Potassium Chloride 0.3% W/V And Glucose 5% W/V Solution For Infusion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.3% w/v and Glucose 5% w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 0.3% w/v and Glucose 5% w/v Solution for Infusion (in the following referred to as “0.3% KCl and 5% Glucose”) contains:
|
1,000 ml |
mg/ml | |
|
Potassium chloride |
3.00 g |
3.00 |
|
Anhydrous glucose (as Glucose monohydrate) |
50.00 g |
50.00 |
|
Electrolyte concentrations: Potassium |
40 mmol/l | |
|
Chloride |
40 mmol/l |
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Colourless up to faintly straw-coloured solution
Caloric value (approx.) 200 kcal
Theoretical osmolarity 358 mOsm/l
(approx.)
pH 3.5 - 6 .5
CLINICAL PARTICULARS
4
4.1 Therapeutic indications
Correction of hypokalaemia and maintenance of potassium ion homoeostasis in cases where a supply of energy is required.
4.2 Posology and method of administration
The dosage is dependent on age, weight and clinical condition of the patient, especially those with renal or cardiac insufficiency. Dosage and rate of infusion should be determined by ECG and serum electrolyte monitoring.
Posology
Adults:
Potassium Dosage/Rate of Infusion Guidelines
Serum K+ Maximum Maximum
infusion rate concentration
> 2.5 mmol/l 10 mmol/h 40 mmol/l
< 2 mmol/l 40 mmol/h 80 mmol/l
The maximum recommended dose of potassium is 2 - 3 mmol/kg b.w./24 h.
The administered amount of glucose should not exceed 3 - 4 g/kg b.w. in 24 h. Generally, not more than 40 ml fluid/kg b.w./d should be supplied.
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.
The administered amount of potassium should not exceed 2-3 mmol//kg b.w. in 24 h
Rate of Infusion:
The rate of infusion should be guided by ECG and serum electrolyte monitoring. Adequate urine flow must be ensured.
The maximum rate of infusion should not exceed 10 mmol potassium/h when serum potassium levels are above 2.5 mmol/l and 40 mmol/h if serum potassium levels are below 2 mmol/l.
Duration of use
“0.3% KCl and 5% Glucose” may be administered as long as there is an indication for energy, electrolyte and fluid administration.
Method and route of administration
Intravenous infusion via a large peripheral or central vein to avoid the risk of sclerosing. If infused through a central vein, to avoid localised hyperkalaemia the catheter must not be in the atrium or ventricle.
This container contains a significant volume of air. To avoid risk of air embolism, this product must not be administered by pressure infusion.
4.3 Contraindications
- Hyperkalaemia,
- Severe renal impairment with oliguria, anuria, or azotaemia,
- Hyperchloraemia,
- Acute ischaemic stroke,
- Head trauma (first 24 hours)
- Hyperhydration
4.4 Special warnings and precautions for use
- Solutions with low salt concentrations, especially sodium, should only be administered with special caution to children and close monitoring of electrolyte and fluid balance should be performed.
- 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. Rapid lowering of plasma potassium concentrations (e.g. when discontinuing the infusion) in digitalised patients can cause cardiac glycoside toxicity.
- Care must be exercised in the administration of large volume infusion of hypotonic fluids to patients with congested states or pulmonary oedema.
-As a solution with low electrolyte content containing only 40 mmol potassium/l, the infusion should also be administered with care in patients with hypotonic dehydration and in cases of hyponatraemia.
- Caution should be exercised when the solution is administered to patients with diabetes, especially those with insulin-refractory hyperglycaemia and in patients with glucose intolerance for any other reason (see section 4.5). Blood glucose monitoring will be required.
- Caution should be exercised when the solution is administered to patients with Addison’s disease as these patients are predisposed to hyperkalaemia.
- Solutions containing glucose should not be administered simultaneously with, before or after an administration of blood through the same infusion equipment because of the possibility of pseudoagglutination.
- It is recommended that all intravenous apparatus be replaced at least once every 24 h.
Clinical supervision should include ECGs, regular checks of fluid balance and serum electrolytes.
4.5 Interaction with other medicinal products and other forms of interaction
“0.3% KCl and 5% Glucose” as a glucose containing solution should not be administered simultaneously with, before or after an administration of blood through the same infusion equipment because of the possibility of pseudoagglutination (see section 4.4).
Corticosteroids or corticotropins may lead to reduced glucose tolerance.
In patients on digoxin, hypokalaemia may result in digoxin toxicity. Potassium administration must be very carefully discontinued in these patients (see section 4.4).
Care should be taken in the concurrent use of drugs containing potassium and drugs with the potential to induce hyperkalaemia, such as:
- potassium-sparing diuretics e.g. spironolactone, triamterene
- ACE inhibitors
- angiotensin II receptor antagonists
- tacrolimus
- cyclosporine
- suxamethonium
Other clinically relevant pharmacological drug interactions are not known.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of potassium chloride and glucose in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). However, as all components of “0.3% KCl and 5% Glucose” are naturally present in the body and their biochemical properties are well known, no toxic effects in relation to pregnancy are to be expected.
It has been suggested that if used during labour, the glucose load on the mother may lead to foetal hyperglycaemia, hyperinsulinaemia and acidosis, with subsequent neonatal hypoglycaemia. Others have found no evidence of such an effect.
“0.3% KCl and 5% Glucose” can be used during pregnancy if clinically needed.
Lactation
There are no or limited amount of data from the use of potassium chloride and glucose in lactating women.
However, as all components of “0.3% KCl and 5% Glucose” are naturally present in the body and their biochemical properties are well known, no toxic effects in relation to lactation are to be expected.
“0.3% KCl and 5% Glucose” can be used during breastfeeding if clinically needed.
4.7. Effects on ability to drive and use machines Not relevant.
4.8. Undesirable effects
When used accordingly no adverse drug reactions are to be expected.
The frequencies of the undesirable effects described hereinafter vary depending on the dose or the technique of administration.
Metabolism and nutrition disorders
In patients with severe renal or metabolic impairment or when the infusion is either carried out too rapidly or to excess, it is possible that overhydration, hyperglycaemia or potassium intoxication results.
Symptoms of hyperkalaemia include paraesthesias of extremities, muscle or respiratory paralysis, areflexia, weakness, listlessness, cold skin, gray pallor, mental confusion, weakness and heaviness of legs, hypotension, cardiac arrhythmia, heart block, ECG abnormalities with development of biphasic curves and cardiac arrest.
General disorders and administration site conditions
Local pain and phlebitis may occur during administration of solutions containing 40 mmol or more potassium 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms
If excretory mechanisms are impaired or the infusion is either carried out too rapidly or to excess, hyperkalaemia, hyperhydration, metabolic and electrolyte disorders can result. Especially the potassium homeostasis will be affected in case of overdose. The possible symptoms of potassium intoxication are described in section 4.8.
Excessive administration of chloride may cause a loss of bicarbonate with an acidifying effect.
Emergency treatment, antidotes
Immediate interruption of the infusion, ECG monitoring, if necessary enhancement of urine flow and thus fluid and electrolyte excretion, administration of sodium bicarbonate. 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. Caution should be exercised if the patient is on cardiac glycosides as rapid lowering of the potassium levels may enhance cardiac glycoside toxicity. Haemodialysis or peritoneal dialysis may be required in patients with renal insufficiency.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group (ATC code): B05B B
“0.3% KCl and 5% Glucose” contains glucose and the electrolytes potassium and chloride in water for injection.
Potassium is the major cation of intracellular fluid and is essential for maintenance of acid-base balance, isotonicity, and electrodynamic characteristics of the cell. The electrolyte is an important activator in many enzymatic reactions and is essential to a number of physiologic processes including transmission of nerve impulses, contraction of cardiac, smooth, and skeletal muscles, gastric secretion, renal function, tissue synthesis, carbohydrate utilisation and protein synthesis. Chloride, the major extracellular anion and closely follows the physiologic disposition of sodium and also potassium. Together with sodium and bicarbonate, chloride plays an important role in the regulation of acid-base balance and changes in the acid-base balance of the body are reflected by changes in serum chloride concentration.
Glucose is the main carbohydrate in the body and is essential to some organs. In the body glucose itself and derivates of glucose metabolism are used for energy supply, modification of proteins and lipids, formation of mucopolysaccarides and lactose, as components of nucleic acids, and conjugates for the excretion of various substances.
In postoperative, posttraumatic and other clinical instances severe fluid and electrolyte losses and catabolic situations are frequently observed and the above named physiologic functions are impaired. In these patients the application of the components contained in “0.3% KCl and 5% glucose” is indicated to restore electrolyte levels, supply energy and thus prevent further damage to the body.
5.2 Pharmacokinetic properties
Absorption
Since the ingredients of “0.3% KCl and 5% Glucose” are infused intravenously their bioavailability is 100%.
Distribution/Metabolism
Infused potassium is actively transported into the cells, where its concentration is up to 40 times that outside the cell. Plasma potassium concentrations generally range from 3.5-5 mmol/l. Chloride mainly distributes in the extracellular space. Plasma chloride concentration is normally regulated at a concentration of 95-107 mmol/l.
Plasma glucose levels are most closely regulated mainly by the liver together with various hormones and skeletal muscle. Normally glucose is completely oxidised to CO2 and water, but this metabolic pathway is limited. Excess glucose is stored as glycogen or converted to fat. In severe trauma and other clinical situations such as e.g. diabetes, glucose clearance, oxidation, and recycling are affected and administration must be careful as otherwise hyperglycaemia may result. Cautious administration of glucose can substantially reduce catabolism, help to cover increased energy needs and supply enough glucose for the glucose dependent tissues.
Excretion
The kidneys are the main route of excretion for potassium and chloride but small amounts are lost via the skin and intestinal tract. Especially surgery results in increased urinary excretion of potassium while water and sodium is retained. For supplementation it is essential to take into consideration that the homeostasis of the single electrolytes is influenced each other and their regulation is thus interdependent to some degree. For example, a deficiency of either potassium or chloride will lead to a deficit of the other and supplementation in this case has to provide both electrolytes to be effective.
5.3 Preclinical safety data
No preclinical studies have been conducted with “0.3% KCl and 5% Glucose”. However, if the dosage instructions are followed, administration of “0.3% KCl and 5% Glucose” will only restore physiological electrolyte and fluid homeostasis and supply a fraction of the energy needed by the patient. All components of “0.3% KCl and 5% Glucose” are naturally present in the body and their biochemical properties are well known. Therefore, toxic effects are not to be expected.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections.
6.2 Incompatibilities
Any questions on compatibility of additives should be directed to the manufacturer, i.e. B. Braun Melsungen AG or to the manufacturer of the additive.
As with all parenteral solutions, before adding medications, compatibility of these additives with the solution in the container must be assessed.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Those additives known to be incompatible should not be used.
It is the responsibility of the user to judge the incompatibility of an additive medication with “0.3% KCl and 5% Glucose” by checking for eventual colour change and/or eventual precipitate, insoluble complexes or crystals.
Before introducing an additive verify it is soluble and stable in water at the pH of “0.3% KCl and 5% Glucose”.
6.3 Shelf life
Shelf life before opening 3 years
Shelf-life after first opening (Additives)
Chemical and physical in-use stability of any additive medication at the pH of “0.3%% KCl and 5% Glucose” in the container should be established prior to use.
From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6.4 Special precautions for storage
Do not store above 25 °C.
For storage conditions after first opening of the medicinal product, see section 6.3
6.5. Nature and contents of container Polyethylene bottles 500 ml and 1,000 ml in packs of 10.
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling Handling:
Use only if the solution is clear, without visible particles and if the container is undamaged. The solution should not be administered if the container or its closure shows visible signs of damage.
For single use only. Do not reconnect partially used container.
Administer immediately following the insertion of infusion set.
The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.
Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately after preparation, unless preparation has taken place in controlled and validated aseptic conditions.
In case of an adverse reaction, infusion must be stopped immediately.
Disposal:
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
B. BRAUN Melsungen AG Carl-Braun-Str. 1 34212 Melsungen Germany
PL 03551/0081
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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28 August 2003 Date of latest renewal: 04 March 2009
DATE OF REVISION OF THE TEXT
15/07/2014