SOLYSTAT SUSPENSION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SODIUM POLYSTYRENE SULFONATE

Tersedia dari:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Kode ATC:

V03AE01

INN (Nama Internasional):

POLYSTYRENE SULPHONATE

Dosis:

250MG

Bentuk farmasi:

SUSPENSION

Komposisi:

SODIUM POLYSTYRENE SULFONATE 250MG

Rute administrasi :

ORAL

Unit dalam paket:

60ML/500ML

Jenis Resep:

Prescription

Area terapi:

POTASSIUM-REMOVING AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2012-01-16

Karakteristik produk

PRESCRIBING INFORMATION
PR
SOLYSTAT
®
Sodium Polystyrene Sulfonate Suspension, USP
Powder for Suspension: 1 g / g (For oral and rectal use)
Oral Suspension: 250 mg / mL (For oral use)
CATION EXCHANGE RESIN
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave.
Montréal, Québec
H4P 2T4
DATE OF REVISION:
March 5, 2024
Control #232015
®
Registered Trademark of Pharmascience Inc.
_Prescribing Information - SOLYSTAT_
_® _
Page 2 of 14
_ _
PR
SOLYSTAT
®
Sodium Polystyrene Sulfonate Suspension, USP
Powder for Suspension: 1 g / g (For oral and rectal use)
Oral Suspension: 250 mg / mL (For oral use)
THERAPEUTIC CLASSIFICATION
Cation Exchange Resin
DESCRIPTION
SOLYSTAT POWDER FOR 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.
SOLYSTAT 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_.
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 them 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.