NDC 70518-2313 Potassium Chloride

Potassium Chloride

NDC Product Code 70518-2313

NDC Code: 70518-2313

Proprietary Name: Potassium Chloride 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.

Non-Proprietary Name: Potassium Chloride 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.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
13 MM
Imprint(s):
KCL;10
Score: 1

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-2313-0

Package Description: 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Potassium Chloride with NDC 70518-2313 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Potassium Chloride is potassium chloride. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.

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 750 mg/1

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.

  • HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: NDA019123 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: NDA - A product marketed under an approved 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: 09-13-2019 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 Label Images

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 extended-release 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 is insufficient.

2.1 Administration And Monitoring

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

Other

MonitoringMonitor serum potassium and adjust dosages accordingly. Monitor serum potassium periodically during maintenance therapy to ensure potassium remains in desired range.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.

AdministrationTake potassium chloride extended-release tablets with meals and with a glass of water or other liquid. Do not take potassium chloride extended-release tablets on an empty stomach because of its potential for gastric irritation


[see


Warnings and Precautions (5.1)]


.


Swallow tablets whole without crushing, chewing or sucking.

Treatment of Hypokalemia: Typical dose range is 40 to 100 mEq per day.

Maintenance or Prophylaxis: Typical dose range is 20 mEq per day.

Risk SummaryThere are no human data related to use of potassium chloride extended-release during pregnancy, and animal reproduction 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% to 4% and 15% to 20%, respectively.

Risk SummaryThe 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.

Specific Populations

CirrhoticsBased on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load.

Manufactured by


UPSHER-SMITH LABORATORIES, LLCMaple Grove, MN 55369


Revised 1018

2.2 Dosing

Dosage must be adjusted to the individual needs of each patient. Dosages greater than 40 mEq per day should be divided such that no more than 40 mEq is given in a single dose.

3 Dosage Forms And Strengths

Potassium chloride extended-release tablets are supplied as:600 mg (8 mEq) are film-coated, round light blue tablets debossed with "KC 8".750 mg (10 mEq) are film-coated, round yellow tablets debossed with "KC 10".

4 Contraindications

Potassium chloride is contraindicated in patients on triamterene and amiloride.

5.1 Gastrointestinal Adverse Reactions

Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly if the drug maintains contact with the gastrointestinal mucosa for prolonged periods. Consider the use of liquid potassium in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders.If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue potassium chloride extended-release tablets and consider possibility of ulceration, obstruction or perforation.Potassium chloride extended-release tablets should not be taken on an empty stomach because of its potential for gastric irritation


[see


Dosage and Administration (2.1)]


.

6 Adverse Reactions

The following adverse reactions have been identified with use of oral potassium salts. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.There have been reports hyperkalemia and of upper and lower gastrointestinal condition including obstruction, bleeding, ulceration, perforation.Skin rash has been reported rarely.

7.1 Triamterene Or Amiloride

Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated


[see


Contraindications (4)]


.

7.2 Renin-Angiotensin-Aldosterone 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 on concomitant RAAS inhibitors.

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.

8.4 Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

8.5 Geriatric Use

Clinical studies of potassium chloride extended-release 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

Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. 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


Clinical Pharmacology (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 RAAS inhibitors or NSAIDs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia


[see


Drug Interactions (7.2,


7.3)]


. 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, potentially fatal hyperkalemia can result


[see


Contraindications and


Warnings]


.


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

10.2 Treatment

  • Treatment measures for hyperkalemia include the following:Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties.
  • Intravenous administration of 300 mL/hr to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.
  • Correction of acidosis, if present, with intravenous sodium bicarbonate.
  • Use of exchange resins, hemodialysis or peritoneal dialysis.
  • In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.The extended-release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

11 Description

Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet.Potassium chloride extended-release tablets, USP, are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide. Yellow tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Blue tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake.

12.1 Mechanism Of Action

The potassium ion 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 mEq to 160 mEq per liter. The normal adult plasma concentration is 3.5 mEq 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

The potassium chloride in potassium chloride extended-release is completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from the potassium chloride extended-release is compared to that of a true solution the extent of absorption is similar.The extended-release properties of potassium chloride extended-release are demonstrated by the finding that a significant increase in time is required for renal excretion of the first 50% of the Potassium chloride extended-release dose as compared to the solution.Increased urinary potassium excretion is first observed 1 hour after administration of potassium chloride extended-release, reaches a peak at approximately 4 hours, and extends up to 8 hours.Mean daily steady-state plasma levels of potassium following daily administration of potassium chloride extended-release tablets cannot be distinguished from those following administration of potassium chloride solution or from control plasma levels of potassium ion.

13.1 Carcinogenesis, Mutagenesis And Impairment Of Fertility

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

16 How Supplied/Storage And Handling

Potassium chloride extended-release tablets, USP contains 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq or 10 mEq of potassium respectively). Table 1: How SuppliedDoseShapeColorDebossmentNDC#: 0832-xxxx-xxBottle of 100 TabletsBottle of 1,000 Tablets600 mg (8 mEq)roundlight blue"KC 8"5322-115322-10750 mg (10 mEq)roundyellow"KC 10"5323-115323-10

Storage And Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight container with a child-resistant closure.Keep tightly closed.

17 Patient Counseling Information

  • Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. Inform patients that the wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool.Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed.

* Please review the disclaimer below.