"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Cases of colonic necrosis and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with KAYEXALATE (sodium polystyrene) 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 (see PRECAUTIONS: DRUG INTERACTIONS).
Alternative Therapy in Severe Hyperkalemia
Since effective lowering of serum potassium with KAYEXALATE (sodium polystyrene) 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) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.
Serious potassium deficiency can occur from therapy with KAYEXALATE (sodium polystyrene) . The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with KAYEXALATE (sodium polystyrene) should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient's clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.
Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.
Like all cation-exchange resins, KAYEXALATE (sodium polystyrene) 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. Accordingly, patients receiving KAYEXALATE (sodium polystyrene) should be monitored for all applicable electrolyte disturbances.
Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with KAYEXALATE (sodium polystyrene) . One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given KAYEXALATE (sodium polystyrene) with magnesium hydroxide as laxative. (See PRECAUTIONS: DRUG INTERACTIONS.)
Caution is advised when KAYEXALATE (sodium polystyrene) is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances compensatory restriction of sodium intake from other sources may be indicated.
In the event of clinically significant constipation, treatment with KAYEXALATE (sodium polystyrene) should be discontinued until normal bowel motion is resumed. Magnesium-containing laxatives or sorbitol should not be used (see PRECAUTIONS: DRUG INTERACTIONS).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed.
Pregnancy Category C
Animal reproduction studies have not been conducted with KAYEXALATE (sodium polystyrene) . It is also not known whether KAYEXALATE (sodium polystyrene) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. KAYEXALATE (sodium polystyrene) should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when KAYEXALATE (sodium polystyrene) is administered to a nursing woman.
The effectiveness of KAYEXALATE (sodium polystyrene) in pediatric patients has not been established. In neonates, KAYEXALATE (sodium polystyrene) should not be given by the oral route. In both children and neonates particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin.
Due to the risk of digestive hemorrhage or colonic necrosis, particular care should be observed in premature infants or low birth weight infants.
Last reviewed on RxList: 2/28/2011
This monograph has been modified to include the generic and brand name in many instances.
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