Isolyte S

Isolyte S

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Questions & Answers

Side Effects & Adverse Reactions

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

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 is sodium retention with edema.

Solutions containing 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.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Solutions containing gluconate or 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 these ions, such as severe hepatic insufficiency.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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

This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration, and as an alkalinizing agent.

History

There is currently no drug history available for this drug.

Other Information

Each 100 mL of Isolyte® S (Multi-Electrolyte Injection) contains:
Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g
Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 g
Magnesium Chloride Hexahydrate USP 0.03 g
Water for Injection USP qs

pH adjusted with Glacial Acetic Acid USP
pH: 6.7 (6.3–7.3)
Calculated Osmolarity: 295 mOsmol/liter

Concentration of Electrolytes (mEq/liter): Sodium 140; Potassium 5
Magnesium 3; Chloride 98; Acetate (CH3COO) 27
Gluconate (HOCH2(CHOH)4COO) 23

Isolyte® S is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.

The formulas of the active ingredients are:

Ingredients Molecular
Formula
Molecular
Weight
 Sodium Chloride USP  NaCl    58.44
 Sodium Acetate Trihydrate USP  CH3COONa•3H2O  136.08
 Potassium Chloride USP  KCl    74.55
 Magnesium Chloride Hexahydrate USP  MgCl2•6H2O  203.30
 Sodium Gluconate USP  
structural formula
 218.14

The EXCEL® Container is Latex-free, PVC-free, and DEHP-free.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

Isolyte S Manufacturers


  • B. Braun Medical Inc.
    Isolyte S (Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, And Magnesium Chloride) Injection, Solution [B. Braun Medical Inc.]

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