Consumer medicine information

Calcium Resonium [8989]

Calcium polystyrene sulfonate

BRAND INFORMATION

Brand name

Calcium Resonium Powder for suspension

Active ingredient

Calcium polystyrene sulfonate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Calcium Resonium [8989].

What is in this leaflet

This leaflet answers some common questions about Calcium Resonium.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What Calcium Resonium is used for

Calcium Resonium is a type of medicine used to help remove excessive amounts of potassium from the blood.

Calcium Resonium contains calcium polystyrene sulfonate which contains calcium atoms. This calcium is swapped for potassium in the body, particularly in the large intestine.

Calcium Resonium does not enter the bloodstream from the intestine. It is passed (with the potassium ions) with the faeces.

Your doctor, however, may prescribe Calcium Resonium for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

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

Before you take it

When you must not take it

Do not take Calcium Resonium if you have:

  • a bowel obstruction
  • high calcium levels in the blood
  • high levels of parathyroid hormone (PTH)
  • multiple myeloma (a cancer of the blood) or sarcoidosis (an inflammatory disorder)
  • low levels of potassium (less than 5 mmol/L).

Do not take Calcium Resonium if you are allergic to it or any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Do not give oral Calcium Resonium to newborn babies.

Orally administered Calcium Resonium has caused bowel obstruction in newborns. Calcium Resonium should only be given rectally to newborns.

Do not take it if you are pregnant or intend to become pregnant.

Do not take it if you are breastfeeding or planning to breastfeed.

Do not take it after the expiry date (EXP) printed on the pack.

If you take it after the expiry date has passed, it may not work as well.

Do not take it if the packaging is damaged or shows signs of tampering.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

  • any of the ingredients listed at the end of this leaflet,
  • any other medicines which contain polystyrene sulfonate resins,
  • any other substances, such as foods, preservatives or dyes.

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

Like most medicines of this kind, Calcium Resonium is not recommended to be used during pregnancy.

Tell your doctor or pharmacist if you are breastfeeding or planning to breastfeed.

It is not known whether Calcium Resonium passes into breast milk.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

  • thyroid conditions
  • constipation
  • bone marrow (blood) disorders or tumours.

Tell your doctor if you plan to have surgery.

If you have not told your doctor or pharmacist about any of the above, tell them before you take Calcium Resonium.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

Some medicines may interfere with Calcium Resonium. These include:

  • sorbitol
  • digoxin, a medicine used for heart problems
  • laxatives
  • thyroxine, a medicine for hypothyroidism
  • lithium, a medicine which can be used to treat bipolar disorder
  • antacids containing aluminium or magnesium

These medicines may be affected by Calcium Resonium, or may affect how well it works. You may need to use different amounts of your medicine, or take different medicines. Your doctor or pharmacist will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Calcium Resonium.

How to take it

How it is given

Calcium Resonium can be given by mouth or rectally (via the back passage).

How much to take

The amount of Calcium Resonium you need to take will depend upon the amount of potassium in your blood.

Your doctor will decide exactly how much Calcium Resonium you need to take. The usual doses are:

Oral

Adults:
15 g three to four times daily. The spoon provided in the jar contains 15 g of powder when filled level.

Children:
1 g/kg of body weight in divided doses.

Calcium Resonium powder is usually given by mouth as a suspension in a small amount of water (3-4 mL per gram of powder), or it may be mixed with some sweetened liquid (but not fruit juices, which contain potassium). For children it is preferably given with a drink (not a fruit juice because of the high potassium content) or a little jam or honey.

Do not take Calcium Resonium with fruit juices or sorbitol.

Once the mixture has been prepared it should be used straight away. If it needs to be stored, it should be stored for no longer than 24 hours. Once reconstituted, Calcium Resonium is a cream to light brown coloured suspension in which small white particles may be visible.

Rectal (via the back passage)

Adults:
30 g in 150 mL of water or 10% dextrose in water, as a retention enema. Your pharmacist will make this up.

Infants & children:
Lower dosages are usually used.

Newborn babies (Neonates):
Calcium Resonium should not be given by mouth. With rectal administration the minimum effective dose range 0.5 g/kg to 1 g/kg should be used. This enema should be retained for at least nine hours. Afterwards the colon needs to be irrigated to remove the Calcium Resonium.

You will usually be given the enema by a doctor or nurse.

