NDC 48433-217 Potassium Chloride

Potassium Chloride

NDC Product Code 48433-217

NDC 48433-217-40

Package Description: 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 15 mL in 1 CUP, UNIT-DOSE (48433-217-15)

NDC Product Information

Potassium Chloride with NDC 48433-217 is a a human prescription drug product labeled by Safecor Health, Llc. The generic name of Potassium Chloride is potassium chloride. The product's dosage form is solution and is administered via oral form.

Labeler Name: Safecor Health, Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug 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.

Potassium Chloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • POTASSIUM CHLORIDE 20 meq/15mL

Inactive Ingredient(s)

About the 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • WATER (UNII: 059QF0KO0R)

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Safecor Health, Llc
Labeler Code: 48433
FDA Application Number: ANDA211067 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 05-24-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Potassium Chloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.

Other

MonitoringMonitor 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.

AdministrationDilute 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 less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation.

Treatment of hypokalemiaDaily 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 ProphylaxisTypical 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 hypokalemiaPediatric 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 ProphylaxisPediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.

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 diuretic can produce severe hyperkalemia. Avoid concomitant use.

7.2 Angiotensin-Converting Enzyme Inhibitors

Use with angiotensin converting enzyme (ACE) inhibitors produces potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

7.3 Angiotensin Receptor Blockers

Use with angiotensin receptor blockers (ARBs) produces potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ARBs only with close monitoring.

8.1 Pregnancy

Pregnancy Category C
Animal reproduction studies have not been conducted with potassium chloride. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

8.2 Nursing Mothers

The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so 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.

8.3 Pediatric Use

The safety and effectiveness of potassium chloride have been demonstrated in children with diarrhea and malnutrition from birth to18 years.

8.4 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.

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 to 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 to12 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, USP is a colorless, elongated, prismatic, or cubical crystals, or white, granular powder. It is soluble in water and slightly soluble in alcohol. Chemically, potassium chloride is K-Cl with a molecular mass of 74.55 g/mol.
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, glycerin, methylparaben, natural orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.
Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.
Natural orange flavor includes fruit extract and natural flavor.

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 is an orange solution available in two strengths as follows:
10%: 20 mEq/15 mL oral solutionNDC# 48433-217-15 Unit Dose Cup of 15 mLNDC# 48433-217-40 Box of 40 Unit Dose Cups, each with 15 mL
20%: 40 mEq/15 mL oral solutionNDC# 48433-218-15 Unit Dose Cup of 15 mLNDC# 48433-218-40 Box of 40 Unit Dose Cups, each with 15 mL
For Institutional Use OnlyThis Package is Not Child Resistant

Storage And Handling

StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
PROTECT from LIGHT.
POTASSIUM CHLORIDE ORAL SOLUTION, USP, 10% and 20%Packaged by:Safecor Health, LLC4060 Business Park DriveColumbus, OH 43204
Manufactured by:Apotex Inc. Toronto, Ontario Canada M9L 1T9
Manufactured for: Apotex Corp. Weston, Florida USA 33326
Rev: 03/2019 PN5644

* Please review the disclaimer below.