Sodium Polystyrene Sulfonate
Active ingredient
Sold as SOLYSTAT · KAYEXALATE · RESONIUM A
- Drug class
- -
- Availability
- Prescription only
- Routes
- Rectal, Oral
- Markets covered
- 3
- Products on record
- 11
- FDA reports (12 mo)
- 46
Overview
Plain-language summary, compiled from the cited regulatory records
Sodium Polystyrene Sulfonate is a medication used to treat hyperkalemia [1]. It is a potassium binder [1].
Sodium Polystyrene Sulfonate is indicated for the treatment of hyperkalemia [1]. However, it should not be used as an emergency treatment for life-threatening hyperkalemia due to its delayed onset of action [1].
In the past 12 months, there have been 46 adverse event reports associated with Sodium Polystyrene Sulfonate [2]. Among the reported adverse events, the most frequent were Toxic Epidermal Necrolysis, Pyrexia, Diarrhoea, Dyspnoea, and Off Label Use [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 8 | March 22, 2025 |
| US United States | FDA | 2 | April 12, 2024 |
| GB United Kingdom | MHRA | 1 | May 29, 2026 |
CACanada· Health Canada
8 products
How to take
SOLYSTAT (sodium polystyrene sulfonate) is for oral or rectal administration only. The dosage recommendations given below are approximate. The precise requirements for each individual patient should be determined on the basis of regular clinical and biochemical assessments.
Powder for Suspension Suspensions of SOLYSTAT should be freshly prepared and not stored beyond 24 hours. SOLYSTAT powder should not be heated as heating may alter the exchange properties of the resin.
Adults, Including the Elderly Oral:
The average daily adult dose of SOLYSTAT is 15 to 60 grams. This is provided by administering 15 grams (approximately 4 level teaspoons) of SOLYSTAT one to four times daily. 5 grams of SOLYSTAT powder and 15 mmol of sodium. A heaping teaspoon may contain as much as 10-12 grams of SOLYSTAT powder.
Since the in vivo efficiency of sodium-potassium exchange resins is approximately 33 per cent, about one third of the resin’s actual sodium content is being delivered to the body. Each dose should be given as a suspension in a small quantity of water or, for greater palatability, in syrup, but not in orange juice or other fruit juices that are known to contain potassium.
The amount of fluid usually ranges from 20 to 100 mL, depending on the dose. It may be simply determined by allowing 3 to 4 mL per gram of resin. Administer SOLYSTAT at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis, a 6-hour separation should be considered (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
The resin may be introduced into the stomach through a plastic tube. If desired, it may be mixed with a diet appropriate for a patient in renal failure.
Rectal:
For adults, SOLYSTAT may also be given, although with less effective results, in a daily enema. Thirty (30) to 50 g of resin is given once or twice daily (at intervals of six hours). Each dose is administered as a warm emulsion (at body temperature) in 150 to 200 mL of aqueous vehicle (such as plain water, 10 per cent dextrose in water or equal parts of water and 2 per cent methylcellulose suspension).
The emulsion should be agitated gently during administration. The enema should be retained for as long as possible and should be followed by a cleansing enema. After the initial cleansing enema, insert a soft, large size (French 28) rubber tube into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon.
Then tape the tube in place. Suspend the resin in the appropriate amount of water or 10 percent dextrose in water at body temperature. While constantly stirring to keep the particles in suspension, introduce the Prescribing Information - SOLYSTAT® Page 8 of 14 suspension into the colon by gravitational flow.
The suspension should be flushed with 50 or 100 mL of saline solution, following which the tube is clamped and left in place. If back leakage occurs, the hips may be elevated on pillows or a temporary knee-chest position may be taken.
A somewhat thicker suspension may be used, but care should be taken that no paste is formed. Paste formation has a greatly reduced exchange surface and is particularly ineffective, if deposited in the rectal ampulla. If possible, keep the suspension in the sigmoid colon for several hours.
In order to remove the resin, irrigate the colon with non-sodium containing solution at body temperature. Two quarts of flushing solution may be necessary. The returns should be drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to the cleansing enema whenever sorbitol has been used.
