Consumer medicine information

DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection

Dibasic sodium phosphate dodecahydrate; Potassium phosphate, monobasic

BRAND INFORMATION

Brand name

DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection

Active ingredient

Dibasic sodium phosphate dodecahydrate; Potassium phosphate, monobasic

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some common questions about DBL™ Sodium Phosphate and Potassium Phosphate 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™ Sodium Phosphate and Potassium Phosphate Injection against the benefits this medicine is expected to have for you.

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

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

What DBL™ Sodium Phosphate and Potassium Phosphate Injection is used for

DBL™ Sodium Phosphate and Potassium Phosphate Injection is a mixture of simple phosphate used to quickly increase the amount of phosphate in your body.

Sodium phosphate and potassium phosphate work 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 Sodium Phosphate and Potassium Phosphate has been prescribed for you.

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

DBL™ Sodium Phosphate and Potassium Phosphate Injection is not addictive.

Before you are given DBL™ Sodium Phosphate and Potassium Phosphate Injection

When you must not be given it

You should not be given sodium phosphate and potassium phosphate if:

  • the packaging is torn or shows signs of tampering
  • 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 have any of the following medical conditions:
    - kidney disease
    - Addison’s disease (a disease of the adrenal glands)
    - high blood levels of potassium or sodium or phosphate, or low blood levels of calcium.

Before you are given it

Your doctor must know about all the following before you start treatment with sodium phosphate and potassium phosphate:

  1. if you have or have ever had any other health problems/medical conditions, including:
- kidney disease
- pancreatic disease
- liver disease
- Addison’s disease
- parathyroid problems
- muscle disease
- fluid retention
- rickets
- electrolyte disturbances
  1. if you are pregnant or intend to become pregnant
Your doctor will discuss the risks and benefits of you being given sodium phosphate and potassium phosphate during pregnancy.
  1. if you are breast-feeding or plan to breast-feed
Your doctor will discuss the risks and benefits of you being given sodium phosphate and potassium phosphate when breast-feeding.

If you have not told your doctor about any of the above, tell them before you are given DBL™ Sodium Phosphate and Potassium Phosphate 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 may interfere with sodium phosphate and potassium phosphate. These include:

  • medicines containing calcium, sodium, potassium or phosphate
  • cardiac glycosides such as digoxin
  • corticosteroids
  • salicylates
  • non-steroidal anti-inflammatory drugs.

These medicines may be affected by sodium phosphate and potassium phosphate, or may affect how well they work.

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 sodium phosphate and potassium phosphate.

How DBL™ Sodium Phosphate and Potassium Phosphate Injection is given

DBL™ Sodium Phosphate and Potassium Phosphate Injection is given as a slow injection into a vein.

DBL™ Sodium Phosphate and Potassium Phosphate Injection must only be given by a doctor or nurse.

Your doctor will decide what dose you will receive and how long you will need it for. 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™ Sodium Phosphate and Potassium Phosphate Injection is most likely to be given to you in hospital under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience severe side effects tell your doctor immediately.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much sodium phosphate and potassium phosphate injection. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of a sodium phosphate and potassium phosphate injection overdose include the side effects listed below in the ‘Side Effects’ section but are usually of a more severe nature.

Ask your doctor or pharmacist if you have any concerns.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given DBL™ Sodium Phosphate and Potassium Phosphate 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.

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

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

While being given it

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

  • muscle weakness
  • convulsions
  • breathing difficulties
  • tingling, prickling or burning sensations

Some people may get other side effects while being given DBL™ Sodium Phosphate and Potassium Phosphate Injection.

After being given DBL™ Sodium Phosphate and Potassium Phosphate Injection

Storage

DBL™ Sodium Phosphate and Potassium Phosphate 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™ Sodium Phosphate and Potassium Phosphate Injection is a clear, colourless solution.

Ingredients

DBL™ Sodium Phosphate and Potassium Phosphate Injection contains

  • dibasic sodium phosphate dodecahydrate (192 mg/mL),
  • monobasic potassium phosphate (17.4 mg/mL),
  • water for injection.

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

Supplier / Sponsor

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

DBL™ Sodium Phosphate and Potassium Phosphate Injection is available in the following presentation:

  • 5 x 20mL Ampoule.
    AUST R 16270

Date of leaflet preparation:
June 2019

Published by MIMS September 2019

BRAND INFORMATION

Brand name

DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection

Active ingredient

Dibasic sodium phosphate dodecahydrate; Potassium phosphate, monobasic

Schedule

Unscheduled

 

1 Name of Medicine

Dibasic sodium phosphate dodecahydrate.
Monobasic potassium phosphate.

