SODIUM POLYSTYRENE SULFONATE

1 ). 1 ). 1 General Information Administer sodium polystyrene sulfonate at least 3 hours before or 3 hours after other oral medications. 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. 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. 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.

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.

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. gov/medwatch .

1 ).

Electrolyte Disturbances :

Severe hypokalemia can occur. 2 ).

Fluid overload in patient sensitive to high sodium intake :

Monitor patients who are sensitive to sodium intake for signs of fluid overload. 3 ).

Risk of aspiration :

Acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles has been reported. 4 ). 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. 2 Electrolyte Disturbances Monitor serum potassium during therapy because severe hypokalemia may occur. Sodium polystyrene sulfonate is not totally selective for potassium, and small amounts of other cations such as magnesium and calcium can also be lost during treatment.

Monitor calcium and magnesium in patients receiving sodium polystyrene sulfonate. 3 Fluid Overload in Patients Sensitive to High Sodium Intake Each 15 g dose of sodium polystyrene sulfonate contains 1500 mg (60 mEq) of sodium. Monitor patients who are sensitive to sodium intake (heart failure, hypertension, edema) for signs of fluid overload.

4 CONTRAINDICATIONS 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 )