POTASSIUM CHLORIDE

1 mg K + The dosage of this solution depends on the age, weight, clinical and biological (acid- base balance) conditions of the patient, concomitant therapy and in particular the patient's hydration state. 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 3 litres/24 h - 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 - Adults, Older people and Adolescents:

Typical dose of potassium for the prevention of hypokalaemia may be up to 50 mmol daily and similar doses may be adequate in mild potassium deficiency. When used for treatment of hypokelaemia, the recommended dosage is 20 mmol of potassium over 2 to 3 hours (i.

e. 7-10 mmol/h) under ECG control. /h. The dose has to be adjusted on frequently obtained lab values. /day. - Patients with renal impairment Patients with renal impairment should receive lower doses. Method of Administration Route 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.

Solutions containing potassium should be administered slowly. Rate of administration As administered intravenously, potassium should not be given faster than 15 to 20 mmol/h to avoid a dangerous hyperkalaemia. In any case, the dosage given under “General Posology” should not be exceeded.

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. System Organ Class (SOC) MedDRA Preferred Term Infections and infestations Injection site infection(1) Metabolism and nutrition disorders Hypervolemia(1) General disorders and administration site conditions Extravasation(1) Injection site irritation(1) Injection site pain(1) Injection site phlebitis(1) Injection site reaction(1) Injection site thrombosis(1) Pyrexia(1) (1)Adverse reactions that may be associated with the technique of administration In case of undesirable effect(s), the infusion must be discontinued Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

9% w/v is a hypertonic solution, with an approximate osmolarity of 388 mOsm/l. Administration should be carried out under regular and careful surveillance. Regular monitoring of clinical status, plasma electrolyte concentrations, plasma creatinine levels, BUN level, acid-base balance and ECG is essential in patients receiving potassium therapy, particularly those with cardiac or renal impairment.

Adequate urine flow should be ensured and fluid balance should be monitored. 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).

hyperkalaemia, hyperchloraemia or hypernatraemia - severe renal insufficiency (with oliguria/anuria) - uncompensated cardiac failure - Addison’s disease