Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension

Summary of Product Characteristics Updated 23-Feb-2022 | Sovereign Medical

1. Name of the medicinal product

Calcium Polystyrene Sulfonate 99.75% Powder for Oral/Rectal Suspension

2. Qualitative and quantitative composition

Calcium polystyrene sulfonate

Each 100 g powder for oral/rectal suspension contain 99.75 g calcium polystyrene sulfonate.

Excipient(s) with known effect

Each 1g contains a maximum of 2.3mg (0.23% w/w) of sodium benzoate (E 211).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Powder for oral/rectal suspension.

Golden or brown fine powder.

4. Clinical particulars
4.1 Therapeutic indications

Calcium Polystyrene Sulfonate is an ion-exchange resin that is recommended for the treatment of hyperkalaemia.

4.2 Posology and method of administration

Posology

Calcium Polystyrene Sulfonate is for oral or rectal administration only.

The dosage recommendations detailed below are a guide only; the precise requirements should be decided on the basis of regular serum electrolyte determinations.

Adults, including the elderly:

Oral

The usual dose is 15 g three or four times a day. 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 to 4 ml per gram of resin.

Rectal

This route should be reserved for the patient who is vomiting or who has upper gastrointestinal tract problems, including paralytic ileus or it may be used simultaneously with the oral route for more rapid initial results. The resin may be given rectally as a suspension of 30 g resin in 150 ml of water or 10% dextrose, as a daily retention enema. In the initial stages administration by this route as well as orally may help to achieve a rapid lowering of the serum potassium level.

The enema should, if possible, be retained for at least nine hours, then the colon should be irrigated to remove the resin. If both routes are used initially it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum.

Paediatric population

Children:

Oral

In smaller children and infants, correspondingly smaller doses should be employed by using as a guide a rate of 1mEq of 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. Dosage may be reduced to 0.5 g/kg body weight daily in divided doses for maintenance therapy.

The resin is given orally, preferably with a drink (not a fruit squash because of the high potassium content) or a little jam or honey.

Rectal

When refused by mouth it should 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 Polystyrene Sulfonate should not be given by the oral route. With rectal administration, the minimum effective dosage within the range 0.5 g/kg to 1g/kg should be employed, diluted as for adults with adequate irrigation to ensure recovery of the resin.

4.3 Contraindications

- In patients with plasma potassium levels below 5 mmol/litre.

- Conditions associated with hypercalcaemia (e.g. hyperparathyroidism, multiple myeloma, sarcoidosis or metastatic carcinoma).

- History of hypersensitivity to polystyrene sulfonate resins.

- Obstructive bowel disease.

- Calcium Polystyrene Sulfonate should not be administered orally to neonates and is contraindicated in neonates with reduced gut motility (post-operatively or drug induced).

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Gastrointestinal stenosis and ischaemia: Gastrointestinal stenosis, intestinal ischemia 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 polystyrene sulfonate is not recommended (see section 4.5 and section 4.8).

Patients should be advised to seek prompt medical advice in case of newly developed severe abdominal pain, nausea and vomiting, stomach distension and rectal bleeding.

Lesions seen in polystyrene sulfonate-induced gastrointestinal damage may overlap with those seen in inflammatory bowel disease, ischemic colitis, infectious colitis, and microscopic colitis.

Hypokalaemia: The possibility of severe potassium depletion should be considered, and adequate clinical and biochemical control is essential during treatment, especially in patients on digitalis. Administration of the resin should be stopped when the serum potassium falls to 5mmol/litre.

Other electrolyte disturbances: Like all cation-exchange resins, calcium polystyrene sulfonate is not totally selective for potassium. Hypomagnesaemia and/or hypercalcaemia may occur. Accordingly, patients should be monitored for all applicable electrolyte disturbances. 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.

Other risks: 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).

The patient should be positioned carefully when ingesting the resin, to avoid aspiration, which may lead to bronchopulmonary complications.

Children and neonates: In neonates, calcium polystyrene sulfonate should not be given by the oral route. In children and neonates, particular care is needed with rectal administration as excessive dosage or inadequate dilution could result in impaction of the resin. Due to the risk of digestive haemorrhage or colonic necrosis, particular care should be observed in premature infants or low birth weight infants.

