Potassium Chloride 0.15% W/V And Sodium Chloride 0.9 % W/V Solution For Infusion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Chloride 0.15% w/v and Sodium Chloride 0.9% w/v Intravenous Infusion BP (in the following referred to as “0.15% KCl and 0.9% NaCl”) contains:
|
1,000 ml |
mg/ml | |
|
Potassium chloride |
1.50 g |
1.50 |
|
Sodium chloride |
9.00 g |
9.00 |
|
Electrolyte concentrations: Potassium |
20 mmol/l | |
|
Sodium |
154 mmol/l | |
|
Chloride |
174 mmol/l |
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear colourless aqueous solution
Theoretical osmolarity 348 mOsmol/l
(approx.) (388 mOsm/l)
pH 4.5 - 7.0
4. CLINICAL PARTICULARS
Therapeutic indications
4.1
Correction or maintenance of potassium, sodium, chloride and fluid balance, depending upon the clinical condition of the patient. The solution is particularly indicated in the treatment of hypokalaemia, hypotonic and isotonic dehydration, and hypochloraemic alkalosis.
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. 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 will 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.
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 “0.15% KCl and 0.9% NaCl” may be administered as long as there is an indication for 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
- Hyperhydration
4.4 Special warnings and precautions for use
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.
Solutions containing sodium chloride must be used with caution in patients who have an impaired ability to handle sodium and fluid such as heart disease especially with a history of congestive heart failure, patients with renal insufficiency, cirrhosis of the liver, cardio-pulmonary disease, or patients receiving salt-retaining steroids.
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 fluids to patients with congested states or pulmonary oedema or hypernatraemia. 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.
As a slightly hypertonic solution the infusion should also be administered with care in patients with hypertonic dehydration.
Special caution must be exercised if the solution is administered to acidotic patients.
Caution should be exercised when the solution is administered to patients with Addison’s disease as these patients are predisposed to hyperkalaemia.
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
In patients on digoxin, hypokalaemia may result in digoxin toxicity. Potassium administration must be very carefully discontinued in these patients.
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
Corticosteroids are associated with the retention of sodium and water.
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 sodium chloride in pregnant women. Although adverse reactions of sodium chloride were seen in animal studies, the relevance of these data for clinical use is unknown.
In many years of clinical experience with solutions such as “0.15% KCl and 0.9% NaCl” no adverse effects on the course of pregnancy and the foetus have been reported in the literature. All components of “0.15% KCl and 0.9% NaCl” are naturally present in the body and their biochemical properties are well known.
“0.15% KCl and 0.9% NaCl” can be used during pregnancy if clinically needed
Lactation
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 “0.15% KCl and 0.9% NaCl” are naturally present in the body and their biochemical properties are well known, no toxic effects in relation to lactation are to be expected.
“0.15% KCl and 0.9% NaCl” can be used during breastfeeding if clinically needed.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
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, acid-base imbalances, and electrolyte disorders, particularly hypernatraemia, hyperchloraemia or potassium intoxication result.
Symptoms of hyperkalaemia include paresthesias 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.
Adverse effects of excess sodium in the body include nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation and lachrymation, sweating, fever, tachycardia, hypertension, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, convulsions, coma and death.
Nervous system disorders
With too rapid infusion of hypertonic or isotonic saline infusion neurological adverse effects may result in patients treated for chronic hyponatraemia. This osmotic demyelination syndrome is characterised by nerve dysfunction and symptoms including convulsion, behavioural disturbances, fluctuating levels of consciousness swallowing dysfunction, akinetic mutism, movement disorders, and in severe cases also pseudobulbar palsy and quadriparesis.
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 of overdose
If excretory mechanisms are impaired or the infusion is either carried out too rapidly or to excess, hyperkalaemia, hyperhydration, acid-base imbalances, and electrolyte disorders can result. Especially the potassium homeostasis will be affected in case of overdose. The possible symptoms of potassium and sodium excess are described in section 4.8.
Excessive administration of chloride may cause a loss of bicarbonate with an acidifying effect.
Treatment of overdose
- 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
“0.15% KCl and 0.9% NaCl” contains the electrolytes potassium, sodium, and chloride in water.
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.
Sodium is the major cation of the extracellular fluid and is principally responsible for the control of water distribution, fluid and electrolyte balance, and osmotic pressure of body fluids. Together with chloride and bicarbonate, sodium plays also an important role in the regulation of acid-base balance. Chloride, the major extracellular anion, closely follows the physiologic disposition of sodium, and changes in the acid-base balance of the body are reflected by changes in serum chloride concentration.
In postoperative, posttraumatic and other clinical instances severe fluid and electrolyte losses are frequently observed and the above named physiologic functions are impaired. In these patients the application of the components contained in “0.15% KCl and 0.9% NaCl” is indicated to restore fluid and electrolyte levels and thus prevent further damage to the body.
5.2. Pharmacokinetic properties
Absorption
Since the ingredients of “0.15% KCl and 0.9% NaCl” 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 3.55 mmol/l. Sodium and chloride mainly distribute in the extracellular space. Plasma sodium concentration is normally regulated at a concentration of 135-145 mmol/l and chloride at 95107 mmol/l.
Excretion
The kidneys are the main route of excretion for potassium, sodium, 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 by the others 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 “0.15% KCl and 0.9% NaCl”. However, if the dosage instructions are followed, administration of “0.15% KCl and 0.9% NaCl” will only restore physiological electrolyte and fluid homeostasis of the patient. All components of “0.15% KCl and 0.9% NaCl” are naturally present in the body and their biochemical properties are well known. Therefore, toxic effects are not to be expected.
5.3 Preclinical safety data
No preclinical studies have been conducted with “0.15% KCl and 0.9% NaCl”. However, if the dosage instructions are followed, administration of “0.15% KCl and 0.9% NaCl” will only restore physiological electrolyte and fluid homeostasis of the patient. All components of “0.15% KCl and 0.9% NaCl” 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.
Incompatibilities
6.2
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 the “0.15% KCl and 0.9% NaCl” 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 “0.15% KCl and 0.9% NaCl”.
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 “0.15% KCl and 0.9% NaCl” 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 containing 500 ml and 1,000 ml in packs of 10.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
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
8. MARKETING AUTHORISATION NUMBER
PL 03551/0079
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
UK: Date of first authorisation: 28 August 2003 Date of latest renewal: 19 February 2009
15/07/2014