This information is intended for use by health professionals

1. Name of the medicinal product

Sterile Potassium Chloride 20% w/v Concentrate for Solution for Infusion

2. Qualitative and quantitative composition

Potassium Chloride 20% w/v

Each 5ml of solution contains 1000 mg of potassium chloride, equivalent to approximately 13 mmol potassium ions

Each 10ml of solution contains 2000 mg of potassium chloride, equivalent to approximately 26 mmol potassium ions

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Concentrate for Solution for Infusion

A clear, colourless solution.

4. Clinical particulars
4.1 Therapeutic indications

Sterile Potassium Chloride 20% w/v Concentrate for Solution for Infusion is used as a source of the potassium cation for the treatment or prevention of potassium depletion in patients for whom dietary measures or oral medication are inadequate. Potassium salts may also be used cautiously in those taking digoxin where potassium depletion may cause arrhythmias. Sterile Potassium Chloride 20% w/v Concentrate for Solution for Infusion

4.2 Posology and method of administration

Dilute by adding to an appropriate volume of a suitable infusion fluid and mix well before use, to produce a potassium concentration of 20 mmol per litre and not more than 40 mmol per litre. Infuse at a rate not exceeding 20 mmol potassium per hour.

In the treatment of severe hypokalaemia or diabetic ketoacidosis, the higher concentration and a higher infusion rate may be required. In this case the infusion should be into a high blood flow vein and continuous ECG monitoring is advisable.

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).

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

Adults and the elderly

Up to 6g (80 mmol) daily, after dilution to a concentration of 20 mmol/litre and no greater than 40 mmol/litre.

Infants and children

Up to 3 mmol per kg per day, after dilution to a concentration of 20 mmol/litre.

Method of administration:

Slow intravenous infusion, as a dilute solution

4.3 Contraindications

Potassium Chloride is contraindicated in patients with:

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

• Hyperkalaemia

• Impaired renal function with oliguria, anuria or azotaemia

• Hyperchloraemia

• Addison's disease

• Acute dehydration and heat cramps

4.4 Special warnings and precautions for use

This product must not be injected undiluted. It must be diluted with sodium chloride intravenous infusion 0.9% w/v or other suitable diluent to a concentration not more than 40 mmol per litre, mixed well and given by slow intravenous infusion, under ECG control, ensuring adequate urine flow and with careful monitoring of electrolytes.

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

Potassium salts should be administered with considerable care to patients with renal and adrenal insufficiency, intestinal stricture, history of peptic ulcer, cardiac disease, acute dehydration, heat cramps, extensive tissue destruction as occurs with severe burns, or to patients receiving potassium sparing diuretics.

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

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.

Blood transfusions can contain significant serum potassium levels. If exchange resins or sodium cycles are administered with potassium supplements, serum potassium levels are reduced by sodium replacement of the potassium.

Hyperkalaemia can be very dangerous in digitalised patients and careful monitoring of serum potassium levels is very important.

Hyperkalaemia may also result from concurrent use of thiazide diuretics, tacrolimus, β-Adrenoceptor blockers, non-steroidal anti-inflammatory drugs and drugs that contain potassium, such as the potassium salts of penicillin.

Potassium can enhance the antiarrhythmic effect of quinidine.

Concurrent use of adrenocorticoids, glucocorticoids and mineralocorticoids may all decrease the effects of potassium supplements.

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

Sterile Potassium Chloride 20% w/v concentrate for solution for infusion may be used during pregnancy and lactation under the supervision of the prescribing physician.

4.7 Effects on ability to drive and use machines

None stated

4.8 Undesirable effects

Metabolism and Nutrition disorders: Hyperkalaemia is the most common and serious hazard of potassium therapy.

Cardiac disorders: Rapid infusion can be toxic to the heart. Cardiac arrhythmias may occur.

Gastrointestinal disorders: Nausea and vomiting (severe symptoms may indicate obstruction), oesophageal or small bowel ulceration.

General disorders and administration site conditions: Pain at the injection site and phlebitis may occur during IV administration of solutions at concentrations in excess of about 30 mmol of potassium per litre.

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

Clinical signs and symptoms of potassium overdosage include: paraesthesia of the extremities, listlessness, mental confusion, muscle 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: In the event of hyperkalaemia, discontinue all potassium containing medications and foods. If the condition is serious then intravenous glucose and insulin may be necessary to facilitate the transfer of potassium into the cells. Serum concentrations 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.

The administration of calcium gluconate (though not to digitalised patients) may be needed to antagonise cardiotoxic effects. 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 E.C.G. monitoring.

If hyperkalaemia is very severe, techniques such as haemodialysis, peritoneal dialysis or the use of ion exchange resins may be necessary to rapidly lower the potassium level.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Electrolyte solutions

ATC Code: B05XA01

Potassium is the major cation of intracellular fluid and is essential for maintenance of acid-base balance, isotonicity and the electrodynamic characteristics of the cell. Potassium chloride is used as a source of the potassium cation for treatment or prevention of potassium depletion in patients in whom dietary measures are inadequate. Potassium chloride may also be used cautiously to abolish arrhythmias or cardiac glycoside toxicity precipitated by a loss of potassium.

5.2 Pharmacokinetic properties

Distribution:

Potassium is quickly transferred to the intracellular fluid by an active transport system which maintains high levels within cells. Extracellular fluid contains 4 – 5 mmol/litre. Intracellular fluid contains 150 mmol/litre.

Elimination:

The capacity of the kidneys to conserve potassium is poor and urinary excretion of potassium continues even when there is severe depletion. Tubular secretion of potassium is influenced by several factors, including chloride ion concentration, hydrogen ion exchange, acid-base equilibrium and adrenal hormones. Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules in exchange for sodium or hydrogen ions. Some potassium is excreted in the faeces, and small amounts may also be excreted in sweat, saliva, bile and pancreatic juice.

5.3 Preclinical safety data

No further information other than that which is included in the Summary of Product Characteristics.

6. Pharmaceutical particulars
6.1 List of excipients

Dilute hydrochloric acid (for pH adjustment)

Potassium hydroxide (for pH adjustment)

Water for Injections

6.2 Incompatibilities

The compatibility of the large volume IV fluid intended for dilution should be checked before use.

6.3 Shelf life

Unopened: 36 months

Once opened: dilute and use immediately

After dilution: From a microbiological point of view, dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Clear Ph Eur type I glass ampoules containing 5ml or 10ml of solution.

The ampoules are packed in cartons to contain 10 ampoules.

6.6 Special precautions for disposal and other handling

Do not use unless the solution is clear and practically free from particles.

For single use only.

Potassium chloride concentrate must be diluted before use by not less than 70 times its volume with sodium chloride 0.9% w/v intravenous infusion or another suitable solution for infusion, to a maximum concentration of 40 mmol potassium per litre.

The solution must be mixed well before use.

Discard any unused portion.

7. Marketing authorisation holder

Macarthys Laboratories Ltd

T/A Martindale Pharma

Bampton Road

Harold Hill

Romford

Essex

RM3 8UG

8. Marketing authorisation number(s)

PL 01883/6185R

9. Date of first authorisation/renewal of the authorisation

Date of first Authorisation: 10 May 1989

Date of latest renewal: 14 July 2005

10. Date of revision of the text

10/08/2018