Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/305
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Isolyte S (Injection)
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| dailymed-instance:dosage |
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.
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| dailymed-instance:descripti... |
Each 100 mL of Isolyte S pH 7.4 (Multi-Electrolyte Injection) contains:Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 gSodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 gMagnesium Chloride Hexahydrate USP 0.03 gDibasic Sodium Phosphate Heptahydrate USP 0.012 gMonobasic Potassium Phosphate NF 0.00082 g; Water for Injection USP qspH may be adjusted with Glacial Acetic Acid USP or Sodium Hydroxide NFpH: 7.4 (7.0���7.8) Calculated Osmolarity: 295 mOsmol/literConcentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5Magnesium 3; Chloride 98;Phosphate (HPO) 1; Acetate (CHCOO) 27 Gluconate (HOCH(CHOH)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: 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 thephysical 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.
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| dailymed-instance:clinicalP... |
Isolyte S pH 7.4 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. Phosphate is a major intracellular anion which participates in providing energy for metabolism of substrates and contributes to significant metabolic and enzymatic reactions in almost all organs and tissues. It exerts a modifying influence on calcium levels, a buffering effect on acid-base equilibrium and has a primary role in the renal excretion of hydrogen ions. 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, and serve as alkalinizing agents.
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Contraindications: None known. Accurate clinical and laboratory estimation of fluid and electrolyte balance in order to access benefit/risk ratio are essential prior to administration of this solution .
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| dailymed-instance:supply |
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. 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.
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| dailymed-instance:overdosag... |
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: Over-aggressive phosphate replacement may precipitate hypocalcemic tetany. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration.
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| dailymed-instance:genericMe... |
Sodium Chloride, Sodium Gluconate, Sodium Acetate Trihydrate, Potassium Chloride, Magnesium Chloride Hexahydrate, Dibasic Sodium Phosphate Heptahydrate, and Monobasic Potassium Phosphate
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| dailymed-instance:fullName |
Isolyte S (Injection)
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| dailymed-instance:adverseRe... |
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability. Abnormally high plasma levels of magnesium can result in flushing, sweating, hypotension, circulatory collapse, and depression of cardiac and central nervous system function. Respiratory depression is the most immediate threat to life. Magnesium deficits can result in tachycardia, hypertension, hyperirritability and psychotic behavior. The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
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| dailymed-instance:indicatio... |
This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.
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Isolyte S
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