SUMMARY CMI

DBL™ Potassium Acetate Concentrated Injection

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 being treated with DBL Potassium Acetate Concentrated Injection?

DBL Potassium Acetate Concentrated Injection contains the active ingredient potassium acetate. DBL Potassium Acetate Concentrated Injection is a potassium salt used to quickly increase the amount of potassium in your body.

This medicine is used to treat low blood levels of potassium (hypokalaemia) and can also be added to total parenteral nutrition (TPN) solutions as a source of potassium and acetate ions.

For more information, see Section 1. Why am I being treated with DBL Potassium Acetate Concentrated Injection? in the full CMI.

2. What should I know before treatment with DBL Potassium Acetate Concentrated Injection?

Do not use if you have ever had an allergic reaction to potassium acetate or any of the ingredients listed at the end of the CMI.

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 treatment with DBL Potassium Acetate Concentrated Injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DBL Potassium Acetate Concentrated Injection 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 DBL Potassium Acetate Concentrated Injection given?

• DBL Potassium Acetate Concentrated Injection is given as a slow injection into a vein (i.e. drip).
• This medicine must only be given by a doctor or nurse.
• Your doctor will decide what dose of this medicine 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 this medicine is required.

More instructions can be found in Section 4. How is DBL Potassium Acetate Concentrated Injection given? in the full CMI.

5. What should I know during treatment with DBL Potassium Acetate Concentrated Injection?

For more information, see Section 5. What should I know during treatment with DBL Potassium Acetate Concentrated Injection? in the full CMI.

6. Are there any side effects?

Side effects include: redness, swelling, tenderness and/or pain at injection site, confusion, muscle weakness, cold or grey skin, irregular or rapid heart beat, tingling in fingers or toes, lack of energy and dizziness or lightheadedness. Tell your doctor immediately if you notice any of these side effects.

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

DBL™ Potassium Acetate Concentrated Injection

Active ingredient(s): potassium acetate

Consumer Medicine Information (CMI)

This leaflet provides important information about using DBL Potassium Acetate Concentrated Injection. 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 DBL Potassium Acetate Concentrated Injection.

Where to find information in this leaflet:

1. Why am I being treated with DBL Potassium Acetate Concentrated Injection?
2. What should I know before treatment with DBL Potassium Acetate Concentrated Injection?
3. What if I am taking other medicines?
4. How is DBL Potassium Acetate Concentrated Injection given?
5. What should I know during treatment with DBL Potassium Acetate Concentrated Injection?
6. Are there any side effects?
7. Product details

1. Why am I being treated with DBL Potassium Acetate Concentrated Injection?

DBL Potassium Acetate Concentrated Injection contains the active ingredient potassium acetate. DBL Potassium Acetate Concentrated Injection is a potassium salt used to quickly increase the amount of potassium in your body. This medicine works by providing a source of potassium for your body to use.

DBL Potassium Acetate Concentrated Injection is used to treat low blood levels of potassium (hypokalaemia).

This medicine can also be added to total parenteral nutrition (TPN) solutions as a source of potassium and acetate ions.

2. What should I know before treatment with DBL Potassium Acetate Concentrated Injection?

Warnings

Do not use DBL Potassium Acetate Concentrated Injection if you:

• are allergic to potassium acetate or any of the ingredients listed at the end of this leaflet. 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.
• have any of the following medical conditions:
  - high blood pH (alkalosis)
  - severe kidney disease
  - high blood levels of potassium (hyperkalaemia)
  - Addison's disease
  - excessive loss of body water (dehydration)
  - severe heart disease
  - severe burns
  - heat cramps
  - continuing or severe diarrhoea
  - uncontrolled diabetes mellitus
  - hyperadrenalism.

Tell your doctor if you have or have had any other medical conditions including:

• kidney disease
• adrenal insufficiency
• heart disease
• low blood pH (acidosis).

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

Tell your doctor if you are pregnant or intend to become pregnant.

Tell your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the risks and benefits involved.

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 may interfere with DBL Potassium Acetate Concentrated Injection and affect how it works. These include:

• digoxin, a drug used to treat heart failure or heart disease
• diuretics (fluid tablets) such as triamterene, spironolactone and amiloride
• some medicines for blood pressure and heart disease
• bicarbonate.

These medicines may be affected by potassium acetate, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect DBL Potassium Acetate Concentrated Injection.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while being given DBL Potassium Acetate Concentrated Injection.

