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| Product NDC Code | 0990-7077 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | ||||||
| RxCUI drug identifier | 312507, 1860239, 1860241, 1860463, 1860466 |
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| Application Number | NDA020161 | ||||||
| Labeler Name | ICU Medical Inc. | ||||||
| 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 hyperkalemia, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels as necessary. The use of potassium containing foods or medications must also be eliminated. Treatment of mild to severe hyperkalemia with signs and symptoms of potassium intoxication 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 per hour. Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema. Hemodialysis and peritoneal dialysis. 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 Potassium intoxication with mild or severe hyperkalemia has been reported. The signs and symptoms of intoxication include paresthesia of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmia, heart block, electrographic abnormalities and cardiac arrest. EKG abnormalities serve as a clinical reflection of the seriousness of changes in serum potassium concentrations: peaked T waves and prolonged P-R intervals usually occur with modest elevations above the upper limit of normal potassium concentrations; P waves disappear, the QRS complex widens, and eventual asystole usually occurs with higher elevations. 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 and hypervolemia. Infusion of highly concentrated potassium chloride solutions may cause local pain and vein irritation. (See WARNINGS ). Reactions reported with the use of potassium-containing solutions include nausea, vomiting, and abdominal pain and diarrhea. 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 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.
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 Injection 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 This Potassium Chloride Injection is a sterile, nonpyrogenic, highly concentrated, ready-to-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. 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 *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage. This flexible plastic container is fabricated from a specially formulated polyvinylchloride. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain of its chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
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 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. Because pain associated with peripheral infusion of Potassium Chloride solution has been reported, whenever possible, administration via central route is recommended for thorough dilution by the blood stream and avoidance of extravasation. Highest concentrations (300 and 400 mEq/L) should be exclusively administered via central route. Recommended administration rates should not usually exceed 10 mEq/hour or 200 mEq for a 24-hour period if the serum potassium level is greater than 2.5 mEq/liter. In urgent cases where the serum potassium level is less than 2 mEq/liter or where severe hypokalemia is a threat (serum potassium level less than 2 mEq/liter and electrocardiographic changes and/or muscle paralysis), rates up to 40 mEq/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. Use of a final filter is recommended during administration of all parenteral solutions where possible. Do not add supplementary medication. Preparation for Administration (Use aseptic technique) Close flow control clamp of administration set. Remove cover from outlet port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber. Open flow control clamp and clear air from set. Close clamp. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. Regulate rate of administration with flow control clamp. WARNING: Do not use flexible container in series connections. Do not add supplementary medication. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
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 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.
Spl product data elements
Usually a list of ingredients in a drug product.Potassium Chloride POTASSIUM CHLORIDE POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION WATER Potassium Chloride POTASSIUM CHLORIDE POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION WATER Potassium Chloride POTASSIUM CHLORIDE POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION WATER
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.Laboratory Tests Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac or renal disease. 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.
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 - 100 mL Bag Label For Use Only With A Calibrated Infusion Device Highly Concentrated 100 mEq/L 100 mL NDC 0990-7074-26 POTASSIUM CHLORIDE Inj. 10 mEq EACH 100 mL CONTAINS POTASSIUM CHLORIDE 745 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: POTASSIUM 100 mEq; CHLORIDE 100 mEq. 200 mOsmol/LITER (CALC.) pH 5.8 (4.0 to 8.0) DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE. 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 IM-4339 PRINCIPAL DISPLAY PANEL - 100 mL Bag Label
PRINCIPAL DISPLAY PANEL - 100 mL Bag Pouch Label TO OPEN – TEAR AT NOTCH NDC 0990-7074-26 For use only with a calibrated infusion device. HIGHLY CONCENTRATED 100 mEq/L POTASSIUM CHLORIDE Inj. 10 mEq Total in 100 mL Each 100 mL contains potassium chloride 745 mg in water for injection. Electrolytes per 1000 mL: potassium 100 mEq; chloride 100 mEq. 200 mOsmol/liter (CALC.) pH 5.8 (4.0 to 8.0) DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE. Single-dose container. For I.V. use. Usual dosage: See insert. Sterile, nonpyrogenic. Use only if solution is clear. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Must not be used in series connections. The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Rx only 7 OTHER F WR-0529 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 100 mL Bag Pouch Label
