SODIUM POLYSTYRENE SULFONATE- sodium polystyrene sulfonate_powder, for suspension

Sodium Polystyrene Sulfonate Powder, for Suspension is a non-absorbed, cation exchange polymer that contains a sodium counterion. Sodium Polystyrene Sulfonate Powder, for Suspension increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels. The practical exchange ratio is 1 mEq K per 1 gram of resin. As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. This action occurs primarily in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. The effective lowering of serum potassium with Sodium Polystyrene Sulfonate Powder, for Suspension may take hours to days. The in vivo Sodium Polystyrene Sulfonate Powder, for Suspension is not absorbed systemically. Drug Interactions In vitro.

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).

1 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) Drug Interaction (7) ] 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. 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. 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.

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. 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: Metabolic: 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. gov/medwatch.

Sodium Polystyrene Sulfonate Powder, for Suspension is contraindicated in patients with the following conditions: Hypersensitivity to polystyrene sulfonate resins Hypersensitivity to polystyrene sulfonate resins (4)Obstructive bowel disease (4)Neonates with reduced gut motility (4).

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. Risk Summary Sodium Polystyrene Sulfonate Powder, for Suspension is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant. Studies of safety and efficacy have not been conducted in pediatric patients. In pediatric patients, as in adults, Sodium Polystyrene Sulfonate Powder, 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 Powder, 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 Powder, for Suspension use [ see Warnings and Precautions (5.

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 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. 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 Sorbitol may contribute to the risk of intestinal necrosis [ see Warnings and Precautions (5.

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.
NONCLINICAL TOXICOLOGY
Studies have not been performed.

ATLANTIC BIOLOGICALS CORP.

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