If you forget to take it

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Do not take a double dose to make up for the dose you have missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Calcium Resonium.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Large doses of Calcium Resonium may cause serious potassium ion deficiency. If you take too much you may feel irritable, confused, have muscle weakness, have diminished reflexes or paralysis.

While you are taking it

Things you must do

Take Calcium Resonium exactly as prescribed.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Your doctor will regularly check the potassium, calcium and magnesium levels in your blood. The doctor may change the dose or stop the Calcium

Resonium depending on what the results of these blood tests are.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Calcium Resonium.

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are taking Calcium Resonium.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.

If you become pregnant while you are taking this medicine, stop taking it and tell your doctor or pharmacist immediately.

Things you must not do

Do not take more than the recommended dose unless your doctor tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not stop taking Calcium Resonium, or lower the dosage, without checking with your doctor.

Side effects

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor as soon as possible if you do not feel well while you are taking Calcium Resonium.

It helps most people, but it may have unwanted side effects in a few people.

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

  • nausea and vomiting
  • constipation
  • diarrhoea
  • muscle cramps
  • loss of appetite
  • gastric irritation

These are mild side effects of this medicine and are usually short-lived.

If any of the following happen, stop taking this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
  • hives
  • fainting

These are very serious side effects. If you have them, you may have had a serious allergic reaction to Calcium Resonium. You may need urgent medical attention or hospitalisation.

These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some consumers.

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.

After taking it

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

Keep Calcium Resonium in a cool, dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a windowsill.

Do not leave it in the car.

Heat and damp can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking Calcium Resonium, or the medicine has passed its expiry date, ask your pharmacist what to do with any that are left over.

Return any unused medicine to your pharmacist.

Product description

What it looks like

Calcium Resonium is a buff coloured powder with a vanilla odour.

Calcium Resonium comes in a container containing 300 g of powder. The container also contains a plastic spoon which, when filled level measures 15 g of powder.

Ingredients

Active Ingredient:
Calcium Resonium- Each 100 g contains 99.934 g of Calcium Polystyrene Sulfonate.

Inactive Ingredients:

  • vanillin
  • saccharin.

Calcium Resonium does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.

Manufacturer/Sponsor

Calcium Resonium is made in France .

Calcium Resonium is supplied in Australia by:
Sanofi-Aventis Australia Pty Ltd
12-24 Talavera Road
Macquarie Park NSW 2113

Calcium Resonium is supplied in New Zealand by:
Sanofi -Aventis New Zealand Limited
Level 8, James and Wells Tower
56 Cawley Street
Ellerslie
Auckland

This leaflet was prepared in January 2014

Australian Register Number(s)
AUST R 12567

®Registered Trademark

BRAND INFORMATION

Brand name

Calcium Resonium Powder for suspension

Active ingredient

Calcium polystyrene sulfonate

Schedule

S4

 

1 Name of Medicine

Calcium polystyrene sulfonate.

2 Qualitative and Quantitative Composition

Calcium Resonium contains 99.93% calcium polystyrene sulfonate ground and flavoured to a vanilla odour and sweet taste. The sodium content of Calcium Resonium is less than 1 mg/g. Calcium content is about 8% w/w (1.6-2.4 mmol/g).

Excipients with known effect.

Saccharin sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Buff coloured very fine powder.
Once reconstituted, Calcium Resonium is a cream to light brown coloured suspension in which small white particulates may remain visible.

4 Clinical Particulars

4.1 Therapeutic Indications

Calcium Resonium is an ion-exchange resin. It is recommended for the treatment of hyperkalaemia associated with anuria and severe oliguria.
It is also used to treat hyperkalaemia in patients requiring dialysis and in patients on regular haemodialysis or on prolonged peritoneal dialysis.

4.2 Dose and Method of Administration

Calcium Resonium is for oral or rectal administration only. The dosage recommendations detailed below are a guide only; the precise requirements should be determined on the basis of regular clinical and serum electrolyte monitoring.

Adults, including the elderly.

Oral.

Usual dose 15 g three or four times a day. The resin is given by mouth as a suspension in a small amount of water (3-4 mL per gram of resin), or it may be mixed with some sweetened vehicle (but not fruit juices, which contain potassium).
Administer at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis, a 6-hour separation should be considered (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Rectal.

