Label: POTASSIUM CHLORIDE FOR ORAL SOLUTION- potassium chloride powder, for solution

  • NDC Code(s): 69543-379-01, 69543-379-10, 69543-379-30
  • Packager: Virtus Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 13, 2017

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

    POTASSIUM CHLORIDE for oral solution
    Initial U.S. Approval: 1948

    INDICATIONS AND USAGE

    Potassium Chloride is 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

    Dilute prior to administration. (2.1, 5.1)
    Monitor serum potassium and adjust dosage accordingly (2.2, 2.3)
    If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation (2.1)

    Treatment of hypokalemia:

    • Adults: Initial doses range from 40-100 mEq/day in 2-5 divided doses: limit doses to 40 mEq per dose. Total daily dose should not exceed 200 mEq (2.2)
    • Pediatric patients aged birth to 16 years old: 2-4 mEq/kg/day in divided doses; not to exceed 1 mEq/kg as a single dose or 40 mEq whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy. Total daily dose should not exceed 100 mEq (2.3)

    Maintenance or Prophylaxis of hypokalemia:

    • Adults: Typical dose is 20 mEq per day (2.2)
    • Pediatric patients aged birth to 16 years old: typical dose is 1 mEq/kg/day. Do not to exceed 3 mEq/kg/day (2.3)

    DOSAGE FORMS AND STRENGTHS

    • Potassium Chloride for Oral Solution, USP 20 mEq: Each pouch contains 1.5 g of Potassium Chloride providing potassium 20 mEq and chloride 20 mEq. (3)

    CONTRAINDICATIONS

    • Concomitant use with potassium sparing diuretics. (4)

    WARNINGS AND PRECAUTIONS

    • Gastrointestinal Irritation: Dilute before use, 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 Pharm-Olam at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    • Potassium sparing diuretics: Avoid concomitant use (7.1)
    • Angiotensin converting enzyme inhibitors: Monitor for hyperkalemia (7.2)
    • Angiotensin receptor blockers: Monitor for hyperkalemia (7.3)

    USE IN SPECIFIC POPULATIONS

    Cirrhosis: Initiate therapy at the low end of the dosing range (8.5)

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

    Revised: 11/2016

  • Table of Contents
  • 1 INDICATIONS AND USAGE

    Potassium Chloride 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 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. 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.

    Administration

    Dilute the potassium chloride for oral solution with at least 4 ounces of cold water [see Warnings and Precautions (5.1)].

    Take with meals or immediately after eating.

    2.2 Adult Dosing

    Treatment of hypokalemia:

    Daily 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 Prophylaxis

    Typical 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.

    2.3 Pediatric Dosing

    Treatment of hypokalemia:

    Pediatric 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 Prophylaxis

    Pediatric 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

    Each pouch contains 1.5 g of potassium chloride supplying 20 mEq of potassium and 20 mEq of chloride.

  • 4 CONTRAINDICATIONS

    Potassium chloride is contraindicated in patients on potassium sparing diuretics.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Gastrointestinal Irritation

    May cause gastrointestinal irritation. 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 DRUG INTERACTIONS

    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 USE IN SPECIFIC POPULATIONS

    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.

    8.3 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.

    8.4 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

    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 ACE inhibitors, ARBs, 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. 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 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 (6.5–8.0 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 (9–12 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 of 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 intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1000 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.

  • 11 DESCRIPTION

    Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55.

    Each pouch of light pink to orange powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose.

  • 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

    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.

    Specific Populations

    Cirrhotics

    Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 h 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 for Oral Solution, is a light pink to orange powder available in one strength as follows:

    20 mEq
    NDC# 69543-379-01 pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq
    NDC# 69543-379-30 carton of 30 pouches
    NDC# 69543-379-10 carton of 100 pouches

    Storage

    Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F).

    Dispense in a tight, light-resistant container as defined in the USP PROTECT from LIGHT.

  • SPL UNCLASSIFIED SECTION

    Rx only

    Manufactured by:
    Lehigh Valley Technologies, Inc.
    Allentown, PA 18102

    Distributed by:
    Virtus Pharmaceuticals, LLC
    Newtown, PA 18940

  • PRINCIPAL DISPLAY PANEL - 1.5 g Pouch Label

    NDC 69543-379-01

    POTASSIUM CHLORIDE FOR
    ORAL SOLUTION, USP

    20 mEq

    Rx Only

    Single Dose (1.5 g)

    VIRTUS
    PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL - 1.5 g Pouch Label
  • INGREDIENTS AND APPEARANCE
    POTASSIUM CHLORIDE FOR ORAL SOLUTION 
    potassium chloride powder, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69543-379
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE1.5 g  in 1.58 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorORANGE (light pink to orange) Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69543-379-3030 in 1 CARTON01/09/2017
    1NDC:69543-379-011.58 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69543-379-10100 in 1 CARTON01/09/2017
    2NDC:69543-379-011.58 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20801901/09/2017
    Labeler - Virtus Pharmaceuticals (079659493)