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

Calcium Resonium 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 15g 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 4ml 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 30g resin in 150ml 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 a 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.
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 1g/kg body weight daily
in divided doses, in acute hyperkalaemia. Dosage may be reduced to 0.5g/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 Resonium should not be given by the oral route. With rectal
administration, the minimum effective dosage within the range 0.5g/kg to
1g/kg should be employed, diluted as for adults with adequate irrigation to
ensure recovery of the resin.

 In patients with plasma potassium levels below 5mmol/litre.  Conditions associated with hypercalcaemia (e.g. hyperparathyroidism, multiple myeloma, sarcoidosis or metastatic carcinoma).  History of hypersensitivity to polystyrene sulphonate resins.  Obstructive bowel disease.  Calcium Resonium 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.

Sorbitol: concomitant use of Sorbitol with calcium polystyrene sulphonate is
not recommended since cases of intestinal necrosis, which may be fatal, have
been reported (see Section 4.5 Interactions and Section 4.8 Undesirable
effects).
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 sulphonate 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
Interactions).
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 sulphonate 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.

Concomitant use not recommended
Sorbitol (oral or rectal): Concomitant use of Sorbitol with calcium polystyrene
sulphonate is not recommended due to cases of intestinal necrosis, which may
be fatal (see Section 4.4 Special warnings and precautions for use and Section
4.8 Undesirable effects).
To be used with caution
Cation-donating agents: may reduce the potassium binding effectiveness of
Calcium Resonium.
Non-absorbable cation-donating antacids and laxatives: There have been
reports of systemic alkalosis following concurrent administration of cationexchange
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 Special warnings and precautions for use).
Lithium: Possible decrease of lithium absorption.
Levothyroxine: Possible decrease of levothyroxine absorption.

No data are available regarding the use of polystyrene sulphonate resins in
pregnancy and lactation. The administration of Calcium Resonium in
pregnancy and during breast feeding therefore, is not advised unless, in the
opinion of the physician, the potential benefits outweigh any potential risks.

There are no specific warnings.

 Metabolism and nutrition disorders
In accordance with its pharmacological actions, the resin may give rise to
hypokalaemia and hypercalcaemia, and their related clinical manifestations
(see Section 4.4 Special warnings and precautions for use and Section 4.9
Overdose).
Cases of hypomagnesaemia 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.
 Gastrointestinal disorders
Gastric irritation, anorexia, nausea, vomiting, constipation and occasionally
diarrhoea may occur. Faecal impaction following rectal administration
particularly in children and gastrointestinal concretions (bezoars) following
oral administration have been reported. Intestinal obstruction has also been
reported, although this has been extremely rare and, possibly, a reflection of
co-existing pathology or inadequate dilution of resin.
Ischemic colitis, gastro-intestinal tract ulceration or necrosis, which could
lead to intestinal perforation have been reported.
Intestinal necrosis has been reported with concomitant use of Sorbitol (see
Section 4.4 Special warnings and precautions for use and Section 4.5
Interactions).
 Respiratory, thoracic and mediastinal disorders
Some cases of acute bronchitis and/or bronchopneumonia associated with
inhalation of particles of calcium polystyrene sulphonate have been described.

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.

Pharmacotherapeutic group: All other therapeutic products; Drugs for
treatment of hyperkalemia and hyperphosphatemia
ATC code: V03AE01
Ion-exchange resin

Not applicable as this product is not absorbed.

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

Vanillin
Saccharin

Not applicable

5 years.

Store in a dry place.

HDPE bottle with a LDPE cap containing 300mg Calcium Resonium, together
with a plastic scoop, which, when filled level, contains approximately 15g.

No special requirements.