5 gm, 15 gm,
For the use of a Registered Medical Practitioner or a Hospital or a Institution only.
KREDUCE (Calcium Polystyrene Sulphonate) is an ion exchange resin presented as a powder.
STRUCTURAL FORMULA :
Its structural formula is :
KREDUCE powder is a buff coloured fine powder with a vanilla flavour.
Each sachet contains :
Calcium Polystyrene Sulphonate B.P. 15 gm
Contains added synthetic flavour.
Calcium polystyrene sulphonate is a cation exchange resin prepared in the calcium phase. 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. Calcium polystyrene sulphonate is not absorbed from the gastrointestinal tract. Calcium polystyrene sulphonate removes potassium from the body by exchanging it within the gut for calcium. 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.
KREDUCE 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.
KREDUCE 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 clinical and serum electrolyte determinations.
Adults, including the Elderly :
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).
In cases where vomiting or upper gastrointestinal problems, including paralytic ileus, may make oral administration difficult, the resin may be given rectally as a suspension of 30 g resin in 150 mL water or 10 % dextrose in water, 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 initially it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum.
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 fruit juice because of the high potassium content) or a little jam or honey.
When the resin cannot be given by mouth, it may be given rectally using a dose at least as great as that which would be 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.
KREDUCE 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.
• History of hypersensitivity to polystyrene sulphonate resins.
• Serum potassium levels less than 5 mmol/L.
• Conditions associated with hypercalcaemia (eg. hyperparathyroidism, multiple myeloma, sarcoidosis or metastatic carcinoma). Obstructive bowel disease.
• KREDUCE should not be administered orally to neonates and is contraindicated in neonates with reduced gut motility (e.g. post-operatively or drug induced).
SPECIAL WARNINGS AND PRECAUTIONS :
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 5 mmol/litre.
Other electrolyte disturbances :
Like all cation-exchange resins, calcium polystyrene sulphonate is not totally selective for potassium. Hypomagnesemia 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.
No data are available regarding the use of polystyrene sulphonate resins in pregnancy and lactation. The administration of KREDUCE in pregnancy and during breast feeding therefore, is not advised unless, in the opinion of the physician, the potential benefits outweigh
any potential risks.
INTERACTIONS AND INCOMPATIBILITIES :
Concomitant use not recommended :
Sorbitol (oral or rectal) : Concomitant use of sorbitol with sodium polystyrene sulphonate may cause colonic necrosis. Therefore concomitant administration of sorbitol with calcium polystrene sulphonate is not recommended.
To be used with caution :
Cation-donating agents : May reduce the potassium binding effectiveness of KREDUCE. 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 oncretions 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.
SIDE EFFECTS :
In accordance with its pharmacological actions, the resin may give rise to hypokalaemia and hypercalcaemia and their related clinical manifestations. Hypercalcaemia has been reported in well dialysed patients receiving calcium resin, and in the occasional patient 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. Gastro-intestinal tract ulceration or necrosis which could lead to intestinal perforation have been reported following
administration of sodium polystyrene sulphonate.
Respiratory disorders :
Some cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of calcium polystyrene sulphonate have been described.
Symptoms of overdosage :
Biochemical disturbances from overdosage may give rise to clinical signs of 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.
TREATMENT OF OVERDOSAGE :
In the event of overdosage the resin should be removed from the alimentary tract by the use of laxatives or enemas, and appropriate measure should be taken to restore serum potassium levels to normal and to reduce blood calcium levels if these are raised.
Store below 30° C (86° F), protected from moisture.
Do not refrigerate.
SHELF LIFE :
24 months from the date of manufacture.
15 gm powder packed in Aluminium Sachet.
10 Sachets are packed in a box.
Disclaimer : For the use of a Registered Medical Practitioner or a Hospital or a Institution only. Also it is not intended to be used by healthcare professionals or patients for the purpose of prescribing or administering these products. Questions regarding the complete and current content of product labeling / specification / presentation should be directed to SGPharma.