Potassium Chloride


B. Braun Medical Inc.
Human Prescription Drug
NDC 0264-1940
Potassium Chloride is a human prescription drug labeled by 'B. Braun Medical Inc.'. National Drug Code (NDC) number for Potassium Chloride is 0264-1940. 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 - 14.9 g/100mL . The currest status of Potassium Chloride drug is Active.

Drug Information:

Drug NDC: 0264-1940
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: B. Braun Medical 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 - 14.9 g/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:PARENTERAL
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: 21 Mar, 1978
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 14 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: ANDA085870
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:B. Braun Medical Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:204520
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
0264-1940-2012 CONTAINER in 1 CASE (0264-1940-20) / 250 mL in 1 CONTAINER21 Mar, 1978N/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

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. this is a concentrated solution which is intended for use in a pharmacy admixture service and is restricted to the preparation of admixtures for intravenous infusion.

Warnings:

Warnings strongly hypertonic solution. must be properly diluted and thoroughly mixed before injection. 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. this concentrated solution of potassium chloride is for use in intravenous admixtures only and must not be used undiluted for direct patient injection. direct patient injection of potassium chloride at this concentration may be instantaneou
sly fatal. 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. 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. in patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention.

General Precautions:

General 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. potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. serum potassium levels are not necessarily indicative of tissue potassium levels. solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. solutions containing potassium in a greater concentration than 40 meq/liter may result in significant irrit
ation to peripheral or central veins. for peripheral administration of solutions containing potassium, slowly infuse the solution through a small bore needle, placed well within the lumen of a large vein. carefully avoid infiltration. solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. if the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. to minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. use only if solution is clear and vacuum is present. discard the container no later than 4 hours after initial closure puncture.

Dosage and Administration:

Dosage and administration not for direct patient injection. potassium chloride for injection concentrate usp, pharmacy bulk package is for preparation of intravenous admixtures only and 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 or bag type containers are used. dosage and rate of administration are to be directed by the physician and are dependent upon the specific conditions of each patient ( e.g. , age, weight, clinical condition of the patient and laboratory determinations). frequent laboratory determinations and clinical evaluation are essential to monitor changes in electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. if the serum potassium level is greater than 2.5 meq/liter, potassium can be given at a rate not to exceed 10 meq/hour and in a concentration of up to 40 meq/liter. the 24 hour total dose should no
t exceed 200 meq. if urgent treatment is indicated (serum potassium level less than 2.0 meq/liter 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 contraindicated) rather than in dextrose containing fluids, as dextrose may lower serum potassium levels. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. directions for use of pharmacy bulk package in b. braun glass containers with solid stoppers warning: not for direct infusion. for preparation of admixtures for intravenous infusion. the pharmacy bulk package is for use in a pharmacy admixture service only. use of this product is restricted to a suitable work area, such as a laminar flow hood (or an equivalent clean air compounding area). additives should not be made to pharmacy bulk packages. designed for use with a vented sterile dispensing set. before use, perform the following checks: inspect each container. read the label. ensure solution is the one ordered and is within the expiration date. verify that closure is black and is printed with the words "must be diluted". invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. in checking for cracks, do not be confused by normal surface marks and seams on bottom and sides of bottle. these are not flaws. look for bright reflections that have depth and penetrate into the wall of the bottle. reject any such bottle. remove plastic cap (see figure 1). swab exposed stopper surface with a suitable disinfectant. check for vacuum at first puncture of the stopper. insert the spike fully into the target area of the rubber stopper (see figure 2) and promptly invert the bottle. verify vacuum by observing rising air bubbles. do not use the bottle if vacuum is not present. refer to directions for use of set to be used. if set insertion is not performed immediately following swabbing, swab stopper again with a suitable disinfectant. the container closure may be penetrated only one time, utilizing a suitable sterile dispensing set which allows measured dispensing of the contents. transfer individual dose(s) to appropriate intravenous infusion solutions. use of a syringe with needle is not recommended. multiple entries increase the potential of the microbial and particulate contamination. the withdrawal of container contents should be accomplished without delay using aseptic technique. discard container no later than 4 hours after initial closure puncture. the bottle may be stored under laminar flow hood at room temperature (25°c) after the closure has been entered. date and time of container entry should be noted in the area designated on the container label. figure 1 illustration figure 2 illustration

Contraindications:

Contraindications potassium chloride for injection concentrate usp is contraindicated in diseases where high potassium levels may be encountered, in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present, or where additives of potassium and chloride could be clinically detrimental.

Adverse Reactions:

Adverse reactions reactions which may occur because of the potassium-containing solutions or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection or extravasation, hypervolemia, and hyperkalemia. to 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 of neuromuscular function, and intestinal ileus and dilatation. if infused in large amounts, chloride ions ma
y cause a loss of bicarbonate ions, resulting in an acidifying effect. potassium-containing solutions are intrinsically irritating 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. 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.

Use in Pregnancy:

Pregnancy (i) teratogenic effects. pregnancy category c animal reproduction studies have not been conducted with potassium chloride injection. it is also not known whether potassium chloride injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. potassium chloride injection should be given to a pregnant woman only if clearly needed.

Overdosage:

Overdosage in the event of fluid overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment. in the event 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 per 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.

Clinical Pharmacology:

Clinical pharmacology potassium is the chief 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 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 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.

How Supplied:

How supplied potassium chloride for injection concentrate usp (2 meq k + /ml) is supplied sterile and nonpyrogenic in 250 ml glass containers with solid stoppers, pharmacy bulk packages, packaged 12 per case. ndc ref size potassium chloride for injection concentrate usp 0264-1940-20 s9402-11 250 ml exposure of pharmaceutical products to heat should be minimized. avoid excessive heat (40°c/104°f). protect from freezing. it is recommended that the product be stored at room temperature (25°c); however, brief exposure up to 40°c does not adversely affect the product.

Package Label Principal Display Panel:

Principal display panel - 250 ml container label potassium chloride for injection concentrate usp (2 meq k + /ml) ref s9402-11 ndc 0264-1940-20 250 ml pharmacy bulk package not for direct infusion each 100 ml contains: potassium chloride usp 14.9 g; water for injection usp qs ph: 5.4 (4.0-8.0); calc. osmolarity: 4000 mosmol/liter electrolytes meq/ml: potassium 2; chloride 2 contains no more than 25 mcg/l of aluminum. b. braun medical inc. bethlehem, pa 18018-3524 usa 1-800-227-2862 opened: date time sterile, nonpyrogenic. pharmacy bulk package. no antimicrobial or bacteriostatic agent has been added. recommended storage: room temperature (25°c). avoid excessive heat (40°c/104°f). protect from freezing. see package insert. usual dosage and directions for use: see package insert. warning: not for direct infusion. for preparation of intravenous admixtures only. concentrated solution: dilute in suitable fluid prior to administration. use only if solution is clear and vacuum is present. a single entry through the vial closure should be made with a sterile dispensing set. transfer individual doses to appropriate intravenous infusion solutions without delay. use of a syringe with needle is not recommended. the above process should be carried out under a laminar flow hood using aseptic technique. discard the container no later than 4 hours after initial closure puncture. rx only y37-002-548 ld-614-1 exp lot s9402-11 250 ml container label


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