SOLYSTAT SUSPENSION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SODIUM POLYSTYRENE SULFONATE

Disponible depuis:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Code ATC:

V03AE01

DCI (Dénomination commune internationale):

POLYSTYRENE SULPHONATE

Dosage:

250MG

forme pharmaceutique:

SUSPENSION

Composition:

SODIUM POLYSTYRENE SULFONATE 250MG

Mode d'administration:

RECTAL

Unités en paquet:

120ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

POTASSIUM-REMOVING AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2019-07-30

Résumé des caractéristiques du produit

PRESCRIBING INFORMATION
PR
SOLYSTAT
®
Sodium Polystyrene Sulfonate, USP
Powder for Suspension
Oral Suspension 250 mg/mL
Rectal Suspension (Retention Enema) 250 mg/mL
CATION EXCHANGE RESIN
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave., suite 100
Montréal, Québec
DATE OF REVISION:
H4P 2T4
July 23, 2014
Control #171500
®
Registered Trademark of Pharmascience Inc.
_Prescribing Information - SOLYSTAT_
_® _
Page 2 of 10
_ _
PR
SOLYSTAT
®
Sodium Polystyrene Sulfonate, USP
Powder for Suspension
Oral Suspension 250 mg/mL
Rectal Suspension (Retention Enema) 250 mg/mL
THERAPEUTIC CLASSIFICATION
Cation exchange resin
DESCRIPTION
POWDER FOR ORAL SUSPENSION
Each gram of light brown, finely ground powder contains 1 gram of
sodium polystyrene
sulfonate. The sodium content is approximately 4.1 mmol (94.3 mg) per
gram of the drug.
SOLYSTAT is a cation exchange resin prepared in the sodium phase.
Exchange capacity:
approximately 3 mmol of potassium per gram
_in vitro_
and approximately 1 mmol of potassium
per gram
_in vivo_
. SOLYSTAT
can be administered either orally or as an enema.
ORAL SUSPENSION
Each 60 mL of brown, cherry-flavored suspension contains 15 g of
sodium polystyrene sulfonate
USP and 14.1 g of sorbitol. 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_
.
RETENTION ENEMA
Each 120 mL of brown suspension contains 30 g of sodium polystyrene
sulfonate USP and 28.2
g of sorbitol. 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
ion