– NEVER USE BY IV OR IM OR SC INJECTION. Athenex has initiated temporary importation of another manufacturer's Potassium Chloride Injection Concentrate 2 mEq/mL into the U.S. market. (Galenica). Dilute the solution immediately after opening the container; the diluted solution must be used immediately. It is not known whether this drug is present in human milk. If you are in any doubt about the use of Potassium Chloride, ask your doctor or pharmacist. Revision date: 4/9/2019. CONTAINER EACH 100 mL CONTAINS Acute hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Potassium participates in carbohydrate utilization and protein synthesis and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. Review of the package leaflet by the Italian Medicines Agency: 20 February 2013, I N D U S T R I A - F A R M A C E U T I C A, Via Cassia Nord, 351 - 53014 MONTERONI D'ARBIA (SI) - ITALY 076068001-R00, PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – AMPULE LABEL, Concentrate for Solution, For Infusion, To Be Diluted, PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON, Other brands: Klor-Con, K-Dur, Slow-K, Klor-Con Sprinkle, ... +5 more, potassium chloride, Klor-Con, spironolactone, Aldactone, K-Dur. Highest concentrations (400 mEq/L) should be exclusively administered via central intravenous route. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=559a0a8c-a8fe-40a5-b196-21f9308780ab&audience=consumer. The concentrated version should be diluted before use. Ask your doctor or pharmacist for advice before taking any medicine. Use of a final filter is recommended during administration of all parenteral solutions where possible. Potassium Chloride for Injection Concentrate, USP is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Healthwise, Incorporated, disclaims any warranty or liability for your use of this information. Hypotension, arrhythmias, conduction disturbances, P wave disappearance, QRS widening in the ECG trace, cardiac arrest. The dose depends on the patient's age, weight and clinical condition, taking into account that the ordinary daily potassium requirement is as follows. Higher temperatures lead to greater losses. OVERWRAP AT ROOM TEMPERATURE (77°F or Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. A healthcare provider will give you this medicine by injection if you have severely low potassium levels. The following adverse reactions were reported in association with extravasation: Skin necrosis, skin ulcer, soft tissue necrosis, muscle necrosis, nerve injury, tendon injury, and vascular injury. WHENEVER POSSIBLE DO NOT ADD A healthcare provider will give you this medicine by injection if you have severely low potassium levels. Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. There is no barcode on the ampule or carton. Therefore, it is not known whether Potassium Chloride Injection can cause fetal harm when administered to a pregnant woman. Potassium Chloride Injection should be administered with extreme caution, if at all, to patients with conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with: Potassium Chloride Injection should be administered with caution to patients who are at risk of experiencing hyperosmolality, acidosis, or undergo correction of alkalosis (conditions associated with a shift of potassium from intracellular to extracellular space) and patients treated concurrently or recently with agents or products that can cause hyperkalemia (see PRECAUTIONS, Drug Interactions). THIS HIGHLY CONCENTRATED, READY-TO-USE Potassium Chloride Injection IS INTENDED FOR THE MAINTENANCE OF SERUM K. Administer intravenously only with a calibrated infusion device at a slow, controlled rate. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. medicine to prevent organ transplant rejection. 50 mL STERILE SINGLE DOSE CONTAINER The medicinal product shall not be injected as such. Learn about the foods to eat or avoid to help control your condition. Baxter, PL 146 and Viaflex are trademarks of Baxter International Inc. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Compliance with the instructions contained in the package leaflet reduces the risk of adverse effects. Adults: 40-80 mEq per day. mEq/L CHLORIDE 200 mEq/L HYPERTONIC Because many drugs are present in human milk, caution should be exercised when Potassium Chloride Injection is administered to a nursing mother. You may need to follow a special diet while using potassium chloride. Neuromuscular disorders, paraesthesia, flaccid paralysis, weakness, mental confusion. It is given by slow injection into a vein or by mouth. Potassium chloride oral is taken by mouth. If use cannot be avoided, monitor serum sodium concentrations. Administration of Potassium Chloride Injection in patients treated concurrently or recently with other products that can cause hyperkalemia or increase the risk of hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, cyclosporine and tacrolimus) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia (see WARNINGS). Under urgent conditions (potassium values less than or equal to 2 mEq/l with electrocardiographic changes and muscular paralysis) do not exceed the infusion rate of 40 mEq/h, under electrocardiographic monitoring and do not exceed the dose of 400 mEq in 24 hours. – For dilution: TEMPERATURE (77°F or 25°C) UNTIL READY TO To order or if you have questions about Galenica's KCl Injection 2 mEq/mL, 10 mL ampules, please contact Athenex's Customer Service by phone at 1-855-273-0154. This must be clear, colourless and free from visible particles. At this time, however, no other entity except Athenex Pharmaceutical Division, LLC is authorized by the FDA to import or distribute Galenica's Potassium Chloride Injection Concentrate 2 mEq/mL ampule. The adverse effects of Potassium Chloride are listed below. Copyright 1996-2020 Cerner Multum, Inc. However, fatal arrhythmias can develop at any time. Potassium Chloride Injection Description. Follow standard aseptic technique and withdraw contents of the ampule with a 5-micron filter needle. General disorders and administration site conditions: Chest pain, infusion site thrombosis, infusion site phlebitis, infusion site erythema, infusion site swelling, infusion site pain, infusion site irritation, and/or a burning sensation. Shake well during dilution preparation and before administration. Please refer to the package insert for the FDA-approved Potassium Chloride for Injection Concentrate, USP drug product for full prescribing information. The following adverse reactions associated with the use of Potassium Chloride Injection were identified in postmarketing reports. Measure liquid medicine carefully. Dosage Form: injection, solution, concentrate. See PRECAUTIONS for information on the avoidance of air embolism. SEE INSERT USE ONLY WITH A CALIBRATED Thomas J. Moutvic Reporting suspected adverse reactions after authorisation of the medicinal product is important. © Copyright 1995-2020 Regents of the University of Michigan, you have high levels of potassium in your blood (hyperkalemia); or. The medicine does not affect the ability to drive or use machines. You may report side effects to FDA at 1-800-FDA-1088. CHLORIDE pH 5 (4 TO 8) POTASSIUM 400 This is normal and will not make the medicine less effective. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. THIS HIGHLY CONCENTRATED, READY-TO-USE Potassium Chloride Injection IS INTENDED FOR THE MAINTENANCE OF SERUM K+ LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. Potassium chloride must always be administered by slow IV infusion, diluted in 0.9% sodium chloride. See Posology and method of administration. Potassium Chloride Injection Administration of Potassium Chloride Injection in patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia (see WARNINGS). Disorders of the water and electrolyte balance, General disorders and administration site conditions.