Consumer medicine information

Sterile Potassium Chloride Concentrate (Pfizer)

Potassium chloride

BRAND INFORMATION

Brand name

Pfizer (Perth) 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 (Pfizer).

What is in this leaflet

This leaflet answers some common questions about Sterile Potassium Chloride Concentrate. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

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

This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What STERILE POTASSIUM CHLORIDE CONCENTRATE is used for

Potassium chloride increases the potassium levels that are in the blood. Potassium is naturally present in body fluids and is needed for normal body function. Potassium chloride is given to patients who have very low levels of potassium or who are unable to take tablets. It may also be used for the treatment of poisoning by digitalis.

Potassium Chloride Concentrate may be used for the treatment of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed potassium chloride.

Ask your doctor if you have any questions about why it has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you are treated with STERILE POTASSIUM CHLORIDE CONCENTRATE

When Sterile Potassium Chloride Concentrate must not be given

You should not be given this medicine if the packaging is torn or show signs of tampering or if the expiry date on the pack has passed.

You will not be given Potassium Chloride if:

  1. You have or have had:
  • an allergy to potassium chloride
  • high potassium levels in your blood

It may not be safe for you to be given potassium chloride, if you are not sure whether any of these apply to you, check with your doctor.Before treatment with Sterile Potassium Chloride Concentrate

You must tell your doctor if:

  1. you have allergies to:
  • any other medicine
  • any other substances, such as foods, preservatives or dye
  1. you have or have had:
  • abnormal heart beat
  • heart disease
  • adrenal gland problems (e.g. Addison's disease)
  • severe burns
  • kidney problems
  • dehydration
  • sickle cell anaemia
  • heat cramps
  1. you are pregnant or intend to become pregnant
Your doctor will discuss the possible risks and benefit of being given potassium chloride during pregnancy.
  1. you are breast-feeding or plan to breast feed
Potassium chloride passes into breast milk, however there have been no problems reported in breast fed infants.
  1. Tell your doctor if you are on a low salt diet.
You may require chloride as well as potassium.

Taking other medicines

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

Some medicines may affect the way potassium chloride works. These include:

  • fluid tablets such as triamterene and thiazine
  • heart drugs such as enalapril, captopril and digitalis
  • medicines to relieve inflammation
  • medicines to treat thrombosis such as heparin
  • products containing salt substitutes
  • other medicines that contain potassium
  • insulin
  • antacids like sodium bicarbonate

If you are unsure whether you are taking one of the above drugs, ask your doctor or pharmacist. These medicines may be affected by potassium chloride or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines.

Your doctor and pharmacist may have more information on medicines to be careful with while being given Potassium Chloride and will advise you about continuing to take other medicines.

Your doctor will advise you about continuing to take other medicines

How STERILE POTASSIUM CHLORIDE CONCENTRATE is given

Potassium Chloride Concentrate treatment usually occurs in a hospital. It will be diluted and given to you as a slow injection into one of your veins (this is called an intravenous infusion) by your doctor or a specially trained nurse.

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.

Follow all directions given to you by your doctor and pharmacist carefully.

Follow all directions given to you by your doctor and pharmacist carefully. These directions may differ from the information contained in this leaflet.

Never administer this medicine yourself..

If you are given too much (overdose)

This rarely happens as Potassium Chloride is administered under the care of a highly trained doctor or nurse.

However, if you are given too much potassium chloride you may experience some of the effects listed under "Side Effects" below.

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

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while being given Potassium Chloride Concentrate

Like other medicines, potassium chloride can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.

Ask your doctor or nurse to answer any questions that may have. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or nurse immediately if you experience any of the following:

  • tingling in the arms or legs
  • confusion
  • abnormal heart beat
  • muscle weakness
  • peeling skin at the site of injection
  • pain at the injection site

These side effects are serious. You may need urgent medical attention.

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

  • nausea
  • vomiting
  • diarrhoea
  • stomach pain

These are the more common side effects of potassium chloride. Mostly these are mild and short-lived.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Some side effects may only be seen by your doctor.

Storage

Sterile Potassium Chloride Concentrates should be stored below 25°C.

Product description

What it looks like

Sterile Potassium Chloride Concentrates are clear, colourless solutions that are contained in plastic ampoules. They are available in 5 different strengths.

Sterile Potassium Chloride Concentrates can be identified by an Australian Register Number, which is found on the packaging -

AUST R 10793

AUST R 10794

AUST R 10810

AUST R 10811

AUST R 49282

Ingredients

Sterile Potassium Chloride Concentrate contains

  • Potassium chloride
  • Water for Injections.

It does not contain a preservative.

Sponsor in Australia

Pfizer Australia Pty Ltd
Sydney NSW Toll Free Number:
1800 675 229
www.pfizer.com.au

This leaflet was prepared in May 2020.

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Pfizer (Perth) Sterile Potassium Chloride Concentrate

Active ingredient

Potassium chloride

Schedule

Unscheduled

 

1 Name of Medicine

Potassium chloride.

6.7 Physicochemical Properties

Chemical structure.

The molecular formula is KCl.

CAS number.

7447-40-7.

2 Qualitative and Quantitative Composition

Sterile Potassium Chloride Concentrate contains:
13.4 mmol (1 g) of potassium chloride in 4 mL Steriluer;
26.8 mmol (2 g) of potassium chloride in 8 mL Steriluer;
10 mmol (750 mg) of potassium chloride in 10 mL Steriluer;
13.4 mmol (1 g) of potassium chloride in 10 mL Steriluer;
20 mmol (1.5 g) of potassium chloride in 10 mL Steriluer.
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.

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.

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.

4.3 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.

4.8 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.

4.2 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.

4.7 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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

Not scheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

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:
50 x 10 mmol (750 mg) in 10 mL Steriluer plastic ampoule;
50 x 13.4 mmol (1 g) in 10 mL Steriluer plastic ampoule;
50 x 20 mmol (1.5 g) in 10 mL Steriluer plastic ampoule;
50 x 13.4 mmol (1 g) in 4 mL Steriluer plastic ampoule;
50 x 26.8 mmol (2 g) in 8 mL Steriluer plastic ampoule.

6.6 Special Precautions for Disposal

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

Summary Table of Changes