Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Potassium chloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR Potassium Chloride Concentrate belongs to a group of medicines called electrolyte replacement solutions. Electrolytes are a group of chemicals and salts that are in the body fluids. Potassium Chloride Concentrate is used in patients needing additional amounts of potassium.
POTASSIUM CHLORIDE CONCENTRATE You should not be given Potassium Chloride Concentrate if:
Talk to your doctor or nurse before you are given Potassium Chloride Concentrate if you:
POTASSIUM CHLORIDE CONCENTRATE POTCHLORIDE Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Potassium Chloride Concentrate is diluted and then slowly dripped through a needle into a vein. The process may take an hour or more depending on your dose. Your doctor will decide the best dose for you. While this medicine is being injected, your ECG (electrocardiogram, measuring the heart) should be monitored continuously. If you are given more Potassium Chloride Concentrate than you should As Potassium Chloride Concentrate is administered by a healthcare professional it is unlikely that you will be given too much. If you think you have been given too much medicine, tell your doctor. The likely signs of an overdose are the occurrence of side-effects as listed below. In this event, you will be treated in the hospital and you will be given the necessary treatment.
If you miss a dose of Potassium Chloride Concentrate This is unlikely as the injection is given by a healthcare professional but if you are concerned about missing a dose speak to your doctor.
. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. The most likely side-effects are:
Potassium Chloride concentrate 6. Contents of the pack and other information
. FURTHER INFORMATION The active substance is potassium chloride. The other ingredient is Water for Injections. Potassium Chloride must be diluted before use to not less than fifty times its volume of sodium chloride injection or other suitable liquids for dilution. What Potassium Chloride Concentrate looks like and contents of pack Potassium Chloride Concentrate is a clear, colourless, sterile aqueous solution for injection. Each 10ml glass ampoule contains 15%w/v (1.5g) of active ingredient, potassium chloride. Potassium Chloride Concentrate is supplied in pack of 10 ampoules. Marketing Authorisation Holder Mercury Pharmaceuticals Limited, Dashwood House, 69 Old Broad Street,
London, EC2M 1QS, United Kingdom Manufacturer B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany. This leaflet was last revised in December 2023.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For use in patients requiring supplemental potassium therapy.
Posology
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.
Method 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.
1.) Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
2.) Sterile Potassium Chloride Concentrate should never be used undiluted.
3.) Hyperkalaemia (plasma-potassium concentration above 5 mmol/litre).
4.) Hyperchloraemia,
5.) Impaired renal function with oliguria, anuria or azotaemia
6.) Addison's disease,
7.) Acute dehydration
8.) Heat cramps.
Administration – see also section 4.2
• Only use with specialist advice
• ECG should be used throughout and monitored continuously
• High concentrations of potassium cause serious cardiotoxicity, so the concentration of the solution should not exceed 3g (40mmol)/L and the diluted solution given slowly (maximal rate 20mmol/L)
• Initially do not use with glucose infusions – glucose may further decrease potassium levels
Other concurrent treatment – also see section 4.5
• Extreme caution in patients on potassium sparing diuretics and other drugs that may increase potassium
• Glucose infusion – see above Administration
Monitoring
• Continuous ECG monitoring – see above Administration
• Regular potassium levels especially in patients with renal impairment (see section 4.3)
Underlying conditions – see also section 4.3
• Dehydration must be corrected to ensure adequate urinary output (and potassium excretion)
• Where renal excretion of potassium or cellular uptake deficient – life threatening hyperkalaemia can occur with standard doses
• Extreme caution with extensive tissue destruction (eg burns)
• Extreme caution in cardiac disease
Increased risk of severe hyperkalaemia with the following
• ACE-inhibitors
• Aliskerin
• Angiotensin-II receptor anatagonists
• Potassium sparing diuretics such as: amiloride, spironolactone and triamterene and aldosterone antagonists
• Ciclosporin
• Tacrolimus (not topical formulations)
Particularly close monitoring required with these (see section 4.4) and any other medicines or conditions that may increase potassium levels
Further reductions in potassium occurs with glucose infusions – see also section 4.4
Potassium chloride should be used during pregnancy or lactation only under the supervision of the prescribing physician if considered essential by the physician.
System Organ Class
Frequency
Adverse events
Metabolism and nutrition disorders
Not known
Hyperkalaemia1
Nervous system disorders
Not known
Paraesthesia1, paralysis1
Cardiac disorders
Not known
Cardiac arrhythmias1, cardiac arrest1
Vascular disorders
Not known
Phlebitis2, hypotension1
Musculoskeletal and connective tissue disorders
Not known
Muscle weakness1
General disorders and administration site conditions
Not known
Pain2
1Excessive intake of potassium.
2Pain at the injection site and phlebitis may occur during IV administration of solutions containing 30 mmol potassium or more 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 viavia Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine
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, 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
Ask anything about Potassium Chloride Concentrate BP, 15% w/v, 1.5g in 10ml. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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