CMP Pharma, Inc.

Cation-Exchange Resin

Rx Only

Sodium Polystyrene Sulfonate Suspension USP (SPS® Suspension) can be administered orally or in an enema. It is a cherry-flavored suspension containing 15 grams of cation-exchange resin (Sodium Polystyrene Sulfonate USP); 21.5 mL of Sorbitol Solution USP (equivalent to approximately 20 grams of Sorbitol); 0.18 mL (0.3%) of Alcohol per 60 mL of suspension. Also contains Purified Water USP; Propylene Glycol USP; Magnesium Aluminum Silicate NF; Sodium Saccharin USP; Methylparaben NF; Propylparaben NF; and flavor.

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

The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an in‑vitro exchange capacity of approximately 3.1 mEq (in-vivo approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.

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%, but the range is so large that definitive indices of electrolyte balance must be clearly monitored.

Metabolic data are unavailable.

SPS® Suspension is indicated for the treatment of hyperkalemia.

SPS® Suspension is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, oral or rectal administration in neonates  (See PRECAUTIONS).

Caution is advised when sodium polystyrene sulfonate 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.

Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

In the event of clinically significant constipation, treatment with SPS® Suspension should be discontinued until normal bowel motion is resumed (See WARNINGS, Intestinal Necrosis).

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 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.

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.

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

NDC 46287–006–01

473 mL

SPS® Suspension

SODIUM POLYSTYRENE SULFONATE SUSPENSION, USP

For Oral or Rectal Use

Sodium Polystyrene Sulfonate USP 15 g/60 mL

Also contains: Sorbitol Solution USP (equivalent to

approximately 20 g of Sorbitol), Alcohol 0.3%, Purified

Water USP, Propylene Glycol USP, Magnesium Aluminum

Silicate NF, Sodium Saccharin USP, Methylparaben NF,

Propylparaben NF, & Flavor

Sodium content 1.5 g (65 mEq) in 60 mL

USUAL DOSE: See accompanying package insert for full

information.

Store at 20°-25°C (68°-77°F); excursions permitted

to 15°-30°C (59°-86°F). [See USP Controlled Room

Temperature].

Dispense in a tight container, as defined in the USP.

GTIN: 00346287006015

SHAKE WELL

Rx Only

cmp

PHARMA

Farmville, NC 27828

3064

R1219