4. How is DBL Potassium Acetate Concentrated Injection given?

How it is given

• DBL Potassium Acetate Concentrated Injection is given as a slow injection into a vein (i.e. drip).
• This medicine must only be given by a doctor or nurse.

How much is given

• Your doctor will decide what dose of this medicine 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 this medicine is required.

If you are given too much (overdose)

As this medicine is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

If you think that you have been given too much DBL Potassium Acetate Concentrated Injection, you may need urgent medical attention. Symptoms of potassium acetate overdose include the side effects listed under Section 6. Are there any side effects? but are usually of a more severe nature.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know during treatment with DBL Potassium Acetate Concentrated Injection?

Things you should do

• Tell your doctor, nurse or pharmacist if you have any concerns before, during or after administration of DBL Potassium Acetate Concentrated Injection.
• Tell any other doctors, dentists and pharmacists who treat you that you are being given this medicine.
• If you become pregnant after being given this medicine, tell your doctor or pharmacist.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how DBL Potassium Acetate Concentrated Injection affects you.

Looking after your medicine

• DBL Potassium Acetate Concentrated Injection will be stored in the pharmacy or on the ward.
• Keep in a cool, dry place where the temperature stays below 25°C.
• Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

DBL Potassium Acetate Concentrated Injection will be disposed of by a nurse or pharmacist.

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.

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.

Your doctor may do some tests such as taking blood or monitoring the heart from time to time to make sure the medicine is working and to prevent unwanted side effects.

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

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

What DBL Potassium Acetate Concentrated Injection contains

Do not use this medicine if you are allergic to any of these ingredients.

DBL Potassium Acetate Concentrated Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

What DBL Potassium Acetate Concentrated Injection looks like

DBL Potassium Acetate Concentrated Injection is a clear, colourless solution.

It is available in the following presentation:

• 2.45 g/5 mL ampoule (AUST R 16266)

Who distributes DBL Potassium Acetate Concentrated Injection

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

This leaflet was prepared in January 2023.

Published by MIMS March 2023

1 Name of Medicine

Potassium acetate.

2 Qualitative and Quantitative Composition

DBL Potassium Acetate Concentrated Injection contains 490.0 mg of potassium acetate in each mL of water for injections. The strength supplied is 2.45 g/5 mL in a glass ampoule. Each mL of injection contains 200 mg of potassium. Each mL of DBL Potassium Acetate Concentrated Injection contains 5 mEq (5 mmol) of potassium ions and 5 mEq (5 mmol) of acetate ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

DBL Potassium Acetate Concentrated Injection is a clear, colourless solution. The pH of the solution ranges between 7.5 and 8.5.

4 Clinical Particulars

4.1 Therapeutic Indications

DBL Potassium Acetate Concentrated Injection is indicated for the prophylaxis and treatment of hypokalaemia in patients with or without metabolic acidosis; in chronic digitalis intoxication; and in patients with hypokalaemic familial periodic paralysis. DBL Potassium Acetate Concentrated Injection is only indicated when oral therapy is contraindicated or not tolerated.
DBL Potassium Acetate Concentrated Injection is also indicated for use in total parenteral nutrition (TPN) solutions as an electrolyte supply.

4.2 Dose and Method of Administration

DBL Potassium Acetate Concentrated Injection must be diluted with a suitable infusion solution prior to administration (see Section 4.2 Dose and Method of Administration, Compatibilities).
Do not administer unless solution is clear and seal is intact. Discard unused portion.
Each mL of DBL Potassium Acetate Concentrated Injection contains 5 mEq (5 mmol) of potassium ions and 5 mEq (5 mmol) of acetate ions.
Potassium is administered by intravenous infusion; the dose and rate of infusion are dependent on individual patient requirements. In patients whose serum potassium concentration is above 2.5 mEq/L (2.5 mmol/L), the rate of infusion should not exceed 10 mEq/hour (10 mmol/hour). The concentration of potassium within the prepared infusion should be less than 40 mEq/L. The total daily dose should normally not exceed 150 mEq/24 hours (150 mmol/24 hours) in adults, and children should not receive in excess of 3 mmol/kg per day.
Care must be taken to avoid extravasation. Dehydrated patients should initially receive one litre of potassium free fluid and urine flow must be adequate before potassium solutions are administered.
For urgent treatment [plasma potassium concentration < 2 mEq/L (2 mmol/L) with electrocardiogram (ECG) changes or paralysis], infuse potassium at a rate of 40 mEq/hour (40 mmol/hour), up to a maximum of 400 mEq/24 hour period (400 mmol/24 hour). If doses greater than 20 mEq/hour are used, an infusion pump, ECG and frequent serum potassium monitoring are essential. In critical states, potassium may be infused in saline (unless saline is contraindicated) rather than in glucose solutions, as the latter may decrease plasma potassium concentrations.
Potassium acetate has also been incorporated into the formulation of total parenteral nutrition (TPN) solutions.

Compatibilities.

4.3 Contraindications

Potassium acetate concentrated injection is contraindicated for use in patients with the following disorders:
metabolic or respiratory alkalosis (use oral potassium chloride if possible), as acetate is a precursor of bicarbonate and may exacerbate the condition;
severe renal impairment with associated oliguria, anuria or azotaemia;
hyperkalaemia, including the hyperkalaemic form of familial periodic paralysis;
untreated chronic adrenocortical insufficiency (Addison's disease);
acute dehydration;
ventricular fibrillation;
atrioventricular or intraventricular heart block;
extensive tissue breakdown (e.g. severe burns);
heat cramps;
diarrhoea, severe or prolonged, as renal function may be impaired with the combination of fluid loss and potassium administration;
uncontrolled diabetes mellitus;
hyperadrenalism associated with adrenogenital syndrome;
hypersensitivity to potassium.

4.4 Special Warnings and Precautions for Use

Potassium acetate concentrated injection must be diluted with a compatible infusion fluid prior to administration (see Section 4.2 Dose and Method of Administration).
Diluted solutions of potassium acetate must be administered slowly to the patient. Hyperkalaemia may result from rapid intravenous injection of potassium. Elevated plasma potassium concentration (8 to 11 mEq/L) may cause death from cardiac depression, arrhythmias, or arrest.
In patients with impaired mechanisms for excreting potassium (e.g. chronic renal disease, adrenal insufficiency), administration of potassium salts can produce hyperkalaemia and cardiac arrest, especially if administered intravenously. Potentially fatal hyperkalaemia can develop rapidly and asymptomatically. Therefore, careful monitoring of serum potassium concentration and appropriate dosage adjustment is recommended.
Potassium acetate concentrated injection should not be used concomitantly with potassium sparing diuretics such as amiloride, triamterene and spironolactone or other drugs causing hyperkalaemia such as angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, lisinopril, enalapril, quinapril, perindopril, fosinopril and ramipril) in patients with hypokalaemia. Simultaneous administration of these agents can result in severe hyperkalaemia.
Hyperkalaemia has occurred following addition of concentrated potassium chloride solutions to infusions from a hanging flexible plastic container, apparently as a result of pooling of the concentrated potassium solution at the base of the container and infusion of undiluted solution. Squeezing the container did not facilitate mixing but tended to pump the concentrated solution into the infusion chamber. Mixing of the solutions can be achieved if the plastic container is inverted during the addition of potassium solutions and subsequently agitated and/or kneaded.
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, electrocardiogram and the patient's clinical status.
Use potassium with caution in diseases associated with heart block since increased serum potassium may increase the degree of block.
Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilisation of this ion, such as severe hepatic insufficiency.
Solutions containing acetate ion should be used with caution as excess administration may result in metabolic alkalosis.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Potassium interacts with the following drugs.

Potassium sparing diuretics.

Angiotensin converting enzyme (ACE) inhibitors.

Digoxin.

Bicarbonate.

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)

Pain at the injection site and phlebitis may occur during intravenous administration of solutions containing 30 mEq or more potassium per litre.
Hyperkalaemia is the most common and serious hazard of therapy with potassium. Clinical signs and symptoms of hyperkalaemia include paraesthesiae of the extremities, listlessness, mental confusion, weakness or heaviness of the legs, flaccid paralysis, cold skin, grey pallor, peripheral vascular collapse with fall in blood pressure, cardiac arrhythmias, and heart block. Electrocardiogram (ECG) changes that are characteristic of hyperkalaemia include tall, peaked T waves, depression of the ST segment, disappearance of the P wave, prolongation of the QT interval, and widening and slurring of the QRS complex with development of a biphasic curve and cardiac arrest.

Reporting suspected adverse effects.

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

Water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
Also 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). 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

DBL Potassium Acetate Concentrated Injection is available in glass ampoules.

Pack sizes.

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)

Not scheduled.

Summary Table of Changes