Sodium Polystyrene Sulfonate
Generic: SODIUM POLYSTYRENE SULFONATE
Basic Information
Manufacturer
Epic Pharma, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
61cc890b-eb3d-494c-ae45-629a27e721ce
Indications & Usage
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) .
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) .
Adverse Reactions
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.
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.