Consumer medicine information

DBL Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection

Potassium phosphate, dibasic; Potassium phosphate, monobasic

BRAND INFORMATION

Brand name

DBL Potassium Phosphate - Monobasic and Potassium Phosphate - Dibasic

Active ingredient

Potassium phosphate, dibasic; Potassium phosphate, monobasic

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using DBL Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection.

What is in this leaflet

This leaflet answers some common questions about DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection. It does not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection against the benefits this medicine is expected to have for you.

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

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

What DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate Concentrated Injection is used for

DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection is a mixture of simple phosphate salts used to quickly increase the amount of phosphate in your body.

It works by providing a source of phosphate for your body to use.

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection has been prescribed for you.

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

This medicine is not addictive.

Before you are given DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate Concentrated Injection

When you must not be given it

You should not be given DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate Concentrated Injection if the packaging is torn or shows signs of tampering

You should not be given DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection if the expiry date on the pack has passed. If this medicine is used after the expiry date has passed, it may not work as well.

You should not be given it if you have any of the following medical conditions:

  • kidney disease
  • Addison's disease
  • high blood levels of potassium or phosphate, or low blood levels of calcium.

Before you are given it

Tell your doctor if you have any allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have or have had any other health problems/medical conditions, including:

  • kidney disease
  • pancreatic disease
  • parathyroid problems
  • muscle disease
  • rickets
  • electrolyte disturbances.

Tell your doctor if you are pregnant or intend to become pregnant Your doctor will discuss the risks and benefits of using this medicine during pregnancy.

Tell your doctor if you are breast-feeding or plan to breast-feed. Your doctor will discuss the risks and benefits of using this medicine when breast-feeding.

If you have not told your doctor about any of the above, tell them before you are given DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate 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 or health food shop.

Some medicines and DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection may interfere with each other. These include:

  • ACE inhibitors (medicines used to treat high blood pressure and some other heart conditions)
  • medicines containing calcium, potassium or phosphate
  • cardiac glycosides such as digitalis
  • salicylates
  • non-steroidal anti-inflammatory drugs.

These medicines may be affected by DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid while being given this medicine.

How DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate Concentrated Injection is given

How it is given

This medicine is given as a slow injection into a vein.

It must only be given by a doctor or nurse.

How long it is given for

Your doctor will decide what dose and for how long you will receive this medicine. This depends on your medical condition and other factors, such as your weight.

Sometimes only a single dose is required.

If you take too much (overdose)

As DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate Concentrated Injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any severe side effects after being given DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate Concentrated Injection, tell your doctor immediately or go to Accident and Emergency at the nearest hospital.

In case of overdose, immediately contact the Poisons Information Centre for advice (telephone 13 11 26 in Australia, or call 0800 764 766 in New Zealand)

While you are being given DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate Concentrated Injection

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection.

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

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

If you become pregnant while taking this medicine, tell your doctor immediately.

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

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate Concentrated Injection.

This medicine helps most people with low levels of phosphate in their bodies, 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.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • swelling in the feet or lower legs
  • weight gain

Tell your doctor immediately if you notice any of the following:

  • increased thirst
  • muscle weakness
  • irregular heart beat
  • unexplained anxiety
  • weakness or heaviness in the hands or feet
  • tiredness or confusion
  • convulsions (fits) or muscle cramps
  • numbness or pain
  • breathing difficulties
  • tingling, prickling or burning sensations.

Some people may get other side effects while being given this medicine.

After being given DBL™ Potassium Dihydrogen Phosphate And Dipotassium Hydrogen Phosphate Concentrated Injection

Storage

DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place where the temperature stays below 25°C.

Product description

What it looks like

DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection is a clear, colourless solution.

Ingredients

Each 10 mL ampoule of DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection contains:

  • potassium phosphate dibasic (1.83 grams)
  • potassium phosphate monobasic (540 milligrams) and
  • water for injection .

DBL™ Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

Australian Sponsor:

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

New Zealand Sponsor:

Pfizer New Zealand Limited
P O Box 3998
Auckland, New Zealand, 1140.
Toll Free Number: 0800 736 363

Pack size: 10 mL x 10 amp
AUST R 16268

This leaflet was updated in:
July 2019.

Published by MIMS October 2019

BRAND INFORMATION

Brand name

DBL Potassium Phosphate - Monobasic and Potassium Phosphate - Dibasic

Active ingredient

Potassium phosphate, dibasic; Potassium phosphate, monobasic

Schedule

Unscheduled

 

1 Name of Medicine

Monobasic potassium phosphate.
Dibasic potassium phosphate.

6.7 Physicochemical Properties

Potassium phosphate dibasic is a colourless or white, hygroscopic granular powder. It is freely or very soluble in water and very slightly soluble in alcohol. Potassium phosphate monobasic is a white, odourless, granular or crystalline powder, or colourless crystals. It is freely soluble in water and practically insoluble in alcohol.

Chemical structure.

The molecular formula of potassium phosphate dibasic is K2HPO4, and of potassium phosphate monobasic is KH2PO4. The molecular weight of potassium phosphate dibasic is 174.2, and of potassium phosphate monobasic is 136.1.

CAS number.

The CAS Registry number of potassium phosphate dibasic is 7758-11-4, and of potassium phosphate monobasic is 7778-77-0.

2 Qualitative and Quantitative Composition

Each 10 mL ampoule contains 540 milligrams of potassium phosphate monobasic (KH2PO4) and 1.83 g of potassium phosphate dibasic (K2HPO4) in water for injection. The pH of the solution is approximately 7.5. Each mL of injection contains 2.5 mmol of potassium ions, 1.45 mmol of phosphate ions and 1.84 mmol of hydrogen ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

DBL Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection is a clear, colorless, sterile solution.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The majority (80%) of the body's phosphate is found as calcium phosphate in the skeleton, where it gives rigidity to the bone. The remainder is found in soft tissues. Phosphate is the principle anion of intracellular fluid. In body fluids, phosphate is present mainly as divalent hydrogen phosphate (HPO42-) ions (approximately 80%) and monovalent dihydrogen phosphate (H2PO4-) ions (approximately 20%).
Apart from its essential role in bone structure, phosphate is also important in many metabolic and enzymatic pathways. It is involved in energy storage and transfer, the utilization of B complex vitamins, the buffering of body fluids, and in the renal excretion of hydrogen ions.
Hypophosphataemia may arise from a variety of causes including primary hyperparathyroidism, vitamin D deficiency, X-linked familial hypophosphataemia, alcoholism, hepatic failure and septicaemia. The symptoms of hypophosphataemia include muscle weakness, paraesthesia, convulsions, cardiomyopathy, respiratory failure and haematological abnormalities. Prolonged hypophosphataemia may result in rickets or osteomalacia.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

The normal concentration range of phosphate in plasma is 0.8 to 1.5 mmol/L.
Phosphate is primarily excreted in the urine. Over 90% of plasma phosphate is filtered in the kidneys with the majority being reabsorbed in the proximal tubule. Parathyroid hormone decreases the tubular reabsorption of phosphate, thereby increasing urinary excretion. In addition, serum phosphate levels are inversely related to serum calcium levels and to renal metabolism of vitamin D. A decrease in serum calcium concentration will result in increased serum phosphate levels.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of severe hypophosphataemia (serum levels less than 0.3 mmol/L) and other degrees of hypophosphataemia when oral therapy is not possible.
The cause of hypophosphataemia should be identified and treated.

4.3 Contraindications

Phosphate administration is contraindicated in patients with severe renal function impairment (less than 30% normal) since there is an increased risk of hyperphosphataemia in these patients.
Phosphate administration is contraindicated in patients with hyperphosphataemia, since phosphate therapy will exacerbate the condition.
Phosphate administration is contraindicated in patients with hypocalcaemia due to the close relationship between hypocalcaemia and hyperphosphataemia.
Potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection is contraindicated in patients with hyperkalaemia, since the potassium in the injection may exacerbate the condition.
Potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection is contraindicated in Addison's disease since there is an increased risk of hyperkalaemia in these patients.
Phosphate administration is contraindicated in urolithiasis (magnesium ammonium phosphate type, infected) since it may exacerbate the condition.

4.4 Special Warnings and Precautions for Use

Phosphate should be administered with caution in conditions where high phosphate levels may be encountered, such as hypoparathyroidism, chronic renal disease, and rhabdomyolysis.
Phosphate should be administered with caution in conditions where low calcium levels may be encountered, such as hypoparathyroidism, osteomalacia, chronic renal disease, acute pancreatitis, rhabdomyolysis and rickets.
Potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection should be administered with caution in conditions where high potassium levels may be encountered, such as acute dehydration, pancreatitis, rhabdomyolysis, severe renal insufficiency and extensive tissue damage (such as severe burns).
Potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection should be administered with caution in patients with myotonia congenita, and heart disease (particularly in digitalised patients), (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions), since these conditions may be exacerbated by the potassium in the injection.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Saturation of bone binding sites by phosphate ions may cause decreased bone uptake of technetium Tc99m labelled contrast agents in bone imaging.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Angiotensin converting enzyme (ACE) inhibitors.

Concurrent use with potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection may result in hyperkalaemia, especially in patients with renal impairment.

Calcium containing medicines.

Concurrent use of phosphate and calcium containing medicines may increase the risk of deposition of calcium in soft tissues.

Digitalis glycosides.

The administration of potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection in digitalised patients with severe or complete heart block may result in hyperkalaemia.

Diuretics, potassium sparing.

Concurrent use with potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection may result in hyperkalaemia, especially in patients with renal impairment.

Nonsteroidal anti-inflammatory agents (NSAIDs).

Concurrent use with potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection may result in hyperkalaemia, especially in patients with renal impairment.

Other phosphate containing medicines.

Concurrent use with potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection may result in hyperphosphataemia, especially in patients with impaired renal function.

Potassium containing medicines.

Concurrent use with potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection may result in hyperkalaemia, especially in patients with renal impairment.

Salicylates.

Concurrent use with potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection may increase the serum concentration of salicylates, since salicylate excretion is decreased in acidified urine. This may result in toxic salicylate concentrations when phosphate is administered to patients already stabilized on salicylates.
For information regarding physicochemical incompatibilities please, see Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Animal reproduction studies have not been conducted with this product. It is not known whether this product can adversely affect the foetus when administered to a pregnant woman. Therefore, potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection is not recommended for use during pregnancy.
It is not known whether phosphates are excreted into breast milk, therefore potassium dihydrogen phosphate and dipotassium hydrogen phosphate concentrated injection is not recommended for use during lactation.

4.8 Adverse Effects (Undesirable Effects)

Cardiovascular.

Uncommon: hypotension. Rare: myocardial infarction.

Endocrine/metabolic.

The following events have been reported but are uncommon.
Fluid retention as indicated by swelling of feet or lower legs or weight gain.
Hyperkalaemia leading to confusion, tiredness or weakness, irregular or slow heart rate, numbness or tingling around lips, hands or feet, unexplained anxiety, weakness or heaviness of legs, shortness of breath or troubled breathing.
Hypernatraemia leading to confusion, tiredness or weakness, convulsions, oliguria or decreased frequency of micturition, tachycardia, headache or dizziness, increased thirst.
Hyperphosphataemia, hypocalcaemia or hypomagnesaemia leading to convulsions, muscle cramps, numbness, tingling, pain or weakness in hands or feet, shortness of breath or troubled breathing, tremor.
Extraskeletal calcification as nephrocalcinosis has been reported in children with hypophosphataemic rickets treated with phosphate supplements.

Genitourinary.

Rare: acute renal failure.

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.

For the treatment of severe hypophosphataemia, the following doses are suggested.

Adults.

Up to 10 mmol phosphate administered over 12 hours. The dose may be repeated at 12 hour intervals until serum phosphate exceeds 0.3 mmol/L.

Children.

0.15 to 0.33 mmol/kg administered over 6 hours. The dose may be repeated at 6 hour intervals until serum phosphate exceeds 0.6 mmol/L. The dose should not exceed the maximum recommended adult dose. The rate of infusion should not exceed 0.2 mmol/kg/hour.

Renal impairment.

Dose should be reduced. Use of phosphates in severe renal impairment is contraindicated (see Section 4.3 Contraindications).

Method of administration.

DBL Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection is administered by slow intravenous infusion.

Dilution.

DBL Potassium Dihydrogen Phosphate and Dipotassium Hydrogen Phosphate Concentrated Injection must be diluted before use. The drug can be given in 0.9% sodium chloride or 5% glucose solution. It should be administered by slow infusion to avoid phosphate intoxication.

Monitoring.

Serum sodium, potassium, phosphate and calcium concentrations and renal function should be monitored every 12 to 24 hours during therapy.
Conversion to oral phosphate therapy should occur as soon as possible.

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

Clinical features.

Hyperphosphataemia may occur when large doses of phosphate are given, especially in patients with renal failure. Symptoms associated with hyperphosphataemia include muscle weakness, paraesthesia, muscle cramps, convulsions, cardiomyopathy, respiratory failure and haematological abnormalities.
Hyperphosphataemia may in turn lead to hypocalcaemia and to ectopic calcification, which may be severe.
Crystal deposition may occur in important structures including blood vessels of the eye, lung, heart and kidney. Fatal alveolar diffusion block has occurred, the risk being greater if the patient is alkalotic.

Treatment.

Treatment of overdosage involves the following measures:
immediate cessation of phosphate therapy;
correction of serum electrolyte concentrations, especially calcium;
general supportive treatment.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

Phosphates are reported to be incompatible with calcium or magnesium containing solutions.

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

Ampoule containing a clear colourless solution. See Table 1.

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