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| Product NDC Code | 63323-965 | ||||||||
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| Drug Name | Potassium chloride |
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| Type | Generic | ||||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC] |
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| Active Ingredients |
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| Route | INTRAVENOUS | ||||||||
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE | ||||||||
| RxCUI drug identifier | 204520, 1860132, 1860136, 1860139 |
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| Application Number | ANDA088901 | ||||||||
| Labeler Name | Fresenius Kabi USA, LLC | ||||||||
| Packages |
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Overdosage of POTASSIUM CHLORIDE
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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/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.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS: 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. 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, hypervolemia, and hyperkalemia. Too rapid infusion of hypertonic solutions may cause local pain and, rarely, vein irritation. Rate of administration should be adjusted according to tolerance. 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 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY: Potassium is the chief cation of body cells (160 mEq/L of intracellular water) and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium participates in carbohydrate utilization and 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 balance 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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS: Potassium Chloride for Injection Concentrate 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.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION: Potassium Chloride for Injection Concentrate, USP is a sterile, nonpyrogenic concentrated solution of Potassium Chloride, USP in Water for Injection to be administered by intravenous infusion only after dilution in a larger volume of fluid. Each mL of Potassium Chloride for Injection Concentrate contains 2 mEq of K + and Cl – equivalent to 149 mg of potassium chloride and has an osmolarity of 4000 mOsmol/L (calc). A more concentrated Potassium Chloride for Injection Concentrate is also available. Each mL of this injection contains 3 mEq of K + and Cl – equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mOsmol/L(calc). pH (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide. Some packages are intended for multiple dose use and contain preservatives (0.05% methylparaben and 0.005% propylparaben). A summary of the available products is presented in the HOW SUPPLIED section. Potassium Chloride for Injection Concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION: Potassium Chloride for Injection Concentrate must be diluted before administration. Care must be taken to ensure there is complete mixing of the potassium chloride with the large volume fluid, particularly if soft or bag type containers are used. The dose and rate of administration are dependent upon the specific condition of each patient. If the serum potassium level is greater than 2.5 mEq/L, potassium can be given at a rate not to exceed 10 mEq/hour and in a concentration of up to 40 mEq/L. The 24 hour total dose should not exceed 200 mEq. If urgent treatment is indicated (serum potassium level less than 2 mEq/L and electrocardiographic changes and/or muscle paralysis), potassium chloride may be infused very cautiously at a rate of up to 40 mEq/hour. In such cases, continuous cardiac monitoring is essential. As much as 400 mEq may be administered in a 24 hour period. In critical conditions, potassium chloride may be administered in saline (unless contraindicated) rather than in dextrose containing fluids, as dextrose may lower serum potassium levels. Prior to entering a vial, cleanse the rubber closure with a suitable antiseptic agent. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE: Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
Spl product data elements
Usually a list of ingredients in a drug product.Potassium Chloride POTASSIUM CHLORIDE POTASSIUM CHLORIDE POTASSIUM CATION HYDROCHLORIC ACID POTASSIUM HYDROXIDE WATER Potassium Chloride POTASSIUM CHLORIDE POTASSIUM CHLORIDE POTASSIUM CATION METHYLPARABEN PROPYLPARABEN HYDROCHLORIC ACID POTASSIUM HYDROXIDE WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 5 mL Single Dose Vial Label NDC 63323-965-01 96505 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 10 mEq per 5 mL (2 mEq per mL) 5 mL Single Dose Vial Rx only 5mlvial
PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 5 mL Single Dose Vial Tray Label NDC 63323-965-05 96505 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 10 mEq per 5 mL (2 mEq per mL) Rx only 25 x 5 mL Single Dose Vials 5mltray
PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Single Dose Vial Label NDC 63323-965-03 96510 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 20 mEq per 10 mL (2 mEq per mL) 10 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Single Dose Vial Label
PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Tray Label NDC 63323-965-10 96510 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 20 mEq per 10 mL (2 mEq per mL) 25 x 10 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 10 mL Tray Label
PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Single Dose Vial Label NDC 63323-965-02 96520 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 40 mEq per 20 mL (2 mEq per mL) 20 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Single Dose Vial Label
PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Tray Label NDC 63323-965-20 96520 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 40 mEq per 20 mL (2 mEq per mL) 25 x 20 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 20 mL Tray Label
PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 30 mL Multiple Dose Vial Label NDC 63323-967-01 96730 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 60 mEq per 30 mL (2 mEq per mL) 30 mL Multiple Dose Vial Rx only 30mlvial
PACKAGE LABEL - PRINCIPAL DISPLAY - Potassium Chloride 30 mL Multiple Dose Vial Tray Label NDC 63323-967-30 96730 POTASSIUM CHLORIDE For Injection Concentrate, USP Concentrate Must Be Diluted Before Use 60 mEq per 30 mL (2 mEq per mL) Rx only 25 x 30 mL Multiple Dose Vials 30mltray
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx only Concentrate Must Be Diluted Before Use FOR INTRAVENOUS INFUSION ONLY MUST BE DILUTED PRIOR TO INJECTION
Lake Zurich, IL 60047 www.fresenius-kabi.com/us 45767H Revised: February 2023 fklogo
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED: The following are packaged in plastic vials. Product Code Unit of Sale Total Potassium Ion Potassium Chloride per mL Each 96505 NDC 63323-965-05 Unit of 25 10 mEq (0.39 g) 149 mg NDC 63323-965-01 5 mL in a 10 mL Single Dose Vial 96510 NDC 63323-965-10 Unit of 25 20 mEq (0.78 g) 149 mg NDC 63323-965-03 10 mL Single Dose Vial 96520 NDC 63323-965-20 Unit of 25 40 mEq (1.56 g) 149 mg NDC 63323-965-02 20 mL Single Dose Vial These are Single Dose Vials, no preservative added, packaged 25 vials per tray. Unused portion of vial should be discarded. Product Code Unit of Sale Total Potassium Ion Potassium Chloride per mL Each 96730 NDC 63323-967-30 Unit of 25 60 mEq (2.35 g) 149 mg NDC 63323-967-01 30 mL Multiple Dose Vial This is a Multiple Dose Vial, preserved with 0.05% methylparaben and 0.005% propylparaben, packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Use only if solution is clear, seal intact and undamaged. Vial stoppers do not contain natural rubber latex.
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| 96505 | NDC 63323-965-05 Unit of 25 | 10 mEq (0.39 g) | 149 mg | NDC 63323-965-01 5 mL in a 10 mL Single Dose Vial |
| 96510 | NDC 63323-965-10 Unit of 25 | 20 mEq (0.78 g) | 149 mg | NDC 63323-965-03 10 mL Single Dose Vial |
| 96520 | NDC 63323-965-20 Unit of 25 | 40 mEq (1.56 g) | 149 mg | NDC 63323-965-02 20 mL Single Dose Vial |
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| 96730 | NDC 63323-967-30 Unit of 25 | 60 mEq (2.35 g) | 149 mg | NDC 63323-967-01 30 mL Multiple Dose Vial |
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS: General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. Pregnancy Teratogenic Effects: Pregnancy Category C — Animal reproduction studies have not been conducted with potassium chloride. It is also not known whether potassium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride should be given to a pregnant woman only if clearly needed.
General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.
Pregnancy Teratogenic Effects: Pregnancy Category C — Animal reproduction studies have not been conducted with potassium chloride. It is also not known whether potassium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride should be given to a pregnant woman only if clearly needed.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS: Potentially Fatal Cardiac Adverse Reactions with Undiluted Intravenous Administration Direct patient injection of potassium chloride at this concentration may be instantaneously fatal. Potassium Chloride for Injection Concentrate must be diluted before administration. Fatal cardiac arrhythmia and cardiac arrest have occurred when potassium chloride was administered in an undiluted form. To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with renal insufficiency, administration of potassium chloride may cause potassium intoxication and life-threatening hyperkalemia. The administration of intravenous solutions can cause fluid and/or solute overload 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. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API