Label: POTASSIUM CHLORIDE IN SODIUM CHLORIDE- sodium chloride and potassium chloride solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 17, 2019

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  • DESCRIPTION

    Each 100 mL of 0.15% Potassium Chloride in 0.9% Sodium Chloride Injection (20 mEq K+/liter) contains: Sodium Chloride USP 0.9 g
    Potassium Chloride USP 0.15 g; Water for Injection USP qs

    pH may be adjusted with Hydrochloric Acid NF

    pH: 5.6 (3.5–6.5)              Calculated Osmolarity: 350 mOsmol/liter

    Concentration of Electrolytes (mEq/liter):
    Sodium 154             Potassium 20             Chloride 174

    Potassium Chloride in 0.9% Sodium Chloride Injection is sterile, nonpyrogenic, hypertonic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration.

    The formulas of the active ingredients are:

    IngredientsMolecular
    Formula
    Molecular
    Weight
     Sodium Chloride USP NaCl 58.44
     Potassium Chloride USP KCl 74.55

    Not made with natural rubber latex, PVC or DEHP.

    The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

    Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

  • CLINICAL PHARMACOLOGY

    Potassium Chloride in 0.9% Sodium Chloride Injection provides electrolytes and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient.

    Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of acid-base equilibrium of body fluid.

    Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

    Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

  • INDICATIONS AND USAGE

    Potassium Chloride in 0.9% Sodium Chloride Injection is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.

  • CONTRAINDICATIONS

    Potassium Chloride in 0.9% Sodium Chloride Injection is contraindicated in clinical conditions where additives of sodium, potassium or chloride could be clinically detrimental.

  • WARNINGS

    The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

    Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema.

    Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient's circulatory system status as a guide.

    In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

  • PRECAUTIONS

    General

    This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

    Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

    Additional essential electrolytes, minerals, and vitamins should be supplied as needed.

    Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Infusion of more than one liter of isotonic (0.9%) sodium chloride may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect.

    Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels.

    Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease.

    Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

    To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

    Do not use plastic containers in series connection.

    If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

    This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

    Use only if solution is clear and container and seals are intact.

    Laboratory Tests

    Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or alternative solutions.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies with Potassium Chloride in 0.9% Sodium Chloride Injection have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

    Pregnancy

    Teratogenic Effects

    Animal reproduction studies have not been conducted with Potassium Chloride in 0.9% Sodium Chloride Injection. It is also not known whether Potassium Chloride in 0.9% Sodium Chloride Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in 0.9% Sodium Chloride Injection should be given to a pregnant woman only if clearly needed.

    Labor and Delivery

    The effects of Potassium Chloride in 0.9% Sodium Chloride Injection on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and on the later growth, development, and functional maturation of the child are unknown. As reported in the literature, potassium containing solutions have been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Potassium Chloride in 0.9% Sodium Chloride Injection is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness of Potassium Chloride in Sodium Chloride Injection in pediatric patients has not been established by adequate and well-controlled studies. However, as referenced in the medical literature, potassium chloride injection has been used to treat pediatric patients with potassium deficiency when oral replacement therapy is not feasible.

    For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.

    In neonates or in very small infants even small volumes of fluid may affect fluid and electrolyte balance. Care must be exercised in treatment of neonates, especially pre-term neonates, whose renal function may be immature and whose ability to excrete fluid and solute loads may be limited. Fluid intake, urine output, and serum electrolytes should be monitored closely.

    See WARNINGS and DOSAGE AND ADMINISTRATION.

    Geriatric Use

    Clinical studies of Potassium Chloride in Sodium Chloride Injection 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 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.

    See WARNINGS.

  • ADVERSE REACTIONS

    Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

    Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended.

    (See DOSAGE AND ADMINISTRATION.)

    Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

    Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

    Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation.

    If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

    The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.

    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

  • OVERDOSAGE

    In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

    In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels.

