Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP is supplied in single-dose free flex ® plastic containers as follows: Product Code Unit of Use Strength Unit of Sale 245075 NDC 65219-150-00 One 500 mL free flex ® bag 10 mEq Potassium Chloride NDC 65219-150-75 Package of 20 free flex ® bags 224210 NDC 65219-142-02 One 1000 mL free flex ® bag 10 mEq Potassium Chloride NDC 65219-142-10 Package of 10 free flex ® bags 244410 NDC 65219-144-04 One 1000 mL free flex ® bag 20 mEq Potassium Chloride NDC 65219-144-10 Package of 10 free flex ® bags 244610 NDC 65219-146-06 One 1000 mL free flex ® bag 30 mEq Potassium Chloride NDC 65219-146-10 Package of 10 free flex ® bags 244810 NDC 65219-148-08 One 1000 mL free flex ® bag 40 mEq Potassium Chloride NDC 65219-148-10 Package of 10 free flex ® bags Avoid excessive heat. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.; PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 10 mEq POTASSIUM 1000 mL NDC 65219- 142 -02 free flex ® 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-142-10 224210 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 20 mEq POTASSIUM 1000 mL NDC 65219- 144 -04 free flex ® 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-144-10 244410 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 30 mEq POTASSIUM 1000 mL NDC 65219- 146 -06 free flex ® 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-146-10 244610 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 40 mEq POTASSIUM 1000 mL NDC 65219- 148 -08 free flex ® 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-148-10 244810 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL Bag Label 10 mEq POTASSIUM 500 mL NDC 65219- 150 -00 free flex ® 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL Bag Label; PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-150-75 245075 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL x 20 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label
- HOW SUPPLIED Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP is supplied in single-dose free flex ® plastic containers as follows: Product Code Unit of Use Strength Unit of Sale 245075 NDC 65219-150-00 One 500 mL free flex ® bag 10 mEq Potassium Chloride NDC 65219-150-75 Package of 20 free flex ® bags 224210 NDC 65219-142-02 One 1000 mL free flex ® bag 10 mEq Potassium Chloride NDC 65219-142-10 Package of 10 free flex ® bags 244410 NDC 65219-144-04 One 1000 mL free flex ® bag 20 mEq Potassium Chloride NDC 65219-144-10 Package of 10 free flex ® bags 244610 NDC 65219-146-06 One 1000 mL free flex ® bag 30 mEq Potassium Chloride NDC 65219-146-10 Package of 10 free flex ® bags 244810 NDC 65219-148-08 One 1000 mL free flex ® bag 40 mEq Potassium Chloride NDC 65219-148-10 Package of 10 free flex ® bags Avoid excessive heat. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
- PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 10 mEq POTASSIUM 1000 mL NDC 65219- 142 -02 free flex ® 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-142-10 224210 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 20 mEq POTASSIUM 1000 mL NDC 65219- 144 -04 free flex ® 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-144-10 244410 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 30 mEq POTASSIUM 1000 mL NDC 65219- 146 -06 free flex ® 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-146-10 244610 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 30 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label 40 mEq POTASSIUM 1000 mL NDC 65219- 148 -08 free flex ® 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-148-10 244810 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 1000 mL x 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 40 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL Bag Label 10 mEq POTASSIUM 500 mL NDC 65219- 150 -00 free flex ® 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq POTASSIUM CHLORIDE in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL Bag Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label NDC 65219-150-75 245075 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 500 mL x 20 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. PACKAGE LABEL - PRINCIPAL DISPLAY – 10 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Case Label
Overview
Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See table below for summary of content and characteristics of these solutions. Table 1 COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na + ) Potassium (K + ) Chloride (Cl - ) Approximate Kcal/L 10 mEq 500 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 10 mEq 1000 50 4.5 0.745 426 4.2 (3.5 to 6.5) 77 10 87 170 20 mEq 1000 50 4.5 1.49 447 4.2 (3.5 to 6.5) 77 20 97 170 30 mEq 1000 50 4.5 2.24 467 4.2 (3.5 to 6.5) 77 30 107 170 40 mEq 1000 50 4.5 2.98 487 4.2 (3.5 to 6.5) 77 40 117 170 May contain HCl for pH adjustment. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag) . Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. 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. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the 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. Figure
Indications & Usage
These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride.
Dosage & Administration
These solutions should be administered only by intravenous infusion and as directed by the physician. The dose and rate of injection are dependent upon the age, weight and clinical condition of the patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium should be given at a rate not to exceed 10 mEq/hour in a concentration less than 30 mEq/liter. Somewhat faster rates and greater concentrations (usually up to 40 mEq/liter) of potassium may be indicated in patients with more severe potassium deficiency. The total 24- hour dose should not generally exceed 200 mEq of potassium. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .
Warnings & Precautions
WARNINGS Solutions which contain 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. To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with severe renal insufficiency or adrenal insufficiency, administration of potassium chloride may cause potassium intoxication. 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 exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. The intravenous administration of these solutions can cause fluid and/or solute overloading 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 of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Contraindications
Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered.
Adverse Reactions
Reactions which may occur because of the solutions or 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. 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. Nausea, vomiting, abdominal pain and diarrhea have been reported with potassium therapy. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest. Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration. Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported. Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once. Local infiltration of the affected area with procaine hydrochloride, 1%, to which hyaluronidase may be added, will often reduce venospasm and dilute the potassium remaining in the tissues locally. Local application of heat may also be helpful. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.