POTASSIUM CHLORIDE

8). Monitoring of serum sodium is particularly important for hypotonic fluids. g. 4. 8). 1 mg K+ General posology The recommended dosage for treatment of isotonic fluid depletion (extracellular dehydration) by means of any intravenous solution is: - for adults : 500 ml to 3Liters /24h - for babies and children : 20 to 100 ml per 24 h and per kg of body weight, depending of the age and the total body mass.

Posology for prevention and treatment of potassium depletion Typical dose of potassium for the prevention of hypokalemia may be up to 50 mmoles daily and similar doses may be adequate in mild potassium deficiency. The maximal recommended dose of potassium is 2 to 3 mmol/kg/24h.

e. 7-10 mmol/h) under ECG control. The maximum recommended administration rate should not exceed 15-20 mmol/h. Patient with renal impairment should receive lower doses. In any case, the dosage given under “general posology” should not be exceeded.

Method of Administration The administration is performed by intravenous route using sterile and non- pyrogenic equipment. Intravenous potassium should be administered in a large peripheral or central vein to diminish the risk of causing sclerosis.

If infused through central vein, be sure the catheter is not in the atrium or ventricle to avoid localized hyperkalaemia. 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. Additional electrolyte supplementation may be indicated according to the clinical needs of the patient.

6). Risk of air embolism Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Rate of administration Solutions containing potassium should be administered slowly. As administered intravenously, to avoid a dangerous hyperkalemia potassium should not be given faster than 15 to 20 mmoles/h. 4). Monitoring Adequate urine flow must be ensured and careful monitoring of plasma- potassium and other electrolyte concentrations is essential.

High dosage or high speed infusion must be performed under ECG control.

The following adverse reactions have been reported spontaneously during Post-Marketing use of the product. The frequencies cannot be estimated due to the nature of the data. 5). Adverse reactions may be associated to the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Other adverse reactions reported with other potassium chloride and sodium chloride formulations include: hypersensitivity, hyperkalemia, acidosis hyperchloremic and cardiac arrest as a manifestation of rapid intravenous administration and/or of hyperkalemia.

In case of undesirable effect(s), the infusion must be discontinued.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

9% w/v solution for infusion is a hypertonic solution. 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. 9% w/v Solution for infusion can cause:  electrolyte disturbances such as - Hypernatremia, - Hyponatremia (see use in patients at risk for sodium imbalance).

 acid–base imbalance. , pulmonary congestion) and peripheral edema. 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 the rate of administration warrants such evaluation.

High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatraemia (see below).

g. 5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids. Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea, seizures, lethargy and vomiting.

Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury. g. meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

Potassium salts should be administered with considerable care to patients with cardiac disease or conditions predisposing to hyperkalaemia such as renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns.

In patients under digitalis therapy, regular monitoring of the plasma potassium level is mandatory. 5 – Interactions with other medicinal products and other forms of interaction). Pediatric use 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.

Elderly use When selecting the type of infusion solution and the volume/rate of infusion for an elderly patient, consider that elderly patients are generally more likely to have cardiac, renal, hepatic, and other diseases and/or concomitant drug therapy.

9% w/v solution for infusion is contra-indicated in patients with: - known hypersensitivity to the product - documented hyperkalaemia, hyperchloraemia or hypernatraemia - severe renal insufficiency (with oliguria/anuria) - uncompensated cardiac failure - Addision’s disease