POTASSIUM CHLORIDE EXTENDED RELEASE- potassium chloride tablet, extended release

POTASSIUM CHLORIDE EXTENDED RELEASE by

Drug Labeling and Warnings

POTASSIUM CHLORIDE EXTENDED RELEASE by is a Prescription medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Casper Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS & USAGE

    Potassium chloride extended-release tablets 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 DOSAGE & ADMINISTRATION

    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 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.

    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 to 100 mEq per day.

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

  • 3 DOSAGE FORMS & STRENGTHS

    Potassium chloride extended-release tablets, USP are supplied as:
    600 mg (8 mEq) are blue colored, round shaped, biconvex film coated tablets having 'C 15' debossing on one side and plain on other side.
    750 mg (10 mEq) are yellow colored, round shaped, biconvex film coated tablets having 'C 16' debossing on one side and plain on other side.


  • 4 CONTRAINDICATIONS

    Potassium chloride is contraindicated in patients on triamterene and amiloride.

  • 5 WARNINGS AND PRECAUTIONS

    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 DRUG INTERACTIONS

    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 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    There are no human data related to use of potassium chloride extended-release tablets 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.

    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 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 OVERDOSAGE

    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:
    1. Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties.
    2. 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.
    3. Correction of acidosis, if present, with intravenous sodium bicarbonate.
    4. 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 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, crystalline powder or colorless crystals. It is odorless and has a salty taste. It's solutions are neutral to litmus. It is freely soluble in water and practically insoluble in ethanol.

    Inactive Ingredients: colloidal silicon dioxide, ethyl cellulose, isopropyl alcohol, magnesium stearate, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, 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.

    FDA approved dissolution test specifications differ from USP.

  • 12 CLINICAL PHARMACOLOGY

    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 tablets is completely absorbed before it leaves the small intestine. The 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 is compared to that of a true solution the extent of absorption is similar.

    The extended-release properties of potassium chloride extended-release tablets 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 tablets, 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.

    Specific Populations
    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.

  • 13 NONCLINICAL TOXICOLOGY

    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 contains 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq or 10 mEq of potassium respectively). Potassium chloride extended-release tablets, USP are supplied in following strengths:

    600 mg (8 mEq) are blue colored, round shaped, biconvex film coated tablet having 'C 15' debossing on one side and plain on other side, and are supplied in:
    Bottle of 100 tablets        NDC: 16571-842-01
    Bottle of 500 tablets        NDC: 16571-842-50

    750 mg (10 mEq) are yellow colored, round shaped, biconvex film coated tablets having 'C 16' debossing on one side and plain on other side, and are supplied in:
    Bottle of 100 tablets        NDC: 16571-843-01
    Bottle of 500 tablets        NDC: 16571-843-50

    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]. Protect from light and moisture.

    Dispense in a tight 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 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.

    Manufactured for:
    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816

    Made in India.
    Neutral Code: 3407600/TS/DRUGS/2022

    PIR84350-03
    Revised: 07/2023

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 8mEq Tablet Bottle Label

    Rising Pharma Holdings, Inc.

    NDC: 16571-842-01

    Potassium Chloride Extended-Release Tablets, USP
    8 mEq (600mg)

    100 Tablets
    Rx only





    8meq


    PRINCIPAL DISPLAY PANEL -10mEq Tablet Bottle Label

    Rising Pharma Holdings, Inc.

    NDC: 16571-843-01

    Potassium Chloride Extended-Release Tablets, USP
    10 mEq (750mg)

    100 Tablets
    Rx only





    10meq

  • INGREDIENTS AND APPEARANCE
    POTASSIUM CHLORIDE EXTENDED RELEASE 
    potassium chloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 16571-842
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE600 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code C15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 16571-842-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/19/2023
    2NDC: 16571-842-50500 in 1 BOTTLE; Type 0: Not a Combination Product12/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21741212/19/2023
    POTASSIUM CHLORIDE EXTENDED RELEASE 
    potassium chloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 16571-843
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code C16
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 16571-843-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/19/2023
    2NDC: 16571-843-50500 in 1 BOTTLE; Type 0: Not a Combination Product12/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21741212/19/2023
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casper Pharma Private Limited854125972ANALYSIS(16571-842, 16571-843) , LABEL(16571-842, 16571-843) , MANUFACTURE(16571-842, 16571-843) , PACK(16571-842, 16571-843)
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