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Prescribing information for Potassium Chloride in 0.45% Sodium Chloride Injection, USP, including indications, contraindications, warnings, precautions, and storage instructions. It also includes information on the product's composition, packaging, and administration.
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VIAFLEX Container
20 mmol/L Potassium Chloride in 0.45% Sodium Chloride Injection
Solution for Infusion Solutions Affecting the Electrolyte Balance
Mississauga, ON L5N 0C
Date of Revision: Dec. 10, 2018
Control No. 221539
For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Potassium Chloride in 0.45% Sodium Chloride Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Hypersensitivity reactions
Hypersensitivity/infusion reactions, including anaphylaxis, have been reported with other products containing potassium chloride and sodium chloride. Stop the infusion immediately if signs or symptoms of hypersensitivity/infusion reactions develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated (see CONTRAINDICATIONS ).
Hyperkalemia
Potassium Chloride in 0.45% Sodium Chloride Injection, USP should be administered with caution, to patients with conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury or burns, certain cardiac disorders such as congestive heart failure or AV block (especially if they receive digitalis), potassium-aggravated skeletal muscle channelopathies (e.g., hyperkalemic periodic paralysis, paramyotonia congenita, and potassium-aggravated myotonia/paramyotonia), Potassium Chloride in 0.45% Sodium Chloride Injection, USP should be administered with caution to patients who are at risk of experiencing hyperosmolality, acidosis, or undergoing correction of alkalosis (conditions associated with a shift of potassium from intracellular to extracellular space) and patients treated concurrently or recently with agents or products that can cause hyperkalemia (see DRUG INTERACTIONS ).
Hyperkalemia can cause cardiac conduction disorders (including complete heart block) and other cardiac arrhythmias at any time during infusion. Continuous ECG monitoring may be necessary to aid in the detection of cardiac arrhythmias due to hyperkalemia (see ADVERSE REACTIONS ).
Frequently, mild or moderate hyperkalemia is asymptomatic and may be manifested only by increased serum potassium concentrations and, possibly, characteristic ECG changes. However, fatal arrhythmias can develop at any time during hyperkalemia.
Sodium retention, fluid overload, edema, and metabolic disorders
Potassium Chloride in 0.45% Sodium Chloride Injection, USP should be used with particular caution, in patients with or at risk for: Conditions that may cause sodium retention, fluid overload and edema (central and peripheral), such as patients with
Regarding medications that increase the risk of Hyponatremia or sodium and fluid retention, see DRUG INTERACTIONS.
Serum electrolytes and water imbalance
Depending on the volume and rate of infusion and depending on a patient’s underlying clinical condition, intravenous administration of Potassium Chloride in 0.45% Sodium Chloride Injection, USP can cause: Electrolyte disturbances such as
Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid–base balance during prolonged parenteral therapy or whenever the condition of the patient or dosage and rate of administration warrants such evaluation.
Hyponatremia
Monitoring of serum sodium is particularly important for hypotonic fluids. Potassium Chloride in 0.45% Sodium Chloride Injection, USP has an osmolarity of 194 mOsmol/L.
High volume infusion must be used under specific monitoring in patients with cardiac or
Pregnancy and Lactation
Pregnancy Category C. Animal reproduction studies have not been conducted with Potassium Chloride in 0.45% Sodium Chloride Injection, USP. It is also not known whether Potassium Chloride in 0.45% Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
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 0.45% Sodium Chloride Injection, USP is administered to a nursing mother.
There are no adequate data from the use of Potassium Chloride in 0.45% Sodium Chloride Injection, USP in pregnant or lactating women. Healthcare providers should carefully consider the potential risks and benefits for each specific patient before administering Potassium Chloride in 0.45% Sodium Chloride Injection, USP.
Pediatrics
The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy, and should be determined by a physician experienced in pediatric intravenous fluid therapy. Safety and effectiveness of Potassium Chloride in 0.45% Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well-controlled studies. However, the use of potassium chloride injection in pediatric patients to treat potassium deficiency states when oral replacement therapy is not feasible is referenced in the medical literature.
Pediatric Hyponatremia-related issues
Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy. The infusion of Potassium Chloride in 0.45% Sodium Chloride Injection, USP together with the non-osmotic secretion of ADH (antidiuretic hormone) may result in hyponatremia. Plasma electrolyte concentrations should be closely monitored in the pediatric population.
Geriatric use
When selecting the type of infusion solution and the volume/rate of infusion for a geriatric patient, consider that geriatric patients are generally more likely to have cardiac, renal, hepatic, and other diseases and/or concomitant drug therapy.
Adverse Drug Reaction Overview 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.
