Sodium polystyrene sulfonate

FDA label, ATLANTIC BIOLOGICALS CORP., oral, effective 2025-05-27. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Potassium Binder

Dosing in kidney impairment

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.

Preparation and administration

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]. 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.

Drug interactions

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Label text (5 paragraphs)

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

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 lactation

Pregnancy

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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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