Sodium Polystyrene Sulfonate

Mechanism-of-action classes: Potassium Ion Exchange Activity; Sodium-Potassium Exchanging ATPase Interactions.

• 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 ).ICD-10: E87.5

• 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 )contraindicated

Oral : The average total daily adult dose of sodium polystyrene sulfonate 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 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 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 as it could alter the exchange properties of the resin. One level teaspoon contains approximately 3.5 g of sodium polystyrene sulfonate 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.

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 ). 5.1 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. 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. Concomitant administration of sorbitol is not recommended. Use only in patients who have normal bowel function. Avoid use in patients who have not had a bowel movement post-surgery. Avoid use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction). Discontinue use in patients who develop constipation.

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 .

8.1 Pregnancy Risk Summary Sodium polystyrene sulfonate is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk. 8.2 Lactation Risk Summary Sodium polystyrene sulfonate is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant. 8.4 Pediatric Use Studies of safety and efficacy have not been conducted in pediatric patients. In pediatric patients, as in adults, sodium polystyrene sulfonate is expected to bind potassium at the practical exchange ratio of 1mEq potassium per 1 gram of resin. In neonates, sodium polystyrene sulfonate should not be given by the oral route. In both children and neonates, excessive dosage or inadequate dilution could result in impaction of the resin. Premature infants or low birth weight infants may have an increased risk for gastrointestinal adverse effects with sodium polystyrene sulfonate use [ see Warnings and Precautions (5.4) ].

Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium, magnesium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

• Dec 8, 1982ANDAANDA087859Cmp Pharma Inc
• Jan 19, 1989ANDAANDA089910Cmp Pharma Inc
• Sep 17, 2007ANDAANDA040028Ani Pharms
• Mar 30, 2009ANDAANDA040905Kvk Tech
• Mar 19, 2014ANDAANDA202333Epic Pharma Llc
• Nov 28, 2014ANDAANDA204071Nuvo Pharms Inc
• Feb 18, 2016ANDAANDA206815Chartwell Rx
• Jun 10, 2025ANDAANDA214912Lyne

1. 1Hyperkalaemia1096.9%
2. 2Diarrhoea1086.9%
3. 3Acute Kidney Injury996.3%
4. 4Constipation976.2%
5. 5Renal Failure956.0%
6. 6Chronic Kidney Disease915.8%
7. 7Death825.2%
8. 8Nausea764.8%
9. 9Fatigue694.4%
10. 10Vomiting694.4%
11. 11End Stage Renal Disease654.1%
12. 12Off Label Use583.7%
13. 13Pneumonia573.6%
14. 14Drug Interaction563.6%
15. 15Dyspnoea553.5%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Sodium Polystyrene Sulfonate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparison of Potassium Binders in the ER
  Terminated · Phase 4 · Interventional · 37 enrolled · University of California, Irvine
  NCT04585542updated 2026-04-22
• Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
  Active not recruiting · Interventional · 340 enrolled · Societe ACTIVBIOMAT
  NCT03113981updated 2025-12-22
• OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure
  Active not recruiting · Phase 2 · Interventional · 110 enrolled · Michael Fu
  NCT04789239updated 2025-07-04
• Recovery After Dialysis-Requiring Acute Kidney Injury
  Terminated · Interventional · 16 enrolled · University of California, San Francisco
  NCT03305549updated 2025-03-19
• SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients
  Completed · Interventional · 120 enrolled · Alexandria University
  NCT06029179updated 2025-02-11
• The Effect of Renastart Formula Supplementation in Children With Acute Kidney Injury in Maintaining Normal Serum Electrolytes Levels
  Completed · Interventional · 24 enrolled · Ain Shams University
  NCT06218212updated 2024-02-05
• Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia
  Completed · Observational · 147 enrolled · AstraZeneca
  NCT04566653updated 2023-11-07
• Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients
  Completed · Phase 4 · Interventional · 38 enrolled · Maisonneuve-Rosemont Hospital
  NCT02065076updated 2014-10-03
• Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia
  Terminated · Phase 4 · Interventional · 32 enrolled · ZS Pharma, Inc.
  NCT01866709updated 2014-09-03

Frequently asked questions

How does Sodium Polystyrene Sulfonate work?

Mechanism-of-action classes: Potassium Ion Exchange Activity; Sodium-Potassium Exchanging ATPase Interactions.

What is Sodium Polystyrene Sulfonate used for?

According to FDA labeling, Sodium Polystyrene Sulfonate carries indications including: 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 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sodium Polystyrene Sulfonate?

Sodium Polystyrene Sulfonate is classified as Potassium Binder, Potassium Ion Exchange Activity, Sodium-Potassium Exchanging ATPase Interactions, Increased Renal K+ Excretion.

What are the brand names for Sodium Polystyrene Sulfonate?

Sodium Polystyrene Sulfonate is marketed under brand names including Kionex, SPS.

What are the contraindications for Sodium Polystyrene Sulfonate?

Sodium Polystyrene Sulfonate labeling lists contraindications including: 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 ). Always consult the full prescribing information and a clinician.