DailyMed Label: Isolyte S pH 7.4

DailyMed Label: Isolyte S pH 7.4

2023

DailyMed Prescription

Isolyte S pH 7.4

SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE

B. Braun Medical Inc.

NDC: 0264-7707

NDC: 0264-7707

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

This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.

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.

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 (see WARNINGS and PRECAUTIONS ).

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. 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 when accompanied by renal disease. 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. 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. 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. Long term animal studies with Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) have not been performed to evaluate the carcinogenic potential, mutagenic potential, or effects on fertility. 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. As reported in the literature, electrolyte solutions have been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus. Caution should be exercised when Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established. 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 .

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.

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.

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.

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.

Isolyte ® S pH 7.4 (Multi-Electrolyte Injection) REF L7070 NDC 0264-7707-00 DIN 01931679 HK 22410 1000 mL EXCEL ® CONTAINER Electrolytes (mEq/liter): Na + 141 K + 5 Mg ++ 3 Cl – 98 Acetate 27 Phosphate (HPO ) 1 (0.5 mmole P/L) Gluconate 23 Each 100 mL contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g; Sodium Acetate•3H 2 O USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride•6H 2 O USP 0.03 g; Dibasic Sodium Phosphate•7H 2 O 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);  Calc. Osmolarity: 295 mOsmol/liter Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL and Isolyte are registered trademarks of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-323 LD-149-4 EXP LOT Figure Recycle symbol 1000 mL container label L7070