POTASSIUM CHLORIDE

1 Dosing Considerations  The dose and rate of administration are dependent upon the specific condition of each patient. 5 mEq/L. 0 mEq/L and ECG changes and/or muscle paralysis) rates up to 40 mEq/hour or 400 mEq over a 24 hour period can be administered very carefully when guided by continuous monitoring of the ECG and frequent serum K+ determinations to avoid hyperkalemia and cardiac arrest.

Health Canada has not authorized an indication for pediatric use. 4 Administration For intravenous use only. Administer only with a calibrated infusion device at a slow, controlled rate. The higher concentrations (300 mEq/L and higher) should be exclusively administered via central intravenous route.

Because pain and phlebitis associated with peripheral infusion of potassium chloride solutions has been reported, administration via a central route for all concentrations is recommended for thorough dilution by the blood stream and avoidance of extravasation.

Correct placement of the catheter should be verified before administration. Parenteral drug products should be inspected visually for particulate matter and discolouration, whenever solution and container permit. Do not administer unless the solution is clear, and the seal is intact.

Use of a final filter is recommended during administration of all parenteral solutions where possible. Do not add supplementary medication. 5 Missed Dose If you miss your scheduled infusion, contact your doctor or nurse as soon as possible to schedule your next treatment.

1 Adverse Reaction Overview Potassium intoxication with mild or severe hyperkalemia has been reported. The signs and symptoms of intoxication include paresthesia of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmia, heart block, electrographic abnormalities and cardiac arrest.

0 mEq/L; loss of P waves, widening of the QRS complex, and eventual asystole occurs with higher elevations. Nausea, vomiting, abdominal pain and diarrhea have been reported with the use of potassium-containing solutions. 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, and institute appropriate therapeutic countermeasures. Pain associated with peripheral infusion of potassium chloride solution has been reported. 5 Post-Market Adverse Reactions The following adverse reactions have been reported in the post-marketing experience.

Events are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible. Table 2 – Post-market adverse reactions reported by MedRA.

Immune System Disorders:

Hypersensitivity, as manifested by rash and angioedema Metabolism And Nutrition Disorders: Hyperkalemia Cardiac Disorders: Cardiac arrest*, Asystole*, Ventricular fibrillation*, Bradycardia Respiratory, Thoracic, And Mediastinal Disorders: Dyspnea General Disorders And Administration Site Conditions: Chest pain, Infusion site pain, Infusion site irritation, Burning sensation * as a manifestation of rapid intravenous administration and/or of hyperkalemia Class Reactions Other adverse reaction associated with administration of concentrated potassium chloride solutions include:  In association with extravasation: Skin necrosis, Skin ulcer, Soft tissue necrosis, Muscle necrosis, Nerve injury, Tendon injury, and Vascular injury  In association administration: Infusion site thrombosis, Infusion site phlebitis, Infusion site swelling, Infusion site erythema, hyponatremia, hyponatremic encephalopathy.

01/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES............................................................................................

2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................

4 1 INDICATIONS .............................................................................................................. 1 Pediatrics (< 16 years of age):.............................................................................

2 Geriatrics (> 65 years of age): ............................................................................. 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................

5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment.....................................................

4 Administration....................................................................................................... 5 Missed Dose ..........................................................................................................

6 5 OVERDOSAGE ............................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS ..................................................................................

 Potassium Chloride Injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING.

, in congenital paramyotonia or adynamia episodica hereditaria) Product Monograph Master Template Template Date: September 2020 Potassium Chloride Injection Page 5 of 20  Hyperadrenalism associated with adrenogential syndrome.  Digitalis-induced second- or third-degree heart block is the only type of dysrhythmia in which potassium is contraindicated.