Potassium Chloride


Icu Medical Inc.
Human Prescription Drug
NDC 0990-7077
Potassium Chloride is a human prescription drug labeled by 'Icu Medical Inc.'. National Drug Code (NDC) number for Potassium Chloride is 0990-7077. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Potassium Chloride drug includes Potassium Chloride - 400 meq/1000mL . The currest status of Potassium Chloride drug is Active.

Drug Information:

Drug NDC: 0990-7077
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
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
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:POTASSIUM CHLORIDE - 400 meq/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: 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: 01 Apr, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 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: NDA020161
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:312507
1860239
1860241
1860463
1860466
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: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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
0990-7077-1424 POUCH in 1 CASE (0990-7077-14) / 1 BAG in 1 POUCH / 50 mL in 1 BAG01 Jun, 2019N/ANo
0990-7077-2624 POUCH in 1 CASE (0990-7077-26) / 1 BAG in 1 POUCH / 100 mL in 1 BAG31 Dec, 2019N/ANo
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 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

Drug Interactions:


Boxed Warning:

Highly concentrated

Indications and Usage:

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.

Warnings:

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 ro
ute 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.

Dosage and Administration:

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 admini
stered 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.

Contraindications:

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.

Adverse Reactions:

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 solu
tions 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.

Drug Interactions:


Use in Pregnancy:

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:

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.

Overdosage:

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.

Description:

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.

Clinical Pharmacology:

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.

Clinical Studies:


How Supplied:

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

Information for Patients:


Package Label Principal Display Panel:

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


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