Consumer medicine information

DBL Potassium Dihydrogen Phosphate Concentrated Injection

Potassium phosphate, monobasic

BRAND INFORMATION

Brand name

DBL Potassium Dihydrogen Phosphate Concentrated Injection

Active ingredient

Potassium phosphate, monobasic

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

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

SUMMARY CMI

DBL™ Potassium Dihydrogen Phosphate 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 Dihydrogen Phosphate Concentrated Injection?

DBL Potassium Dihydrogen Phosphate Concentrated Injection contains the active ingredient monobasic potassium phosphate. This medicine is used to quickly increase the amount of phosphate in your body.

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

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

Do not use if you have ever had an allergic reaction to DBL Potassium Dihydrogen Phosphate Concentrated Injection 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 Dihydrogen Phosphate Concentrated Injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DBL Potassium Dihydrogen Phosphate 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 Dihydrogen Phosphate Concentrated Injection given?

  • DBL Potassium Dihydrogen Phosphate Concentrated Injection is given as a slow injection into a vein (intravenous infusion) by a doctor or a nurse.
  • Your doctor will decide what dose you will receive and for how long you will receive it. This depends on your medical condition and other factors, such as your weight or age.

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

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

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you have been given DBL Potassium Dihydrogen Phosphate Concentrated Injection.
  • If you are about to have any blood tests, tell your doctor that you have been given this medicine.
Looking after your medicine
  • Store below 25°C. DBL Potassium Dihydrogen Phosphate Concentrated Injection will be stored in the pharmacy or on the ward.

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

6. Are there any side effects?

Side effects include swelling of legs or feet, or weight gain. Serious side effects include muscle weakness or muscle cramps, convulsions (fits), confusion, tiredness, irregular or slow heart rate, unexplained anxiety, tingling or numbness of the hands or feet, breathing difficulties, increased thirst and decrease in urination.

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 Dihydrogen Phosphate Concentrated Injection

Active ingredient(s): monobasic potassium phosphate (potassium dihydrogen phosphate)

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

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

DBL Potassium Dihydrogen Phosphate Concentrated Injection contains the active ingredient monobasic potassium phosphate. DBL Potassium Dihydrogen Phosphate Concentrated Injection is a simple phosphate salt used to quickly increase the amount of phosphate in your body.

DBL Potassium Dihydrogen Phosphate Concentrated Injection works by providing a source of phosphate for your body to use.

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

Warnings

You should not be given DBL Potassium Dihydrogen Phosphate Concentrated Injection if you:

  • are allergic to potassium dihydrogen phosphate 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:
    - a dangerously fast heart rate
    - severe burns
    - acute dehydration
    - heat cramps
    - kidney disease causing less urine than normal or severe kidney disease
    - certain types of kidney stones
    - higher than normal levels of adrenal hormones known as hyperadrenalism
    - lower than normal levels of adrenal hormones known as Addison's disease
    - high blood levels of potassium or phosphate or low blood levels of calcium
    - higher than normal sensitivity to potassium.

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

  • kidney disease
  • pancreatic disease
  • parathyroid problems
  • muscle disease
  • heart disease
  • slow or irregular heart beat
  • rickets
  • electrolyte disturbances.

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. Your doctor will discuss the risks and benefits of you being given this medicine during pregnancy.

Tell your doctor if you are breastfeeding or intend to breastfeed. Your doctor will discuss the risks and benefits of you being given this medicine when breastfeeding.

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 Dihydrogen Phosphate Concentrated Injection and affect how it works. These include:

  • medicines containing calcium, potassium or phosphate
  • medicines that reduce the excretion of potassium such as spironolactone or triamterene
  • cardiac glycosides such as digoxin
  • medicines used to treat high blood pressure and some heart conditions known as ACE inhibitors
  • salicylates
  • non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen.

These medicines may be affected by DBL Potassium Dihydrogen 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.

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 Dihydrogen Phosphate Concentrated Injection.

4. How is DBL Potassium Dihydrogen Phosphate Concentrated Injection given?

How is it given

  • DBL Potassium Dihydrogen Phosphate Concentrated Injection is given as a slow injection into a vein (intravenous infusion).
  • It must only be given by a doctor or nurse.

How much will be given

  • Your doctor will decide what dose of DBL Potassium Dihydrogen Phosphate Concentrated Injection you will receive and how long you will receive it for. This depends on your medical condition and other factors, such as your weight or age.
  • Sometimes only a single dose of DBL Potassium Dihydrogen Phosphate Concentrated Injection is required.

If too much is given

As DBL Potassium Dihydrogen Phosphate Concentrated Injection is given to you under the supervision of your doctor, it is unlikely that you will receive an overdose.

However, if you experience severe side effects, you may need urgent medical attention.

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 Dihydrogen Phosphate Concentrated Injection?

Things you should do

  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given DBL™ Potassium Dihydrogen Phosphate Concentrated Injection.
  • Tell any other doctors, dentists and pharmacists who treat you that you have been given this medicine.
  • If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine. It may affect other medicines used during surgery.
  • If you are about to have any blood tests, tell your doctor that you have been given this medicine. It may interfere with the results of some tests.

Things to be careful of

  • If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Driving or using machines

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

DBL Potassium Dihydrogen Phosphate Concentrated Injection may cause dizziness in some people.

Looking after your medicine

  • DBL™ Potassium Dihydrogen Phosphate Concentrated Injection will be stored in the pharmacy or on the ward.
  • Store in a cool dry place where the temperature stays below 25°C.

Keep it where young children cannot reach it.

When to discard this medicine

Discard any medicine that has passed the expiry date. Do not use this medicine after the expiry date.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

DBL™ Potassium Dihydrogen Phosphate Concentrated Injection 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. 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

Side effectsWhat to do
  • swelling of feet or lower legs
  • weight gain
  • nausea, vomiting, diarrhoea and abdominal discomfort
Speak to your doctor if you have any of these side effects and they worry you.
They are usually mild and short-lived.

Serious side effects

Serious side effectsWhat to do
  • muscle weakness or muscle cramps
  • convulsions (fits)
  • confusion
  • tiredness
  • headache, dizziness or light-headedness
  • irregular or slow heart rate or chest pain
  • sweating, trembling
  • anxiety
  • tingling or numbness of the lips, hands or feet
  • breathing difficulties
  • increased thirst and decrease in urination
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious 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.

Some side effects can only be found when your doctor does tests from time to time to check your progress.

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 Dihydrogen Phosphate Concentrated Injection contains

Active ingredient
(main ingredient)		Monobasic potassium phosphate
Other ingredients
(inactive ingredients)		Water for injections

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

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

Each 10 mL ampoule contains 1.361 g of monobasic potassium phosphate. Each mL of injection contains 1 mmol of potassium ions, 1 mmol of phosphate ions and 2 mmol of hydrogen ions.

What DBL Potassium Dihydrogen Phosphate Concentrated Injection looks like

DBL Potassium Dihydrogen Phosphate Concentrated Injection is a clear, colourless solution.

It is available in the following presentation:

  • 1.361 g/10 mL ampoule (AUST R 16263)

Who distributes DBL Potassium Dihydrogen Phosphate 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

BRAND INFORMATION

Brand name

DBL Potassium Dihydrogen Phosphate Concentrated Injection

Active ingredient

Potassium phosphate, monobasic

Schedule

Unscheduled

 

1 Name of Medicine

Monobasic potassium phosphate.

2 Qualitative and Quantitative Composition

Each 10 mL ampoule contains 1.361 g of monobasic potassium phosphate (KH2PO4) in Water for Injection. The pH of the solution is approximately 4.5. Each mL of injection contains 1 mmol of potassium ions, 1 mmol of phosphate ions and 2 mmol of hydrogen ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

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 Potassium Dihydrogen 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.

0.15-0.33 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 Potassium Dihydrogen Phosphate Concentrated Injection is administered by slow intravenous infusion. The injection must be diluted before use.

Dilution.