2 Qualitative and Quantitative Composition

Each 20 mL ampoule contains 3.840 g dibasic sodium phosphate dodecahydrate (Na2HPO4.12H2O) and 348 mg monobasic potassium phosphate (KH2PO4) in water for injection. The pH of the solution ranges between 6.5 and 8.0. Each mL of injection contains 0.13 mmol (5 mg) of potassium ions, 1.07 mmol (24.6 mg) of sodium ions, 0.67 mmol (63 mg) of phosphate ions and 0.79 mmol (0.79 mg) of hydrogen ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dibasic sodium phosphate dodecahydrate appears as colourless, transparent, very efflorescent crystals. It is very soluble in water and practically insoluble in alcohol. Monobasic potassium phosphate is a white odourless granular or crystalline powder or colourless crystals. It is freely soluble in water and practically insoluble in alcohol.
DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection is a clear, colorless, sterile solution.

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.

4.2 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/h.

Method of administration.

DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection is administered by slow intravenous infusion.

Dilution.

DBL Sodium Phosphate and Potassium 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.

Dosage adjustments.

Renal impairment.

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

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.
DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection is contraindicated in patients with hyperkalaemia, since the potassium in the injection may exacerbate the condition.
DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection is contraindicated in patients with hypernatraemia since the sodium in the injection may exacerbate the condition.
DBL Sodium Phosphate and Potassium 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

Identified precautions.

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.
DBL Sodium Phosphate and Potassium 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).
DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection should be administered with caution in conditions where high sodium levels may be encountered, such as hypertension, toxaemia of pregnancy, peripheral oedema, pulmonary oedema, cirrhosis of the liver, severe hepatic disease or cardiac failure.
DBL Sodium Phosphate and Potassium 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.

See Section 4.8 Adverse Effects (Undesirable Effects).

Effects on laboratory tests.

Saturation of bone binding sites by phosphate may cause decreased bone uptake of technetium Tc99m labelled contrast agents in bone imaging.
Renal function should also be monitored closely during therapy.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Angiotensin converting enzyme (ACE) inhibitors.

Concurrent use with DBL Sodium Phosphate and Potassium 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.

Corticosteroids (especially mineralocorticoids).

Concurrent use of DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection and corticosteroids with mineralocorticoid activity may result in the formation of oedema due to the sodium content.

Digitalis glycosides.

The administration of DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection in digitalised patients with severe or complete heart block may result in hyperkalaemia.

Diuretics, potassium sparing.

Concurrent use with DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection may result in hyperkalaemia, especially in patients with renal impairment.

Nonsteroidal anti-inflammatory agents (NSAIDs).

Concurrent use with DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection may result in hyperkalaemia, especially in patients with renal impairment.

Other phosphate containing medicines.

Concurrent use with DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection may result in hyperphosphataemia, especially in patients with impaired renal function.

Potassium containing medicines.

Concurrent use with DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection may result in hyperkalaemia, especially in patients with renal impairment.

Salicylates.

Concurrent use with DBL Sodium Phosphate and Potassium 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 stabilised on salicylates.

Sodium containing medicines.

Concurrent use with DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection may result in hypernatraemia due to the sodium content of the injection.

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, DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection is not recommended for use during pregnancy.
 It is not known whether phosphates are excreted into breast milk, therefore, DBL Sodium Phosphate and Potassium Phosphate Concentrated Injection is not recommended for use during lactation.

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)

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.

4.9 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.
In case of overdose, immediately contact the Poison Information Centre for advice (In Australia, call 13 11 26). In New Zealand, call 0800 764 766.

5 Pharmacological Properties

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.

5.1 Pharmacodynamic Properties

Mechanism of action.

No data available.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

No data available.

Distribution.

The normal concentration range of phosphate in plasma is 0.8 to 1.5 mmol/L.

Metabolism.

No data available.

Excretion.

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.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.
See Section 2 Qualitative and Quantitative Composition.

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

Strength.

Dibasic sodium phosphate dodecahydrate 192 mg/mL, monobasic potassium phosphate 17.4 mg/mL.

Pack.

5 x 20 mL.

AUST R.

16270.

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.

The molecular formula of dibasic sodium phosphate dodecahydrate is Na2HPO4.12H2O and of monobasic potassium phosphate is KH2PO4. The molecular weight of sodium phosphate dibasic dodecahydrate is 358.1, and of potassium phosphate monobasic is 136.1.

CAS number.

Dibasic sodium phosphate dodecahydrate is 10039-32-4.
Monobasic potassium phosphate is 7778-77-0.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes