Potassium Chloride In Dextrose
Dextrose Monohydrate And Potassium Chloride Injection, Solution
Icu Medical Inc.
Human Prescription Drug
NDC 0990-7905Potassium Chloride In Dextrose also known as Dextrose Monohydrate And Potassium Chloride Injection, Solution is a human prescription drug labeled by 'Icu Medical Inc.'. National Drug Code (NDC) number for Potassium Chloride In Dextrose is 0990-7905. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Potassium Chloride In Dextrose drug includes Dextrose Monohydrate - 5 g/100mL Potassium Chloride - .149 g/100mL . The currest status of Potassium Chloride In Dextrose drug is Active.
Drug Information:
| Drug NDC: | 0990-7905 |
| 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 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: | Dextrose Monohydrate And Potassium Chloride Injection, Solution |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Icu Medical Inc. |
| 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: | DEXTROSE MONOHYDRATE - 5 g/100mL
POTASSIUM CHLORIDE - .149 g/100mL
|
| 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: | NDA |
| 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: | 20 Nov, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jun, 2026 |
| 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: | NDA018371 |
| 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: | ICU Medical Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309783
|
| 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: | LX22YL083G
660YQ98I10
|
| 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: | 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 |
|---|
| 0990-7905-09 | 12 POUCH in 1 CASE (0990-7905-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG | 20 Nov, 2020 | 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 dextrose dextrose monohydrate and potassium chloride injection, solution dextrose monohydrate anhydrous dextrose potassium chloride potassium cation chloride ion water hydrochloric acid
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.
Indications and Usage:
Indications and usage this solution is indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories.
Warnings:
Warnings 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. in patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. 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 ele
Read more...ctrolyte 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. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administr
Read more...ation, whenever solution and container permit. see precautions . drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store.
Contraindications:
Contraindications solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered.
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.
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.
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with dextrose or potassium chloride. it is also not known whether dextrose or potassium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. dextrose or potassium chloride 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 potassium chloride in dextrose injection, usp is a sterile and nonpyrogenic solution in water for injection. this solution is for administration by intravenous infusion only. see table for summary of content and characteristics of this solution. this solution contains no bacteriostat, antimicrobial agent or added buffer and 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 electrolyte replenisher. dextrose, usp is chemically designated d-glucose monohydrate (c 6 h 12 o 6 â 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. water for injection, usp is chemically designated h 2 o. the flexible plastic container is fabricated from a specially formulated polyvinyl chloride. 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 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. chemical structure
Clinical Pharmacology:
Clinical pharmacology when administered intravenously, this solution provides a source of water and potassium chloride with carbohydrate. 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. 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 po
Read more...tassium 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. 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 in dextrose injection, usp solution is supplied in single-dose flexible plastic containers. see table : table of contents and characteristics grams/100 ml per 1000 ml meq potassium size (ml) ndc no. dextrose hydrous potassium chloride potassium (k+) chloride (cl¯) caloric value calculated osmolarity (mosmol) tonicity ph 20 meq 1000 0409â7905â09 5 0.149 20 meq 20 meq 170 292 isotonic 4.3 (3.5 to 6.5) 20 meq 1000 0990â7905â09 5 0.149 20 meq 20 meq 170 292 isotonic 4.3 (3.5 to 6.5) icu medical is transitioning ndc codes from the "0409" to "0990" labeler code. both ndc codes are expected to be in the market for a period of time. may contain hcl for ph adjustment. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] protect from freezing.
Package Label Principal Display Panel:
Principal display panel - 1000 ml bag label 20 meq potassium 1000 ml ndc 0990-7905-09 20 meq potassium chloride in 5% dextrose inj., usp each 100 ml contains potassium chloride 149 mg; dextrose, hydrous 5 g in water for injection. may contain hcl for ph adjustment. electrolytes per 1000 ml (not including ions for ph adjustment): potassium 20 meq; chloride 20 meq. 292 mosmol/liter (calc). ph 4.3 (3.5 to 6.5) additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. 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 imp0000051 icu medical, inc., lake forest, illinois, 60045, usa icumedical principal display panel - 1000 ml bag label