Potassium Chloride in Dextrose and Sodium Chloride

INDICATIONS AND USAGE These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories and water for hydration.

DOSAGE AND ADMINISTRATION These solutions are 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. Usually, up to 40 mEq of potassium per liter daily is sufficient to replace normal loss in adults. Typical infusion rates should not exceed 10 mEq per hour or 120 mEq per day. Pediatric patients may require 2 to 3 mEq per kg of body weight daily. See WARNINGS and PRECAUTIONS for pediatric use. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Dextrose may be administered to normal individuals at a rate of 0.5 g/kg/hour without producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95% of the dextrose is retained. Potassium Chloride in Dextrose and Sodium Chloride Injections USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. 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 These solutions are contraindicated where the administration of sodium, potassium or chloride could be clinically detrimental. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

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. The physician should also be alert to the possibility of adverse reaction 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.

DESCRIPTION (See chart below for quantitative information.) Potassium Chloride in Dextrose and Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Chloride USP Potassium Chloride USP NaCl KCl 58.44 74.55 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 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. Composition – Each 100 mL contains: Solution Hydrous Dextrose USP Sodium Chloride USP Potassium Chloride USP Concentration of Electrolytes (mEq/liter) Calories per liter Calculated Osmolarity mOsmol/liter pH Sodium Potassium Chloride Water for Injection USP qs 0.15% Potassium Chloride in 5% Dextrose and 0.20% Sodium Chloride Injection USP 5 g 0.2 g 0.15 g 34 20 54 170 360 4.4 (3.5–6.5) 0.075% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.075 g 77 10 87 170 425 4.4 (3.5–6.5) 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.15 g 77 20 97 170 445 4.4 (3.5–6.5) 0.22% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.22 g 77 30 107 170 465 4.4 (3.5–6.5) 0.30% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.3 g 77 40 117 170 490 4.4 (3.5–6.5) 0.15% Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP 5 g 0.9 g 0.15 g 154 20 174 170 600 4.4 (3.5–6.5) 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. Chemical Structure

OVERDOSAGE In the event of fluid 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.

HOW SUPPLIED Potassium Chloride in Dextrose and Sodium Chloride Injections USP are supplied in EXCEL ® Containers. The 1000 mL containers are packaged 12 per case. Canada DIN NDC REF Size 0.15% Potassium Chloride in 5% Dextrose and 0.20% Sodium Chloride Injection USP (20 mEq K + /liter) 01931598 0264-7645-00 L6450 1000 mL 0.075% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (10 mEq K + /liter) 0264-7634-00 L6340 1000 mL 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (20 mEq K + /liter) 01931547 0264-7635-00 L6350 1000 mL 0.22% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (30 mEq K + /liter) 0264-7636-00 L6360 1000 mL 0.30% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP (40 mEq K + /liter) 01931571 0264-7638-00 L6380 1000 mL 0.15% Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection USP (20 mEq K + /liter) 01931644 0264-7652-00 L6520 1000 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).