Ionosol And Dextrose Recall
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Questions & Answers
Side Effects & Adverse Reactions
Solutions which contain potassium ions 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.
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.
In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.
Solutions containing lactate ions should be used with great care, if at all, in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of lactate ions, such as severe hepatic insufficiency.
The intravenous administration of Ionosol B and 5% Dextrose Injection 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.
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FDA Safety Alerts
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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.
Ionosol B and 5% Dextrose Injection is indicated for intravenous administration to patients who require a maintenance source of fluid and electrolytes.
Ionosol B and 5% Dextrose Injection is used in patients requiring polyionic fluid maintenance, for alkalosis due to vomiting, diabetic acidosis, fluid losses due to burns or stress and postoperative dehydration.
There is currently no drug history available for this drug.
Ionosol B and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic solution designed for intravenous administration. The solution is formulated to meet maintenance requirements for fluid and electrolytes.
Each 100 mL contains dextrose, hydrous 5 g plus sodium chloride 180 mg; potassium chloride 100 mg; sodium lactate, anhydrous 280 mg; magnesium chloride, hexahydrate 53 mg; dibasic potassium phosphate, anhydrous 100 mg; and monobasic sodium phosphate, monohydrate 16 mg.
Each liter contains 57 mEq sodium (Na+); 25 mEq potassium (K+); 5 mEq magnesium (Mg++); 49 mEq chloride (Cl−); 7 mM phosphate (PO4≡); and 25 mEq lactate (CH3CH(OH)COO–).
The electrolyte content is hypotonic (174 mOsmol/L, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/L). The osmolarity for the total solution is 426 mOsmol/L (calc.). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 5.0 (4.0 to 6.5).
Dextrose, USP, hydrous is chemically designated C6H12O6 • H2O (D-glucose, monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula:
structural formula dextrose
Magnesium Chloride, USP, hexahydrate is chemically designated MgCl2 • 6H2O, colorless flakes or crystals very soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.
Dibasic Potassium Phosphate, USP, anhydrous is chemically designated K2HPO4, white granules very soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.
Sodium Lactate, USP is chemically designated CH3CH(OH)COONa, a 60% aqueous solution miscible in water.
Monobasic Sodium Phosphate, USP, monohydrate is chemically designated NaH2PO4 • H2O, white crystals or granules freely soluble in water.
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.