Potassium Chloride 15% W/V Concentrate For Solution For Infusion
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Potassium Chloride 15% w/v Concentrate for Solution for Infusion
Potassium Chloride
Please read all of this leaflet carefully. It includes important information on how you should take this medicine correctly and safely.
• Keep this leaflet. You may need to read it again.
• If you are the parent of a child who is to be given this medicine, read the leaflet replacing
• ‘you’ with ‘your child’ throughout.
• This medicine is prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or you notice any side effects not listed in the leaflet, please tell your doctor, nurse or pharmacist.
• If you have any further questions, please ask your doctor, nurse or pharmacist.
The name of your medicine is Potassium Chloride 15% w/v Concentrate for Solution for Infusion.
In the rest of this leaflet Potassium Chloride 15% w/V Concentrate for Solution for Infusion is called Potassium Chloride.
In this leaflet:
1. What Potassium Chloride is and what it is used for
2. Before you take Potassium Chloride
3. How to take Potassium Chloride
4. Possible side effects
5. How to store Potassium Chloride
6. Further information
1. What Potassium Chloride is and what it is used for
Potassium Chloride is a type of medicine called an electrolyte. Electrolytes help keep the water levels in different parts of your body in the right balance. Potassium Chloride works by replacing a substance called potassium that your body has lost.Your body needs the right amount of potassium. Potassium helps your muscles, heart and other organs to work properly. Potassium also helps balance the water levels that affect many electrical and chemical processes in your body. Without the right amount of potassium your heart may start to beat abnormally, which could be life-threatening. If you cannot take potassium by mouth, your doctor or nurse will give you this medicine as a drip (infusion).
2. Before you take Potassium Chloride
The doctor or nurse giving you this medicine will ask some questions about you. They need the following information before you have this medicine for the first time.
Do not take Potassium Chloride
• If you have hyperkalaemia (high levels of potassium in your blood).
Do not take Potassium Chloride if the above statement is true.
Take special care with Potassium Chloride
Tell your doctor or nurse before your treatment starts if:
• You have problems with your kidneys or adrenal glands
• You have problems with your heart
• You have been told you are very dehydrated (you do not have enough water in your body)
• You have heat cramps
• You have a lot of your skin damaged (such as extreme burns)
• You are elderly (over 65 years old)
• You have problems passing urine
• You are having a drip (infusion) containing the sugar called glucose.
Taking other medicines: Please tell your doctor about any medicines you may be taking or have recently been taking. Remember also any medicines you may be taking that do not need a prescription.
If you are taking any of the following medicines it is very important to tell your doctor:
• ACE inhibitors such as lisinopril, captopril, enalapril (may make the amount of potassium in your blood too high)
• Angiotensin-ll receptor antagonists such as losartan, valsartan, candesartan (may make the amount of potassium in your blood too high)
• Blood transfusion (may make the amount of potassium in your blood too high)
• Ciclosporin (may make the amount of potassium in your blood too high)
• Corticosteroids such as cortisone, hydrocortisone, prednisone, prednisolone, betamethasone (may make your potassium chloride not work properly)
• Digoxin (may give you more side effects)
• Potassium-sparing diuretics such as spironolactone (may make the amount of potassium in your blood too high)
• Quinidine (may make your heart start to beat abnormally)
• Tacrolimus (may make the amount of potassium in your blood too high).
Taking salt-substitutes: If you are using potassium-containing salt substitutes in your diet, you must tell your doctor. You may be getting too much potassium if you take this medicine at the same time. Pregnancy and breast-feeding
• If you are pregnant, or think you may be pregnant you must tell your doctor.
• If you are breast-feeding you must tell your doctor.
Your doctor will advise you if you should have this medicine.
Please read the other side of this leaflet.
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Technical Information Leaflet
Potassium Chloride 15% w/v Concentrate for Solution for Infusion
This leaflet provides information for the healthcare professional. There is a separate Patient Information
Leaflet.
1. NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 15% w/v Concentrate for Solution for Infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 150mg/ml or 15% w/v (2 mmol/ml). For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate). A clear colourless solution.
CLINICAL PARTICULARS
4.1 Therapeutic Indications: The prevention and treatment of potassium deficiency when oral replacement therapy is not feasible.
4.2 Posology and Method of Administration:
Method of administration: Slow intravenous infusion. Dilute with 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.
Adults and the elderly: Up to 6 g (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. For children weighing 25 kg or over, refer to the adult dosage.
