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Drug Details

Calcium Resonium 99.934% w/w Powder for Oral/Rectal Suspension

• Drug Class Description
  Ion-exchange resins.
• Generic Name
  Calcium polystyrene sulphonate
• Presentation
  Powder for Oral/Rectal Suspension Cream or light brown coloured, fine powder
• Description
  Each bottle contains 99.934% w/w of the active substance Calcium Polystyrene Sulphonate.
• Indications
  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.
• Adult Dosage
  

  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.

• Child Dosage
  

  Children:

  Oral

  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.

• Contra Indications
  

  • 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
• Special Precautions
  

  Sorbitol: concomitant use of Sorbitol with calcium polystyrene sulphonate is not recommended since cases of intestinal necrosis, which may be fatal, have been reported.

  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.

  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.

• Interactions
  

  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.

  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 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.

  Lithium: Possible decrease of lithium absorption.

  Levothyroxine: Possible decrease of levothyroxine absorption.

  Levothyroxine: Possible decrease of levothyroxine absorption.

• Adverse Drug Reactions
  

  • Metabolism and nutrition disorders

  In accordance with its pharmacological actions, the resin may give rise to hypokalaemia and hypercalcaemia, and their related clinical manifestations.

  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.

  • 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.