SODIUM POLYSTYRENE SULFONATE
Generic: SODIUM POLYSTYRENE SULFONATE
Basic Information
Manufacturer
SUNRISE PHARMACEUTICAL, INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
c73b9661-2378-4336-8be0-098e7c1ae522
Indications & Usage
1 INDICATIONS AND USAGE Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia.
Limitation of Use : Sodium polystyrene sulfonate 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 for suspension is a potassium binder indicated for the treatment of hyperkalemia ( 1 ).
Limitation of Use : Sodium polystyrene sulfonate for suspension should not be used an emergency treatment for life threatening hyperkalemia because of its delayed onset of action ( 1 ).
Limitation of Use : Sodium polystyrene sulfonate 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 for suspension is a potassium binder indicated for the treatment of hyperkalemia ( 1 ).
Limitation of Use : Sodium polystyrene sulfonate for suspension should not be used 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.
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 .
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 .