Sterile Potassium Chloride Concentrate Bp 15%W/V
1.
NAME OF THE MEDICINAL PRODUCT
Sterile Potassium Chloride 15% w/v Concentrate for Solution for Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 15% w/v
Each 10ml of solution contains 1500 mg of potassium chloride, equivalent to approximately 20 mmol potassium ions
Each 20ml of solution contains 3000 mg of potassium chloride, equivalent to approximately 40 mmol potassium ions
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Concentrate for Solution for Infusion A clear, colourless solution pH: 4.5 - 7.5
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Electrolyte imbalance.
4.2. Posology and method of administration
Method of administration: slow intravenous infusion, as a dilute solution
Dilute by adding to an appropriate volume of 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 6g (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.
1.1 4.3 Contraindications
Potassium Chloride is contraindicated in patients with:
• Hyperkalaemia
• Impaired renal function with oliguria, anuria or azotaemia
• Hyperchloraemia
• Addison's disease
• Acute dehydration and heat cramps
1.2 4.4 Special warnings and precautions for use
This product must not be injected undiluted. It must be diluted with sodium chloride intravenous infusion 0.9% w/v or other suitable diluent to a concentration not more than 40 mmol per litre, mixed well and given by slow intravenous infusion, under ECG control, ensuring adequate urine flow and with careful monitoring of electrolytes.
Plasma potassium concentration must be measured at regular intervals to avoid the development of hyperkalaemia, especially in patients with renal impairment.
Potassium salts should be administered with considerable care to patients with renal and adrenal insufficiency, intestinal stricture, history of peptic ulcer, cardiac disease, acute dehydration, heat cramps, extensive tissue destruction as occurs with severe burns, or to patients receiving potassium sparing diuretics.
Initial potassium replacement therapy should not involve glucose infusions, because glucose may cause a further decrease in the plasma-potassium concentration.
1.3 4.5 Interaction with other medicinal products and other forms of interaction
Potassium sparing diuretics:
Potassium supplements should not be administered with potassium sparing diuretics (such as amiloride, spironolactone and triamterene), particularly in patients with impaired renal function. Any patients on this combination require close monitoring in order to diagnose a potential hyperkalaemic condition as soon as possible.
Angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists:
Patients taking ACE-inhibitors or angiotensin II receptor antagonists, especially those with impaired renal function, should be closely monitored, as the potassium sparing effect in combination with potassium infusion may result in hyperkalaemia.
Ciclosporin:
Concurrent use of ciclosporin may increase the risk of hyperkalaemia.
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 be very dangerous in digitalised patients and careful monitoring of serum potassium levels is very important.
Hyperkalaemia may also result from concurrent use of thiazide diuretics, tacrolimus, p-Adrenoceptor blockers, non-steroidal anti-inflammatory drugs and drugs that contain potassium, such as the potassium salts of penicillin.
Potassium can enhance the antiarrhythmic effect of quinidine.
Concurrent use of adrenocorticoids, glucocorticoids and mineralocorticoids may all decrease the effects of potassium supplements.
Glucose Infusion:
Concomitant use of glucose infusions in hypokalaemic patients may cause a further decrease in plasma potassium concentrations.
1.4 4.6 Fertility, pregnancy and lactation
There is no, or inadequate, evidence of safety of the drug in human pregnancy or breast feeding, but it has been in wide use for many years without apparent ill consequence. If drug therapy in pregnancy is needed, the use of the drug is acceptable. Sterile Potassium Chloride 15% concentrate for solution for infusion may be used during pregnancy and lactation under the supervision of the prescribing physician.
4.7 Effects on ability to drive and use machines
None stated
1.5 4.8
Undesirable effects
Metabolism and Nutrition disorders: Hyperkalaemia is the most common and serious hazard of potassium therapy.
Cardiac disorders: Rapid infusion can be toxic to the heart. Cardiac arrhythmias may occur.
Gastrointestinal disorders: Nausea and vomiting (severe symptoms may indicate obstruction), oesophageal or small bowel ulceration.
General disorders and administration site conditions: Pain at the injection site and phlebitis may occur during IV administration of solutions at concentrations in excess of about 30 mmol of potassium per litre.
1.6 4.9 Overdose
Clinical signs and symptoms of potassium overdosage include: paraesthesia of the extremities, listlessness, mental confusion, muscle weakness or heaviness of the legs, flaccid paralysis, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure, cardiac arrhythmias and heart block. Extremely high plasma potassium concentrations (8-11 mmol/litre) may cause death from cardiac depression, arrhythmias or arrest.
Treatment: In the event of hyperkalaemia, discontinue all potassium containing medications and foods. If the condition is serious then intravenous glucose and insulin may be necessary to facilitate the transfer of potassium into the cells. 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.
The administration of calcium gluconate (though not to digitalised patients) may be needed to antagonise cardiotoxic effects. 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, with E.C.G. monitoring.
If hyperkalaemia is very severe, techniques such as haemodialysis, peritoneal dialysis or the use of ion exchange resins may be necessary to rapidly lower the potassium level.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Electrolyte solutions ATC Code: B05XA01
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.
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/litre. Intracellular fluid contains 150 mmol/litre. Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules in exchange for sodium or hydrogen ions. Some potassium is excreted in the faeces, and small amounts may also be excreted in sweat, saliva, bile and pancreatic juice.
5.3. Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics.
2 6 PHARMACEUTICAL PARTICULARS
2.1 6.1 List of excipients
Dilute hydrochloric acid (for pH adjustment) Potassium hydroxide (for pH adjustment) Water for Injections
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in Section 6.6
2.2 6.3 Shelf life
Unopened: 36 months
Once opened: dilute and use immediately
After dilution: From a microbiological point of view, dilutions should be used immediately. 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
Do not store above 25°C.
6.5. Nature and contents of container
Clear Ph Eur type I glass ampoules containing 10ml or 20ml of solution. The ampoules are packed in cartons to contain 10 ampoules.
6.6. Special precautions for disposal
Do not use unless the solution is clear and practically free from particles.
For single use only.
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 or another suitable solution for infusion, to a maximum concentration of 40 mmol potassium per litre.
The solution must be mixed well before use.
Discard any unused portion.
7. MARKETING AUTHORISATION HOLDER
Macarthys Laboratories Ltd
t/a Martindale Pharmaceuticals
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
8. MARKETING AUTHORISATION NUMBER
PL 01883/6186R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 10 May 1989 Date of latest renewal: 14 July 2005
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DATE OF REVISION OF THE TEXT
29/08/2013