Isolyte P in Dextrose
ISOLYTE P IN DEXTROSE- dextrose monohydrate, sodium acetate, potassium chloride, magnesium chloride and potassium phosphate, dibasic injection, solution
B. Braun Medical Inc.
Each 100 mL of Isolyte® P (Multi-Electrolyte Injection) in 5% Dextrose contains:
Hydrous Dextrose USP 5 g; Sodium Acetate Trihydrate USP 0.32 g
Potassium Chloride USP 0.13 g; Magnesium Chloride Hexahydrate USP 0.031 g
Dibasic Potassium Phosphate USP 0.026 g; Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.0 (4.0–6.0) Calories per liter: 170
Calculated Osmolarity: 340 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 23; Chloride 29Acetate (CH3 COO–) 23; Potassium 20; Magnesium 3; 1Phosphate (HPO) 3
Isolyte® P in 5% Dextrose is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents or added buffers. This product is intended for intravenous administration.
The formulas of the active ingredients are:
|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|
|Dibasic Potassium Phosphate USP||K2 HPO4||174.18|
|Hydrous Dextrose USP||198.17|
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. The solution contact layer is a rubberized copolymer of ethylene and propylene. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. 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. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
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 site. Refer to the Directions for Use of the container.
- 1.5 mmole P/liter
Isolyte® P in 5% Dextrose provides electrolytes and calories, 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.
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.
Acetate is an organic ion which is a hydrogen ion acceptor and contributes bicarbonate during its metabolism to carbon dioxide and water, and in sufficient quantities may serve as an alkalinizing agent.
Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.
INDICATIONS AND USAGE
This solution is indicated for use in adults as a source of electrolytes, calories and water for hydration, and as an alkalinizing agent.
Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
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.
Infuse solutions containing phosphate slowly to avoid phosphate intoxication. Infusing high concentrations of phosphate may cause hypocalcemia and tetany. Serum phosphorus and calcium levels should be monitored frequently.
Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate should be done with great care in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.
This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, 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.
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.
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.
Solutions containing potassium or magnesium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease.
Solutions containing acetate should be used with caution. Excess administration may result in metabolic alkalosis.
Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.
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.
Use only if solution is clear and container and seals are intact.
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