STERILE POTASSIUM CHLORIDE CONCENTRATE (15% W/V) BP

Posology The dosage should be adjusted according to the actual serum electrolyte concentrations and the acid base status and the individual requirements of the patient. v. solution prior to administration. 15 mmol potassium/kg body weight per hour).

3 mmol potassium/kg body weight per hour). If serum potassium levels are below 2 mmol per litre and continuous ECG monitoring is ensured, the infusion rate may be as high as 40 mmol per hour. 5 mmol/ kg body weight. 15 mmol potassium/ kg body weight per hour) Paediatric population Treatment of potassium deficiency In children, the solution must be diluted to a concentration of 20-40 mmol of KCl per litre before administration.

Maximum daily dose The maximum daily dose depends on the severity of potassium deficiency and overall condition of the individual patient. The maximum daily dose might therefore exceed the amount of potassium given as part of parenteral nutrition (see section “Potassium supplementation as part of parenteral nutrition” below).

Maximum infusion rate Symptomatic hypokalemia can be corrected at a maximal rate of 1 mmol/kg body weight per hour with a maximum rate of 20 mmol/h. 0 Children and infants after the first month of life must not receive more than 3 mmol per kg body weight per day.

Other special patient groups Changes in acid-base balance affect plasma concentrations. The demand of potassium is increased in compensation of ketoacidosis in diabetic patients and when glucose/insulin is given. 4). Only to be administered by infusion after dilution in suitable infusion solutions.

The potassium concentration in the infusion solution should normally not exceed 40 mmol per litre. If serum potassium levels in adults are below 2 mmol per litre the potassium concentration in the infusion solution may be as high as 80 mmol per litre.

6. As a matter of principle, infusion pumps should be used for the infusion of potassium in the setting of correction therapy.

Undesirable effects are listed according to their frequencies as follows:

Very 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 (Frequency cannot be estimated from the available data) Metabolism and nutrition disorders Not known: Acidosis, hyperchloraemia Cardiac disorders Not known: Too rapid infusion may provoke cardiac arrhythmia.

Gastrointestinal disorders Not known:

Nausea General disorders and administration site conditions Not known: Local reactions at the site of administration, including local pain, vein irritation, thrombophlebitis and extravasation 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Sterile Potassium Chloride Concentrate (15% w/v) BP should only be administered with caution in the presence of: ● Cardiac disease ● Disorders associated with potassium retention such as impaired renal function, Addison’s disease, sickle cell anaemia.

Treatment of patients with severe renal impairment and patients on dialysis must be consulted with nephrologist. 5. g. burn injuries) ● Hyperkalaemic familial periodic paralysis Sudden discontinuation of potassium administration may be followed by marked hypokalaemia, which may lead to increased toxicity of cardiac glycosides taken concomitantly.

Initial potassium replacement therapy must not include glucose infusions, because glucose may cause a further decrease in the plasma-potassium concentration. ECG monitoring should be available. 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. Refeeding syndrome Refeeding severely undernourished patients may result in the refeeding syndrome. Refeeding syndrome consists of hypophosphatemia which is often accompanied by hypokalaemia, hypomagnesaemia, fluid retention and hyperglycaemia.

Thiamine deficiency and fluid retention may also develop. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent these complications. Clinical monitoring should include checks of the serum electrolyte levels and the acid-base balance.

It must be made absolutely sure that the solution is administered intravenously, because paravenous administration may cause tissue necrosis. As a matter of principle, infusion pumps should be used for the infusion of potassium in the setting of correction therapy.

Elderly patients:

Elderly patients, who are more likely to suffer from cardiac insufficiency and renal impairment, should be closely monitored during treatment, and the dosage should be carefully adjusted.

Sterile Potassium Chloride Concentrate (15% w/v) BP must not be administered in case of: ● Hyperkalaemia, ● Hyperchloraemia,