Sodium Polystyrene Sulfonate (Local)


VA CLASSIFICATION
Primary: AD400

Commonly used brand name(s): K-Exit; Kayexalate; Kionex; PMS-Sodium Polystyrene Sulfonate; SPS Suspension.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antihyperkalemic—

Indications

Accepted

Hyperkalemia (treatment)—Sodium polystyrene sulfonate is indicated in the treatment of hyperkalemia {01} {02} {09} {14} {15} {16} associated with oliguria or anuria due to acute renal failure. {17}


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Antihyperkalemic—In the intestine (mostly the large intestine), sodium ions are released and are replaced by potassium and other cations before the resin is passed from the body. {01} {09} {14} {15} {16} {17}


Other actions/effects:

Sodium polystyrene sulfonate also exchanges small amounts of other cations such as magnesium and calcium. {01} {09} {14} {15} {16}

Absorption:

Not absorbed from gastrointestinal tract; {09} exchanges sodium for potassium and is excreted from the intestine.

Onset of action:

Hours to days; therefore, other measures such as dialysis may be necessary in emergency situations. {01} {09} {14} {15} {16}


Precautions to Consider

Carcinogenicity/Mutagenicity

Studies have not been done to evaluate the carcinogenic or mutagenic potential of sodium polystyrene sulfonate. {14} {15}

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans.

Studies have not been done in animals.

FDA Pregnancy Category C. {01} {14} {15}

Breast-feeding

It is not known whether sodium polystyrene sulfonate is distributed into breast milk. {14} {15}

Pediatrics

Appropriate studies on the relationship of age to the effects of sodium polystyrene sulfonate have not been performed in the pediatric population. However, pediatrics-specific problems that would limit the usefulness of this medication in children are not expected.


Geriatrics


Although appropriate studies on the relationship of age to the effects of sodium polysytrene sulfonate have not been performed in the geriatric population, the elderly may be more likely to develop fecal impaction. {01} {14} {15} {16}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

» Antacids or
» Laxatives    (sodium polystyrene sulfonate may bind with magnesium or calcium found in nonsystemic antacids and laxatives, preventing neutralization of bicarbonate ions and leading to systemic alkalosis that may be severe; concurrent use is not recommended, although the risk may be less with rectal administration of the resin {01} {05} {06} {07} {09} {14} {15} {16})


Diuretics, potassium-sparing or
Potassium supplements{01}{09}    (sodium polystyrene sulfonate reduces serum potassium concentrations by replacing potassium with sodium; fluid retention may occur in some patients because of the increased sodium intake {08})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Calcium and
Magnesium    (serum concentrations may be decreased since sodium polystyrene sulfonate exchanges for cations in addition to potassium {01} {09} {14} {15} {16})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Edematous conditions, such as:
Congestive heart failure, severe or
Hypertension, severe    (may require compensatory restriction of sodium intake from other sources or use of dialysis instead of sodium polystyrene sulfonate {01} {09} {14} {15} {17})


Sensitivity to sodium polystyrene sulfonate{14}{15}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Bicarbonate concentrations, serum    (determinations recommended once a week during chronic therapy, especially if patient is also receiving antacids or laxatives {09})


Calcium concentrations, serum or
Magnesium concentrations, serum    (determinations recommended in patients receiving sodium polystyrene sulfonate for longer than 3 days {01} {09} {14} {15} {16})


Electrocardiogram (ECG)    (may be useful in some patients {01} {09} {14} {15} {16})


» Potassium concentrations, serum    (determinations recommended at least once a day or as necessary to monitor effectiveness of treatment {09} {14} {15} {16} {17})




Side/Adverse Effects

Note: Cases of colonic necrosis have been reported and may have occurred because cleansing enemas were not administered before and after treatment with sodium polystyrene sulfonate enemas. {03} {04} {14} {15} {16} However, some clinicians think that colonic necrosis may be caused by using sorbitol as a vehicle for sodium polystyrene sulfonate. {04} {13}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
—dose-related    
Fecal impaction (severe stomach pain with nausea and vomiting){01}{09}{14}{15}{16}
    
hypocalcemia (abdominal and muscle cramps){01}{14}{15}
    
hypokalemia (confusion with irritability; delayed thought processes; irregular heartbeat; severe muscle weakness){01}{09}{14}{15}{16}
    
sodium retention (decrease in urination; swelling of hands, feet, or lower legs; weight gain){01}{14}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
—especially with large doses{01}{09}{14}{15}{16}    
Constipation
    
loss of appetite
    
nausea or vomiting





General Dosing Information
Exchange efficiency of sodium polystyrene sulfonate resin is approximately 33%; although each gram contains about 4.1 mEq (mmol) of sodium, {01} {09} {14} {16} 15 grams of resin bind about 46.5 mEq (mmol) of potassium {01} in exchange for the release of an equal amount of sodium. However, these values are variable and electrolyte balance must be monitored to determine dosage and duration of therapy.

Treatment with sodium polystyrene sulfonate may be discontinued when the serum potassium concentrations have been reduced to 4 to 5 mEq (mmol) per liter.

For oral use
Sodium Polystyrene Sulfonate USP is usually mixed with sorbitol. However, to improve palatability, Sodium Polystyrene Sulfonate USP may be mixed with food or a beverage, with the sorbitol given in addition. Alternate vehicles for mixing include warm water, 1% methylcellulose, or 5 to 10% dextrose in water. {11} {12}

To prevent constipation, patients should be treated with oral 70% sorbitol syrup, {01} {14} {15} 10 to 20 mL every 2 hours as needed to produce one or two watery stools a day, or a mild laxative. This will also hasten elimination of potassium and help prevent fecal impaction. {14} {15}

For rectal use
The rectal route is recommended when the patient is vomiting or is restricted from taking anything by mouth (NPO), {09} or when there are upper gastrointestinal tract problems.

After a cleansing enema, the resin suspension is introduced into the rectum via a Foley catheter, and is gently agitated during administration to keep the particles in suspension; administration is followed by flushing with 50 to 100 mL of fluid. The enema is retained as long as possible (anywhere from 30 to 45 minutes to 4 to 10 hours) and is followed by a non–sodium-containing cleansing enema. To prevent back leakage, elevation of the hips on pillows or a knee-chest position may be necessary. In a child, the buttocks may be taped together. {01}
Note: Cases of colonic necrosis have been reported and may have occurred because cleansing enemas were not administered before and after treatment with sodium polystyrene sulfonate enemas. {03} {04} {14} {15} However, some clinicians think that colonic necrosis may be caused by using sorbitol as a vehicle for sodium polystyrene sulfonate. {04} {13}




Oral/Rectal Dosage Forms

SODIUM POLYSTYRENE SULFONATE SUSPENSION USP

Usual adult dose
Antihyperkalemic
Oral, 15 grams one to four times a day, up to 40 grams four times a day. {01} {15} {17}

Note: A dose of 15 grams is approximately equivalent to 4 level tablespoonfuls. {01}


Rectal, 25 to 100 grams as needed, administered as a retention enema or inserted into the rectum in a dialysis bag to facilitate recovery. Sodium polystyrene sulfonate is less effective with rectal administration than by the oral route.


Usual pediatric dose
Antihyperkalemic
Oral, usually 1 gram per kg of body weight per dose as needed to correct hyperkalemia. {10}

Rectal, 1 gram per kg of body weight per dose, {10} administered as a retention enema or inserted into the rectum in a dialysis bag to facilitate recovery. Sodium polystyrene sulfonate is less effective with rectal administration than by the oral route.


Strength(s) usually available
U.S.—


250 mg per mL (Rx) [SPS Suspension][Generic](Roxane—sorbitol 235 mg)

Canada—


250 mg per mL (Rx) [PMS-Sodium Polystyrene Sulfonate (sorbitol 235 mg)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), {15} unless otherwise specified by manufacturer. Store in a well-closed container. {15} Protect from freezing.

