Sodium Polystyrene Sulfonate (Page 2 of 3)

Antacids

The simultaneous oral administration of sodium polystyrene sulfonate with nonabsorbable cation-donating antacids and laxatives may reduce the resin’s potassium exchange capability.

Nonabsorbable 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. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative.

Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate 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 has been implicated in cases of intestinal necrosis, which may be fatal (See WARNINGS).

Lithium

SPS^® Suspension may decrease absorption of lithium.

Thyroxine

SPS^® 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. It is also not known whether sodium polystyrene sulfonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium polystyrene sulfonate 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 is administered to a nursing woman.

Pediatric Use

The effectiveness of SPS^® Suspension in pediatric patients has not been established. The use of SPS^® Suspension is contraindicated in neonates and especially in premature infants. In children and neonates, particular care should be observed with rectal administration, as excessive dosage could result in impaction of the resin. Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

ADVERSE REACTIONS

SPS^® Suspension may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, hypomagnesemia and significant sodium retention, and their related clinical manifestations, may occur (See WARNINGS). Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (See PRECAUTIONS). Rare instances of intestinal necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, has been reported.

The following events have been reported from worldwide post marketing experience:

• Fecal impaction following rectal administration, particularly in children;
• Gastrointestinal concretions (bezoars) following oral administration;
• Ischemic colitis, gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and
• Rare cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of polystyrene sulfonate (see WARNINGS).

To report suspected adverse reactions, contact CMP Pharma, Inc., toll free at 1-844-321-1443 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea. Tetany may occur. Electrocardiographic changes may be consistent with hypokalemia or hypocalcemia; cardiac arrhythmias may occur. 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.

DOSAGE AND ADMINISTRATION

Administer sodium polystyrene sulfonate 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, Drug Interactions).

The average daily adult dose is 15 g (60 mL) to 60 g (240 mL) of suspension. This is best provided by administering 15 g (60 mL) of SPS^® Suspension one to four times daily. Each 60 mL of SPS^® Suspension contains 1500 mg (65 mEq) of sodium. Since the in-vivo efficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resin’s actual sodium content is being delivered to the body.

In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation. Administer with patient in an upright position (see WARNINGS).

SPS^® Suspension may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure.

SPS^® Suspension may also be given, although with less effective results, as an enema consisting (for adults) of 30 g (120 mL) to 50 g (200 mL) every six hours. The enema should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped into place. The suspension is introduced at body temperature by gravity. The suspension is flushed with 50 or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. The suspension is kept in the sigmoid colon for several hours, if possible. Then the colon is irrigated with a sodium-free cleansing enema at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. Particular attention should be paid to this cleansing enema, because sorbitol is present in the vehicle.

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

SPS^® Suspension should not be heated for to do so may alter the exchange properties of the resin.

HOW SUPPLIED

SPS^® Suspension is a light brown, cherry-flavored suspension supplied in pint (473 mL) bottles (NDC 46287-006-01), 120 mL bottles (NDC 46287-006-04), and 60 mL unit dose bottles, 10 bottles per carton (NDC 46287-006-60).

Dispense in a tight container, as defined in the USP. If repackaging into other containers, store in refrigerator and use within 14 days of packaging.

SHAKE WELL BEFORE USING.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

CMP Pharma, Inc.
P.O. Box 147
Farmville, North Carolina 27828

Revised August 2021

3081 R0821