It should be noted that the rectal route of administration should be reserved for patients who are vomiting or who have upper gastrointestinal tract problems, including paralytic ileus. The rectal route may also be used simultaneously with oral administration in cases where more rapid initial results are desirable.
If both routes are used initially, it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum. The intensity and duration of therapy depends upon the severity and resistance of hyperkalemia.
Children Oral:
In smaller children and infants, correspondingly lower doses should be employed. Calculation of the dose may be based upon the exchange rate of 1 mmol of potassium per gram of SOLYSTAT. An appropriate initial dose is 1 g/kg body weight daily in divided doses in acute hyperkalemia.
5 g/kg body weight daily.
Rectal:
When refused by mouth, SOLYSTAT may be given rectally using a dose at least as great as that which would have been given orally. SOLYSTAT should be suspended in a proportional amount of 10% dextrose in water. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin (see WARNINGS AND PRECAUTIONS).
Neonates Rectal:
Since it is advised that the oral route should not be employed; only rectal administration should be considered. 5 to 1 g/kg of SOLYSTAT should be employed. The resultant suspension should be diluted as for adults. Following administration of SOLYSTAT, the colon should be adequately irrigated to ensure recovery of the resin (see WARNINGS AND PRECAUTIONS).
Oral Suspension Adults, Including the Elderly Oral Only:
The average daily adult dose of SOLYSTAT is 15 to 60 grams (60 to 240 mL). This is provided by administering 60 mL (15 grams) of SOLYSTAT one to four times daily. Since the in vivo efficiency of sodium-potassium exchange resins is approximately 33 per cent, about one third of the resin's actual sodium content is being delivered to the body.
Prescribing Information - SOLYSTAT® Page 9 of 14 SOLYSTAT may be introduced into the stomach through a plastic tube. If […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
g. burns and renal failure). In such instances, some form of dialysis (peritoneal or hemo-) may be imperative. g. 5 mmol/liter), immediate treatment with intravenous glucose and insulin, or intravenous sodium bicarbonate may be necessary as a temporary measure to lower serum potassium, while other long-term potassium lowering therapy is initiated.
Binding to other orally administered medications:
When administered orally, SOLYSTAT may bind to other orally administered medications, which could decrease their gastrointestinal absorption and efficacy. Avoid co-administration of SOLYSTAT with other orally administered medications.
Administer SOLYSTAT at least 3 hours before or 3 hours after administration of other oral medications. For patients with gastroparesis, a 6-hour separation should be considered (see DRUG INTERACTIONS and DOSAGE AND ADMINISTRATION, Powder for Suspension).
Gastrointestinal injuries:
Cases of gastrointestinal stenosis, intestinal ischemia, ischemic colitis, peritonitis, gastro-intestinal tract ulceration, rectal haemorrhage, gastrointestinal necrosis and intestinal perforation with fatal outcomes have been reported in patients treated with sodium polystyrene sulfonate alone or in combination with sorbitol.
Although all patients are potentially susceptible, risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, immunosuppressant therapy, severe burns, and renal insufficiency and failure.
Patients should be advised to seek prompt medical attention in case of newly developed severe abdominal pain, nausea and vomiting, stomach distension and rectal bleeding. Concomitant administration of sorbitol with SOLYSTAT is not recommended (see DRUG INTERACTIONS and ADVERSE REACTIONS).
Hypokalemia:
SOLYSTAT therapy can precipitate serious potassium deficiency and the possibility of severe potassium depletion should be considered. It is therefore imperative to determine serum potassium levels at least daily and more frequently when indicated.
Adequate clinical and biochemical control is essential during treatment especially in patients on digitalis. Therapy should be discontinued as soon as serum potassium falls below 5 mmol/L (see DRUG INTERACTIONS). Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with SOLYSTAT should be discontinued must be determined individually for each patient.
The patient's clinical condition and electrocardiogram are important in making this determination. Early clinical signs of severe hypokalemia include a pattern of irritability, confusion and delayed thought processes. Severe hypokalemia is often associated with a lengthened Q-T interval, Prescribing Information - SOLYSTAT® Page 4 of 14 widening, flattening or inversion of the T wave, and the appearance of U waves on the electrocardiogram (ECG).
