Product Monograph - Jamp Sodium Polystyrene Sulfonate (Jamp Pharma, 250 mg)
CONTRAINDICATIONS
JAMP Sodium Polystyrene Sulfonate should not be administered to patients with the following conditions:
- serum potassium <5 mmol/L
- history of hypersensitivity to polystyrene sulfonate resins
- obstructive bowel disease
JAMP Sodium Polystyrene Sulfonate should not be administered to neonates.
WARNINGS AND PRECAUTIONS
Alternative therapy in severe hyperkalemia: Since effective lowering of serum potassium with JAMP 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). In such instances, some form of dialysis (peritoneal or hemo -) may be imperative.
If hyperkalemia is so marked as to constitute a medical emergency (e.g. serum potassium above
7.5 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, sodium polystyrene sulfonate suspension USP may bind to other orally administered medications, which could decrease their gastrointestinal absorption and efficacy. Avoid co-administration of JAMP Sodium Polystyrene Sulfonate with other orally administered medications. Administer JAMP Sodium Polystyrene Sulfonate 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).
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 JAMP Sodium Polystyrene Sulfonate is not recommended (see DRUG INTERACTIONS and ADVERSE REACTIONS).
Hypokalemia: Sodium polystyrene sulfonate suspension 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 JAMP Sodium Polystyrene Sulfonate 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, 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 JAMP Sodium Polystyrene Sulfonate 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, JAMP Sodium Polystyrene Sulfonate should not be given (see CONTRAINDICATIONS). Excessive dosage result in impaction of the resin.
Benzyl alcohol
JAMP Sodium Polystyrene Sulfonate contains benzyl alcohol as a component of flavouring. The drug should not be administered to patients who are hypersensitive to benzyl alcohol.
Benzyl alcohol has been associated with the risk of serious adverse reactions involving metabolic acidosis called “gasping syndrome” in young children. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known.
Young children (below 3 years of age) may not be sufficiently mature to metabolize and eliminate benzyl alcohol as efficiently as adults. Manifestations of the disease included: metabolic acidosis, respiratory distress, gasping respirations, central-nervous system dysfunction, convulsions, intracranial hemorrhages, hypoactivity, hypotonia, hepatic and renal failure, hypotension, cardiovascular collapse and death. These serious adverse events were observed clinically in infants following intravenous administration of doses of benzyl alcohol that were reportedly 20–90 times the acceptable daily intake (established at 5 mg/kg bodyweight) in adults. If patients experience any of these symptoms, the treatment with JAMP Sodium Polystyrene Sulfonate should be immediately stopped.
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. Since the resin is a source of sodium, caution is advised when JAMP Sodium Polystyrene Sulfonate is administered to patients who cannot tolerate even a small increase in sodium loads and for whom an increase in sodium load may be detrimental (i.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 biochemical control is essential. The calcium form of the resin may offer advantages in this situation.
DRUG INTERACTIONS
Orally administered medications: When administered orally, sodium polystyrene sulfonate has the potential to bind to other orally administered medications. Binding of sodium polystyrene sulfonate to other oral medications could decrease their gastrointestinal absorption and efficacy. Dosing separation of sodium polystyrene sulfonate from other orally administered medications is recommended (see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS).
Sorbitol (oral or rectal): Concomitant administration of sorbitol with sodium polystyrene sulfonate is not recommended due to cases of intestinal necrosis, perforation, and other serious gastrointestinal adverse reactions, which may be fatal (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS).
To be used with caution:
Cation donating agents: may reduce the effectiveness of the resin in binding potassium.
Aluminum hydroxide: intestinal obstruction due to concretions of aluminum hydroxide has been reported when aluminum hydroxide was combined with the resin.
Digitalis drugs: the toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated if hypokalemia is allowed to develop (see WARNINGS AND PRECAUTIONS).
Non-absorbable cation-donating antacids and laxatives: systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with non-absorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate.
Lithium: possible decrease of lithium absorption.
Thyroxine: possible decrease of thyroxine absorption.
PREGNANCY
Sodium polystyrene sulfonate is not absorbed from the gastrointestinal tract. No data are available concerning the use of polystyrene sulfonate resins in humans during pregnancy.
LACTATION
Sodium polystyrene sulfonate is not absorbed from the gastrointestinal tract. No data are available concerning the use of polystyrene sulfonate resins in humans during lactation.
OVERDOSAGE
Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, and eventually frank paralysis. Apnea may be a serious consequence of the progression. Electrocardiographic changes may be consistent with hypokalemia; cardiac arrhythmia may occur. Hypocalcemic tetany may occur.
Appropriate measures should be taken to correct serum electrolytes (potassium, calcium). The resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X
(1-844-764-7669).
ADVERSE REACTIONS
Gastrointestinal disorders
Sodium Polystyrene Sulfonate Suspension may cause some degree of gastric irritation. Anorexia, nausea, vomiting and constipation may occur especially if high doses are given. Occasionally diarrhea develops.
Large doses in elderly individuals may cause fecal impaction. These effects may be obviated through usage of the resin in enemas as described under DOSAGE AND ADMINISTRATION.
Gastrointestinal concretions (bezoars) following oral administration have been reported. Gastrointestinal stenosis and intestinal obstruction have also been reported, possibly due to co-existing pathology or inadequate dilution of the resin. Intestinal obstruction due to concretions of aluminum hydroxide has been reported when aluminum hydroxide was used in combination with sodium polystyrene sulfonate.
Gastrointestinal ischemia, ischemic colitis, peritonitis, gastrointestinal stenosis, rectal haemorrhage, gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation have been reported, which is sometimes fatal.
Metabolism and nutrition disorders
In accordance with its pharmacological actions, the resin may give rise to sodium retention, hypokalemia and hypocalcemia, and their related clinical manifestations (see WARNINGS AND PRECAUTIONS and OVERDOSAGE). Cases of hypomagnesemia have been reported.
Respiratory, thoracic and mediastinal disorders
Some cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of sodium polystyrene sulfonate have been described.
DOSAGE AND ADMINISTRATION
JAMP Sodium Polystyrene Sulfonate is for oral 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.
Oral Suspension
Adults, Including the Elderly
Oral Only: The average daily adult dose of JAMP Sodium Polystyrene Sulfonate is 15 to 60 grams (60 to 240 mL). This is provided by administering 60 mL (15 grams) of JAMP Sodium Polystyrene Sulfonate 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.
JAMP Sodium Polystyrene Sulfonate 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.
The intensity and duration of therapy depends upon the severity and resistance of hyperkalemia.
Children
Oral Only: 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 g of JAMP Sodium Polystyrene Sulfonate. An appropriate initial dose is 1 g/kg (4 mL/kg) body weight daily in divided doses in acute hyperkalemia. For maintenance therapy, dosage may be reduced to 0.5 g/kg body weight daily.
AVAILABILITY
Oral Suspension
Supplied in unit dose HDPE bottles of 60 mL and in HDPE bottles of 500 mL.
STORAGE
Oral Suspension
Store between 15-30°C. Keep container tightly closed. Protect from freezing and from excessive heat.
Keep out of reach and sight of children.
REFERENCES
- 1. KAYEXALATE® (Sodium Polystyrene Sulfonate) Prescribing Information, sanofi-aventis Canada Inc., submission control number #: 263510, Date of Revision: June 24, 2022.
- 2. PrSOLYSTAT® (Sodium Polystyrene Sulfonate Suspension, USP - 250 mg / mL - For oral use), Prescribing Information, PENDOPHARM, Division of Pharmascience Inc., submission control number: 288586, Date of Revision: December 5, 2024.