Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v Solution for Infusion
⚠ This medicine appears to have been discontinued
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, Sodium chloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for This medicine contains a solution of potassium chloride and sodium chloride. It is administered to you through a tube placed into a vein (intravenous drip). This medicine is used in patients needing restoration of potassium level. Potassium helps your muscles, heart and other organs to work properly. Without the right amount of potassium your heart may start to beat abnormally, which could be life-threatening.
What you need to know before you take it
e Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v Do not use Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v:
- if you are allergic to potassium chloride or any of the other ingredients of this medicine
- if you have high levels of potassium (hyperkalaemia)
- if you have high levels of chloride in your blood (hyperchloremia)
- if you have too high levels of sodium in your blood (severe hypernatraemia)
- if you have severe kidney disease Warnings and precautions Talk to your doctor before you are given Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v Solution for Infusion. Special care is necessary:
- if you have high levels of sodium in your blood (hypernatraemia)
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• • • •
if you have any other condition where your sodium intake must be low, like heart failure, swelling, water on your lungs, high blood pressure, pre-eclampsia (see section "Pregnancy and breast-feeding") or severe kidney disease if you have a shock if you suffer from severe tissue damage, such as in burn injuries if you have too much water in your body (hyperhydration)
Before or when giving you this medicine, your doctor will pay special attention to the following:
- Swelling of the lower limbs (oedematous states) or water on your lungs (pulmonary oedema): If you have one of these conditions, you will be given large amounts of this medicine only carefully.
- Kidney function: You will receive this medicine as a slow intravenous drip after your doctor has made sure that your kidneys are working properly. If they don't do so, your potassium blood levels and your ECG will be monitored while you receive this medicine. Your doctor will make sure to stop the infusion in case your condition worsens.
- Heart disease: If you suffer from a heart disease, this medicine will be given to you with caution. If you have high levels of acidic substances in your blood your doctor will take special care when giving you this solution. Your doctor will take special care if you have Addison's disease (a specific disease of the adrenal gland) as your potassium levels might become too high. It will be made absolutely sure that the solution is administered into your vein in order to avoid tissue damage. Your ECG, your fluid balance, the salts in your blood and your level of glucose will be checked regularly while you are receiving this medicine. Children: This medicine will be given to children only with special caution. In addition, their salt and fluid balance will be closely monitored. Elderly patients, who are more likely to suffer from heart and kidney problems, will be closely monitored during treatment and the dosage will be carefully adjusted. Other medicines and Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v Tell your doctor if you are taking, have recently taken or might take any other medicine. In particular, your doctor will pay attention to: Medicines for treatment of heart weakness (digoxin, cardiac glycosides): The effects of these medicines will become weaker when the blood potassium level rises. They will become stronger (possibly with irregular heartbeat) when your blood potassium level decreases. Medicines that contain potassium or may lead to high potassium levels in your blood, such as:
- potassium-sparing medicines e.g. spironolactone or triamterene (medicines that increase urine flow)
- ACE inhibitors (medicines to treat high blood pressure or heart failure)
- AT1-receptor antagonists (a type of antihypertensive medicine)
- non-steroidal anti-inflammatory agents (medicines used as painkillers or to treat inflammation)
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• • •
cyclosporine, tacrolimus (medicines that are used after an organ transplant) suxamethonium (a medicine that is used during anaesthesia) aliskiren (a medicine used to treat high blood pressure)
Your doctor will take special care of you if you receive/take medicines that make you retain potassium as these may lead to heart problems (cardiac arrhythmia). Medicines that may lead to a decrease of potassium level in your blood: If you are taking certain medicines, namely corticosteroids, amphotericin B, ACTH and loop diuretics, your renal elimination of potassium can be increased. Medicines causing sodium retention: You doctor will take care if you use medicines that make you retain sodium such as corticosteroids and nonsteroidal anti-inflammatory agents because these may lead to swelling due to fluids (oedema). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will administer Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v Solution for Infusion to you only with caution and when clearly needed. Driving and using machines This medicine has no influence on the ability to drive or use machines.
