Kayexalate (Sodium Polystyrene): Side Effects, Uses, Dosage, Interactions, Warnings (2024)

Description for Kayexalate

KAYEXALATE is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:

The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq (in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or rectally as an enema.

One gram of KAYEXALATE contains 4.1 mEq of sodium.

Uses for Kayexalate

KAYEXALATE is indicated for thetreatment of hyperkalemia.

Limitation Of Use

KAYEXALATE should not be usedas an emergency treatment for life-threatening hyperkalemia because of itsdelayed onset of action [see CLINICAL PHARMACOLOGY].

Dosage for Kayexalate

General Information

Administer KAYEXALATE at least 3 hours before or 3 hoursafter other oral medications. Patients with gastroparesis may require a 6 hourseparation [see WARNINGS AND PRECAUTIONS and DRUG INTERACTION]

Recommended Dosage

The intensity and duration of therapy depend upon theseverity and resistance of hyperkalemia.

Oral

The average total daily adult dose of KAYEXALATE is 15 gto 60 g, administered as a 15-g dose (four level teaspoons), one to four timesdaily.

Rectal

The average adult dose is 30 g to 50 g every six hours.

Preparation And Administration

Prepare suspension fresh and use within 24 hours.

Do not heat KAYEXALATE as it could alter the exchangeproperties of the resin.

One level teaspoon contains approximately 3.5 g ofKAYEXALATE 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. Administer with patient inan upright position [see WARNINGS AND PRECAUTIONS].

Enema

After an initial cleansing enema, insert a soft, largesize (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 100mL of aqueous vehicle and flush with 50 to 100 ml of fluid. A somewhat thickersuspension may be used, but do not form a paste.

Agitate the emulsion gently during administration. Theresin should be retained for as long as possible and follow by a cleansingenema with a nonsodium containing solution. Ensure an adequate volume ofcleansing solution (up to 2 liters) is utilized.

HOW SUPPLIED

Dosage Forms And Strengths

KAYEXALATE is a cream to light brown, finely groundpowder and is available in 453.6 g jars.

Storage And Handling

KAYEXALATE is available as a cream to light brown, finelyground powder in jars of 1 pound (453.6 g), NDC 59212-075-01.

Store at 25° C (77° F); excursions permitted to 15° – 30°C (59° – 86° F) [see USP Controlled Room Temperature]

Manufactured for: Concordia Pharmaceutical Inc. St.Michael, Barbados BB11005. Revised Jul 2017

Side Effects for Kayexalate

The following adverse reactions are discussed elsewherein the labeling:

• Intestinal Necrosis [see WARNINGS AND PRECAUTIONS]
• Electrolyte Disturbances [see WARNINGS AND PRECAUTIONS]
• Aspiration [see WARNINGS AND PRECAUTIONS]

The following adverse reactions have been identifiedduring post-approval use of KAYEXALATE. Because these reactions are reportedvoluntarily from a population of uncertain size, it is not always possible toestimate their frequency reliably or establish a causal relationship to drugexposure.

Gastrointestinal: anorexia, constipation, diarrhea, fecal impaction,gastrointestinal concretions (bezoars), ischemic colitis, nausea, ulcerations,vomiting, gastric irritation, intestinal obstruction (due to concentration ofaluminium hydroxide)

Metabolic: systemic alkalosis

Drug Interactions for Kayexalate

General Interactions

No formal drug interaction studies have been conducted inhumans.

KAYEXALATE has the potential to bind other drugs. In invitro binding studies, KAYEXALATE was shown to significantly bind the oralmedications (n=6) that were tested. Decreased absorption of lithium andthyroxine have also been reported with co-administration of KAYEXALATE. Bindingof KAYEXALATE to other oral medications could cause decreased gastrointestinalabsorption and loss of efficacy when taken close to the time KAYEXALATE is administered.Administer KAYEXALATE at least 3 hours before or 3 hours after other oralmedications. Patients with gastroparesis may require a 6 hour separation.Monitor for clinical response and/or blood levels where possible.

Cation-Donating Antacids

The simultaneous oral administration of KAYEXALATE withnonabsorbable cation-donating antacids and laxatives may reduce the resin'spotassium exchange capability and increase the risk of systemic alkalosis.

Sorbitol

Sorbitol may contribute to the risk of intestinalnecrosis [see WARNINGS AND PRECAUTIONS] and concomitant use is notrecommended.

Warnings for Kayexalate

Included as part of the PRECAUTIONS section.