In cases where vomiting or upper gastrointestinal problems, including paralytic ileus, may make oral administration difficult, the resin may be given rectally in a suspension of 30 g resin in 150 mL water or 10% dextrose in water, given as a daily retention enema. In the initial stages, administration by this route as well as orally may help to achieve a more rapid lowering of the serum potassium level.
The enema should, if possible, be retained for at least nine hours, following which the colon should be irrigated to remove the resin. If both routes are used at first, it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum.

Children.

Oral.

Lower doses should be used, as a guide, 1 mmol potassium per gram of resin. The initial dose is 1 g/kg body weight daily in divided doses, in acute hyperkalaemia. For maintenance therapy dosage may be reduced to 0.5 g/kg body weight daily in divided doses.
The resin is given orally, preferably with a drink (not a fruit juice because of the high potassium content) or a little jam or honey.

Rectal.

When the resin cannot be given by mouth, it may be given rectally using a dose at least as great as that which would have been given orally, diluted in the same ratio as described for adults. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin.

Neonates.

Calcium Resonium should not be given by the oral route, only rectal administration should be considered. With rectal administration, the minimum effective dosage within the range 0.5 g/kg to 1 g/kg should be employed, diluted as for adults and with adequate irrigation to ensure recovery of the resin.

4.3 Contraindications

History of hypersensitivity to polystyrene sulfonate resins.
Serum potassium levels less than 5 mmol/L.
Conditions associated with hypercalcaemia (e.g. hyperparathyroidism, multiple myeloma, sarcoidosis or metastatic carcinoma).
Obstructive bowel disease.
Calcium Resonium should not be administered orally to neonates and is contraindicated in neonates with reduced gut motility (e.g. post-operatively or drug induced).

4.4 Special Warnings and Precautions for Use

The possibility of severe potassium depletion should be considered and adequate clinical and biochemical control is essential during treatment, especially in patients on digoxin. Administration of the resin should be stopped when the serum potassium falls to 5 mmol/litre.
Like all cation-exchange resins, Calcium Resonium is not totally selective for potassium in its actions. Serum calcium levels should be estimated at weekly intervals to detect the early development of hypercalcaemia, and the dose of resin adjusted to levels at which hypercalcaemia and hypokalaemia are prevented. Hypomagnesaemia may also occur and serum magnesium levels should be monitored. Patients should be monitored for all applicable electrolyte disturbances.
In the event of clinically significant constipation, treatment should be discontinued until normal bowel movement has resumed. Magnesium containing laxatives should not be used (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
With oral administration, care should be taken to avoid aspiration, which may lead to bronchopulmonary complications.
Gastrointestinal stenosis, intestinal ischaemia and its complications (necrosis and perforation) may occur in patients treated with polystyrene sulfonate, especially in patients using sorbitol. Therefore, concomitant use of sorbitol with calcium polystyrene sulfonate is not recommended (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.8 Adverse Effects (Undesirable Effects)).
Since effective lowering of serum potassium with Calcium Resonium may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalaemia, often associated with states of rapid tissue breakdown, e.g. burns or trauma. In such instances, some form of dialysis may be imperative. If hyperkalaemia is so marked as to constitute a medical emergency, immediate treatment with intravenous glucose and insulin or intravenous sodium bicarbonate may be necessary as a temporary measure to lower serum potassium while other long-term potassium lowering therapy is being prepared.

Binding to other orally administered medications.

Calcium Resonium may bind to orally administered medications, which could decrease their gastrointestinal absorption and efficacy. Avoid co-administration of Calcium Resonium with other orally administered medications. Administer Calcium Resonium at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis, a 6-hour separation should be considered (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in the elderly.

No data available.

Paediatric use.

In neonates, Calcium Resonium should not be given by the oral route.
In children and neonates, particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin.
Due to the risk of digestive haemorrhage or colic necrosis, particular care should be observed in premature infants or low birth weight infants.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant use not recommended.

Calcium Resonium has the potential to bind to other orally administered medications. Binding of Calcium Resonium to other oral medications could cause decrease in their gastrointestinal absorption and efficacy. Dosing separation of Calcium Resonium from other orally administered medications is recommended (see Section 4.2 Dose and Method of Administration).
Concomitant use of sorbitol with calcium polystyrene sulfonate is not recommended due to cases of intestinal necrosis, and other serious gastrointestinal adverse reactions, which may be fatal (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).

To be used with caution.

