Label: POTASSIUM CHLORIDE capsule, extended release

  • NDC Code(s): 0574-0180-01, 0574-0181-01, 0574-0181-05, 0574-0181-90
  • Packager: Paddock Laboratories, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 30, 2019

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP.

    Potassium chloride extended-release tablets, USP for oral use
    Initial U.S. Approval: 1948

    INDICATIONS AND USAGE

    Potassium Chloride Extended-release Capsules, USP contain potassium chloride, a potassium salt 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. (1)

    DOSAGE AND ADMINISTRATION

    Monitor serum potassium and adjust dosage accordingly (2.1) If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation. (2.1) (2)

    Treatment of hypokalemia: (2)

    Adults: Typical doses range from 40-100 mEq/day in 2-5 divided doses; limit doses to 40 mEq per dose. (2.2)
    Pediatric patients: 2-4 mEq/kg/day in divided doses not to exceed 1 mEq/kg as a single dose or 20 mEq, whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy. (2.3)

    Maintenance or Prophylaxis of hypokalemia: (2)

    Adults: Typical dose is 20 mEq per day (2.2)
    Pediatric patients: Typical dose is 1 mEq/kg/day. (2.3)

    DOSAGE FORMS AND STRENGTHS

    Extended-release capsules: 600 mg (8mEq) and 750 mg (10 mEq)

    CONTRAINDICATIONS

    Concomitant use with triamterene and amiloride. (4)

    WARNINGS AND PRECAUTIONS

    Gastrointestinal Irritation: Take with meals (5.1)

    ADVERSE REACTIONS

    Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. (6)

    To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    Triamterene and amiloride: Concomitant use is contraindicated (7.1)
    Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia (7.2)
    Nonsteroidal Anti-inflammatory drugs (NSAIDS): Monitor for hyperkalemia (7.3)

    USE IN SPECIFIC POPULATIONS

    Cirrhosis: Initiate therapy at the low end of the dosing range (8.6)
    Renal Impairment: Initiate therapy at the low end of the dosing range (8.7)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 5/2018

  • Table of Contents
  • 1 INDICATIONS AND USAGE

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

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Administration and Monitoring

    If serum potassium concentration is <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 with meals and with a full glass of water or other liquid. Do not take on an empty stomach because of the potential for gastric irritation [see Warnings and Precautions (5.1)].

    Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of water or juice to ensure complete swallowing of the microcapsules. Do not added to hot foods. Any microcapsule/food mixture should be used immediately and not stored for future use.

    2.2 Adult 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 is 20 mEq per day.

    2.3 Pediatric Dosing

    Pediatric patients aged birth to 16 years old: Dosage must be adjusted to the individual needs of each patient. Do not exceed as a single dose 1 mEq/kg or 20 mEq, whichever is lower.

    Treatment of hypokalemia: The recommended initial dose is 2 to 4 mEq/kg/day in divided doses. If deficits are severe or ongoing losses are great, consider intravenous therapy.

    Maintenance or Prophylaxis: Typical dose is 1 mEq/kg/day.

  • 3 DOSAGE FORMS AND STRENGTHS

    600 mg (8 mEq): White capsules containing a white opaque cap, printed PAD over 0180 radially in black ink and white opaque body

    750 mg (10 mEq ): White capsules containing a white opaque cap, printer PAD over 0181 radially in black ink and white opaque body

  • 4 CONTRAINDICATIONS

    Potassium chloride extended-release capsules are contraindicated in patients on amiloride or triamterene.

  • 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 is in contact with the gastrointestinal mucosa for a prolonged period of time. 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 capsules and consider possibility of ulceration, obstruction or perforation.

    Potassium chloride extended-release capsules 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 of hyperkalemia and of upper and lower gastrointestinal conditions including, obstruction, bleeding, ulceration, and perforation.

    Skin rash has been reported rarely.

  • 7 DRUG INTERACTIONS

    7.1 Amiloride and Triamterene

    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-aldosternone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produces potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients taking drugs that inhibit RAAS.

    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 taking NSAIDS.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    There are no human data related to use of potassium chloride extended-release capsules during pregnancy and animal reproductive 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, 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

    Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium chloride in children with diarrhea and malnutrition from birth to 18 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

    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. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors 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 [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.

