Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, And Potassium Phosphate, Dibasic

Description

DESCRIPTION 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 29 Acetate (CH 3 COO - ) 23; Potassium 20; Magnesium 3; 1.5 mmole P/liter Phosphate (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: Ingredients Molecular Formula Molecular Weight Sodium Acetate Trihydrate USP CH 3 COONa

What Is Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, And Potassium Phosphate, Dibasic Used For?

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.

Dosage and Administration

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. When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. 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.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS 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. Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended. (See DOSAGE AND ADMINISTRATION .) 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. 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. 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. 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.

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.

Contraindications

CONTRAINDICATIONS Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Pregnancy and Breastfeeding

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Isolyte® P in 5% Dextrose. It is also not known whether Isolyte® P in 5% Dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isolyte® P in 5% Dextrose should be given to a pregnant woman only if clearly needed.

Nursing Mothers Caution should be exercised when Isolyte® P in 5% Dextrose is administered to a nursing woman.

Overdosage

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.

How Supplied

HOW SUPPLIED Isolyte ® P (Multi-Electrolyte Injection) in 5% Dextrose is supplied sterile and nonpyrogenic in EXCEL® containers. The 500 mL containers are packaged 24 per case. NDC REF Size Isolyte® P in 5% Dextrose 0264-7730-10 L7301 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).