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.
Symptoms may result from an ion excess or deficit, therefore frequent monitoring of electrolyte levels is essential.
Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain, and diarrhea.
Signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, and cardiac arrest.
Potassium-containing solutions are irritating to tissues, therefore extreme care should be taken to avoid perivascular infiltration.
Post-Marketing Adverse Reactions
Other (Class) Reactions
IMMUNE SYSTEM DISORDERS : Hypersensitivity
METABOLISM AND NUTRITIONAL DISORDERS : Hyperkalemia, Hyponatremia, Hypernatremia, Acidosis hyperchloremic, Fluid overload
CARDIAC DISORDERS: Cardiac arrest as a manifestation of rapid intravenous administration and/or of hyperkalemia.
NERVOUS SYSTEM DISORDERS: Hyponatremic encephalopathy
DRUG INTERACTIONS
Drug-Drug Interactions
No studies have been conducted by Baxter Healthcare Corporation. Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be increased during administration
Frequent laboratory determinations and clinical evaluations are essential to monitor changes in blood glucose, electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.
Fluid administration should be based on calculated maintenance of replacement fluid requirements for each patient. In the average adult, daily requirements of sodium, chloride, potassium and fluids can generally be met by the infusion of two litres of 0.45% sodium chloride solution with 20 mmol of potassium chloride.
Administration
To avoid potassium intoxication, do not infuse solutions rapidly.
Infusion rates for the administration of potassium-containing solutions generally should not exceed 10 mmol per hour or 120 mmol per day. The maximum rate of infusion should not exceed 20 mmol per hour in the absence of cardiac monitoring.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Use of an in-line filter is recommended during administration of all parenteral solutions, where possible.
Potassium Chloride in 0.45% Sodium Chloride Injection, USP in VIAFLEX plastic containers should be infused intravenously using sterile equipment.
The osmolarity of a final admixed infusion solution must be taken into account when peripheral administration is considered. Hyperosmolar solutions may cause venous irritation and phlebitis. Thus, clinically significant Hyperosmolar solutions are recommended to be administered through a large central vein, for rapid dilution of the Hyperosmolar solution. For osmolarity and pH of Potassium Chloride in 0.45% Sodium Chloride Injection, USP please refer to the Table 1.
Rapid correction of hyponatremia and hypernatremia is potentially dangerous (risk of serious neurologic complications).
INSTRUCTIONS FOR USE AND HANDLING AND DISPOSAL
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Before adding a substance or medication, verify that it is soluble and stable in Potassium Chloride in 0.45% Sodium Chloride Injection, USP, and that the pH range of Potassium Chloride in 0.45% Sodium Chloride Injection, USP is appropriate. Additional electrolyte supplementation may be indicated according to the clinical needs of the patient. When introducing additives to Potassium Chloride in 0.45% Sodium Chloride Injection, USP, the instructions for use of the medication to be added and other relevant literature must be consulted. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is
deemed advisable to introduce additives, use aseptic technique. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Mix thoroughly when additives have been introduced. Do not store solutions containing additives. Discard any unused portion. For single use only.
DIRECTIONS FOR USE OF VIAFLEX PLUS PLASTIC CONTAINER
Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
To Open:
Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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. Check for minute leaks by squeezing inner bag firmly. In the case of damage, the container should be discarded If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.
Preparation for Administration:
Warning: Additives may be incompatible.
To add medication before solution administration
To add medication during solution administration
Mechanism of Action Potassium Chloride in 0.45% Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
STORAGE AND STABILITY
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (15oC-30oC); brief exposure up to 40 oC (104oF) does not adversely affect the product.
DOSAGE FORMS, COMPOSITION AND PACKAGING
Description
Potassium Chloride in 0.45% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1.
Table 1
Size (mL)
Composition (g/L)
*Osmolarity (mOsmol/L)(Calc.)pH
Ionic Concentration (mmol/L)
Sodium Chloride, USP(NaCl)Potassium Chloride, USP(KCl) Sodium PotassiumChloride 20 mmol/L Potassium Chloride in 0.45% Sodium Chloride 1000 4.5 1.5 (^194) (3.5 to 6.5)5.5 77 20 97
Potassium Chloride in 0.45% Sodium Chloride Injection, USP in VIAFLEX Plus Plastic Container is available as follows:
Code Size (mL) Product Name
JB1357 1000 20 mmol/L Potassium Chloride in 0.45% Sodium Chloride Injection
The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Date of Revision. Dec. 10, 2018
Baxter Corporation Mississauga, ON L5N 0C
Baxter, and Viaflex are trademarks of Baxter International Inc.
For Product Information 1-800-933-