Stability:
Heating may alter the exchange properties of the resin. {15}

Auxiliary labeling:
   • Shake well before using. {15}


SODIUM POLYSTYRENE SULFONATE (FOR SUSPENSION) USP

Usual adult dose
Antihyperkalemic
Oral, 15 grams one to four times a day, up to 40 grams four times a day. {01} {09} {14} {16}

Note: A dose of 15 grams is approximately equivalent to 4 level teaspoonfuls. {01} {09} {14} {16}


Rectal, 25 to 100 grams as needed, administered as a retention enema or inserted into the rectum in a dialysis bag to facilitate recovery. Sodium polystyrene sulfonate is less effective with rectal administration than by the oral route.


Usual pediatric dose
See Sodium Polystyrene Sulfonate Suspension USP.

Strength(s) usually available
U.S.—


3.5 grams per level teaspoonful (Rx) [Kayexalate] [Kionex][Generic]

Canada—


3.5 grams per level teaspoonful (Rx) [Kayexalate] [K-Exit] [PMS-Sodium Polystyrene Sulfonate]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), {09} unless otherwise specified by manufacturer. Store in a well-closed container. {09}

Preparation of dosage form:
To facilitate and hasten action and prevent constipation, Sodium Polystyrene Sulfonate USP should be suspended in 3 to 4 mL of 70% sorbitol syrup (which acts as an osmotic cathartic) per gram of resin. The resin also may be mixed with water or a diet appropriate for a patient with renal failure and administered orally through a plastic tube. {09} {14} {16}

For rectal administration, Sodium Polystyrene Sulfonate USP is suspended in 100 to 200 mL of an aqueous vehicle (for example, 25% sorbitol, 1% methylcellulose, or 10% dextrose). Care should be taken that the paste is not too thick because it will be less effective.

Stability:
The suspension should be freshly prepared and used within 24 hours. {01} {09} {14} {16}

Heating may alter the exchange properties of the resin. {01} {09} {14}

Auxiliary labeling:
   • Shake well before using. {09}



Revised: 08/15/1995



References
  1. Kayexalate (Sanofi Winthrop). In: PDR Physicians' desk reference. 46th ed. 1992. Montvale, NJ: Medical Economics Data, 1992.
  1. Drug evaluations subscription. Chicago: American Medical Association, Spring 1990.
  1. Wootton FT, Rhodes DF, Lee WM, et al. Colonic necrosis with Kayexalate-sorbitol enemas after renal transplantation. Ann Intern Med 1989; 111: 947-9.
  1. 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.
  1. Knoben J, Anderson P. Handbook of clinical drug data. 6th ed. Hamilton, IL: Drug Intelligence Publications, 1988.
  1. Ziessman H. Alkalosis and seizure due to a cation-exchange resin and magnesium hydroxide. South Med J 1976; 69: 497-9.
  1. Tatro DS, editor. Drug interaction facts. St. Louis: Facts and Comparisons, Inc., 1990.
  1. Triamterene package insert (Dyrenium, SKF—US), Rev 1/88, Rec 5/89.
  1. K-Exit package insert (Luvabec—Canada), Rev 10/87, Rec 8/3/93.
  1. Benitz WE, Tatro DS. The pediatric drug handbook. 2nd ed. Chicago: Year Book Medical Publishers, Inc., 1988.
  1. McEvoy GK, editor. AHFS Drug information 93. Bethesda, MD: American Society of Hospital Pharmacists, 1993: 1435.
  1. Panel comment, 1991.
  1. Reviewers' consensus on monograph revision of 1991.
  1. Kayexalate (Sanofi Winthrop). In: PDR Physicians' desk reference. 49th ed. 1995. Montvale, NJ: Medical Economics Data, 1995: 2212-3.
  1. Sodium Polystyrene Sulfonate (Roxane). In: PDR Physicians' desk reference. 49th ed. 1995. Montvale, NJ: Medical Economics Data, 1995: 2139-40.
  1. Kayexalate (Sanofi Winthrop). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 30th ed. Ottawa: Canadian Pharmaceutical Association, 1995: 659.
  1. Koda-Kimble MA, Young LY, editors. Applied therapeutics. The clinical use of drugs. 5th ed. Vancouver, WA: Applied Therapeutics, Inc., 1992: 25–8-25–9.
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