Sodium Polystyrene Sulfonate Suspension
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Questions & Answers
Side Effects & Adverse Reactions
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.
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.
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.
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 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).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
SPS® Suspension is indicated for the treatment of hyperkalemia.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Sodium Polystyrene Sulfonate Suspension Manufacturers
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Carolina Medical Products Company
![Sodium Polystyrene Sulfonate Suspension [Carolina Medical Products Company]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sodium Polystyrene Sulfonate Suspension | Carolina Medical Products Company
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.
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.
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Cardinal Health
Sodium Polystyrene Sulfonate Suspension | Chain Drug Consortium, Llc
shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluidadults and children 2-4 tablespoons (30-60 mL)
12 years and overchildren 6 years to 11 years 1-2 tablespoons (15-30 mL)
children under 6 years ask a doctor
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Paddock Laboratories, Llc
Sodium Polystyrene Sulfonate Suspension | Paddock Laboratories, Llc
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 Sodium Polystyrene Sulfonate Suspension, USP one to four times daily. Each 60 mL of Sodium Polystyrene Sulfonate Suspension, USP 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.
Sodium Polystyrene Sulfonate Suspension, USP may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure.
Sodium Polystyrene Sulfonate Suspension, USP 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. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.
The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.
Sodium Polystyrene Sulfonate Suspension, USP should not be heated for to do so may alter the exchange properties of the resin.
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Roxane Laboratories, Inc.
Sodium Polystyrene Sulfonate Suspension | Roxane Laboratories, Inc.
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 sodium polystyrene sulfonate suspension one to four times daily. Each 60 mL of sodium polystyrene sulfonate suspension contains 1575 mg (68.5 mEq) per 60 mL which is equivalent to 1500 mg on the anhydrous basis 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.
Sodium polystyrene sulfonate 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.
Sodium polystyrene sulfonate 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 in 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. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.
The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.
Sodium polystyrene sulfonate suspension should not be heated for to do so may alter the exchange properties of the resin.
![Sodium Polystyrene Sulfonate Suspension [Cardinal Health]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
![Sodium Polystyrene Sulfonate Suspension [Paddock Laboratories, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=085fa3d6-b4fa-4734-8f44-d8282d0225a3&name=6a1ab414-4b9d-492f-8d8d-bc24be207ab7-02.jpg)
![Sodium Polystyrene Sulfonate Suspension [Roxane Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=83f3f990-4fab-43c7-9100-092d64ab6213&name=77dbddb4-9d28-4a67-bd63-f8ffb091f1d9-02.jpg)
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