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Sodium Polystyrene Sulfonate

Class: Potassium-removing Agents
VA Class: AD400
CAS Number: 9003-59-2
Brands: Kayexalate, Kionex, SPS

Introduction

A sulfonated cation-exchange resin used for the removal of excess potassium.107 108 b

Uses for Sodium Polystyrene Sulfonate

Hyperkalemia

Treatment of hyperkalemia.107 108 b Used as an adjunct to other measures (e.g., restriction of electrolyte intake, control of acidosis, high-calorie diet).b

Prior to initiating therapy, determine cause of hyperkalemia and eliminate if possible.b

Not recommended for treatment of hyperkalemia evidenced by conduction defects (widening of the QRS complex) or arrhythmiasb because action of the resin is slow.107 108 b

Most useful when hyperkalemia is not life-threatening or when other measures have reduced the dangers of hyperkalemia.b

Sodium Polystyrene Sulfonate Dosage and Administration

General

  • Dosage and duration of therapy must be individualized and depend on frequent assessment of total body potassium.107 108 b

Administration

Administer orally or rectally.107 108 b Consider administering other oral drugs ≥6 hours before or 6 hours after oral administration of sodium polystyrene sulfonate.105

Oral Administration

Administer orally as a suspension (either as the commercially available suspension108 b or prepared extemporaneously from the powdered resin).107 b

May be mixed with a diet appropriate for a patient in renal failure.107 108 Do not mix with foods or liquids that contain a large amount of potassium (e.g., bananas, orange juice).b

Suspension also may be introduced into the stomach via a tube.107 108 b

Prior to administration, shake suspension well.108

Follow full precautions to prevent aspiration (e.g., keep patient in upright position during administration).107

Reconstitution

Reconstitute each 1 g of the powdered resin in 3–4 mL of water or a syrup;107 usually 20–100 mL of fluid is used.107 b

Rectal Administration

Administer rectally as a retention enema by gravity feed (either as the commercially available suspension108 b or prepared extemporaneously from the powdered resin).107 b

Prior to administration, administer an initial cleansing enema, and then insert a soft, large (French 28) rubber tube about 20 cm into the rectum, with the tip well into the sigmoid colon, and tape in place.107 108 b

Prior to administration, warm suspension to body temperature107 108 b and shake well.108

During administration, extemporaneously prepared suspension should be kept in suspension by stirring.107 b The tube may be flushed with 50–100 mL of fluid, clamped, and left in place.107 108 b If back-leakage occurs, the hips should be elevated on pillows or a knee-chest position assumed.107 108 b

Retain suspension in the colon for at least 30–60 minutesb or for several hours if possible,107 108 b then irrigate the colon with a non-sodium-containing solution at body temperature to remove the resin.107 108 b Returns should be drained constantly through a Y-tube connection.107 108 Approximately 2 L of irrigating solution may be needed to adequately flush out the resin;107 108 b proper removal of resin is particularly important if sorbitol is used (sorbitol use is not recommended).107 108

Alternatively, some clinicians recommend placing the resin in a sealed dialysis bag and inserting the bag into the rectum.b

Reconstitution

Suspend appropriate dose of powdered resin in 100–200 mL of an aqueous vehicle (e.g., 1% methylcellulose, 10% dextrose, water) at body temperature.b

A thicker suspension may be used; however, care should be taken that a paste, which would greatly reduce the exchange surface and be particularly ineffective if deposited in the rectal ampulla, is not formed.107 b

Dosage

Pediatric Patients

Hyperkalemia
Oral

Infants and small children: Reduced dosage recommended.107 108 Calculate dosage based on the fact that 1 g of the resin binds approximately 1 mEq of potassium.107 108 b

Oral administration contraindicated in neonates.107 108 (See Pediatric Use under Cautions.)

Rectal

Infants and small children: Reduced dosage recommended.107 108 Calculate dosage based on the fact that 1 g of the resin binds approximately 1 mEq of potassium.107 108 b

Use with caution.107 Some manufacturers state rectal administration is contraindicated in neonates and premature infants.108 (See Pediatric Use under Cautions.)

Adults

Hyperkalemia
Oral

15 g (approximately 4 level teaspoonfuls of the powder or 60 mL of the commercially available suspension) 1–4 times daily (average 15–60 g daily).107 108 b

Rectal

May administer 30–50 g (120–200 mL of the commercially available suspension) every 6 hours.107 108

Cautions for Sodium Polystyrene Sulfonate

Contraindications

  • Hypokalemia.107 108

  • Obstructive bowel disease.107 108

  • Neonates with decreased gut mobility (postoperative or drug induced).107

  • Oral administration contraindicated in neonates.107 Some manufacturers state that use (oral or rectal) is contraindicated in neonates and premature infants.108 (See Pediatric Use under Cautions.)

  • Known hypersensitivity to sodium polystyrene sulfonate resins.107 108

Warnings/Precautions

Warnings

Intestinal Necrosis

Intestinal necrosis, which may be fatal, and other serious adverse GI events (bleeding, ischemic colitis, perforation) reported.107 108 109 110 Most cases involved concomitant sorbitol use; many of the patients had risk factors for adverse GI events (e.g., prematurity, history of intestinal disease or surgery, hypovolemia, renal insufficiency or failure).107 108 110

Concomitant administration of sorbitol not recommended.107 108 109 Most commercially available suspensions reformulated without sorbitol;108 112 however, preparations in 33% sorbitol vehicle remain commercially available.111 112

Use only in patients with normal bowel function.107 108 Avoid use in patients who have not had a bowel movement following surgery.107 108

Avoid use in patients at risk for developing constipation or impaction (e.g., those with history of fecal impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction).107 108

Discontinue use if constipation occurs.107 108

Severe Hyperkalemia

Because of its slow action, sodium polystyrene sulfonate alone may be insufficient (effective lowering of serum potassium may occur within hours to days) to rapidly correct severe hyperkalemia, including that associated with states of rapid tissue breakdown (e.g., burns, renal failure).107 108 b If severe hyperkalemia occurs, consider other definitive measures, including dialysis.107 108 b

Hypokalemia

Possible severe hypokalemia (manifested by irritable confusion, delayed thought processes, muscle cramps, muscle weakness, and, occasionally, frank paralysis),107 108 b electrocardiogram (ECG) abnormalities (e.g., lengthened QT intervals; widened, flat, or inverted T waves; prominent U waves), and cardiac abnormalities (e.g., premature atrial, nodal, or ventricular contractions; supraventricular and ventricular tachycardias) may occur.107 108 b

Intracellular potassium deficiency is not always reflected by serum potassium levels; individualize decision to discontinue sodium polystyrene sulfonate therapy, taking into account patient's clinical condition and ECG.107 108

Other Electrolyte Effects

Cation-exchange action is not totally selective for potassium; possible increased excretion of other cations (e.g., magnesium, calcium).107 108 b

Systemic Alkalosis

Systemic alkalosis reported after oral administration of cation-exchange resins in combination with nonabsorbable cation-donating antacids and laxatives (e.g., magnesium hydroxide, aluminum carbonate).107 108 b (See Specific Drugs under Interactions.)

General Precautions

Binding to Other Orally Administered Drugs

FDA is requiring the manufacturer to conduct studies assessing the potential of sodium polystyrene sulfonate to bind to other oral agents; binding could decrease GI absorption and reduce efficacy of other oral agents.105 In vitro studies indicated that patiromer, another potassium-reducing agent, binds to approximately 50% of the oral drugs tested.105 106 (See Effects on GI Absorption of Drugs under Interactions.)

Patient Monitoring

Determine serum potassium concentrations frequently within each 24-hour period.107 108

Monitor for other electrolyte (e.g., calcium, magnesium) abnormalities.107 108 b

Closely monitor ECGs and clinical condition of the patient during therapy.b

Sodium Content

Each 1 g of the powdered resin contains approximately 4.1 mEq of sodium;107 b each 60 mL of the commercially available suspension contains 68.5 mEq of sodium.108

Clinically important sodium retention may occur.107 108 Use with caution in patients who cannot tolerate even a small increase in sodium loads (e.g., severe CHF, severe hypertension, marked edema); restriction of sodium intake from other sources may be required.107 108 b

Rectal Administration Precautions

Ensure adequate volume of non-sodium-containing cleansing enemas after rectal administration.108 (See Rectal Administration under Dosage and Administration.)

