Consumer medicine information

Potassium Chloride Juno

Potassium chloride

BRAND INFORMATION

Brand name

Potassium Chloride Juno

Active ingredient

Potassium chloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

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

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

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.

You should not be given Potassium Chloride if you are pregnant or breastfeeding unless your doctor says it is safe. Ask your doctor about the risks and benefits involved.

You must not be given Sterile Potassium Chloride Concentrate if:

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

If you have an allergic reaction, you may get a skin rash, hayfever, asthma or feel faint.

You should not be given Sterile Potassium Chloride Concentrate if you have or have had the following medical conditions:

  • 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

You must tell your doctor if you have any of these medical conditions:

  • low salt diet
  • sickle cell disease

It may not be safe for you to be given Sterile Potassium Chloride Concentrate if you have any of these conditions.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy at the chemist, supermarket or health food shop.

Some medicines and Sterile Potassium Chloride Concentrate may interfere with each other. These include:

  • 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

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you are given any Sterile Potassium Chloride Concentrate.

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

The doctor or nurse giving you Sterile Potassium Chloride Concentrate will be experienced in its use, so it is extremely unlikely that you will be given too much.

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

If these signs occur administration of Sterile Potassium Chloride Concentrate must be discontinued immediately along with any foods or medicines that contain potassium. Monitoring with an ECG machine will be necessary along with treatment with appropriate injection solutions.

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

These are all mild side effects of Sterile Potassium Chloride Concentrate.

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

  • tingling in the arms and legs
  • muscle weakness
  • confusion
  • weakness and heaviness in the legs
  • abnormal heart beats
  • pain at the injection site

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

Serious side effects are rare.

Tell your doctor if you notice anything else that is making you feel unwell. Some people may get other side effects while being given Sterile Potassium Chloride Concentrate.

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

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Potassium Chloride Juno

Active ingredient

Potassium chloride

Schedule

Unscheduled

 

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

4.1 Therapeutic Indications

1. The treatment of hypokalaemia.
2. Treatment of digitalis intoxication.
The IV route is indicated when the patient is unable to take potassium orally or if hypokalaemia is severe.

4.2 Dose and Method of Administration

This product contains no antimicrobial preservative and should be used in one patient on one occasion only.
Sterile Potassium Chloride Concentrate is a concentrated solution and must be diluted before use. Sterile Potassium Chloride Concentrate 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.
To reduce microbiological hazard, use as soon as practical after dilution. If storage is necessary, hold at 2-8°C for not more than 24 hours.

Diluents compatibility.

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.

4.3 Contraindications

Renal impairment with oliguria or azotemia, ventricular fibrillation, atrioventricular or intraventricular heart block, 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, hyperkalaemia of any etiology and hyperchloraemia.

4.4 Special Warnings and Precautions for Use

Only use with specialist advice.
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 mechanisms for excreting potassium, administration of potassium salts can produce hyperkalaemia and cardiac arrest. This is of particular concern in patients given IV potassium. Potentially fatal hyperkalaemia can develop rapidly and be asymptomatic. 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.
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 diuretic (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.
Initially do not use with glucose infusions as glucose may further decrease potassium levels.
Parenteral potassium chloride solutions may cause pain if given in a small vein.
Sickle cell disease.
Particularly close monitoring is required where potassium salts are given to patients who are taking medicines that may increase potassium levels (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Pain at the injection site and phlebitis may occur during IV administration of solutions containing 30 mmol potassium or more per litre.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effect on laboratory tests.

No data 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 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, such as thiazide, increase the risk of hypokalaemia when a potassium wasting diuretic is discontinued after concurrent use with a potassium supplement.
Potassium supplementation is not recommended with concurrent use of digitalis glycosides in those patients with severe or complete heart block. Careful monitoring is necessary if potassium chloride is used to correct hypokalaemia in such patients.
Concurrent use with insulin may decrease serum potassium.
Concurrent use with sodium bicarbonate may decrease serum potassium.
Concomitant use of other drugs containing potassium or agents having the potential for hyperkalaemia, may lead to accumulation of potassium: aliskiren, angiotensin-II receptor antagonists, cyclosporine, tacrolimus.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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 cause an adverse effect on fertility.
Both potassium and chloride ions are essential constituents of human tissues and fluids. However, supraphysiological levels of potassium are detrimental to maternal and fetal cardiac function. Exogenous potassium may be used as replacement therapy for pregnant women with hypokalaemia; treatment with oral therapy is always 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.

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 the following:

Cardiovascular.

Fall in blood pressure, cardiac arrhythmias and heart block. Hyperkalaemia 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.

Gastrointestinal.

Nausea, vomiting, diarrhoea and abdominal discomfort.

Other.

Paraesthesia of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs.
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 http://www.tga.gov.au/reporting-problems.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Potassium ion is the principal intracellular ion of most body tissues. Potassium ions are involved in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal, and smooth muscle and the maintenance of normal renal function.
Excretion of potassium occurs mainly via the kidneys and normally any amounts given in excess of intracellular requirements are rapidly eliminated.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

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

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

Potassium chloride solution has been reported to be incompatible when diluted in solutions containing the following drugs: amikacin sulfate, amphotericin B, amoxicillin sodium, benzylpenicillin, diazepam, dobutamine hydrochloride, ergotamine tartrate, etoposide with cisplatin and mannitol, methylprednisolone sodium succinate, phenytoin sodium, promethazine hydrochloride, sodium nitroprusside, streptomycin sulfate.
The above list may not be complete.

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.

6.5 Nature and Contents of Container

Polypropylene ampoules in packs of 50: 0.75 g (10 mmol) in 10 mL.

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

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