Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Intravenous solutions with potassium chloride (I.V. solution with KCl) are supplied in single-dose flexible plastic containers. See Table: Potassium Chloride in 0.9% Sodium Chloride Inj., USP COMPOSITION Approx. Ionic Concentrations (g/L) Calculated (mEq/L) NDC No. mEq Potassium Size (mL) Sodium Chloride Potassium Chloride Osmolarity (mOsmol/L) pH (range) Sodium (Na + ) Potassium (K + ) Chloride (Cl¯) Approximate kcal/L 0409–7115–09 20 mEq 1000 9 1.49 348 4.8 (3.5 to 6.5) 154 20 174 0 0990–7115–09 20 mEq 1000 9 1.49 348 4.8 (3.5 to 6.5) 154 20 174 0 0409–7116–09 40 mEq 1000 9 2.98 388 4.8 (3.5 to 6.5) 154 40 194 0 0990–7116–09 40 mEq 1000 9 2.98 388 4.8 (3.5 to 6.5) 154 40 194 0 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: March, 2020 IFU0000168 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA; PRINCIPAL DISPLAY PANEL - 20 mEq Bag Label 20 mEq POTASSIUM 1000 mL NDC 0990-7115-09 20 mEq POTASSIUM CHLORIDE in 0.9% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 149 mg; SODIUM CHLORIDE 900 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: POTASSIUM 20 mEq; SODIUM 154 mEq; CHLORIDE; 174 mEq. 348 mOsmol/LITER (CALC.) pH 4.8 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical IMP0000049 PRINCIPAL DISPLAY PANEL - 20 mEq Bag Label; PRINCIPAL DISPLAY PANEL - 40 mEq Bag Label 40 mEq POTASSIUM 1000 mL NDC 0990-7116-09 40 mEq POTASSIUM CHLORIDE in 0.9% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 298 mg; SODIUM CHLORIDE 900 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: POTASSIUM 40 mEq; CHLORIDE 194 mEq; SODIUM 154 mEq. 388 mOsmol/LITER (CALC.) pH 4.8 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IMP0000050 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 40 mEq Bag Label; PRINCIPAL DISPLAY PANEL - 1000 mL Bag Pouch TO OPEN TEAR AT NOTCH DO NOT REMOVE FROM 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. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 2 HDPE PRINCIPAL DISPLAY PANEL - 1000 mL Bag Pouch
- HOW SUPPLIED Intravenous solutions with potassium chloride (I.V. solution with KCl) are supplied in single-dose flexible plastic containers. See Table: Potassium Chloride in 0.9% Sodium Chloride Inj., USP COMPOSITION Approx. Ionic Concentrations (g/L) Calculated (mEq/L) NDC No. mEq Potassium Size (mL) Sodium Chloride Potassium Chloride Osmolarity (mOsmol/L) pH (range) Sodium (Na + ) Potassium (K + ) Chloride (Cl¯) Approximate kcal/L 0409–7115–09 20 mEq 1000 9 1.49 348 4.8 (3.5 to 6.5) 154 20 174 0 0990–7115–09 20 mEq 1000 9 1.49 348 4.8 (3.5 to 6.5) 154 20 174 0 0409–7116–09 40 mEq 1000 9 2.98 388 4.8 (3.5 to 6.5) 154 40 194 0 0990–7116–09 40 mEq 1000 9 2.98 388 4.8 (3.5 to 6.5) 154 40 194 0 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: March, 2020 IFU0000168 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
- PRINCIPAL DISPLAY PANEL - 20 mEq Bag Label 20 mEq POTASSIUM 1000 mL NDC 0990-7115-09 20 mEq POTASSIUM CHLORIDE in 0.9% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 149 mg; SODIUM CHLORIDE 900 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: POTASSIUM 20 mEq; SODIUM 154 mEq; CHLORIDE; 174 mEq. 348 mOsmol/LITER (CALC.) pH 4.8 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical IMP0000049 PRINCIPAL DISPLAY PANEL - 20 mEq Bag Label
- PRINCIPAL DISPLAY PANEL - 40 mEq Bag Label 40 mEq POTASSIUM 1000 mL NDC 0990-7116-09 40 mEq POTASSIUM CHLORIDE in 0.9% Sodium Chloride Injection, USP EACH 100 mL CONTAINS POTASSIUM CHLORIDE 298 mg; SODIUM CHLORIDE 900 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: POTASSIUM 40 mEq; CHLORIDE 194 mEq; SODIUM 154 mEq. 388 mOsmol/LITER (CALC.) pH 4.8 (3.5 to 6.5) ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH PHARMACIST, IF AVAILABLE. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR I.V. USE. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 3 v CONTAINS DEHP IMP0000050 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 40 mEq Bag Label
- PRINCIPAL DISPLAY PANEL - 1000 mL Bag Pouch TO OPEN TEAR AT NOTCH DO NOT REMOVE FROM 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. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 2 HDPE PRINCIPAL DISPLAY PANEL - 1000 mL Bag Pouch
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 for summary of content and characteristics of these solutions. 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 and/or electrolyte replenishers. 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 0. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
Indications & Usage
These solutions are indicated in patients requiring parenteral administration of potassium chloride 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. 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.
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 .)
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