Country: Canada
Language: English
Source: Health Canada
SODIUM POLYSTYRENE SULFONATE
PENDOPHARM DIVISION OF PHARMASCIENCE INC
V03AE01
POLYSTYRENE SULPHONATE
250MG
SUSPENSION
SODIUM POLYSTYRENE SULFONATE 250MG
RECTAL
120ML
Prescription
POTASSIUM-REMOVING AGENTS
Active ingredient group (AIG) number: 0108701001; AHFS:
CANCELLED POST MARKET
2019-07-30
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 Read the complete document