Calcium Polystyrene Sulfonate contains sodium benzoate: This medicine contains a maximum of 35 mg sodium benzoate in each dosage unit (15 g).

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended

Sorbitol (oral or rectal): 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 and section 4.8).

To be used with caution

Cation-donating agents: may reduce the potassium binding effectiveness of Calcium Polystyrene Sulfonate.

Non-absorbable cation-donating antacids and laxatives: There have been reports of systemic alkalosis following concurrent administration of cation-exchange resins and non-absorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminium carbonate.

Aluminium hydroxide: Intestinal obstruction due to concretions of aluminium hydroxide has been reported when aluminium hydroxide has been combined with the resin (sodium form).

Digitalis-like drugs: The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated if hypokalaemia and/or hypercalcaemia are allowed to develop (see section 4.4).

Lithium: Possible decrease of lithium absorption.

Levothyroxine: Possible decrease of levothyroxine absorption.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is a limited amount of data from the use of calcium polystyrene sulfonate in pregnant women. Calcium Polystyrene Sulfonate is not recommended during pregnancy and in woman of childbearing potential not using contraception.

Breast-feeding

There is insufficient information on the excretion of calcium polystyrene sulfonate in human milk. A risk to the newborns/infants cannot be excluded.

Fertility

There is no data available on fertility.

4.7 Effects on ability to drive and use machines

There are no specific warnings.

4.8 Undesirable effects

The undesirable effects are classified as follows:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Table 1: Calcium Polystyrene Sulfonate undesirable effects

Metabolism and nutrition disorders

Common

Hypokalaemia, hypercalcaemia, hypomagnesaemia

Uncommon

Decreased appetite

Respiratory, thoracic and mediastinal disorders

Very rare

Acute bronchitis and/or bronchopneumonia associated with inhalation of particles of calcium polystyrene sulfonate

Gastrointestinal disorders

Common

Nausea, vomiting, constipation

Uncommon

Diarrhoea, gastric irritation, gastrointestinal ulcer, intestinal obstruction

Rare

Faecaloma (faecal impaction) following rectal administration particularly in children and gastrointestinal concretions (bezoars) following oral administration.

Gastrointestinal necrosis (colon necrosis), which could lead to intestinal perforation which is sometimes fatal (see sections 4.4 and 4.5).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Biochemical disturbances from overdosage may give rise to clinical signs or symptoms of hypokalaemia, including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia and eventual paralysis. Apnoea may be a serious consequence of this progression. Electrocardiographic changes may be consistent with hypokalaemia or hypercalcaemia; cardiac arrhythmia may occur. Appropriate measures should be taken to correct serum electrolytes and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: All other therapeutic products; Drugs for treatment of hyperkalaemia and hyperphosphatemia, ATC code: V03AE01

Ion-exchange resin.

5.2 Pharmacokinetic properties

Not applicable as this product is not absorbed.

5.3 Preclinical safety data

There is no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6. Pharmaceutical particulars
6.1 List of excipients

Vanilla flavour (it contains sodium benzoate E 211).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years.

For the 400 g or 300 g multi-dose container: Shelf life after first opening the container: 1 month.

Do not store above 25°C and keep the container tightly closed.

The single use 15g sachet should be used immediately after opening.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Calcium Polystyrene Sulfonate is packaged in:

• Polyethylene multi-dose container with 400 g or 300 g of powder, fitted with a screw cap with a safety seal (operculum), and with a polypropylene (PP) measuring spoon which, when filled level, contains approximately 15g.

• Paper/polyethylene/aluminium/polyethylene sachet containing 15 g of powder. Boxes of 26 sachets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

The suspension should be prepared immediately before use.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

Waymade PLC,

Sovereign House,

Miles Gray Road, Basildon,

Essex, SS14 3FR, UK

8. Marketing authorisation number(s)

PL 06464/3119

9. Date of first authorisation/renewal of the authorisation

25/08/2020

10. Date of revision of the text

15/02/2022

Company Contact Details
Sovereign Medical
Address

Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR

Fax

+44 (0)1268 535 299

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+44 (0)1268 535 200

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