Consumer medicine information

Resonium A

Sodium polystyrene sulfonate

BRAND INFORMATION

Brand name

Resonium A

Active ingredient

Sodium polystyrene sulfonate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Resonium A.

What is in this leaflet

This leaflet answers some common questions about Resonium A.

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 Resonium A is used for

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

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

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

Your doctor, however, may prescribe Resonium A 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 Resonium A if you have:

  • a bowel obstruction
  • low levels of potassium (less than 5 mmol/L)

Do not take Resonium A 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 Resonium A to newborn babies. Orally administered Resonium A has caused bowel obstruction in newborns. Resonium A 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, Resonium A 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 Resonium A passes into breast milk.

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

  • any heart conditions
  • high blood pressure
  • problems with your bowel or constipation
  • delayed gastric emptying
  • kidney problems
  • oedema (swelling with fluid)

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 Resonium A.

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 Resonium A. 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 Resonium A, 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.

Take Resonium A at least 3 hours before or 3 hours after other oral medications.

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

How to take it

How it is given

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

How much to take

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

Your doctor will decide exactly how much Resonium A you need to take.

The usual doses are:

Oral

Adults:
15 g three to four times daily.

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

Resonium A 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 mix Resonium A with fruit juices or sorbitol.

Take Resonium A at least 3 hours before or 3 hours after other oral medications.

If you have been diagnosed with delayed gastric emptying, ask your doctor for instructions on when to take Resonium A.

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, Resonium A is a cream to light brown coloured suspension in which small white particles may be visible.

Rectal (via the back passage)

Adults:
30 - 50 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.

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 764766), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Resonium A.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Large doses of Resonium A 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 Resonium A 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 Resonium A 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 Resonium A.

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

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 Resonium A, 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 Resonium A. 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 Resonium A. 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 Resonium A 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 Resonium A, 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

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

Resonium A comes in a container containing 454 g of powder. The container also contains a plastic spoon which, when filled level measures 15 g of powder.

Ingredients

Active Ingredient:

Resonium A- Each 100 g contains 99.934 g of Sodium Polystyrene Sulfonate.

Inactive Ingredients:

  • vanillin
  • saccharin.

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

Manufacturer/Sponsor

Resonium A is made in France.

Resonium A is supplied in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall No: 1800 818 806

Resonium A is supplied in New Zealand by:

sanofi -aventis new zealand limited
Level 8
56 Cawley Street
Ellerslie
Auckland
Freecall No: 0800 283 684

This leaflet was prepared in July 2018

Australian Register Number(s)

AUST R 15497

® Registered Trademark

resonium-a-ccdsv6-cmiv3-d2-02jul18

Published by MIMS August 2018

BRAND INFORMATION

Brand name

Resonium A

Active ingredient

Sodium polystyrene sulfonate

Schedule

S4

 

1 Name of Medicine

Sodium polystyrene sulfonate.

2 Qualitative and Quantitative Composition

Resonium A contains 99.93% sodium polystyrene sulfonate, saccharin sodium and vanillin.
The sodium content is approximately 4.1 mmol (100 mg) per gram of Resonium A.

Excipients with known effect.

Saccharin.

3 Pharmaceutical Form

Buff coloured powder.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of hyperkalaemia.

4.2 Dose and Method of Administration

Resonium A 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.

Oral.

15 g three to four times daily. Each dose should be given as a suspension in a small amount of water or, for greater palatability, in syrup (but not fruit juices, which contain potassium), in the ratio of 3-4 mL per gram of resin.
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, Resonium A may be given rectally in a suspension of 30 g to 50 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.

Infants and children.

Oral.

Lower doses should be employed using, as a guide, a rate of 1 mmol potassium per gram of resin as the basis for calculation. An appropriate 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. Each dose should be given as a suspension in a small amount of water or, for greater palatability, in syrup (but not fruit juices, which contain potassium), in the ratio of 3-4 mL per gram of resin.

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.
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. If both routes are used at first, it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum.

4.3 Contraindications

History of hypersensitivity to polystyrene sulfonate resins.
Serum potassium levels less than 5 mmol/L.
Obstructive bowel disease.
Resonium A 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

Due to the risk of severe gastrointestinal disorders, the use of polystyrene sulfonate is not recommended in patients with compromised gastrointestinal motility (including immediate post-surgery or drug-induced).
Serious potassium deficiency can result from Resonium A therapy. It is imperative to determine serum potassium levels at least daily and more frequently when indicated, especially in patients on digoxin. Therapy should be discontinued when serum potassium falls below 5 mmol/L.
Caution is advised when Resonium A is administered to patients in whom an increase in sodium load may be detrimental (i.e. severe congestive heart failure, severe hypertension, renal damage or marked oedema). In such instances, adequate clinical and biochemical control is essential.
Like all cation-exchange resins, Resonium A is not totally selective for potassium in its actions and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving Resonium A should be monitored for all applicable electrolyte disturbances.
In the event of clinically significant constipation, treatment with the resin should be discontinued until normal bowel habit is 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), some of them fatal, were reported in patients treated with polystyrene sulfonate alone or in combination with sorbitol. Concomitant use of sorbitol with sodium 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 Resonium A 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.

Resonium A may bind to orally administered medications, which could decrease their gastrointestinal absorption and efficacy. Avoid co-administration of Resonium A with other orally administered medications. Administer Resonium A 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, Resonium A 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, colic necrosis or sodium overload, 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.

Resonium A has the potential to bind to other orally administered medications. Binding of Resonium A to other oral medications could cause decrease in their gastrointestinal absorption and efficacy. Dosing separation of Resonium A from other orally administered medications is recommended (see Section 4.2 Dose and Method of Administration).
Concomitant use of sorbitol with sodium 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 effectiveness of the resin in binding potassium.
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.

Intestinal obstruction due to concretions of aluminium hydroxide has been reported when aluminium hydroxide was combined with the resin.

Digoxin.

The toxic effects of digoxin on the heart, especially various ventricular arrhythmias and AV nodal depression/dissociation are likely to be exaggerated if hypokalaemia is allowed to 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 Resonium A 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 Resonium A 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 sodium 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.

Respiratory, thoracic and mediastinal disorders.

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

Gastrointestinal disorders.

Gastric irritation, anorexia, constipation, nausea, vomiting and occasionally diarrhoea may also occur. Large doses in elderly individuals may cause faecal impaction. These effects may be obviated through usage of the resin in enemas. Faecal impaction following rectal administration, particularly in children, and gastrointestinal concretions (bezoars) following oral administration have been reported.
Gastrointestinal stenosis and intestinal obstruction have also been reported possibly due to co-existing pathology 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 sodium polystyrene sulfonate, which is sometimes fatal (see 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.

4.9 Overdose

Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalaemia, including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia or paralysis. Apnoea may be a serious consequence of this progression. ECG changes may be consistent with hypokalaemia; cardiac arrhythmia may occur. Hypocalcaemic tetany may occur. Appropriate measures should be taken to monitor and correct serum electrolytes, and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

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

Mechanism of action.

It has an in vitro exchange capacity of approximately 3.1 mmol of potassium per gram of resin. However, in vivo the actual amount of potassium bound is closer to 1 mmol of potassium per gram.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Sodium polystyrene sulfonate is not absorbed from the gastrointestinal tract.

Distribution.

Sodium polystyrene sulfonate removes potassium from the body by exchanging it within the gut for sodium.

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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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. Store in a dry place.
Suspensions of the resin should be freshly prepared and not stored beyond 24 hours. Once reconstituted, Resonium A is a cream to light brown coloured suspension in which small white particulates may remain visible.

6.5 Nature and Contents of Container

High density polyethylene (HDPE) bottle with cap composed of low and density polyethylene (LDPE/HDPE) containing 454 g of sodium polystyrene sulfonate powder and a HDPE dosing spoon.

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

Sodium polystyrene sulfonate is a cation exchange resin prepared in the sodium phase.

Chemical structure.


CAS number.

9080-79-9.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes