Active ingredients: Polystyrenesulfonate
KAYEXALATE powder for oral and rectal suspension
Why is Kayexalate used? What is it for?
PHARMACO-THERAPEUTIC CATEGORY
Medication for the treatment of hyperkalaemia.
THERAPEUTIC INDICATIONS
Treatment of hyperkalaemia.
Contraindications When Kayexalate should not be used
Potassemia <5 mEq / l.
Hypersensitivity to the active substance or to any of the excipients.
Obstructive intestinal pathology.
Sodium polystyrene sulphonate should not be administered orally to neonates and is contraindicated in neonates with impaired intestinal motility (following surgery or drug induced).
Precautions for use What you need to know before taking Kayexalate
Hypokalaemia: Since there is the possibility of severe potassium depletion, it is essential to carry out adequate clinical and biochemical checks during treatment, especially in patients receiving digitalis. Therapy should be discontinued as soon as serum potassium levels drop below 5 mEq / L (see Contraindications and Interactions). Since an intracellular potassium deficiency is not always reflected in serum values, it is recommended not to overlook the early clinical or electrocardiographic signs of hypokalaemia (see "Overdose").
Other electrolyte disturbances: Like any cation exchange resin, KAYEXALATE has a selective action for potassium, but a small amount of other cations, such as magnesium and calcium, can be bound and therefore lost during treatment. For this reason patients taking KAYEXALATE should be checked for any electrolyte disturbances.
Interactions What medications or foods may change the effect of Kayexalate
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Not recommended use:
- Sorbitol: the concomitant use of sorbitol and Kayexalate has been implicated in some cases of intestinal necrosis, which can be fatal: the combination of the two drugs is therefore to be avoided (see Special warnings and Undesirable effects).
To be used with caution:
- Cationic donors: can reduce the resin's effectiveness in binding potassium.
- Non-absorbable cationic donor antacids and laxatives: Systemic alkalosis has occurred after oral administration of cation exchange resins with non-absorbable cationic donor antacids and laxatives, such as magnesium hydroxide and aluminum carbonate.
- Aluminum hydroxide: intestinal obstruction due to compact masses of aluminum hydroxide has occurred when combined with resin.
- Digitalis: Increased toxic effects of digitalis on the heart, particularly ventricular arrhythmias and nodal AV dissociations, are likely in cases of hypokalaemia (see Precautions for use).
- Lithium: possible decrease in lithium absorption.
- Thyroxine: possible decrease in the absorption of thyroxine.
Warnings It is important to know that:
Therapeutic alternatives in severe hyperkalaemia: Since it may take hours or days to effectively lower serum potassium with KAYEXALATE, treatment with this drug alone may not be sufficient to quickly correct severe hyperkalaemia caused by conditions of rapid tissue destruction, such as example in burns and kidney failure. In such cases it may be necessary to resort to peritoneal dialysis or hemodialysis.
If the hyperkalaemia is so severe that it constitutes a medical emergency (for example, potassium above 7.5 mEq / liter), immediate treatment with intravenous glucose and insulin or intravenous sodium bicarbonate may be required: these are temporary measures to lower serum potassium while other long-term treatment is prepared to reduce potassium.
Sorbitol: Cases of intestinal necrosis, which can be fatal, have occurred with concomitant administration of sorbitol and sodium polystyrene sulphonate. Therefore, although "insufficient colonic irrigation after treatment cannot be ruled out as a cause, it is better to avoid concomitant administration of these drugs" (see interactions and side effects).
Other Risks: If clinically significant constipation occurs, treatment should be discontinued until normal bowel motility is restored. Laxatives containing magnesium or sorbitol should not be used (see Interactions and side effects).
To ingest the resin the patient must put himself in a correct position to avoid aspiration which can lead to bronchopulmonary complications.
Patients at risk for the increased sodium load: since the resin contains sodium (about 100 mg for each gram of powder), particular caution must be exercised when administering the drug to patients who cannot tolerate even small sodium loads (severe insufficiency congestive heart disease, severe hypertension, renal damage or the presence of marked edema). In such cases it is therefore essential to carry out adequate clinical and biochemical checks. In this situation, a compensatory restriction of sodium intake from other sources or the use of resin may be useful. calcium.