    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 QTinterval). 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:

    1.
    Monitor closely for arrhythmias and electrolyte changes.
    2.
    Eliminate foods and medications containing potassium and any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements, and many others.
    3.
    Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
    4.
    Administer 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.
    5.
    Correct acidosis, if present, with intravenous sodium bicarbonate.
    6.
    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.

    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 capsules are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively.

    The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white granular powder or as 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: black iron oxide, citric acid, dibutyl sebacate, ethylcellulose, gelatin, hypromellose, magnesium stearate, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, titanium dioxide.

  • 12 CLINICAL PHARMACOLOGY

    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

    Each crystal of KCl is microencapsulated and allows for the controlled release of potassium and chloride ions over an eight- to ten-hour period.

    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.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Potassium chloride extended-release capsules contain 600 mg and 750 mg mg of potassium chloride (equivalent to 8 mEq and 10 mEq, respectively).

    Table 1: How Supplied

    Dose

    Color

    Printing

    Bottle Count

    NDC

    600 mg (8 mEq)

    White

    PAD over 0180

    100

    0574-0180-01

    750 mg (10 mEq)

    White

    PAD over 0181

    90

    0574-0181-90

    100

    0574-0181-01

    500

    0574-0181-05

    Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

    Dispense in tight container.

    Rx only

  • 17 PATIENT COUNSELING INFORMATION

    Inform patients to take each dose with meals and with a full glass of water or other liquid.
    Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal toxicity is noticed.
  • SPL UNCLASSIFIED SECTION

    Manufactured By:

    Cipla Ltd., Verna Goa,

    India

    Distributed By:

    Perrigo®

    Allegan, MI 49010

    5S700 RC J2

    Revised: 05/2018

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Rx Only

    NDC 0574-0180-01

    Potassium Chloride Extended-Release Capsules USP

    (600 mg) 8 mEq K

    100 Capsules

    8Y8RC-potassium-chloride-extended-release-capsules-600mg.jpg

    The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

    serialization-template.jpg
  • PRINCIPAL DISPLAY PANEL - 750 mg Capsule - Bottle of 90

    Rx Only

    NDC 0574-0181-90

    Potassium Chloride Extended-Release Capsules USP

    (750 mg) 10 mEq K

    90 Capsules

    5S7RC-potassium-chloride-extended-release-capsules-750mg.jpg

    The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

    serialization-template.jpg
  • PRINCIPAL DISPLAY PANEL - 750 mg Capsule - Bottle of 100

    Rx Only

    NDC 0574-0181-01

    Potassium Chloride Extended-Release Capsules USP

    (750 mg) 10 mEq K

    100 Capsules

    5S7RC-potassium-chloride-extended-release-capsules-750mg(2).jpg

    The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

    serialization-template.jpg
  • PRINCIPAL DISPLAY PANEL - 750 mg Capsule - Bottle of 500

    Rx Only

    NDC 0574-0181-05

    Potassium Chloride Extended-Release Capsules USP

    (750 mg) 10 mEq K

    500 Capsules

    5S7RC-potassium-chloride-extended-release-capsules-750mg(3).jpg

    The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

    serialization-template.jpg
  • INGREDIENTS AND APPEARANCE
    POTASSIUM CHLORIDE 
    potassium chloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0574-0180
    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
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
    DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHELLAC (UNII: 46N107B71O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Product Characteristics
    ColorWHITE (opaque cap and body) Scoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code PAD;0180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0574-0180-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/03/201103/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20018506/03/201103/01/2020
    POTASSIUM CHLORIDE 
    potassium chloride capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0574-0181
    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
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLCELLULOSE (10 MPA.S) (UNII: 3DYK7UYZ62)  
    DIBUTYL SEBACATE (UNII: 4W5IH7FLNY)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHELLAC (UNII: 46N107B71O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Product Characteristics
    ColorWHITE (opaque cap and body) Scoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code PAD;0181
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0574-0181-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/03/2011
    2NDC:0574-0181-05500 in 1 BOTTLE; Type 0: Not a Combination Product06/03/2011
    3NDC:0574-0181-9090 in 1 BOTTLE; Type 0: Not a Combination Product06/03/201108/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20018506/03/2011
    Labeler - Paddock Laboratories, LLC (967694121)