Sodium Polystyrene Sulfonate

1 INDICATIONS AND USAGE Sodium Polystyrene Sulfonate Powder, for Suspension is indicated for the treatment of hyperkalemia. Limitation of Use: Sodium Polystyrene Sulfonate Powder, for Suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2)] . Sodium Polystyrene Sulfonate Powder, for Suspension is indicated for the treatment of hyperkalemia (1) . Limitation of Use: Sodium Polystyrene Sulfonate Powder, for Suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action (1) .

2 DOSAGE AND ADMINISTRATION Oral : The average total daily adult dose of Sodium Polystyrene Sulfonate Powder, for Suspension is 15 g to 60 g, administered as a 15-g dose (four level teaspoons), one to four times daily ( 2.1 ). Rectal : The average adult dose is 30 g to 50 g every six hours ( 2.1 ). 2.1 General Information Administer Sodium Polystyrene Sulfonate Powder, for Suspension at least 3 hours before or 3 hours after other oral medications. Patients with gastroparesis may require a 6 hour separation [ see Warnings and Precautions (5.5) and Drug Interaction (7) ] 2.2 Recommended Dosage The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia. Oral The average total daily adult dose of Sodium Polystyrene Sulfonate Powder, for Suspension is 15 g to 60 g, administered as a 15-g dose (four level teaspoons), one to four times daily. Rectal The average adult dose is 30 g to 50 g every six hours. 2.3 Preparation and Administration Prepare suspension fresh and use within 24 hours. Do not heat Sodium Polystyrene Sulfonate Powder, for Suspension as it could alter the exchange properties of the resin. One level teaspoon contains approximately 3.5 g of Sodium Polystyrene Sulfonate Powder, for Suspension and 15 mEq of sodium. Oral Suspension Suspend each dose in a small quantity of water or syrup, approximately 3 to 4 mL of liquid per gram of resin. Administer with patient in an upright position [ see Warnings and Precautions (5.4) ] . Enema After an initial cleansing enema, insert a soft, large size (French 28) rubber tube into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and tape in place. Administer as a warm (body temperature) emulsion in 100 mL of aqueous vehicle and flush with 50 to 100 ml of fluid. A somewhat thicker suspension may be used, but do not form a paste. Agitate the emulsion gently during administration. The resin should be retained for as long as possible and follow by a cleansing enema with a nonsodium containing solution. Ensure an adequate volume of cleansing solution (up to 2 liters) is utilized.

4 CONTRAINDICATIONS Sodium Polystyrene Sulfonate Powder, for Suspension is contraindicated in patients with the following conditions: • Hypersensitivity to polystyrene sulfonate resins • Obstructive bowel disease • Neonates with reduced gut motility • Hypersensitivity to polystyrene sulfonate resins (4) • Obstructive bowel disease (4) • Neonates with reduced gut motility (4)

Not available.

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: • Intestinal Necrosis [ see Warnings and Precautions (5.1) ] • Electrolyte Disturbances [see Warnings and Precautions (5.2, 5.3) ] • Aspiration [ see Warnings and Precautions (5.4) ] The following adverse reactions have been identified during post-approval use of Sodium Polystyrene Sulfonate Powder, for Suspension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure. Gastrointestinal: anorexia, constipation, diarrhea, fecal impaction, gastrointestinal concretions (bezoars), ischemic colitis, nausea, ulcerations, vomiting, gastric irritation, intestinal obstruction (due to concentration of aluminium hydroxide) Metabolic: systemic alkalosis Adverse reactions reported include: anorexia, constipation, diarrhea, fecal impaction, gastrointestinal concretions (bezoars), ischemic colitis, nausea, vomiting (6) . To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.