POTASSIUM CHLORIDE Concentrate for solution for infusion Ref.[7041] Active ingredients: Potassium chloride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Therapeutic indications

For use in patients requiring supplemental potassium therapy.

Posology and method of administration

Route of administration: Intravenous, after dilution.

Before administering Sterile Potassium Chloride Concentrate:

  1. This solution must be diluted with not less than 50 times its volume of sodium chloride solution or other suitable diluent.
  2. The solution should be carefully mixed with the infusion fluid.

During administration:

  1. The diluted injection should be administered by slow intravenous infusion at a maximal rate of 20mmol of potassium per hour.
  2. The ECG should be monitored continuously.

The goal of potassium replacement therapy is to elevate the plasma concentration of the ion to within the normal range.

Dose per hour: The maximal rate of intravenous infusion is 20mmol/hour.

Dose per day: Since the normal dietary intake of potassium is 50 to 100mmol daily, it is rare that a larger amount is required during potassium replacement therapy.

Overdose

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, due to which patients may deteriorate rapidly.

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

All drugs containing potassium should be withdrawn and potassium-sparing diuretics discontinued.

Treatment

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.

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 B.P. with E.C.G. monitoring. Mild hyperkalaemia may be treated with sodium polystyrene sulphonate, a cation-exchange resin administered by mouth or as an enema. If the above measures fail, haemodialysis or peritoneal dialysis may be required.

Monitoring:

  • Measure urea, electrolytes and creatinine.
  • Monitor potassium levels regularly (2 to 3 hourly if raised).
  • Continuous 12 lead ECG.
  • Observe asymptomatic patients for at least 6 hours.

Shelf life

5 years (60 months).

Special precautions for storage

Keep in outer carton.

Do not store above 25°C.

Nature and contents of container

10ml, clear Open point cut (OPC) glass ampoules, glass type 1 Ph.Eur. packed in cardboard cartons to contain 10 × 10ml ampoules.

Special precautions for disposal and other handling

Warning: Must be diluted before use.

Dilute before use with not less than 50 times its volume of Sodium Chloride Injection or another suitable diluent. Discard
if cloudy or deposit present.

Use as directed by the physician.

If only part used, discard the remaining solution.

Keep out of reach of children.

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