Potassium Chloride


Henry Schein, Inc.
Human Prescription Drug
NDC 0404-9936
Potassium Chloride is a human prescription drug labeled by 'Henry Schein, Inc.'. National Drug Code (NDC) number for Potassium Chloride is 0404-9936. This drug is available in dosage form of Injection, Solution, Concentrate. The names of the active, medicinal ingredients in Potassium Chloride drug includes Potassium Chloride - 2 meq/mL . The currest status of Potassium Chloride drug is Active.

Drug Information:

Drug NDC: 0404-9936
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: Henry Schein, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution, Concentrate
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 - 2 meq/mL
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: 13 Jan, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 20 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: ANDA088901
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:Henry Schein, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1860132
1860139
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.
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
0404-9936-101 VIAL, SINGLE-DOSE in 1 BAG (0404-9936-10) / 5 mL in 1 VIAL, SINGLE-DOSE13 Jan, 2022N/ANo
0404-9936-201 VIAL, SINGLE-DOSE in 1 BAG (0404-9936-20) / 20 mL in 1 VIAL, SINGLE-DOSE13 Jan, 2022N/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 potassium hydroxide

Indications and Usage:

Indications and usage potassium chloride for injection concentrate, usp is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.

Warnings:

Warnings warning: 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. 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 elec
trolyte 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 potassium chloride for injection concentrate 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 of 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/l, potassium can be given at a rate not to exceed 10 meq/hour and in a concentration of up to 40 meq/l. the 24 hour total dose should not exceed 200 meq. if urgent treatment is indicated (serum potassium level less than 2meq/l and 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 contraindic
ated) rather than in dextrose containing fluids, as a dextrose may lower serum potassium levels. prior to entering a vial, cleanse the rubber closure with a suitable antiseptic agent. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Contraindications:

Contraindications potassium chloride for injection concentrate 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 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 phelbitis 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 or neuromuscular function, and intestinal ileus and dilatation. if an adverse reaction does occur, discontinue the infusion, evaluat
e the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Overdosage:

Overdosage in the event of fluid overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment. in the even 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, 300 to 500 ml/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.

Description:

Description concentrate must be diluted before use for intravenous infusion only must be diluted prior to injection potassium chloride for injection concentrate, usp is a sterile, nonpyrogenic concentrated solution of potassium chloride, sup in water for injection to be administered by intravenous infusion only after dilution in a larger volume of fluid. each ml of potassium chloride for injection concentrate contains 2 meq of k+ and cl-equivalent to 149 mg of potassium chloride and has an osmalarity of 4000 mosmol/l (calc). a more concentrated potassium chloride for injection concentrate is also available. each ml of this injection contains 3 meq of k+ and cl- equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mosmol/l (calc). ph (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide. some packages are intended for multiple dose use and contain preservatives (0,05% methylparaben and 0.005% propylparaben). a summary of the available products is presented in the how supplied section. potassium chloride for injection concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher.

Clinical Pharmacology:

Clinical pharmacology potassium is the chief cation of body cells (160 meq/l) of intracellular water) and is concenrtned 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 80-90% 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.

How Supplied:

How supplied the following are packaged in plastic vials. these are single dose vials, no preservative added, packaged 25 vials per tray. unused portion of vial should be discarded. this is a multiple dose vial, preserved with 0.05% methylparaben and 0.005% propylparaben, packaged 25 vials per tray. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. use only if solution is clear, seal intact and undamaged. vial stoppers do not contain natural rubber latex. product repackaged by: henry schein, inc., bastian, va 24314 from original manufacturer/distributor's ndc and unit of sale to henry schein repackaged product ndc and unit of sale total strength/total volume (concentration) per unit ndc 63323-965-05 unit of 25 ndc 0404-9936-10 1 5 ml in a 10 ml single dose vial in a bag (vial bears ndc 63323-965-01) 10 meq (0.39 g) 149 mg per ml ndc 63323-965-20 unit of 25 ndc 0404-9936-20 1 20 ml single dose vial in a bag (vial bears ndc 63323-965-02) 40 meq (1.56 g
) 149 mg per ml fresenius kabi lake zurich, il 60047 www.fresenius-kabi.com/us 45767g revised: september 2018 image1.jpg image2.jpg

Package Label Principal Display Panel:

Sample package label label1.jpg label2.jpg


Comments/ Reviews:

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