    Treatment of hyperkalemia includes the following:

    1. Dextrose Injection USP, 10% or 25% containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour.
    2. Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema.
    3. Hemodialysis and peritoneal dialysis. The use of potassium-containing foods or medications must be eliminated. However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.
  • DOSAGE AND ADMINISTRATION

    This solution is for intravenous use only.

    Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

    When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

    In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

    Usually up to 40 mEq of potassium per liter daily is sufficient to replace normal loss in adults. Infusion rates should not exceed 10 mEq per hour or 120 mEq per day. A liter of fluid containing 40 mEq of potassium should be administered over an 8-hour period.

    Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

    Pediatric Dosage and Administration

    There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results.

    See WARNINGS and PRECAUTIONS.

    Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  • HOW SUPPLIED

    Potassium Chloride in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in EXCEL® Containers packaged 12 per case. 

    NDC REF Size
    0.15% Potassium Chloride in 0.9% Sodium Chloride Injection
    (20 mEq K+/liter)
         0264-7865-00 L8650 1000 mL

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

    Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

  • SPL UNCLASSIFIED SECTION

    Rx only

    Revised: June 2018

    EXCEL is a registered trademark of B. Braun Medical Inc.

  • Directions for Use of EXCEL® Container

    Caution: Do not use plastic containers in series connection.

    To Open

    Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

    Note: Before use, perform the following checks:

               Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.

               Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. 
               Any container which is suspect should not be used.

               Use only if solution is clear and container and seals are intact.

    Preparation for Administration

    1. Remove plastic protector from sterile set port at bottom of container.
    2. Attach administration set. Refer to complete directions accompanying set.

    To Add Medication

    Warning: Some additives may be incompatible.

    To Add Medication Before Solution Administration

    1. Prepare medication site.
    2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
    3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

    To Add Medication During Solution Administration

    1. Close clamp on the set.
    2. Prepare medication site.
    3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Evacuate both ports by tapping and squeezing them while container is in the upright position.
    6. Mix solution and medication thoroughly.
    7. Return container to in use position and continue administration.
  • SPL UNCLASSIFIED SECTION

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y36-002-956   LD-234-5

  • PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

    0.15% Potassium Chloride
    in 0.9% Sodium Chloride
    Injection

    REF L8650
    NDC 0264-7865-00

    1000 mL
    EXCEL® CONTAINER

    20 mEq K+/liter
    Y94-003-345  LD-502-2

    Each 100 mL contains: Sodium Chloride USP 0.9 g; Potassium
    Chloride USP 0.15 g; Water for Injection USP qs

     pH may be adjusted with HCl NF
    pH: 5.6 (3.5-6.5); Calc. Osmolarity: 350 mOsmol/liter,
    hypertonic

    Electrolytes (mEq/liter): Na+ 154;     K+ 20;      Cl174

    Sterile, nonpyrogenic. Single dose container. Do not use in series
    connection. For intravenous use only. Use only if solution is clear
    and container and seals are intact.

    WARNINGS: Some additives may be incompatible. Consult with
    pharmacist. When introducing additives, use aseptic techniques.
    Mix thoroughly. Do not store.

    Recommended Storage: Room temperature (25°C). Avoid excessive
    heat. Protect from freezing. See Package Insert.

    Do not remove overwrap until ready for use. After removing the
    overwrap, check for minute leaks by squeezing container firmly. If
    leaks are found, discard solution as sterility may be impaired.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

    Other symbol
    EXCEL is a registered trademark of B. Braun Medical Inc.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862
    www.bbraun.com
     

    Y94-003-270  LD-128-3

    EXP
    LOT

    100 mL Container Label L8650
  • INGREDIENTS AND APPEARANCE
    POTASSIUM CHLORIDE IN SODIUM CHLORIDE 
    sodium chloride and potassium chloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-7865
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0264-7865-0012 in 1 CASE09/29/1989
    11000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01970809/29/1989
    Labeler - B. Braun Medical Inc. (002397347)