DBL Potassium Dihydrogen 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

DBL Potassium Dihydrogen Phosphate Concentrated Injection is contraindicated in:
Patients with severe renal function impairment (less than 30% normal), since there is an increased risk of hyperphosphataemia in these patients.
Patients with hyperphosphataemia, since phosphate therapy will exacerbate the condition.
Patients with hypocalcaemia, due to the close relationship between hypocalcaemia and hyperphosphataemia.
Patients with hyperkalaemia, since the potassium in the injection may exacerbate the condition.
Addison's disease since there is an increased risk of hyperkalaemia in these patients.
Urolithiasis (magnesium ammonium phosphate type, infected), since it may exacerbate the condition.
Renal impairment with oliguria and azotaemia.
Ventricular fibrillation.
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 paramytonia.

4.4 Special Warnings and Precautions for Use

Potassium.

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.
Potassium should be used with caution in diseases associated with heart block since increased serum potassium may increase the degree of block.

Hyperkalaemia.

Monobasic potassium phosphates should be avoided in patients with hyperkalaemia. Sodium phosphates may be substituted.
In patients with impaired mechanisms for excreting potassium, administration of potassium salts can produce hyperkalaemia and cardiac arrest. This is an important concern in patients given IV potassium. Potentially fatal hyperkalaemia can develop rapidly and be asymptomatic. In patients being given potassium especially by IV, monitoring of serum electrolytes, the ECG and the patient's clinical status is indicated.

Phosphate.

Phosphate should be administered with caution in conditions where high phosphate levels may be encountered, such as hypoparathyroidism, chronic renal disease, acute dehydration, pancreatitis, rhabdomyolysis, severe renal insufficiency and extensive tissue damage (such as severe burns).
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, rickets, 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.
Caution should be used where patients may be hypocalcaemic.
Serum electrolyte and especially phosphate levels in the body and renal function should be monitored during treatment.
Phosphates should not be administered to patients with severely impaired renal function. Aluminium, calcium, or magnesium salts should not be administered concomitantly with phosphates as they bind phosphate thus impairing its absorption from the gastro-intestinal tract.

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 DBL Potassium Dihydrogen Phosphate Concentrated Injection may result in hyperkalaemia, especially in patients with renal impairment.

Calcium containing medicines.

Concurrent use of DBL Potassium Dihydrogen Phosphate Concentrated Injection and calcium containing medicines may increase the risk of deposition of calcium in soft tissues.

Digitalis glycosides.

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

Potassium sparing diuretics.

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

Nonsteroidal anti-inflammatory agents (NSAIDs).

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

Phosphate containing medicines.

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

Potassium containing medicines.

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

Salicylates.

Concurrent use with DBL Potassium Dihydrogen 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.

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

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.
The symptoms and signs of potassium intoxication include paraesthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, 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. Nausea, vomiting, diarrhoea and abdominal discomfort have been reported.
Treatment of adverse effects involves withdrawal of phosphate, general supportive measures, and correction of serum-electrolyte concentrations, especially calcium (see Section 4.9 Overdose).

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

Phosphate.

Excessive administration of phosphate, particularly by the intravenous route, may cause hyperphosphataemia but this rarely occurs unless there is renal failure. Hyperphosphataemia may also occur in the presence of acidosis, acromegaly, haemolysis, hypoparathyroidism, tissue destruction, or vitamin D toxicity. Symptoms associated with hyperphosphataemia include muscle weakness, paraesthesia, convulsions, cardiomyopathy, respiratory failure and haematological abnormalities.
Hyperphosphataemia leads in turn to hypocalcaemia, which may be severe, and to ectopic calcification. Secondary hyperparathyroidism may develop in the presence of renal failure.
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.

Potassium.

If excretory mechanisms are impaired or if IV 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. Should any of these manifestations occur, discontinue potassium administration immediately.

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; in presence of life-threatening cardiac arrhythmias, IV administration of 10 to 50 mL calcium gluconate 10% over 5 minutes. 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).

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 utilisation 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.

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. Admixture will lead to precipitates being formed in the solution. Solutions containing other cations such as iron and aluminium may also form precipitates when added to the product.

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.

Potassium phosphate monobasic 136.1 milligrams/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

Chemical structure.

The molecular formula of potassium phosphate monobasic is KH2PO4. Its molecular weight is 136.1.

CAS number.

7778-77-0.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes