- Approval Id
- 9fdc4bf4e3971add
- Drug Approval Emc Name
- Potassium Chloride Concentrate 15%
- Drug Name
- Potassium Chloride Concentrate 15%
- Company Name
- hameln pharma ltd
- Company Address
- Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
- Company Website
- https://www.hameln-pharma.com
- Company Telephone
- +44 (0)1452 621 661
- Company Medical Info Email
- drug.safety@hameln-pharma.co.uk
- Legal Category
- Prescription only medicine
- Authorisation Holder
- hameln pharma ltd
Nexus, Gloucester Business Park,
Gloucester, GL3 4AG,
UK
- Authorisation Number
- PL 01502/0007R
- Authorisation Date
- 22nd May 2002
- Instruction Authorisation Holder
- hameln pharma ltd
Nexus, Gloucester Business Park,
Gloucester, GL3 4AG,
UK
- Instruction Authorisation Number
- PL 01502/0007R
- Instruction Authorisation Date
- 22nd May 2002
- Instruction Composition
- 15% of Potassium Chloride in 10 ml.
- Instruction Dosage Form
- Sterile Injection.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Potassium Chloride Concentrate 15% is for use as a source of potassium for the treatment or prevention of potassium depletion in patients for whom dietary measures or oral medication are inadequate.4.2 Posology and method of administration
\*\*Posology\*\*
\*Adults (including elderly) and Children:\*
Dosage depends on the serum ionogram value and the acid-base state. A potassium deficiency is calculated according to the formula:
MMOL Potassium = KG BW x 0.2 x 2 x (4.5 – actual serum potassium (MMOL)).
(The extracellular volume is calculated from the body weight in KG x 0.2).
The maximal rate of infusion is 20 MMOL potassium per hour.
It is recommended not to exceed 2-3 MMOL potassium per kg body weight in 24 hours.
\*\*Method of administration\*\*
Potassium Chloride Concentrate 15% must be administered by slow intravenous infusion, as a dilute solution.
Potassium Chloride Concentrate 15% must be diluted with not less than 50 times its volume by adding to a large volume intravenous fluid before use.
For example, 10mls diluted with not less than 500mls 0.9% Sodium Chloride Intravenous Infusion BP, or other suitable diluent, and mixed well.4.3 Contraindications
• Hyperkalaemia
• Hyperchloraemia
• Impaired renal function with oliguria, anuria or azotaemia
• Addison's disease
• Acute dehydration
• Heat cramps4.4 Special warnings and precautions for use
Potassium Chloride Concentrate 15% must bediluted before use.
Care should be taken to prevent extravasation during intravenous administration (see section 4.8).
Plasma potassium concentration must be measured at regular intervals to avoid the development of hyperkalaemia, especially in patients with renal impairment.
ECG monitoring facilities should be available.
Initial potassium replacement therapy should not involve glucose infusions, because glucose may cause a further decrease in the plasma potassium concentration.
Potassium supplements should be administered with caution in patients with cardiac disease and in patients who are receiving potassium sparing diuretics or other medications which may increase plasma potassium levels.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.
\*\*\*Digoxin:\*\*\*
Potassium salts may be used cautiously in those taking digoxin where potassium depletion may cause arrhythmias.
\*\*\*Glucose Infusion:\*\*\*
Concomitant use of glucose infusions in hypokalaemic patients may cause a further decrease in plasma potassium concentrations.4.6 Fertility, pregnancy and lactation
Potassium Chloride Concentrate 15% may be used during pregnancy and lactation under the supervision of the prescribing physician.4.7 Effects on ability to drive and use machines
Not known.4.8 Undesirable effects
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse events\*\* |
| Metabolism and nutrition disorders | Not known | Hyperkalaemia |
| Nervous system disorders | Not known | Paraesthesia1, paralysis1 |
| Cardiac disorders | Not known | Cardiac arrhythmias1, cardiac arrest1 |
| Vascular disorders | Not known | Phlebitis |
| Musculoskeletal and connective tissue disorders | Not known | Muscle weakness1 |
| General disorders and administration site conditions | Not known | Extravasation2 Pain at the injection site |
(1)As a complication of hyperkalaemia.
(2)Adverse events noted with extravasation in the post-marketing period include oedema, erythema, pain, and blistering, which could potentially result in skin/tissue necrosis.
\*\*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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*\*Symptoms\*\*
Clinical signs and symptoms of potassium overdosage include:
Paraesthesia of the extremities, listlessness, mental confusion, 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\*\*
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 ECG monitoring.
Serum concentrations of potassium 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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Potassium is the major cation of intracellular fluid and is essential for maintenance of acid-base balance, isotonicity and the electrodynamic characteristics of the cell. Potassium chloride is used as a source of the potassium cation for treatment or prevention of potassium depletion in patients in whom dietary measures are inadequate. Potassium chloride may also be used cautiously to abolish arrhythmias or cardiac glycoside toxicity precipitated by a loss of potassium.5.2 Pharmacokinetic properties
Potassium chloride is generally readily absorbed from the gastro-intestinal tract. Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules which are also the site of sodium-potassium exchange. The capacity of the kidneys to conserve potassium is poor and urinary excretion of potassium continues even when there is severe depletion. Tubular secretion of potassium is influenced by several factors, including chloride ion concentration, hydrogen ion exchange, acid-base equilibrium and adrenal hormones. Some potassium is excreted in the faeces and small amounts may also be excreted in saliva, sweat, bile and pancreatic juice.5.3 Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Hydrochloric acid Ph. Eur.
Water for Injections Ph. Eur.6.2 Incompatibilities
The compatibility of the large volume IV fluid intended for dilution should be checked before use.6.3 Shelf life
36 months.6.4 Special precautions for storage
Protect from light and store at less than 25°C.6.5 Nature and contents of container
10ml clear glass ampoules, hermetically sealed under flame at the gauging point. The ampoules are packed in cartons to contain 10 ampoules.6.6 Special precautions for disposal and other handling
Potassium Chloride Concentrate 15% must be diluted with not less than 50 times its volume by adding to a large volume intravenous fluid before use.
If only part used, discard the remaining solution.
- Instruction Content
- ## Composition
15% of Potassium Chloride in 10 ml.
## Pharmaceutical Form
Sterile Injection.
## Clinical Particulars
4.1 Therapeutic indications
Potassium Chloride Concentrate 15% is for use as a source of potassium for the treatment or prevention of potassium depletion in patients for whom dietary measures or oral medication are inadequate.4.2 Posology and method of administration
\*\*Posology\*\*
\*Adults (including elderly) and Children:\*
Dosage depends on the serum ionogram value and the acid-base state. A potassium deficiency is calculated according to the formula:
MMOL Potassium = KG BW x 0.2 x 2 x (4.5 – actual serum potassium (MMOL)).
(The extracellular volume is calculated from the body weight in KG x 0.2).
The maximal rate of infusion is 20 MMOL potassium per hour.
It is recommended not to exceed 2-3 MMOL potassium per kg body weight in 24 hours.
\*\*Method of administration\*\*
Potassium Chloride Concentrate 15% must be administered by slow intravenous infusion, as a dilute solution.
Potassium Chloride Concentrate 15% must be diluted with not less than 50 times its volume by adding to a large volume intravenous fluid before use.
For example, 10mls diluted with not less than 500mls 0.9% Sodium Chloride Intravenous Infusion BP, or other suitable diluent, and mixed well.4.3 Contraindications
• Hyperkalaemia
• Hyperchloraemia
• Impaired renal function with oliguria, anuria or azotaemia
• Addison's disease
• Acute dehydration
• Heat cramps4.4 Special warnings and precautions for use
Potassium Chloride Concentrate 15% must bediluted before use.
Care should be taken to prevent extravasation during intravenous administration (see section 4.8).
Plasma potassium concentration must be measured at regular intervals to avoid the development of hyperkalaemia, especially in patients with renal impairment.
ECG monitoring facilities should be available.
Initial potassium replacement therapy should not involve glucose infusions, because glucose may cause a further decrease in the plasma potassium concentration.
Potassium supplements should be administered with caution in patients with cardiac disease and in patients who are receiving potassium sparing diuretics or other medications which may increase plasma potassium levels.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.
\*\*\*Digoxin:\*\*\*
Potassium salts may be used cautiously in those taking digoxin where potassium depletion may cause arrhythmias.
\*\*\*Glucose Infusion:\*\*\*
Concomitant use of glucose infusions in hypokalaemic patients may cause a further decrease in plasma potassium concentrations.4.6 Fertility, pregnancy and lactation
Potassium Chloride Concentrate 15% may be used during pregnancy and lactation under the supervision of the prescribing physician.4.7 Effects on ability to drive and use machines
Not known.4.8 Undesirable effects
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse events\*\* |
| Metabolism and nutrition disorders | Not known | Hyperkalaemia |
| Nervous system disorders | Not known | Paraesthesia1, paralysis1 |
| Cardiac disorders | Not known | Cardiac arrhythmias1, cardiac arrest1 |
| Vascular disorders | Not known | Phlebitis |
| Musculoskeletal and connective tissue disorders | Not known | Muscle weakness1 |
| General disorders and administration site conditions | Not known | Extravasation2 Pain at the injection site |
(1)As a complication of hyperkalaemia.
(2)Adverse events noted with extravasation in the post-marketing period include oedema, erythema, pain, and blistering, which could potentially result in skin/tissue necrosis.
\*\*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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*\*Symptoms\*\*
Clinical signs and symptoms of potassium overdosage include:
Paraesthesia of the extremities, listlessness, mental confusion, 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\*\*
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 ECG monitoring.
Serum concentrations of potassium 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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Potassium is the major cation of intracellular fluid and is essential for maintenance of acid-base balance, isotonicity and the electrodynamic characteristics of the cell. Potassium chloride is used as a source of the potassium cation for treatment or prevention of potassium depletion in patients in whom dietary measures are inadequate. Potassium chloride may also be used cautiously to abolish arrhythmias or cardiac glycoside toxicity precipitated by a loss of potassium.5.2 Pharmacokinetic properties
Potassium chloride is generally readily absorbed from the gastro-intestinal tract. Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules which are also the site of sodium-potassium exchange. The capacity of the kidneys to conserve potassium is poor and urinary excretion of potassium continues even when there is severe depletion. Tubular secretion of potassium is influenced by several factors, including chloride ion concentration, hydrogen ion exchange, acid-base equilibrium and adrenal hormones. Some potassium is excreted in the faeces and small amounts may also be excreted in saliva, sweat, bile and pancreatic juice.5.3 Preclinical safety data
No further information other than that which is included in the Summary of Product Characteristics.
## Pharmaceutical Particulars
6.1 List of excipients
Hydrochloric acid Ph. Eur.
Water for Injections Ph. Eur.6.2 Incompatibilities
The compatibility of the large volume IV fluid intended for dilution should be checked before use.6.3 Shelf life
36 months.6.4 Special precautions for storage
Protect from light and store at less than 25°C.6.5 Nature and contents of container
10ml clear glass ampoules, hermetically sealed under flame at the gauging point. The ampoules are packed in cartons to contain 10 ampoules.6.6 Special precautions for disposal and other handling
Potassium Chloride Concentrate 15% must be diluted with not less than 50 times its volume by adding to a large volume intravenous fluid before use.
If only part used, discard the remaining solution.