Precautions for Kayexalate

Intestinal Necrosis

Cases of intestinal necrosis, some fatal, and otherserious gastrointestinal adverse events (bleeding, ischemic colitis,perforation) have been reported in association with KAYEXALATE use. Themajority of these cases reported the concomitant use of sorbitol. Risk factorsfor gastrointestinal adverse events were present in many of the cases includingprematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiencyand 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.

Electrolyte Disturbances

Monitor serum potassium during therapy because severehypokalemia may occur.

KAYEXALATE is not totally selective for potassium, andsmall amounts of other cations such as magnesium and calcium can also be lostduring treatment. Monitor calcium and magnesium in patients receivingKAYEXALATE.

Fluid Overload In Patients Sensitive To High Sodium Intake

Each 15 g dose of KAYEXALATE contains 1500 mg (60 mEq) ofsodium. Monitor patients who are sensitive to sodium intake (heart failure,hypertension, edema) for signs of fluid overload. Adjustment of other sourcesof sodium may be required.

Risk Of Aspiration

Cases of acute bronchitis or bronchopneumonia caused byinhalation of sodium polystyrene sulfonate particles have been reported.Patients with impaired gag reflex, altered level of consciousness, or patientsprone to regurgitation may be at increased risk. Administer KAYEXALATE with thepatient in an upright position.

Binding To Other Orally Administered Medications

KAYEXALATE may bind orally administered medications,which could decrease their gastrointestinal absorption and lead to reducedefficacy. Administer other oral medications at least 3 hours before or 3 hoursafter KAYEXALATE. Patients with gastroparesis may require a 6 hour separation. [seeDOSAGE AND ADMINISTRATION and DRUG INTERACTIONS].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies have not been performed.

Use In Specific Populations

Pregnancy

Risk Summary

KAYEXALATE is not absorbed systemically following oral orrectal administration and maternal use is not expected to result in fetal risk.

Lactation

Risk Summary

KAYEXALATE is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant.

Pediatric Use

Studies of safety and efficacy have not been conducted inpediatric patients.

In pediatric patients, as in adults, KAYEXALATE isexpected to bind potassium at the practical exchange ratio of 1mEq potassiumper 1 gram of resin.

In neonates, KAYEXALATE should not be given by the oralroute. In both children and neonates, excessive dosage or inadequate dilutioncould result in impaction of the resin. Premature infants or low birth weightinfants may have an increased risk for gastrointestinal adverse effects withKAYEXALATE. use [see WARNINGS AND PRECAUTIONS].

Overdose Information for Kayexalate

Overdosage may result in electrolyte disturbancesincluding hypokalemia, hypocalcemia, and hypomagnesemia. Appropriate measuresshould be taken to correct serum electrolytes (potassium, calcium, magnesium),and the resin should be removed from the alimentary tract by appropriate use oflaxatives or enemas.

Contraindications for Kayexalate

KAYEXALATE is contraindicated in patients with thefollowing conditions:

• Hypersensitivity to polystyrene sulfonate resins
• Obstructive bowel disease
• Neonates with reduced gut motility

Clinical Pharmacology for Kayexalate

Mechanism Of Action

KAYEXALATE is a non-absorbed,cation exchange polymer that contains a sodium counterion.

KAYEXALATE increases fecalpotassium excretion through binding of potassium in the lumen of thegastrointestinal tract. Binding of potassium reduces the concentration of freepotassium in the gastrointestinal lumen, resulting in a reduction of serumpotassium levels. The practical exchange ratio is 1 mEq K per 1 gram of resin.

As the resin passes along theintestine or is retained in the colon after administration by enema, the sodiumions are partially released and are replaced by potassium ions. This actionoccurs primarily in the large intestine, which excretes potassium ions to agreater degree than does the small intestine. The efficiency of this process islimited and unpredictably variable.

Pharmacodynamics

The effective lowering of serumpotassium with KAYEXALATE may take hours to days.

Pharmaco*kinetics

The in vivo efficiency ofsodium-potassium exchange resins is approximately 33 percent; hence, about onethird of the resin's actual sodium content is delivered to the body.

KAYEXALATE is not absorbed systemically.

Drug Interactions

In vitro binding studies showed that KAYEXALATE boundsignificantly to the following tested drugs – warfarin, metoprolol, phenytoin,furosemide, amlodipine and amoxicillin.

Patient Information for Kayexalate

Drug Interactions

Advise patients who are taking other oral medication toseparate the dosing of KAYEXALATE by at least 3 hours (before or after) [see DOSAGEAND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and DRUGINTERACTIONS]