Get your patient on Potassium Chloride - Potassium Chloride injection (Potassium Chloride)
Potassium Chloride - Potassium Chloride injection prescribing information
INDICATIONS AND USAGE
Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
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.
When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.
DOSAGE AND ADMINISTRATION
The dose and rate of administration are dependent upon the specific condition of each patient.
Administer intravenously only with a calibrated infusion device at a slow, controlled rate. Highest concentrations (400 mEq/L) should be exclusively administered via central intravenous route. Whenever possible, administration via a central route is recommended for all concentrations of Potassium Chloride Injection for thorough dilution by the blood stream and decreasing the risk of extravasation and to avoid pain and phlebitis associated with peripheral infusion (see WARNINGS ). Correct placement of the catheter should be verified before administration.
Recommended administration rates should not usually exceed 10 mEq per hour or 200 mEq for a 24 hour period if the serum potassium level is greater than 2.5 mEq per liter.
In urgent cases where the serum potassium level is less than 2.0 mEq per liter or where severe hypokalemia is a threat, (serum potassium level less than 2.0 mEq per liter and electrocardiographic changes and/or muscle paralysis), rates up to 40 mEq per hour or 400 mEq over a 24 hour period can be administered very carefully when guided by continuous monitoring of the EKG and frequent serum K + determinations to avoid hyperkalemia and cardiac arrest.
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Use of a final filter is recommended during administration of all parenteral solutions where possible.
Do not add supplementary medication.
CONTRAINDICATIONS
Potassium Chloride Injection is contraindicated in patients with:
- hyperkalemia
- known hypersensitivity to Potassium Chloride Injection
ADVERSE REACTIONS
The following adverse reactions associated with the use of Potassium Chloride Injection were identified in postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.
Immune system disorders : Hypersensitivity, as manifested by rash and angioedema
Metabolism and nutrition disorders : Hyperkalemia, hyponatremia
Cardiac disorders : Cardiac arrest•, asystole•, ventricular fibrillation•, bradycardia
•as a manifestation of rapid intravenous administration and/or of hyperkalemia
Respiratory, Thoracic, and Mediastinal Disorders : Dyspnea
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.
Nervous System Disorders : Hyponatremic encephalopathy
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.
Drug Interactions
Other Products that Cause Hyperkalemia
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 ). Avoid use of Potassium Chloride injection in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations.
Other Drugs that Increase the Risk of Hyponatremia
Administration of Potassium Chloride Injection in patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia (see WARNINGS ). Avoid use of Potassium Chloride Injection in patients receiving drugs that may increase the risk of hyponatremia, such as diuretics and antiepileptics. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids.
If use cannot be avoided, monitor serum sodium concentrations.
DESCRIPTION
This Potassium Chloride Injection, is a sterile, nonpyrogenic, highly concentrated, readyto-use, solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents.
• Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage. | |||||
| Potassium Chloride Injection mEq Potassium/ Container | Composition (g/L) Potassium Chloride, USP (KCl) | Osmolarity• (mOsmol/L) (calc) | pH | Ionic Concentration (mEq/L) | |
| Potassium | Chloride | ||||
| 10 mEq/100 mL | 7.45 | 200 | 5.8 (4.0 to 8.0) | 100 | 100 |
| 10 mEq/50 mL 20 mEq/100 mL | 14.9 | 400 | 5.8 (4.0 to 8.0) | 200 | 200 |
| 20 mEq/50 mL 40 mEq/100 mL | 29.8 | 799 | 5.8 (4.0 to 8.0) | 400 | 400 |
CLINICAL PHARMACOLOGY
Potassium is the major cation of body cells (160 mEq/liter of intracellular water) and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium participates in carbohydrate utilization, protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base of the body are reflected by changes in the chloride concentration.
Normally about 80 to 90% of the potassium intake is excreted in the urine, the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting, or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.
HOW SUPPLIED
Potassium Chloride Injection in flexible plastic containers is available as follows:
| NDC for each individual IV Bag | Potassium per container |
| 14789-109-16 | 10 mEq/100 mL |
| 14789-108-08 | 10 mEq/50 mL |
| 14789-108-16 | 20 mEq/100 mL |
| 14789-107-08 | 20 mEq/50 mL |
| 14789-107-16 | 40 mEq/100 mL |
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Manufactured in the UK
Manufactured for Nexus Pharmaceuticals, Inc., Lincolnshire, IL 60069 USA KCLPI01GBR02
Revised: 03/2023
NEXUS PHARMACEUTICALS