4.3 Contraindications: Potassium Chloride is contraindicated in patients with hyperkalaemia.
4.4 Special Warnings and Precautions for Use:
Potassium chloride concentrate must be diluted with sodium chloride solution for injection (0.9% w/v) or other suitable diluent, thoroughly mixed and given by slow intravenous infusion under ECG control, ensuring adequate urine flow and with careful monitoring of electrolytes. Concentrated potassium solutions are for intravenous admixtures only. Do not use undiluted. Direct injection may be instantaneously fatal. Initial potassium replacement therapy should not involve glucose infusions, because glucose may cause a further decrease in the plasma-potassium concentration. Repeated measurements of plasma-potassium concentration are necessary to determine whether further infusions are required and to avoid the development of hyperkalaemia. Patients with mild to moderate renal impairment and adrenal insufficiency should be closely monitored. Considerable care should also be taken with patients having cardiac disease, acute dehydration, heat cramps, extensive tissue destruction e.g severe bums. Care should be taken with elderly patients since renal function may be impaired.
4.5 Interaction with other Medicinal Products and other Forms of Interaction:
Concurrent use with ACE inhibitors may result in hyperkalaemia. There is an increased risk of hyperkalaemia with use of angiotensin-ll receptor antagonists, cyclosporin, potassium-sparing diuretics, tacrolimus and potassium-containing salt substitutes. In patients receiving digoxin, hypokalaemia may result in digoxin toxicity. Caution is therefore advised if discontinuing a potassium preparation in patients maintained on digoxin. 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. Potassium can enhance the antiarrhythmic effect of quinidine. Concurrent use of adrenocorticoids, glucocorticoids and mineralocorticoids may all decrease the effects of potassium supplements.
4.6 Pregnancy and Lactation:
There are no adequate data on the use of potassium chloride in pregnant women. Caution should therefore be exercised when prescribing to pregnant women.
Potassium salts are likely to be excreted in milk. Caution should therefore be exercised when prescribing to women who are breast-feeding.
4.7 Effects on Ability to Drive and Use Machines: None stated.
3. How to take Potassium Chloride
Potassium chloride must be diluted before use at least 50 times its volume with a suitable diluent. A doctor or a nurse will usually give you this medicine. Your doctor or nurse will give you the correct dose as a drip into your vein (your doctor or nurse may call this an IV or intravenous infusion).
Your doctor will decide the amount (dose) of your medicine that you should receive and how long you will need to take it for. Your doctor will also decide the strength of the medicine to give to you. The medicine is very strong, and must always be made weaker by adding more liquid (diluting) before you receive it. Your doctor will monitor your heart while you receive your medicine. Your doctor will also take some blood tests, and check the amount of urine you make. This is to check the amount of potassium in your blood while you are having your medicine. If you have a very low amount of potassium in your blood, or you have diabetic ketoacidosis (a complication of diabetes), you may receive the medicine more quickly than usual.
Adults and the elderly: The usual dose is up to 80 mmol (millimoles) per day. The medicine will be made at a strength of 20 - 40 mmol/litre.
Infants and children: The usual dose is up to 3 mmol (millimoles) per kg of bodyweight per day. The medicine will be made at a strength of 20 mmol/litre. For children weighing 25Kg or over, refer to the adult dosage.
If you take more Potassium Chloride than you should: A doctor or a nurse will usually give you this medicine. If you think you may have received too much medicine, please tell your doctor or nurse at once.
Too much potassium in your blood will cause serious side effects that may be life-threatening.
Please read carefully the important advice at the beginning of the next section, Section 4, about how you can spot the signs of too much potassium in your blood.
If you forget to take Potassium Chloride: A doctor or a nurse will usually give you this medicine. If you think you have missed a dose, please tell your doctor or nurse. If you have any further questions on the use of your medicine, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines, Potassium Chloride can cause side effects, but not everyone gets them. The expected benefit of your medicine will usually be greater than the risk of you suffering any harmful side effects.
Important: Side effects or symptoms to look out for, and what to do if you are affected.
The first signs of having too much potassium in your blood are abnormal heartbeats, chest pain, possible heart attack, muscle weakness, paralysis or difficulty breathing. If you get any of these symptoms you must seek urgent medical advice.
The following other side effects may occur in some people:
Nervous system problems:
• Prickling or tingling of the hands or feet
• Paralysis where the muscles are floppy
• Loss of reflexes
• Weakness, lack of energy
• Mental confusion
• Weakness and heaviness of legs.
Immune system problems:
• Fever.
Heart and circulation problems:
• Low blood pressure (you may feel light-headed). Infusion site problems:
• Pain, redness, soreness and swelling at the site of the drip.
If any of these side effects gets serious, or if you notice any troublesome symptoms which you think may be side effects, please tell your doctor, nurse or pharmacist.