Cation donating agents may reduce the potassium binding effectiveness of Calcium Resonium.
Non-absorbable cation containing antacids and laxatives (such as magnesium hydroxide); and concomitant oral use of cation exchange resins has been reported to cause systemic alkalosis.

Aluminium hydroxide hydrate.

Intestinal obstruction due to concretions of aluminium hydroxide hydrate has been reported when taken in combination with the resin (sodium form).

Digoxin.

The toxic effects of digoxin on the heart, especially ventricular arrhythmias and AV nodal depression/dissociation, are likely to be exaggerated if hypokalaemia and/or hypercalcaemia develop.

Lithium.

Possible decrease of lithium absorption.

Thyroxine.

Possible decrease of thyroxine absorption.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
No data are available regarding the use of polystyrene sulfonate resins in pregnancy. The administration of Calcium Resonium in pregnancy is not advised unless the potential benefits outweigh any potential risks.
No data are available regarding the use of polystyrene sulfonate resins in lactation. The administration of Calcium Resonium during breast-feeding, therefore, is not advised unless the potential benefits outweigh any potential risks.

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)

Metabolism and nutrition disorders.

In accordance with its pharmacological actions, the resin may give rise to calcium retention, hypokalaemia and hypocalcaemia and their related clinical manifestations (see Section 4.4 Special Warnings and Precautions for Use). Cases of hypomagnesemia, have been reported.
Hypercalcaemia has been reported in well-dialysed patients receiving calcium resin, and occasionally in patients with chronic renal failure. Many patients in chronic renal failure have low serum calcium and high serum phosphate, but some, who cannot be screened out beforehand, show a sudden rise in serum calcium to high levels after therapy. The risk emphasises the need for adequate biochemical control.

Respiratory, thoracic and mediastinal disorders.

Some cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of calcium polystyrene sulfonate have been described.

Gastrointestinal disorders.

Gastric irritation, anorexia, nausea, vomiting, constipation and occasionally diarrhoea may also occur. Faecal impaction following rectal administration has been reported, particularly in children, and gastro-intestinal concretions (bezoars) following oral administration.
Gastrointestinal stenosis and intestinal obstruction have also been reported, possibly due to coexisting pathology, excessive dosage or inadequate dilution of the resin.
Gastrointestinal ischemia, ischemic colitis, gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation have been reported following administration of calcium polystyrene sulfonate, which is sometimes fatal (see Section 4.4 Special Warnings and Precautions for Use).
The majority of cases has been reported with concomitant use of sorbitol (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.4 Special Warnings and Precautions for Use).

Reporting suspected adverse reactions.

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 (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

4.9 Overdose

Hypokalaemia may manifest clinically by signs of irritability, confusion, delayed thought processes, severe muscle weakness, hyporeflexia or paralysis. ECG abnormalities may be evident and cardiac arrhythmias may occur. Consideration should be given to accelerated elimination of the resin, particularly if intestinal motility is reduced. In the event of overdosage appropriate measures should be taken to correct serum electrolytes (restore serum potassium levels to normal, and reduce blood calcium levels if these are raised) and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.
For general advice on overdose management, contact the Poisons Information Centre, telephone number 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Drugs for treatment of hyperkalemia and hyperphosphatemia, ATC code: V03AE01.

Mechanism of action.

Each gram of resin has a theoretical in vitro exchange capacity of about 1.3 to 2 millimoles of potassium. However, in vivo, the actual amount of potassium bound will be less than this. The resin is insoluble in water.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Calcium polystyrene sulfonate is not absorbed from the gastrointestinal tract.

Distribution.

Calcium polystyrene sulfonate removes potassium from the body by exchanging it within the gut for calcium.

Metabolism.

No data available.

Excretion.

For the most part, this action occurs in the large intestine, which excretes potassium to a greater degree than does the small intestine.
The efficiency of potassium exchange is unpredictable and variable. The resin is not selective for potassium.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Saccharin sodium and vanillin.

6.2 Incompatibilities

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

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 30°C.
Suspensions of the resin should be freshly prepared and not stored beyond 24 hours.

6.5 Nature and Contents of Container

HDPE containers of 300 g each containing a plastic scoop which, when filled level, contains approximately 15 g.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Calcium polystyrene sulfonate is a cation exchange resin prepared in the calcium phase.

Chemical structure.


CAS number.

37286-92-3.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes