NDC 0121-2520 Potassium Chloride
Solution Oral

Product Information

Product Code0121-2520
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Potassium Chloride
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Potassium Chloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Pharmaceutical Associates, Inc.
Labeler Code0121
FDA Application Number What is the FDA Application Number?
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.
ANDA210766
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-02-2019
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)ORANGE (C48331)
Flavor(s)BERRY (C73365)
CITRUS (C73378)

Product Packages

NDC 0121-2520-00

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE

NDC 0121-2520-30

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE

NDC 0121-2520-40

Package Description: 4 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE

NDC 0121-2520-50

Package Description: 5 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE

Product Details

Potassium Chloride is a human prescription drug product labeled by Pharmaceutical Associates, Inc.. The product's dosage form is solution and is administered via oral form.


What are Potassium Chloride Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


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Patient Education

Potassium

Potassium is pronounced as (poe tass' i um)

Why is potassium medication prescribed?
Potassium is essential for the proper functioning of the heart, kidneys, muscles, nerves, and digestive system. Usually the food you eat supplies all of the potassium you...
[Read More]

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Potassium Chloride Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



1 Indications And Usage



Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.


Other



Monitoring

Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or more often depending on the severity of hypokalemia until they return to normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis.

The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms and the clinical status of the patient. Correct volume status, acid-base balance and electrolyte deficits as appropriate.

Administration

Dilute the potassium chloride solution with at least 4 ounces of cold water [see Warnings and Precautions (5.1)] .

Take with meals or immediately after eating.

If serum potassium concentration is ˂2.5 mEq/L, use intravenous potassium instead of oral supplementation.

Treatment of hypokalemia

Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses; limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24 hour period.

Maintenance or Prophylaxis

Typical dose is 20 mEq per day. Individualize dose based upon serum potassium levels.

Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain.

Treatment of hypokalemia

Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy.

Maintenance or Prophylaxis

Pediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.

There are no human data related to use of Potassium Chloride during pregnancy, and animal studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm.

The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, berry citrus flavor, potassium sorbate, purified water and sodium saccharin.

Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: glycerin, potassium sorbate, purified water and sodium saccharin.

Rx Only

MANUFACTURED BY

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R11/20


3 Dosage Forms And Strengths



Oral Solution 10%: 1.3 mEq potassium per mL.

Oral Solution 20%: 2.6 mEq potassium per mL.


4 Contraindications



Potassium chloride is contraindicated in patients on potassium sparing diuretics.


5.1 Gastrointestinal Irritation



May cause gastrointestinal irritation if administered undiluted. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [see Dosage and Administration (2.1)] .


6 Adverse Reactions



The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.


7.1 Potassium-Sparing Diuretics



Use with potassium-sparing diuretics can produce severe hyperkalemia. Avoid concomitant use.


7.2 Renin-Angiotensin-Aldosterone System Inhibitors



Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy.


7.3 Nonsteroidal Anti-Inflammatory Drugs (Nsaids)



NSAIDS may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.


8.2 Lactation



Risk Summary

The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as Potassium Chloride becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.


8.4 Pediatric Use



The safety and effectiveness of Potassium Chloride have been demonstrated in children with diarrhea and malnutrition from birth to 16 years.


8.5 Geriatric Use



Clinical studies of Potassium Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


8.6 Cirrhotics



Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently. [see 12.3 Pharmacokinetics ( 12.3) ].


8.7 Renal Impairment



Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on ACE inhibitors, ARBs, or nonsteroidal anti-inflammatory drugs should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia. The serum potassium level should be monitored frequently. Renal function should be assessed periodically.


10.1 Symptoms



The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly potentially fatal hyperkalemia can result.

Hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).


10.2 Treatment



Treatment measures for hyperkalemia include the following:

  • Monitor closely for arrhythmias and electrolyte changes.
  • Eliminate foods and medications containing potassium and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.
  • Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
  • Administer intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1000 mL.
  • Correct acidosis, if present, with intravenous sodium bicarbonate.
  • Use exchange resins, hemodialysis, or peritoneal dialysis.
  • In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.


11 Description



Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55.


12.1 Mechanism Of Action



The potassium ion (K+) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.

The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.

Potassium is a normal dietary constituent, and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.


12.3 Pharmacokinetics



Based on published literature, the rate of absorption and urinary excretion of potassium from KCl oral solution were higher during the first few hours after dosing relative to modified release KCl products. The bioavailability of potassium, as measured by the cumulative urinary excretion of K + over a 24 hour post dose period, is similar for KCl solution and modified release products.


16 How Supplied/Storage And Handling



Potassium Chloride Oral Solution, USP 10% (20 mEq/15 mL) is a berry citrus flavored, orange-colored solution available as follows:

NDC 0121-1680-16:16 fl oz (473 mL) Bottle.
NDC 0121-1680-15:15 mL unit dose cup, in a tray of ten cups.
NDC 0121-2520-30:30 mL unit dose cup, in a tray of ten cups.

Potassium Chloride Oral Solution, USP 20% (40 mEq/15 mL) is an unflavored, clear, dye free/sugar free solution available as follows:

NDC 0121-0841-15:15 mL unit dose cup, in a tray of ten cups.


Storage And Handling



STORAGE

Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP.

PROTECT from LIGHT and FREEZING.


Principal Display Panel - 16 Fl Oz (473 Ml)



Delivers 16 fl oz (473 mL)

NDC 0121-1680-16

Potassium Chloride Oral Solution, USP 10%

20 mEq per 15 mL

DILUTE PRIOR TO ADMINISTRATION

Rx ONLY

16 fl oz (473 mL)

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

X1680161120         R11/20


Principal Display Panel - 15 Ml Cup Label



Delivers 15 mL
NDC 0121-1680-15

Potassium Chloride Oral Solution, USP 10%

20 mEq per 15 mL

DILUTE PRIOR TO ADMINISTRATION

Package Not Child-Resistant

Rx ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

A0840151120


Principal Display Panel - 30 Ml Cup Label



Delivers 30 mL
NDC 0121-2520-30

Potassium Chloride Oral Solution, USP 10%

40 mEq per 30 mL

DILUTE PRIOR TO ADMINISTRATION

Package Not Child-Resistant

Rx ONLY

PHARMACEUTICAL ASSOCIATES, INC. 

GREENVILLE, SC 29605

SEE INSERT

A0840301120


Principal Display Panel - 15 Ml Cup Label - 20%



Delivers 15 mL
NDC 0121-0841-15

Potassium Chloride Oral Solution, USP 20%

Dye Free / Sugar Free

40 mEq per 15 mL

DILUTE PRIOR TO ADMINISTRATION

Package Not Child-Resistant

Rx ONLY

PHARMACEUTICAL ASSOCIATES, INC. 

GREENVILLE, SC 29605

SEE INSERT

A0841151120


* Please review the disclaimer below.