PRINCIPAL DISPLAY PANEL - 50 mL Bag Label - IM-4340 For Use Only With A Calibrated Infusion Device Highly Concentrated 200 mEq/L 50 mL NDC 0990-7075-14 POTASSIUM CHLORIDE Inj. 10 mEq EACH 100 mL CONTAINS POTASSIUM CHLORIDE 1490 mg IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: POTASSIUM 200 mEq; CHLORIDE 200 mEq. 400 mOsmol/LITER (CALC.) pH 5.8 (4.0 to 8.0) DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE. SINGLE-DOSE CONTAINER. USUAL DOSAGE: SEE INSERT. FOR I.V. USE. 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 icumedical IM-4340 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 50 mL Bag Label - IM-4340
PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label - WR-0530 TO OPEN – TEAR AT NOTCH NDC 0990-7075-14 For use only with a calibrated infusion device. HIGHLY CONCENTRATED 200 mEq/L POTASSIUM CHLORIDE Inj. 10 mEq Total in 50 mL Each 100 mL contains potassium chloride 1490 mg in water for injection. Electrolytes per 1000 mL: potassium 200 mEq; chloride 200 mEq. 400 mOsmol/liter (CALC.) pH 5.8 (4.0 to 8.0) DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE. Single-dose container. For I.V. use. Usual dosage: See insert. Sterile, nonpyrogenic. Use only if solution is clear. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Must not be used in series connections. The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Rx only 7 OTHER F WR-0530 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label - WR-0530
PRINCIPAL DISPLAY PANEL - 50 mL Bag Label - IM-4342 For Use Only With A Calibrated Infusion Device Highly Concentrated 400 mEq/L 50 mL NDC 0990-7077-14 POTASSIUM CHLORIDE Inj. 20 mEq EACH 50 mL CONTAINS POTASSIUM CHLORIDE 1.49 g IN WATER FOR INJECTION. ELECTROLYTES PER 1000 mL: POTASSIUM 400 mEq; CHLORIDE 400 mEq. 799 mOsmol/LITER (CALC.) pH 5.8 (4.0 to 8.0) HYPERTONIC – MAY CAUSE VEIN DAMAGE. DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE. DISCONTINUE INFUSION IF ADVERSE REACTION OCCURS. 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 IM-4342 icumedical PRINCIPAL DISPLAY PANEL - 50 mL Bag Label - IM-4342
PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label - WR-0536 TO OPEN – TEAR AT NOTCH NDC 0990-7077-14 For use only with a calibrated infusion device. HIGHLY CONCENTRATED 20 mEq POTASSIUM CHLORIDE Inj. 400 mEq/L Total in 50 mL Each 50 mL contains potassium chloride 1.49 g in water for injection. Electrolytes per 1000 mL: potassium 400 mEq; chloride 400 mEq. 799 mOsmol/liter (CALC.) pH 5.8 (4.0 to 8.0) Hypertonic – may cause vein damage. DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL ROUTE. Discontinue infusion if adverse reaction occurs. Single-dose container. For I.V. use. Usual dosage: See insert. Sterile, nonpyrogenic. Use only if solution is clear. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. Must not be used in series connections. The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Rx only 7 OTHER F WR-0536 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label - WR-0536
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.For Use Only With A Calibrated Infusion Device
Flexible Plastic Container Ready To Use R x only
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use: These products should not be used in pediatric patients at this time. Do not administer unless solution is clear and seal is intact.
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: 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.
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 Injection in flexible plastic containers is available as follows: NDC No. Potassium per container 0409–7074–26 10 mEq/100 mL 0990-7074-26 10 mEq/100 mL 0409–7075–14 10 mEq/50 mL 0990-7075-14 10 mEq/50 mL 0409–7075–26 20 mEq/100 mL 0990-7075-26 20 mEq/100 mL 0409–7077–14 20 mEq/50 mL 0990-7077-14 20 mEq/50 mL 0409–7077–26 40 mEq/100 mL 0990-7077-26 40 mEq/100 mL ICU Medical is transitioning NDC codes from "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.] Revised: June, 2018 EN-4654 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
| 0990-7074-26 | 10 mEq/100 mL |
| 0990-7075-14 | 10 mEq/50 mL |
| 0990-7075-26 | 20 mEq/100 mL |
| 0990-7077-14 | 20 mEq/50 mL |
| 0990-7077-26 | 40 mEq/100 mL |
Boxed warning
Information about contraindications or serious warnings, particularly those that may lead to death or serious injury.Highly Concentrated
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Laboratory Tests Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac or renal disease. 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. Pregnancy: 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. Pediatric Use: These products should not be used in pediatric patients at this time. Do not administer unless solution is clear and seal is intact.
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 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. TO AVOID POTASSIUM INTOXICATION, DO NOT INFUSE THESE SOLUTIONS RAPIDLY. PATIENTS REQUIRING HIGHLY CONCENTRATED SOLUTIONS SHOULD BE KEPT ON CONTINUOUS CARDIAC MONITORING AND UNDERGO FREQUENT TESTING FOR SERUM POTASSIUM AND ACID-BASE BALANCE, ESPECIALLY IF THEY RECEIVE DIGITALIS. In patients with renal insufficiency, administration of potassium chloride may cause potassium intoxication and life-threatening hyperkalemia. Administer intravenously only with a calibrated infusion device at a slow, controlled rate. ( See DOSAGE AND ADMINISTRATION .) Because pain associated with peripheral infusion of Potassium Chloride solution has been reported, whenever possible administration via a central route is recommended for thorough dilution by the blood stream and avoidance of extravasation. Highest concentrations (300 and 400 mEq/L) should be exclusively administered via central route. 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.
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