical, Inc. Revised: March, 2020 IFU0000172 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.