How to take it
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Dosage The recommended dose that you will be given will be determined by your doctor. It will depend on your age, weight and condition, especially if your heart or kidneys do not work properly. While you receive this medicine your blood sodium chloride and electrolyte (salt) levels, water balance and ECG will be checked regularly. Your doctor will make sure that your urine flow is sufficient. This medicine may be given to you as long as you need potassium by an infusion. Children and adolescents: In children and adolescents, the dose will depend upon the individual needs. They may receive a reduced dose. Elderly patients: In principle, the same dose as for adults can be used. However, in older people it might be necessary to adjust the dose stated to avoid circulatory and kidney problems. Method of administration This medicine will be administered to you through a tube placed into a vein (intravenous drip). If you receive more Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v than you should It is unlikely that this occurs because your doctor will determine your daily doses. 01294.0LB0120F21
Signs of an overdose: If you have received too much of this medicine or you have an impairment of your kidney function you may experience disorders of your electrolyte levels, water and acid-base balance. You may also experience tissue fluid accumulation and potassium intoxication. Potassium blood levels may especially be excessively increased. Signs of such disorder may be:
- Low blood pressure (hypotension)
- Irregular heartbeats or your heart stops beating
- General weakness and listlessness
- Muscle weakness, inability to move
- Very marked numbness, weakness or heaviness of your legs
- Confusion. If your sodium level increases too rapidly your brain may become damaged (osmotic demyelination syndrome). If you have received too much chloride this may cause a loss of bicarbonate and consequently high levels of acidic substances in your blood. Actions to be taken in case of an overdose: In such a case the infusion rate will be stopped immediately. Additionally, you may be given medicines that increase your urine flow. Your ECG will be monitored continuously. Your doctor will decide on further medication such as insulin or other measures to normalise your electrolyte levels, water balance and acid-base balance. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may be serious. If any of the following side effects occur, consult a doctor immediately
- irregular heartbeat (cardiac arrhythmia, the result of abnormally high administration rates) Other side effects
- pain or tenderness, irritation or inflammation of veins (thrombophlebitis) at the site of injection The frequency at which these side effects may occur is not known (frequency cannot be estimated from the available data). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v Keep this medicine out of the sight and reach of children.
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Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month. For 50 ml plastic bags: Store below 25°C. For 100 ml plastic bags: This medicinal product does not require any special precautions for storage. Do not freeze. Only to be used if the solution is clear, colourless and the container and its closure are undamaged. This container is for single use only. After use discard container and any remaining contents.
Contents of the pack and other information
What Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v contains
- The active substances are potassium chloride and sodium chloride. 1 ml of solution for infusion contains 29.8 mg potassium chloride and 9 mg sodium chloride. 1000 ml of solution for infusion contains 400 mmol potassium, 154 mmol sodium and 554 mmol chloride.
- The other ingredients are: water for injections hydrochloric acid and sodium hydroxide for pH adjustment What Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v looks like and contents of the pack Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v is a clear, colourless solution of potassium chloride and sodium chloride in water. It comes in plastic bags sealed in an overwrap containing 50 ml or 100 ml, supplied in packs of 20 x 50 ml and 20 x 100 ml. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer responsible for batch release B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen, Germany Postal address 34209 Melsungen, Germany Tel.: +49/5661/71-0 Fax: +49/5661/71 4567 Manufacturer B. Braun Medical AG Route de Sorge 9 1023 Crissier, Switzerland
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The leaflet was last revised in: 10/2024 __________________________________________________________________________________ The following information is intended for healthcare professionals only: Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v must be administered by slow intravenous infusion via a central venous route using an infusion pump. Method of administration: Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v must be used only via a central venous route. Slow intravenous infusion at a rate normally not exceeding 20 mmol potassium per hour using an infusion pump. In urgent cases where the serum potassium level is less than 2.0 mmol/l or where severe hypokalemia is a threat, rates up to 40 mmol per hour or 400 mmol over a 24 hour period can be administered very carefully when infused via a central vein to diminish the risk of causing sclerosis and when guided by continuous monitoring of the ECG and frequent serum K+ determinations to avoid hyperkalemia and cardiac arrest. Ensure that the catheter is not in the atrium or ventricle to avoid localized hyperkalaemia. As a matter of principle, infusion pumps should be used for the infusion of potassium in the setting of correction therapy. Posology: Adults: The following recommendations are general guidelines on potassium.
- Potassium The amount required for correction of moderate potassium deficiency and in maintenance may be calculated according to the following formula: mmol K+required = (body weight [kg] × 0.2)* × 2 × (serum-K+target** – serum-K+actual [mmol/l]) *Term represents the extracellular fluid volume ** should be 4.5 mmol/l The maximum recommended dose of potassium is 2 – 3 mmol/kg body weight (b.w.)/24 h. Infusion rate The infusion rate will depend on the conditions of the individual patient. Generally, the maximum potassium substitution rate is 20 mmol per hour. In patients with chronic hyponatraemia the rate of infusion should be slow, so that the resulting increase of the serum sodium level is limited to a maximum of 0.35 mmol/l/h Paediatric population Generally, a substitution rate of 0.5 mmol/kg potassium BW per hour should not be exceeded. Maximum daily dose The maximum recommended dose of potassium is 3 mmol/kg BW per 24 hours. In any case the limits for daily fluid intake must not be exceeded.
