NDC 42794-025 Potassium Chloride

NDC Product Code 42794-025

NDC CODE: 42794-025

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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with "water pills"/diuretics.

Product Characteristics

Color(s):
BLUE (C48333)
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
12 MM
13 MM
Imprint(s):
24
25
Score: 1

NDC Code Structure

NDC 42794-025-02

Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC 42794-025-04

Package Description: 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC 42794-025-06

Package Description: 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

This product is EXCLUDED from the official NDC directory .

NDC Product Information

Potassium Chloride with NDC 42794-025 is a product labeled by Sigmapharm Laboratories, Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 312529 and 628953.

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 (UNII: 532B59J990)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Labeler Information

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

Labeler Name: Sigmapharm Laboratories, Llc
Labeler Code: 42794
Start Marketing Date: 08-19-2021 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: 12-31-2019 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: 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".

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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 tablets, USP are 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.
Monitoring Monitor 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.Administration Take potassium chloride extended-release tablets, USP with meals and with a glass of water or other liquid. Do not take potassium chloride extended-release tablets, USP 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.

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


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

3 Dosage Forms And Strengths

Potassium chloride extended-release tablets, USP are supplied as:600 mg (8 mEq) are Blue Film-Coated Round Concave Beveled Edge tablets debossed “Ʃ 24” on one side and plain on the other side.750 mg (10 mEq) are Yellow Film-Coated Round Concave Beveled Edge tablets debossed “Ʃ 25” on one side and plain on the other side.

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, USP and consider possibility of ulceration, obstruction or perforation.Potassium chloride extended-release tablets, USP 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.To report SUSPECTED ADVERSE REACTIONS, contact Sigmapharm Laboratories, LLC, Pharmacovigilance at 1-855-332-0731 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7.1 Triamterene And Amiloride

Use with triamterene and 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 imparing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.

8.1 Pregnancy

Risk Summary There are no human data related to use of potassium chloride extended-release tablets, USP 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 2-4% and 15-20%, respectively.

8.2 Lactation

Risk Summary 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.

8.4 Pediatric Use

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

8.5 Geriatric Use

Clinical studies of potassium chloride extended-release tablets, USP 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 publish 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


[see Warnings and Precautions (5.2)]. 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 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 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. In addition, 8 mEq Tablets contain FD&C Blue No.2 aluminum lake and black iron oxide. 10 mEq Tablets contain FD&C Yellow No.5 and FD&C Blue No.2 aluminum lakes.

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 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

The potassium chloride in potassium chloride extended-release tablets, USP 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 tablets, USP is compared to that of a true solution the extent of absorption is similar.The extended-release properties of potassium chloride extended-release tablets, USP 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 tablets, USP dose as compared to the solution.Increased urinary potassium excretion is first observed 1 hour after administration of potassium chloride extended-release tablets, USP, 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, USP cannot be distinguished from those following administration of potassium chloride solution or from control plasma levels of potassium ion.Specific Populations Cirrhotics Based on publish 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.

13.1 Carcinogenesis, Mutagenesis, 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 contain 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq and 10 mEq respectively). Potassium chloride extended-release tablets, USP are provided as extended release tablets. Table 1: How SuppliedDoseShapeColorDebossment   NDC#: 42794-xxx-xxBottle of 100 tabletsBottle of 500 tabletsBottle of 1000 tablets  600 mg (8mEq) RoundBlue"Ʃ 24"024-02024-04024-06 750 mg (10 mEq) RoundYellow"Ʃ 25"025-02025-04025-06Store at 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]. Protect from light and moisture.Dispense in a tight, light-resistant container with a child-resistant closure.

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.Sigmapharm Laboratories, LLC     Bensalem, PA 19020OS025-03 REV.0518

Potassium Chlolride Extended-Release Tablets, Usp 8 Meq (600 Mg) Container Label

NDC 42794-024-02Potassium Chloride Extended-Release Tablets, USP8 mEq (600 mg)Rx only100 TabletsSigmapharm Laboratories, LLC

Potassium Chlolride Extended-Release Tablets, Usp 10 Meq (750 Mg) Container Label

NDC 42794-025-02Potassium Chloride Extended-Release Tablets, USP10 mEq (750 mg)Contains FD&C Yellow No. 5 (tartrazine) as a color additive.Rx only100 TabletsSigmapharm Laboratories, LLC

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