Potassium Chloride 15% W/V Concentrate For Solution For Infusion
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
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 (1.5g/10ml total volume)
For excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion (Colourless solution)
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Electrolyte imbalance
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 20mmol per litre and not more than 40mmol per litre. Infuse at a rate not exceeding 20mmol 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 6g (80mmol) daily after dilution to a concentration of 20mmol/litre and no greater than 40mmol/litre.
Infants and children:
Up to 3mmol per kg per day after dilution to a concentration of 20mmol/litre.
4.3 Contraindications
Do not use:-
1) In patients with hyperkalaemia
2) In patients with severe renal impairment (plasma potassium concentrations above 5mmol/litre)
4.4 Special warnings and precautions for use
This product must be diluted with sodium chloride intravenous infusion BP (0.9% w/v) or other suitable diluent to a concentration not more than 40mmol per litre, thoroughly mixed and given by slow intravenous infusion under ECG control, ensuring adequate urine flow and with careful monitoring of electrolytes.
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 eg severe burns and those receiving potassium-sparing diuretics. 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
ACE inhibitors
Concurrent treatment may cause severe hyperkalaemia.
Angiotensin-II Receptor Antagonists There is an increased risk of hyperkalaemia.
Ciclosporin
There is an increased risk of hyperkalaemia.
Potassium-sparing Diuretics
There is a risk of hyperkalaemia but occasionally this combination may prove useful if the hypokalaemia is very severe.
Tacrolimus
There is an increased risk of hyperkalaemia.
Other Forms of Interaction
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 result from the use of thiazide diuretics and potassium containing medicaments.
Hyperkalaemia can be very dangerous in digitalised patients and careful monitoring of serum potassium levels is very important.
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 from the use of potassium chloride in pregnant women. Animal data are insufficient with respect to effects on pregnancy and embryonal/foetal development.
Caution should be exercised when prescribing to pregnant women.
Potassium salts are likely to be excreted in milk. It would be prudent to cease breast-feeding during infusion.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Cardiovascular effects
Rapid infusion or injection can be toxic to the heart. Cardiac arrhythmias can occur and even cardiac arrest.
Other undesirable effects
Hyperkalaemia can cause muscle weakness, mental confusion and, in extreme cases, chest pain and paralysis.
Pain and phlebitis can occur during IV administration of solutions at concentrations in excess of about 30mmol of potassium.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
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 the cardiotoxic effects.
Intravenous glucose and insulin may be necessary to facilitate the transfer of potassium into the cells.
Severe and unresponsive hyperkalaemia can be effectively treated with haemodialysis, peritoneal dialysis or the use of ion exchange resins.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: 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 45 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
Potassium hydroxide Hydrochloric acid Water for Injections
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
No special precautions for storage
6.5 Nature and contents of container
10ml clear glass (Ph. Eur. Type I) ampoules containing 10ml concentrate for solution for injection.
Pack size: 10 or 20 ampoules per carton.
6.6 Instructions for use and handling
Potassium chloride concentrate must be diluted before use with sodium chloride intravenous infusion (0.9%w/v) or other suitable diluent to a concentration not more than 40mmol per litre.
It is important to mix thoroughly. If the solutions are not thoroughly mixed a concentrated layer of potassium chloride may form owing to differences in density.
Do not use unless solution is clear and practically free from particles.
7 MARKETING AUTHORISATION HOLDER
Auden Mckenzie (Pharma Division) Ltd
Mckenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL
UK
8. MARKETING AUTHORISATION NUMBER
PL 17507/0026
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/02/2009
10 DATE OF REVISION OF THE TEXT
22/06/2015