Constipation

Possible constipation.107 108 If clinically important constipation occurs, discontinue therapy until normal bowel movements resume; administration of magnesium hydroxide laxatives and sorbitol not recommended.107 108 (See Specific Drugs under Interactions and see Intestinal Necrosis under Cautions.)

Specific Populations

Pregnancy

Category C.107

Lactation

Not known whether sodium polystyrene sulfonate is distributed into milk.107 108 Caution if used in nursing women.107 108

Pediatric Use

Efficacy not established.107 108

Administer rectally with particular caution; excessive dosages or inadequate dilution may result in impaction of the resin.107 108 Ensure adequate volume of non-sodium-containing cleansing enemas after rectal administration.108

Possible risk of digestive hemorrhage or intestinal necrosis in premature infants or low birth weight infants; particular caution required.107 Some manufacturers state that use is contraindicated in premature infants.108

Contraindicated in neonates with reduced gut motility (postoperatively or drug induced).107

Oral administration contraindicated in neonates.107 108 Some manufacturers state rectal administration also is contraindicated in neonates.108

Geriatric Use

Large doses in geriatric individuals may cause fecal impaction.107 108

Renal Impairment

Severe systemic alkalosis and a tonic-clonic seizure reported in one patient with chronic hypocalcemia secondary to renal failure who received magnesium hydroxide and sodium polystyrene sulfonate concomitantly.107 108 b (See Systemic Alkalosis under Cautions and Specific Drugs under Interactions.)

Common Adverse Effects

Gastric irritation.107 108 b Anorexia, nausea, vomiting, and constipation may occur, especially with high doses.107 108 Hypokalemia, hypocalcemia, hypomagnesemia, and clinically important sodium retention also may occur.107 108

Interactions for Sodium Polystyrene Sulfonate

Effects on GI Absorption of Drugs

May bind to other oral drugs.105 Binding could reduce GI absorption of the drugs and result in loss of efficacy when administration times are close to those of sodium polystyrene sulfonate.105 (See Binding to Other Orally Administered Drugs under Cautions.)

Consider administering other oral agents ≥6 hours before or 6 hours after oral administration of sodium polystyrene sulfonate.105 Monitor clinical response and/or blood concentrations of the drugs whenever possible.105

Specific Drugs

Drug

Interaction

Comments

Antacids, cation-donating (e.g., aluminum carbonate, aluminum hydroxide, magnesium hydroxide, calcium carbonate)

Possible reduced potassium exchange capability107 108 b

Concomitant oral administration of sodium polystyrene sulfonate may result in systemic alkalosis107 108 b

Possible intestinal obstruction due to concretions of aluminum hydroxide107 108 b

Concomitant use of orally administered sodium polystyrene sulfonate with magnesium hydroxide not recommended107 108

Rectal use of sodium polystyrene sulfonate may avoid systemic alkalosisb

Cardiac glycosides

Sodium polystyrene sulfonate-induced hypokalemia may increase toxic effects of cardiac glycosides on the heart (e.g., ventricular arrhythmias, AV nodal dissociation)107 108 (See Hypokalemia under Cautions)

Laxatives, cation-donating

Possible reduced potassium exchange capability107 108 b

Concomitant oral administration of sodium polystyrene sulfonate may result in systemic alkalosis107 108 b

Concomitant use of orally administered sodium polystyrene sulfonate with magnesium hydroxide not recommended107 108

Rectal use of sodium polystyrene sulfonate may avoid systemic alkalosis)b

Lithium

Possible decreased absorption of lithium107 108

Sorbitol

Possible intestinal necrosis107 108 109 110

Concomitant administration not recommended107 108 109

Thyroxine

Possible decreased absorption of thyroxine 107 108

Sodium Polystyrene Sulfonate Pharmacokinetics

Absorption

Onset

Following administration, effective lowering of serum potassium may take hours to days.107 108

Elimination

Elimination Route

Modified resin is excreted in the feces.b

Stability

Storage

Oral or Rectal

Powder for Suspension

25°C (may be exposed to 15–30°C).107

Suspension (Sorbitol-free or in 33% Sorbitol Vehicle)

