Normosol-m And Dextrose

Normosol-m And Dextrose

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

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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:

structural formula dextrose

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.

Normosol-m And Dextrose Manufacturers


  • Hospira, Inc.
    Normosol-m And Dextrose (Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate) Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Normosol-m And Dextrose (Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate) Injection, Solution [Hospira, Inc.]

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