Cardiac arrhythmias such as premature atrial, nodal and ventricular contractions, and supraventricular and ventricular tachycardias may also occur. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.
The toxic effects of digitalis on the heart, especially various ventricular arrhythmia and A-V nodal dissociation, are likely to be exaggerated by hypokalemia. These effects can occur even though serum digoxin concentration is within the ‘normal range’.
Other electrolytes 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. Patients receiving SOLYSTAT should be monitored for all applicable electrolyte disturbances.
Other risks:
In the event of clinically significant constipation, treatment with the resin should be discontinued until normal bowel motion is resumed. Magnesium-containing laxatives should not be used (see DRUG INTERACTIONS). The patient should be positioned carefully when ingesting the resin, in order to avoid aspiration, which could lead to bronchopulmonary complications.
Due to the risk of severe gastrointestinal disorders, the use of polystyrene sulfonate is not recommended in patients with compromised gastrointestinal motility (including immediate post- surgery or drugs that decrease gastrointestinal motility, such as anticholinergics or narcotic analgesics).
Special Populations Children and neonates:
In neonates, SOLYSTAT should not be given by the oral route. In both children and neonates, particular care should be observed with rectal administration. Excessive dosage or inadequate dilution could result in impaction of the resin.
Due to the risk of gastrointestinal tract hemorrhage, colonic necrosis, or sodium overload, particular care should be observed in premature infants or low birth weight infants.
Patients at risk from an increase in sodium load:
During the resin’s action in the intestinal tract, sodium is released mole for mole with potassium uptake. A single dose of sodium polystyrene sulfonate (15 grams) contains approximately 60 mmol of sodium. e. severe congestive heart failure, severe hypertension, marked edema or renal damage).
In such instances, compensatory restriction of sodium intake from other sources may be indicated and adequate clinical and […]
This is not medical advice. Consult a qualified healthcare professional.
USUnited States· FDA
2 products
Uses
1 INDICATIONS AND USAGE Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia. 2) ] Sodium polystyrene sulfonate for suspension is a potassium binder indicated for the treatment of hyperkalemia ( 1 ).
Limitation of Use :
Sodium polystyrene sulfonate for suspension should not be used an emergency treatment for life threatening hyperkalemia because of its delayed onset of action ( 1 ).
How to take
1 ). 1 ). 1 General Information Administer sodium polystyrene sulfonate at least 3 hours before or 3 hours after other oral medications. 2 Recommended Dosage The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.
Oral The average total daily adult dose of sodium polystyrene sulfonate is 15 g to 60 g, administered as a 15-g dose (four level teaspoons), one to four times daily. Rectal The average adult dose is 30 g to 50 g every six hours. 3 Preparation and Administration Prepare suspension fresh and use within 24 hours.
Do not heat sodium polystyrene sulfonate as it could alter the exchange properties of the resin. 5 g of sodium polystyrene sulfonate and 15 mEq of sodium. Oral Suspension Suspend each dose in a small quantity of water or syrup, approximately 3 to 4 mL of liquid per gram of resin.
4) ]. Enema After an initial cleansing enema, insert a soft, large size (French 28) rubber tube into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and tape in place. Administer as a warm (body temperature) emulsion in 100 mL of aqueous vehicle and flush with 50 to 100 ml of fluid.
A somewhat thicker suspension may be used, but do not form a paste. Agitate the emulsion gently during administration. The resin should be retained for as long as possible and follow by a cleansing enema with a nonsodium containing solution.
Ensure an adequate volume of cleansing solution (up to 2 liters) is utilized.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 46 reports total. [4]
- Toxic Epidermal Necrolysis 9
- Pyrexia 7
- Diarrhoea 6
- Dyspnoea 5
- Off Label Use 5
- Arthralgia 4
- Blood Potassium Increased 4
- Conjunctivitis 4
- Dizziness 4
- Fatigue 4
- Mouth Ulceration 4
- Mucosa Vesicle 4
Side effects & warnings
4) ] The following adverse reactions have been identified during post-approval use of sodium polystyrene sulfonate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.