Gastrointestinal lesions: special attention must be paid during the administration of KAYEXALATE in patients suffering from chronic uremia and both functional and organic lesions of the digestive system.
Intestinal hypomotility in addition to the concomitant administration of acid secretion inhibitors and / or antacids (aluminum hydroxide) often require an increase in resin dosage. These conditions can cause an accumulation of the resin in the gastric cavity with partial passage of this into the duodenum and in very rare cases the formation of bezoars in turn responsible for intestinal sub-occlusion.
Very rare cases of gastrointestinal bezoar have been reported. Cases of formation of "sodium polystyrene sulfonate" "crystals" adhering to the mucosa (with or without lesions) are also described.
In patients at risk (uremic, burned with gastrointestinal lesions and reduced gastrointestinal motility) the conditions of hyperkalaemia could be treated with other therapeutic aids (insulin-glucose or dialysis). However, an endoscopic evaluation (even in urgency) is recommended to evaluate possible mucosal damage (ulcers, erosions) or any bleeding.
Systemic alkalosis: the use of calcium carbonate or aluminum hydroxide can induce alkalosis as the neutralization of protons by antacids in the stomach increases the production of bicarbonates in the duodenal which, in the presence of sodium polystyrene sulfonate, are not buffered, but absorbed, causing a "metabolic alkalosis which, in extreme cases, could trigger convulsive crises.
Children and babies
Do not use sodium polystyrene sulphonate orally in infants. Particular caution should be exercised in rectal administration in both children and infants, as excessive dosage or inadequate dilution can lead to resin packing.
Particular caution should be exercised in premature and underweight infants due to the risk of digestive haemorrhage, colonic necrosis and sodium overload.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Sodium polystyrene sulfonate is not absorbed from the gastrointestinal tract. There are no data on the use of polystyrene sulfonate resins during pregnancy and lactation in humans, however, as for any drug, their use in the first trimester of pregnancy is not recommended; in the further period it will be administered only in case of real need under the direct supervision of the doctor
Dosage and method of use How to use Kayexalate: Dosage
The routes of administration of Kayexalate are oral and rectal; the latter can be used in patients who cannot take the drug by mouth (due to vomiting or problems with the upper gastrointestinal tract, including paralytic ileus) or it can be used at the same time as the oral one to obtain faster initial results. Both routes are used, it is probably not necessary to continue rectal administration by the time the orally administered resin has reached the rectum.
The dosages recommended below are indicative; the precise individual requirements must be determined on the basis of regular clinical and biochemical examinations.
The duration of therapy depends on the severity and resistance of the hyperkalaemia.
The resin suspension should be prepared shortly before use and should not be stored beyond 24 hours. Heat can alter the resin exchange properties. In the absence of incompatibility studies, this medicinal product should not be mixed with other medicinal products.
Adults, including the elderly
Orally: 15 g (one measuring cup) one to four times a day.
Method of administration
Administer the powder after mixing it (made pulp) or suspended in a small amount of water or, to improve palatability, in water and sugar (not fruit juices, which contain potassium); the limitation of the volume of water is particularly recommended in patients with renal insufficiency: generally 3 or 4 ml of water can be used for each gram of powder.
The suspension can also be introduced into the stomach through a tube or the powder can be taken by mixing it with food.
Rectal route: 30 g of powder suspended in 150-200 ml of water or 10% dextrose (in a retention enema) once or twice a day.
Method of administration
Administration should be preceded by a cleansing enema.
The kayexalate enema should be held, if possible, for 10-12 hours, and then followed by a cleansing enema to remove the drug. The Kayexalate suspension should be gently shaken during administration.
The Kayexalate suspension should be administered at body temperature, without exceeding 37 ° C because heating can alter the exchange properties of the resin.
The cleansing enema should be performed with a sodium-free solution, also heated to body temperature; two liters of cleansing solution may be required.
Children
Experience with the use of KAYEXALATE in children is limited.
Oral route: as a useful guide for personalizing the treatment, consider that the exchange capacity of sodium polystyrene sulfonate is 1 mEq of potassium per gram of resin.
The initial dosage is 1 g / kg of body weight per day, in divided doses; for maintenance therapy the daily dosage can be reduced to 0.5 g / kg body weight. In younger children proportionately smaller doses should be used.
Method of administration
See adults.
Rectal: if rejected by mouth, the resin can be administered rectally at a dose equal to at least that which would have been given orally, suspended in a proportionate amount of water and 10% dextrose.
Method of administration
See adults. The utmost caution is recommended: particularly in children and infants, an excessive dosage or inadequate dilution can cause the resin to compact and the consequent intestinal obstruction due to fecaloma.
Babies
Experience with the use of KAYEXALATE in neonates is limited.
Administration should only take place rectally.
The dosage must be the minimum effective dose between 0.5 g / kg and 1 g / kg,
Method of administration
See adults. The utmost caution is recommended: particularly in children and infants, an excessive dosage or inadequate dilution can cause the resin to compact and the consequent intestinal obstruction due to fecaloma.
Overdose What to do if you have taken too much Kayexalate
Biochemical disorders due to overdose can result in clinical symptoms and signs of hypokalaemia, including irritability, confusion, slowing of intellectual abilities, muscle weakness, hyporeflexia and possibly frank paralysis. Apnea can be a serious consequence of this progression. Electrocardiographic changes may occur with hypokalemia; cardiac arrhythmias may occur. Hypocalcemic tetany may also occur. Appropriate measures should be taken to correct serum electrolytes (potassium and calcium) and the resin should be removed from the gastrointestinal tract using laxatives or enemas appropriately.
If you accidentally take an overdose of KAYEXALATE, notify your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT USING KAYEXALATE, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Kayexalate
Like all medicines, Kayexalate can cause side effects, although not everybody gets them.
Metabolism and nutrition disorders
Sodium retention, hypokalaemia and hypocalcaemia, with related clinical manifestations, may occur following therapy with KAYEXALATE (see Precautions for use and Overdose). Hypomagnesaemia: cases have been reported.
Gastrointestinal disorders
KAYEXALATE can cause some degree of gastric irritation. Anorexia, nausea and vomiting, constipation may also occur. Sometimes diarrhea occurs. Cases of fecal impaction have been reported, particularly in the elderly who received high doses or in children after rectal administration and gastrointestinal (bezoar) concrements after oral administration. Intestinal obstruction has been reported, although extremely rare and possibly as a reflection of coexisting disease or inadequate dilution of the resin or associated with concomitant administration of aluminum hydroxide.
Two cases of intestinal obstruction caused by the formation of a gastrointestinal bezoar have been reported following administration of sodium polystyrene sulphonate.
Cases of formation of "sodium polystyrene sulfonate" "crystals" adhering to the gastrointestinal mucosa have also been described.
Ischemic colitis, ulceration of the gastrointestinal tract or necrosis which can lead to intestinal perforation.
Some patients have reported intestinal necrosis after concomitant administration of sodium polystyrene sulfonate and sorbitol solutions (see Interactions).
Respiratory, thoracic and mediastinal disorders
Cases of acute bronchitis and / or bronchopneumonia associated with inhalation of polystyrene sulfonate particles have been described.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Warning: do not use the medicine after the expiry date indicated on the package.
Expiry: see the expiry date indicated on the package. The expiry date refers to the product in intact packaging, correctly stored.
Keep this medicine out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
COMPOSITION
One bottle contains:
Active principle:
sodium polystyrene sulfonate 453.6 g
Excipients:
vanillin, saccharin.
PHARMACEUTICAL FORM AND CONTENT
Powder in 454 g bottle, with 15 g measuring cup.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
KAYEXALATE POWDER FOR ORAL AND RECTAL SUSPENSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One bottle contains
active ingredient: sodium polystyrene sulfonate 453.6 g
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Powder for oral and rectal suspension
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of hyperkalaemia.
04.2 Posology and method of administration
The routes of administration of Kayexalate are oral and rectal; the latter can be used in patients who cannot take the drug by mouth (due to vomiting or problems with the upper gastrointestinal tract, including paralytic ileus) or it can be used at the same time as the oral one to obtain faster initial results. Both routes are used, it is probably not necessary to continue rectal administration by the time the orally administered resin has reached the rectum.
The dosages recommended below are indicative; the precise individual requirements must be determined on the basis of regular clinical and biochemical examinations.
The duration of therapy depends on the severity and resistance of the hyperkalaemia.
The resin suspension must have been prepared shortly before use and must not be kept beyond 24 hours. Heat can alter the exchange properties of the resin (not to exceed 37 ° C).
Adults, including the elderly
Oral way: 15 g (one measuring cup) one to four times a day.
Method of administration
Administer the powder after mixing it (made pulp) or suspended in a small amount of water or, to improve palatability, in water and sugar (not fruit juices, which contain potassium); the limitation of the volume of water is particularly recommended in patients with renal insufficiency: generally 3 or 4 ml of water can be used for each gram of powder.
The suspension can also be introduced into the stomach through a tube or the powder can be taken by mixing it with food.
Rectal route: 30 g of powder suspended in 150-200 ml of water or 10% dextrose (in a retention enema) once or twice a day.
Method of administration
Administration should be preceded by a cleansing enema.
The Kayexalate enema should be held, if possible, for 10-12 hours and then followed by a cleansing enema to remove the drug.
The Kayexalate suspension should be gently shaken during administration.
The Kayexalate suspension should be administered at body temperature, without exceeding 37 ° C because heating can alter the exchange properties of the resin.
The cleansing enema should be performed with a sodium-free solution, also heated to body temperature; two liters of cleansing solution may be required.
Children
Experience with the use of KAYEXALATE in children is limited.
Oral way: as a useful guide for personalizing the treatment, consider that the exchange capacity of sodium polystyrene sulfonate is 1 mEq of potassium per gram of resin.
The initial dosage is 1 g / kg of body weight per day, in divided doses; for maintenance therapy the daily dosage can be reduced to 0.5 g / kg body weight.In younger children proportionately smaller doses should be used.
Method of administration
See adults.
Rectal route: if rejected by mouth, the resin can be administered rectally at a dose equal to at least that which would have been given orally, suspended in a proportionate amount of water and 10% dextrose.
Method of administration
See adults. The utmost caution is recommended: particularly in children and infants, an excessive dosage or inadequate dilution can cause the resin to compact and the consequent intestinal obstruction due to fecaloma.
Babies
Experience with the use of KAYEXALATE in neonates is limited.
Administration should only take place rectally.
The dosage should be the minimum effective dosage between 0.5 g / kg and 1 g / kg.
Method of administration
See adults. The utmost caution is recommended: particularly in children and infants, an excessive dosage or inadequate dilution can cause the resin to compact and the consequent intestinal obstruction due to fecaloma.
04.3 Contraindications
Potassemia
Hypersensitivity to the active substance or to any of the excipients.
Obstructive intestinal pathology.
Sodium polystyrene sulphonate should not be administered orally to neonates and is contraindicated in neonates with impaired intestinal motility (following surgery or drug induced).
04.4 Special warnings and appropriate precautions for use
Therapeutic alternatives in severe hyperkalaemia: As it may take hours or days for effective serum potassium lowering with KAYEXALATE, treatment with this drug alone may not be sufficient to rapidly correct severe hyperkalaemia caused by conditions of rapid tissue destruction, such as in burns and " renal insufficiency In such cases it may be necessary to resort to peritoneal dialysis or hemodialysis.
If the hyperkalaemia is so severe that it constitutes a medical emergency (for example, potassium above 7.5 mEq / liter), immediate treatment with intravenous glucose and insulin or intravenous sodium bicarbonate may be required: these are temporary measures to lower serum potassium while other long-term treatment is prepared to reduce potassium.
Hypokalemia: Since there is the possibility of strong potassium depletion, it is essential to carry out adequate clinical and biochemical checks during treatment, especially in patients receiving digitalis. Therapy should be discontinued as soon as serum potassium levels drop below 5 mEq / L (see sections 4.3 and 4.5). Since intracellular potassium deficiency is not always reflected in serum values, it is recommended not to overlook the early clinical or electrocardiographic signs of hypokalaemia (see section 4.9).
Sorbitol: gastrointestinal stenosis, intestinal ischaemia and its complications (necrosis and perforation) may occur in patients treated with polystyrene sulfonate, especially in those using sorbitol. Therefore, although "insufficient colonic irrigation after treatment cannot be ruled out as a cause, concomitant administration of sorbitol and sodium polystyrene sulphonate is not recommended (see sections 4.5 and 4.8)."
Other electrolyte disturbances: Like any cation exchange resin, KAYEXALATE does not have a totally selective action for potassium, but a small amount of other cations, such as magnesium and calcium, can be bound and therefore lost during treatment. For this reason patients taking KAYEXALATE should be checked for any electrolyte disturbances.
Other risks: If clinically significant constipation occurs, treatment should be discontinued until normal bowel motility is restored. Laxatives containing magnesium or sorbitol should not be used (see sections 4.5 and 4.8).
To ingest the resin the patient must put himself in a correct position to avoid aspiration which can lead to bronchopulmonary complications.
Patients at risk for increased sodium load: since the resin contains sodium (about 100 mg for each gram of powder) particular caution must be exercised when administering the drug to patients who cannot tolerate even small sodium loads (severe congestive heart failure, severe hypertension, kidney damage or the presence of marked edema). In such cases it is therefore essential to carry out adequate clinical and biochemical checks. In such a situation, a compensatory restriction of sodium intake from other sources or the use of lime resin may be useful.
Gastrointestinal lesions: Special attention must be paid during the administration of KAYEXALATE in patients suffering from chronic uremia and both functional and organic lesions of the digestive system.
Intestinal hypomotility in addition to the concomitant administration of acid secretion inhibitors and / or antacids (aluminum hydroxide) often require an increase in resin dosage. These conditions can cause an accumulation of the resin in the gastric cavity with partial passage of this into the duodenum and in very rare cases the formation of bezoars in turn responsible for intestinal sub-occlusion.
Very rare cases of gastrointestinal bezoar have been reported. Cases of formation of "sodium polystyrene sulfonate" "crystals" adhering to the mucosa (with or without lesions) are also described.
In patients at risk (uremic, burned with gastrointestinal lesions and reduced gastrointestinal motility) the conditions of hyperkalaemia could be treated with other therapeutic aids (insulin-glucose or dialysis). However, an endoscopic evaluation (even in urgency) is recommended to evaluate possible mucosal damage (ulcers, erosions) or any bleeding.
Systemic alkalosis: the use of calcium carbonate or aluminum hydroxide can induce alkalosis as the neutralization of protons by antacids in the stomach increases the production of bicarbonates in the duodenal which, in the presence of sodium polystyrene sulfonate, are not buffered, but absorbed, causing a "metabolic alkalosis which, in extreme cases, could trigger convulsive crises.
Children and babies
Do not use sodium polystyrene sulphonate orally in infants. Particular caution should be exercised in rectal administration in both children and infants, as excessive dosage or inadequate dilution can lead to resin packing.
Particular caution should be exercised in premature and underweight infants due to the risk of digestive haemorrhage, colonic necrosis and sodium overload.
04.5 Interactions with other medicinal products and other forms of interaction
Use not recommended:
• Sorbitol: The concomitant use of sorbitol and Kayexalate has been implicated in some cases of intestinal necrosis and other serious gastrointestinal adverse reactions, which can be fatal; the combination of the two drugs is therefore to be avoided (see sections 4.4 and 4.8).
To be used with care:
• Cationic donors: can reduce the effectiveness of the resin in binding potassium.
• Non-absorbable cationic donor antacids and laxatives: Systemic alkalosis has occurred after oral administration of cation exchange resins with non-absorbable cationic donor antacids and laxatives, such as magnesium hydroxide and aluminum carbonate.
• Aluminum hydroxide: intestinal obstruction due to compact masses of aluminum hydroxide has occurred when this is combined with the resin.
• Digital: Increased toxic effects of digitalis on the heart, particularly ventricular arrhythmias and AV nodal dissociations, are likely in cases of hypokalaemia (see section 4.4).
- Lithium: possible decrease in lithium absorption.
• Thyroxine: possible decrease in the absorption of thyroxine.
04.6 Pregnancy and lactation
Sodium polystyrene sulfonate is not absorbed from the gastrointestinal tract. There are no data on the use of polystyrene sulfonate resins during pregnancy and lactation in humans, however, as for any drug, their use in the first trimester of pregnancy is not recommended; in the further period it will be administered only in case of real need under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
Not relevant.
04.8 Undesirable effects
Metabolism and nutrition disorders
Sodium retention, hypokalaemia and hypocalcaemia, with related clinical manifestations, may occur following therapy with KAYEXALATE (see sections 4.4 and 4.9).
Hypomagnesaemia: Cases have been reported
Gastrointestinal disorders
KAYEXALATE can cause some degree of gastric irritation. Anorexia, nausea and vomiting, constipation may also occur. Sometimes diarrhea occurs. Cases of fecal impaction have been reported, particularly in the elderly who received high doses or in children after rectal administration and gastrointestinal (bezoar) concrements after oral administration. Gastrointestinal stenosis and intestinal obstruction have been reported, possibly due to coexisting disease or inadequate dilution of the resin or associated with concomitant administration of aluminum hydroxide.
Two cases of intestinal obstruction caused by the formation of a gastrointestinal bezoar have been reported following administration of sodium polystyrene sulphonate.
Cases of formation of "sodium polystyrene sulfonate" crystals adhering to the gastrointestinal mucosa have also been described.
Gastrointestinal ischaemia, ischemic colitis, ulceration of the gastrointestinal tract or necrosis which can lead to intestinal perforation, sometimes fatal, have been reported.
Most cases have been reported following concomitant administration of sodium polystyrene sulfonate and sorbitol solutions (see section 4.5).
Respiratory, thoracic and mediastinal disorders
Cases of acute bronchitis and / or bronchopneumonia associated with inhalation of polystyrene sulfonate particles have been described.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili".
04.9 Overdose
Biochemical disorders due to overdose can result in clinical symptoms and signs of hypokalaemia, including irritability, confusion, slowing of intellectual abilities, muscle weakness, hyporeflexia and possibly frank paralysis. Apnea can be a serious consequence of this progression. Electrocardiographic changes may occur with hypokalemia; cardiac arrhythmias may occur. Hypocalcemic tetany may also occur. Appropriate measures should be taken to correct serum electrolytes (potassium and calcium) and the resin should be removed from the gastrointestinal tract using laxatives or enemas appropriately.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC code: V03AE01
Kayexalate comes in the form of a very fine golden yellow powder; not absorbable.
When ingested in suspension, the cationic polystyrene, prepared in the sodium phase, exchanges the sodium ion with hydrogen ions in the stomach. The resin thus transformed transits into the intestine, where it gradually exchanges hydrogen ions with potassium ions to be finally eliminated with the faeces. Given the greater concentration of potassium ions in the colon, it is also possible to administer the resin by enema. It is possible to use the capacity. exchange of the resin - KAYEXALATE - also to bind other ammonium - calcium - magnesium ions After administration by enema the exchange is between sodium ions and potassium ions.
The period required for KAYEXALATE to fully carry out its action is approximately 12 hours.
The ability to exchange with potassium is a variable that cannot be predicted.
05.2 Pharmacokinetic properties
Sodium polystyrene sulfonate is a cation exchange resin, prepared in the sodium phase, with an exchange capacity in vitro approximately 3.1 mEq of potassium per gram of resin. The ability to exchange in vivo it is close to 1 mEq of potassium per gram. The sodium content of the resin is approximately 4.1 mEq per gram.
Sodium polystyrene sulfonate is not absorbed from the gastrointestinal tract.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Vanillin, saccharin.
06.2 Incompatibility
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products.
06.3 Period of validity
4 years
06.4 Special precautions for storage
This medicine does not require any special storage conditions
06.5 Nature of the immediate packaging and contents of the package
Bottle of 454 g of powder, with 15 g measuring cup.
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi S.p.A. - Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. n. 021394022
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal 1 June 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of February 2015
