Sodium Polystyrene Sulfonate: Package Insert - Drugs.com (2024)

Package insert / product label
Dosage form: oral and rectal suspension
Drug class: Cation exchange resins

Sodium Polystyrene Sulfonate Description

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:

Sodium Polystyrene Sulfonate: Package Insert - Drugs.com (1)

The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an invitro 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.

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

Metabolic data are unavailable.

Related/similar drugs

sodium bicarbonate, Lokelma, insulin regular, Humulin R, Kayexalate, Veltassa

Indications and Usage for Sodium Polystyrene Sulfonate

SPS® Suspension is indicated for the treatment of hyperkalemia.

Contraindications

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).

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 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 additional 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 the effective lowering of serum potassium with sodium polystyrene sulfonate 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 sodium polystyrene sulfonate therapy. 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 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 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 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. 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 (See PRECAUTIONS, Drug Interactions).

Risk of Aspiration

Cases of acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles has been reported. Patients with impaired gag reflex, altered level of consciousness, or patients prone to regurgitation may be at increased risk. Administer sodium polystyrene sulfonate suspension with the patient in an upright position.

Binding to Other Orally Administered Medications

Sodium polystyrene sulfonate suspension may bind orally administered medications, which could decrease their gastrointestinal absorption and lead to reduced efficacy. Administer other oral medications at least 3 hours before or 3 hours after sodium polystyrene sulfonate suspension. Patients with gastroparesis may require a 6 hour separation (see DOSAGE AND ADMINISTRATION and PRECAUTIONS, Drug Interactions).

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).

Drug Interactions

General Interactions

No formal drug interaction studies have been conducted in humans.
Sodium polystyrene sulfonate suspension has the potential to bind other drugs. In in-vitro binding studies, sodium polystyrene sulfonate 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. Binding of sodium polystyrene sulfonate suspension to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time sodium polystyrene sulfonate suspension is administered. 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. Monitor for clinical response and/or blood levels where possible.

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/Side Effects

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.

Sodium Polystyrene Sulfonate 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 is Sodium Polystyrene Sulfonate supplied

SPS® Suspension is a light brown, cherry-flavored suspension supplied:

Overbagged with 2 x 60 mL unit dose bottles, NDC 55154-7353-2.

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

Distributed By:

Cardinal Health

Dublin, OH 43017

L45323470124

Revised August 2021

3081 R0821

Package/Label Display Panel

SPS® SUSPENSION

Sodium Polystyrene Sulfonate Suspension, USP

15 g/ 60 mL

2 x 60 mL Bottles

Sodium Polystyrene Sulfonate: Package Insert - Drugs.com (2)

Sodium Polystyrene Sulfonate: Package Insert - Drugs.com (2024)

FAQs

What is the medication sodium polystyrene sulfonate used for? ›

Sodium polystyrene sulfonate is used to treat high levels of potassium in the blood, also called hyperkalemia. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: Powder for Suspension.

When is the best time to take sodium polystyrene sulfonate? ›

Take this medicine at least 3 hours before or after taking other oral medicines. If your stomach takes too long to empty food (gastroparesis), take this medicine 6 hours before or after other oral medicines.

Which drug should not be given with sodium polystyrene sulfonate? ›

Before taking or receiving sodium polystyrene sulfonate,

Be sure to mention any of the following: antacids, antibiotics taken by mouth; anticoagulants such as warfarin (Coumadin, Jantoven); digoxin (Lanoxin); laxatives; lithium (Lithobid); or thyroxine.

How do you administer a sodium polystyrene sulfonate enema? ›

Use sodium polystyrene sulfonate rectally as an enema as directed by your doctor, usually every 6 hours as needed. Keep the enema in the rectum for several hours, if possible. Use a non-sodium-containing cleansing enema after each dose as directed.

What medical condition is treated by polystyrene sulfonate? ›

Sodium polystyrene sulfonate is a medication used in the management and treatment of hyperkalemia. This activity outlines and reviews the indications, mechanism of action, and contraindications for sodium polystyrene sulfonate in the treatment of hyperkalemia.

What foods should you avoid while taking sodium polystyrene sulfonate? ›

Foods high in potassium such as orange juice and other fruit juices may reduce the effectiveness of sodium polystyrene sulfonate in treating your condition. Do not mix sodium polystyrene sulfonate in fruit juice or drink fruit juice with it.

How fast does sodium polystyrene sulfonate work? ›

How long does sodium polystyrene sulfonate (SPS) take to work? It can take 2 to 24 hours to start working to lower potassium. The effects can last for up to 4 to 6 hours.

What are the symptoms of high potassium levels? ›

It can cause:
  • Muscle fatigue.
  • Weakness.
  • Paralysis.
  • Abnormal heart rhythms (arrhythmias)
  • Nausea.

Is sodium polystyrene sulfonate safe? ›

Caution is advised when using this medication rectally in newborns and children. They may be more sensitive to the side effects of this drug, especially severe constipation and intestinal problems. Tell your doctor if you are pregnant before using this medication.

What should I check before giving sodium polystyrene sulfonate? ›

Talk to your doctor if you have questions. If you are taking aluminum or magnesium-containing antacids or laxatives, tell your doctor before using sodium polystyrene sulfonate. These medicines may keep sodium polystyrene sulfonate from working properly and may cause serious side effects.

Does polystyrene sulfonate cause constipation? ›

This medication may cause serious (rarely fatal) intestinal problems (such as bleeding, blockage). Get medical help right away if any of these very serious side effects occur: severe constipation, bloating/swelling/pain in the stomach/abdomen, black/bloody stools, vomit that looks like coffee grounds.

What are the side effects of sodium polystyrene sulfonate Kayexalate? ›

Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: muscle weakness/spasms, fast/irregular heartbeat, mental/mood changes (such as irritability, confusion, slowed thinking), swelling hands/ankles/feet.

What drug interacts with sodium polystyrene? ›

Some products that may interact with this drug include: antacids/laxatives that contain aluminum/calcium/magnesium (such as aluminum carbonate, aluminum hydroxide, calcium carbonate, magnesium hydroxide). Do not use any laxatives that contain sorbitol with this medication.

What is the other name for sodium polystyrene sulfonate? ›

Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal. Sodium polystyrene sulfonate is available as the brand name Kayexalate, as generic brands, and also as non-branded generics.

Why is sodium polystyrene sulfonate given? ›

Sodium polystyrene sulfonate is used to treat high levels of potassium in the blood, also called hyperkalemia. This medicine is available only with your doctor's prescription.

What are the side effects of calcium polystyrene sulfonate? ›

Gastric irritation, anorexia, nausea, vomiting, constipation and occasionally diarrhoea may occur. Faecal impaction following rectal administration particularly in children and gastrointestinal concretions (bezoars) following oral administration have been reported.

Is sodium polystyrene sulfonate good for hair? ›

For hair styling, the film-forming Sodium Polystyrene Sulfonate is truly multifunctional. In styling aids, such as lotions, spritzes, mousses, and waxes, it provides flexible styling and manageability without a stiff hold. It covers hair with a flexible film, fixing the style in place, and easing combing and brushing.

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