4.1. Therapeutic indications

Potassium Chloride Concentrate 15% is for use as a source of potassium for the treatment or prevention of potassium depletion in patients for whom dietary measures or oral medication are inadequate.

4.2. Posology and method of administration

Posology

Adults (including elderly) and Children:

Dosage depends on the serum ionogram value and the acid-base state. A potassium deficiency is calculated according to the formula:

MMOL Potassium = KG BW x 0.2 x 2 x (4.5 – actual serum potassium (MMOL)).

(The extracellular volume is calculated from the body weight in KG x 0.2).

The maximal rate of infusion is 20 MMOL potassium per hour.

It is recommended not to exceed 2-3 MMOL potassium per kg body weight in 24 hours.

Method of administration

Potassium Chloride Concentrate 15% must be administered by slow intravenous infusion, as a dilute solution.

Potassium Chloride Concentrate 15% must be diluted with not less than 50 times its volume by adding to a large volume intravenous fluid before use.

For example, 10mls diluted with not less than 500mls 0.9% Sodium Chloride Intravenous Infusion BP, or other suitable diluent, and mixed well.

4.3. Contraindications

• Hyperkalaemia

• Hyperchloraemia

• Impaired renal function with oliguria, anuria or azotaemia

• Addison's disease

• Acute dehydration

• Heat cramps

4.4. Special warnings and precautions for use

Potassium Chloride Concentrate 15% must bediluted before use.

Care should be taken to prevent extravasation during intravenous administration (see section 4.8).

Plasma potassium concentration must be measured at regular intervals to avoid the development of hyperkalaemia, especially in patients with renal impairment.

ECG monitoring facilities should be available.

Initial potassium replacement therapy should not involve glucose infusions, because glucose may cause a further decrease in the plasma potassium concentration.

Potassium supplements should be administered with caution in patients with cardiac disease and in patients who are receiving potassium sparing diuretics or other medications which may increase plasma potassium levels.

4.5. Interaction with other medicinal products and other forms of interaction

Potassium sparing diuretics:

Potassium supplements should not be administered with potassium sparing diuretics (such as amiloride, spironolactone and triamterene), particularly in patients with impaired renal function. Any patients on this combination require close monitoring in order to diagnose a potential hyperkalaemic condition as soon as possible.

Angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists:

Patients taking ACE-inhibitors or angiotensin II receptor antagonists, especially those with impaired renal function, should be closely monitored, as the potassium sparing effect in combination with potassium infusion may result in hyperkalaemia.

Ciclosporin:

Concurrent use of ciclosporin may increase the risk of hyperkalaemia.

Digoxin:

Potassium salts may be used cautiously in those taking digoxin where potassium depletion may cause arrhythmias.

Glucose Infusion:

Concomitant use of glucose infusions in hypokalaemic patients may cause a further decrease in plasma potassium concentrations.

4.6. Fertility, pregnancy and lactation

Potassium Chloride Concentrate 15% may be used during pregnancy and lactation under the supervision of the prescribing physician.

4.7. Effects on ability to drive and use machines

Not known.

4.8. Undesirable effects

System Organ Class

Frequency

Adverse events

Metabolism and nutrition disorders

Not known

Hyperkalaemia

Nervous system disorders

Not known

Paraesthesia1, paralysis1

Cardiac disorders

Not known

Cardiac arrhythmias1, cardiac arrest1

Vascular disorders

Not known

Phlebitis

Musculoskeletal and connective tissue disorders

Not known

Muscle weakness1

General disorders and administration site conditions

Not known

Extravasation2

Pain at the injection site

(1)As a complication of hyperkalaemia.

(2)Adverse events noted with extravasation in the post-marketing period include oedema, erythema, pain, and blistering, which could potentially result in skin/tissue necrosis.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Clinical signs and symptoms of potassium overdosage include:

Paraesthesia of the extremities, listlessness, mental confusion, weakness or heaviness of the legs, flaccid paralysis, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure, cardiac arrhythmias and heart block.

Extremely high plasma potassium concentrations (8-11 MMOL/litre) may cause death from cardiac depression, arrhythmias or arrest.

Treatment

Cardiac arrhythmias or a serum concentration above 6.5 MMOL/litre, require immediate attention and may be treated by intravenous injection over 1 – 5 minutes of 10 – 20 ml of 10% Calcium Gluconate Injection with ECG monitoring.

Serum concentrations of potassium may be reduced by infusion of 300 – 500 mls per hour of 10% - 25% glucose solutions containing up to 10 units of insulin for each 20 g of glucose, or by the infusion of sodium bicarbonate solution.