POTASSIUM CHLORIDE for solution

Potassium chloride by

Drug Labeling and Warnings

Potassium chloride by is a Prescription medication manufactured, distributed, or labeled by ANI Pharmaceuticals, Inc., Novitium Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS & 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 & ADMINISTRATION

    2.1 Administration and Monitoring

    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 contents of 1 pouch of potassium chloride for oral solution in at least 4 ounces of cold water [see Warnings and Precautions (5.1)].

    Take with meals or immediately after eating.

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


    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 & 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 Renin-Angiotensin-Aldosterone System 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 receiving concomitant RAAS therapy.

    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

    There are no human data related to use of Potassium Chloride during pregnancy, and animal 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 potassium from oral supplements such as Potassium Chloride 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 to16 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: colloidal silicon dioxide, citric acid anhydrous, sucralose, natural orange flavor, and. FD&C Yellow #6.

  • 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, USP is a light pink to orange free flowing powder, free of lumps available in one strength as follows: 20 mEq


    Potassium chloride for Oral Solution, USP 20 mEq pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq (NDC: 70954-197-10)


    (NDC: 70954-197-20) Carton of 30 pouches

    (NDC: 70954-197-30) Carton of 100 pouches

    Storage

    Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F); excursions are permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]

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

    PROTECT from LIGHT.

    Rx only

    Manufactured by:

    Novitium Pharma LLC.

    70 Lake Drive,

    East Windsor, New Jersey-08520

    Issued Date: 04/2020

    LB4168-00

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Pouch Label
    pouch
    Carton - 30's Count
    30-carton

    Carton - 100's Count
    100countcarton

  • INGREDIENTS AND APPEARANCE
    POTASSIUM CHLORIDE 
    potassium chloride for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70954-197
    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 1.56 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorPINK (Light Pink to Orange) Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70954-197-2030 in 1 CARTON07/19/2023
    1NDC: 70954-197-101.56 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC: 70954-197-30100 in 1 CARTON07/19/2023
    2NDC: 70954-197-101.56 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21281607/19/2023
    Labeler - ANI Pharmaceuticals, Inc. (145588013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novitium Pharma LLC080301870ANALYSIS(70954-197) , LABEL(70954-197) , MANUFACTURE(70954-197) , PACK(70954-197)
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