Label: POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE- potassium chloride, sodium chloride, calcium chloride, sodium lactate, and dextrose monohydrate injection, solution
- NDC Code(s): 0990-7111-09
- Packager: ICU Medical Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated June 24, 2021
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- SPL UNCLASSIFIED SECTION
Intravenous solution with potassium chloride (I.V. solutions with KCl) is a sterile and nonpyrogenic solution in water for injection. This solution is for administration by intravenous infusion only.
See Table for summary of content and characteristics of this solution.
The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.
This solution is a parenteral fluid, nutrient and/or electrolyte replenisher.
Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula:
Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl2 • 2H2O), white fragments or granules freely soluble in water.
Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula:
Water for Injection, USP is chemically designated H20.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
When administered intravenously, this solution provides a source of water and electrolytes with carbohydrate calories.
Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.
Calcium chloride in water dissociates to provide calcium (Ca++) and chloride (Cl¯) ions. They are normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. Approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%.
Sodium lactate provides sodium (Na+) and lactate (C3H5O¯) ions. The lactate anion is in equilibrium with pyruvate and has an alkalizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. In the liver, lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism. The sodium (Na+) ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). The normal plasma level of lactate ranges from 0.9 to 1.9 mEqK/liter.
Intravenous solutions containing potassium chloride are particularly intended to provide needed potassium cation (K+). Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). Potassium plays an important role in electrolyte balance. Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.
Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl¯) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl¯) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl¯) are largely under the control of the kidney which maintains a balance between intake and output.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.
- INDICATIONS AND USAGE
Solutions containing calcium ions should not be administered simultaneously through the same administration set as blood because of the likelihood of coagulation.
Solutions which contain 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.
To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with severe renal insufficiency or adrenal insufficiency, administration of potassium chloride may cause potassium intoxication.
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 exists edema with sodium retention.
In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.
Solutions containing lactate ions should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in severe hepatic insufficiency.
The intravenous administration of this solution can cause fluid and/or solute overloading 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 of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
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.
Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
Potassium replacement therapy should be guided primarily by serial electrocardiograms. Plasma potassium levels are not necessarily indicative of tissue potassium levels.
High plasma concentrations of potassium may cause death through cardiac depression, arrhythmias or arrest.
Potassium-containing solutions should be used with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.
Solutions containing lactate ions should be used with caution as excess administration may result in metabolic alkalosis.
Care should be exercised to insure that the needle (or catheter) is well within the lumen of the vein and that extravasation does not occur.
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Pregnancy Category C. Animal reproduction studies have not been conducted with dextrose, potassium chloride or Lactated Ringer’s Injection. It is also not known whether dextrose, potassium chloride or Lactated Ringer’s Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose, potassium chloride or Lactated Ringer’s Injection should be given to a pregnant woman only if clearly needed.
The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.
In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.
Reactions which may occur because of the solutions or 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.
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.
Nausea, vomiting, abdominal pain and diarrhea have been reported with potassium therapy. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest.
Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration. Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported.
Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once. Local infiltration of the affected area with procaine hydrochloride, 1%, to which hyaluronidase may be added, will often reduce venospasm and dilute the potassium remaining in the tissues locally. Local application of heat may also be helpful.
DOSAGE AND ADMINISTRATION
This solution should be administered only by intravenous infusion and as directed by the physician. The dose and rate of injection are dependent upon the age, weight and clinical condition of the patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium should be given at a rate not to exceed 10 mEq/hour in a concentration less than 30 mEq/liter. Somewhat faster rates and greater concentrations (usually up to 40 mEq/liter) of potassium may be indicated in patients with more severe potassium deficiency. The total 24-hour dose should not generally exceed 200 mEq of potassium.
As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
The presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)
INSTRUCTIONS FOR USE
Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Add Medication
Prepare additive port.
Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.
The additive port may be protected by covering with an additive cap.
Mix container contents thoroughly.
Preparation for Administration
(Use aseptic technique)
Close flow control clamp of administration set.
Remove cover from outlet port at bottom of container.
Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.
Suspend container from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber.
Open flow control clamp and clear air from set. Close clamp.
Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.
Intravenous solution with potassium chloride (I.V. solution with KCl) is supplied in single-dose flexible plastic container. See Table:
in Lactated Ringer’s
and 5% Dextrose
NDC No. 0409-7111-09 0990-7111-09
in Lactated Ringer’s
and 5% Dextrose
Injection, USP (Continued)
Approx. Ionic Concentrations (mEq/L)
(3.5 to 6.5)
ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time.
May contain HCl for pH adjustment.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
Revised: March, 2020
ICU Medical, Inc., Lake Forest, Illinois, 60045, USA
PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label
20 mEq POTASSIUM ADDED
in Lactated Ringer's
and 5% Dextrose
EACH 100 mL CONTAINS POTASSIUM CHLORIDE
179 mg; SODIUM CHLORIDE 600 mg; SODIUM
LACTATE, ANHYDROUS 310 mg; CALCIUM CHLORIDE,
DIHYDRATE 20 mg; DEXTROSE, HYDROUS 5 g IN
WATER FOR INJECTION. MAY CONTAIN HCl FOR
pH ADJUSTMENT. ELECTROLYTES PER 1000 mL
(NOT INCLUDING IONS FOR pH ADJUSTMENT):
POTASSIUM 24 mEq; SODIUM 130 mEq; CHLORIDE
129 mEq; CALCIUM 2.7 mEq; LACTATE 28 mEq.
563 mOsmol/LITER (CALC.)
pH 4.9 (3.5 to 6.5)
NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.
ADDITIVES MAY BE INCOMPATIBLE. CONSULT WITH
PHARMACIST, IF AVAILABLE. WHEN INTRODUCING
ADDITIVES, USE ASEPTIC TECHNIQUE, MIX
THOROUGHLY AND DO NOT STORE.
SINGLE-DOSE CONTAINER. FOR I.V. USE.
USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC.
USE ONLY IF SOLUTION IS CLEAR AND CONTAINER
IS UNDAMAGED. MUST NOT BE USED IN SERIES
ICU Medical, Inc.,
Lake Forest, Illinois, 60045, USA
INGREDIENTS AND APPEARANCE
POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE
potassium chloride, sodium chloride, calcium chloride, sodium lactate, and dextrose monohydrate injection, solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0990-7111 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 1.79 g in 1000 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 g in 1000 mL CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 0.2 g in 1000 mL SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE 3.1 g in 1000 mL DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 50 g in 1000 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0990-7111-09 12 in 1 CASE 11/25/2019 1 1 in 1 POUCH 1 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019685 11/25/2019 Labeler - ICU Medical Inc. (118380146) Establishment Name Address ID/FEI Business Operations Purac Biochem B.V. 405232687 API MANUFACTURE(0990-7111)