Gastrointestinal : anorexia, constipation, diarrhea, fecal impaction, gastrointestinal concretions (bezoars), ischemic colitis, nausea, ulcerations, vomiting, gastric irritation, intestinal obstruction (due to concentration of aluminium hydroxide) Metabolic : systemic alkalosis Adverse reactions reported include: anorexia, constipation, diarrhea, fecal impaction, gastrointestinal concretions (bezoars), ischemic colitis, nausea, vomiting ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Sunrise Pharmaceutical Inc. gov/medwatch .
1 ).
Electrolyte Disturbances :
Severe hypokalemia can occur. 2 ).
Fluid overload in patient sensitive to high sodium intake :
Monitor patients who are sensitive to sodium intake for signs of fluid overload. 3 ).
Risk of aspiration :
Acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles has been reported. 4 ). 1 Intestinal Necrosis Cases of intestinal necrosis, some 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 sorbitol is not recommended. 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. 2 Electrolyte Disturbances Monitor serum potassium during therapy because severe hypokalemia may occur. Sodium polystyrene sulfonate is not totally selective for potassium, and small amounts of other cations such as magnesium and calcium can also be lost during treatment.
Monitor calcium and magnesium in patients receiving sodium polystyrene sulfonate. 3 Fluid Overload in Patients Sensitive to High Sodium Intake Each 15 g dose of sodium polystyrene sulfonate contains 1500 mg (60 mEq) of sodium. Monitor patients who are sensitive to sodium intake (heart failure, hypertension, edema) for signs of fluid overload.
Adjustment of other sources of sodium may be required. 4 Risk of Aspiration Cases of acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles have 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 with the patient in an upright position. 5 Binding to Other Orally Administered Medications Sodium polystyrene sulfonate 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. Patients with gastroparesis may require a 6 hour separation. 1) and Drug Interactions (7) ].
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
4 CONTRAINDICATIONS Sodium polystyrene sulfonate is contraindicated in patients with the following conditions: Hypersensitivity to polystyrene sulfonate resins Obstructive bowel disease Neonates with reduced gut motility Hypersensitivity to polystyrene sulfonate resins ( 4 ) Obstructive bowel disease ( 4 ) Neonates with reduced gut motility ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
GBUnited Kingdom· MHRA
1 product
Uses
Resonium A is an ion-exchange resin that is recommended for the treatment of hyperkalaemia associated with anuria or severe oliguria. It is also used to treat hyperkalaemia in patients requiring dialysis and in patients on regular haemodialysis or on prolonged peritoneal dialysis.
How to take
Posology The dosage recommendations detailed in this section are a guide only; the precise requirements should be decided on the basis of regular serum electrolyte determinations.
Adults, including the elderly:
Oral: The usual dose is 15g three or four times a day. Each dose should be given as a suspension in a small amount of water or, for greater palatability, in syrup (but not fruit juices which contain potassium), in the ratio of 3 to 4ml per gram of resin.
Administer Resonium A at least 3 hours before or 3 hours after other oral medications. 5).
Rectal:
This route should be reserved for the patient who is vomiting or who has upper gastrointestinal tract problems, including paralytic ileus. It may be used simultaneously with the oral route for more rapid initial results or in patients with gastroparesis, who have other orally administered medications that are administered within 6 hours of Resonium A.
The resin may be given rectally as a suspension of 30g resin in 150ml of water or 10% dextrose, as a daily retention enema. In the initial stages administration by this route as well as orally may help to achieve a more rapid lowering of the serum potassium level.
The enema should if possible be retained for at least nine hours following which the colon should be irrigated to remove the resin. If both routes are used initially it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum.
Paediatric population Oral:
In smaller children and infants correspondingly smaller doses should be employed by using as a guide a rate of 1mEq of potassium per gram of resin as the basis for calculation. An appropriate initial dose is 1g/kg body weight daily in divided doses, in acute hyperkalaemia.
5g/kg of body weight daily in divided doses for maintenance therapy. The resin is given orally, preferably with a drink (not a fruit squash because of the high potassium content) or a little jam or honey.
Rectal:
When refused by mouth it should be given rectally, using a dose at least as great as that which would have been given orally, diluted in the same ratio as described for adults. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin.
Neonates Resonium A should not be given by the oral route. 5g/kg to 1g/kg should be employed diluted as for adults and with adequate irrigation to ensure recovery of the resin. Method of Administration Resonium A is for oral or rectal administration only.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
). To be used with caution • Cation-donating agents: may reduce the potassium binding effectiveness of Resonium A. • Non-absorbable cation-donating antacids and laxatives: There have been reports of systemic alkalosis following concurrent administration of cation-exchange resins and non-absorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminium carbonate.
• Aluminium hydroxide: Intestinal obstruction due to concretions of aluminium hydroxide has been reported when aluminium hydroxide has been combined with the resin. • Digitalis-like drugs: The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated if hypokalaemia is allowed to develop.
4 Special warnings and special precautions for use). • Lithium: Possible decrease of lithium absorption. 6 Fertility, pregnancy and lactation No data are available regarding the use of polystyrene sulfonate resins in pregnancy and lactation.
The administration of Resonium A in pregnancy and during breast feeding therefore is not advised unless, in the opinion of the physician, the potential benefits outweigh any potential risks. 7 Effects on ability to drive and use machines There are no specific warnings.
4 Special warnings and Section
Binding to other orally administered medications:
Calcium Resonium may bind to orally administered medications, which could decrease their gastrointestinal absorption and efficacy. Avoid co-administration of Calcium Resonium with other orally administered medications. Administer Calcium Resonium at least 3 hours before or 3 hours after other oral medications.
5).
Gastrointestinal stenosis and ischaemia:
Gastrointestinal stenosis, intestinal ischemia and its complications (necrosis and perforation), some of them fatal, were reported in patients treated with polystyrene sulfonate alone or in combination with sorbitol. 5). Patients should be advised to seek prompt medical advice in case of newly developed severe abdominal pain, nausea and vomiting, stomach distension and rectal bleeding.
Lesions seen in polystyrene sulfonate-induced gastrointestinal damage may overlap with those seen in inflammatory bowel disease, ischemic colitis, infectious colitis, and microscopic colitis.
Severe gastrointestinal disorders:
Due to the risk of severe gastrointestinal disorders (such as bowel obstruction, ischaemia, necrosis or perforation) the use of polystyrene sulfonate is not recommended in patients with compromised gastrointestinal motility (including immediate post-surgery or drug-induced).
Hypokalaemia:
The possibility of severe potassium depletion should be considered and adequate clinical and biochemical control is essential during treatment, especially in patients on digitalis. Administration of the resin should be stopped when the serum potassium falls to 5mmol/litre.
Other electrolyte disturbances:
Like all cation-exchange resins, calcium polystyrene sulfonate is not totally selective for potassium. Hypomagnesaemia and/or hypercalcaemia may occur. Accordingly, patients should be monitored for all applicable electrolyte disturbances.
Serum calcium levels should be estimated at weekly intervals to detect the early development of hypercalcaemia, and the dose of resin adjusted to levels at which hypercalcaemia and hypokalaemia are prevented.
Other risks:
In the event of clinically significant constipation, treatment should be discontinued until normal bowel movement has resumed. Magnesium-containing laxatives should not be used (see section
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
1 • In patients with plasma potassium levels below 5mmol/litre. • History of hypersensitivity to polystyrene sulfonate resins. • Obstructive bowel disease. • Resonium A should not be administered orally to neonates and is contraindicated in neonates with reduced gut motility (post-operatively or drug-induced).
This is not medical advice. Consult a qualified healthcare professional.
Brands in United Kingdom (1)
Sources & citations
- [1]Health Canada (DPD) · 00755338 · revised March 22, 2025
- [2]FDA DailyMed · 03a0b525-5e48-4e… · revised April 12, 2024 [PDF]
- [3]MHRA (UK) · PL044250178 · revised May 29, 2026
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.