Consumer medicine information

What is in this leaflet

This leaflet answers some of the common questions people ask about Sterile Potassium Chloride Concentrate. It does not contain all the information that is known about Sterile Potassium Chloride Concentrate.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the risks of you being given Sterile Potassium Chloride Concentrate against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.

What Sterile Potassium Chloride Concentrate is for

Sterile Potassium Chloride Concentrate increases levels of potassium in the blood. It is given to patients who have very low potassium levels or who are unable to take tablets. It is also used in digoxin poisoning.
Your doctor will have explained why you are being treated with Sterile Potassium Chloride Concentrate.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
Sterile Potassium Chloride Concentrate is not addictive.

Before you are given Sterile Potassium Chloride Concentrate

You may already have been given Sterile Potassium Chloride Concentrate. Your doctor will have considered the situation carefully and decided to use it. However, if any of the following applies to you, tell your doctor immediately.

When you must not use it

• you are sensitive to potassium

• have an allergy to any ingredient listed at the end of this leaflet or any other related medicines.

• high potassium levels

• kidney problems or you pass less urine than is normal

• heart disease or abnormal heart beats

• adrenal gland problems (e.g. Addison's disease)

• tumour on the adrenal cortex

• severe burns

• dehydration

• muscle twitching caused by heat exposure

Before you are given it

• low salt diet

• sickle cell disease

Taking other medicines

• potassium sparing diuretics (fluid tablets)

• some medicines to treat high blood pressure or heart problems such as enalapril and captopril and any other ACE inhibitors, Beta blockers and digitalis glycosides

• medicine used to treat diabetes e.g. insulin

• medicine to help prevent clotting e.g. heparin

• nonsteroidal anti-inflammatory drugs (NSAIDs)

• sodium bicarbonate

How Sterile Potassium Chloride Concentrate will be given

Sterile Potassium Chloride Concentrate will be diluted, mixed thoroughly and then given to you by your doctor or a specially trained nurse.
It will be given by a drip into your bloodstream.

Overdose

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Sterile Potassium Chloride Concentrate.
Sterile Potassium Chloride Concentrate helps most people with low potassium levels, 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.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:

• nausea

• vomiting

• diarrhoea

• stomach pain

• tingling in the arms and legs

• muscle weakness

• confusion

• weakness and heaviness in the legs

• abnormal heart beats

• pain at the injection site

Storage

Potassium Chloride Juno should be kept in a cool, dry place where the temperature stays below 25 degrees C.

Disposal

Ask your pharmacist what to do with any injection that is unused or you find that the expiry date has passed.

Product Description

Potassium Chloride Juno is a clear, colourless solution.
The active ingredient is potassium chloride
Plus
Water for Injections
It is available in 0.75, 1.0, 1.5, 2.0 grams of potassium chloride in 10mL, in ampoules in packs of 50.

Manufacturer

Juno Pharmaceuticals Pty Ltd
42 Kelso Street
Cremorne, VIC – 3121
Australia
www.junopharm.com.au
This leaflet was prepared in March 2020.
Australian Registration Number:
0.75G/10mL ARTG 320597
1.0G/10mL* ARTG 12041
1.5G/10mL* ARTG 12434
2.0G/10mL* ARTG 12042
*Non marketed

Boxed Warnings

Must be diluted before administration.

1 Name of Medicine

The Australian Approved name is Potassium Chloride.

2 Qualitative and Quantitative Composition

Sterile Potassium Chloride Concentrate is a sterile solution of potassium chloride in Water for Injections, containing no preservatives.

3 Pharmaceutical Form

Concentrated injection.
Clear, colourless solution.

4 Clinical Particulars

4.9 Overdose

Symptoms. If excretory mechanisms are impaired or if I.V potassium is administered too rapidly, potentially fatal hyperkalaemia can result (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 S-T segment, and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest. Other symptoms that may occur are paraesthesia of the extremities, listlessness, mental confusion, weakness or heaviness of the legs, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure, cardiac arrhythmias and heart block, due to which patients may deteriorate rapidly. Should any of these manifestations occur, discontinue potassium administration immediately.
Extremely high plasma potassium concentrations (8-11 mmol/litre) may cause death from cardiac depression, arrhythmias or arrest.
Treatment. If hyperkalaemia develops, the following measures should be considered: elimination of foods and medications containing potassium and of potassium-sparing diuretics; IV administration of 300 to 500 mL/hour of 10% glucose solution containing 10 to 20 units of insulin/1000 mL; correction of acidosis, if present, with IV sodium bicarbonate, use of exchange resins, haemodialysis, or peritoneal dialysis. Cardiac arrhythmias or a serum concentration above 6.5 mmol/L require immediate attention and may be treated by intravenous administration over 1-5 minutes of 10-20 mL of 10% calcium gluconate solution. Continuous ECG monitoring is mandatory.
In treating hyperkalaemia in digitalised patients, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.
Monitoring. Measure urea, electrolytes and creatinine.
Monitor potassium levels regularly (2 to 3 hourly if raised).
Continuous 12 lead ECG.
Observe asymptomatic patients for at least 6 hours.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data are available. Both potassium and chloride ions are essential constituents of human tissues and body fluids. At physiological levels, neither of these ions is known to have a genotoxic activity.
Carcinogenicity. No data are available. Both potassium and chloride ions are essential constituents of human tissues and body fluids. At physiological levels, neither of these ions is known to have a carcinogenic activity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

CAS number. The CAS number for potassium chloride is 7447-40-7.
The molecular formula is KCl.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

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