ODAN-SODIUM POLYSTYRENE SULFONATE SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SODIUM POLYSTYRENE SULFONATE

Available from:

ODAN LABORATORIES LTD

ATC code:

V03AE01

INN (International Name):

POLYSTYRENE SULPHONATE

Dosage:

250MG

Pharmaceutical form:

SUSPENSION

Composition:

SODIUM POLYSTYRENE SULFONATE 250MG

Administration route:

ORAL

Units in package:

60ML/500ML

Prescription type:

Prescription

Therapeutic area:

POTASSIUM-REMOVING AGENTS

Product summary:

Active ingredient group (AIG) number: 0108701001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-03-15

Summary of Product characteristics

Odan-Sodium Polystyrene Sulfonate
PRESCRIBING INFORMATION
PR
ODAN-SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene Sulfonate, USP
Powder for Suspension: 1 g / g
Oral / Rectal Suspension: 250 mg / mL
Cation - Exchange Resin
ODAN LABORATORIES LTD.
325 Stillview Ave.
Pointe-Claire, QC Date of Revision:
H9R 2Y6
JANUARY 2, 2024
Submission Control No.: 278084
www.odanlab.com
________________________________________________________________________________________
Odan-Sodium Polystyrene Sulfonate
2
DESCRIPTION
POWDER FOR ORAL SUSPENSION AND RETENTION ENEMA
ODAN-SODIUM POLYSTYRENE SULFONATE (sodium polystyrene sulfonate) is a
golden
brown fine powder of sodium polystyrene sulfonate. ODAN-SODIUM
POLYSTYRENE
SULFONATE is a cation-exchange resin prepared in the
sodium phase, with an _in vivo _exchange
capacity of approximately 1 mmol (_in vitro _ approximately 3.1 mmol)
of potassium per gram. The
sodium content is approximately 4.1 mmol
(100 mg) per gram of the drug. ODAN-SODIUM
POLYSTYRENE SULFONATE can be administered either orally or as an
enema.
ORAL AND RECTAL SUSPENSION
Each 60 mL of cream to light brown, cherry-flavored suspension
contains 15 g of sodium
polystyrene sulfonate USP. Also contains methylparaben and
propylparaben as preservatives.
The sodium content is 65
mmol (1.5 g)/60 mL Exchange capacity: approximately 3 mmol of
potassium per 4 mL (per gram of resin) of suspension _in vitro _and
approximately 1 mmol _in _
_vivo_.
ACTION
Sodium polystyrene sulfonate is not absorbed from the gastrointestinal
tract. As the resin passes
through the gastrointestinal tract, the resin removes the potassium
ions by exchanging it for
sodium ions. Most of this action occurs in the large intestine, which
excretes potassium ions to a
greater degree than does the small intestine. Potassium exchange also
occurs in the colon
following retention of the resin, when administered as an enema. The
efficiency of this process is
limited
and unpredictable. It commonly approximates the order of 33 per cent
but the range is so
large that defi