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.
In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.
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.
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.
There is currently no manufacturer warning information available for this drug.
This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.
Each 100 mL of Isolyte® S pH 7.4 (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
Dibasic Sodium Phosphate Heptahydrate USP 0.012 g
Monobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qs
pH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NF
pH: 7.4 (7.0–7.8) Calculated Osmolarity: 295 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5
Magnesium 3; Chloride 98; 1Phosphate (HPO
) 1; Acetate (CH3COO–) 27 Gluconate (HOCH2(CHOH)4COO–) 23
Isolyte® S pH 7.4 is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration.
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 |
| Dibasic Sodium Phosphate Heptahydrate USP | Na2HPO4•7H2O | 268.07 |
| Monobasic Potassium Phosphate NF | KH2PO4 | 136.09 |
| Sodium Gluconate USP |  |
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.