Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium, magnesium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.
KAYEXALATE is contraindicated in patients with the following conditions:
The following adverse reactions are discussed elsewhere in the labeling:
The following adverse reactions have been identified during post-approval use of KAYEXALATE. 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
KAYEXALATE is indicated for the treatment of hyperkalemia.
Limitation Of UseKAYEXALATE should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
The effective lowering of serum potassium with KAYEXALATE may take hours to days.
The in vivo efficiency of sodium-potassium exchange resins is approximately 33 percent; hence, about one third of the resin's actual sodium content is delivered to the body.
KAYEXALATE is not absorbed systemically.
KAYEXALATE is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk.
KAYEXALATE is a cream to light brown, finely ground powder and is available in 453.6 g jars.
Storage And HandlingKAYEXALATE is available as a cream to light brown, finely ground 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)
Manufactured for: Concordia Pharmaceutical Inc. St. Michael, Barbados BB11005. Revised Jul 2017
Included as part of the PRECAUTIONS section.
PRECAUTIONS Intestinal NecrosisCases of intestinal necrosis, some fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with KAYEXALATE 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.
Monitor serum potassium during therapy because severe hypokalemia may occur.
KAYEXALATE 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 KAYEXALATE.
Fluid Overload In Patients Sensitive To High Sodium IntakeEach 15 g dose of KAYEXALATE 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.
Risk Of AspirationCases 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 KAYEXALATE with the patient in an upright position.
Binding To Other Orally Administered MedicationsKAYEXALATE 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 KAYEXALATE. Patients with gastroparesis may require a 6 hour separation..
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of FertilityStudies have not been performed.
Use In Specific Populations Pregnancy Risk SummaryKAYEXALATE is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk.
Lactation Risk SummaryKAYEXALATE is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant.
Pediatric UseStudies of safety and efficacy have not been conducted in pediatric patients.
In pediatric patients, as in adults, KAYEXALATE is expected to bind potassium at the practical exchange ratio of 1mEq potassium per 1 gram of resin.
In neonates, KAYEXALATE should not be given by the oral route. In both children and neonates, excessive dosage or inadequate dilution could result in impaction of the resin. Premature infants or low birth weight infants may have an increased risk for gastrointestinal adverse effects with KAYEXALATE. use.
Administer KAYEXALATE at least 3 hours before or 3 hours after other oral medications. Patients with gastroparesis may require a 6 hour separation
Recommended DosageThe intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.
OralThe average total daily adult dose of KAYEXALATE is 15 g to 60 g, administered as a 15-g dose (four level teaspoons), one to four times daily.
RectalThe average adult dose is 30 g to 50 g every six hours.
Preparation And AdministrationPrepare suspension fresh and use within 24 hours.
Do not heat KAYEXALATE as it could alter the exchange properties of the resin.
One level teaspoon contains approximately 3.5 g of KAYEXALATE and 15 mEq of sodium.
Oral SuspensionSuspend each dose in a small quantity of water or syrup, approximately 3 to 4 mL of liquid per gram of resin. Administer with patient in an upright position.
EnemaAfter 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.
In vitro binding studies showed that KAYEXALATE bound significantly to the following tested drugs – warfarin, metoprolol, phenytoin, furosemide, amlodipine and amoxicillin.
Medication Guide PATIENT INFORMATION
