POTASSIUM CHLORIDE

Posology The dosage is dependent on age, weight and clinical condition of the patient, especially in patients with renal or cardiac insufficiency. Dosage and rate of infusion should be determined by ECG and serum electrolyte monitoring.

Adequate urine flow must be ensured. 9% w/v is particularly adapted for fluid restricted patients. Adults The following recommendations are general guidelines on potassium. 5 mmol/l The maximum recommended dose of potassium is 2 – 3 mmol/kg body weight (BW)/24 h.

4). Generally, the maximum potassium substitution rate is 20 mmol per hour. 35 mmol/l/h. Duration of use This medicinal product may be administered as long as there is an indication for potassium administration. Maximum daily dose The maximum recommended dose of potassium is 3 mmol/kg BW per 24 hours.

In any case the limits for daily fluid intake must not be exceeded. Paediatric population The volume and rate of infusion will depend upon the requirements of the individual patient. Reduced volumes and rates of infusion may be required.

5 mmol/kg BW per hour should not be exceeded. Elderly patients Basically, the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age.

See section 4. Method of administration Intravenous use. 9% w/v must be used only via a central venous route. Slow intravenous infusion at a rate normally not exceeding 20 mmol potassium per hour using an infusion pump. 0 mmol/l or where severe hypokalemia is a threat, rates up to 40 mmol per hour or 400 mmol over a 24 hour period can be administered very carefully when infused via a central vein to diminish the risk of causing sclerosis and when guided by continuous monitoring of the ECG and frequent serum K+ determinations to avoid hyperkalemia and cardiac arrest.

Ensure that the catheter is not in the atrium or ventricle to avoid localized hyperkalaemia. As a matter of principle, infusion pumps should be used for the infusion of potassium in the setting of correction therapy.

Summary of the safety profile Adverse reactions which may occur are related to the potassium content of the solution. common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse events Cardiac disorders Not known Too rapid infusion may provoke cardiac arrhythmias General disorders and administration site conditions Not known Local reactions at the infusion site, including local pain, venous irritation and occasionally thrombophlebitis may occur 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 should only be administrated with caution in cases of: • hypernatraemia • disorders where restriction of sodium intake is indicated, such as cardiac insufficiency, generalized oedema, pulmonary oedema, hypertension, pre- eclampsia, severe renal insufficiency.

g. burn injuries) • hyperhydration Care must be exercised in the administration of large volume infusion of solution to patients with oedematous states or pulmonary oedema. Solutions containing potassium should be administered slowly and only after renal function has been established and proved adequate.

In patients with renal impairment, its use must be carefully controlled by frequent determinations of plasma potassium concentrations and periodic ECGs. The infusion must be discontinued if signs of renal insufficiency develop during infusion.

5). There are typical changes in the ECG when the potassium balance is disturbed (hypo- or hyperkalaemia). However, there is no linear relationship between the ECG changes and the concentration of potassium in the blood. Sodium chloride supplementation must be exercised slowly in patients with chronic hyponatraemia as too rapid correction of serum sodium levels may in rare cases lead to osmotic side effects.

9% w/v is hypertonic. The administration of a substantially hypertonic solution may lead to a variety of complications such as crenation (shrinkage) of red blood cells and general cellular dehydration. It should be administered with care in patients with hypertonic dehydration.

Special caution must be exercised if the solution is administered to acidotic patients as a decrease of serum pH (acidosis) is frequently accompanied by an increase in serum potassium. Caution should be exercised when the solution is administered to patients with Addison’s disease as these patients are predisposed to hyperkalaemia.

It must be made absolutely sure that the solution is administered intravenously, because paravenous administration may cause tissue necrosis. Clinical supervision should include ECGs, regular checks of fluid balance and serum electrolytes.

1. • Hyperkalaemia • Hyperchloraemia • Severe hypernatraemia • Severe renal impairment with oliguria and anuria