PMS-SODIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION 94.3 mgg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

SODIUM POLYSTYRENE SULPHONATE

Available from:

MEDICELL PHARMACEUTICAL (S) PTE. LTD.

ATC code:

V03AE01

Dosage:

94.3 mg/g

Pharmaceutical form:

POWDER, FOR SUSPENSION

Composition:

SODIUM POLYSTYRENE SULPHONATE 94.3 mg/g

Administration route:

ORAL, RECTAL

Prescription type:

Prescription Only

Manufactured by:

DSP S.A.S.

Authorization status:

ACTIVE

Authorization date:

1991-05-14

Summary of Product characteristics

pms-SODIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION
SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION USP
CATION EXCHANGE RESIN
ACTION
The action of this product is to partially release sodium
ions from the resin and replace them by potassium
ions as the resin passes along the intestine or is
retained in the colon after administration by enema.
For the most part, this action occurs in the large
intestine which excretes potassium ions to a greater
degree than does the small intestine. The efficiency of
this process is limited and unpredictably variable. It
commonly approximates the order of 33% but the
range is so large that definitive indices of electrolyte
balance must be clearly monitored. Frequent serum
potassium
determinations,
at
least
once
every
24
hours, should be done in order to adjust the individual
dosage.
The
action
of
this
product
can
be
accomplished
by
either
oral
administration
or
by
retention enema.
INDICATION
Sodium Polystyrene Sulfonate suspension is indicated
for the treatment of hyperkalemia.
WARNINGS
Since the effective lowering of serum potassium with
this product may take hours to days, treatment with
this drug alone may be insufficient to rapidly correct
severe hyperkalemia associated with states of rapid
tissue breakdown (e.g.
burns and renal failure) or
hyperkalemia so marked as to constitute a medical
emergency.
Therefore,
other
definitive
measures,
including dialysis, should always be considered and
may be imperative. Serious potassium deficiency can
occur from Sodium Polystyrene Sulfonate therapy.
The effect must be carefully controlled by frequent
serum potassium determinations within each 24 hour
period. Since intracellular potassium deficiency is not
always reflected by serum potassium levels, the level
at
which
treatment
with
the
product
should
be
discontinued must be determined individually for each
patient. Important aids in making this determination
are
the
patient’s
clinical
condition
and
electrocardiogram.
Early
clinical
signs
of
severe
hypokalemia include a pattern of irritab