Potassium Chloride In Lactated Ringers And Dextrose
Potassium Chloride, Sodium Chloride, Calcium Chloride, Sodium Lactate, And Dextrose Monohydrate
Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 65219-246Potassium Chloride In Lactated Ringers And Dextrose also known as Potassium Chloride, Sodium Chloride, Calcium Chloride, Sodium Lactate, And Dextrose Monohydrate is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Potassium Chloride In Lactated Ringers And Dextrose is 65219-246. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Potassium Chloride In Lactated Ringers And Dextrose drug includes Calcium Chloride - .2 g/1000mL Dextrose Monohydrate - 50 g/1000mL Potassium Chloride - 1.79 g/1000mL Sodium Chloride - 6 g/1000mL Sodium Lactate - 3.1 g/1000mL . The currest status of Potassium Chloride In Lactated Ringers And Dextrose drug is Active.
Drug Information:
| Drug NDC: | 65219-246 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Potassium Chloride In Lactated Ringers And Dextrose |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Potassium Chloride, Sodium Chloride, Calcium Chloride, Sodium Lactate, And Dextrose Monohydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Fresenius Kabi Usa, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CALCIUM CHLORIDE - .2 g/1000mL
DEXTROSE MONOHYDRATE - 50 g/1000mL
POTASSIUM CHLORIDE - 1.79 g/1000mL
SODIUM CHLORIDE - 6 g/1000mL
SODIUM LACTATE - 3.1 g/1000mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 03 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA211428 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Fresenius Kabi USA, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 847626
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | M4I0D6VV5M
LX22YL083G
660YQ98I10
451W47IQ8X
TU7HW0W0QT
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Blood Coagulation Factor [EPC]
Calcium [CS]
Cations
Divalent [CS]
Increased Coagulation Factor Activity [PE]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 65219-246-10 | 10 BAG in 1 CASE (65219-246-10) / 1000 mL in 1 BAG (65219-246-00) | 04 Nov, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Potassium chloride in lactated ringers and dextrose potassium chloride, sodium chloride, calcium chloride, sodium lactate, and dextrose monohydrate potassium chloride potassium cation chloride ion sodium chloride sodium cation chloride ion calcium chloride calcium cation chloride ion sodium lactate sodium cation lactic acid, unspecified form dextrose monohydrate anhydrous dextrose water
Drug Interactions:
Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. the presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .
Indications and Usage:
Indications and usage this solution is indicated in patients requiring parenteral administration of potassium chloride and the replacement of extracellular losses of fluids and electrolytes with minimal carbohydrate calories.
Warnings:
Warnings solutions containing calcium ions should not be administered simultaneously through the same administration set as blood because of the likelihood of coagulation. solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. to avoid potassium intoxication, do not infuse these solutions rapidly. in patients with severe renal insufficiency or adrenal insufficiency, administration of potassium chloride may cause potassium intoxication. solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. in patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. solutions containing lactate ions should be used
Read more...with great care in patients with metabolic or respiratory alkalosis. the administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in severe hepatic insufficiency. the intravenous administration of this solution can cause fluid and/or solute overloading 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 of administered parenteral solutions. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
Dosage and Administration:
Dosage and administration this solution should be administered only by intravenous infusion and as directed by the physician. the dose and rate of injection are dependent upon the age, weight and clinical condition of the patient. if the serum potassium level is greater than 2.5 meq/liter, potassium should be given at a rate not to exceed 10 meq/hour in a concentration less than 30 meq/liter. somewhat faster rates and greater concentrations (usually up to 40 meq/liter) of potassium may be indicated in patients with more severe potassium deficiency. the total 24-hour dose should not generally exceed 200 meq of potassium. as reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additive
Read more...s, use aseptic technique, mix thoroughly and do not store. the presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .
Contraindications:
Contraindications solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. solutions containing lactate are not for use in the treatment of lactic acidosis.
Adverse Reactions:
Adverse reactions reactions which may occur because of the solutions or 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. 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. nausea, vomiting, abdominal pain and diarrhea have been reported with potassium therapy. the signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of p waves, spreading and slurring of the qrs complex with development of a biphasic curve and cardiac arrest. potassium-containing solutions are intrinsically i
Read more...rritating to tissues. therefore, extreme care should be taken to avoid perivascular infiltration. local tissue necrosis and subsequent sloughing may result if extravasation occurs. chemical phlebitis and venospasm have also been reported. should perivascular infiltration occur, i.v. administration at that site should be discontinued at once. local infiltration of the affected area with procaine hydrochloride, 1%, to which hyaluronidase may be added, will often reduce venospasm and dilute the potassium remaining in the tissues locally. local application of heat may also be helpful. 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.
Drug Interactions:
Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. the presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .
Use in Pregnancy:
Pregnancy. animal reproduction studies have not been conducted with dextrose, potassium chloride or lactated ringer's injection. it is also not known whether dextrose, potassium chloride or lactated ringer's injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. dextrose, potassium chloride or lactated ringer's injection should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use: the safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. in very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.
Overdosage:
Overdosage in the event of potassium overdosage, discontinue the infusion immediately and institute intensive corrective therapy to reduce serum potassium levels. see warnings and precautions .
Description:
Description intravenous solution with potassium chloride (i.v. solutions with kcl) is a sterile and nonpyrogenic solution in water for injection. this solution is for administration by intravenous infusion only. see table 1 below for summary of content and characteristics of this solution. table 1 composition (g/l) calculated osmolarity (mosmol/l) potassium chloride in lactated ringer's and 5% dextrose injection, usp meq potassium added size (ml) dextrose, hydrous potassium chloride sodium chloride sodium lactate, anhydrous calcium chloride dihydrate 20 meq 1000 50 1.79 6 3.1 0.2 563 ph approx. ionic concentrations (meq/l) approx. kcal/l calcium (ca++) sodium (na+) potassium (k+) chloride (cl-) lactate 4.9 (3.5 to 6.5) 2.7 130 24 129 28 179 may contain hcl for ph adjustment. the solution contains no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. when smaller doses are required the unused portion should be discarded. this solution is a parenteral fluid, nutrient and/or electrolyte replenisher. dextrose, usp is chemically designated d-glucose, monohydrate (c 6 h 12 o 6 ⢠h 2 o), a hexose sugar freely soluble in water. it has the following structural formula: potassium chloride, usp is chemically designated kcl, a white granular powder freely soluble in water. sodium chloride, usp is chemically designated nacl, a white crystalline powder freely soluble in water. calcium chloride, usp is chemically designated calcium chloride dihydrate (cacl 2 ⢠2h 2 o), white fragments or granules freely soluble in water. sodium lactate, usp is chemically designated monosodium lactate [ch 3 ch(oh)coona], a 50% aqueous solution miscible in water. it has the following structural formula: water for injection, usp is chemically designated h 2 0. the flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. exposure to temperatures above 25°c/77°f during transport and storage will lead to minor losses in the 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. dextrose structural formula calcium chloride structural formula
Clinical Pharmacology:
Clinical pharmacology when administered intravenously, this solution provides a source of water and electrolytes with carbohydrate calories. solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein- sparing action. dextrose injected parenterally undergoes oxidation to carbon dioxide and water. calcium chloride in water dissociates to provide calcium (ca ++ ) and chloride (cl - ) ions. they are normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%. sodium lactate provides sodium (na + ) and lactate (c 3 h 5 o - ) ions. the lactate anion is in equilibrium with pyruvate and has an alkalizing effect resulting from simult
Read more...aneous removal by the liver of lactate and hydrogen ions. in the liver, lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism. the sodium (na + ) ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). the normal plasma level of lactate ranges from 0.9 to 1.9 meqk/liter. intravenous solutions containing potassium chloride are particularly intended to provide needed potassium cation (k + ). potassium is the chief cation of body cells (160 meq/liter of intracellular water). it is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 meq/liter in a healthy adult). potassium plays an important role in electrolyte balance. 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. sodium chloride in water dissociates to provide sodium (na + ) and chloride (cl - ) ions. sodium (na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. chloride (cl - ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. the distribution and excretion of sodium (na + ) and chloride (cl - ) are largely under the control of the kidney which maintains a balance between intake and output. water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). water balance is maintained by various regulatory mechanisms. water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (na+) plays a major role in maintaining physiologic equilibrium.
How Supplied:
How supplied potassium chloride (20 meq added) in lactated ringer's and 5% dextrose injection, usp is supplied in single-dose free flex ® plastic containers as follows: product code unit of use unit of sale 360236 ndc 65219-246-00 one 1000 ml free flex ® bag ndc 65219-246-10 package of 10 free flex ® bags store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] avoid excessive heat. protect from freezing. the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile.
Package Label Principal Display Panel:
Package label - principal display âpotassium chloride in lactated ringer's and 5% dextrose bag label 20meq potassium added 1000 ml ndc 65219 -246- 00 free flex ® 20 meq potassium chloride in lactated ringer's and 5% dextrose injection, usp rx only package label - principal display âpotassium chloride in lactated ringer's and 5% dextrose bag label
Package label - principal display âpotassium chloride in lactated ringer's and 5% dextrose case label ndc 65219-246-10 360236 20 meq potassium chloride in lactated ringer's and 5% dextrose injection, usp 1000 ml x 10 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. avoid excessive heat. protect from freezing. package label - principal display âpotassium chloride in lactated ringer's and 5% dextrose case label