Consumer medicine information

Sterile Potassium Chloride Concentrate

Potassium chloride

BRAND INFORMATION

Brand name

Bridgewest Sterile Potassium Chloride Concentrate

Active ingredient

Potassium chloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sterile Potassium Chloride Concentrate.

SUMMARY CMI

Sterile Potassium Chloride Concentrate

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I given Sterile Potassium Chloride Concentrate?

Sterile Potassium Chloride Concentrate contains potassium chloride as the active ingredient. Sterile Potassium Chloride Concentrate is used to increase the potassium level that is in the blood. It may also be used to treat poisoning by digitalis.

For more information, see Section 1. Why am I given Sterile Potassium Chloride Concentrate? in the full CMI.

2. What should I know before receiving Sterile Potassium Chloride Concentrate?

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before receiving Sterile Potassium Chloride Concentrate? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sterile Potassium Chloride Concentrate and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Sterile Potassium Chloride Concentrate given?

Sterile Potassium Chloride Concentrate MUST be diluted before use according to the instructions on the label. If this concentrated solution has not been diluted correctly and mixed thoroughly IT MUST NOT BE USED.

Your doctor or a specially trained nurse will be responsible for diluting Sterile Potassium Chloride Concentrate correctly before giving it to you as a slow injection into one of your veins (called an intravenous infusion).

More information can be found in Section 4. How is Sterile Potassium Chloride Concentrate given? in the full CMI.

5. What should I know after receiving Sterile Potassium Chloride Concentrate?

Things you should do
  • Tell your doctor or nurse if you do not feel well after you have been given potassium chloride.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how potassium chloride affects you.

For more information, see Section 5. What should I know after receiving Sterile Potassium Chloride Concentrate? in the full CMI.

6. Are there any side effects?

Common side effects are nausea, vomiting, diarrhoea, stomach pain, feeling tired, drowsy, or lack of energy and pain or swelling and redness along a vein. Serious side effects include low blood pressure, abnormal heart beat, confusion, tingling in the arms or legs and muscle weakness.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Sterile Potassium Chloride Concentrate

Active ingredient(s): potassium chloride


Consumer Medicine Information (CMI)

This leaflet provides important information about using Sterile Potassium Chloride Concentrate. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Sterile Potassium Chloride Concentrate.

Where to find information in this leaflet:

1. Why am I given Sterile Potassium Chloride Concentrate?
2. What should I know before receiving Sterile Potassium Chloride Concentrate?
3. What if I am taking other medicines?
4. How is Sterile Potassium Chloride Concentrate given?
5. What should I know after receiving Sterile Potassium Chloride Concentrate?
6. Are there any side effects?
7. Product details

1. Why am I given Sterile Potassium Chloride Concentrate?

Sterile Potassium Chloride Concentrate contains potassium chloride as the active ingredient. Potassium is naturally present in body fluids and is needed for normal body function.

Sterile Potassium Chloride Concentrate helps to increase the potassium level that is in the blood. It is given to patients who have very low levels of potassium or who are unable to take tablets. It may also be used to treat poisoning by digitalis.

2. What should I know before receiving Sterile Potassium Chloride Concentrate?

Warnings

You must not be given Sterile Potassium Chloride Concentrate if:

  • you have or have had any of the following medical conditions:
    - high potassium levels in your blood
    - adrenal gland problems
    - severe burns
    - severe dehydration
    - muscle spasm or twitching caused by heat exposure
    - abnormal heartbeat
    - certain heart problems
    - kidney problems where you pass less urine than is normal and have high levels of urea and other nitrogen compounds in your blood
    - Addison's disease
    - any condition which increases your sensitivity to potassium (e.g., adynamia episodica hereditaria or paramyotonia congenita).

Check with your doctor if you:

  • have or have had any other medical conditions, especially the following:
    - kidney problems
    - heart problems
    - sickle cell anaemia
  • take medicines to treat high blood pressure and fluid build-up, especially triamterene, spironolactone and amiloride
  • are on a low-salt diet.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the possible risks and benefit of being given potassium chloride during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Potassium chloride passes into breast milk, however, there have been no problems reported in breast fed infants.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and potassium chloride may interfere with each other. These include:

  • medicines used to treat high blood pressure and fluid build-up such as triamterene, spironolactone, amiloride and thiazide
  • medicines used to treat high blood pressure and some other heart conditions such as enalapril, captopril
  • medicines used to treat high blood pressure, heart conditions, glaucoma and migraine
  • medicines to relieve pain and inflammation
  • medicines to help prevent clotting such as heparin
  • digitalis glycosides such as digoxin
  • insulin
  • antacids like sodium bicarbonate
  • other medicines or supplements that contain potassium.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Sterile Potassium Chloride Concentrate.

Your doctor will advise you about continuing to take other medicines.

4. How is Sterile Potassium Chloride Concentrate given?

How much is given

Your doctor will decide what dose, how often and how long you will receive it. This depends on your condition and other factors, such as your weight, age, blood tests, how well your kidneys are working, and whether or not other medicines are being given at the same time.

How is it given

Sterile Potassium Chloride Concentrate MUST be diluted before use according to the instructions on the label. If this concentrated solution has not been diluted correctly and mixed thoroughly IT MUST NOT BE USED.

Your doctor or a specially trained nurse will be responsible for diluting Sterile Potassium Chloride Concentrate correctly and mixing thoroughly before giving it to you as a slow injection into one of your veins (called an intravenous infusion).

If you are given too much

This rarely happens as potassium chloride will be given to you in hospital under the care of a highly trained doctor.

In the unlikely event that you are given too much (an overdose), you may experience some of the effects listed under Section 6. Are there any side effects?

The signs of overdose are tingling in the arms and legs, weakness, confusion, and abnormal heart beats.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

5. What should I know after receiving Sterile Potassium Chloride Concentrate?

Things you should do

Tell your doctor or nurse if you do not feel well after you have been given potassium chloride.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how potassium chloride affects you.

Looking after your medicine

Sterile Potassium Chloride Concentrate is usually stored on the hospital ward or at the pharmacy.

Your doctor, pharmacist or nurse is responsible for storing Sterile Potassium Chloride Concentrate in a cool dry place, where the temperature stays below 25°C and disposing of any unused product correctly.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • nausea
  • vomiting
  • diarrhoea
  • stomach pain
  • feeling tired, drowsy, or lack of energy
  • pain or swelling and redness along a vein
Tell your doctor or nurse as soon as possible if you notice any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • low blood pressure
  • abnormal heart beat
  • confusion
  • tingling in the arms or legs
  • muscle weakness
Tell your doctor or nurse immediately if you experience any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

What Sterile Potassium Chloride Concentrate contains

Active ingredient
(main ingredient)
  • potassium chloride
Other ingredients
(inactive ingredients)
  • water for Injections
  • potassium hydroxide
  • hydrochloric acid

Tell your doctor if you are allergic to any of these ingredients. Symptoms of an allergic reaction include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.

What Sterile Potassium Chloride Concentrate looks like

Sterile Potassium Chloride Concentrate is a clear, colourless solution in a plastic ampoule. It is available in packs of 50 ampoules (Aust R 10793)

Who manufactures and distributes Sterile Potassium Chloride Concentrate

Bridgewest Perth Pharma Pty Ltd
15 Brodie Hall Drive
Bentley WA 6102
Telephone: 1800 161 156
[email protected]

This leaflet was prepared in September 2023.

Published by MIMS November 2023

BRAND INFORMATION

Brand name

Bridgewest Sterile Potassium Chloride Concentrate

Active ingredient

Potassium chloride

Schedule

Unscheduled

 

1 Name of Medicine

Potassium chloride.

2 Qualitative and Quantitative Composition

Sterile Potassium Chloride Concentrate contains 10 mmol (750 mg) of potassium chloride in 10 mL.
It is a sterile, preservative-free solution of potassium chloride.

3 Pharmaceutical Form

Concentrate for injection.
It is a clear, colourless solution, and free from visible impurities.

4 Clinical Particulars

4.1 Therapeutic Indications

For the prevention and treatment of potassium deficiency (hypokalaemia).
As an electrolyte supply.
Treatment of digitalis intoxication.
These solutions are for use in patients who are unable to take potassium orally.
These solutions are for the preparation of dilute potassium chloride injections or for addition to intravenous fluids.

4.2 Dose and Method of Administration

Dosage.

Solutions should be diluted before use with not less than the recommended volume of suitable diluent (as indicated on individual labels). Careful and thorough mixing of solution after dilution is essential. Intravenous potassium injections must be given slowly. The rate of administration should not exceed 20 mmol of potassium per hour. The dose is dependent on individual patient requirements but total daily dosage should generally not exceed 150 mmol potassium.
In patients whose serum potassium concentration is above 2.5 mmol/L, the rate of infusion should not exceed 10 mmol/hour and the total dose should not exceed 200 mmol/24 hours.
If urgent treatment is required, e.g. if serum potassium concentration is less than 2 mmol/L with ECG changes or paralysis, infuse potassium in a suitable concentration at a rate of 40 mmol/hour, up to a rate of 400 mmol/24 hour period.
In critical states, potassium may be infused in saline (unless saline is contraindicated) rather than in glucose solutions, as glucose may decrease serum potassium concentrations.

Dilution.

Potassium chloride concentrate is compatible with most commonly used intravenous infusion fluids.
The product and its admixtures contain no antimicrobial agent. In order to reduce microbiological hazards it is recommended that further dilution be effected immediately prior to use and infusion commenced as soon as practicable after preparation of the admixture. Infusion should be completed within 24 hours of preparation and the residue discarded.

4.3 Contraindications

Hyperkalaemia.
Hyperadrenalism associated with adrenogenital syndrome.
Tissue breakdown as with severe burns.
Acute dehydration.
Heat cramps.
Renal impairment with oliguria and azotaemia.
Untreated Addison's disease.
Ventricular fibrillation.
Atrioventricular or intraventricular heart block.
Any condition which will increase sensitivity to potassium administration such as adynamia episodica hereditaria or congenital paramyotonia and hyperkalaemia of any aetiology.

4.4 Special Warnings and Precautions for Use

Solutions of potassium chloride must be diluted before use according to dilution instructions on individual labels.
Careful and thorough mixing of solution after dilution is essential.
In patients with impaired renal function, adrenal insufficiency or impaired mechanisms for excreting potassium, intravenous administration may result in hyperkalaemia or cardiac arrest. This is of particular concern in patients given IV potassium. Potentially fatal hyperkalaemia can develop quickly and without apparent warning. Careful monitoring of serum potassium levels during administration and appropriate adjustment of dosage is essential. It is also recommended that acid/ base balance, serum electrolytes, ECG and clinical status of the patient be monitored during therapy.
Concomitant administration of potassium salts and a potassium sparing diuretic (e.g. spironolactone or triamterene) can produce severe hyperkalaemia.
Potassium should be used with caution in diseases associated with heart block. High levels of serum potassium may increase the degree of heart block in patients associated with bradycardia.
The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease or acidosis, requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the patient's ECG and clinical status.
In patients on a low salt diet particularly, hypokalaemic hypochloraemic alkalosis is a possibility that may require chloride as well as potassium supplementation.
Parenteral potassium chloride may cause pain if injected into a small vein.
Sickle cell disease.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No information is available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Potassium sparing diuretics, including triamterene, spironolactone and amiloride.

Increase potassium retention by reducing renal elimination of the potassium ion and hence can produce severe hyperkalaemia.

ACE inhibitors including enalapril and captopril.

Elevate serum potassium and may produce hyperkalaemia when administered concurrently with potassium. ACE inhibitors decrease aldosterone secretion, possibly resulting in potassium retention.

Beta adrenergic agents.

Beta adrenergic blockade increases both peak serum potassium concentration and the time required for serum potassium to return to basal levels in subjects receiving an acute intravenous potassium load.

Nonsteroidal anti-inflammatory drugs (NSAIDs).

May cause hyperkalaemia by inducing secondary hypoaldosteronism following inhibition of renal prostaglandin synthesis.

Heparin.

Reduces the synthesis of aldosterone which may result in hyperkalaemia, especially in patients with underlying renal insufficiency or other problems that impair potassium excretion.

Diuretics, thiazide.

There is an increased risk of hyperkalaemia when a potassium wasting diuretic is stopped after continued use with a potassium supplement.

Digitalis glycosides, in the presence of heart block.

Potassium supplements are not recommended for concurrent use in digitalised patients with severe or complete heart block. Careful monitoring is extremely important if potassium chloride is used to correct hypokalaemia in such patients.

Insulin.

Concurrent use may decrease serum potassium.

Sodium bicarbonate.

Concurrent use may decrease serum potassium.
For information regarding incompatibilities with other products see Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Animal reproduction studies have not been performed with potassium chloride. Both potassium and chloride ions are essential constituents of human tissues and fluids. However, supraphysiological levels of potassium are detrimental to maternal and foetal cardiac function. It is also not known whether therapeutic doses of potassium chloride can cause foetal harm when administered to pregnant women. Potassium chloride should be used during pregnancy only when clearly needed. If treatment is required, oral therapy is preferred. Serum levels should be closely monitored in pregnant women receiving potassium therapy.
Potassium is excreted into breast milk. Because of the potential for potassium to cause serious adverse effects on the breastfeeding baby, caution should be exercised when potassium therapy is given to a breastfeeding woman. However, problems in humans have not been reported.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The symptoms and signs of potassium intoxication include:

Cardiovascular.

Fall in blood pressure, cardiac depression, arrhythmias and heart block.
Hyperkalaemia is usually asymptomatic but may exhibit the following ECG abnormalities: disappearance of the P wave, widening and slurring of QRS complex, changes of the ST segment, tall peaked T waves.

Gastrointestinal.

Nausea, vomiting, diarrhoea and abdominal discomfort may occur.

Other.

Listlessness, mental confusion, paraesthesia of the extremities, weakness and heaviness of the legs, flaccid paralysis.

General.

Pain or phlebitis may occur if solutions containing more than 30 mmol/L of potassium are given intravenously.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

If excretory mechanisms are impaired, or if intravenous potassium is administered too rapidly, potentially fatal hyperkalaemia may result from overdosage with potassium chloride (See Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use). However, hyperkalaemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic ECG changes (peaking of T-waves, loss of P-wave, depression of ST segment, and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest. Should any of these manifestations occur, discontinue potassium administration immediately.
Potassium levels of 8-11 mmol/L may result in death from cardiac depression, arrhythmias or arrest.

Treatment.

If hyperkalaemia develops, the following measures should be considered: elimination of foods and discontinue administration of medicines containing potassium and potassium sparing diuretics. Parenteral frusemide with substantial doses of sodium chloride and bland fluids will assist excretion of excess potassium through the kidneys.
In renal failure, a cation exchange resin may be given, e.g. sodium polystyrene sulphonate 15 g four times daily by mouth or 30 g in 200 mL water as an enema. In severe hyperkalaemia, treatment with haemodialysis or peritoneal dialysis may become necessary.
To correct acidosis, intravenous infusion of sodium bicarbonate 45-150 mEq over 5 minutes (repeated after 15 to 20 minutes if necessary) has been recommended. In the presence of life threatening cardiac arrhythmias, discontinue potassium administration immediately. Continuous ECG monitoring is mandatory.
In treating hyperkalaemia in digitalised patients, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Potassium is an essential body electrolyte found in intracellular fluid where it is the principal cation. It is involved in cell function and metabolism, including maintenance of intracellular acid-base balance and isotonicity, transmission of nerve impulses, contraction of muscle and maintenance of renal function.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Distribution.

After intravenous administration, potassium is actively transported from extracellular fluid into cells where concentrations reach up to 40 times that of extracellular fluid.

Excretion.

It is excreted mainly by the kidneys and is secreted in the distal tubule where it is involved in the sodium-potassium exchange process. Some potassium is excreted in the faeces and small amounts may also be excreted in the sweat, saliva, bile and pancreatic juice.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid, potassium hydroxide, water for injections.

6.2 Incompatibilities

Potassium chloride solution has been reported as being incompatible when diluted in solutions containing the following drugs: adrenaline hydrochloride, amikacin sulphate, amphotericin B, amoxycillin sodium, atropine sulphate, benzylpenicillin, cephalothin sodium, chloramphenicol sodium succinate, chlorpromazine hydrochloride, diazepam, dobutamine hydrochloride, ergotamine tartrate, etoposide with cisplatin and mannitol, methicillin sodium, methylprednisolone sodium succinate, phenytoin sodium, promethazine hydrochloride, sodium nitroprusside, streptomycin sulfate, suxamethonium chloride, sulfadiazine sodium, thiopentone sodium.
The drugs listed above may not be complete. Check compatibility between the additives and potassium chloride solution before mixing.
Potassium chloride injection has been reported to be compatible with the following IV infusion fluids: glucose/ Ringer's injection combinations, glucose/ lactated Ringer's injection combinations, glucose 5% in lactated Ringer's injection, glucose-saline combinations, glucose 5% in sodium chloride 0.9%, glucose 2.5% in water, glucose 5% in water, glucose 10% in water, glucose 20% in water, Ringer's injection, lactated Ringer's injection, sodium chloride 0.45%, sodium chloride 0.9%, sodium chloride 3%.
Potassium chloride injection has been reported to be incompatible with the following IV infusion fluids: mannitol, sterile fat emulsions containing soya oil and lecithin.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
Use once only and discard any remaining portion.

6.5 Nature and Contents of Container

Sterile Potassium Chloride Concentrate is available as 750 mg (10 mmol) in 10 mL sterile plastic (LDPE) ampoules in packs of 50.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

The molecular formula is KCl.

CAS number.

7447-40-7.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes