Sodium Polystyrene Sulfonate

Sodium polystyrene sulfonate is indicated for the treatment of hyperkalemia. Limitation of Use: Sodium Polystyrene Sulfonate 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 is a potassium binder indicated for the treatment of hyperkalemia ( 1 ) Limitation of Use: Sodium polystyrene sulfonate should not be used an emergency treatment for life threatening hyperkalemia because of its delayed onset of action.

( 1 )

Sodium Polystyrene Sulfonate 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 )

Intestinal Necrosis: cases of intestinal necrosis and other serious gastrointestinal events have been reported ( 5.1 ). Electrolyte Disturbances: Severe hypokalemia can occur. ( 5.2 ). Fluid overload in patient sensitive to high sodium intake: Monitor patients who are sensitive to sodium intake for signs of fluid overload. (5.3). Risk of aspiration: Acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles has been reported.

( 5.4 ).

5.1Intestinal Necrosis Cases

of intestinal necrosis, some fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with sodium polystyrene sulfonate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure.