Magnesium Chloride 0.00148 MEQ/ML / Monobasic K+ phosphate 0.0082 MG/ML / K+ Chloride 0.00497 MEQ/ML / Sodium Acetate 0.0272 MEQ/ML / NaCl 0.0906 MEQ/ML / Sodium gluconate 5 MG/ML / Sodium Phosphate, Dibasic 0.12 MG/ML Injectable Solution
Generic Name: SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE
Brand Name: Isolyte S pH 7.4
- Substance Name(s):
- MAGNESIUM CHLORIDE
- POTASSIUM CHLORIDE
- POTASSIUM PHOSPHATE, MONOBASIC
- SODIUM ACETATE
- SODIUM CHLORIDE
- SODIUM GLUCONATE
- SODIUM PHOSPHATE, DIBASIC
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.
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.
DRUG INTERACTIONS
Drug Interactions Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients.
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.
Parenteral magnesium should be administered with extreme caution to patients receiving digitalis preparations.
OVERDOSAGE
In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition, and institute appropriate corrective treatment.
In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels.
Treatment of hyperkalemia includes the following: Dextrose Injection USP, 10% or 25%, containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour.
Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema.
Hemodialysis and peritoneal dialysis.
The use of potassium-containing foods or medications must be eliminated.
However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.
Over-aggressive phosphate replacement may precipitate hypocalcemic tetany.
To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration.
DESCRIPTION
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; 0.5 mmole P/liter Phosphate (HPO ) 1; Acetate (CH 3 COO – ) 27 Gluconate (HOCH 2 (CHOH) 4 COO – ) 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 CH 3 COONa•3H 2 O 136.08 Potassium Chloride USP KCl 74.55 Magnesium Chloride Hexahydrate USP MgCl 2 •6H 2 O 203.30 Dibasic Sodium Phosphate Heptahydrate USP Na 2 HPO 4 •7H 2 O 268.07 Monobasic Potassium Phosphate NF KH 2 PO 4 136.09 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.
symbol Structural formula
HOW SUPPLIED
Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) is supplied sterile and nonpyrogenic in EXCEL ® Containers.
The 1000 mL containers are packaged 12 per case and the 500 mL containers are packaged 24 per case.
NDC REF Size Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) (Canada DIN 01931679) 0264-7707-00 L7070 1000 mL 0264-7707-10 L7071 500 mL Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat.
Protect from freezing.
It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
GERIATRIC USE
Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
See WARNINGS .
INDICATIONS AND USAGE
This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.
PEDIATRIC USE
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
PREGNANCY
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Isolyte ® S pH 7.4 (Multi-Electrolyte Injection).
It is also not known whether Isolyte ® S pH 7.4 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Isolyte ® S pH 7.4 should be given to a pregnant woman only if clearly needed.
NUSRING MOTHERS
Nursing Mothers Caution should be exercised when Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) is administered to a nursing woman.
DOSAGE AND ADMINISTRATION
This solution is for intravenous use only.
Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations.
Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.
Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.
Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) may be admixed with solutions which contain phosphate or which have been supplemented with phosphate.
The presence of magnesium and phosphate ions in this solution should be considered when phosphate is present in the additive solution, in order to avoid precipitation.
Some additives may be incompatible.
Consult with pharmacist.
When introducing additives, use aseptic techniques.
Mix thoroughly.
Do not store.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.