Data from FDA - Curated by EPG Health - Last updated 17 March 2018

Indication(s)

1 INDICATIONS AND USAGE SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION is indicated for the treatment of hyperkalemia. 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 as 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)].

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Advisory information

contraindications
4 CONTRAINDICATIONS SODIUM POLYSTYRENE SULFONATE 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)
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 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 CMP Pharma, Inc. at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Oral: The average total daily adult dose of SODIUM POLYSTYRENE SULFONATE 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 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 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 FOR SUSPENSION as it could alter the exchange properties of the resin. One level teaspoon contains approximately 3.5 g of SODIUM POLYSTYRENE SULFONATE 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.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION 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 FOR SUSPENSION 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 FOR SUSPENSION is expected to bind potassium at the practical exchange ratio of 1mEq potassium per 1 gram of resin. In neonates, SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION 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 FOR SUSPENSION use [see Warnings and Precautions (5.4)].

Interactions

7 DRUG INTERACTIONS Take other orally administered drugs at least 3 hours before or 3 hours after SODIUM POLYSTYRENE SULFONATE 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 FOR SUSPENSION has the potential to bind other drugs. In in vitro binding studies, SODIUM POLYSTYRENE SULFONATE 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 FOR SUSPENSION. Binding of SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION is administered. Administer SODIUM POLYSTYRENE SULFONATE 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 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.

More information

Category Value
Authorisation number ANDA089910
Agency product number 1699G8679Z
Orphan designation No
Product NDC 46287-012
Date Last Revised 08-03-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 313072
Storage and handling Store at 20° - 25° C (68° - 77° F); excursions permitted to 15° – 30° C (59° – 86° F) [see USP Controlled Room Temperature]
Marketing authorisation holder CMP Pharma, Inc.