Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Potassium Chloride Concentrated Injection.

It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Potassium Chloride Concentrated Injection against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet in a safe place. You may need to read it again.

What Potassium Chloride Concentrated Injection is used for

Potassium Chloride Concentrated Injection is a concentrated solution and is diluted before it is used.

Potassium Chloride Concentrated Injection is used to treat:

• patients with lower than normal levels of potassium in their blood.
• patients with an overdose of digoxin, a medicine used to treat heart failure.

Potassium Chloride Concentrated Injection is used as an injection to raise the level of potassium in the blood when a patient is unable to take potassium by mouth or potassium levels in the blood are very low.

Ask your doctor if you have any questions about why Potassium Chloride Concentrated Injection has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you are given Potassium Chloride Concentrated Injection

When you must not be given it

You should not be given Potassium Chloride Concentrated Injection if you have an allergy to:

• any medicine containing potassium chloride
• any of the ingredients listed at the end of this leaflet
• any other similar medicines.
• or have increased sensitivity to potassium.

Some of the symptoms of an allergic reaction may 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.

You should not be given Potassium Chloride Concentrated Injection if you have:

• a dangerously fast heart beat
• severe burns
• severe dehydration
• heat cramps
• high levels of potassium in the blood.

You should not be given Potassium Chloride Concentrated Injection if you have the following medical conditions:

• higher than normal levels of adrenal hormones known as hyperadrenalism
• lower than normal levels of adrenal hormones known as Addison’s disease
• kidney problems causing the passing of less urine than normal
• kidney disease.

You should not be given this medicine if the solution is discoloured, cloudy, turbid, or particles or a precipitate is present. The solution is normally a clear, colourless to faintly straw coloured solution.

You should not be given this medicine, if when diluted with another solution, it causes the solution to precipitate, become cloudy, turbid, discolour, or particles are visible.

You should not be given this medicine if the packaging is torn or shows signs of tampering, or if the expiry date on the pack has passed. If you are given this medicine after the expiry date has passed, it may not work as well.

If you are not sure you should be given this medicine talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• chronic kidney problems
• any disease which affects the adrenal glands
• any disease affecting the excretion of potassium
• heart disease
• slow or irregular heart beat
• too much acid in the blood which may cause an increased rate of breathing.

Tell your doctor if you are on a low salt diet. You may require chloride as well as potassium.

Tell your doctor if you are pregnant, plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given Potassium Chloride Concentrated Injection.

Taking other medicines

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

Some medicines and Potassium Chloride Concentrated Injection may interfere with each other. These include:

• medicines used to reduce the excretion of potassium in the urine such as spironolactone or triamterene.

These medicines may be affected by Potassium Chloride Concentrated Injection or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How Potassium Chloride Concentrated Injection is given

Potassium Chloride Concentrated Injection must only be given by a doctor or nurse.

How it is given

Potassium Chloride Concentrated Injection is a concentrated solution and must be diluted before use. It will be diluted with a large volume of intravenous solution and then infused into a vein.

How much is given

Your doctor will decide what dose of Potassium Chloride Concentrated Injection you will receive and for how long you will receive it. This depends on your medical condition and other factors, such as your weight.

Sometimes only a single dose of Potassium Chloride Concentrated Injection is required.

If you are given too much (overdose)

As Potassium Chloride Concentrated Injection is always given to you in a hospital under the supervision of a doctor, it is unlikely that you will receive an overdose.

Some medical conditions may result in too much potassium in the blood. Your doctor or nurse will monitor the level of potassium in your blood and any change in heart function.

Symptoms of an overdose are the same as side effects but may be more severe.

The symptoms of a side effect are listed under Side effects below.

If you notice any symptoms of an overdose, immediately contact your doctor or go to the Emergency Department at the nearest hospital.

For information on the management of overdose, contact the Poisons information centre on 13 11 26 (Australia).

While you are being given Potassium Chloride Concentrated Injection

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Potassium Chloride Concentrated Injection.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine. It may affect other medicines used during the surgery.

If you are about to have any blood tests, tell your doctor that you have been given this medicine. It may interfere with the results of some tests.

Keep all your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how Potassium Chloride Concentrated Injection affects you.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from beds or chairs, will help your body get used to the change in position and blood pressure. If this problem continues to get worse talk to your doctor.

Side Effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Potassium Chloride Concentrated Injection. This medicine helps most people with low levels of potassium in their blood, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

Tell your doctor or nurse as soon as possible if you notice any of the following and they worry you:

• nausea, vomiting
• diarrhoea
• stomach pain
• pain at infusion site.

The above list includes the more common side effects of your medicine.

