Isolyte S

ISOLYTE S- sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride injection, solution
B. Braun Medical Inc.

DESCRIPTION

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 (CH₃ COO⁻) 27Gluconate (HOCH₂ (CHOH)₄ COO⁻) 23

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

The formulas of the active ingredients are:

Ingredients	MolecularFormula	MolecularWeight
Sodium Chloride USP	NaCl	58.44
Sodium Acetate Trihydrate USP	CH3 COONa•3H2 O	136.08
Potassium Chloride USP	KCl	74.55
Magnesium Chloride Hexahydrate USP	MgCl2 •6H2 O	203.30
Sodium Gluconate USP		218.14

Not made with natural rubber latex, PVC or DEHP.

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.

CLINICAL PHARMACOLOGY

Isolyte^® S provides electrolytes and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Magnesium, a principal cation of soft tissue, is primarily involved in enzyme activity associated with the metabolism of carbohydrates and protein. Magnesium is also involved in neuromuscular irritability.

Gluconate and acetate are organic ions which are hydrogen ion acceptors and contribute bicarbonate during their metabolism to carbon dioxide and water.

INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

This solution is contraindicated where the administration of sodium, potassium, magnesium, chloride, acetate or gluconate could be clinically detrimental.

WARNINGS

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.

PRECAUTIONS

General

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or an alternative solution.

This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

Additional essential electrolytes, minerals, and vitamins should be supplied as needed.

Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients.

Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels.

Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

Solutions containing potassium or magnesium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease.

Parenteral magnesium should be administered with extreme caution to patients receiving digitalis preparations.

Administration of barbiturates, narcotics, hypnotics or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect.

Solutions containing gluconate or acetate should be used with caution. Excess administration may result in metabolic alkalosis.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Do not use plastic containers in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with Isolyte^® S (Multi-Electrolyte Injection). It is also not known whether Isolyte S can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isolyte S should be given to a pregnant woman only if clearly needed.