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| Product NDC Code | 14789-136 | ||||
|---|---|---|---|---|---|
| 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 | ||||
| RxCUI drug identifier | 1860136, 1860139 |
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| Application Number | ANDA217704 | ||||
| Labeler Name | Nexus Pharmaceuticals 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, re-evaluate 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, at a rate of 300 to 500 mL per 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 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. To report SUSPECTED ADVERSE REACTIONS, contact Lambda Therapeutics Limited at 1-855-642-2594 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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/liter 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 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, 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.
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 administered by intravenous infusion only after dilution in a larger volume of fluid. They are provided in the following variety of concentrations and sizes comprising a choice of single-dose containers, all designed to provide the commonly prescribed amounts of potassium chloride for single-dose infusion after dilution in suitable large volume parenterals. * May contain hydrochloric acid for pH adjustment. Additive Solution * (conc. & size) K+ mEq/mL KCl mg/mL mOsmol/mL (calc.) 20 mEq/10 mL 2 149 4 40 mEq/20 mL 2 149 4 The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for single-dose injection (after dilution). When smaller doses are required, discard the unused portion. The pH is 4.6 (4.0 to 8.0). Potassium Chloride for Injection Concentrate, USP (appropriately diluted) is a parenteral fluid and electrolyte replenisher. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.
| 20 mEq/10 mL | 2 | 149 | 4 |
| 40 mEq/20 mL | 2 | 149 | 4 |
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, USP 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/liter, potassium can be given at a rate not to exceed 10 mEq/hour in a concentration of up to 40 mEq/liter. The 24-hour total dose should not exceed 200 mEq. If urgent treatment is indicated (serum potassium level less than 2.0 mEq/liter with 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 vial, remove the metal seal and cleanse the rubber closure with a suitable antiseptic agent. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. TO PREVENT NEEDLE-STICK INJURIES, NEEDLES SHOULD NOT BE RECAPPED, PURPOSELY BENT, OR BROKEN BY HAND.
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 Potassium Chloride Potassium Chloride POTASSIUM CHLORIDE POTASSIUM CATION
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.Principal Display Panel – 10 mL Carton Label NDC 14789- 136 -05 Rx only Potassium Chloride For Injection Concentrate , USP 20 mEq/10mL (2 mEq/mL) CONCENTRATE MUST BE DILUTED BEFORE USE For Intravenous Use 25 x 10 mL Single-dose Vials NEXUS PHARMACEUTICALS Principal Display Panel – 10 mL Carton Label
Principal Display Panel – 10 mL Vial Label NDC 14789- 136 -07 Rx only Potassium Chloride For Injection Concentrate , USP 20 mEq/10mL (2 mEq/mL) CONCENTRATE MUST BE DILUTED BEFORE USE 10 mL Single-dose Vial For Intravenous Use. NEXUS PHARMACEUTICALS Principal Display Panel – 10 mL Vial Label
Principal Display Panel – 20 mL Carton Label NDC 14789- 137 -05 Rx only Potassium Chloride For Injection Concentrate , USP 40 mEq/20mL (2 mEq/mL) CONCENTRATE MUST BE DILUTED BEFORE USE For Intravenous Use 25 x 20 mL Single-dose Vials NEXUS PHARMACEUTICALS Principal Display Panel – 20 mL Carton Label
Principal Display Panel – 20 mL Vial Label NDC 14789- 137 -07 Rx only Potassium Chloride For Injection Concentrate , USP 40 mEq/20 mL (2 mEq/mL) CONCENTRATE MUST BE DILUTED BEFORE USE 20 mL Single-dose Vial For Intravenous Use. NEXUS PHARMACEUTICALS Principal Display Panel – 20 mL Vial Label
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
Potassium Chloride for Injection Concentrate , USP CONCENTRATE MUST BE DILUTED BEFORE USE.
FOR INTRAVENOUS INFUSION ONLY; MUST BE DILUTED PRIOR TO INJECTION .
Fliptop Vials
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects : 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.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects : 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.
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 Potassium Chloride for Injection Concentrate, USP, is supplied in single-dose containers as follows: Unit of Sale Concentration NDC 14789-136-05 Tray of 25 single-dose containers 20 mEq/10 mL (2 mEq/mL) NDC 14789-137-05 Tray of 25 single-dose containers 40 mEq/20 mL (2 mEq/mL) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Container closure was not made with natural rubber latex. Manufactured in the USA by: Nexus Pharmaceuticals, Inc. Lincolnshire KCVPI01R02 Revised: 3/2023
| 20 mEq/10 mL (2 mEq/mL) | |
| 40 mEq/20 mL (2 mEq/mL) |
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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.
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 : 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