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Normosol-m And Dextrose Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.
Administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. 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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories from dextrose. Magnesium in the formula may help to prevent iatrogenic magnesium deficiency in patients receiving prolonged parenteral therapy.
History
There is currently no drug history available for this drug.
Other Information
Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic, hypertonic solution of balanced maintenance electrolytes and 5% dextrose injection in water for injection.
The solution is administered by intravenous infusion for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories.
Each 100 mL contains dextrose, hydrous 5 g, sodium chloride, 234 mg, potassium acetate, 128 mg and magnesium acetate, anhydrous 21 mg. May contain hydrochloric acid for pH adjustment. The electrolyte content (not including hydrochloric acid) and other characteristics are as follows:
Sodium (Na+) |
40 mEq/liter |
Potassium (K+) |
13 mEq/liter |
Magnesium (Mg++) |
3 mEq/liter |
Chloride (Cl−) |
40 mEq/liter |
Bicarbonate (HCO3−) as acetate |
16 mEq/liter |
Caloric value (dextrose) |
170 Calories/liter |
Tonicity |
Hypertonic |
Osmolarity |
363 mOsmol/liter (calc.) |
pH (range) |
5.0 (4.0 to 6.5) |
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-M and 5% Dextrose Injection is a parenteral fluid, electrolyte and nutrient replenisher.
Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula:
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Potassium Acetate, USP is chemically designated CH3COOK, colorless crystals or white crystalline powder very soluble in water.
Magnesium acetate is chemically designated Mg (C2H3O2)2, colorless or white crystals very soluble in water.
Water for Injection, USP is chemically designated H2O.
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.
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™Normosol −−multiple electrolyte solutions, Hospira.
Sources
Normosol-m And Dextrose Manufacturers
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Hospira, Inc.
Normosol-m And Dextrose | Hospira, Inc.
Normosol-M and 5% Dextrose Injection is administered by intravenous infusion. The dose is dependent upon the age, weight and clinical condition of the patient. A daily total amount of 1500 mL/M2of body surface will meet the usual adult daily requirements for water and principal electrolytes in patients unable to take anything by mouth. The usual daily maintenance amount for an average adult (70 kg and 1.8 square meters of body surface) is approximately three liters.
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.
To avoid precipitation of calcium salts that may occur when certain drugs are added, Normosol-M and 5% Dextrose Injection does not contain calcium.
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.
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Hospira, Inc.
Normosol-m And Dextrose | Hospira, Inc.
Normosol-M and 5% Dextrose Injection is administered by intravenous infusion. The dose is dependent upon the age, weight and clinical condition of the patient. A daily total amount of 1500 mL/M2 of body surface will meet the usual adult daily requirements for water and principal electrolytes in patients unable to take anything by mouth. The usual daily maintenance amount for an average adult (70 kg and 1.8 square meters of body surface) is approximately three liters.
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.
To avoid precipitation of calcium salts that may occur when certain drugs are added, Normosol‑M and 5% Dextrose Injection does not contain calcium.
Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)
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