Kayexalate

/ Sanofi

In adults Oral route: A dosage of 15 g, or 1 measuring-spoonful or 4 level teaspoonfuls, once to four times a day by oromucosal use, is commonly prescribed. Sodium polystyrene sulfonate is administered after being put in suspension in a little water. Patients may decide to add a little fruit syrup to the water. Suspension in fruit juice is not allowed, because of the latter’s high potassium content.
Rectal route: This route should be reserved for the patients who are 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. Sodium polystyrene sulfonate can be administered in an enema after being put in suspension in 100 ml of 10% dextrose solution at body temperature, or after mixing equal proportions of water and a 2% methylcellulose suspension. The liquid containing the sodium polystyrene sulfonate in suspension should be agitated gently during administration to ensure it remains in suspension. The enema should be retained for 4 to 10 hours if possible, followed by a cleansing enema. This operation can be repeated twice a day, if necessary.
N.B.: given that ion exchange occurs mainly in the colon, it may be necessary at the beginning of treatment to start by administering the product in both an enema and by oromucosal use. A reduction in blood potassium levels will thus be achieved more rapidly and then can be sustained by oral administration. When it is necessary to pursue treatment for a long period of time, monitoring ensured by assays of blood potassium levels will enable adjustment of the effective dose.
In children Oral route: Adjustments of quantity should be based on the principle that 1 g of resin eliminates1 mmol (1 mEq) of potassium. The usual initial dosage via the oral route in children is1 g/kg body weight/day in several intakes, which can then be reduced for maintenance therapy to 0.5 g/kg body weight/day.
Rectal route: When refused by mouth, Sodium polystyrene sulfonate can be administered in children via the rectal route at the same dosage as that used via the oral route and using the same methods as in adults. In newborns: Sodium polystyrene sulfonate should only be administered via the rectal route. The minimum effective dose is between 0.5 g/kg and 1 g/kg body weight/day.

Hyperkalemia.

Hypersensitivity to the active substance or to any of the excipients listed. Pregnancy and lactation.

Sorbitol: Concomitant use of sorbitol with sodium polystyrene sulfonate 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.
Electrolyte disorders: Biological monitoring of the patient must be ensured throughout treatment. Frequent assays of electrolytes, and particularly serum potassium, are essential. Serum potassium levels should not be reduced too much: levels should be maintained at around 5 mmol/l (5 mEq/l). Serum calcium and magnesium levels should be verified at regular intervals. During exchange, for each potassium ion taken up by the resin, a sodium ion is released into the blood, i.e. 1 gram of resin releases approximately 1 mmol (1 mEq) of sodium.
Other risks: In the event of constipation with a clinical effect, treatment should be discontinued until a return to normal motility. Magnesium-based laxatives require precautions for use. The patient must remain in an appropriate position while ingesting the resin so as to avoid inhalation which could cause bronchial and pulmonary complications.
Children and newborns: Possibility of blockage of the resin administered via the rectal route in the event of an excessive dosage or incorrect dilution. Risk of digestive haemorrhage or colon necrosis in premature and low birth weight newborn infants.
Patients with a risk of water and sodium overload: This medicinal product contains approximately 345 mg sodium per measuring-spoonful:account must be taken of this in patients following a strict low-salt diet. (i.e., patients with severe congestive heart failure, severe hypertension, renal damage or marked edema). In such instances, adequate clinical and biochemical control is essential. The calcium form of the resin may offer advantages in this situation.
For full details see prescribing information.

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.
Cases of hypomagnesaemia have been reported.
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 bronco-pneumonia associated with inhalation of particles of sodium polystyrene sulphonate have been described.
For full details see prescribing information.

Concomitant use not recommended
Sorbitol (oral and rectal routes): Concomitant use of Sorbitol with sodium polystyrene sulphonate is not recommended due to cases of intestinal necrosis, which may be fatal.
Combinations requiring precautions for use
Cation-donating agents: may reduce the potassium binding effectiveness of Resonium A.
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.
Digitalis-like drugs: The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and AV nodal dissociation, are likely to be exaggerated if hypokalaemia is allowed to develop.
Lithium: Possible decrease of lithium absorption.
Levothyroxine: Possible decrease of levothyroxine absorption.
For full details see prescribing information

No data are available on the use of resin during pregnancy or breastfeeding. The administration of Kayexalate in pregnancy and during breast feeding therefore, is not advised unless, in the opinion of physician, the potential benefits outweigh any potential risks.

Biochemical disturbances resulting from overdose may give rise to clinical signs and symptoms of hypokalemia, including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, and eventually frank paralysis. Apnea may be a serious consequence of this progression. Electrocardiographic changes may be consistent with hypokalemia; cardiac arrhythmia may occur. Hypocalcemic tetany may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.