SODIUM POLYSTYRENE SULFONATE

SODIUM POLYSTYRENE SULFONATE- sodium polystyrene sulfonate powder, for suspension
Belcher Pharmaceuticals, LLC

Sodium Polystyrene Sulfonate, USP is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:

structure

The drug is a cream to light brown finely ground, powdered form of Sodium polystyrene sulfonate, USP 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 in an enema.

CLINICAL PHARMACOLOGY

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. For the most part, this action occurs 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. It commonly approximates the order of 33 percent but the range is so large that definitive indices of electrolyte balance must be clearly monitored.
Metabolic data are unavailable.

INDICATIONS AND USAGE

Sodium Polystyrene Sulfonate for suspension is indicated for the treatment of hyperkalemia.

CONTRAINDICATIONS

Sodium Polystyrene Sulfonate for suspension is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates (see PRECAUTIONS).

WARNINGS

Intestinal Necrosis

Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Sodium Polystyrene Sulfonate for suspension 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 (see PRECAUTIONS, Drug Interactions).

  • 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.

Alternative Therapy in Severe Hyperkalemia

Since effective lowering of serum potassium with Sodium Polystyrene Sulfonate for suspension may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

Hypokalemia

Serious potassium deficiency can occur from therapy with Sodium Polystyrene Sulfonate for suspension. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with Sodium Polystyrene Sulfonate for suspension should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient’s clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.

Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.

Electrolyte Disturbances

Like all cation-exchange resins, Sodium Polystyrene Sulfonate for suspension is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving Sodium Polystyrene Sulfonate for suspension should be monitored for all applicable electrolyte disturbances.

Systemic Alkalosis

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Sodium Polystyrene Sulfonate for suspension. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Sodium Polystyrene Sulfonate for suspension with magnesium hydroxide as laxative. (See PRECAUTIONS, Drug Interactions.)

PRECAUTIONS

Caution is advised when Sodium Polystyrene Sulfonate for suspension is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances compensatory restriction of sodium intake from other sources may be indicated.

In the event of clinically significant constipation, treatment with Sodium Polystyrene Sulfonate for suspension should be discontinued until normal bowel motion is resumed (see WARNINGS, Intestinal Necrosis).

DRUG INTERACTIONS

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.

Non-absorbable cation-donating antacids and laxatives

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Sodium Polystyrene Sulfonate for suspension. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Sodium Polystyrene Sulfonate for suspension with magnesium hydroxide as a laxative.

Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with Sodium Polystyrene Sulfonate for suspension has been reported.

Digitalis

The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the “normal range”. (See WARNINGS.)

Sorbitol

Concomitant use of Sorbitol with Sodium Polystyrene Sulfonate for suspension has been implicated in cases of intestinal necrosis, which may be fatal. Therefore, concomitant administration is not recommended. (See WARNINGS.)

Lithium

Sodium Polystyrene Sulfonate for suspension may decrease absorption of lithium.

Thyroxine

Sodium Polystyrene Sulfonate for suspension may decrease absorption of thyroxine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed.

Pregnancy Category C

Animal reproduction studies have not been conducted with Sodium Polystyrene Sulfonate for suspension. It is also not known whether Sodium Polystyrene Sulfonate for suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Polystyrene Sulfonate for suspension should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Polystyrene Sulfonate for suspension is administered to a nursing woman.

Pediatric Use

The effectiveness of Sodium Polystyrene Sulfonate for suspension in pediatric patients has not been established. In neonates, Sodium Polystyrene Sulfonate for suspension should not be given by the oral route. In both children and neonates particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin.

Due to the risk of digestive hemorrhage or intestinal necrosis, particular care should be observed in premature infants or low birth weight infants.

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