If any of the following happen, tell your doctor or nurse immediately or go to the Emergency Department at your nearest hospital:

• tingling or numbness of the hands or feet
• weakness or heaviness of the legs or limp muscles
• a lack in mental and physical alertness and activity
• mental confusion
• dizziness or light-headedness
• changes in heart rate
• slow or irregular heart beat.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or nurse if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

After being given Potassium Chloride Concentrated Injection

Storage

Potassium Chloride Concentrated Injection will be stored in the surgery, pharmacy or ward of a hospital. The injection is kept in a cool dry place where the temperature stays below 30°C.

Potassium Chloride Concentrated Injection will be opened when it is time for you to have the injection.

Product description

What it looks like

Potassium Chloride Concentrated Injection is a clear, colourless solution in a clear glass vial sealed with a grey rubber stopper and aluminium seal with a black plastic flip off cap.

The vial stopper is not made with natural rubber latex.

Potassium Chloride Concentrated Injection is available in a 10 mL vial.

Ingredients

Potassium Chloride Concentrated Injection contains 2.23 g/10 mL of potassium chloride in water for injections.

This medicine does not contain lactose, sucrose, gluten, tartrazine, dyes or any preservatives.

Manufacturer

Potassium Chloride Concentrated Injection is made in Australia by:

Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

Potassium Chloride 22.3% Concentrated Injection for Infusion 2.23 g/10 mL
10 mL vial
AUST R 23073
Phebra product code- INJ014

This leaflet was prepared in Aug 2022.

Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS October 2022

1 Name of Medicine

Potassium chloride.

2 Qualitative and Quantitative Composition

Potassium Chloride 22.3% Concentrated Injection contains 2.23 g of potassium chloride. Each Potassium Chloride 22.3% Concentrated Injection vial contains 30 mmol potassium ions and 30 mmol chloride ions in 10 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Potassium Chloride 22.3% Concentrated Injection is a clear colourless sterile solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Potassium Chloride 22.3% Concentrated Injection is indicated for the treatment of potassium depletion in patients with hypokalaemia and treatment of digitalis intoxication. IV administration is indicated when the patient is unable to take potassium orally or if hypokalaemia is severe.

4.2 Dose and Method of Administration

Potassium Chloride 22.3% Concentrated Injection is a concentrated solution and must be diluted before use.
Potassium Chloride 22.3% Concentrated Injection is administered intravenously only after dilution in a large volume parenteral fluid. The dose and rate of injection are dependent upon the individual patient's condition. The usual maximum concentration is 40 mmol/L.
In patients whose serum potassium concentration is above 2.5 mmol/L, the rate of infusion should not exceed 10 mmol/hour. The total dose should not exceed 200 mmol/24 hours.
If urgent treatment is required (serum potassium concentration 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 the latter may decrease serum potassium concentrations.

Diluent's compatibility.

4.3 Contraindications

Renal impairment with oliguria or azotaemia, ventricular fibrillation, untreated Addison's disease, hyperadrenalism associated with adrenogenital syndrome, extensive tissue breakdown as in severe burns, acute dehydration, heat cramps, increased sensitivity to potassium administration as in adynamia episodica hereditaria or congenital paramyotonia and hyperkalaemia of any aetiology.

4.4 Special Warnings and Precautions for Use

The use of potassium salts in patients with chronic renal disease, adrenal insufficiency or any other condition which impairs potassium excretion requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.
Hypokalaemia should not be treated by the concomitant administration of potassium salts and potassium sparing diuretics (e.g. spironolactone or triamterene), since the simultaneous administration of these agents can produce severe hyperkalaemia.
In patients on a low salt diet particularly, hypokalaemic hypochloraemic alkalosis is a possibility that may require chloride as well as potassium supplementation. 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 ECG and the patient's clinical status.
Potassium should be used with caution in diseases associated with heart block since increased serum potassium may increase the degree of block.
Parenteral potassium chloride solutions may cause pain if given in a small vein.

Warnings.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Potassium Chloride 22.3% Concentrated Injection has been reported to be incompatible when diluted in solutions containing the following drugs:
(Note: this list may not be complete.)
Adrenaline HCl; atropine sulfate; cephalothin sodium; chloramphenicol sodium succinate; chlorpromazine HCl; diazepam; methicillin sodium; phenytoin sodium; suxamethonium chloride; sulfadiazine sodium; thiopentone sodium.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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 paraesthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, fall in blood pressure, cardiac arrhythmias and heart block. Hyperkalemia may exhibit the following ECG abnormalities: disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves. Nausea, vomiting, diarrhoea and abdominal discomfort have been reported.

Reporting suspected adverse reactions.

4.9 Overdose

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Distribution.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Potassium Chloride 22.3% Concentrated Injection contains 2.23 g potassium chloride in water for injections. Contains no preservatives.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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)¹. The expiry date can be found on the packaging.
¹ AUST R 23073.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Potassium Chloride 22.3% Concentrated Injection is presented in a 10 mL glass vial in a carton of 10 vials.
The vial stopper is not made with natural rubber latex.

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.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes