Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Binding to other orally administered medications:
Kayexalate may bind to orally administered medications, which could decrease their gastrointestinal absorption and efficacy. Avoid co-administration of Kayexalate with other orally administered medications. Administer Kayexalate at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis, a 6-hour separation should be considered (see Sections 4.2 & 4.5).

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 sodium polystyrene sulfonate is not recommended (see Section 4.5).

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.

Severe gastrointestinal disorders:
Due to the risk of severe gastrointestinal disorders (such as bowel obstruction, ischaemia, necrosis or perforation) the use of polystyrene sulfonate is not recommended in patients with compromised gastrointestinal motility (including immediate post-surgery or drug- induced).

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:
Because the resin may bind calcium and magnesium ions, deficiencies of these electrolytes may occur. Accordingly, patients should be monitored for all applicable electrolyte disturbances.

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, in order to avoid aspiration, which may lead to bronchopulmonary complications.

Children and neonates:

In neonates, sodium 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.

Sodium:
This medicinal product contains 1,400 to 1,700 mg sodium per 15g dose, equivalent to 70 to 85% of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 280 to 340% of the WHO recommended maximum daily intake for sodium. Kayexalate is considered high in sodium. This should be particularly taken into account for those on a low salt diet.


Patients at risk from an increase in sodium load:
Care should be taken when administering to patients in whom an increase in sodium load may be detrimental (i.e. congestive heart failure, hypertension, renal damage or oedema).
In such instances, adequate clinical and biochemical control is essential. The calcium form of the resin may have advantages in this situation.

Effects on Driving

4.7 Effects on ability to drive and use machines

There are no specific warnings.