Label: KIONEX- sodium polystyrene sulfonate suspension

  • NDC Code(s): 62559-356-01, 62559-356-60
  • Packager: ANI Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 3, 2024

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  • Cation-Exchange ResinRx only

  • DESCRIPTION

    Kionex® (Sodium Polystyrene Sulfonate Suspension USP) can be administered orally or in an enema. It is a raspberry flavored suspension containing 15 grams of cation-exchange resin (sodium polystyrene sulfonate USP) and 21.5 mL of sorbitol solution (equivalent to approximately 19.3 grams of sorbitol) per 60 mL of suspension. Also contains purified water, propylene glycol, xanthan gum, sodium saccharin, methylparaben, propylparaben, and flavor.

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

    Structure

    The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an in-vitro exchange capacity of approximately 3.1 mEq (in-vivo approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.

  • CLINICAL PHARMACOLOGY

    As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33%, but the range is so large that definitive indices of electrolyte balance must be clearly monitored.

    Metabolic data are unavailable.

  • INDICATIONS AND USAGE

    Kionex Suspension is indicated for the treatment of hyperkalemia.

  • CONTRAINDICATIONS

    Kionex Suspension is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, oral or rectal administration in neonates (see PRECAUTIONS).

  • WARNINGS

    Intestinal Necrosis

    Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with sodium polystyrene sulfonate 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 additional sorbitol is not recommended (see PRECAUTIONS, Drug Interactions).

    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.

    Alternative Therapy in Severe Hyperkalemia

    Since the effective lowering of serum potassium with 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) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

    Hypokalemia

    Serious potassium deficiency can occur from sodium polystyrene sulfonate therapy. 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 sodium polystyrene sulfonate 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.

    Electrolyte 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. Accordingly, patients receiving sodium polystyrene sulfonate should be monitored for all applicable electrolyte disturbances.

    Systemic Alkalosis

    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 sodium polystyrene sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative (see PRECAUTIONS, Drug Interactions).

    Risk of Aspiration

    Cases of acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles has been reported. Patients with impaired gag reflex, altered level of consciousness, or patients prone to regurgitation may be at increased risk. Administer Kionex Suspension with the patient in an upright position.

    Binding to Other Orally Administered Medications

    Kionex Suspension 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 Kionex Suspension. Patients with gastroparesis may require a 6 hour separation (see DOSAGE AND ADMINISTRATION and PRECAUTIONS, Drug Interactions).

  • PRECAUTIONS

    Caution is advised when sodium polystyrene sulfonate 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.

    Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

    In the event of clinically significant constipation, treatment with Kionex Suspension should be discontinued until normal bowel motion is resumed. (see WARNINGS, Intestinal Necrosis).

    Drug Interactions

    General Interactions

    No formal drug interaction studies have been conducted in humans.

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

    Antacids

    The simultaneous oral administration of sodium polystyrene sulfonate with nonabsorbable cation-donating antacids and laxatives may reduce the resin’s potassium exchange capability.

    Nonabsorbable cation-donating antacids and laxatives

    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 sodium polystyrene sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative.

    Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate has been reported.

    Digitalis

    The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even if the face of serum digoxin concentrations in the “normal range” (see WARNINGS).

    Sorbitol

    Concomitant use of sorbitol with sodium polystyrene sulfonate has been implicated in cases of intestinal necrosis, which may be fatal. (See WARNINGS).

    Lithium

    Kionex Suspension may decrease absorption of lithium.

    Thyroxine

    Kionex Suspension may decrease absorption of thyroxine.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies have not been performed.

    Pregnancy

    Animal reproduction studies have not been conducted with sodium polystyrene sulfonate. It is also not known whether sodium polystyrene sulfonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium polystyrene sulfonate should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    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 sodium polystyrene sulfonate is administered to a nursing woman.

    Pediatric Use

    The effectiveness of Kionex Suspension in pediatric patients has not been established. The use of Kionex Suspension is contraindicated in neonates and especially in premature infants. In children and neonates, particular care should be observed with rectal administration, as excessive dosage could result in impaction of the resin. Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

  • ADVERSE REACTIONS

    Kionex Suspension may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, hypomagnesemia and significant sodium retention, and their related clinical manifestations, may occur (see WARNINGS). Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (see PRECAUTIONS). Rare instances of intestinal necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, has been reported.

    The following events have been reported from worldwide post marketing experience:

    Fecal impaction following rectal administration, particularly in children;
    Gastrointestinal concretions (bezoars) following oral administration;
    Ischemic colitis, gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and
    Rare cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of polystyrene sulfonate (see WARNINGS).

    To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • OVERDOSAGE

    Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea. Tetany may occur. Electrocardiographic changes may be consistent with hypokalemia or hypocalcemia; cardiac arrhythmias may occur. 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.

  • DOSAGE AND ADMINISTRATION

    Administer Kionex Suspension at least 3 hours before or 3 hours after other oral medications. Patients with gastroparesis may require a 6 hour separation (see WARNINGS and PRECAUTIONS, Drug Interactions).

    The average daily adult dose is 15 g (60 mL) to 60 g (240 mL) of suspension. This is best provided by administering 15 g (60 mL) of Kionex Suspension one to four times daily. Each 60 mL of Kionex Suspension contains 1500 mg (65 mEq) of sodium. Since the in-vivo efficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resin’s actual sodium content is being delivered to the body.

    In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation. Administer with patient in an upright position (see WARNINGS).

    Kionex Suspension may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure.

    Kionex Suspension may also be given, although with less effective results, as an enema consisting (for adults) of 30 g (120 mL) to 50 g (200 mL) every six hours. The enema should be retained as long as possible and followed by a cleansing enema.

    After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped into place. The suspension is introduced at body temperature by gravity. The suspension is flushed with 50 or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. The suspension is kept in the sigmoid colon for several hours, if possible. Then the colon is irrigated with a sodium-free cleansing enema at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. Particular attention should be paid to this cleansing enema, because sorbitol is present in the vehicle.

    The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia. Kionex Suspension should not be heated for to do so may alter the exchange properties of the resin.

  • HOW SUPPLIED

    Kionex® Suspension is a light brown, raspberry-flavored suspension supplied as follows:
          NDC 62559-356-01: Case containing 10 unit dose bottles of 60 mL (NDC 62559-356-60)

    Dispense in a tight container, as defined in the USP. If repackaging into other containers, store in refrigerator and use within 14 days of packaging.

    SHAKE WELL UNTIL FULLY SUSPENDED BEFORE USING.

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

    Distributed by:
    ANI Pharmaceuticals, Inc.
    Baudette, MN 56623

    Logo
    Issued: 04/2024
    LB4701-00

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC 62559-356-60
    KIONEX®
    (Sodium Polystyrene Sulfonate Suspension USP), 15g/60mL
    For Oral or Rectal Use
    Shake Well Until Fully Suspended
    Rx only
    60 mL

    60mL_label
  • INGREDIENTS AND APPEARANCE
    KIONEX 
    sodium polystyrene sulfonate suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62559-356
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z) (POLYSTYRENE SULFONIC ACID - UNII:70KO0R01RY) SODIUM POLYSTYRENE SULFONATE15 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBROWN (light) Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62559-356-0110 in 1 CASE05/03/2024
    1NDC:62559-356-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04002805/03/2024
    Labeler - ANI Pharmaceuticals, Inc. (145588013)