Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
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 Sunrise Pharmaceutical Inc.
at 1-732-382-6085 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
5 WARNINGS AND PRECAUTIONS Intestinal Necrosis : cases of intestinal necrosis and other serious gastrointestinal events have been reported ( 5.1 ).
Electrolyte Disturbances : Severe hypokalemia can occur.
Fluid overload in patient sensitive to high sodium intake : Monitor patients who are sensitive to sodium intake for signs of fluid overload.
Risk of aspiration : Acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles has been reported.
5.1 Intestinal 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.
Like all medications, Sodium Polystyrene Sulfonate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: