DailyMed Label: Kionex

DailyMed Label: Kionex

2024

DailyMed Prescription

Kionex

Sodium Polystyrene Sulfonate

ANI Pharmaceuticals, Inc.

NDC: 62559-356

NDC: 62559-356

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: 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. Structure

Kionex Suspension is indicated for the treatment of hyperkalemia.

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.

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 ).

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 ). 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. Studies have not been performed. 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. 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. 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.

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

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 Issued: 04/2024 LB4701-00 Logo

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.

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