5. How to store Potassium Chloride
Keep your medicine out of the reach and sight of children. Do not use your medicine after the expiry date (EXP) given on the carton and the label on the plastic container (ampoule). The expiry date is the last day of the month written on the packaging. Store below 25°C. Only use your medicine if it is a clear and colourless liquid. Open it and use it straight away. The product should be diluted and used immediately after opening. Any unused product should be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Potassium Chloride contains: The active medicine is Potassium Chloride. The other ingredient is Water for Injections. The medicine contains 15 % w/v (150 mg per ml) of Potassium Chloride. Each ml (millilitre) of this medicine contains 2 mmol of potassium and 2mmol chloride.
What Potassium Chloride looks like: Potassium Chloride is a concentrate for solution for infusion. This means it is a concentrated (strong) solution in a plastic container. It is a clear, colourless liquid. Potassium chloride must be diluted before use at least 50 times its volume with a suitable diluent. The solution must have more liquid added (diluted) to make a weaker solution that can then be given to you as a drip (an infusion).
Contents of the pack: Each plastic ampoule will contain 5 ml (millilitres), 10 ml or 20 ml of your medicine. 20 ampoules come in a box. Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Suit. 115,1065 Nicosia, Cyprus.
Manufacturer: Demo S.A., 21st Km National Road Athens-Lamia, 14568 Athens, Greece.
This leaflet was approved in June 2010.
If this leaflet is difficult to see or read please contact the following address for help:
Fannin Limited, Fannin House, South County Business Park, Leopardstown, Dublin 18, Ireland, Tel +353-1-2907000.
4.8 Undesirable Effects:
Hyperkalaemia: Adverse reactions involve the possibility of potassium intoxication. Signs and symptoms include parasthesias of extremities, flaccid paralysis, muscle or respiratory paralysis, areflexia, weakness, listlessness, mental confusion, weakness and heaviness of legs, hypotension, cardiac arrhythmia, heart block, ECG abnormalities. Cardiovascular: Rapid infusion or injection can be toxic to the heart. Cardiac arrhythmias can occur and even cardiac arrest.
Reactions due to technique of administration: Febrile response, infection at injection site, venous thrombosis, phlebitis extending from the injection site and extravasation.
4.9 Overdose:
If excretory mechanisms are impaired or if potassium is administered too rapidly, potentially fatal hyperkalaemia can result. Signs: Signs of hyperkalaemia include cardiac arrhythmias, chest pain, muscle weakness and paralysis. Treatment: In the event of hyperkalaemia, all potassium-containing medications and foods should be discontinued immediately. If the condition is serious, the first priority is to ensure stability of the cardiac rhythm. Continuous ECG monitoring is essential. Administration of calcium gluconate (but not to patients on digitalis) may be needed to reduce cardiotoxic effects. Intravenous glucose and insulin may be necessary to facilitate the transfer of potassium into cells. Severe and unresponsive hyperkalaemia can be effectively treated with haemodialysis, peritoneal dialysis or use of ion exchange resins.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties:
Pharmacotherapeutic group: Eletrolyte solution. ATC Code B05X A01. Potassium is the predominant cation within cells. It is involved in numerous cellular metabolic processes and is necessary for the conduction of nerve impulses in such tissues as the heart, brain and skeletal muscle. In hypokalaemia, prolongation of the QT interval and depression of the ST segment may be seen whereas hyperkalaemia results in increased height of T-waves, lengthened PR interval, and even asystole or ventricular fibrillation.
5.2 Pharmacokinetic Properties:
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 per litre while intracellular fluid contains 150 mmol per litre. Potassium is mainly excreted by the kidneys, although about 10% is excreted by the colonic mucosa.
5.3 Preclinical Safety Data: There is no additional information relevant to the prescriber.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients: Water for Injections.
6.2 Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Section 6.6.
6.3 Shelf Life: Unopened: 2 years. From a microbiological point of view, the product should be diluted and used immediately after opening. 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 Unopened product: Store below 25°C.
Opened product: For storage conditions of the opened, reconstituted or diluted medicinal product, see section 6.3.
6.5 Nature and Contents of Container: Polypropylene ampoules of 5,10 ml or 20 ml packed into cartons of 20 ampoules. Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling:
Do not use unless the solution is clear and practically free from particles. Discard after single use. Discard any unused portion. Potassium chloride concentrate must be diluted before use by not less than 50 times its volume with sodium chloride 0.9% w/v intravenous infusion (0.9% w/v), dextrose 5% w/v intravenous solution to a maximum concentration of 40 mmol potassium per litre. The solution must be mixed well before use.
MARKETING AUTHORISATION HOLDER
Noridem Enterpirses Ltd., Evagorou & Makariou, Mitsi Building 3, Suit. 115, 1065 Nicosia, Cyprus.
8. MARKETING AUTHORISATION NUMBER
PL 24598/0003 PA 1122/3/1 38123330-6