Home › Drugs › Sodium Polystyrene Sulfonate

Sodium Polystyrene Sulfonate

FDA Drug Information • Also known as: Kionex, Sodium Polystyrene Sulfonate

Brand Names
Kionex, Sodium Polystyrene Sulfonate
Dosage Form
POWDER
Product Type
BULK INGREDIENT

Description

11 DESCRIPTION Sodium Polystyrene Sulfonate Powder, for Suspension is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula: The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq ( in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or rectally as an enema. One gram of Sodium Polystyrene Sulfonate Powder, for Suspension contains 4.1 mEq of sodium. L:\Labeling Department\ANDA\Sodium Polystyrene Sulfonate_SZ- Done\Epic\Package Insert\2017.10 RLD update\Platimun\Docs for Submission\SBS\Structure

What Is Sodium Polystyrene Sulfonate Used For?

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) .

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Oral : The average total daily adult dose of Sodium Polystyrene Sulfonate Powder, for Suspension 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 Powder, for Suspension 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 Powder, for Suspension 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 Powder, for Suspension as it could alter the exchange properties of the resin. One level teaspoon contains approximately 3.5 g of Sodium Polystyrene Sulfonate Powder, for Suspension 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. Administer as a warm (body temperature) emulsion in 100 mL of aqueous vehicle and flush with 50 to 100 ml of fluid. A somewhat thicker suspension may be used, but do not form a paste. Agitate the emulsion gently during administration. The resin should be retained for as long as possible and follow by a cleansing enema with a nonsodium containing solution. Ensure an adequate volume of cleansing solution (up to 2 liters) is utilized.

Side Effects (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.

    • Drug Interactions

    7 DRUG INTERACTIONS

  • Take other orally administered drugs at least 3 hours before or 3 hours after Sodium Polystyrene Sulfonate Powder, for Suspension ( 7.1 ).
  • Cation-Donating Antacids: may reduce the resin’s potassium exchange capability and increase risk of systemic alkalosis ( 7.2 ).
  • Sorbitol: Concomitant use may contribute to the risk of intestinal necrosis and is not recommended ( 7.3 ). 7.1 General Interactions No formal drug interaction studies have been conducted in humans. Sodium Polystyrene Sulfonate Powder, for Suspension has the potential to bind other drugs. In in vitro binding studies, Sodium Polystyrene Sulfonate Powder, for Suspension was shown to significantly bind the oral medications (n=6) that were tested. Decreased absorption of lithium and thyroxine have also been reported with co-administration of Sodium Polystyrene Sulfonate Powder, for Suspension. Binding of Sodium Polystyrene Sulfonate Powder, for Suspension to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time Sodium Polystyrene Sulfonate Powder, for Suspension is administered. Administer Sodium Polystyrene Sulfonate Powder, for Suspension at least 3 hours before or 3 hours after other oral medications. Patients with gastroparesis may require a 6 hour separation. Monitor for clinical response and/or blood levels where possible. 7.2 Cation-Donating Antacids The simultaneous oral administration of Sodium Polystyrene Sulfonate Powder, for Suspension with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability and increase the risk of systemic alkalosis 7.3 Sorbitol Sorbitol may contribute to the risk of intestinal necrosis [ see Warnings and Precautions (5.1) ] and concomitant use is not recommended.

    • Contraindications

    4 CONTRAINDICATIONS Sodium Polystyrene Sulfonate Powder, for Suspension 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)

    • Pregnancy and Breastfeeding

    8.1 Pregnancy Risk Summary Sodium Polystyrene Sulfonate Powder, for Suspension is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk.

    Overdosage

    10 OVERDOSAGE 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.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING Sodium Polystyrene Sulfonate Powder, for Suspension is available as a cream to light brown, finely ground powder in jars of 1 pound (453.6 g). NDC 42806-013-96, and in bottles of 15 g, NDC 42806-013-94. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.