25°C (may be exposed to 15–30°C).108 111 If repackaged, refrigerate and use within 14 days of repackaging.108 111

Extemporaneous suspensions of the resin should be freshly prepared and should not be stored for >24 hours.107 b

Suspension should not be heated because changes in the exchange properties of the resin may occur.107 108 b

Actions

  • A cation-exchange resin used for the removal of excess potassium.107 108 b

  • Releases sodium in exchange for other cations (e.g., potassium, calcium, magnesium, iron, organic cations, lipids, steroids, proteins).b

  • Sodium is released from the resin in exchange for potassium primarily in the large intestine, where there is a relatively high concentration of potassium present.107 b Each 1 g of the resin has an in vitro exchange capacity of about 3.1 mEq of potassium; an in vivo exchange capacity >1 mEq of potassium per g of resin is not likely.107 108 b

Advice to Patients

  • Importance of informing patients that it may be advisable to administer other oral drugs ≥6 hours before or 6 hours after oral administration of sodium polystyrene sulfonate.105

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.107 108

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.107 108

  • Importance of informing patients of other important precautionary information.107 108 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sodium Polystyrene Sulfonate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral or Rectal

Powder, for suspension

Kayexalate

Covis

Kionex

Perrigo

Sodium Polystyrene Sulfonate Powder

Suspension

1.25 g/5 mL*

Kionex

Perrigo

Sodium Polystyrene Sulfonate Suspension

SPS

CMP

AHFS DI Essentials. © Copyright 2017, Selected Revisions January 23, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

100. Lillemoe KD, Romolo JL, Hamilton SR et al. Intestinal necrosis due to sodium polystyrene (Kayexalate) in sorbitol enemas: clinical and experimental support for the hypothesis. Surgery. 1987; 101:267-72. [PubMed 3824154]

101. Wootton FT, Rhodes DF, Lee WM et al. Colonic necrosis with Kayexalate-sorbitol enemas after renal transplantation. Ann Intern Med. 1989; 111:947-9. [PubMed 2817643]

102. Arvanitakis C, Malek G, Uehling D et al. Colonic complications after renal transplantation. Gastroenterology. 1973; 64:533-8. [PubMed 4144776]

103. Burnett RJ. Sodium polystyrene-sorbitol enemas. Ann Intern Med. 1990; 112:311-2. [PubMed 2297214]

104. Shepard KV. Cleansing enemas after sodium polystyrene sulfonate enemas. Ann Intern Med. 1990; 112:711. [PubMed 2334084]

105. Food and Drug Administration. FDA drug safety communication: FDA requires drug interaction studies with potassium-lowering drug Kayexalate (sodium polystyrene sulfonate). Rockville, MD; 2015 Oct 22. From FDA website. Accessed 2016 Mar 3.

106. Relypsa, Inc. Veltassa (patiromer) powder for oral suspension prescribing information. Redwood City, CA; 2015 Oct.

107. Covis Pharmaceuticals, Inc. Kayexalate (sodium polystyrene sulfonate) prescribing information. Cary, NC; 2013 Apr.

108. Roxane Laboratories. Sodium polystyrene sulfonate suspension prescribing information. Columbus, OH; 2013 Jun.

109. McGowan CE, Saha S, Chu G et al. Intestinal necrosis due to sodium polystyrene sulfonate (Kayexalate) in sorbitol. South Med J. 2009; 102:493-7. [PubMed 19373153]

110. Harel Z, Harel S, Shah PS et al. Gastrointestinal adverse events with sodium polystyrene sulfonate (Kayexalate) use: a systematic review. Am J Med. 2013; 126:264.e9-24.

111. Carolina Medical Products Company. Sodium polystyrene sulfonate suspension prescribing information. Farmvivlle, NC; 2011 Mar.

112. Sterns RH, Rojas M, Bernstein P et al. Ion-exchange resins for the treatment of hyperkalemia: are they safe and effective?. J Am Soc Nephrol. 2010; 21:733-5. [PubMed 20167700]

b. AHFS Drug Information 2005. McEvoy, GK, ed. Sodium Polystyrene Sulfonate. Bethesda, MD: American Society of Health-System Pharmacists; 2005: 2550-1.

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