RESONIUM A Powder Ref.[10832] Active ingredients: Polystyrene sulfonate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

4.1. Therapeutic indications

Resonium A 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.

4.2. Posology and method of administration

Resonium A is for oral or rectal administration only.

The dosage recommendations detailed in this section 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.

Administer Resonium A 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 4.4 & 4.5).

Rectal

This route should be reserved for the patient who is vomiting or who has upper gastrointestinal tract problems, including paralytic ileus. It may be used simultaneously with the oral route for more rapid initial results or in patients with gastroparesis, who have other orally administered medications that are administered within 6 hours of Resonium A. 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 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.

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 of 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

Resonium A 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 and with adequate irrigation to ensure recovery of the resin.

4.9. Overdose

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; cardiac arrhythmia may occur. Hypocalcaemic tetany 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.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

None stated.

6.5. Nature and contents of container

Supplied in HDPE containers with LDPE tamper evident closures containing 454g Resonium A together with a plastic scoop, which, when filled level, contains approximately 15g.

6.6. Special precautions for disposal and other handling

Refer to 4.2. Posology and method of administration.

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