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Special warnings and precautions: 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. Sodium chloride supplementation must be exercised slowly in patients with chronic hyponatraemia as too rapid correction of serum sodium levels may in rare cases lead to osmotic side effects. Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v is hypertonic. The administration of a substantially hypertonic solution may lead to a variety of complications such as crenation (shrinkage) of red blood cells and general cellular dehydration. It should be administered with care in patients with hypertonic dehydration. Paediatric population: Premature or term infants may retain an excess of sodium due to immature renal function. In premature or term infants, repeated infusion of sodium chloride should therefore only be given after determination of the serum sodium level. Incompatibilities: This medicinal product must not be mixed with other medicinal. Shelf life after addition of additives: Not applicable. For complete information on this medicinal product please refer to the summary of product characteristics.
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About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Official document: view the original leaflet →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v is used for the treatment of potassium depletion in patients for whom oral medication are inadequate or in critical care settings (e.g. Intensive Care and High Dependency Units) in which patients are often fluid restricted and have regular measurement of serum potassium levels and continuous ECG monitoring.
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v must be administered by slow intravenous infusion via a central venous route using an infusion pump.
4.2. Posology and method of administration
Posology
The dosage is dependent on age, weight and clinical condition of the patient, especially in patients with renal or cardiac insufficiency.
Dosage and rate of infusion should be determined by ECG and serum electrolyte monitoring. Adequate urine flow must be ensured.
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v is particularly adapted for fluid restricted patients.
Adults
The following recommendations are general guidelines on potassium.
• Potassium
The amount required for correction of moderate potassium deficiency may be calculated according to the following formula:
mmol K+required = (body weight [kg] × 0.2)* × 2 × (serum-K+target** – serum-K+actual [mmol/l])
*Term represents the extracellular fluid volume
** should be 4.5 mmol/l
The maximum recommended dose of potassium is 2 – 3 mmol/kg body weight (BW)/24 h.
Infusion rate
The infusion rate will depend on the conditions of the individual patient (see section 4.4).
Generally, the maximum potassium substitution rate is 20 mmol per hour.
In patients with chronic hyponatraemia the rate of infusion should be slow, so that the resulting increase of the serum sodium level is limited to a maximum of 0.35 mmol/l/h.
Duration of use
This medicinal product may be administered as long as there is an indication for potassium administration.
Maximum daily dose
The maximum recommended dose of potassium is 3 mmol/kg BW per 24 hours. In any case the limits for daily fluid intake must not be exceeded.
Paediatric population
The volume and rate of infusion will depend upon the requirements of the individual patient.
Reduced volumes and rates of infusion may be required. Generally, a substitution rate of 0.5 mmol/kg BW per hour should not be exceeded.
Elderly patients
Basically, the same dosage as for adults applies, but caution should be exercised in patients suffering from further diseases like cardiac insufficiency or renal insufficiency that may frequently be associated with advanced age. See section 4.
Method of administration
Intravenous use.
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v must be used only via a central venous route. Slow intravenous infusion at a rate normally not exceeding 20 mmol potassium per hour using an infusion pump.
In urgent cases where the serum potassium level is less than 2.0 mmol/l or where severe hypokalemia is a threat, rates up to 40 mmol per hour or 400 mmol over a 24 hour period can be administered very carefully when infused via a central vein to diminish the risk of causing sclerosis and when guided by continuous monitoring of the ECG and frequent serum K+ determinations to avoid hyperkalemia and cardiac arrest. Ensure that the catheter is not in the atrium or ventricle to avoid localized hyperkalaemia.
As a matter of principle, infusion pumps should be used for the infusion of potassium in the setting of correction therapy.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Hyperkalaemia
• Hyperchloraemia
• Severe hypernatraemia
• Severe renal impairment with oliguria and anuria
4.4. Special warnings and precautions for use
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v should only be administrated with caution in cases of:
• hypernatraemia
• disorders where restriction of sodium intake is indicated, such as cardiac insufficiency, generalized oedema, pulmonary oedema, hypertension, pre-eclampsia, severe renal insufficiency.
• Shock
• Extensive tissue destruction (e.g. burn injuries)
• hyperhydration
Care must be exercised in the administration of large volume infusion of solution to patients with oedematous states or pulmonary oedema.
Solutions containing potassium should be administered slowly and only after renal function has been established and proved adequate. In patients with renal impairment, its use must be carefully controlled by frequent determinations of plasma potassium concentrations and periodic ECGs. The infusion must be discontinued if signs of renal insufficiency develop during infusion.
Potassium supplements should be administered with caution in patients with cardiac disease particularly in digitalised patients (see section 4.5).
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.
Sodium chloride supplementation must be exercised slowly in patients with chronic hyponatraemia as too rapid correction of serum sodium levels may in rare cases lead to osmotic side effects.
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v is hypertonic. The administration of a substantially hypertonic solution may lead to a variety of complications such as crenation (shrinkage) of red blood cells and general cellular dehydration. It should be administered with care in patients with hypertonic dehydration.
Special caution must be exercised if the solution is administered to acidotic patients as a decrease of serum pH (acidosis) is frequently accompanied by an increase in serum potassium.
Caution should be exercised when the solution is administered to patients with Addison's disease as these patients are predisposed to hyperkalaemia.
It must be made absolutely sure that the solution is administered intravenously, because paravenous administration may cause tissue necrosis.
Clinical supervision should include ECGs, regular checks of fluid balance and serum electrolytes.
Paediatric population
Premature or term infants may retain an excess of sodium due to immature renal function. In premature or term infants, repeated infusion of sodium chloride should therefore only be given after determination of the serum sodium level.
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, in order to avoid cardio circulatory and renal complications resulting from fluid overload.
4.5. Interaction with other medicinal products and other forms of interaction
• Digoxin, cardiac glycosides
In patients under treatment with cardiac glycosides, care should be taken to keep the potassium concentration constant. In case of hyperkalaemia - the effect of cardiac glycosides may be weakened, and in case of hypokalaemia it may result in cardiac glycoside toxicity.
Interactions might occur in the concurrent administration of other antiarrhythmics.
• Drugs with the potential to induce hyperkalaemia
Care should be taken in the concurrent use of drugs containing potassium and other drugs with a potential to induce hyperkalaemia, such as:
– potassium-sparing diuretics such as spironolactone, triamterene
– ACE inhibitors
– AT1-receptor antagonists
– non-steroidal anti-inflammatory agents
– cyclosporine. tacrolimus
– suxamethonium – aliskiren
The concomitant administration of potassium-containing solutions and these drugs may lead to severe hyperkalaemia, which may in turn lead to cardiac arrhythmia.
• Drugs leading to a decrease of the serum potassium level
ACTH, corticosteroids, amphotericin B and loop diuretics can increase the renal elimination of potassium.
• Medicinal products causing sodium retention
The concomitant use of sodium-retaining drugs (e.g. corticosteroids, non-steriodal anti-inflammatory agents) may lead to oedema.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). However, as all components of Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v are naturally present in the body and their biochemical properties are well known, no toxic effects in relation to pregnancy are to be expected.
Caution should be exercised when prescribing this medicine to pregnant women. The products should be used only when clearly needed and after careful weighing out expected benefits against possible risks.
Caution should be exercised in the presence of pre-eclampsia (see section 4.4).
Breast-feeding
There are no or limited amount of data from the use of potassium chloride and sodium chloride in lactating women. However, as all components of this medicinal product are naturally present in the body and their biochemical properties are well known, no toxic effects in relation to lactation are to be expected.
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v can be used during breastfeeding if clinically needed.
Fertility
No data available.
4.7. Effects on ability to drive and use machines
Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
Adverse reactions which may occur are related to the potassium content of the solution.
Listing of undesirable effects
The following convention has been used for the classification of undesirable effects in terms of frequency: 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 (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse events
Cardiac disorders
Not known
Too rapid infusion may provoke cardiac arrhythmias
General disorders and administration site conditions
Not known
Local reactions at the infusion site, including local pain, venous irritation and occasionally thrombophlebitis may occur
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.
4.9. Overdose
Symptoms
In case of overdose hyperkalaemia, hyperhydration, acid-base imbalances, oedema, particularly hypernatraemia, hyperchloraemia or potassium intoxication and electrolyte disorders can result.
The symptoms of hyperkalaemia are primarily cardiovascular disorders and include hypotension, cardiac arrhythmia, heart block, ECG abnormalities with development of biphasic curves and cardiac arrest. Other symptoms include paresthesias of extremities, muscle or respiratory paralysis, areflexia, weakness and mental confusion
Rapid increase of the serum sodium level in patients with chronic hyponatraemia may lead to the osmotic demyelination syndrome (see section 4.4).
Excessive administration of chloride may cause a loss of bicarbonate with an acidifying effect.
Treatment
Immediate interruption of the infusion, ECG monitoring, if necessary enhancement of urine flow and thus fluid and electrolyte excretion, administration of sodium bicarbonate and insulin. If insulin is given to increase cellular uptake of potassium, glucose should be given to avoid hypoglycaemia. In patients with persistent ECG abnormalities e.g. calcium gluconate may be administered to antagonise the cardiotoxic effects of potassium. Haemodialysis or peritoneal dialysis may be required in patients with renal insufficiency.
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Ask anything about Potassium Chloride 2.98% w/v and Sodium Chloride 0.9% w/v Solution for Infusion. 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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